Company · US
Applied Medical Resources Corp
FDA 510(k) clearances and medical device recalls filed under this name, 1992 to 2026. Name variants (Inc, Corp, punctuation) are merged.
115510(k) clearances (2 in 12 months)
75recalls (1 in 12 months)
42recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 61 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 23 |
| FAD | Stent, Ureteral | 11 |
| HET | Laparoscope, Gynecologic (And Accessories) | 11 |
| DXE | Catheter, Embolectomy | 8 |
| KGW | Ring (Wound Protector), Drape Retention, Internal | 7 |
| DSS | Clip, Vascular | 5 |
| DXC | Clamp, Vascular | 5 |
| FER | Anoscope And Accessories | 5 |
| FZP | Clip, Implantable | 5 |
| NWV | Laparoscopic Accessories, Gynecologic | 5 |
| EYB | Catheter, Ureteral, Gastro-Urology | 4 |
| MCH | Clip, Hemostatic | 4 |
| DYB | Introducer, Catheter | 3 |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | 3 |
| GBZ | Catheter, Cholangiography | 3 |
| HEW | Culdoscope (And Accessories) | 3 |
| LYK | Angioscope | 3 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 2 |
| KKX | Drape, Surgical, Antimicrobial | 2 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 24, 2026 | K260982 | Alexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis lighted wound protector-retractor, flexib Applied Medical Resources Corporation | KGW |
| Feb 23, 2026 | K253531 | Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, M Applied Medical Resources Corporation | KGW |
| Nov 4, 2025 | K252740 | Voyant® Open Fusion Device (EB240/Open Fusion) Applied Medical Resources Corp. | GEI |
| Oct 31, 2025 | K252442 | Kii Structural Balloon Access System Applied Medical Resources Corp. | GCJ |
| Oct 31, 2025 | K252412 | Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator) Applied Medical Resources Corporation | GEI |
| Oct 2, 2025 | K243152 | GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device Applied Medical Resources Corp. | HEW |
| Nov 1, 2023 | K232880 | Inzii Ripstop Redeployable Retrieval System Applied Medical Resources Corporation | GCJ |
| Oct 14, 2022 | K222284 | Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214) Applied Medical Resources Corporation | GEI |
| Sep 16, 2022 | K220969 | GelPOINT V-Path Vaginal Access System Applied Medical Resources Corporation | MOK |
| Mar 31, 2022 | K211043 | Alexis Contained Extraction System Applied Medical Resources Corporation | GCJ |
| Sep 7, 2021 | K202049 | Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter Applied Medical Resources Corporation | DXE |
| Jan 6, 2021 | K200021 | Applied Medical Anoscope Applied Medical Resources | FER |
| Jun 5, 2020 | K201212 | Voyant Open Fusion Device Applied Medical Resources Corp. | GEI |
| Apr 8, 2020 | K200598 | Voyant Maryland Fusion Device Applied Medical Resources Corp. | GEI |
| Dec 20, 2019 | K193292 | Voyant 5mm Fusion Device, Voyant Maryland Fusion Device Applied Medical Resources Corp. | GEI |
| Nov 22, 2019 | K190331 | Applied Medical Laparoscopic Linear Cutter Applied Medical Resources Corporation | GDW |
| Sep 6, 2019 | K191294 | Transvaginal Access Platform Applied Medical Resources Corp. | HEW |
| Nov 14, 2018 | K182653 | Voyant Maryland Fusion Device Applied Medical Resources Corp. | GEI |
| Oct 11, 2018 | K182244 | Voyant Electrosurgical Generator Applied Medical Resources Corp. | GEI |
| Aug 30, 2018 | K182024 | Dissecting Balloon System Applied Medical Resources Corp. | GCJ |
| Apr 13, 2018 | K180699 | Voyant Open Fusion Device Applied Medical Resources Corporation | GEI |
| Feb 13, 2018 | K172624 | Voyant 5mm Fusion Device Applied Medical Resources Corporation | GEI |
| Aug 7, 2017 | K171684 | Epix Electrosurgical Probe with Smoke Evacuation Applied Medical Resources Corporation | GEI |
| Jul 20, 2017 | K171701 | GelPOINT Path Transanal Access Platform Applied Medical Resources Corp. | FER |
| Dec 1, 2016 | K162676 | Voyant Open Fusion Device Applied Medical Resources | GEI |
| Jul 6, 2016 | K153017 | Voyant Fine Fusion Applied Medical Resources | GEI |
| Jun 1, 2016 | K153288 | Voyant Open Fusion Device Applied Medical Resources | GEI |
| Feb 19, 2016 | K151480 | Epix Electrosurgical Probe with Smoke Evacuation Applied Medical Resources | GEI |
| Oct 13, 2015 | K143308 | GelPOINT Transvaginal Access Platform Applied Medical Resources | HEW |
| Apr 16, 2015 | K143536 | Voyant Fine Fusion Device Applied Medical Resources | GEI |
| Mar 27, 2015 | K143517 | Voyant Open Sealer-Divider Device Applied Medical Resources | GEI |
| Dec 23, 2014 | K142427 | TISSUE CONTAINMENT SYSTEM; 10, 14, 17, 25 Applied Medical Resources | GCJ |
| Aug 22, 2014 | K141288 | VOYANT ELECTROSURGICAL GENERATOR, VOYANT 5MM LAPAROSCOPIC SEALER-DIVIDER DEVICE Applied Medical Resources | GEI |
| Jan 24, 2014 | K132300 | EPIX ELECTROSURGICAL PROBE SPATULA TIP, EPIX ELECTROSURGICAL PROBE L-HOOK TIP, EPIX ELECTROSURGICAL PROBE J-HOOK TIP, RE Applied Medical Resources Corp. | GEI |
| Jan 2, 2014 | K133393 | GELPOINT PATH TRANSANAL ACCESS PLATFORM Applied Medical Resources Corp. | FER |
| Feb 8, 2013 | K113268 | ALEXIS O WOUND PROTECTOR/RETRACTOR Applied Medical Resources Corp. | KGW |
| May 23, 2011 | K110792 | GELPOINT PATH Applied Medical Resources Corp. | FER |
| Nov 16, 2010 | K103282 | LAPAROSCOPIC DISSECTOR Applied Medical Resources Corp. | GEI |
| Apr 22, 2010 | K100959 | SPECIMEN RETRIEVAL SYSTEM Applied Medical Resources | GCJ |
| Apr 2, 2010 | K100120 | ALEXIS ORTHOPAEDIC WOUND RETRACTOR Applied Medical Resources Corp. | KGW |
| Nov 5, 2009 | K093296 | ALEXIS LAPAROSCOPIC SYSTEM Applied Medical Resources Corp. | KGW |
| Feb 18, 2009 | K090275 | GELPORT SINGLE INCISION ACCESS SYSTEM Applied Medical Resources Corp. | GCJ |
| Dec 23, 2008 | K083638 | FIXATION TROCARS Applied Medical Resources Corp. | GCJ |
| Oct 5, 2007 | K072674 | KII TROCAR SYSTEM Applied Medical Resources Corp. | GCJ |
| Sep 12, 2007 | K063658 | INTRAVASCULAR INTRODUCER SYSTEM Applied Medical Resources Corp. | DYB |
| Jan 9, 2007 | K062907 | ALEXIS WOUND RETRACTOR Applied Medical Resources | KGW |
| Aug 24, 2006 | K062169 | APPLIED LAPAROSCOPIC DISPOSABLE MONOPOLAR SCISSORS Applied Medical Resources Corp. | HET |
| Apr 7, 2006 | K060629 | GELPORT BLUNT TIP TROCAR SYSTEM Applied Medical Resources Corp. | GCJ |
| Mar 29, 2006 | K060673 | PEDIATRIC URETERAL STENT Applied Medical Resources Corp. | FAD |
| Mar 13, 2006 | K060534 | INTUITIVE SURGICAL SEAL Applied Medical Resources Corp. | GCJ |
Newest 50 of 115.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 2, 2026 | Applied Medical Resources Corp Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm
REF: CTB23 Open, Classified |
GCJ | K060096 |
| Mar 27, 2024 | Applied Medical Resources Corp Epix Universal Clip Applier, REF: CA500, STERILEEO included within the following kit Reference Numbers:
GK1003, AME Kit 54562
GK1004, KIT LAP CHOL DEN HOED 2,
GK1005, K2550 - HPATECTOMIE ERASME,
GK101 Open, Classified |
MDM | None listed |
| Mar 27, 2024 | Applied Medical Resources Corp Epix Universal Clip Applier, REF: CA500, STERILEEO Open, Classified |
MDM | None listed |
| May 7, 2020 | Applied Medical Resources Corp Applied Medical Dual Lumen Graft Cleaning Catheter & 1cc SYRINGE Nonpyrogenic, REF: A4GW6, 5F X 60cm, 9mm, Sterile EO, CE, UDI: (01)00607915111175 Terminated |
DXE | K973465 |
| May 7, 2020 | Applied Medical Resources Corp Bard Embolectomy Catheter & 1 ml SYRINGE, REF numbers/UDI:
CE0340DR/(01)H699CE0340DR10R;
CE0380DR/(01)H699CE0380DR10V;
CE0440DR/(01)H699CE0440DR10S;
CE0480DR/(01)H699CE0480DR10W;
CE0540DR/(01)H69 Terminated |
DXE | K970762 |
| May 7, 2020 | Applied Medical Resources Corp Python Embolectomy Catheters, Sterile EO, CE, Ref numbers/UDI:
A4E01/(01)00607915113407;
A4E02/(01)00607915113414;
A4E03/(01)00607915113421;
A4E04/(01)00607915113438;
A4E05/(01)00607915113445;
A4 Terminated |
DXE | K970762 |
| Mar 17, 2020 | Applied Medical Resources Corp Clip Applier Kit, REF: K2887, UDI: (01)30607915139132(17)220822(30)1(10) Terminated |
NWV | None listed |
| Mar 17, 2020 | Applied Medical Resources Corp DR. THAMES - LAP CHOLE, REF: K0880, UDI: (01)30607915139620 Terminated |
NWV | None listed |
| Mar 17, 2020 | Applied Medical Resources Corp Epix latis GRASPER, 5mm x 45 cm, REF: C4140, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110154 Terminated |
NWV | None listed |
| Mar 17, 2020 | Applied Medical Resources Corp Epix latis GRASPER, 5 mm x 35 cm, REF C4130, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110147 Terminated |
NWV | None listed |
| Jan 31, 2020 | Applied Medical Resources Corp STEALTH SPRING CLIP 6mm latis (1/4 Force). Non-Sterile, REF/UDI::A1702/(01)10607915110649 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and Terminated |
DSS | K883909 |
| Jan 31, 2020 | Applied Medical Resources Corp STEALTH SPRING CLIP 6mm latis (3/4 Force). REF/UDI::A1603/(01)00607915110581 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surg Terminated |
DSS | K883909 |
| Jan 31, 2020 | Applied Medical Resources Corp STEALTH SPRING CLIP 6mm latis (1/4 Force). REF/UDI::A1602/(01)00607915110574 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surg Terminated |
DSS | K883909 |
| Jan 31, 2020 | Applied Medical Resources Corp STEALTH SPRING CLIP 6mm latis (1/2 Force). REF/UDI::A1601/(01)00607915110567 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surg Terminated |
DSS | K883909 |
| Jan 28, 2019 | Applied Medical Resources Corp Kii Fios First Entry, 5 X 75 mm, RX only, REF CFF05 Qty: 6, Sterile R, Lot: 1330981, Exp: July 15, 2021, Applied Medical Resource Corp.
Product Usage:
Kii Fios first entry is indicated for use in g Terminated |
GCJ | K041795 K083638 |
| Dec 12, 2018 | Applied Medical Resources Corp GelPOINT Path Transanal Procedural Pack with Epix Electrosurgical L-Hook with Smoke Evacuation, 4x5.5cm and 5mm x 42cm
REF TA211
Product Usage: The GelPOINT Path Transanal Access Platform is indicat Terminated |
FER | K171701 |
| Dec 12, 2018 | Applied Medical Resources Corp Epix Electrosurgical Probes with Smoke Evacuation, Angled L-Hook Tip, 5mm x 42 cm
REF CW002 QTY: 1 - Product Usage:
The Epix Electrosurgical Probe with Smoke Evacuation is intended to deliver energy Terminated |
GEI | K171684 |
| Jun 14, 2017 | Applied Medical Resources Corp Kii Shielded Bladed trocars (CTB14), Kii Low profile trocars (CTB23), and
Kii 5x55mm Optical Z-Thread Dual Pack (CTR14) trocars. Terminated |
GCJ | K060096 K072674 |
| May 6, 2016 | Applied Medical Resources Corp Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.
Distributed individually and in kits. Terminated |
FZP | K011236 |
| Apr 5, 2016 | Applied Medical Resources Corp STD KIT GK260, Standard Set 360 Z
Product Usage:
The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedu Terminated |
MCH | None listed |
| Apr 5, 2016 | Applied Medical Resources Corp STD KIT GK213, AME Standard Kit 15
Product Usage:
The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical proced Terminated |
MCH | None listed |
| Apr 5, 2016 | Applied Medical Resources Corp STD GK258, AME Standard Kit 44
Product Usage:
The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures Terminated |
MCH | None listed |
| Apr 5, 2016 | Applied Medical Resources Corp CA500 Epix Universal Clip Applier
Product Usage:
The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedu Terminated |
MCH | None listed |
| Sep 15, 2015 | Applied Medical Resources Corp Voyant Open Fusion Device
Models: EB040 and EB040+
Product Usage: The Applied Voyant Open Fusion Device is designed for use with the Voyant Electrosurgical Generator. The device is an advanced bipol Terminated |
GEI | K143517 |
| Jan 24, 2014 | Applied Medical Resources Corp Applied Medical's Inzii 12/15mm Retrieval System.
Applieds Inzii Tissue Retrieval Bag, Model Number CD004, is classified as a Class II device. It was cleared to market via 510(k) filing K060051. The Terminated |
GCJ | K060051 |
| Jun 7, 2013 | Applied Medical Resources Corp Applied Medicals Epix and Direct Drive Laparoscopic Graspers, Model Numbers C4130 and C4140.
Used for grasping and manipulating tissue during general or laparoscopic surgery. Terminated |
NWV | None listed |
| Jan 7, 2013 | Applied Medical Resources Corp Laparoscope, general; plastic surgery
Used for general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue plan Terminated |
CGJ | K072674 |
| Sep 25, 2012 | Applied Medical Resources Corp Irrigation Catheters (Models IRR-XXX-XX):
Model Numbers & Description:
IRR-023-10F,CATHETER IRRIGATION 10F 23CM;
IRR-080-4F, CATHETER, IRRIGATION 4F 80CM;
IRR-080-6F, CATHETER, IRRIGATION 6F 80CM.
I Terminated |
DQY | K902256 |
| Sep 25, 2012 | Applied Medical Resources Corp Biliary Catheters (Models A47XX and CB0XXXXX):
Model Numbers & Description:
A4752, SYNTEL BILIARY 5F-23CM CATHETER;
A4754, SYNTEL BILIARY 5F-40CM CATHETER;
A4762, SYNTEL BILIARY 6F-23CM CATHETER;
CB0 Terminated |
FGE | K910006 |
| Sep 25, 2012 | Applied Medical Resources Corp Embolectomy Catheters (Models A44XX, A4FXX, CE0XXXST, and CE0XXX):
Model Numbers & Description:
A4402, 3F-40CM, SYNTEL RT-EMB;
A4403, 3F-80CM, SYNTEL RT-EMB;
A4404, 4F-40CM, SYNTEL RT-EMB;
A4405, 4F- Terminated |
DXE | K901627 |
| Aug 24, 2011 | Applied Medical Resources Corp Applied Medical 15x100 mm Kii Optical Access Systems, Non-Threaded 6/Box, Model C0R39
Product Usage: Applied Medical's C0R36, C0R37, C0R38, and C0R39 trocars are diposable single-use devices indica Terminated |
GCJ | K060096 |
| Aug 24, 2011 | Applied Medical Resources Corp Applied Medical 15x100 mm Kii Optical Access Systems, Non-Threaded 6/Box, Model C0R38
Product Usage: Applied Medical's C0R36, C0R37, C0R38, and C0R39 trocars are diposable single-use devices indica Terminated |
GCJ | K060096 |
| Aug 24, 2011 | Applied Medical Resources Corp Applied Medical 15x100 mm Kii Optical Access Systems, Non-Threaded 6/Box, Model C0R37
Product Usage: Applied Medical's C0R36, C0R37, C0R38, and C0R39 trocars are diposable single-use devices indica Terminated |
GCJ | K060096 |
| Aug 24, 2011 | Applied Medical Resources Corp Applied Medical 15x100 mm Kii Optical Access Systems, Non-Threaded 6/Box, Model C0R36
Product Usage: Applied Medical's C0R36, C0R37, C0R38, and C0R39 trocars are diposable single-use devices indica Terminated |
GCJ | K060096 |
| Aug 11, 2011 | Applied Medical Resources Corp Surgical Clamp Inserts, Model#G-8655, 86MM Insert Fibra/Fibra 15/Bx
Surgical Clamps and inserts are indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery. Th Terminated |
DXC | K883790 |
| Aug 11, 2011 | Applied Medical Resources Corp Surgical Clamp Inserts, Model#G-8650, 86MM Insert Soft/Fibra 15/Bx
Surgical Clamps and inserts are indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery. The Terminated |
DXC | K883790 |
| Aug 11, 2011 | Applied Medical Resources Corp Surgical Clamp Inserts, Model#G-8600, 86MM Insert Soft/Traction, 15/Bx
Surgical Clamps and inserts are indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery. Terminated |
DXC | K883790 |
| Aug 10, 2011 | Applied Medical Resources Corp Direct Drive Grasper, VARIOUS KITS CONTAINING EITHER C4130
OR C4140
Intended Usage: The grasper is indicated for grasping and manipulating tissue during general or laparoscopic surgery. The instrume Terminated |
GCJ | None listed |
| Aug 10, 2011 | Applied Medical Resources Corp Direct Drive Grasper, Model number C4140, 5MM X 45CM DIRECT DRIVE
GRASPER 10/BX
Intended Usage: The grasper is indicated for grasping and manipulating tissue during general or laparoscopic surgery. Terminated |
GCJ | None listed |
| Aug 10, 2011 | Applied Medical Resources Corp Direct Drive Grasper, Model numbers C4130, 5MM X 35CM DIRECT DRIVE GRASPER 10/BX
Intended Usage: The grasper is indicated for grasping and manipulating tissue during general or laparoscopic surgery. Terminated |
GCJ | None listed |
| Mar 3, 2011 | Applied Medical Resources Corp Applied Medical's KW/MOH LAP CHOLE KIT; Model Number: K2184
The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures. Terminated |
GCJ | None listed |
| Mar 3, 2011 | Applied Medical Resources Corp Applied Medical's LAP CHOLE ; Model Number: K2155
The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures. Terminated |
GCJ | None listed |
| Mar 3, 2011 | Applied Medical Resources Corp Applied Medical's LAP CHOLE KIT; Model Number: K2154
The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures. Terminated |
GCJ | None listed |
| Mar 3, 2011 | Applied Medical Resources Corp Applied Medical's PREMIUM DISPOSABLE LAP CHOLE KIT; Model Number: K2136
The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedu Terminated |
GCJ | None listed |
| Mar 3, 2011 | Applied Medical Resources Corp Applied Medical's LAP CHOLE KIT ; Model Number: K2114
The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures. Terminated |
GCJ | None listed |
| Mar 3, 2011 | Applied Medical Resources Corp Applied Medical's LAP CHOLE KIT ; Model Number: K0684
The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures. Terminated |
GCJ | None listed |
| Mar 3, 2011 | Applied Medical Resources Corp Applied Medical's LAP CHOLE KIT ; Model Number: K0630
The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures. Terminated |
GCJ | None listed |
| Mar 3, 2011 | Applied Medical Resources Corp Applied Medical's LAP CHOLE KIT - BLADED; Model Number: K0552
The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures. Terminated |
GCJ | None listed |
| Mar 3, 2011 | Applied Medical Resources Corp Applied Medical's LAP CHOLE KIT - 1A; Model Number: K0522
The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures. Terminated |
GCJ | None listed |
| Mar 3, 2011 | Applied Medical Resources Corp Applied Medical's AM CHOLE KIT-TAM1; Model Number: K0509
The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures. Terminated |
GCJ | None listed |
Newest 50 of 75.