Panels › General, Plastic Surgery › Product code KDD · Class 1
Kit, Surgical Instrument, Disposable
Regulation 878.4800
0510(k)s in 12 months (62 all time)
16recalls in 12 months (252 all time)
9recalls that name a 510(k)
Top companies in KDD
| Company | 510(k)s | Recalls |
|---|---|---|
| Beaver Visitec International, Inc. | 0 | 160 |
| Windstone Medical Packaging, Inc. | 0 | 17 |
| MEDLINE INDUSTRIES, LP - Northfield | 0 | 13 |
| Biomet Microfixation, Inc. | 0 | 9 |
| Medline Industries, LP | 0 | 9 |
| ARROW INTERNATIONAL, LLC | 0 | 6 |
| Deroyal Industries, Inc. | 1 | 5 |
| Bioseal Corporation | 0 | 4 |
| Merit Medical Systems, Inc. | 0 | 4 |
| MICROspecialties, Inc. | 0 | 4 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 3, 2023 | MEDLINE INDUSTRIES, LP - Northfield Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following:
a. CATH LAB BASIN PACK, Model Number: DYNJ69864A;
b. DELNOR VASCULAR BASIN PACK, Mode Open, Classified |
KDD | None listed |
| Jul 20, 2023 | MEDLINE INDUSTRIES, LP - Northfield Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: CATH LAB BASIN PACK, Model Number DYNJ69864A Open, Classified |
KDD | None listed |
| Jul 3, 2023 | DeRoyal Industries Inc Custom medical procedure packs labeled as:
a) STANDARD OB PACK ASCENSION WI, REF 89-10640
b) ANGIO PACK, REF 89-10901
c) BASIN, REF 89-1924
d) CYSTO PACK, REF 89-7133
e) TOTAL HIP PACK, REF 89-9134
Open, Classified |
KDD | None listed |
| May 23, 2023 | Windstone Medical Packaging, Inc. Aligned Medical Solutions Hand Pack, REF: AmS4601E, containing P 2 Cover Light Handle Blue STE, Sterile EO Open, Classified |
KDD | None listed |
| May 23, 2023 | Windstone Medical Packaging, Inc. Aligned Medical Solutions Minor Hand Pack, REF: AMS6539E, containing P 2 Cover Light Handle Blue STE, Sterile EO Open, Classified |
KDD | None listed |
| May 23, 2023 | Windstone Medical Packaging, Inc. Aligned Medical Solutions Spine Pack, REF: AMS4599(C, containing P 2 Cover Light Handle Blue STE, Sterile EO Open, Classified |
KDD | None listed |
| Mar 1, 2023 | Beaver Visitec International, Inc. CustomEyes kits Open, Classified |
KDD | None listed |
| Feb 10, 2023 | MEDLINE INDUSTRIES, LP - Northfield Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS L & D TRAY, Reorder Number MNS9065 Open, Classified |
KDD | None listed |
| Feb 6, 2023 | MEDLINE INDUSTRIES, LP - Northfield Sterile Procedural Trays, labeled as the following:
a. ST. ANNE'S MAJOR BASIN SET UP
b. SINGLE BASIN SET
c. DOUBLE BASIN SET
d. LAPAROTOMY BASIN
e. ORTHOPEDIC CUSTOM BASIN SET
f. OISC BASIN TRAY
g. Open, Classified |
KDD | None listed |
| Jan 4, 2023 | Windstone Medical Packaging, Inc. Various Custom Surgical Instrument Disposable Kits:
Part Numbers / Product Description
26000004M Custom Lasik Kit
AMS10411A Nasal Endoscopy Pack
AMS10710A Ultrasound Tray w/PDI
AMS11941 Total Knee Pac Open, Classified |
KDD | None listed |
| Mar 21, 2022 | Windstone Medical Packaging, Inc. Prevantics swabs and/or swabsticks contained inside the following Aligned Medical Solutions convenience kits with Name/Pack numbers:
Ports Cath Pack (1794)/AMS6569,
Minor Procedure Pack (20527)/AMS65 Open, Classified |
KDD | None listed |
| May 11, 2021 | Medical Action Industries, Inc. 306 Medical Action INDUSTRIES INC., General Purpose Instrument Tray, REF 61209 Terminated |
KDD | None listed |
| May 11, 2021 | Medical Action Industries, Inc. 306 novaplus, General Purpose Kit, Cat. No. 56603 Terminated |
KDD | None listed |
| Apr 8, 2021 | Windstone Medical Packaging, Inc. Angio Pack REF: AMS8050A, Sterile EO, Contents:2 Glove Dermassist 7.5 PF PR S
1 Bowl Fluid Containment W/LI
1 Cover Probe 6 X 48 NS
2 Gown surgical STD XLG NR
1 Needle RB 18x1.5
1 Spike Bag Decanter
Terminated |
KDD | None listed |
| Apr 8, 2021 | Windstone Medical Packaging, Inc. Angio Pack REF: AMS6908C, Sterile EO, Contents:1 Blade Scalpel # 11 SS
1 Bowl Guidewire 80 oz
4 Clamp Towel 2.5
1 Cover Probe 6X48 NS
2 Gown Surgical STD XLG NR
16 Label Custom
1 Counter Needle Nest
Terminated |
KDD | None listed |
| Mar 23, 2021 | Bioseal Corporation Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC009/20, Sterile EO, Single Use Only, UDI: (01)00630094430096 Completed |
KDD | None listed |
| Mar 23, 2021 | Bioseal Corporation Bioseal, Chest Tube Insertion Tray, containing ChloraPREP Applicator 3 mL, REF: CHT017/20, Sterile EO, Single Use Only, UDI: (01)10630094820177 Completed |
KDD | None listed |
| Mar 23, 2021 | Bioseal Corporation Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC015/20, Sterile EO, UDI: (01)00630094430157 Completed |
KDD | None listed |
| Apr 24, 2020 | DeRoyal Industries Inc DeRoyal Sterile Custom Kits packaged as a Piggy Back with the BD PosiFlush SF Saline Flush Syringe, labeled as follows:
a. H* Vein Pack Pgybk, 89-6209.03
b. H* Vein Pack, 89-6209.04
c. PICC Line Terminated |
KDD | None listed |
| Jan 6, 2020 | Medical Action Industries, Inc. 306 Medical convenience trays and kits, labeled as:
Medical Action Industries, Inc.:
***CVC*** Clear Sequence Change Kit, REF 77070B
***DIALYSIS*** Clear Sequence Change Kit, REF 77068B
***PEDS CVC*** C Terminated |
KDD | None listed |
| Mar 21, 2019 | ROi Consolidated Service Center (CSC) Regard custom surgical pack labeled as "LAPAROSCOPIC - OSU" including recalled Stryker part numbers 0620 040 660 Pneumosure High Flow II Tubeset, 0620 040 690 Pneumosure Heated Tubeset with RTP and 0 Open, Classified |
KDD | None listed |
| Mar 21, 2019 | ROi Consolidated Service Center (CSC) Regard custom surgical pack labeled as "LAP - FLOL LADY OF ANGELS" including recalled Stryker part numbers 0620 040 660 Pneumosure High Flow II
Tubeset, 0620 040 690 Pneumosure Heated Tubeset with RT Open, Classified |
KDD | None listed |
| Apr 11, 2018 | Arrow International Inc Maximal Barrier Drape; Product Code: ASK-01000-UPMS Terminated |
KDD | K870572 |
| Apr 11, 2018 | Arrow International Inc Maximal Barrier Drape; Product Codes: ASK-00376-SU Terminated |
KDD | K874063 |
| Nov 17, 2017 | Stryker Corporation ACL DISPOSABLE PACK BONE-TENDON-BONE, Model 0234020280, labeled sterile. Terminated |
KDD | None listed |
| Oct 24, 2017 | Arrow International Inc Pneumothorax Kit Terminated |
KDD | K904021 |
| Oct 24, 2017 | Arrow International Inc ArrowClarke" PleuraSeal Thoracentesis Kit Terminated |
KDD | K870572 |
| Oct 24, 2017 | Arrow International Inc Large Volume Abdominal Paracentesis Kit Terminated |
KDD | K874063 |
| Oct 18, 2017 | Bioseal Corporation Custom surgical kits labeled as follows:
(a) Suture Removal Set, 910-0002
(b) Instrument Set, INST03/20
(c) Suture Removal Set, SUT309/100
(d) Incision & Drainage Tray, INC03/20
(e) Suture Remova Completed |
KDD | None listed |
| Nov 6, 2015 | Utah Medical Products, Inc Myelo-Nate CSF Sampling Kit, Neonatal/Pediatric cerebralspinal fluid sampling sterile tray, including a lumbar puncture needle, four collection vials, an iodine swabstick package, a fenestrated drape, Terminated |
KDD | K821814 |
| Nov 2, 2015 | Windstone Medical Packaging, Inc. AMS 4675 Angio Pack. For use in a general clinical procedure. Terminated |
KDD | None listed |
| Nov 2, 2015 | Windstone Medical Packaging, Inc. AMS 4674 Custom Pack. For use in a general clinical procedure. Terminated |
KDD | None listed |
| May 11, 2013 | Covidien LLC Curity Staple Remover Kit; Product Code: 66701.
Staple Remover Kit. Terminated |
KDD | K761193 |
| Apr 17, 2012 | Deroyal Industries, Inc. Lafollette Sterile sterile surgical kits containing Episeal products, packaged as follows:
DeRoyal CLINIC PICC KIT, REF 47-483, STERILE EO, Rx Only, Manufactured by: DeRoyal Industries, 200 DeBusk Lane, Powell T Terminated |
KDD | None listed |
| Jul 19, 2011 | Biomet Microfixation, Inc. "***REF: 24-4050 TMJ SYSTEM ArthroSimplicity KIT***STERILE PRODUCT***STERILE EO***KIT CONTAINS BOTH STERILE AND NON-STERILE COMPONENTS DISTRIBUTED BY: BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKS Terminated |
KDD | None listed |
| Jul 19, 2011 | Biomet Microfixation, Inc. "***REF: 922090 TMJ SYSTEM InnerVue SCOPE PROCEDURE KIT***STERILE PRODUCT***STERILE EO***KIT CONTAINS BOTH STERILE AND NON-STERILE COMPONENTS DISTRIBUTED BY: BIOMET MICROFIXATION 1520 TRADEPORT DRI Terminated |
KDD | None listed |
| Jul 19, 2011 | Biomet Microfixation, Inc. "***REF: 24-3050 TMJ SYSTEM OnPoint SCOPE PROCEDURE KIT***STERILE PRODUCT***STERILE EO***KIT CONTAINS BOTH STERILE AND NON-STERILE COMPONENTS Distributed by: BIOMET MICROFIXATION 1520 TRADEPORT DRI Terminated |
KDD | None listed |
| Jul 19, 2011 | Biomet Microfixation, Inc. "***REF: 922070 TMJ SYSTEM ARTHROSIMPLICITY KIT***STERILE PRODUCT***STERILE EO***DISTRIBUTED BY BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA www.biometmicrofixation.com***" Terminated |
KDD | None listed |
| Dec 15, 2009 | Biomet Microfixation, Inc. BD Recalled component is labeled:
BD 60ml Syringe Luer-Lok Tip, REF 309653 STERILE.
BD Franklin Lakes, NJ 07417 USA Made in USA , www.bd.com.
Lots 7298534 Exp 2012-10 and 7334153 Exp 2012-11.
Compo Terminated |
KDD | None listed |
| Dec 15, 2009 | Biomet Microfixation, Inc. BD Recalled component is labeled:
BD 60ml Syringe Luer-Lok Tip, REF 309653 STERILE.
BD Franklin Lakes, NJ 07417 USA Made in USA , www.bd.com.
Lots 7298534 Exp 2012-10 and 7334153 Exp 2012-11.
Compo Terminated |
KDD | None listed |
| Dec 15, 2009 | Biomet Microfixation, Inc. BD Recalled component is labeled:
BD 60ml Syringe Luer-Lok Tip, REF 309653 STERILE.
BD Franklin Lakes, NJ 07417 USA Made in USA , www.bd.com.
Lots 7298534 Exp 2012-10 and 7334153 Exp 2012-11.
Compo Terminated |
KDD | None listed |
| Dec 15, 2009 | Biomet Microfixation, Inc. BD Recalled component is labeled:
BD 60ml Syringe Luer-Lok Tip, REF 309653 STERILE.
BD Franklin Lakes, NJ 07417 USA Made in USA , www.bd.com.
Lots 7298534 Exp 2012-10 and 7334153 Exp 2012-11.
Compo Terminated |
KDD | None listed |
| Dec 15, 2009 | Biomet Microfixation, Inc. BD Recalled component is labeled:
BD 60ml Syringe Luer-Lok Tip, REF 309653 STERILE.
BD Franklin Lakes, NJ 07417 USA Made in USA , www.bd.com.
Lots 7298534 Exp 2012-10 and 7334153 Exp 2012-11.
Compo Terminated |
KDD | None listed |
| Nov 23, 2009 | Merit Medical Systems, Inc. Merit Medical Systems, Inc., Convenience Trays, custom packaged under the following Merit Medical labels: (1) Prentice PICC Kit, Catalog number K12T-03698; (2) Insertion Kit, catalog number K12T-03050 Terminated |
KDD | K984558 |
| Apr 30, 2009 | Tri-State Hospital Supply Corporation Tri-State Centurion Incision and Drainage Tray, sterile, 20 per case, Tri-State Hospital Supply Corp., Howell, MI; Reorder ID615. Terminated |
KDD | None listed |
| Nov 7, 2008 | DeRoyal Industries Inc DeRoyal Lap Chole Tray, REF 89-4823.06, Rx, Sterile EO. (custom surgical kit) Terminated |
KDD | None listed |
| Nov 7, 2008 | DeRoyal Industries Inc DeRoyal Lap Appy TraceCart, REF53-1776, Rx only, non-sterile. (custom surgical kit) Terminated |
KDD | None listed |
| Sep 19, 2008 | Merit Medical Systems, Inc. Arnot-Ogden Med Ctr Hip Pack, REF: K12T-02159A, Sterile, Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan, Utah 84095. A combination of legally marketed medical devices placed into Terminated |
KDD | None listed |
| Sep 19, 2008 | Merit Medical Systems, Inc. Arnot-Ogden Med Ctr Hip Pack, REF: K12T-02160A, Sterile, Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan, Utah 84095. A combination of legally marketed medical devices placed into Terminated |
KDD | None listed |
| Sep 11, 2008 | Merit Medical Systems, Inc. CABG PACK, Surgical Convenience Kit, Sterile, Reorder #:K12T-02449B, Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan, Utah 84095.
A combination of legally marketed medical devices p Terminated |
KDD | None listed |
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