Panels › General, Plastic Surgery › Product code LRO · Class 2
General Surgery Tray
Regulation 878.4370
0510(k)s in 12 months (110 all time)
101recalls in 12 months (1,082 all time)
141recalls that name a 510(k)
Top companies in LRO
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 12, 2024 | MEDLINE INDUSTRIES, LP - Northfield Clean Catch Kit, SKU DYKM1833A; Component No. 503581 Open, Classified |
LRO | None listed |
| Nov 5, 2024 | DeRoyal Industries Inc DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06 Open, Classified |
LRO | K842648 |
| Nov 5, 2024 | DeRoyal Industries Inc DeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-06 Open, Classified |
LRO | K842648 |
| Oct 23, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline brand medical procedure convenience kits, labeled as:
1) THORACENTESIS TRAY, REF 00-400616J;
2) HH PACK SONICATION SPEC CONTAI, REF 3706WHST;
3) T&A CDS, REF CDS980427J;
4) EVD CDS, REF CDS Open, Classified |
LRO | None listed |
| Oct 17, 2024 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE HEART CABG CDS, REF CDS983376R Open, Classified |
LRO | K213481 |
| Oct 8, 2024 | Windstone Medical Packaging, Inc. Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes.
Product packaged in a convenient manner for use in a general clinical procedure. Open, Classified |
LRO | None listed |
| Oct 8, 2024 | Windstone Medical Packaging, Inc. Aligned Medical T and A Pack REF AMS11482 that contains the Cardinal Health Salem Sump PVC tubes.
Product packaged in a convenient manner for use in a general clinical procedure. Open, Classified |
LRO | None listed |
| Oct 8, 2024 | Windstone Medical Packaging, Inc. Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Salem Sump PVC tubes.
Product packaged in a convenient manner for use in a general clinical procedure. Open, Classified |
LRO | None listed |
| Oct 8, 2024 | Windstone Medical Packaging, Inc. Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes.
Product packaged in a convenient manner for use in a general clinical procedure. Open, Classified |
LRO | None listed |
| Sep 30, 2024 | DeRoyal Industries Inc DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572 Open, Classified |
LRO | K842648 |
| Sep 24, 2024 | American Contract Systems, Inc. Day Surgery General Pack, FHGE18T; Medical convenience kit Open, Classified |
LRO | None listed |
| Sep 11, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline convenience kits containing semi-rigid suction liners labeled as follows:
a) ENDO KIT, Pack Number DYKE1092B;
b) VIDEO BRONCHOSCOPY TRAY, Pack Number DYKE1666;
c) SUCTION CANISTER KIT, Pack Open, Classified |
LRO | None listed |
| Sep 6, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits labeled as:
1) MINOR BASIC PACK-LF, Pack Number DYNJ0281516M;
2) MINOR ACUTE PACK-LF, Pack Number DYNJ0484979B Open, Classified |
LRO | K962826 |
| Sep 6, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits labeled as:
1) MYELOGRAM PACK, Pack Number 00-399025L ;
2) BIOPSY PROCEDURE PACK , Pack Number 00-399227G ;
3) BIOPSY PROCEDURE PACK, Pack Number 00-399607N;
4) THORACENT Open, Classified |
LRO | None listed |
| Aug 28, 2024 | MEDLINE INDUSTRIES, LP - Northfield Centurion procedure packs, containing Caina syringes, labeled as:
1) ARTHROGRAPH TRAY, Pack Name MNS12670A;
2) BREAST BIOPSY KIT, Pack Name DYNDH1512A;
3) CIRCUMCISION TRAY, Pack Name CIT6720;
4) Open, Classified |
LRO | K213481 |
| Aug 28, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline procedural kits labeled as:
1) DRAWER 3 LAB DRAW & IV START, Pack Number ACC010417 ;
2) DRAWER 3 LAB DRAW & IV START, Pack Number ACC010417A;
3) DRAWER 9L , Pack Number ACC010427A;
4) MED Open, Classified |
LRO | None listed |
| Aug 28, 2024 | MEDLINE INDUSTRIES, LP - Northfield Centurion procedure kits, labeled as:
1) 6" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number ART245C;
2) ARTERIAL LINE TRAY-NO CATHETER, Pack Number ART1170;
3) ARTHROGRAM/LP/MYELOGRAM TRAY, Pack Numbe Open, Classified |
LRO | K213481 |
| Aug 27, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline procedure packs containing Shenli syringes, labeled as follows:
1) CVC DOUBLE LUMEN 16CM, Pack Number ECVC8105;
2) VANTEX 7FR 3L 20CM CVC BUNDLE US, Pack Number ECVC8045 Open, Classified |
LRO | K213481 |
| Aug 22, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline medical procedure kits labeled as follows:
a) AAA CDS, REF CDS984011C;
b) CAN KIT, REF DYKM1184;
c) DENTAL CDS, REF CDS984010B;
d) EGD KIT, REF DYK1253578F;
e) EGD REG KIT, REF DYKE1830 Open, Classified |
LRO | None listed |
| Aug 16, 2024 | Alcon Research LLC Product Name: Alcon Custom Pak
Model/Catalog Number: Many
Software Version: N/A
Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intende Open, Classified |
LRO | None listed |
| Aug 7, 2024 | American Contract Systems, Inc. American Contract Systems Hand Pack convenience kit Open, Classified |
LRO | None listed |
| Aug 7, 2024 | MEDLINE INDUSTRIES, LP - Northfield Centurion procedure kits labeled as NEURO ANGIO PACK, Pack Number DYNDA1431A Open, Classified |
LRO | K213481 |
| Jun 28, 2024 | MEDLINE INDUSTRIES, LP - Northfield Non-sterile convenience kits:
a. Medline CC Drawer 4 IV Circulation, Pack #ACC010254B, containing a Pure Pouch component DYND04000, O.R. Scissors S/B, 5.5 Sterile.
b. Medline Code Cart Drawer 2 Adu Open, Classified |
LRO | None listed |
| Jun 28, 2024 | MEDLINE INDUSTRIES, LP - Northfield Sterile convenience kits:
a. Medline Retrograde PK-22025203-LF, Pack #DYNJ47873K, containing a Pure Pouch containing component Sterile Curved Kelly Hemostat, Reorder #66175.
b. Medline Cath Lab Pa Open, Classified |
LRO | None listed |
| Apr 22, 2024 | Alcon Research, LLC Various Alcon Custom Paks Surgical Procedure Pack containing Oasis 27Ga Chang Hydrodissection Cannulas. These Custom Paks are surgical procedure packs used by ophthalmic surgeons in a variety of opht Open, Classified |
LRO | K880961 |
| Mar 29, 2024 | DeRoyal Industries Inc GeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECART, b) 53-1836 GENERAL SURGERY TRACECART Open, Classified |
LRO | K842648 |
| Mar 22, 2024 | Alcon Research, LLC SYRINGE,BULB,2OZ/60CC,GREEN, Part: 300055070, packaged inside Alcon Custom-Pak Surgical Procedure Packs, Products: 18018-06, 3865-44, 5675-76, 13554-11, 18018-06, 15190-16 , 15190-16, 15190-16, 15190 Open, Classified |
LRO | K880961 |
| Feb 25, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline Kits, trays, and packs labeled as follows:
a) 709E RECOVERY PACK A,B,C II SS, REF DYNJ55960G;
b) ABDOMEN PACK, REF DYNJ53643C;
c) BAG TRUNK STOCK KIT, REF DYKM1880;
d) BEDSIDE BRONCH PACK Open, Classified |
LRO | None listed |
| Jan 26, 2024 | American Contract Systems, Inc. Custom procedural convenience kits and trays, general & plastic surgery, labeled as:
a) BRACHY THERAPY PROCEDURE PAC, kit number AGBR90E;
b) BRACHY THERAPY PROCEDURE PAC, kit number AGBR90E;
c) MI Open, Classified |
LRO | None listed |
| Jan 12, 2024 | ROi CPS LLC regard Operative LAP, Item Number 800943001; surgical convenience kit Terminated |
LRO | None listed |
| Dec 22, 2023 | MEDLINE INDUSTRIES, LP - Northfield (1) Nursing Skills kit, SKU #EDUC05038B, Case UPC 40195327019878, Non-sterile, For Training Purposes Only, Not For Human Use. Open, Classified |
LRO | None listed |
| Dec 11, 2023 | MEDLINE INDUSTRIES, LP - Northfield STERILE POVIDONE, REF DYNDA2061 Open, Classified |
LRO | None listed |
| Dec 11, 2023 | MEDLINE INDUSTRIES, LP - Northfield STERILE BETADINE, REF DYNDA1998 Open, Classified |
LRO | None listed |
| Dec 11, 2023 | MEDLINE INDUSTRIES, LP - Northfield PVP SOLUTION SING STRL, REF DYNDA1858 Open, Classified |
LRO | None listed |
| Dec 11, 2023 | MEDLINE INDUSTRIES, LP - Northfield STERILE PVP, REF DYNDA1649 Open, Classified |
LRO | None listed |
| Dec 11, 2023 | MEDLINE INDUSTRIES, LP - Northfield STERILE STERILE PREP STICK, REF DYNDA1134 Open, Classified |
LRO | None listed |
| Dec 11, 2023 | MEDLINE INDUSTRIES, LP - Northfield STERILE PVP SLN KIT, REF DYNDM1097 Open, Classified |
LRO | None listed |
| Nov 16, 2023 | MEDLINE INDUSTRIES, LP - Northfield ADLT BLOOD CULTURE COLLECT KIT, REF DYNDH1245 Open, Classified |
LRO | None listed |
| Nov 7, 2023 | Alcon Research, LLC Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARACT, N VIRGINIA EYE SURG CTR Open, Classified |
LRO | K880961 |
| Oct 26, 2023 | American Contract Systems, Inc. Robotics Pack, REF SSRO22D Open, Classified |
LRO | None listed |
| Oct 26, 2023 | American Contract Systems, Inc. Robotics Pack, REF SJVO56B Open, Classified |
LRO | None listed |
| Oct 26, 2023 | American Contract Systems, Inc. CVS PCSU SJH, REF SJCV48J Open, Classified |
LRO | None listed |
| Oct 26, 2023 | American Contract Systems, Inc. General Pack, REF BBGP31C Open, Classified |
LRO | None listed |
| Oct 16, 2023 | DeRoyal Industries Inc DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit Open, Classified |
LRO | K842648 |
| Oct 10, 2023 | Cardinal Health 200, LLC Procedure packs:
(1) Presource PBDS, Cat. PGMHSUESR, Southeast Hospital MHHS, Kit, Set Up No Drape, SE, Sterile;
(2) Presource PBDS Cat. PGVGLBP20, Parkview Medical Center, Kit, Lap Chole, Sterile;
( Open, Classified |
LRO | None listed |
| Aug 3, 2023 | MEDLINE INDUSTRIES, LP - Northfield Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following:
a. PEDIATRIC CATH ANGIO PACK, Model Number: DYNJ54755B;
b. PEDIATRIC MAX BARRIER KIT- Open, Classified |
LRO | None listed |
| Aug 3, 2023 | MEDLINE INDUSTRIES, LP - Northfield Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following:
a. DR. ROSEN VEIN PACK, Model Number: DYNJ67517;
b. DR. VANBOSSE LOWER EXT PACK, Mode Open, Classified |
LRO | None listed |
| Aug 3, 2023 | MEDLINE INDUSTRIES, LP - Northfield Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following:
a. 7F, 20CM TRIPLE LUMEN CVC BUNDLE, Model Number: ECVC4740;
b. A V GRAFT, Model Numb Open, Classified |
LRO | None listed |
| Jul 20, 2023 | MEDLINE INDUSTRIES, LP - Northfield Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:
a) ULTRASOUND PACK, Model Number DYNDH1112;
b) PARA THORACENTESIS TRAY, Model Number DYNDH1165A;
c) ULTRASOUN Open, Classified |
LRO | None listed |
| Jul 20, 2023 | MEDLINE INDUSTRIES, LP - Northfield Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:
a) BLOCK SUPPLIES NDL CNTR, Model Number DYNJRA1755;
b) VNUS TEST KIT CFP-LF, Model Number DYNJTESTCFP4;
c) UL Open, Classified |
LRO | None listed |
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