ClearanceBrief
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)
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Top companies in LRO

DateFirm and productCodeLinked 510(k)
Nov 12, 2024MEDLINE INDUSTRIES, LP - Northfield
Clean Catch Kit, SKU DYKM1833A; Component No. 503581
Open, Classified
LRONone listed
Nov 5, 2024DeRoyal Industries Inc
DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06
Open, Classified
LROK842648
Nov 5, 2024DeRoyal Industries Inc
DeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-06
Open, Classified
LROK842648
Oct 23, 2024MEDLINE 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
LRONone listed
Oct 17, 2024MEDLINE INDUSTRIES, LP - Northfield
MEDLINE HEART CABG CDS, REF CDS983376R
Open, Classified
LROK213481
Oct 8, 2024Windstone 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
LRONone listed
Oct 8, 2024Windstone 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
LRONone listed
Oct 8, 2024Windstone 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
LRONone listed
Oct 8, 2024Windstone 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
LRONone listed
Sep 30, 2024DeRoyal Industries Inc
DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572
Open, Classified
LROK842648
Sep 24, 2024American Contract Systems, Inc.
Day Surgery General Pack, FHGE18T; Medical convenience kit
Open, Classified
LRONone listed
Sep 11, 2024MEDLINE 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
LRONone listed
Sep 6, 2024MEDLINE 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
LROK962826
Sep 6, 2024MEDLINE 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
LRONone listed
Aug 28, 2024MEDLINE 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
LROK213481
Aug 28, 2024MEDLINE 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
LRONone listed
Aug 28, 2024MEDLINE 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
LROK213481
Aug 27, 2024MEDLINE 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
LROK213481
Aug 22, 2024MEDLINE 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
LRONone listed
Aug 16, 2024Alcon 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
LRONone listed
Aug 7, 2024American Contract Systems, Inc.
American Contract Systems Hand Pack convenience kit
Open, Classified
LRONone listed
Aug 7, 2024MEDLINE INDUSTRIES, LP - Northfield
Centurion procedure kits labeled as NEURO ANGIO PACK, Pack Number DYNDA1431A
Open, Classified
LROK213481
Jun 28, 2024MEDLINE 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
LRONone listed
Jun 28, 2024MEDLINE 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
LRONone listed
Apr 22, 2024Alcon 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
LROK880961
Mar 29, 2024DeRoyal Industries Inc
GeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECART, b) 53-1836 GENERAL SURGERY TRACECART
Open, Classified
LROK842648
Mar 22, 2024Alcon 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
LROK880961
Feb 25, 2024MEDLINE 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
LRONone listed
Jan 26, 2024American 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
LRONone listed
Jan 12, 2024ROi CPS LLC
regard Operative LAP, Item Number 800943001; surgical convenience kit
Terminated
LRONone listed
Dec 22, 2023MEDLINE INDUSTRIES, LP - Northfield
(1) Nursing Skills kit, SKU #EDUC05038B, Case UPC 40195327019878, Non-sterile, For Training Purposes Only, Not For Human Use.
Open, Classified
LRONone listed
Dec 11, 2023MEDLINE INDUSTRIES, LP - Northfield
STERILE POVIDONE, REF DYNDA2061
Open, Classified
LRONone listed
Dec 11, 2023MEDLINE INDUSTRIES, LP - Northfield
STERILE BETADINE, REF DYNDA1998
Open, Classified
LRONone listed
Dec 11, 2023MEDLINE INDUSTRIES, LP - Northfield
PVP SOLUTION SING STRL, REF DYNDA1858
Open, Classified
LRONone listed
Dec 11, 2023MEDLINE INDUSTRIES, LP - Northfield
STERILE PVP, REF DYNDA1649
Open, Classified
LRONone listed
Dec 11, 2023MEDLINE INDUSTRIES, LP - Northfield
STERILE STERILE PREP STICK, REF DYNDA1134
Open, Classified
LRONone listed
Dec 11, 2023MEDLINE INDUSTRIES, LP - Northfield
STERILE PVP SLN KIT, REF DYNDM1097
Open, Classified
LRONone listed
Nov 16, 2023MEDLINE INDUSTRIES, LP - Northfield
ADLT BLOOD CULTURE COLLECT KIT, REF DYNDH1245
Open, Classified
LRONone listed
Nov 7, 2023Alcon Research, LLC
Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARACT, N VIRGINIA EYE SURG CTR
Open, Classified
LROK880961
Oct 26, 2023American Contract Systems, Inc.
Robotics Pack, REF SSRO22D
Open, Classified
LRONone listed
Oct 26, 2023American Contract Systems, Inc.
Robotics Pack, REF SJVO56B
Open, Classified
LRONone listed
Oct 26, 2023American Contract Systems, Inc.
CVS PCSU SJH, REF SJCV48J
Open, Classified
LRONone listed
Oct 26, 2023American Contract Systems, Inc.
General Pack, REF BBGP31C
Open, Classified
LRONone listed
Oct 16, 2023DeRoyal Industries Inc
DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit
Open, Classified
LROK842648
Oct 10, 2023Cardinal 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
LRONone listed
Aug 3, 2023MEDLINE 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
LRONone listed
Aug 3, 2023MEDLINE 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
LRONone listed
Aug 3, 2023MEDLINE 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
LRONone listed
Jul 20, 2023MEDLINE 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
LRONone listed
Jul 20, 2023MEDLINE 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
LRONone listed

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