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)
Jan 29, 2025MEDLINE INDUSTRIES, LP - Northfield
MEDLINE ARTERIAL LINE PACK, REF DYNJ65208B, medical convenience kit containing Infusion Catheter with Antimicrobial Heparin Coating.
Open, Classified
LROK213481
Jan 28, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline procedure kits labeled as: 1) Port Access Kit, Reorder number CVI5130; 2) VANTEX 7FR 3L 20CM CVC STOCK+ BUNDLE US. Reorder number STCVC01USGV; general surgical tray
Open, Classified
LROK213481
Jan 15, 2025Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1) KIT,PLASTIC FLAP,Catalog Number PGHDOT951; 2) KIT,ORP PLASTIC FLAP,Catalog Number PGHDOT952; 3) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT910; 4) KIT,ORP PLASTIC
Open, Classified
LRONone listed
Dec 30, 2024MEDLINE INDUSTRIES, LP - Northfield
See DocMan
Open, Classified
LROK213481
Dec 20, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline brand, medical procedure convenience kits, labeled as: 1) CRANIOTOMY, SKU CDS982719X; 2) MVFF/FIBU #54-RF, SKU DYNJ21927Q; 3) MVFF/FIBU #54-RF, SKU DYNJ21927S; 3) NEURO PEDIATRIC, SKU DYNJ6160
Open, Classified
LRONone listed
Dec 5, 2024MEDLINE INDUSTRIES, LP - Northfield
Refer to RES or lead review memo for complete list of affected reference/catalog numbers
Open, Classified
LRONone listed
Nov 25, 2024MEDLINE INDUSTRIES, LP - Northfield
(1) Medline Pacer Implant Pack, REF DYNJ59194A, 4 kits/case, sterile; and (2) Medline Thoracotomy Morristown, REF DYNJ904220F, 1 kit/case, non-sterile.
Open, Classified
LRONone listed
Nov 22, 2024MEDLINE INDUSTRIES, LP - Northfield
MEDLINE procedure kits labeled as follows: 1) CONT EPI 20G W/HUSTEAD, REF PAIN1069B; 2) CSE TRAY, REF PAIN1941; 3) TRAY CON EPID 20G NYL W/TUOHY, REF PAIN9023; 4) TRAY, CONT EPI 20G NYL W/ HUST, REF
Open, Classified
LRONone listed
Nov 14, 2024AVID Medical, Inc.
Halyard PACK, MINOR - Medical convenience kits Model Number: VMED018-02
Open, Classified
LRONone listed
Nov 14, 2024AVID Medical, Inc.
Halyard ENT - Medical convenience kits Model Number: VMED011-01
Open, Classified
LRONone listed
Nov 14, 2024AVID Medical, Inc.
Halyard VA LUMBAR LAMINECTOMY - Medical convenience kits Model Number: VMED009-03
Open, Classified
LRONone listed
Nov 14, 2024AVID Medical, Inc.
Halyard SPECIALS PACK - Medical convenience kits Model Number: VAST031-08
Open, Classified
LRONone listed
Nov 14, 2024AVID Medical, Inc.
Halyard BIOPSY PACK - Medical convenience kits Model Number: VANW019-04
Open, Classified
LRONone listed
Nov 14, 2024AVID Medical, Inc.
Halyard CPT EP PACK - Medical convenience kits Model Number: SHAN442-04
Open, Classified
LRONone listed
Nov 14, 2024AVID Medical, Inc.
Halyard CPT PEDS ADULT CH PACK - Medical convenience kits Model Number: SHAN431-07
Open, Classified
LRONone listed
Nov 14, 2024AVID Medical, Inc.
Halyard CPT PEDS ADULT CH PACK - Medical convenience kits Model Number: SHAN431-06
Open, Classified
LRONone listed
Nov 14, 2024AVID Medical, Inc.
Halyard EYE PLASTIC TRAY - Medical convenience kits Model Number: SAMM054-19
Open, Classified
LRONone listed
Nov 14, 2024AVID Medical, Inc.
Halyard ORAL SURGERY HEAD - Medical convenience kits Model Number: SAMM029-15
Open, Classified
LRONone listed
Nov 14, 2024AVID Medical, Inc.
Halyard UROLOGY LAPAROTOMY PACK - Medical convenience kits Model Number: SAMM023-13
Open, Classified
LRONone listed
Nov 14, 2024AVID Medical, Inc.
Halyard SHOULDER PACK - Medical convenience kits Model Number: PANJ005
Open, Classified
LRONone listed
Nov 14, 2024AVID Medical, Inc.
Halyard UPPER EXTREMITY PACK - Medical convenience kits Model Number: PANJ002-02
Open, Classified
LRONone listed
Nov 14, 2024AVID Medical, Inc.
Halyard LOWER EXTREMITY PACK - Medical convenience kits Model Number: PANJ001-03
Open, Classified
LRONone listed
Nov 14, 2024AVID Medical, Inc.
Halyard MINOR PACK - Medical convenience kits Model Number: MMOK013-03
Open, Classified
LRONone listed
Nov 14, 2024AVID Medical, Inc.
Halyard EXTREMITY PACK - Medical convenience kits Model Number: MMOK009-03
Open, Classified
LRONone listed
Nov 14, 2024AVID Medical, Inc.
Halyard ORTHO PACK -Medical convenience kits Model Number: MMOK006-04
Open, Classified
LRONone listed
Nov 14, 2024AVID Medical, Inc.
Halyard KNEE ARTHROSCOPY PACK - Medical convenience kits Model Number: MAMC204-16
Open, Classified
LRONone listed
Nov 14, 2024AVID Medical, Inc.
Halyard TAH-BUNDLE - Medical convenience kits Model Number: LANC039-29
Open, Classified
LRONone listed
Nov 14, 2024AVID Medical, Inc.
Halyard LAPAROSCOPY TRAY - Medical convenience kits Model Number: LANC006-25
Open, Classified
LRONone listed
Nov 14, 2024AVID Medical, Inc.
Halyard MINOR PDS - Medical convenience kits Model Number: GVVA009-06
Open, Classified
LRONone listed
Nov 14, 2024AVID Medical, Inc.
Halyard CYSTO PDS - Medical convenience kits Model Number: GVVA002-05
Open, Classified
LRONone listed
Nov 14, 2024AVID Medical, Inc.
Halyard TOTAL KNEE - Medical convenience kits Model Number: GRND008-09
Open, Classified
LRONone listed
Nov 14, 2024AVID Medical, Inc.
Halyard BASIC PROCEDURE PACK - Medical convenience kits Model Number: GRAN019-06
Open, Classified
LRONone listed
Nov 14, 2024AVID Medical, Inc.
Halyard ABDOMINAL PROCEDURE - Medical convenience kits Model Number: GRAN015-06
Open, Classified
LRONone listed
Nov 14, 2024AVID Medical, Inc.
Halyard FOOT ANKLE PACK - Medical convenience kits Model Number: EUOR005-02
Open, Classified
LRONone listed
Nov 14, 2024AVID Medical, Inc.
Halyard KIT, SPINE - Medical convenience kits Model Number: EUOR004-03
Open, Classified
LRONone listed
Nov 14, 2024AVID Medical, Inc.
Halyard KIT, SPINE - Medical convenience kits Model Number: EUOR004-02
Open, Classified
LRONone listed
Nov 14, 2024AVID Medical, Inc.
Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: EUOR002-06
Open, Classified
LRONone listed
Nov 14, 2024AVID Medical, Inc.
Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: EUOR002-05
Open, Classified
LRONone listed
Nov 14, 2024AVID Medical, Inc.
Halyard ANTERIOR HIP PACK - Medical convenience kits Model Number: EUOR001-06
Open, Classified
LRONone listed
Nov 14, 2024AVID Medical, Inc.
Halyard KIT, SHOULDER - Medical convenience kits Model Number: ESJH014-06
Open, Classified
LRONone listed
Nov 14, 2024AVID Medical, Inc.
Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: ESJH012-07
Open, Classified
LRONone listed
Nov 14, 2024AVID Medical, Inc.
Halyard GENERAL SET UP PACK - Medical convenience kits Model Number: ESJH005-02
Open, Classified
LRONone listed
Nov 14, 2024AVID Medical, Inc.
Halyard ENT T AND A PACK - Medical convenience kits Model Number: EAMC106-02
Open, Classified
LRONone listed
Nov 12, 2024MEDLINE INDUSTRIES, LP - Northfield
URINE KIT W/BD CUP, SKU DYLAB1001A; Component No. 503581
Open, Classified
LRONone listed
Nov 12, 2024MEDLINE INDUSTRIES, LP - Northfield
URINE KIT, SKU DYKM1845; Component No. 503581
Open, Classified
LRONone listed
Nov 12, 2024MEDLINE INDUSTRIES, LP - Northfield
URINE COLLECTION VHC, SKU DYLAB1016; Component No. 503581
Open, Classified
LRONone listed
Nov 12, 2024MEDLINE INDUSTRIES, LP - Northfield
URINE COLLECTION KIT, SKU DYKM1848A DYKM2005 DYKM2151 DYLAB1004 DYLAB1004A DYLAB1006 DYLAB1012 ; Component No. 503581
Open, Classified
LRONone listed
Nov 12, 2024MEDLINE INDUSTRIES, LP - Northfield
URINALYSIS KIT 4, SKU DYLAB1021; Component No. 503581
Open, Classified
LRONone listed
Nov 12, 2024MEDLINE INDUSTRIES, LP - Northfield
UA KIT, SKU DYKM1690A; Component No. 503581
Open, Classified
LRONone listed
Nov 12, 2024MEDLINE INDUSTRIES, LP - Northfield
Lab Kit, SKU DYLAB1018; Component No. 503581
Open, Classified
LRONone listed

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