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) |
|---|---|---|---|
| Jan 29, 2025 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE ARTERIAL LINE PACK, REF DYNJ65208B, medical convenience kit containing Infusion Catheter with Antimicrobial Heparin Coating. Open, Classified |
LRO | K213481 |
| Jan 28, 2025 | MEDLINE 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 |
LRO | K213481 |
| Jan 15, 2025 | Cardinal 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 |
LRO | None listed |
| Dec 30, 2024 | MEDLINE INDUSTRIES, LP - Northfield See DocMan Open, Classified |
LRO | K213481 |
| Dec 20, 2024 | MEDLINE 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 |
LRO | None listed |
| Dec 5, 2024 | MEDLINE INDUSTRIES, LP - Northfield Refer to RES or lead review memo for complete list of affected reference/catalog numbers Open, Classified |
LRO | None listed |
| Nov 25, 2024 | MEDLINE 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 |
LRO | None listed |
| Nov 22, 2024 | MEDLINE 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 |
LRO | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard PACK, MINOR - Medical convenience kits
Model Number: VMED018-02 Open, Classified |
LRO | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard ENT - Medical convenience kits
Model Number: VMED011-01 Open, Classified |
LRO | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard VA LUMBAR LAMINECTOMY - Medical convenience kits
Model Number: VMED009-03 Open, Classified |
LRO | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard SPECIALS PACK - Medical convenience kits
Model Number: VAST031-08 Open, Classified |
LRO | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard BIOPSY PACK - Medical convenience kits
Model Number: VANW019-04 Open, Classified |
LRO | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard CPT EP PACK - Medical convenience kits
Model Number: SHAN442-04 Open, Classified |
LRO | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard CPT PEDS ADULT CH PACK - Medical convenience kits
Model Number: SHAN431-07 Open, Classified |
LRO | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard CPT PEDS ADULT CH PACK - Medical convenience kits
Model Number: SHAN431-06 Open, Classified |
LRO | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard EYE PLASTIC TRAY - Medical convenience kits
Model Number: SAMM054-19 Open, Classified |
LRO | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard ORAL SURGERY HEAD - Medical convenience kits
Model Number: SAMM029-15 Open, Classified |
LRO | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard UROLOGY LAPAROTOMY PACK - Medical convenience kits
Model Number: SAMM023-13 Open, Classified |
LRO | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard SHOULDER PACK - Medical convenience kits
Model Number: PANJ005 Open, Classified |
LRO | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard UPPER EXTREMITY PACK - Medical convenience kits
Model Number: PANJ002-02 Open, Classified |
LRO | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard LOWER EXTREMITY PACK - Medical convenience kits
Model Number: PANJ001-03 Open, Classified |
LRO | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard MINOR PACK - Medical convenience kits
Model Number: MMOK013-03 Open, Classified |
LRO | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard EXTREMITY PACK - Medical convenience kits
Model Number: MMOK009-03 Open, Classified |
LRO | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard ORTHO PACK -Medical convenience kits
Model Number: MMOK006-04 Open, Classified |
LRO | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard KNEE ARTHROSCOPY PACK - Medical convenience kits
Model Number: MAMC204-16 Open, Classified |
LRO | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard TAH-BUNDLE - Medical convenience kits
Model Number: LANC039-29 Open, Classified |
LRO | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard LAPAROSCOPY TRAY - Medical convenience kits
Model Number: LANC006-25 Open, Classified |
LRO | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard MINOR PDS - Medical convenience kits
Model Number: GVVA009-06 Open, Classified |
LRO | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard CYSTO PDS - Medical convenience kits
Model Number: GVVA002-05 Open, Classified |
LRO | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard TOTAL KNEE - Medical convenience kits
Model Number: GRND008-09 Open, Classified |
LRO | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard BASIC PROCEDURE PACK - Medical convenience kits
Model Number: GRAN019-06 Open, Classified |
LRO | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard ABDOMINAL PROCEDURE - Medical convenience kits
Model Number: GRAN015-06 Open, Classified |
LRO | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard FOOT ANKLE PACK - Medical convenience kits
Model Number: EUOR005-02 Open, Classified |
LRO | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard KIT, SPINE - Medical convenience kits
Model Number: EUOR004-03 Open, Classified |
LRO | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard KIT, SPINE - Medical convenience kits
Model Number: EUOR004-02 Open, Classified |
LRO | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard KIT, TOTAL KNEE - Medical convenience kits
Model Number: EUOR002-06 Open, Classified |
LRO | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard KIT, TOTAL KNEE - Medical convenience kits
Model Number: EUOR002-05 Open, Classified |
LRO | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard ANTERIOR HIP PACK - Medical convenience kits
Model Number: EUOR001-06 Open, Classified |
LRO | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard KIT, SHOULDER - Medical convenience kits
Model Number: ESJH014-06 Open, Classified |
LRO | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard KIT, TOTAL KNEE - Medical convenience kits
Model Number: ESJH012-07 Open, Classified |
LRO | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard GENERAL SET UP PACK - Medical convenience kits
Model Number: ESJH005-02 Open, Classified |
LRO | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard ENT T AND A PACK - Medical convenience kits
Model Number: EAMC106-02 Open, Classified |
LRO | None listed |
| Nov 12, 2024 | MEDLINE INDUSTRIES, LP - Northfield URINE KIT W/BD CUP, SKU DYLAB1001A; Component No. 503581 Open, Classified |
LRO | None listed |
| Nov 12, 2024 | MEDLINE INDUSTRIES, LP - Northfield URINE KIT, SKU DYKM1845; Component No. 503581 Open, Classified |
LRO | None listed |
| Nov 12, 2024 | MEDLINE INDUSTRIES, LP - Northfield URINE COLLECTION VHC, SKU DYLAB1016; Component No. 503581 Open, Classified |
LRO | None listed |
| Nov 12, 2024 | MEDLINE INDUSTRIES, LP - Northfield URINE COLLECTION KIT, SKU DYKM1848A
DYKM2005
DYKM2151
DYLAB1004
DYLAB1004A
DYLAB1006
DYLAB1012
; Component No. 503581 Open, Classified |
LRO | None listed |
| Nov 12, 2024 | MEDLINE INDUSTRIES, LP - Northfield URINALYSIS KIT 4, SKU DYLAB1021; Component No. 503581 Open, Classified |
LRO | None listed |
| Nov 12, 2024 | MEDLINE INDUSTRIES, LP - Northfield UA KIT, SKU DYKM1690A; Component No. 503581 Open, Classified |
LRO | None listed |
| Nov 12, 2024 | MEDLINE INDUSTRIES, LP - Northfield Lab Kit, SKU DYLAB1018; Component No. 503581 Open, Classified |
LRO | None listed |
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