Panels › General, Plastic Surgery › Product code LYU · Class 1
Accessory, Surgical Apparel
Regulation 878.4040
0510(k)s in 12 months (56 all time)
0recalls in 12 months (9 all time)
7recalls that name a 510(k)
Top companies in LYU
| Company | 510(k)s | Recalls |
|---|---|---|
| Cardinal Health 200, LLC | 0 | 6 |
| Medical Armor Corp. | 5 | 0 |
| Sloan Corp. | 3 | 0 |
| Wells Lamont Corp. | 3 | 0 |
| Aor-Sullivan | 2 | 0 |
| Depuy-Raynham | 2 | 0 |
| Derekduck Industries Corp. | 2 | 0 |
| Instrument Makar, Inc. | 2 | 0 |
| Lovell-Schenck, Inc. | 2 | 0 |
| MEDLINE INDUSTRIES, LP - Northfield | 0 | 2 |
| 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. PROBE COVER PACK, Model Number: DYNDA1219 Open, Classified |
LYU | None listed |
| Jul 20, 2023 | MEDLINE INDUSTRIES, LP - Northfield Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:
PROBE COVER PACK, Model Number DYNDA1219 Open, Classified |
LYU | None listed |
| Jan 7, 2021 | Cardinal Health 200, LLC ChemoPlus" Chemo Prep & Admin Kit, CT4025 Terminated |
LYU | K972615 |
| Jan 7, 2021 | Cardinal Health 200, LLC Kendall Spill Kit, 6 Per Case, NonsterileI, BB6016K Terminated |
LYU | K972615 |
| Jan 7, 2021 | Cardinal Health 200, LLC ChemoPlus Drug Spill Kit-INSTI, SKU DP5016K Terminated |
LYU | K002064 |
| Jan 7, 2021 | Cardinal Health 200, LLC CHEMOPLUS DRUG SPILL KIT HOS, SKU CT4004 Terminated |
LYU | K972615 |
| Jan 7, 2021 | Cardinal Health 200, LLC CHEMOBLOC Preparation and Administration Kit, Extra Large Blue Gown, Medium and Large Gloves, Nonsterile, SKU DP5106K Terminated |
LYU | K002064 |
| Jan 7, 2021 | Cardinal Health 200, LLC Covidien ChemoPlus Chemo Spill Kit, Nonsterile, SKU DP5108K Terminated |
LYU | K002064 |
| Feb 1, 2018 | Zimmer Biomet, Inc. BlockAid Cut Resistant Surgical Glove Liners, combine stainless steel and synthetic fibers woven together to form a cut resistant glove material. Blockaid Cut Resistant Surgical Glove Liners are to be Terminated |
LYU | K902633 |
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