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Product code LKB · Class U

Pad, Alcohol, Device Disinfectant

0510(k)s in 12 months (25 all time)

0recalls in 12 months (9 all time)

2recalls that name a 510(k)

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Top companies in LKB

Company	510(k)s	Recalls
Aplicare, Inc.	4	0
Vygon Corporation	0	4
Concord Laboratories, Inc.	3	0
Span-America Medical Systems, Inc.	3	0
Acme United Corp.	1	0
Alere San Diego	0	1
Bausch & Lomb, Inc.	1	0
Beckman Instruments, Inc.	1	0
Becton, Dickinson & CO	1	0
Bowen & Company, Inc.	1	0

Date	Firm and product	Code	Linked 510(k)
Mar 29, 2024	MEDLINE INDUSTRIES, LP - Northfield MEDLINE SWABSTICKS ALCOHOL 3PK, Product code DYNDA2723 Open, Classified	LKB	None listed
Aug 26, 2022	Mckesson Medical-Surgical Inc. Corporate Office Dynarex PAD, NAIL POLISH REMOVER (100/BX 10BX/CS) DYNREX Catalog # 1501 Open, Classified	LKB	None listed
May 12, 2017	Madison Polymeric Engineering Draco Enzymatic Deep-Cleaning Pad with Enzymatic Detergent Catalogue Number: HY0305Z Terminated	LKB	None listed
Sep 5, 2014	Catheter Connections, Inc. DualCap IV Pole Strips Disinfectant Caps for Luer Access Valves, REF 500-LB, Sterile. When left in place for five (5) minutes DualCap Solo" disinfects needleless luer access valves; thereafter the ca Terminated	LKB	K123065
Nov 16, 2011	Alere San Diego PDI Alcohol Prep Pads packaged in the INRatio kit. PDI Alcohol Prep Pads, 100/box. Alcohol Prep Pads, packaged in the Alere INRatio 2 PT/INR Home Monitoring Kit; or Hemosense INRatio 2 Prothrombin Terminated	LKB	K020679 K021923 +1
Jun 11, 2011	Vygon Corporation Churchill Medical Systems AMS-9189CP-1 (Dressing Change Kit) -Medium Glove. Churchill Medical Systems AMS-9189CP (Dressing Change Kit)-Large Glove. The devices intended use is a Dressing Change K Terminated	LKB	None listed
Jun 11, 2011	Vygon Corporation Churchill Medical Systems AMS-8431CP (PICC insertion Tray). The device intended use is a PICC insertion tray. Terminated	LKB	None listed
Jun 11, 2011	Vygon Corporation Churchill Medical Systems AMS-8316CP-1 (Central Line Dressing Kit). The device intended use is a central line dressing kit. Terminated	LKB	None listed
Jun 11, 2011	Vygon Corporation Churchill Medical Systems AMS-7080CP (Dressing Change Kit). The device intended use is a dressing change kit. Terminated	LKB	None listed

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