Panels › General, Plastic Surgery › Product code KCY · Class 1

Tourniquet, Pneumatic

Regulation 878.5910

0510(k)s in 12 months (34 all time)

70recalls in 12 months (112 all time)

7recalls that name a 510(k)

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Top companies in KCY

Company	510(k)s	Recalls
ASP Global, LLC.	0	64
Zimmer Surgical Inc	0	9
Stryker Corporation	0	7
Stryker Instruments Div. of Stryker Corporation	0	7
Stryker Sustainability Solutions	0	7
Aspen Laboratories, Inc.	5	0
Instrumed, Inc.	5	0
Zimmer Orthopaedic Surgical Products	0	5
Ascent Healthcare Solutions, Inc.	0	4
STERILMED, INC.	0	3

Date	Firm and product	Code	Linked 510(k)
Jan 23, 2009	Virtus, Inc. Expressaire, Disposable Tourniquet Cuff 34", 2 line (18), sterile, Manufactured for Sammons Preston, A Patterson Medical Company, Cedarburg, WI.; Cuff type A70107011. Each cuff is marked ExpressAire Terminated	KCY	None listed
Jan 23, 2009	Virtus, Inc. Expressaire, Disposable Tourniquet Cuff 34", 1 line (18), sterile, Manufactured for Sammons Preston, A Patterson Medical Company, Cedarburg, WI.; Cuff type A70107010. Each cuff is marked ExpressAire Terminated	KCY	None listed
Jan 13, 2009	Sterilmed Inc Tourniquet Cuffs Model #'s: INSDT-7024-02 INSDT-7218-01 SMI553322 SMI7010-7002 SMI7010-7006 SMI7010-7007 SMI7010-7008 SMI7010-7010 SMI7010-7011 SMI7010-7012 SMI7010-7015 STR5921-018-136 STR5921-018-2 Terminated	KCY	None listed
Sep 19, 2008	Ascent Healthcare Solutions, Inc. Zimmer Tourniquet Cuff - Reprocessed Sterile device -- Pneumatic tourniquet. Terminated	KCY	None listed
Sep 19, 2008	Ascent Healthcare Solutions, Inc. Color Cuff II, Double Port Single Bladder - Reprocessed Sterile device -- Pneumatic tourniquet. Terminated	KCY	None listed
Sep 19, 2008	Ascent Healthcare Solutions, Inc. Tourniquet Cuff Single Port Single Bladder - Reprocessed Sterile device -- Pneumatic tourniquet. Terminated	KCY	None listed
Sep 19, 2008	Ascent Healthcare Solutions, Inc. Zimmer, 34" Tourniquet Cuff Single Port Single Bladder Luer Lock Connector Brown Trim, Latex Free - Reprocessed Sterile device -- Pneumatic tourniquet. Terminated	KCY	None listed
Feb 25, 2005	Zimmer Orthopaedic Surgical Products Zimmer Orthopaedic Surgical Products, Disposable Cuff, Single Port, Double Bladder Cuff, Sterile, Zimmer, Dover, OH USA. The cuff is a sterile, single use product equipped with an integral fill line. Terminated	KCY	None listed
Feb 25, 2005	Zimmer Orthopaedic Surgical Products Zimmer Orthopaedic Surgical Products, Disposable Cuff, Dual Port, Double Bladder Cuff, Sterile, Zimmer, Dover, OH USA. The cuff is a sterile, single use product equipped with an integral fill line. T Terminated	KCY	None listed
Jan 12, 2005	Zimmer Orthopaedic Surgical Products Zimmer Orthopaedic Surgical Products, Disposable Cuff, 12'' (30cm), Dual Port, Single Bladder Sterile, Zimmer, Dover, OH USA. The cuff is a sterile, single use product equipped with an integral fill Terminated	KCY	None listed
Jan 12, 2005	Zimmer Orthopaedic Surgical Products Zimmer Orthopaedic Surgical Products, Disposable Cuff, 12'' (30cm), Single Port, Single Bladder Sterile, Zimmer, Dover, OH USA. The cuff is a sterile, single use product equipped with an integral fil Terminated	KCY	None listed
Jan 12, 2005	Zimmer Orthopaedic Surgical Products Zimmer Orthopaedic Surgical Products, Disposable Cuff, 42in (107cm), Single Port, Single Bladder Sterile, Zimmer, Dover, OH USA. The cuff is a sterile, single use product equipped with an integral fi Terminated	KCY	None listed

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