Panels › General, Plastic Surgery › Product code OMP · Class 2

Negative Pressure Wound Therapy Powered Suction Pump

Regulation 878.4780

10510(k)s in 12 months (217 all time)

0recalls in 12 months (47 all time)

42recalls that name a 510(k)

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Top companies in OMP

Company	510(k)s	Recalls
Kci USA, Inc.	26	17
Smith & Nephew, Inc.	14	17
Smith & Nephew Medical Limited	23	3
Genadyne Biotechnologies	16	0
Medela AG	13	2
Kci USA, Inc. (Kinetic Concepts, Inc.)	13	0
Cardinalhealth	7	0
Kinetic Concepts, Inc.	7	0
Molnlycke Health Care Us, LLC	7	0
Convatec Limited	1	5

Decided	510(k)	Device and applicant	Code
Dec 13, 2006	K063426	V.A.C. ATS LARGE (1000 ML) CANISTER WITH GEL, MODELS M6275093/5, M6275093/10 Kci USA, Inc.	OMP
Oct 16, 2006	K062456	NOVASPINE POWERED SUCTION PUMP PRO-1 Novaspine, LLC	OMP
Oct 4, 2006	K062227	V.A.C. THERAPY SYSTEM Kci USA, Inc. (Kinetic Concepts, Inc.)	OMP
Aug 10, 2006	K061367	BLUESKY VISTA WOUND VACUUM SYSTEM, MODEL 100.0500 Blue Sky Medical Group Incorporated	OMP
Jul 11, 2006	K061788	BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM Boehringer Laboratories	OMP
Jun 8, 2006	K061435	MEDELA VARIO SUCTION PUMPS Medela AG, CH	OMP
Feb 6, 2006	K053627	MODIFICATION TO: V.A.C. GRANUFOAM SILVER PROTECTION DRESSING Kci USA, Inc.	OMP
Nov 4, 2005	K052456	MODIFICATION TO VERSATILE 1 WOUND VACUUM SYSTEM Blue Sky Medical Group Incorporated	OMP
May 26, 2005	K050261	V.A.C. GRANUFOAM SILVER PROTECTION DRESSING Kinetic Concepts, Inc.	OMP
Jan 25, 2005	K041642	V.A.C. GRANUFOAM SILVER DRESSING Kinetic Concepts, Inc.	OMP
Nov 1, 2004	K042134	VERSATILE 1 WOUND VACUUM SYSTEM Blue Sky Medical Group Incorporated	OMP
Oct 10, 2003	K032310	MINI V.A.C., V.A.C. FREEDOM, V.A.C. ATS Kinetic Concepts, Inc.	OMP
Aug 21, 2003	K032301	NEOGEN ONE, CLOSED WOUND DRAIN SYSTEM, PART NUMBER: NG9900 Neogen Technologies, Inc.	OMP
Dec 20, 2002	K021500	VACUUM ASSISTED CLOSURE Kinetic Concepts, Inc.	OMP
Dec 2, 2002	K021501	V.A.C. INSTILLAMAT (VACUUM ASSISTED CLOSURE INSTILLAMAT Kinetic Concepts, Inc.	OMP
Jan 18, 2000	K992448	V.A.C. PLUS Kinetic Concepts, Inc.	OMP
May 22, 1997	K971548	AMBUVAC Kinetic Concepts, Inc.	OMP

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