Panels › Cardiovascular › Product code NLH · Class 2

Catheter, Recording, Electrode, Reprocessed

Regulation 870.1220

1510(k)s in 12 months (70 all time)

32recalls in 12 months (49 all time)

47recalls that name a 510(k)

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Top companies in NLH

Company	510(k)s	Recalls
Stryker Sustainability Solutions	4	38
Innovative Health	24	0
Sterilmed, Inc.	10	1
Alliance Medical Corp.	10	0
Vanguard Medical Concepts, Inc.	9	0
Medline Industries, LP	0	8
Surgical Instrument Service and Savings, Inc.	7	0
Ascent Healthcare Solutions	4	0
MEDLINE INDUSTRIES, LP - Northfield	0	2
Surgical Instrument Service and Savings Inc.(Dba Medline Ren	2	0

Decided	510(k)	Device and applicant	Code
Jun 14, 2005	K051220	REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS Sterilmed, Inc.	NLH
Jun 6, 2005	K051043	VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS Vanguard Medical Concepts, Inc.	NLH
Jun 1, 2005	K050763	VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS Vanguard Medical Concepts, Inc.	NLH
Mar 25, 2005	K043392	REPROCESSED ELECTROPHYSIOLOGY CATHETERS Alliance Medical Corp.	NLH
Mar 23, 2005	K043393	REPROCESSED EP TECHNOLOGIES ELECTROPHYSIOLOGY CATHETERS Alliance Medical Corp.	NLH
Mar 10, 2005	K040751	VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS Vanguard Medical Concepts, Inc.	NLH
Mar 9, 2005	K042074	VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS Vanguard Medical Concepts, Inc.	NLH
Mar 1, 2005	K043513	STERILMED REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER Sterilmed, Inc.	NLH
Oct 3, 2003	K030279	REPROCESSED ELECTROPHYSIOLOGY CATHETER Alliance Medical Corp.	NLH
Sep 24, 2003	K030187	REPROCESSED ELECTROPHYSIOLOGY CATHETER Alliance Medical, Inc.	NLH
Aug 8, 2003	K030109	ELECTROPHYSIOLOGY CATHETER Alliance Medical Corp.	NLH
May 2, 2003	K030026	REPROCESSED ELECTROPHYSIOLOGY CATHETER Alliance Medical Corp.	NLH
Mar 21, 2003	K030114	VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS Vanguard Medical Concepts, Inc.	NLH
Dec 12, 2002	K023180	VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS Vanguard Medical Concepts, Inc.	NLH
Oct 10, 2002	K022316	VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS Vanguard Medical Concepts, Inc.	NLH
Aug 14, 2002	K012678	REPROCESSED SEALED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS Sterilmed, Inc.	NLH
Aug 14, 2002	K012523	REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS Sterilmed, Inc.	NLH
Aug 13, 2002	K012708	ELECTROPHYSIOLOGY CATHETER Alliance Medical Corp.	NLH
Aug 1, 2002	K012687	VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS Vanguard Medical Concepts, Inc.	NLH
Jul 31, 2002	K012688	VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS Vanguard Medical Concepts, Inc.	NLH

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