Product code LWS · Class 3

Implantable Cardioverter Defibrillator (Non-Crt)

0510(k)s in 12 months (0 all time)

1recalls in 12 months (219 all time)

0recalls that name a 510(k)

Top companies in LWS

Company	510(k)s	Recalls
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)	0	73
Boston Scientific Corporation	0	32
St Jude Medical	0	20
BIOTRONIK Inc	0	19
Medtronic Inc.	0	19
Medtronic Inc. Cardiac Rhythm Managment	0	15
Boston Scientific CRM Corp	0	14
Medtronic Inc. Cardiac Rhythm Disease Managment	0	10
St Jude Medical Cardiac Rhythm Management Division	0	5
ela Medical Llc	0	3

Decided	510(k)	Device and applicant	Code
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