Medical Device Manufacturer · IL , Rehovot

Mennen Medical , Ltd. - FDA 510(k) Cleared Devices

21 submissions · 21 cleared · Since 2000

21

Total

21

Cleared

0

Denied

FDA 510(k) Regulatory Record - Mennen Medical , Ltd. Cardiovascular ✕

16 devices

1-12 of 16

Cleared Jan 09, 2015

Cardiovascular · 221d

Cleared Aug 30, 2013

HORIZON XVU (FFR)

Cardiovascular · 263d

Cleared May 07, 2010

VITALOGIK 6000/6500

Cardiovascular · 151d

Cleared Aug 07, 2009

Cardiovascular · 107d

Cleared Jun 20, 2008

Cardiovascular · 23d

Cleared Nov 21, 2007

VITALOGIK MODEL 4000/4500

Cardiovascular · 14d

Cleared Sep 07, 2007

EMS-XL CARDIAC ELECTROPHYSIOLOGY SYSTEM

Cardiovascular · 116d

Cleared Apr 19, 2007

Cardiovascular · 83d

Cleared Dec 20, 2005

Cardiovascular · 119d

Cleared Jan 27, 2005

HORIZON ANGIO CATHLAB

Cardiovascular · 31d

Cleared Oct 15, 2003

MODIFICATION TO: HORIZON 9000WS

Cardiovascular · 20d

Cleared Dec 03, 2002

MODIFICATION TO ENVOY PATIENT MONITOR

Cardiovascular · 19d