Bio-Detek, Inc. - FDA 510(k) Cleared Devices
17
Total
17
Cleared
0
Denied
Bio-Detek, Inc. — FDA 510(k) Products and Clearance History Cardiovascular ✕
14 devices
Cleared
May 02, 2015
OneStep Pediatric CPR Multi-Function Electrode
Cardiovascular
110d
Cleared
May 02, 2015
CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel
Cardiovascular
93d
Cleared
Oct 10, 2014
ONESTEP CPR II MULTI-FUNCTION ELECTRODE
Cardiovascular
332d
Cleared
Nov 16, 2010
DURA PADZ (REUSABLE ELECTRODE), DURA PADZ GEL (DISPOSABLE HYDROGEL) MODEL...
Cardiovascular
260d
Cleared
Sep 12, 2007
POCKETCPR
Cardiovascular
125d
Cleared
Apr 09, 2004
BIO-DETEK ELECTRODE ADAPTER, MODEL R2001-90
Cardiovascular
87d
Cleared
Apr 09, 2004
PEDI-PADZ RADIOLUCENT MULTI-FUNCTION PEDIATRIC ELECTRODES, MODEL 8900-1005
Cardiovascular
65d
Cleared
Feb 27, 2004
BIO-DETEK MODIFIED ADULT MULTI-FUNCTION ELECTRODE WITH CONNECTOR
Cardiovascular
86d
Cleared
Mar 16, 1999
ZOLL SUPERPADZ ADULT MULTI-FUNCTION ELECTRODES, MODEL 8900-XXXX
Cardiovascular
83d
Cleared
Feb 26, 1999
ZOLL FIRST RESPONDER PADZ ADULT DEFIBRILLATION ELECTRODES
Cardiovascular
45d
Cleared
Nov 25, 1998
ZOLL STAT*PADZ ADULT MULTI-FUNCTION ELECTRODES MODEL NUMBER 8900-4003
Cardiovascular
188d
Cleared
Nov 25, 1996
TRACE RITE SOLID GEL ECG ELECTRODES
Cardiovascular
34d
Cleared
Jul 25, 1991
RT40 RADIO TRANSLUCENT
Cardiovascular
37d
Cleared
Jan 07, 1986
DE12 RAPID TRACE AT-REST DIAGNOSTIC ECG ELECTRODES
Cardiovascular
172d