Bio-Detek, Inc. is one of 6936 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Bio-Detek, Inc. - FDA 510(k) Cleared Devices
Recent clearances: OneStep Pediatric CPR Multi-Function Electrode, CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel, ONESTEP CPR II MULTI-FUNCTION ELECTRODE
17
Total
17
Cleared
0
Denied
Bio-Detek, Inc. has 17 FDA 510(k) cleared cardiovascular devices. Based in Mansfield, US.
Historical record: 17 cleared submissions from 1985 to 2015.
Browse the complete list of FDA 510(k) cleared cardiovascular devices from this manufacturer. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by ZOLL Medical Corporation as regulatory consultant.
FDA 510(k) Regulatory Record - Bio-Detek, Inc.
17 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