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Bio-Detek, Inc.

11 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Part Number: 8900-4012 Product Usage recall (Z-0052-2015)Bio-Detek, Inc.2014-10-09
ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Single. Part number: 8900-4013 Produ recall (Z-0053-2015)Bio-Detek, Inc.2014-10-09
ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires Part numb recall (Z-0054-2015)Bio-Detek, Inc.2014-10-09
ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires, 1 single recall (Z-0055-2015)Bio-Detek, Inc.2014-10-09
ZOLL Pro-padz Sterile Adult Multi-Function Electrodes Part number: 8900-4012 These MFE Ele recall (Z-2658-2014)Bio-Detek, Inc.2014-09-17
ZOLL Pro-padz Sterile Adult Multi-Function Electrodes ((singles) Part number: 8900-4013 Th recall (Z-2659-2014)Bio-Detek, Inc.2014-09-17
ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires Part numb recall (Z-2660-2014)Bio-Detek, Inc.2014-09-17
Medsolutions4U Multi-Function Electrodes to be used with PhysioControl Lifepak Defibrillat recall (Z-2565-2014)Bio-Detek, Inc.2014-09-02
Zoll pedi.padz Reduced Energy Multi-Function Electrodes (MFE) Part number: 8900-0401 Used recall (Z-1011-2012)Bio-Detek, Inc.2012-02-13
ZOLL OneStep Multi-Function Electrode; Adult Complete Part #: 8900-0214-01. The electrodes recall (Z-2334-2008)Bio-Detek, Inc.2008-09-20
Zoll Pediatric Electrodes labeled: Pedi Padz Multi-Function Electrode part Number: 8900-20 recall (Z-1380-04)Bio-Detek, Inc.2004-08-18

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Every clearance here is in the API, with alerts when new ones post.