Bio-Detek, Inc.
Summary
- Total Recalls
- 9
- 510(k) Clearances
- 17
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1945-2019 | Class II | ZOLL Pro-padz Liquid Gel Radiolucent, Part numbers: 8900-2105-01 (12/case) and 8900-2106-01 (single) | May 28, 2019 |
| Z-0054-2015 | Class II | ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires Part number: 8900 | September 16, 2014 |
| Z-0055-2015 | Class II | ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires, 1 single Part nu | September 16, 2014 |
| Z-0053-2015 | Class II | ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Single. Part number: 8900-4013 Product Usa | September 16, 2014 |
| Z-0052-2015 | Class II | ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Part Number: 8900-4012 Product Usage: Th | September 16, 2014 |
| Z-2660-2014 | Class II | ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires Part number: 8900 | August 26, 2014 |
| Z-2658-2014 | Class II | ZOLL Pro-padz Sterile Adult Multi-Function Electrodes Part number: 8900-4012 These MFE Electrodes | August 26, 2014 |
| Z-2659-2014 | Class II | ZOLL Pro-padz Sterile Adult Multi-Function Electrodes ((singles) Part number: 8900-4013 These M | August 26, 2014 |
| Z-2565-2014 | Class II | Medsolutions4U Multi-Function Electrodes to be used with PhysioControl Lifepak Defibrillators, model | March 12, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K150198 | CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel | May 2, 2015 |
| K150055 | OneStep Pediatric CPR Multi-Function Electrode | May 2, 2015 |
| K133441 | ONESTEP CPR II MULTI-FUNCTION ELECTRODE | October 10, 2014 |
| K100565 | DURA PADZ (REUSABLE ELECTRODE), DURA PADZ GEL (DISPOSABLE HYDROGEL) MODEL 8900-0300, 8900-0325 | November 16, 2010 |
| K071321 | POCKETCPR | September 12, 2007 |
| K040056 | BIO-DETEK ELECTRODE ADAPTER, MODEL R2001-90 | April 9, 2004 |
| K040256 | PEDI-PADZ RADIOLUCENT MULTI-FUNCTION PEDIATRIC ELECTRODES, MODEL 8900-1005 | April 9, 2004 |
| K033771 | BIO-DETEK MODIFIED ADULT MULTI-FUNCTION ELECTRODE WITH CONNECTOR | February 27, 2004 |
| K984582 | ZOLL SUPERPADZ ADULT MULTI-FUNCTION ELECTRODES, MODEL 8900-XXXX | March 16, 1999 |
| K990106 | ZOLL FIRST RESPONDER PADZ ADULT DEFIBRILLATION ELECTRODES | February 26, 1999 |
| K981802 | ZOLL STAT*PADZ ADULT MULTI-FUNCTION ELECTRODES MODEL NUMBER 8900-4003 | November 25, 1998 |
| K964213 | TRACE RITE SOLID GEL ECG ELECTRODES | November 25, 1996 |
| K920352 | BIO-DETEK EEG ELECTRODE | August 14, 1992 |
| K920264 | BIO-DETEK TRACERITE EEG ELECTRODE | June 2, 1992 |
| K912714 | RT40 RADIO TRANSLUCENT | July 25, 1991 |
| K853038 | DE12 RAPID TRACE AT-REST DIAGNOSTIC ECG ELECTRODES | January 7, 1986 |
| K853291 | GP-100 ADULT ELECTROSURGICAL GROUND PAD/200 & 300 | October 10, 1985 |