Certified Safety Mfg Inc
FDA Regulatory Profile
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 17
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1060-2022 | Class II | The following first aid kits and cabinets containing components Medi-First XS Non-Aspirin, Product # | April 5, 2022 |
| Z-1353-2018 | Class II | First aid/emergency kits containing Honeywell eyewash: CSM kit number Kit/cabinet Description CSM E | March 20, 2018 |
| Z-3078-2017 | Class II | Burn Sheet, sterile - 60" x 96". Included in First Aid Kits: 36M - Delmarva Power/ACE - w/Logo, Cer | June 26, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K960587 | CPROTECTOR 2000 | July 21, 1997 |
| K960615 | GAUZE COMPRESS | November 25, 1996 |
| K960624 | CERTI COOL INSTANT COLD COMPRESS | May 6, 1996 |
| K953102 | BLOODBORNE PATHOGEN KIT | December 11, 1995 |
| K946338 | CERTIBURN BURN/TRAUMA FACE DRESSING, TOWEL DRESSING | March 29, 1995 |
| K945004 | 2, 3 & 4 BANDADGE COMPRESS | March 22, 1995 |
| K945002 | 1X6YD, 2X6YD, 4X6YD ROLL BANDAGE | March 22, 1995 |
| K940249 | CERTIBURN BURN/TRAUMA FACE DRESSING /TOWEL DRESSING | October 3, 1994 |
| K941311 | FIRST AID/TRUMA KIT | June 14, 1994 |
| K940358 | X-LARGE MULTI-FUNCTION TRAUMA DRESSING | March 23, 1994 |
| K940336 | CERTI HEAT INSTANT HEAT COMPRESS | March 7, 1994 |
| K940333 | EYE PAD | March 7, 1994 |
| K940351 | EXTRA LARGE COMPRESS DRESSING | February 25, 1994 |
| K940345 | TRIANGULAR BANDAGE | February 25, 1994 |
| K940344 | 8 X 10 NON-STICK PAD | February 25, 1994 |
| K940348 | TRAUMA PAD 5 X 9 | February 25, 1994 |
| K934821 | CPROTECTOR | January 6, 1994 |