Company ยท US
Certified Safety Mfg., Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1994 to 1997. Name variants (Inc, Corp, punctuation) are merged.
17510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 21, 1997 | K960587 | CPROTECTOR 2000 Certified Safety Mfg., Inc. | CBP |
| Nov 25, 1996 | K960615 | GAUZE COMPRESS Certified Safety Mfg., Inc. | EFQ |
| May 6, 1996 | K960624 | CERTI COOL INSTANT COLD COMPRESS Certified Safety Mfg., Inc. | IMD |
| Dec 11, 1995 | K953102 | BLOODBORNE PATHOGEN KIT Certified Safety Mfg., Inc. | FXX |
| Mar 29, 1995 | K946338 | CERTIBURN BURN/TRAUMA FACE DRESSING, TOWEL DRESSING Certified Safety Mfg., Inc. | MGP |
| Mar 22, 1995 | K945004 | 2, 3 & 4 BANDADGE COMPRESS Certified Safety Mfg., Inc. | EFQ |
| Mar 22, 1995 | K945002 | 1X6YD, 2X6YD, 4X6YD ROLL BANDAGE Certified Safety Mfg., Inc. | EFQ |
| Oct 3, 1994 | K940249 | CERTIBURN BURN/TRAUMA FACE DRESSING /TOWEL DRESSING Certified Safety Mfg., Inc. | LRR |
| Jun 14, 1994 | K941311 | FIRST AID/TRUMA KIT Certified Safety Mfg., Inc. | LRR |
| Mar 23, 1994 | K940358 | X-LARGE MULTI-FUNCTION TRAUMA DRESSING Certified Safety Mfg., Inc. | EFQ |
| Mar 7, 1994 | K940336 | CERTI HEAT INSTANT HEAT COMPRESS Certified Safety Mfg., Inc. | IMD |
| Mar 7, 1994 | K940333 | EYE PAD Certified Safety Mfg., Inc. | HMP |
| Feb 25, 1994 | K940351 | EXTRA LARGE COMPRESS DRESSING Certified Safety Mfg., Inc. | EFQ |
| Feb 25, 1994 | K940348 | TRAUMA PAD 5 X 9 Certified Safety Mfg., Inc. | EFQ |
| Feb 25, 1994 | K940345 | TRIANGULAR BANDAGE Certified Safety Mfg., Inc. | EFQ |
| Feb 25, 1994 | K940344 | 8 X 10 NON-STICK PAD Certified Safety Mfg., Inc. | EFQ |
| Jan 6, 1994 | K934821 | CPROTECTOR Certified Safety Mfg., Inc. | CBP |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 5, 2022 | Certified Safety Mfg Inc The following first aid kits and cabinets containing components Medi-First XS Non-Aspirin, Product #80450, 2 tablets/packet, 25 packets/box; and Sinus Pain & Pressure, Product #81950, 2 tablets/packet Terminated |
LRR | K940249 |
| Mar 20, 2018 | Certified Safety Mfg Inc First aid/emergency kits containing Honeywell eyewash:
CSM kit number Kit/cabinet Description CSM Eyewash# Size: Honeywell Part#
K206125 LXXV - 75V " Economy Cabinet 3 Shelf R508016 Eye Wash " 4 oz. Terminated |
LRR | K941311 |
| Jun 26, 2017 | Certified Safety Mfg Inc Burn Sheet, sterile - 60" x 96". Included in First Aid Kits: 36M - Delmarva Power/ACE - w/Logo, Certified Safety Manufacturing logo, and sold blank.
product Usage:
Provides sterile environment to Terminated |
OJJ | None listed |