Certified Safety Mfg Inc
Kansas City, MO, US
CERTIFIED SAFETY MFG., INC. appears in FDA device records in Kansas City, MO. FDA records list 17 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 17 510(k) clearances for Certified Safety Mfg Inc between 1994 and 1997. The busiest year on record is 1994, with 10. The most recent is 1997, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 10 |
| 1995 | 4 |
| 1996 | 2 |
| 1997 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K960587 | CPROTECTOR 2000 | CBP | Substantially Equivalent | |
| K960615 | GAUZE COMPRESS | EFQ | Substantially Equivalent for Some Indications | |
| K960624 | CERTI COOL INSTANT COLD COMPRESS | IMD | Substantially Equivalent for Some Indications | |
| K953102 | BLOODBORNE PATHOGEN KIT | FXX | Substantially Equivalent | |
| K946338 | CERTIBURN BURN/TRAUMA FACE DRESSING, TOWEL DRESSING | MGP | Substantially Equivalent | |
| K945004 | 2, 3 & 4 BANDADGE COMPRESS | EFQ | Substantially Equivalent | |
| K945002 | 1X6YD, 2X6YD, 4X6YD ROLL BANDAGE | EFQ | Substantially Equivalent | |
| K940249 | CERTIBURN BURN/TRAUMA FACE DRESSING /TOWEL DRESSING | LRR | Unknown | |
| K941311 | FIRST AID/TRUMA KIT | LRR | Substantially Equivalent | |
| K940358 | X-LARGE MULTI-FUNCTION TRAUMA DRESSING | EFQ | Substantially Equivalent | |
| K940336 | CERTI HEAT INSTANT HEAT COMPRESS | IMD | Substantially Equivalent | |
| K940333 | EYE PAD | HMP | Substantially Equivalent | |
| K940351 | EXTRA LARGE COMPRESS DRESSING | EFQ | Substantially Equivalent | |
| K940348 | TRAUMA PAD 5 X 9 | EFQ | Substantially Equivalent | |
| K940345 | TRIANGULAR BANDAGE | EFQ | Substantially Equivalent | |
| K940344 | 8 X 10 NON-STICK PAD | EFQ | Substantially Equivalent | |
| K934821 | CPROTECTOR | CBP | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1932902 | 1000158435 | CERTIFIED SAFETY MFG., INC. | 1400 Chestnut Ave, KANSAS CITY, MO 64127 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1060-2022 | 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, 25 packets/box. Product number and description: (1) K614-020 16PW - Firestone Supplemental - w/Logo; (2) KR614-020 16R - Firestone Supplemental - Refill; (3) K616-033 36M - Class A Office - Metal; (4) KR616-006 36R - Class A Office - Refill; (5) KR616-015 75R - Class A Office - Refill; (6) K616-015 75V - Class A Office - 3-Shelf Cabinet; (7) K618-016 EMT - Duke Energy TD - Red Bag; (8) KR618-016 EMTR - Duke Energy TD - Refill; (9) K616-008 FAC-3 - Class B + Meds - 3 Shelf Cabinet; (10) KR616-008 FAC-3R - Class B + Meds - Refill; (11) K618-013 FAC-3 - Five Star Safety - w/Logo; (12) K611-044 FAC-3 - Uline 100 person - w/Logo; (13) K620-609 FAC-3 - Uline Class B + Meds - w/Logo; (14) K616-072 FAC-4 - Choate Construction - w/Logo; (15) KR616-072 FAC-4R - Choate Construction - Refill; (16) K616-066 FAC-4 - Class B + Meds - 4 Shelf Cabinet; (17) KR616-066 FAC-4R - Class B + Meds - Refill; (18) K612-159 FAC-4 - Uline - w/Logo - w/Contents sticker; (19) K616-067 FAC-5 - Class B - 5 Shelf Cabinet; (20 KR616-067 FAC-5R - Class B - Refill | First aid kit and cabinet components are being recalled by the supplier due to cGMP deviations at the manufacturer. | Class II | Open, Classified | |
| Z-1353-2018 | 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. 32-000452-0000 K 206154 LXXV - 75V " Deluxe Cabinet 3 Shelf RS08016 Eye Wash - 4 oz. 32-000452-0000 K206210 FAC- 3 Deluxe Cabinet 3 Shelf R508016 Eye Wash - 4 oz. 32-000452-0000 K606999 ZLBCSX CPR Kit 37 R508016 Eye Wash " 4 oz. 32-000452-0000 KR206152 FAC " 4R 200 Person Deluxe Cabinet - Refill R508016 Eye Wash 4 oz. 32-000452-0000 K608054 Cement Burn Cabinet R511018 Eye Wash " 16 oz. 32-000454 0000- H5 K610045 FAC.3 " Deluxe Cabinet .w/BBP .NO MEDS .3 Shelf R508016 Eye Wash " 4 oz. 32-000452-0000 K606289 Eye Wash Cabinet 316 R511018 Eye Wash - 16oz 32-000454-0000-HS K608061 36MDelmarva Power/ACEw/Logo R508016 Eye Wash4 oz. 32-000452-0000 K611017 16PW " Hospeco " w/logo R508016 Eye Wash " 4 oz. 32-000452-0000 K206152 FAC4 200 Person Deluxe Cabinet 4 Shelf R508016 Eye Wash4 oz. 32-000452-0000 K206140 CLX 100 Person Deluxe Cabinet " 3 Shelf R508016 Eye Wash " 4 oz. 32-000452-0000 KR206210 FAC " 3R " Deluxe Cabinet Refill R508016 Eye Wash " 4 oz 32-000452-0000 K209061 TRMK Trauma Kit with Orange Co-Polymer Case R511018 Eye Wash -16 oz. 32-000454-0000-HS K206130 LXXV7SHStandard Cabinet Swing Out Door2 Shelf R508016 Eye Wash " 4 oz 32-000452-0000 Product Usage: various first aid/emergency kits containing eyewash | Firm is recalling first aid/emergency kits and cabinets which contain Honeywell Eyewash (3 lots) which is being recalled due to leaking bottles. | Class II | Terminated | |
| Z-3078-2017 | 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 protect patient from infection | Burn Sheet has possibility of being shredded. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain