Data / Medical devices / United States / Certified Safety MFG., Inc.
Certified Safety MFG., Inc.: FDA-registered device maker in Kansas City, MO, United States, 9 510(k) clearances
Certified Safety MFG., Inc. is registered with the FDA (registration 1932902) in Kansas City, MO, United States. It lists 4 device types. The FDA files 9 510(k) clearances under its listings, the newest dated November 25, 1996. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1932902
- FEI number
- 1000158435
- Address
- 1400 Chestnut Ave, Kansas City, MO, United States, 64127
- Owner or operator
- CERTIFIED SAFETY MFG., INC. (9010174)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- November 13, 2007
- Registered through
- 2026
- Brand names listed
- Burn Trauma Kit, 16 and 24 Unit, Certi-Gauze Bandage Compress, 2", Certi-Gauze Bandage Compress, 3", Certi-Gauze Bandage Compress, 4", Certi-Gauze Compress 18" X 36", Certi-Gauze Compress 24" X 72", Certi-Gauze Compress 36" X 36", Certi-Gauze Non-Stick Pad, 2" x 3" and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| First Aid Kit With Drug | LRR | N | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Gauze/Sponge, Internal | EFQ | U | Repackager or relabeler | accessdata.fda.gov |
| Pad, Eye | HMP | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 25, 1996 | K960615 | GAUZE COMPRESS | EFQ | Substantially Equivalent for Some Indications | Certified Safety Mfg., Inc. | accessdata.fda.gov |
| March 22, 1995 | K945004 | 2, 3 & 4 BANDADGE COMPRESS | EFQ | Substantially Equivalent | Certified Safety Mfg., Inc. | accessdata.fda.gov |
| March 22, 1995 | K945002 | 1X6YD, 2X6YD, 4X6YD ROLL BANDAGE | EFQ | Substantially Equivalent | Certified Safety Mfg., Inc. | accessdata.fda.gov |
| October 3, 1994 | K940249 | CERTIBURN BURN/TRAUMA FACE DRESSING /TOWEL DRESSING | LRR | Unknown | Certified Safety Mfg., Inc. | accessdata.fda.gov |
| June 14, 1994 | K941311 | FIRST AID/TRUMA KIT | LRR | Substantially Equivalent | Certified Safety Mfg., Inc. | accessdata.fda.gov |
| March 7, 1994 | K940333 | EYE PAD | HMP | Substantially Equivalent | Certified Safety Mfg., Inc. | accessdata.fda.gov |
| February 25, 1994 | K940351 | EXTRA LARGE COMPRESS DRESSING | EFQ | Substantially Equivalent | Certified Safety Mfg., Inc. | accessdata.fda.gov |
| February 25, 1994 | K940348 | TRAUMA PAD 5 X 9 | EFQ | Substantially Equivalent | Certified Safety Mfg., Inc. | accessdata.fda.gov |
| February 25, 1994 | K940344 | 8 X 10 NON-STICK PAD | EFQ | Substantially Equivalent | Certified Safety Mfg., Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 5, 2022 | 89920 | Class II | Terminated | 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. Pr | First aid kit and cabinet components are being recalled by the supplier due to cGMP deviations at the manufacturer. | accessdata.fda.gov |
| March 20, 2018 | 79674 | Class II | Terminated | 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 2061 | Firm is recalling first aid/emergency kits and cabinets which contain Honeywell Eyewash (3 lots) which is being recalled due to leaking bottles. | accessdata.fda.gov |
| June 26, 2017 | 77593 | Class II | Terminated | 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 inf | Burn Sheet has possibility of being shredded. | accessdata.fda.gov |
Compare with other makers
- All makers of Tape And Bandage, Adhesive
- All makers of Gauze/Sponge, Internal
- All makers of Pad, Eye
- All makers of First Aid Kit With Drug
Updated November 25, 1996. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.