Oto Med Inc
Lake Havasu City, AZ, US
Oto Med Inc appears in FDA device records in Lake Havasu City, AZ. FDA records list no 510(k) clearances, no PMA records and no registered establishments. As of , FDA records show 3 recalls for this company.
FDA records held for this company
- 510(k) clearances
- 0
- PMA records
- 0
- Recall records
- 3
- Registered establishments
- 0
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
No FDA product codes recorded against this company.
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1521-2021 | Grace Medical REF S-4500 *** spineX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use. | During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices. | Class II | Open, Classified | |
| Z-1520-2021 | Grace Medical REF S-3500 *** COX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use. | During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices. | Class II | Open, Classified | |
| Z-1519-2021 | Grace Medical REF S-2500 *** SHEEHY BONE DUST COLLECTOR *** Stainless steel filter - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use. | During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain