Trebay Medical Corp.
Clearwater, FL, US
Trebay Medical Corp. appears in FDA device records in Clearwater, FL. FDA records list 14 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 14
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 14 510(k) clearances for Trebay Medical Corp. between 1995 and 1996. The busiest year on record is 1995, with 13. The most recent is 1996, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1995 | 13 |
| 1996 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K955704 | TREBAY MICRODEBRIDER SYSTEM | EQJ | Substantially Equivalent | |
| K955560 | TREBAY SCOPE IRRIGATED CLEARING SLEEVE | EOB | Substantially Equivalent | |
| K955294 | SOF - ABRASION BUR | EQJ | Substantially Equivalent | |
| K955447 | TYMPANOSTOMY TUBE | ETD | Substantially Equivalent | |
| K954912 | TREBAY IRRIGATED CUTTER BLADE (MODIFICATION) | EQJ | Substantially Equivalent | |
| K954795 | AT2 & DOYLE STYLE (C-FLEX) VENT TUBES | ETD | Substantially Equivalent | |
| K954796 | MICRO-INGRESSOR HANDIPIECE | ERL | Substantially Equivalent | |
| K954715 | MICRO-PLANER HANDPIECE | ERL | Substantially Equivalent | |
| K954518 | TREBAY TOTAL RECTANGULAR HEAD | ETA | Substantially Equivalent | |
| K954517 | TREBAY PARTIAL RECTRANGULAR HEADS, MORETZ CAM, INCUS/STAPEDIAL JOINT & STRAIGHT INCUS STRUT | ETB | Substantially Equivalent | |
| K952226 | C-FLEX SEPTAL SPLINTS | LYA | Substantially Equivalent | |
| K952609 | REDI DRILL DRILL SYSTEM | EQJ | Substantially Equivalent | |
| K952227 | C-FLEX ENDOLYMPHATIC SHUNT | ESZ | Substantially Equivalent | |
| K951526 | TREBAY IRRGATED CUTTER BLADE | EQJ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- EQJBur, Ear, Nose And Throat
- ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
- EOBNasopharyngoscope (Flexible Or Rigid)
- ETBProsthesis, Partial Ossicular Replacement
- ETAReplacement, Ossicular Prosthesis, Total
- LYASplint, Intranasal Septal
- ESZTube, Shunt, Endolymphatic
- ETDTube, Tympanostomy
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain