Solway, Inc.
Hollywood, FL, US
Solway, Inc. appears in FDA device records in Hollywood, FL. FDA records list 13 510(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
- 13
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 13 510(k) clearances for Solway, Inc. between 1987 and 1988. The busiest year on record is 1987, with 7. The most recent is 1988, with 6.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1987 | 7 |
| 1988 | 6 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K874960 | CARDIOVASCULAR SURGICAL INSTRUMENTS | DWS | Substantially Equivalent | |
| K874962 | FORCEPS CLIPRACK VENTRICULAR CANNULA SAWS SPATULAS | HAO | Substantially Equivalent | |
| K874956 | SELF-RETAINING RETRACTOR FOR NEUROSURGERY | GZT | Substantially Equivalent | |
| K874964 | DENTAL HAND INSTRUMENTS | EKJ | Substantially Equivalent | |
| K875043 | RONGEUR (NEUROSURGICAL INSTRUMENTS) | HAE | Substantially Equivalent | |
| K874966 | TUNING FORKS | GWX | Substantially Equivalent | |
| K874965 | MANUAL SURGICAL INSTRUMENTS FOR GENERAL USE | HTD | Substantially Equivalent | |
| K874961 | BONE CUTTING INSTRUMENTS & ACCESSORIES | GDR | Substantially Equivalent | |
| K874959 | VASCULAR CLAMP | HXD | Substantially Equivalent | |
| K874954 | MANUAL RONGEUR | HTX | Substantially Equivalent | |
| K874952 | MANUAL CRANIAL DRILL, BURR, TREPHINE & ACCESSORIES | HBG | Substantially Equivalent | |
| K874950 | MICROSURGICAL INSTRUMENTS | HTD | Substantially Equivalent | |
| K874963 | MANUAL OPHTHALMIC SURGICAL INSTRUMENTS | HNA | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- EKJBurnisher, Operative
- HXDClamp
- HBGDrills, Burrs, Trephines & Accessories (Manual)
- HTDForceps
- GWXFork, Tuning
- HAOInstrument, Surgical, Non-Powered
- DWSInstruments, Surgical, Cardiovascular
- GZTRetractor, Self-Retaining, For Neurosurgery
- HTXRongeur
- HAERongeur, Manual
- GDRSaw, Manual And Accessories
- HNASpud, Ophthalmic
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain