Roseburg SA
Washington, DC, US
Roseburg SA appears in FDA device records in Washington, DC. FDA records list 24 510(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
- 24
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 24 510(k) clearances for Roseburg SA between 1985 and 1994. The busiest year on record is 1985, with 8. The most recent is 1994, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 8 |
| 1986 | 4 |
| 1987 | 8 |
| 1988 | 1 |
| 1989 | 2 |
| 1994 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K931155 | STAPLE, FIXATION BONE; SCREW FIXATION BONE | HWC | Substantially Equivalent | |
| K890081 | CALIUS-ISABEL CANOVAS SUNGLASSES | HQY | Substantially Equivalent | |
| K885275 | ASSENAT-BLESCHET SUNGLASSES | HQY | Substantially Equivalent | |
| K882392 | BURNET LABORATOIRE PHARMACEUTIQUE SURGICAL GLOVES | KGO | Substantially Equivalent | |
| K872715 | UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERY | JDN | Substantially Equivalent for Some Indications | |
| K874317 | POIRIER KID-ROLLER MANUAL WHEELCHAIR | IOR | Substantially Equivalent | |
| K872714 | S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY | GBI | Substantially Equivalent | |
| K871689 | SPECTACLE FRAME - LORRAINE | HQZ | Substantially Equivalent | |
| K871688 | SPECTACLE FRAME - DANIELLE | HQZ | Substantially Equivalent | |
| K870654 | EFER ARTHROSCOPE | HRX | Substantially Equivalent | |
| K864436 | STAVIP 3000 | JJN | Substantially Equivalent | |
| K864791 | POIRIER POWERED WHEELCHAIR | ITI | Substantially Equivalent | |
| K864790 | POIRIER MANUAL WHEELCHAIR | IOR | Substantially Equivalent | |
| K860953 | SUNGLASSES (NON-PRESCRIPTION) | HQY | Substantially Equivalent | |
| K860955 | SPECTACLES LENS | HQG | Substantially Equivalent | |
| K860954 | SPECTACLES FRAME | HQZ | Substantially Equivalent | |
| K851560 | PORTASPIR II | BTA | Substantially Equivalent | |
| K850294 | CANAL FINDER | EGS | Substantially Equivalent | |
| K851555 | OPTHALMIC BAR PRISM | HKW | Substantially Equivalent | |
| K851559 | TURQUOISE | FYA | Substantially Equivalent | |
| K851558 | SURGICAL CAP CALOT | FYF | Substantially Equivalent | |
| K851556 | OP-FACE MASK(MASQUE DE CHIRUGIE) | FXX | Substantially Equivalent | |
| K851554 | OVERSHOES (SURCHAUSSURES | FXP | Substantially Equivalent | |
| K850312 | GYNASPYR VACUUM CURETTAGE UNIT | HHI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- JJNApparatus, Electrophoresis, For Clinical Use
- HRXArthroscope
- FYFCap, Surgical
- FXPCover, Shoe, Operating-Room
- HQZFrame, Spectacle
- FYAGown, Surgical
- EGSHandpiece, Contra- And Right-Angle Attachment, Dental
- JDNImplant, Fixation Device, Spinal
- HQGLens, Spectacle, Non-Custom (Prescription)
- FXXMask, Surgical
- GBIMaterial, External Aesthetic Restoration, Used With Adhesive
- HKWPrism, Bar, Ophthalmic
- BTAPump, Portable, Aspiration (Manual Or Powered)
- HWCScrew, Fixation, Bone
- HQYSunglasses (Non-Prescription Including Photosensitive)
- KGOSurgeon'S Gloves
- HHISystem, Abortion, Vacuum
- IORWheelchair, Mechanical
- ITIWheelchair, Powered
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