Company ยท US
O.R. Specialties, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1981 to 1994. Name variants (Inc, Corp, punctuation) are merged.
14510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HQC | Unit, Phacofragmentation | 4 |
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | 3 |
| EFQ | Gauze/Sponge, Internal | 1 |
| EQH | Source, Carrier, Fiberoptic Light | 1 |
| ETD | Tube, Tympanostomy | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 |
| GZX | Instrument, Microsurgical | 1 |
| KYG | Device, Irrigation, Ocular Surgery | 1 |
| LXP | Plug, Scleral | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 6, 1994 | K942607 | LAPAROSCOPIC SCISSORS (DISPOSABLE) O.R. Specialties, Inc. | GEI |
| Apr 6, 1994 | K923630 | PHACO NEEDLES 1000-R & 1000-O NEEDLES O.R. Specialties, Inc. | HQC |
| Aug 2, 1993 | K925671 | DISPOSABLE SCLERAL PLUGS O.R. Specialties, Inc. | LXP |
| Feb 19, 1993 | K923887 | JACK'S VENT TUBES O.R. Specialties, Inc. | ETD |
| Oct 19, 1992 | K923774 | DISPOSABLE ENDOILLUMINATOR O.R. Specialties, Inc. | EQH |
| Aug 18, 1992 | K922355 | POLLY'S VITREOUS SCISSORS J-225-S O.R. Specialties, Inc. | HQE |
| Jul 2, 1992 | K922180 | LEWICKY O.R.S. TUBING O.R. Specialties, Inc. | KYG |
| Dec 9, 1991 | K914038 | POLLY'S CUTTER J-225 O.R. Specialties, Inc. | HQE |
| Aug 26, 1991 | K911932 | J105 JAMES SURGICAL SYSTEM I/A PACK O.R. Specialties, Inc. | GZX |
| Aug 3, 1989 | K890195 | JAMES SURGICAL SYSTEM J1000 O.R. Specialties, Inc. | HQE |
| May 26, 1989 | K891161 | VITRECTOMY PACK #J120 O.R. Specialties, Inc. | HQC |
| May 26, 1989 | K890825 | JUMPER PACK #203 O.R. Specialties, Inc. | HQC |
| Mar 7, 1988 | K880062 | C-MATE #CMU 1001 O.R. Specialties, Inc. | HQC |
| Oct 16, 1981 | K811951 | DRESSING CHANGE TRAYS & STERILE SPONGES O.R. Specialties, Inc. | EFQ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||