Company ยท US
Byron Medical
FDA 510(k) clearances and medical device recalls filed under this name, 1986 to 2004. Name variants (Inc, Corp, punctuation) are merged.
27510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FWP | Prosthesis, Chin, Internal | 4 |
| FRN | Pump, Infusion | 3 |
| FZE | Prosthesis, Nose, Internal | 3 |
| LZK | Implant, Malar | 3 |
| QPB | System, Suction, Lipoplasty For Removal | 3 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 1 |
| EFQ | Gauze/Sponge, Internal | 1 |
| EME | Punch, Biopsy, Surgical | 1 |
| GBA | Catheter, Balloon Type | 1 |
| GEA | Cannula, Surgical, General & Plastic Surgery | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 |
| KGX | Tape And Bandage, Adhesive | 1 |
| KGZ | Accessories, Catheter | 1 |
| KPE | Container, I.V. | 1 |
| MIB | Elastomer, Silicone Block | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 3, 2004 | K040149 | PSI-TEC PERISTALTIC INFILTRATION PUMP Byron Medical | FRN |
| Aug 4, 2000 | K001803 | ACCELERATOR RECIPROCATING CANNULA Byron Medical | QPB |
| Jul 1, 1998 | K981215 | PSI-TEC LIPOSUCTION ASPIRATOR Byron Medical | QPB |
| Jun 30, 1998 | K981172 | LIPOPLASTY/ LIPOSUCTION ASPIRATION AND TUMESCENT INFUSION CANNULAE AND NEEDLES Byron Medical | QPB |
| Jun 16, 1998 | K980738 | PSI-TEC SYRINGE INFUSION PUMP AND ACCESSORIES FOR GENERAL FLUID IRRIGAION/INFILTRATION Byron Medical | FRN |
| Mar 5, 1998 | K980392 | PSI-TEC ASPIRATOR Byron Medical | BTA |
| Feb 10, 1998 | K974295 | BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBING Byron Medical | KGZ |
| Sep 12, 1997 | K973133 | BIG BAG 3000 PRESSURE INFUSOR Byron Medical | FRN |
| May 23, 1994 | K934179 | DISPOSABLE BAG DECANTER Byron Medical | KPE |
| Feb 3, 1994 | K934233 | ZARA ZONE IV MALAR IMPLANT MODIFICATION Byron Medical | LZK |
| Jan 7, 1994 | K933670 | BIOPSY PUNCH, SURGICAL Byron Medical | EME |
| Apr 21, 1992 | K913882 | ZARA SILICONE BLOCK Byron Medical | MIB |
| Dec 5, 1991 | K914016 | ZARA ZONE IV MALAR IMPLANT Byron Medical | LZK |
| Mar 19, 1991 | K910436 | ELASTIC ADHESIVE BANDAGE Byron Medical | KGX |
| Feb 19, 1991 | K910458 | ZARA SOFT TIP CHIN IMPLANT Byron Medical | FWP |
| Feb 19, 1991 | K910457 | ZARA EXTENDED CHIN IMPLANT Byron Medical | FWP |
| Feb 19, 1991 | K910456 | ZARA CHIN IMPLANT Byron Medical | FWP |
| Dec 27, 1989 | K895865 | SERENE WRAP Byron Medical | EFQ |
| May 4, 1988 | K881460 | SMOKEVAC ELECTORSURGICAL PENCIL Byron Medical | GEI |
| Sep 18, 1986 | K863397 | BYRON SILICONE CHIN IMPLANTS Byron Medical | FWP |
| Sep 17, 1986 | K863430 | BYRON BIVALVE NASAL SPLINTS Byron Medical | FZE |
| Sep 17, 1986 | K863400 | BYRON EXTENDED MALAR AND BYRON CONTOURED MALAR Byron Medical | LZK |
| Sep 17, 1986 | K863399 | BYRON DORSAL COLUMELLA IMPLANT Byron Medical | FZE |
| Sep 17, 1986 | K863398 | BYRON NASAL SEPTAL BUTTON Byron Medical | FZE |
| Aug 14, 1986 | K862936 | NEWMAN CANNULAE SYSTEM (NCS) Byron Medical | GEA |
| Jul 1, 1986 | K861878 | BYRON SUCTION TIPS Byron Medical | |
| May 30, 1986 | K861877 | BYRON WORD BARTHOLIAN GLAND CATHETER Byron Medical | GBA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||