Company ยท US
Universal Medical Instrument Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 1996. Name variants (Inc, Corp, punctuation) are merged.
21510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DYB | Introducer, Catheter | 6 |
| DQO | Catheter, Intravascular, Diagnostic | 3 |
| DQX | Wire, Guide, Catheter | 2 |
| FMI | Needle, Hypodermic, Single Lumen | 2 |
| HIO | Sampler, Amniotic Fluid (Amniocentesis Tray) | 2 |
| DWS | Instruments, Surgical, Cardiovascular | 1 |
| DXE | Catheter, Embolectomy | 1 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 1 |
| IME | Pack, Hot Or Cold, Reusable | 1 |
| LYY | Latex Patient Examination Glove | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 7, 1996 | K962180 | CATH SEAL Universal Medical Instrument Corp. | DYB |
| Jun 7, 1994 | K935077 | CATH-SEAL Universal Medical Instrument Corp. | DYB |
| Mar 1, 1990 | K897128 | UMI BRAIDED CATHETER CONNECTOR Universal Medical Instrument Corp. | LYY |
| Jul 26, 1988 | K881796 | UMI DISPOSABLE BUTTERFLY STYLE PUNCTURE NEEDLE Universal Medical Instrument Corp. | DWS |
| Sep 19, 1986 | K863178 | UMI STEERABLE TORQUE GUIDE WIRE Universal Medical Instrument Corp. | DQX |
| Aug 5, 1986 | K861984 | UMI CATH-SEAL, 13+14F & TRANSSEPTAL CATHETER INTRO Universal Medical Instrument Corp. | DYB |
| Feb 19, 1986 | K860168 | UMI (FRANSEEN,WESTCOTT,GREENE,MENGHINI)BIO. NEEDLE Universal Medical Instrument Corp. | |
| May 16, 1985 | K851088 | UMI ANGIOGRAPHIC CATHETER Universal Medical Instrument Corp. | DQO |
| Apr 10, 1985 | K850820 | PERCUTANEOUS CATHETER INTRODUCER W/CATH-SEAL & SID Universal Medical Instrument Corp. | DYB |
| Jan 31, 1985 | K844558 | UMI AMNIOCENTESIS KIT W/SPINAL NEEDLE Universal Medical Instrument Corp. | HIO |
| Aug 1, 1984 | K842259 | PCI W/CATH-SEAL SIDE FLOW FITTING Universal Medical Instrument Corp. | DYB |
| Jul 6, 1984 | K842012 | UMI CURVED CHEMONUCLEOLYSIS NEEDLE Universal Medical Instrument Corp. | FMI |
| Mar 15, 1984 | K834436 | CHEMONUCLEOLYSIS NEEDLE Universal Medical Instrument Corp. | FMI |
| Jan 3, 1984 | K833937 | UMI PERCUTANEOUS TRANSHEPATIC CHOLAN Universal Medical Instrument Corp. | FGE |
| Aug 31, 1983 | K832193 | NICE PACK Universal Medical Instrument Corp. | IME |
| Jan 18, 1983 | K830019 | AMNIO CENTESES KIT W/NEEDLE Universal Medical Instrument Corp. | HIO |
| Oct 18, 1982 | K822586 | TEFLON COATED GUIDE WIRES & CATHETER Universal Medical Instrument Corp. | DQX |
| Aug 31, 1982 | K822290 | STERILE PROTECTIVE SLEEVE W/TOUGH-BORST Universal Medical Instrument Corp. | DQO |
| Aug 19, 1982 | K822247 | CATH-SEAL Universal Medical Instrument Corp. | DYB |
| Nov 16, 1981 | K812999 | PET POLYETHYLENE TORQUE CATHETER Universal Medical Instrument Corp. | DQO |
| Apr 5, 1977 | K770569 | CATHETER, EMBOLECTOMY, UMI Universal Medical Instrument Corp. | DXE |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||