Universal Medical Instrument Corp.
Mchenry, IL, US
Universal Medical Instrument Corp. appears in FDA device records in Mchenry, IL. FDA records list 21 510(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
- 21
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 21 510(k) clearances for Universal Medical Instrument Corp. between 1977 and 1996. The busiest year on record is 1984, with 4. The most recent is 1996, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1981 | 1 |
| 1982 | 3 |
| 1983 | 2 |
| 1984 | 4 |
| 1985 | 3 |
| 1986 | 3 |
| 1988 | 1 |
| 1990 | 1 |
| 1994 | 1 |
| 1996 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K962180 | CATH SEAL | DYB | Substantially Equivalent | |
| K935077 | CATH-SEAL | DYB | Substantially Equivalent | |
| K897128 | UMI BRAIDED CATHETER CONNECTOR | LYY | Substantially Equivalent | |
| K881796 | UMI DISPOSABLE BUTTERFLY STYLE PUNCTURE NEEDLE | DWS | Substantially Equivalent | |
| K863178 | UMI STEERABLE TORQUE GUIDE WIRE | DQX | Substantially Equivalent | |
| K861984 | UMI CATH-SEAL, 13+14F & TRANSSEPTAL CATHETER INTRO | DYB | Substantially Equivalent | |
| K860168 | UMI (FRANSEEN,WESTCOTT,GREENE,MENGHINI)BIO. NEEDLE | Substantially Equivalent | ||
| K851088 | UMI ANGIOGRAPHIC CATHETER | DQO | Substantially Equivalent | |
| K850820 | PERCUTANEOUS CATHETER INTRODUCER W/CATH-SEAL & SID | DYB | Substantially Equivalent | |
| K844558 | UMI AMNIOCENTESIS KIT W/SPINAL NEEDLE | HIO | Substantially Equivalent | |
| K842259 | PCI W/CATH-SEAL SIDE FLOW FITTING | DYB | Substantially Equivalent | |
| K842012 | UMI CURVED CHEMONUCLEOLYSIS NEEDLE | FMI | Substantially Equivalent | |
| K834436 | CHEMONUCLEOLYSIS NEEDLE | FMI | Substantially Equivalent | |
| K833937 | UMI PERCUTANEOUS TRANSHEPATIC CHOLAN | FGE | Substantially Equivalent | |
| K832193 | NICE PACK | IME | Substantially Equivalent | |
| K830019 | AMNIO CENTESES KIT W/NEEDLE | HIO | Substantially Equivalent | |
| K822586 | TEFLON COATED GUIDE WIRES & CATHETER | DQX | Substantially Equivalent | |
| K822290 | STERILE PROTECTIVE SLEEVE W/TOUGH-BORST | DQO | Substantially Equivalent | |
| K822247 | CATH-SEAL | DYB | Substantially Equivalent | |
| K812999 | PET POLYETHYLENE TORQUE CATHETER | DQO | Substantially Equivalent | |
| K770569 | CATHETER, EMBOLECTOMY, UMI | DXE | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DXECatheter, Embolectomy
- DQOCatheter, Intravascular, Diagnostic
- DWSInstruments, Surgical, Cardiovascular
- DYBIntroducer, Catheter
- LYYLatex Patient Examination Glove
- FMINeedle, Hypodermic, Single Lumen
- IMEPack, Hot Or Cold, Reusable
- HIOSampler, Amniotic Fluid (Amniocentesis Tray)
- FGEStents, Drains And Dilators For The Biliary Ducts
- DQXWire, Guide, Catheter
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