Medi-Tech, Inc.
Mchenry, IL, US
Medi-Tech, Inc. appears in FDA device records in Mchenry, IL. FDA records list 36 510(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
- 36
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 36 510(k) clearances for Medi-Tech, Inc. between 1978 and 1996. The busiest year on record is 1984, with 5. The most recent is 1996, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1978 | 1 |
| 1979 | 1 |
| 1981 | 3 |
| 1982 | 2 |
| 1983 | 1 |
| 1984 | 5 |
| 1985 | 3 |
| 1986 | 1 |
| 1987 | 2 |
| 1988 | 3 |
| 1989 | 5 |
| 1990 | 1 |
| 1994 | 5 |
| 1995 | 2 |
| 1996 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K954457 | MEDI-TECH EDDY INTRAVASCULAR INFUSION CATHETER | KRA | Substantially Equivalent | |
| K952345 | MEDI-TECH PLATFORM GUIDE CATHETER | DQY | Substantially Equivalent | |
| K952056 | IMMUNOASSAY DRUGS OF ABUSE CONTROLS | DIF | Substantially Equivalent | |
| K945289 | DOA - IMMUNOASSAY CUT-OFF CALIBRATOR | DKB | Substantially Equivalent | |
| K942551 | THERAPEUTIC DRUG MONITORING CONTROL, ASSAYED | DIF | Substantially Equivalent | |
| K943290 | BILIRUBIN PLUS/PEDIATRIC CONTROLS | JJY | Substantially Equivalent | |
| K922990 | HEMODIALYSIS BATH | KPO | Substantially Equivalent | |
| K942552 | THERAPEUTIC DRUG MONITORING CONTROL, UNASSAYED | DIF | Substantially Equivalent | |
| K904073 | COAGULATION REFERENCE PLASMA, ABNORMAL | GGC | Substantially Equivalent | |
| K895819 | MODIFIED LABELING TO THE SPAND-GEL GRANULATED GEL | KMF | Substantially Equivalent for Some Indications | |
| K873295 | PROSTATIC URETHRO. BALLOON DILATATION CATHETER | KOE | Substantially Equivalent | |
| K884354 | IMAGER FLUSH CATHETERS | DQO | Substantially Equivalent | |
| K883880 | KATZEN THROMBOLYSIS GUIDEWIRE | DQX | Substantially Equivalent | |
| K884513 | PF TEST | GMZ | Substantially Equivalent | |
| K874096 | TITANIUM GREENFIELD VENA CAVA FILTER CARRIER | DTK | Substantially Equivalent | |
| K883118 | ON THE SPOT CANDIDASURE | LRF | Substantially Equivalent | |
| K880298 | PERIPHERAL DILATATION CATHETER | LIT | Substantially Equivalent | |
| K870729 | TITANIUM PERCUTANEOUS GREENFIELD VENA CAVE FILTER | DTK | Substantially Equivalent | |
| K864118 | MEDI-TECH SELECTIVE TORQUE CATHETER | DQY | Substantially Equivalent | |
| K861599 | T-FASTENER | KNT | Substantially Equivalent | |
| K852097 | PERCUTANEOUS GREENFIELD VENA CAVA FILTER SYSTEM | DTK | Substantially Equivalent | |
| K852552 | COONS GASTROSTICK SYSTEM | KNT | Substantially Equivalent | |
| K851402 | LEVEEN INFLATOR DISPOSABLE INFLATION SYRINGE | DXT | Substantially Equivalent | |
| K843012 | WIREGUIDE OR GUIDEWIRE | DQX | Substantially Equivalent | |
| K844292 | MEDI-TECH DILATATION CATHETERS | LCN | Substantially Equivalent | |
| K843383 | MEDI-TECH DILATATION CATHETERS | LIT | Substantially Equivalent | |
| K842890 | PERCUFIX CATHETER CUFF | KOD | Substantially Equivalent | |
| K842205 | OXY-VAC | BSY | Substantially Equivalent | |
| K830483 | COONS SOFT STENT | FGE | Substantially Equivalent | |
| K821816 | ANGIOGRAPHIC CATHETER | DQO | Substantially Equivalent | |
| K821348 | HYPODERMIC NEEDLES & SYRINGES | GAA | Substantially Equivalent | |
| K812279 | ENTER-A1 ENTERIC FEEDING TUBE | KNT | Substantially Equivalent | |
| K811378 | PERCUTANEOUS DRAINING CATHETER | GBW | Substantially Equivalent | |
| K810336 | POLYPECTOMY SNARE | KNS | Substantially Equivalent | |
| K781772 | CATHETER, TRANSLUMINAL BALLOON | GBA | Substantially Equivalent | |
| K781780 | CATHETER, EXTERNAL MALE NURSING CARE | KNX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- GMZAntigens, All Types, Escherichia Coli
- KMFBandage, Liquid
- DKBCalibrators, Drug Mixture
- LRFCandida Spp., Direct Antigen, Id
- LITCatheter, Angioplasty, Peripheral, Transluminal
- GBACatheter, Balloon Type
- KRACatheter, Continuous Flush
- DQOCatheter, Intravascular, Diagnostic
- DQYCatheter, Percutaneous
- GBWCatheter, Peritoneal
- KODCatheter, Urological
- BSYCatheters, Suction, Tracheobronchial
- KNXCollector, Urine, (And Accessories) For Indwelling Catheter
- GGCControl, Plasma, Abnormal
- KPODialysate Concentrate For Hemodialysis (Liquid Or Powder)
- KOEDilator, Urethral
- DIFDrug Mixture Control Materials
- DTKFilter, Intravascular, Cardiovascular
- DXTInjector And Syringe, Angiographic
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- GAANeedle, Aspiration And Injection, Disposable
- LCNScraper, Tongue
- FGEStents, Drains And Dilators For The Biliary Ducts
- KNTTubes, Gastrointestinal (And Accessories)
- KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)
- 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