Medical Engineering Corp.
Mchenry, IL, US
Medical Engineering Corp. appears in FDA device records in Mchenry, IL. FDA records list 28 510(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
- 28
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 28 510(k) clearances for Medical Engineering Corp. between 1977 and 1993. The busiest year on record is 1983, with 7. The most recent is 1993, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1978 | 2 |
| 1979 | 1 |
| 1980 | 4 |
| 1981 | 1 |
| 1982 | 2 |
| 1983 | 7 |
| 1984 | 1 |
| 1988 | 3 |
| 1989 | 2 |
| 1990 | 1 |
| 1991 | 2 |
| 1993 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K934141 | STAND ALONE CYSTOMETROGRAM | FEN | Substantially Equivalent | |
| K905289 | SURGITEK(R) LUBRI-FLEX(TM) URETERAL STENT | FAD | Substantially Equivalent | |
| K903448 | SURGITEK TEX-SPAN TEXTURED TISSUE EXPANDER | LCJ | Substantially Equivalent | |
| K902773 | SURGITEK(R) FLEXIBLE URETEROSCOPY INTRO/SHEATH SET | FGB | Substantially Equivalent | |
| K884746 | SURGITEK FLAT T-SPAN | LCJ | Substantially Equivalent | |
| K883274 | SURGITEK (R) UROFLOW SYSTEM | FFG | Substantially Equivalent | |
| K881736 | SURGITEK CO2 DELIVERY SYSTEM | FAP | Substantially Equivalent | |
| K880802 | SURGITEK ARTICULATING URETEROSCOPE MODEL SU-11 | FGB | Substantially Equivalent | |
| K880801 | SURGITEK FLEXIBLE URETEROSCOPE SU-7 & SU-9 | FGB | Substantially Equivalent | |
| K842748 | SURGITEK RECONSTRUC-NIPPLE PROSTHESIS | Substantially Equivalent | ||
| K832043 | SURGIKEK PENILE PROSTHESIS TAIL EXTEND | FAE | Substantially Equivalent | |
| K833008 | PERCUTANEOUS NEPHROSTOMY CATHETER | LJE | Substantially Equivalent | |
| K831857 | SURGITEK PERCUTANEOUS ARNEGRADE SILITEK | FAD | Substantially Equivalent | |
| K830884 | SURGITEKS PERCUTANEOUS ANTEGRADE ALL - | FAD | Substantially Equivalent | |
| K823757 | SURGITEK ENDOTRACHEAL TUBE, LASER RESIS | BTR | Substantially Equivalent | |
| K830917 | SURGITEK SIZER FOR PENILE PROSTHESIS | FAE | Substantially Equivalent | |
| K830226 | SURGITEK PERCUTANEOUS NEPHROSTOMY CATH | LJE | Substantially Equivalent | |
| K822295 | SURGI TEK'S DISPOS. INNER CANNULA FOR | BTO | Substantially Equivalent | |
| K821776 | SURGITEK PERCUTANEOUS NEPHROST. STENT | LJE | Substantially Equivalent | |
| K803156 | SURGITEK MEDI-LOOPS | KDC | Substantially Equivalent | |
| K800331 | SURGITEK FOERSTER FACE LIFT DRAIN | GCY | Substantially Equivalent | |
| K800109 | SURGITEK URINARY DIVERSION STENT | FAD | Substantially Equivalent | |
| K800249 | SURGITEK FOERSTER MAMMARY BANDAGE | FRL | Substantially Equivalent | |
| K800248 | SURGITEK FOERSTER FACE LIFT BANDAGE | FRL | Substantially Equivalent | |
| K790245 | STANDARD PECTORALIS MUSCLE IMPLANT | Substantially Equivalent | ||
| K781641 | SURGITEK DOUBLE J URETEROL STENT | FAD | Substantially Equivalent | |
| K781336 | SURGITEK DISPOSABLE FLO-RESTER | DWS | Substantially Equivalent | |
| K761328 | ANASTOMASIS OCCLUDER | DWS | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered
- LJECatheter, Nephrostomy
- FAPCystometric Gas (Carbon-Dioxide) On Hydraulic Device
- FENDevice, Cystometric, Hydraulic
- FFGDevice, Urine Flow Rate Measuring, Non-Electrical, Disposable
- FRLFiber, Medical, Absorbent
- KDCInstrument, Surgical, Disposable
- DWSInstruments, Surgical, Cardiovascular
- FAEProsthesis, Penile
- FADStent, Ureteral
- LCJTissue Expander And Accessories
- BTRTube, Tracheal (W/Wo Connector)
- BTOTube, Tracheostomy (W/Wo Connector)
- FGBUreteroscope And Accessories, Flexible/Rigid
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