Company ยท US
Med-Tek Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1978 to 1990. Name variants (Inc, Corp, punctuation) are merged.
16510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 4 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 3 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | 2 |
| BTC | Bag, Reservoir | 1 |
| CAH | Filter, Bacterial, Breathing-Circuit | 1 |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 1 |
| DXW | System, Phonocatheter, Intracavitary | 1 |
| HTY | Pin, Fixation, Smooth | 1 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 1 |
| KWA | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 10, 1990 | K903234 | F-19 TOTAL HIP PROSTHESIS Med-Tek Corp. | JDI |
| Sep 7, 1990 | K901687 | F-24 FEMORAL HIP PROSTHESIS Med-Tek Corp. | LWJ |
| Aug 31, 1990 | K901451 | F-20 CEMENTED METAL-BACKED ACETABULAR CUP Med-Tek Corp. | JDI |
| Aug 17, 1990 | K900428 | ANESTHESIA BREATHING CIRCUITS Med-Tek Corp. | CAI |
| Aug 14, 1990 | K901626 | H.N. METAL BACKED ACETABULAR CUP, NONCEMENTED Med-Tek Corp. | KWA |
| Aug 3, 1990 | K901594 | H.N. TOTAL HIP PROSTHESIS Med-Tek Corp. | LWJ |
| Jun 12, 1990 | K901480 | F-20 TOTAL HIP PROSTHESIS Med-Tek Corp. | JDI |
| Jun 5, 1990 | K901273 | L.M.S. SELF-DETACHABLE BROACH WITH STOP Med-Tek Corp. | HTY |
| Apr 23, 1990 | K901272 | ORION BLADE PLATE FOR TIBIAL OSTEOTOMY Med-Tek Corp. | KTT |
| Mar 26, 1990 | K901240 | ASTEL NON-METAL BACKED ACETABULAR CUP FOR CEMENTED Med-Tek Corp. | JDI |
| Nov 2, 1989 | K894978 | BACTERIAL FILTER Med-Tek Corp. | CAH |
| Sep 18, 1989 | K894906 | ANESTHESIA BREATHING BAGS SIZES 1/2, 1,2,3 LITER Med-Tek Corp. | BTC |
| Aug 13, 1981 | K812059 | SPHGOMOMANOMETER Med-Tek Corp. | DXN |
| Apr 2, 1980 | K800614 | MEDTEK #411 PORTABLE B-P INSTR. Med-Tek Corp. | DXN |
| Feb 29, 1980 | K800222 | MODEL 412 ELECTROFLUIDIC MANOMETER Med-Tek Corp. | DXW |
| Nov 16, 1978 | K781906 | BLOOD PRESSURE DEVICE, 400 SERIES Med-Tek Corp. | DXN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||