Company ยท US
Contour Fabricators, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1979 to 2009. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| EAJ | Apron, Leaded | 1 |
| FMQ | Restraint, Protective | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 |
| IZL | System, X-Ray, Mobile | 1 |
| KKX | Drape, Surgical, Antimicrobial | 1 |
| MMP | Cover, Barrier, Protective | 1 |
| MOS | Coil, Magnetic Resonance, Specialty | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 18, 2009 | K090773 | CFI ULTRASOUND PROBE DRAPE Contour Fabricators, Inc. | IYO |
| May 22, 1997 | K970900 | INSTRUMENT HOLDER Contour Fabricators, Inc. | GCJ |
| Apr 16, 1997 | K971040 | CABLE HOLDER, SUCTION TUBE HOLDER Contour Fabricators, Inc. | GEI |
| Apr 10, 1997 | K970185 | STERILE DISPOSABLE EQUIPMENT MAGNET COVER Contour Fabricators, Inc. | KKX |
| Jan 30, 1997 | K964141 | GE STERILE DISPOSABLE EQUIPMENT COIL COVER Contour Fabricators, Inc. | MOS |
| Nov 15, 1996 | K963453 | CFI RESTRAINT BELT (CFI-168) / CFI RESTRAINT BELT (CFI-4046) Contour Fabricators, Inc. | FMQ |
| May 3, 1982 | K820692 | BANDBAG, WRAP, STERILE Contour Fabricators, Inc. | MMP |
| Jan 17, 1979 | K782155 | GENERAL EQUIPMENT COVER Contour Fabricators, Inc. | IZL |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 13, 2016 | Contour Fabricators Inc Zero-Gravity Radiation Protection System
Radiology
Personnel protective shield. Terminated |
EAJ | None listed |