Company ยท US
Carbomedics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1979 to 1997. Name variants (Inc, Corp, punctuation) are merged.
22510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DTJ | Holder, Heart-Valve, Prosthesis | 4 |
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | 3 |
| LYC | Bone Grafting Material, Synthetic | 3 |
| DTI | Sizer, Heart-Valve, Prosthesis | 2 |
| DZE | Implant, Endosseous, Root-Form | 2 |
| MOP | Rotator, Prosthetic Heart Valve | 2 |
| DXO | Transducer, Pressure, Catheter Tip | 1 |
| JDG | Prosthesis, Hip, Femoral Component, Cemented, Metal | 1 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 1 |
| JDL | Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) | 1 |
| KRH | Ring, Annuloplasty | 1 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | 1 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 25, 1997 | K970375 | ANNULOFLO SYSTEM Carbomedics, Inc. | KRH |
| Feb 19, 1997 | K964665 | VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION) Carbomedics, Inc. | DSY |
| Aug 27, 1996 | K962154 | CARBOMEDICS HANDLE Carbomedics, Inc. | DTJ |
| Apr 29, 1996 | K960923 | CARBOMEDICS MITRAL ROTATOR Carbomedics, Inc. | MOP |
| Apr 25, 1996 | K960706 | VASCUTEK VASCUSOFT PLUS VASCULAR GRAFT Carbomedics, Inc. | DSY |
| Apr 15, 1996 | K960169 | CARBOMEDICS VALVE TESTER Carbomedics, Inc. | DTJ |
| Mar 7, 1996 | K955588 | VASCUTEK GRAFT SIZER SET Carbomedics, Inc. | DSY |
| Nov 29, 1995 | K952184 | CARBOMEDICS SUPRA-ANNULAR VALVE SIZER Carbomedics, Inc. | DTI |
| Jun 20, 1995 | K951368 | CARBOMEDICS EXENDED MITRAL ROTATOR Carbomedics, Inc. | MOP |
| Jul 6, 1994 | K942736 | CARBOMEDICS(R) PROSTHETIC HEART VALVE HOLDER HANDLE Carbomedics, Inc. | DTJ |
| Dec 10, 1993 | K934951 | VALVE SIZER Carbomedics, Inc. | DTI |
| Nov 8, 1984 | K842893 | DORR HIP PROSTHESIS, ACETABULAR COMPON Carbomedics, Inc. | JDL |
| Oct 2, 1984 | K842360 | DORR HIP PROSTHESIS FEMORAL COMPONENT Carbomedics, Inc. | JDI |
| Mar 2, 1984 | K833404 | BDH BIPOLAR FEMORAL COMPONENT A3 Carbomedics, Inc. | KWY |
| Feb 10, 1984 | K834040 | MINATURE PRESSURE TRANSDUCER Carbomedics, Inc. | DXO |
| Jan 10, 1984 | K833403 | BDH UNIPOLAR FEMORAL COMPONENT A2 Carbomedics, Inc. | KWL |
| Dec 27, 1983 | K833468 | BDH UNIVERSAL HIP SYSTEM SURGEON Carbomedics, Inc. | JDG |
| Nov 20, 1981 | K811101 | HYDROXYLAPATITE Carbomedics, Inc. | LYC |
| Mar 20, 1981 | K810382 | HYDROXYLAPATITE ALVEOLAR RIDGE MAIN Carbomedics, Inc. | LYC |
| Oct 9, 1979 | K791416 | PYROLITE CARBON ALVEOLAR MAINTEN IMPLANT Carbomedics, Inc. | LYC |
| Sep 4, 1979 | K791491 | BIOLITE CARBON COATED DENTAL IMPLANT Carbomedics, Inc. | DZE |
| Aug 28, 1979 | K791237 | PYROLITE CARBON ENDOSSEOUS DENTAL IMPL Carbomedics, Inc. | DZE |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Carbomedics, Inc Carbomedics VT-200 Valve Tester Terminated |
DTJ | K960169 |