Carbomedics, Inc.
Mchenry, IL, US
Carbomedics, Inc. appears in FDA device records in Mchenry, IL. FDA records list 22 510(k) clearances between and , 5 PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 22 510(k) clearances for Carbomedics, Inc. between 1979 and 1997. The busiest year on record is 1984, with 5. The most recent is 1997, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1979 | 3 |
| 1981 | 2 |
| 1983 | 1 |
| 1984 | 5 |
| 1993 | 1 |
| 1994 | 1 |
| 1995 | 2 |
| 1996 | 5 |
| 1997 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K970375 | ANNULOFLO SYSTEM | KRH | Substantially Equivalent - Subject to Tracking Reg. | |
| K964665 | VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION) | DSY | Substantially Equivalent - Subject to Tracking Reg. | |
| K962154 | CARBOMEDICS HANDLE | DTJ | Substantially Equivalent | |
| K960923 | CARBOMEDICS MITRAL ROTATOR | MOP | Substantially Equivalent | |
| K960706 | VASCUTEK VASCUSOFT PLUS VASCULAR GRAFT | DSY | Unknown | |
| K960169 | CARBOMEDICS VALVE TESTER | DTJ | Substantially Equivalent | |
| K955588 | VASCUTEK GRAFT SIZER SET | DSY | Substantially Equivalent - Subject to Tracking Reg. | |
| K952184 | CARBOMEDICS SUPRA-ANNULAR VALVE SIZER | DTI | Substantially Equivalent | |
| K951368 | CARBOMEDICS EXENDED MITRAL ROTATOR | MOP | Substantially Equivalent | |
| K942736 | CARBOMEDICS(R) PROSTHETIC HEART VALVE HOLDER HANDLE | DTJ | Substantially Equivalent | |
| K934951 | VALVE SIZER | DTI | Substantially Equivalent | |
| K842893 | DORR HIP PROSTHESIS, ACETABULAR COMPON | JDL | Substantially Equivalent | |
| K842360 | DORR HIP PROSTHESIS FEMORAL COMPONENT | JDI | Substantially Equivalent | |
| K833404 | BDH BIPOLAR FEMORAL COMPONENT A3 | KWY | Substantially Equivalent | |
| K834040 | MINATURE PRESSURE TRANSDUCER | DXO | Substantially Equivalent | |
| K833403 | BDH UNIPOLAR FEMORAL COMPONENT A2 | KWL | Substantially Equivalent | |
| K833468 | BDH UNIVERSAL HIP SYSTEM SURGEON | JDG | Substantially Equivalent | |
| K811101 | HYDROXYLAPATITE | LYC | Substantially Equivalent | |
| K810382 | HYDROXYLAPATITE ALVEOLAR RIDGE MAIN | LYC | Substantially Equivalent | |
| K791416 | PYROLITE CARBON ALVEOLAR MAINTEN IMPLANT | LYC | Substantially Equivalent | |
| K791491 | BIOLITE CARBON COATED DENTAL IMPLANT | DZE | Substantially Equivalent | |
| K791237 | PYROLITE CARBON ENDOSSEOUS DENTAL IMPL | DZE | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- LYCBone Grafting Material, Synthetic
- MALGraft, Vascular, Synthetic/Biologic Composite
- DTJHolder, Heart-Valve, Prosthesis
- DZEImplant, Endosseous, Root-Form
- JDGProsthesis, Hip, Femoral Component, Cemented, Metal
- KWLProsthesis, Hip, Hemi-, Femoral, Metal
- KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- JDLProsthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
- JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- DSYProsthesis, Vascular Graft, Of 6mm And Greater Diameter
- KRHRing, Annuloplasty
- MOPRotator, Prosthetic Heart Valve
- DTISizer, Heart-Valve, Prosthesis
- DXOTransducer, Pressure, Catheter Tip
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0738-04 | Carbomedics VT-200 Valve Tester | Excessive cleaning and resterilization cause cracking and crazing of device causing the device to malfunction during use. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain