Sorin Biomedica, Fiat, USA, Inc.
Mchenry, IL, US
Sorin Biomedica, Fiat, USA, Inc. appears in FDA device records in Mchenry, IL. FDA records list 20 510(k) clearances between and , 3 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
- 20
- PMA records
- 3
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 20 510(k) clearances for Sorin Biomedica, Fiat, USA, Inc. between 1980 and 1994. The busiest year on record is 1993, with 5. The most recent is 1994, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1980 | 4 |
| 1983 | 2 |
| 1984 | 4 |
| 1985 | 1 |
| 1986 | 2 |
| 1992 | 1 |
| 1993 | 5 |
| 1994 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K931444 | PLEXUS 2 & 3.5 HOLLOW FIBER OXYGENATORS | DTZ | Substantially Equivalent | |
| K925661 | STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULE | KRL | Substantially Equivalent | |
| K925615 | SHILEY SPECIALIZED,PEDIATRIC & NEONATAL TRACH.TUBE | CBI | Substantially Equivalent | |
| K925369 | BCD ADVANCED BLOOD CARIOPLEGIA SYSTEMS | DTR | Substantially Equivalent | |
| K924354 | STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITOR | DTW | Substantially Equivalent | |
| K925541 | STOCKERT 1/4 BUBBLE SENSOR | KRL | Substantially Equivalent | |
| K922933 | SORIN MONOLYRH INTEGRATED MEMBRANE LUNG | DTZ | Substantially Equivalent | |
| K854963 | S80 IMPLANTABLE CARDIAC PACING LEAD | DTB | Substantially Equivalent | |
| K852641 | ORION 40 CARDIAC STIMULATOR & PMP 200 PROGRAMMER | DXY | Substantially Equivalent | |
| K851365 | SORIN BIOMEDICA ORION 30/A CARDIAC STIMULATOR & PM | DXY | Substantially Equivalent | |
| K841948 | TESTOSTERONE DIRECT RADIOIMMUNOASSAY | CDZ | Substantially Equivalent | |
| K841947 | ESTRADIOL DIRECT RADIOIMMUNOASSAY KIT | CHP | Substantially Equivalent | |
| K841573 | INSULIN RADIOIMMUNOASSAY KIT | CFP | Substantially Equivalent | |
| K832694 | DIRIA-PROGK IMMUNOASSAY | JLS | Substantially Equivalent | |
| K833768 | C. PTH RADIOIMMUNOASSAY KIT-CPTHK | CEW | Substantially Equivalent | |
| K830563 | CORTISOL RADIOIMMUNOASSAY KIT-CORTCTK | CGR | Substantially Equivalent | |
| K800773 | DIGOCTK 125 | LCS | Substantially Equivalent | |
| K800776 | TESTOK-125 | CDZ | Substantially Equivalent | |
| K800775 | ALDOCTK-125 | CJM | Substantially Equivalent | |
| K800774 | RENCTK | CIB | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KRLDetector, Bubble, Cardiopulmonary Bypass
- DTRHeat-Exchanger, Cardiopulmonary Bypass
- DXYImplantable Pacemaker Pulse-Generator
- DTWMonitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
- DTZOxygenator, Cardiopulmonary Bypass
- DTBPermanent Pacemaker Electrode
- CJMRadioimmunoassay, Aldosterone
- CIBRadioimmunoassay, Angiotensin I And Renin
- CGRRadioimmunoassay, Cortisol
- LCSRadioimmunoassay, Digoxin (125-I)
- CHPRadioimmunoassay, Estradiol
- CFPRadioimmunoassay, Immunoreactive Insulin
- CEWRadioimmunoassay, Parathyroid Hormone
- JLSRadioimmunoassay, Progesterone
- CDZRadioimmunoassay, Testosterones And Dihydrotestosterone
- LOMTest, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- CBITube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
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