Company ยท US
Sorin Biomedica, Fiat, USA, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1980 to 1994. Name variants (Inc, Corp, punctuation) are merged.
20510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 2 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 2 |
| DXY | Implantable Pacemaker Pulse-Generator | 2 |
| KRL | Detector, Bubble, Cardiopulmonary Bypass | 2 |
| CBI | Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) | 1 |
| CEW | Radioimmunoassay, Parathyroid Hormone | 1 |
| CFP | Radioimmunoassay, Immunoreactive Insulin | 1 |
| CGR | Radioimmunoassay, Cortisol | 1 |
| CHP | Radioimmunoassay, Estradiol | 1 |
| CIB | Radioimmunoassay, Angiotensin I And Renin | 1 |
| CJM | Radioimmunoassay, Aldosterone | 1 |
| DTB | Permanent Pacemaker Electrode | 1 |
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | 1 |
| DTW | Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass | 1 |
| JLS | Radioimmunoassay, Progesterone | 1 |
| LCS | Radioimmunoassay, Digoxin (125-I) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 27, 1994 | K931444 | PLEXUS 2 & 3.5 HOLLOW FIBER OXYGENATORS Sorin Biomedica, Fiat, USA, Inc. | DTZ |
| May 18, 1993 | K925661 | STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULE Sorin Biomedica, Fiat, USA, Inc. | KRL |
| Mar 26, 1993 | K925615 | SHILEY SPECIALIZED,PEDIATRIC & NEONATAL TRACH.TUBE Sorin Biomedica, Fiat, USA, Inc. | CBI |
| Mar 26, 1993 | K925369 | BCD ADVANCED BLOOD CARIOPLEGIA SYSTEMS Sorin Biomedica, Fiat, USA, Inc. | DTR |
| Feb 18, 1993 | K924354 | STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITOR Sorin Biomedica, Fiat, USA, Inc. | DTW |
| Feb 2, 1993 | K925541 | STOCKERT 1/4 BUBBLE SENSOR Sorin Biomedica, Fiat, USA, Inc. | KRL |
| Nov 30, 1992 | K922933 | SORIN MONOLYRH INTEGRATED MEMBRANE LUNG Sorin Biomedica, Fiat, USA, Inc. | DTZ |
| Jun 24, 1986 | K854963 | S80 IMPLANTABLE CARDIAC PACING LEAD Sorin Biomedica, Fiat, USA, Inc., IT | DTB |
| Jan 14, 1986 | K852641 | ORION 40 CARDIAC STIMULATOR & PMP 200 PROGRAMMER Sorin Biomedica, Fiat, USA, Inc. | DXY |
| Dec 3, 1985 | K851365 | SORIN BIOMEDICA ORION 30/A CARDIAC STIMULATOR & PM Sorin Biomedica, Fiat, USA, Inc. | DXY |
| Jun 25, 1984 | K841948 | TESTOSTERONE DIRECT RADIOIMMUNOASSAY Sorin Biomedica, Fiat, USA, Inc. | CDZ |
| Jun 25, 1984 | K841947 | ESTRADIOL DIRECT RADIOIMMUNOASSAY KIT Sorin Biomedica, Fiat, USA, Inc. | CHP |
| May 16, 1984 | K841573 | INSULIN RADIOIMMUNOASSAY KIT Sorin Biomedica, Fiat, USA, Inc. | CFP |
| Jan 11, 1984 | K832694 | DIRIA-PROGK IMMUNOASSAY Sorin Biomedica, Fiat, USA, Inc. | JLS |
| Dec 29, 1983 | K833768 | C. PTH RADIOIMMUNOASSAY KIT-CPTHK Sorin Biomedica, Fiat, USA, Inc. | CEW |
| May 13, 1983 | K830563 | CORTISOL RADIOIMMUNOASSAY KIT-CORTCTK Sorin Biomedica, Fiat, USA, Inc. | CGR |
| Apr 24, 1980 | K800773 | DIGOCTK 125 Sorin Biomedica, Fiat, USA, Inc. | LCS |
| Apr 21, 1980 | K800776 | TESTOK-125 Sorin Biomedica, Fiat, USA, Inc. | CDZ |
| Apr 21, 1980 | K800775 | ALDOCTK-125 Sorin Biomedica, Fiat, USA, Inc. | CJM |
| Apr 21, 1980 | K800774 | RENCTK Sorin Biomedica, Fiat, USA, Inc. | CIB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||