Company
Sorin Group Italia SRL - CRF
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
9recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 28, 2017 | Sorin Group Italia SRL - CRF Platinium CRT-D 1741, Model Number TDF037U, UDI/GTIN 08031527015484, Implantable cardioverter defibrillator,
Biventricular or ventricular antitachycardia pacing,
Dual or single chamber arrhythmia Terminated |
NIK | None listed |
| Sep 28, 2017 | Sorin Group Italia SRL - CRF Platinium DR DF4 1540, Model Number TDF036U, UDI/GTIN 08031527015477, Implantable cardioverter defibrillator,
Biventricular or ventricular antitachycardia pacing,
Dual or single chamber arrhythmia Terminated |
MRM | None listed |
| Sep 28, 2017 | Sorin Group Italia SRL - CRF Platinium VR DF4 1240, Model Number TDF035U, UDI/GTIN 08031527015460, Implantable cardioverter defibrillator,
Biventricular or ventricular antitachycardia pacing,
Dual or single chamber arrhythmia Terminated |
MRM | None listed |
| Sep 28, 2017 | Sorin Group Italia SRL - CRF Platinium CRT DF1 1711, Model Number TDF033U, UDI/GTIN 08031527015538, Implantable cardioverter defibrillator,
Biventricular or ventricular antitachycardia pacing,
Dual or single chamber arrhythmi Terminated |
NIK | None listed |
| Sep 28, 2017 | Sorin Group Italia SRL - CRF Platinium DR 1510, Model Number TDF032U, UDI/GTIN 08031527015521, Implantable cardioverter defibrillator,
Biventricular or ventricular antitachycardia pacing,
Dual or single chamber arrhythmia det Terminated |
MRM | None listed |
| Sep 28, 2017 | Sorin Group Italia SRL - CRF Platinium VR 1210, Model Number TDF031U, UDI/GTIN 08031527015514, Implantable cardioverter defibrillator,
Biventricular or ventricular antitachycardia pacing,
Dual or single chamber arrhythmia det Terminated |
MRM | None listed |
| Apr 11, 2017 | Sorin Group Italia SRL - CRF INTENSIA Models: VR 124, DR 154, CRT-D 174
Product Usage:
OVATIO VR 6250, OVATIO DR 6550, PARADYM VR 8250, PARADYM DR 8550, PARADYM RF VR 9250, PARADYM RF DR 9550, INTENSIA VR 124 and INTENSIA DR 15 Terminated |
MRM | None listed |
| Apr 11, 2017 | Sorin Group Italia SRL - CRF PARADYM Models: VR 8250, DR 8550, CRT-D 8750, RF VR 9250, RF DR 9550, RF CRT-D 9750, SonR 8770, RF SonR 9770
Product Usage:
OVATIO VR 6250, OVATIO DR 6550, PARADYM VR 8250, PARADYM DR 8550, PARADYM Terminated |
MRM | None listed |
| Apr 11, 2017 | Sorin Group Italia SRL - CRF OVATIO Models: VR 6250, DR 6550, CRT 6750.
Product Usage:
OVATIO VR 6250, OVATIO DR 6550, PARADYM VR 8250, PARADYM DR 8550, PARADYM RF VR 9250, PARADYM RF DR 9550, INTENSIA VR 124 and INTENSIA DR 1 Terminated |
MRM | None listed |