Sorin Group Deutschland GmbH
Sorin Group Deutschland GmbH holds FDA 510(k) medical device clearances, first cleared 2006, most recent 2017, with 4 FDA device recalls on record.
Top product codes for Sorin Group Deutschland GmbH
FDA recalls by Sorin Group Deutschland GmbH
- Z-0401-2018 — CP5 Centrifugal Pump, made up of the drive unit, the emergency system and the pump control panel. It used with an Electrical Remote-Controlled (ERC) tubing clamp and a bubble sensor.
- Z-0857-2014 — CP5 centrifugal pump system Product Usage: The Stockert S5/ Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.
- Z-0856-2014 — S5/C5 Heart-lung machine Product Usage: The StOckert S5/ Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.
- Z-0142-2014 — S5 Heart-lung machine, Stockert S5 System. Catalogue No: 48-30/40/50-00. The Stockert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six(6) hours or less.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Sorin Group Deutschland GmbH
- K170460 — Sorin Connect
- K131553 — XTRA
- K140012 — SORIN FLEXTHERM
- K131816 — SORIN CONNECT DATA MANAGEMENT SYSTEM
- K112225 — SORIN CENTRIFUGAL PUMP 5 (CP5)
- K103468 — STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (COMPLETE) OR (FOR S5/C5 SYSTEMS)
- K103762 — SORIN C5 SYSTEM; 85/C5 MAST ROLLER PUMP SYSTEM 150(1X RP 150 AND CONTROL PANEL WITH CONNECTING CABLES); S5/C5 MAST ROLLE
- K103469 — STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05
- K103168 — B-CARE5 (B-CARE5 SENSOR MODULE, VENOUS SENSOR, HOLDER FOR MEASURING HEAD)
- K101046 — STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM
- K093882 — SORIN C5 SYSTEM MODEL 58-00-00
- K092463 — SORIN B-CARE5 FOR THE STOCKERT S5 SYSTEM
- K091008 — STOCKERT CENTRIFUGAL PUMP PLUS SYSTEM (SCP PLUS), MODELS 60-00-10, 60-00-55
- K091007 — AIR PURGE CONTROL SYSTEM FOR S5 SYSTEM MODEL 23-45-05
- K082344 — STOCKERT S5 SYSTEM, STOCKERT ELECTRICAL VENOUS OCCLUDER (EVO)
- K080832 — STOCKERT S5 SYSTEM, STOCKERT GAS BLENDER
- K071318 — MODIFICATION TO: STOCKERT S5 SYSTEM
- K062396 — MODIFICATION TO STOCKERT S5 SYSTEM
- K052601 — STOCKERT HEATER-COOLER SYSTEM 3T
- K060053 — STOCKERT S5 SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.