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Codman CereLink ICP Sensor Basic Kit. Catalog Number: 826850. The Codman CereLink ICP Sensor Basic Kit consists of the CereLink ICP Sensor (ICP Sensor) and a 14-gauge Tuohy needle with stylet. The ICP Sensor is a nylon tube with a microminiature strain gauge pressure transducer (sensing element) mounted at one end and an electrical connector at the other end. It is designed for use with a Codman intracranial pressure monitoring device. The ICP Sensor Basic Kit is designed for use with the Codman Cranial Hand Drill. The drill facilitates access to the intraparenchymal area. The drill is also available as a component of the Codman Cranial Access Kit. Use of the ICP Sensor Basic Kit is indicated when direct ICP monitoring is required. The kit is indicated for use in both subdural and intraparenchymal pressure monitoring applications only.

FDA Recall
Open, Classified ·Integra LifeSciences Corp. (NeuroSciences)·Product code GWM·December 12, 2025

Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headset dock), 00-1007-R and 00-1007 (Tempus Pro non-printer, IBP, with headset dock), 00-1024-R (Tempus Pro printer), 00-1026-R (Tempus Pro printer, IBP), 00-1007 [(Tempus Pro, BT Dock (IB Only)], 00-1004 00-1004 [Tempus Pro (IB Only)]

FDA Recall
Open, Classified ·Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom·Product code MHX·April 16, 2025

CereLink ICP Extension Cable (Extension Cable), Model No. 826845 Used with Codman CereLink Intracranial Pressure (ICP) Monitor, Model No. 826820/826820P. Cable is also provided with monitor as part of the same SKU.

FDA Recall
Open, Classified ·Integra LifeSciences Corp.·Product code GWM·October 5, 2023

Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx.

FDA Recall
Open, Classified ·Brasseler USA I Lp·Product code EJL·January 11, 2024

CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracranial pressure monitor.

FDA Recall
Open, Classified ·Integra LifeSciences Corp.·Product code GWM·June 22, 2022

medex TranStar Single ICP Set 1/EA, Product Code REF MX20897

FDA Recall
Open, Classified ·Smiths Medical ASD, Inc.·Product code GWM·September 24, 2024

The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor

FDA Recall
Open, Classified ·Sophysa Rue Sophie Germain Besancon France·Product code GWM·November 17, 2025

Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2, REF IAP-0435 (IPN000312), cardiac pump

FDA Recall
Open, Classified ·ARROW INTERNATIONAL Inc.·Product code DSP·October 17, 2022

Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE, REF IAP-0500 (IPN000320), cardiac pump

FDA Recall
Open, Classified ·ARROW INTERNATIONAL Inc.·Product code DSP·October 17, 2022

Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500NL (IPN000326), cardiac pump

FDA Recall
Open, Classified ·ARROW INTERNATIONAL Inc.·Product code DSP·October 17, 2022

Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT 2 WAVE, REF IAP-0535 (IPN000329), cardiac pump

FDA Recall
Open, Classified ·ARROW INTERNATIONAL Inc.·Product code DSP·October 17, 2022

Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2 WAVE REFURBISHED, REF IAP-0535X (IPN000329), cardiac pump

FDA Recall
Open, Classified ·ARROW INTERNATIONAL Inc.·Product code DSP·October 17, 2022

Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE REFURBISHED, REF IAP-0500X (IPN000328), cardiac pump

FDA Recall
Open, Classified ·ARROW INTERNATIONAL Inc.·Product code DSP·October 17, 2022

Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 IAPB, REFURBISHED, REF IAP-0400X (IPN000311), cardiac pump

FDA Recall
Open, Classified ·ARROW INTERNATIONAL Inc.·Product code DSP·October 17, 2022

Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500EX (IPN000322), cardiac pump

FDA Recall
Open, Classified ·ARROW INTERNATIONAL Inc.·Product code DSP·October 17, 2022

Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN000334), cardiac pump

FDA Recall
Open, Classified ·ARROW INTERNATIONAL Inc.·Product code DSP·October 17, 2022

Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-05001 (IPN000333), cardiac pump

FDA Recall
Open, Classified ·ARROW INTERNATIONAL Inc.·Product code DSP·October 17, 2022

Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500F (IPN000323), cardiac pump

FDA Recall
Open, Classified ·ARROW INTERNATIONAL Inc.·Product code DSP·October 17, 2022

Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500D (IPN000321), cardiac pump

FDA Recall
Open, Classified ·ARROW INTERNATIONAL Inc.·Product code DSP·October 17, 2022

Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500E (IPN000322), cardiac pump

FDA Recall
Open, Classified ·ARROW INTERNATIONAL Inc.·Product code DSP·October 17, 2022