55 results
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Sources: EU EUDAMED, US FDA
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Brand Name: EmpowerCT/EmpowerCTA Injector System Ceiling Column Accessory; Common/Usual Name: CT Injector System Ceiling Column Accessory, Catalog Number 9886S. Ceiling Column Accessory: The CT and CTA Injector Systems employs an Articulating Arm that mounts to the Ceiling Column Accessory, which are designated as 9886S (11.25''), M (21.50''), and L (34.50''), i.e. 9886L.
FDA Recall
Terminated
·E-Z-EM, Inc·Product code JAK·December 3, 2004
Brand Name of Device: EmpowerCT/EmpowerCTA Injector System Ceiling Column Accessory; Common/Usual Name: CT Injector System Ceiling Column Accessory, Catalog Number 9886L. Ceiling Column Accessory: The CT and CTA Injector Systems employs an Articulating Arm that mounts to the Ceiling Column Accessory, which are designated as 9886S (11.25''), M (21.50''), and L (34.50''), i.e. 9886L.
FDA Recall
Terminated
·E-Z-EM, Inc·Product code JAK·December 3, 2004
Brand Name: EmpowerCT/EmpowerCTA Injector System Ceiling Column Accessory; Common/Usual Name: CT Injector System Ceiling Column Accessory, Catalog Number 9886M. Ceiling Column Accessory: The CT and CTA Injector Systems employs an Articulating Arm that mounts to the Ceiling Column Accessory, which are designated as 9886S (11.25''), M (21.50''), and L (34.50''), i.e. 9886L.
FDA Recall
Terminated
·E-Z-EM, Inc·Product code JAK·December 3, 2004
Exacta External Drainage and Monitoring System: 27581 KIT 27581 EXACTA W/EDM VCATH 35CM 27636 EDM 27636 EXACTA W/BRAIDED CORD LOCK 27666 EDM 27666 EXCTA W GLUE STPCK GR PT LN 27732 EDM 27732 EXACTA W/NDL-LS INJ. ST W/CAP 27785 EDMS 27785 EXACTA 50ML BC NDLESS INJ 27795 EDMS 27795 EXACTA 100ML CATH 27861 EDMS 27861 EXACTA 50ML ANTIRFLUX GRNPL 46700 SYSTEM 46700 EXACTA DISP. DRAINAGE 46705 SYSTEM 46705 EXACTA DRAINAGE 100ML The Exacta external drainage and monitoring system (EDMS) is a system for externally draining and monitoring cerebrospinal fluid (CSF) and monitoring intracranial pressure (ICP).
FDA Recall
Open, Classified
·Medtronic Neurosurgery·Product code GWM·November 1, 2024
Becker External Drainage and Monitoring System: 24146 EDMS 24146 BECKER NO Y-SITE 25120 EDMS II 25120 BECKER W/1-WAY VALVE 26040 KIT 26040 BECKER EDMS II 27609 BECKER 27609 W/NEEDLESLESS INJ. SITE 27670 BECKER 27670 STOP BELOW DC NDL-LS IN 27672 BECKER 27672 ONEWAY VLV Y-SITE PT LN 27702 EDMS 27702 EURO BECKER II GR PT LN 27761 BECKER 27761 STOP BCNDLESS PATLN 24 27767 BECKER 27767 NO STPCOCK ON PTLN 63 27779 EDMS 27779 BECKER BC NDLESS BOND CONN 27811 EDMS 27811 BECKER GRN PL VCATH 27931 EDMS 27931 BECKER GS TUBING SMARTSITES 46128 EDMS 46128 BECKER II BLUE PT LN 46129 EDMS 46129 EURO BECKER II BLUE PT LN The Becker External Drainage and Monitoring System (Becker EDMS) is a closed system for: 1. Draining cerebrospinal fluid (CSF) from the lateral ventricles of the brain or the lumbar subarachnoid space. 2. Monitoring CSF pressure and flow rate from the lateral ventricles of the brain and the lumbar subarachnoid space.
FDA Recall
Open, Classified
·Medtronic Neurosurgery·Product code GWM·November 1, 2024
Temporary Pacing Wire, BIPOLAR, Models BM, V, VE and VF, Rx Only, STERILE/EO, Single use only -- Mce (MEDICAL CONCEPTS EUROPE) --- Manufacturer ECM B.V. Oost-Om 54, P.O. Box 53, NL 5420 AB GEMERT --- Shipping or Unit Package: 20 individual units packaged per box with 6 boxes per case. --- Device Classification Name: Electrode, pacemaker, temporary. ---The device is supplied sterile and intended for single use. Used to pace the heart during or after open heart surgery. The electrodes are placed on the heart; the other end of the pacing wire is inserted through the skin of the patient with a thoracic needle. The thoracic needle can snap-off at the end where the pacing wire is attached, after snap-off the remaining pins are connected to an external pacemaker. For temporary atrial and ventrical pacing and sensing for contemplated implant duration of 7 days or less.
FDA Recall
Terminated
·European Custom Manufacturing B.V. Oost-Om 54 Gemert Netherlands·Product code LDF·April 18, 2011
Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098
FDA Recall
Open, Classified
·Intuitive Surgical, Inc.·Product code NAY·March 13, 2024
PROPONENT SR Pacemaker
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code LWP·December 7, 2017
VALITUDE CRT-P Pacemaker
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code NKE·December 7, 2017
ACCOLADE MRI DR Pacemaker
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code LWP·December 7, 2017
ESSENTIO EL DR Pacemaker
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code LWP·December 7, 2017
VISIONIST X4 CRT-P Pacemaker
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code NKE·December 7, 2017
VISIONIST CRT-P Pacemaker
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code NKE·December 7, 2017
ESSENTIO SR Pacemaker
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code LWP·December 7, 2017
VALITUDE X4 CRT-P Pacemaker
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code NKE·December 7, 2017
PROPONENT DR Pacemaker
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code LWP·December 7, 2017
ACCOLADE EL DR Pacemaker
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code LWP·December 7, 2017
ACCOLADE SR Pacemaker
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code LWP·December 7, 2017
ESSENTIO MRI SR Pacemaker
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code LWP·December 7, 2017
ACCOLADE MRI SR Pacemaker
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code LWP·December 7, 2017