116 results
·
9ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
Cobe CML Duo Flat Sheet Membrane Oxygenator, sterile, (Custom Heart/Lung Packs), Catalog numbers: 067100001, 078002103, 078005802, 078159025, 078201013, 078212009, 078310006, 078332022, 078348014, 078428010, 078688007, 078869003. COBE Cardiovascular, Inc..
FDA Recall
Terminated
·Cobe Cardiovascular, Inc·Product code DTZ·June 26, 2006
Coherent brand DUO Diode Laser Systems. A Non-medical, class IV industrial materials processing machine. The following Model---Serial Numbers (S/N) are affected: P/N 1024403---S/Ns 10026 Through 10088; P.V. -4240/4475---S/Ns 2, 7, 3053, and 10002 through 10024; and P. V. -4458 S/Ns 10019, 10019, 10020, 10043, and 10052.
FDA Recall
Terminated
·Coherent, Inc.·Product code L22·January 19, 2004
SOMATOM Emotion Duo (2003) Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code JAK·February 15, 2018
Clearlink System Nitroglycerin Set with DUO-VENT Spike, 60 drops/mL, 105'', PVC Tubing Segment, Luer Activated Valve, Male Luer Lock Adapter, catalog 2C8851; Baxter Healthcare Corporation, Deerfield, IL 60015 USA
FDA Recall
Terminated
·Baxter Healthcare Corp. Rt·Product code FPA·July 16, 2003
VNS Therapy Demipulse Generator, Model 103 and VNS Therapy Demipulse Duo Generator, Model 104 VNS Therapy Programming System, Model 250 Version 7.0 and 7.1 Software
FDA Recall
Terminated
·Cyberonics, Inc·Product code LYJ·April 6, 2010
DePuy Mitek FMS Intermediary Tubing with One-Way valve Product Code: 281142 Product Usage: The Intermediary Tubing for FMS¿ Fluid Management Systems connects the Inflow Tubing to the arthroscopic sheath during arthroscopic procedures. The Polyvinyl Chloride (PVC) tubing integrates several functional components including: luer locks for attaching the tube to the Inflow tubing and sheath, clamps, and a one-way valve. The FMS Intermediary Tubing is sterile and intended for single use with the FMS Fluid Management Systems in a surgical setting by personnel trained in arthroscopy .
FDA Enforcement
Class II
·Terminated·DePuy Mitek, Inc., a Johnson & Johnson Co.·November 20, 2013
AquaBplus and AquaBplus B2 Water Purification System. For use with a hemodialysis system to remove organic and inorganic substances and microbial contaminants from the water used for hemodialysis or related therapies. AquaBplus 1500 - Typ USA - 3 x 208V / 60Hz -Fresenius Part Number: 24-1500-1 AquaBplus B2 2000 / B1 2500 (Bplus DUO 2000) - 3 x 208V / 60Hz- Fresenius Part Number: 24-2000-0
FDA Enforcement
Class II
·Terminated·Fresenius Medical Care Holdings, Inc.·October 21, 2020
DePuy Mitek FMS Outflow Tubing with One-Way valve Product Code:284649 Product Usage: The Intermediary Tubing for FMS¿ Fluid Management Systems connects the Inflow Tubing to the arthroscopic sheath during arthroscopic procedures. The Polyvinyl Chloride (PVC) tubing integrates several functional components including: luer locks for attaching the tube to the Inflow tubing and sheath, clamps, and a one-way valve. The FMS Outflow Tubing with One-Way valve is sterile and intended for single use with the FMS Fluid Management Systems in a surgical setting by personnel trained in arthroscopy.
FDA Enforcement
Class II
·Terminated·DePuy Mitek, Inc., a Johnson & Johnson Co.·November 20, 2013
PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 1829570, UDI: (01) 00801741027192 - Product Usage: The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.
FDA Recall
Terminated
·Bard Peripheral Vascular Inc·Product code LJT·March 25, 2021
PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 1829500, UDI: (01) 00801741027185 - Product Usage: The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.
FDA Recall
Terminated
·Bard Peripheral Vascular Inc·Product code LJT·March 25, 2021
PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 5829502, UDI: (01)00801741027406 - Product Usage: The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.
FDA Recall
Terminated
·Bard Peripheral Vascular Inc·Product code LJT·March 25, 2021
Biograph DUO LSO, Biograph PET/CT Scanner, Catalog No. 8728813, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534
FDA Recall
Terminated
·Siemens Medical Solutions USA Inc·Product code KPS·July 23, 2007
VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment of chronic or recurrent depression in patients who are experiencing a treatment-resistant or treatment- intolerant depressive episode.
FDA Recall
Terminated
·LivaNova USA Inc·Product code LYJ·November 12, 2020
Cyberonics VNS Therapy Demipulse Generator, Model 103; an implantable, multiprogrammable, vagus nerve stimulator.
FDA Recall
Terminated
·Cyberonics, Inc·Product code LYJ·February 7, 2008
Baxter Solution Set with Duo-Vent Spike; 109" (2.8 m), Male Luer Lock Adapter 10 drops/mL. Baxter Healthcare Corporation. A sterile, single use, nonpyrogenic fluid pathway for use with rigid nonvented and flexible containers.
FDA Recall
Terminated
·Baxter Healthcare Corp. Rt.·Product code FPA·July 21, 2011
Medtronic MiniMed Silhouette and/or MiniMed Sure-T Infusion Sets; Paradigm Silhouette infusion sets: MMT-368, MMT-368600, MMT-371, MMT-373, MMT-377, MMT-377600, MMT378, MMT-378600, MMT-38 1, MMT-381 600, MMT-382, MMT-382600, MMT-383, MMT-383600, MMT384, & MMT384600. Sure-T infusion sets MMT-862, MMT-863, MMT-864, MMT-865, MMT-866, MMT-873, MMT-874, MMTMMT-875, MMT-876, MMT-884, & MMT-886. MiniMed Duo sensor/infusion sets: MMT-5001A23, MMT-5001A43, MMT-5001B23, MMT-5001B43, MMT-5011A23, MMT-5011A43, MMT-5011B23, & MMT-5011B43. Silhouette and Sure-T disposable infusion sets are used with Medtronic insulin infusion pumps using Paradigm P-cap connectors. The infusion set connects the insulin reservoir in the pump to the patients body.
FDA Enforcement
Class II
·Terminated·Medtronic MiniMed Inc.·December 17, 2014
AMO COMPLETE Multi-Purpose Solution, Formula: 9424x; Product Code: 93504 (360ml), 93505 (2x 360ml duo pack), 93515 (240 ml). Cleans, rinses, disinfects, and stores all soft contact lenses and helps keep your eyes protected from dryness and irritation throughout the day.
FDA Recall
Terminated
·Abbott Medical Optics Inc (AMO)·Product code LPN·July 23, 2010
Ellex Solitarie Opthalmic Laser System, Model No: LP 4532 - Ellex Medical PTY, LTD 82 Gilbert Street, Adelaide, S.A. 5000, AUSTRALIA.
FDA Recall
Terminated
·Ellex USA·Product code HQF·June 13, 2007
ISMUS Catheter Mapping Catheter with Auto ID Technology, Manufacturing Part Number D-1171-34-S, Catalog Number D7R20P14CT The ISMUS Catheter with Auto ID Technology has been designed for electrophysiological mapping of cardiac structures.
FDA Recall
Terminated
·Biosense Webster, Inc.·Product code DRF·April 29, 2011
AquaBplus and AquaBplus B2 Water Purification System. For use with a hemodialysis system to remove organic and inorganic substances and microbial contaminants from the water used for hemodialysis or related therapies. AquaBplus 1500 - Typ USA - 3 x 208V / 60Hz -Fresenius Part Number: 24-1500-1 AquaBplus B2 2000 / B1 2500 (Bplus DUO 2000) - 3 x 208V / 60Hz- Fresenius Part Number: 24-2000-0
FDA Recall
Terminated
·Fresenius Medical Care Holdings, Inc.·Product code FIP·September 1, 2020