22 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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CONTAK RENEWAL 3 RF (model H210, H215), CONTAK RENEWAL 3 RF HE (model H217, H219) cardiac resynchronization therapy defibrillator (CRT-D).
FDA Recall
Terminated
·Boston Scientific CRM Corp·Product code NIK·March 23, 2007
VITALITY AVT (model A155). Implantable Cardioverter Defibrillator. Atrial and Ventricular Therapies. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, USA.
FDA Recall
Terminated
·Boston Scientific CRM Corp·Product code NIK·March 23, 2007
Silver Speed Hydrophilic Guidewire, for placement of vascular catheters. Model # 103-0601-200.
FDA Recall
Terminated
·Product code MKI·April 5, 2007
These models are not available in the US. Guidant CONTAK RENEWAL 4 RF/HE (model H230, H235) Guidant CONTAK RENEWAL 4 RF HE (model H239 ) cardiac resynchronization therapy defibrillator (CRT-D).
FDA Recall
Terminated
·Boston Scientific CRM Corp·Product code NIK·March 23, 2007
These models are not available in the US. CONTACT RENEWAL 4 AVT HE (model number M170, M175, M177, M179). Cardiac Resynchronization Therapy Defibrillator. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, USA.
FDA Recall
Terminated
·Boston Scientific CRM Corp·Product code NIK·March 23, 2007
CONTAK RENEWAL 3 (model H170, H175) CONTAK RENEWAL 3 HE (model H177, H179) Cardiac Resynchronization Therapy Defibrillator (CRT-D). Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA.
FDA Recall
Terminated
·Boston Scientific CRM Corp·Product code NIK·March 23, 2007
These models are not available in the US. CONTAK RENEWAL 4 (model H190, H195). CONTAK RENEWAL 4 HE (model H197, H199) Cardiac Resynchronization Therapy Defibrillator (CRT-D). Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA.
FDA Recall
Terminated
·Boston Scientific CRM Corp·Product code NIK·March 23, 2007
Ventlab-assembled Anesthesia breathing bags. The recall involves 3 Liter, 2 Liter and 1 Liter latex free bags used with Medline anesthesia circuit kits. The bags are sold in bulk.
FDA Recall
Terminated
·Ventlab Corporation·Product code BTC·December 5, 2007
Mattress Model 5185 and 5185XL. Manufactured by: Invacare Corp., 2101 East Lake Mary Blvd., Sanford, FL 32773. Mattress Model 5185 and 5185XL were packaged in the IVC Bed Models BED2-1633, BED4-1633, BED8-1633, BED9-1633, BED10-1633, BED12-1633, BED38LOW-1633, VCPKGIVC-1633 OR VCPKGIVC2-1633.
FDA Recall
Terminated
·Invacare Corporation·Product code FMW·August 29, 2007
Essential Medical Supply brand Essential Rollator with Loop Hand Brakes, models W1700B (Blue) and W1700R (Red), Four Wheel Aluminum Walker/Rollator
FDA Recall
Terminated
·Essential Medical Supply, Inc.·Product code ITJ·May 8, 2009
bioMerieux, BacT/ALERT FA Culture Bottles, bioMerieux, Inc., Durham, NC 27704
FDA Recall
Terminated
·bioMerieux, Inc.·Product code MDB·November 5, 2007
Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement, (PSD 28-U-V), 28mm, US Surgical Staplers. Each package contains the following components: Cartridge and anvil assemblies, Cartridge cone, PSD Gel, & C-clip
FDA Recall
Terminated
·Synovis Surgical Inovation Div. of·Product code FTM·March 16, 2007
Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement,( PSD 21-E-V), 21mm, Ethicon Circular stapler. Each package contains the following components: Cartridge and anvil assemblies, Cartridge cone, PSD Gel, & C-clip.
FDA Recall
Terminated
·Synovis Surgical Inovation Div. of·Product code FTM·March 16, 2007
VITALITY DR HE Implantable Cardioverter Defibrillator (model T180). Sterile EO. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. This ICD is designed to detect and terminate ventricular tachycardia (VT) and ventricular fibrillation (VF) and provide bradycardia therapy (atrial and ventricular pacing). Therapies include both low- and high-eneergy shocks using either a biphasic or monophasic waveform. Bradycardia pacing, including adaptive-rate features, is available to detect and treat bradyarrhythmias and to support the cardiac rhythm after defibrillation therapy. The device offers dual-chamber bradycardia features (atrial and/or ventricular pacing and sensing).
FDA Recall
Terminated
·Boston Scientific CRM Corp·Product code NIK·March 23, 2007
Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement, (PSD 25-E-V), 25mm, Ethicon Circular stapler. Each package contains the following components: Cartridge and anvil assemblies, Cartridge cone, PSD Gel, & C-clip
FDA Recall
Terminated
·Synovis Surgical Inovation Div. of·Product code FTM·March 16, 2007
Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement, ( PSD 21-U-V), 21mm, US Surgical Staplers. Each package contains the following components: Cartridge and anvil assemblies, Cartridge cone, PSD Gel, & C-clip
FDA Recall
Terminated
·Synovis Surgical Inovation Div. of·Product code FTM·March 16, 2007
Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement, ( PSD 25-U-V), 25 mm, US Surgical Staplers. Each package contains the following components: Cartridge and anvil assemblies, Cartridge cone, PSD Gel, & C-clip
FDA Recall
Terminated
·Synovis Surgical Inovation Div. of·Product code FTM·March 16, 2007
Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement, ( PSD 29-E-V), 29 mm, Ethicon Circular stapler. Each package contains the following components: Cartridge and anvil assemblies, Cartridge cone, PSD Gel, & C-clip
FDA Recall
Terminated
·Synovis Surgical Inovation Div. of·Product code FTM·March 16, 2007
VITALITY 2 (model T165, T175), VITALITY DS (model T125, T135), VITALITY EL (model T127), Implantable Cardioverter Defibrillators (ICD), are designed to detect and terminate ventricular tachycardia (VT) and ventricular fibrillation (VF) and provide bradycardia therapy (atrial and ventricular pacing). Therapies include both low- and high-energy shocks using either a biphasic or monophasic waveform. Vitality 2 devices also offer a wide variety of antitachycardia pacing schemes to terminate slower, more stable ventricular tachyarrhythmias. Bradycardia pacing, including adaptive-rate features, is available to detect and treat bradyarrhythmias and to support the cardiac rhythm after defibrillation therapy. Devices denoted with DR offer dual-chamber bradycardia features (atrial and/or ventricular pacing and sensing), and the devices denoted with VR offer single-chamber bradycardia features (ventricular pacing and sensing).
FDA Recall
Terminated
·Boston Scientific CRM Corp·Product code NIK·March 23, 2007
Hospital Information System Results Reporting Interface Versions 4.0.2.38.1, 4.0.2.39.2, 4.02.40.1, and 4.0.2.41.1. SCC Soft Computer, 5400 Tech Data Drive, Clearwater, FL 33760. Manufacture Dates: 4.0.2.38.1 06/15/07 4.02.39.2 06/29/07, 4.02.40.1 07/19/07, 4.02.41.1 08/20/07. The Result Reporting Interface is a highly versatile interface designed to electronically convey clinical laboratory orders and results for the SCC applications to other recipient information systems.
FDA Recall
Terminated
·SCC Soft Computer·Product code LNX·October 5, 2007