36 results
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21ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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SOMATOM Emotion 16, the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·June 3, 2015
GE Medical Systems Information Technologies Clinical Information Center (CIC) Pro v5.0.3 & v5.0.6 systems, GE Healthcare, Clinical Systems
FDA Recall
Terminated
·General Electric Medical Systems Information Technology·Product code DSI·November 8, 2007
Doro Products Adapter, Product number 5979-300. The adaptor system is attached to OSI''s Spinal Frame, which is an operating room tabletop that is attached to a table base. The Frame is used to support patients during spinal surgery.
FDA Recall
Terminated
·Orthopedic Systems Inc·Product code FWZ·February 14, 2007
Multi-Link Vision RX Coronary Stent System, 3.0 x 15mm, Part number 1007848-15, lot number 7052951
FDA Recall
Terminated
·Abbott Vascular-Cardiac Therapies dba Guidant Corporation·Product code MAF·July 16, 2007
Agfa Heartlab Cardiovascular Results Management Product: Versions 2.03 and 2.04. Heartlab, Inc., Westerly, Rhode Island 02891
FDA Recall
Terminated
·AGFA Corp.·Product code LLZ·July 27, 2007
CELL-DYN 1700 Hematology Analyzer, List Numbers 03H53-01 and 03H53-03, software controlled medical device for diagnostic use., and CELL DYN Control Assay Disk, LIst Numbers 01H91-01 and 01H92-01 when used with above CELL DYN 1700, Abbott Laboratories Diagnostics Division
FDA Recall
Terminated
·Abbott Laboratories·Product code GKZ·May 16, 2007
Cell-Dyn 1700CS (Closed Sampler) Hematology Analyzer, List Numbers 03H57-01 and 03H57-03, software controlled medical device for diagnostic use and CELL DYN Control Assay Disk, LIst Numbers 01H91-01 and 01H92-01 when used with above CELL DYN 1700, Abbott Laboratories Diagnostics Division
FDA Recall
Terminated
·Abbott Laboratories·Product code GKZ·May 16, 2007
Cytomics FC 500 Flow Cytometry System with Data Innovations Instrument Manager, Part Numbers 626553 and 6605628 A system for the qualitative and quantitative measurement of biological and physical properties of cells and other particles.
FDA Recall
Terminated
·Beckman Coulter Inc·Product code GKZ·August 20, 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
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
ABL800 FLEX Series analyzer with FLEXQ module-equipped with software version 5.2 to 5.27
FDA Recall
Terminated
·Radiometer America Inc·Product code CHL·January 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
Novel PEEK VBR XS 16-22 MM, S-5, 26MM, Part Numbers : 64753-126. Indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). Intended for use with supplemental spinal fixation systems.
FDA Recall
Terminated
·Alphatec Spine, Inc.·Product code MQP·August 16, 2007
Novel PEEK VBR XS 16-22 MM, S-5, 20MM, Part Number: 64733-120. Indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). Intended for use with supplemental spinal fixation systems.
FDA Recall
Terminated
·Alphatec Spine, Inc.·Product code MQP·August 16, 2007
Excimer Laser System; WaveScan WaveFront System, Software Version 3.65, for use with the VISX STAR S4 and STAR S4 IR Excimer Laser Systems. System is a diagnostic instrument intended for the automated measurement, analysis and recording of refractive errors and wavefront aberrations to the target shape and then generates the commands for the VISX STAR laser to create the target shape on the cones.
FDA Recall
Terminated
·VISX INCORPORATED, A SUBSIDIARY OF AMO INC·Product code LZS·November 17, 2006
Davol Salute Fixation Reusable Handle Item Code: 0113024-Product Code 9113024 (Refurbished)
FDA Recall
Terminated
·Davol, Inc., Sub. C. R. Bard, Inc.·Product code GDW·July 16, 2007
Davol Salut Fixation Reusable 38cm Shaft (Laparoscopic) Item Numbers: 0113036-Product Code 9113036-(Refurbished)
FDA Recall
Terminated
·Davol, Inc., Sub. C. R. Bard, Inc.·Product code GDW·July 16, 2007