253 results
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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NeuraGen Nerve Guide NeuraGen Nerve Guide is indicated for repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.
FDA Recall
Terminated
·Integra LifeSciences Corporation·Product code JXI·March 28, 2013
NeuraWrap Nerve Protector NeuraWrap Nerve Protector is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.
FDA Recall
Terminated
·Integra LifeSciences Corporation·Product code JXI·March 28, 2013
NeuraGen Nerve Guide, 7mm diameter, 2cm length; Part number PNG72 - Product Usage: NeuraGen nerve guide is indicated for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code JXI·February 7, 2020
The Stryker Visum¿ LED Surgical Lighting system is intended to illuminate the operative site during surgical procedures with high intensity light. Affected part numbers are 0682001432 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 9P/FP), 0682001286 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 5P/FP), 0682001298 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 5P), 0682001299 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 5P/5P), 0682001300 (EDS LIGHT SUSPENSION, CENTRAL AXIS, FP/5P/5P), 0682001433 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 9P), 0682001434 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 9P/5P), 0682001435 (EDS LIGHT SUSPENSION, CENTRAL AXIS, FP/9P/5P) Product Usage: The Stryker Visum LED Surgical Lighting system is intended to illuminate the operative site during surgical procedures with high intensity light
FDA Enforcement
Class II
·Terminated·Stryker Communications·April 5, 2017
The Stryker Visum LED Surgical Lighting system is intended to illuminate the operative site during surgical procedures with high intensity light. Affected part numbers are 0682001432 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 9P/FP), 0682001286 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 5P/FP), 0682001298 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 5P), 0682001299 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 5P/5P), 0682001300 (EDS LIGHT SUSPENSION, CENTRAL AXIS, FP/5P/5P), 0682001433 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 9P), 0682001434 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 9P/5P), 0682001435 (EDS LIGHT SUSPENSION, CENTRAL AXIS, FP/9P/5P) Product Usage: The Stryker Visum LED Surgical Lighting system is intended to illuminate the operative site during surgical procedures with high intensity light
FDA Recall
Terminated
·Stryker Communications·Product code FSY·February 28, 2017
NOMAD Pro2 Packaged X-Ray System, Part Number 08500021; NOMAD Pro2 Packaged X-Ray System Black, Part Number 08500022; NOMAD Pro2 Vet Packaged X-Ray System, Part Number 08500023; NOMAD Pro2 Vet Packaged X-Ray System Black, Part Number 08500024; NOMAD Pro2 Packaged X-Ray System, GBL, Part Number 08500025 and Part Number 08500026; NOMAD Pro2 Packaged X-Ray System, GLB, Vet, Part Number 08500027 and Part Number 08500028; NOMAD Pro2 Package X-Ray System, GLB, Black, Part Number 08500029
FDA Enforcement
Class II
·Terminated·Aribex Inc·September 14, 2016
Gamma camera systems: AXIS SPECT Systems & IRIX SPECT Systems, Model #: AXIS- 882130, IRIX- 882140. Philips Healthcare. Used to do nuclear medicine diagnostic imaging of various body organs.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code KPS·November 18, 2011
Convenience Kits from Centurion that contain an In-Vision- Plus Needleless IV Connector, Model: code RYM5001 InVision-Plus¿ Needless IV Connectors are used for single patient use in IV and blood administration sets without the need for needles, thus eliminating the potential for needle-stick injuries during use.
FDA Enforcement
Class II
·Terminated·Centurion Medical Products Corporation·March 2, 2016
Cook Medical CXI Support Catheter 2.6FR curved catheter and 4.0FR straight catheter, for cardiovascular use.
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 18, 2015
Portex Dual-Axis Swivel Adapter Catalog Number: 525151
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·September 9, 2004
AXIS (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015
IPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neuroworks/Sleepworks software
FDA Enforcement
Class II
·Terminated·Natus Neurology DBA Excel Tech., Ltd. (XLTEK)·March 2, 2022
Axis-Shield DIASTAT Anti-CCP test kit, (code FCCP200)
FDA Recall
Terminated
·Product code NHX·November 11, 2005
Fiberoptic Bronchoscope Dual-Axis Swivel Adapter Catalog Number: 625191
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·September 9, 2004
Coonrad/Morrey New Ulnar Revision Kit for Use with Non-Interchangeable Regular Humerals STERILE Rx, Tivanium QTY/PKG:1 Product Usage: The ulnar and humeral components are connected by placing the hollow, outer axis pin across the two components and securing It with the solid Internal axis pin. The Inner and outer pin connection Is articulation point of the placement elbow.
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·December 26, 2012
Portex PEEP-KEEP Dual-Axis Swivel Adapter Catalog Number: 525351
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·September 9, 2004
Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT; 100 test format, 1000 test format, and 200 test format; and Private Label: (Distributed by BECKMAN COULTER, for professional use only, on the BECKMAN COULTER AU platforms (AU400, AU480, AU680 and AU5800)) Product Usage: For in-vitro quantitative determination of total homocysteine in human plasma or serum.
FDA Recall
Terminated
·Product code LPS·March 20, 2015
Axis Gamma Camera, Scintillation (gamma) camera, Philips Medical System, Cleveland, OH 44143
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code KPS·November 21, 2007
Philips Odyssey FX Workstations, used with Axis, Irix, or Meridian Gamma Camera Systems.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code LLZ·September 15, 2003
Philips Odyssey VP Workstations, used with Axis, Irix, or Meridian Gamma Camera Systems.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code LLZ·September 15, 2003