14 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ReDs Wearable System
FDA 510(k)
FDA Class 2
·Cardiovascular
Vilex Guidewire
FDA UDI
VILEX IN TENNESSEE, INC.·00841731120465·Guidewire 0.9x150mm Dbl Trocar
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690117469·Distal Reamer (Hudson)
APEX Revision Knee
FDA UDI
Omni Life Science, Inc.·00841690111566·Modular Stem 9mm x 150mm
CENTRAL VISION ANALYZER MODEL 1000
FDA 510(k)
FDA Class 1
·Ophthalmic
SIDE EFFECT WITH HAND CONTROLS, HOOK ELECTRODE WITH HAND CONTROLS, 2.3 WEDGE ELECTRODE WITH HAND CONTROLS, S90 WITH HAND
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES GRENCHEN·Product code HRS·January 30, 2017
CSF DRAINAGE SYSTEM USED WITH POLE MOUNT SYSTEM
FDA Adverse Event
Malfunction
·INTEGRA NEUROSCIENCES PR·Product code JXG·October 20, 2015
N/A
FDA UDI
Zimmer, Inc.·00889024033726·
SUPER POLIGRIP COMFORT SEAL STRIPS
FDA Adverse Event
Other
·GLAXOSMITHKLINE·Product code KOO·June 3, 2013
COLLEAGUE PRE 1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 5, 2011
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·August 29, 2008
da Vinci S / Si Surgical System IS2000 / IS3000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·April 15, 2015
da Vinci S / Si Surgical System IS2000 / IS3000, Instrument Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·April 15, 2015