12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FlightPlan for Embolization
FDA 510(k)
FDA Class 2
·Radiology
Universal Wrist Lacer
FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357234905·
COGENTIX MEDICAL, INC.
FDA registration
COGENTIX MEDICAL, INC.·5 products·🇺🇸 United States
GLOBAL
FDA UDI
DEPUY (IRELAND)·10603295105299·GLOBAL GLENOID TRIAL SIZER 44mm
DERMAGRIP-X POWDER FREE LATEX EXAMINATION GLOVES WITH SKIN-CARE INGREDIENTS (VITAMIN A, VITAMIN B, OC-LIPOIC ACID, EUCAL
FDA 510(k)
FDA Class 1
·General Hospital
FORE-SIGHT ELITE Absolute Tissue Oximeter
FDA 510(k)
FDA Class 2
·Cardiovascular
RIATA ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·November 10, 2008
COMPRESSOR MINI
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code BTI·July 15, 2011
TELIGEN
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code LWP·July 12, 2013
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026