12 results · 21ms · Sources: EU EUDAMED, 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