10 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CapnoSpot Pneumothorax Decompression Indicator
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Patellavator Knee Orthosis
FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357236251·
Vinyl Examination Gloves
FDA 510(k)
FDA Class 1
·General Hospital
Numen Coil Embolization System; NumenFR Detachment System
FDA 510(k)
FDA Class 2
·Neurology
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code PQF·April 14, 2017
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 25, 2011
RIATA ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·November 10, 2008
GYNECARE TVT OBURATOR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 12, 2013
DRIVER
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code DZE·June 5, 2019
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