12 results
·
34ms
·
Sources: EU EUDAMED, US FDA
OXYMATICTM ELECTRONIC OXGYEN CONSERVER
FDA 510(k)
FDA Class 2
·Anesthesiology
Rochester
FDA UDI
Advantage Medical Electronics, LLC·00849593025362·DISPOSABLE CONCENTRIC NEEDLE ELECTRODE 26 GA, 5...
PIONEER U601 SERIES ASPIRATOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Disposable Medical Face Mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OT VERIO2 METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 6, 2014
OLM INTRACRANIAL PRESSURE MONITORING KIT
FDA Adverse Event
Malfunction
·INTEGRA NEUROSCIENCES CA/USA·Product code GWM·November 27, 2012
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·October 4, 2010
COMPREHENSIVE SHOULDER SYSTEM PRIMARY MINI LENGTH SHOULDER STEM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code MBF·March 8, 2017
COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY WITH LOCKING RING
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code PAO·April 13, 2017
COMPREHENSIVE REVERSE SHOULDER HUMERAL BEARING/STANDARD
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code PAO·April 13, 2017
COMPREHENSIVE SHOULDER SYSTEM PRIMARY MINI LENGTH SHOULDER STEM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code MBF·April 13, 2017
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·July 30, 2014