11 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MAXO2+, MODEL A AND AE
FDA 510(k)
FDA Class 2
·Anesthesiology
Leksell Stereotactic System
FDA UDI
Elekta Solutions AB·07340201503027·Open CT-Indicator - Right Plate
Mini Master Series Bracket
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746070808·1 PAT SETUP MINI MS ROTH 018 U/L 7X7 IFIT W/HK ...
SYNTHETICARE POWDERED VINYL EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
CARESIDE LDH
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BASIS¿ SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC, INC·Product code KWP·July 19, 2012
SENSATION PLUS 7.5FR. 40CC IAB & ACCESSORIES
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·May 23, 2024
TOTAL ASR ACET IMP SIZE 60
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·April 8, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·August 27, 2014
ACRSYOF
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD.·Product code HQL·May 9, 2008
Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018