20 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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KARL STORZ -ENDOSCOPE STERILIZATION TRAYS, MODELS 39402AS, 39301HCTS, 39301BS
FDA 510(k)
FDA Class 2
·General Hospital
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450214329·
POWDER-FREE LATEX EXAMINATION GLOVES WITH COLORANTS
FDA 510(k)
FDA Class 1
·General Hospital
INFANT LIMB HOLDER, MODELS 306080 & 306081
FDA 510(k)
FDA Class 1
·General Hospital
GYNECARE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTO·August 6, 2018
PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code FTL·August 6, 2018
PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code FTL·August 6, 2018
GYNECARE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTO·August 6, 2018
PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAW·August 3, 2018
PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTP·August 3, 2018
GYNECARE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTO·August 6, 2018
GYNECARE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTO·August 3, 2018
PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code FTL·August 3, 2018
HT70 VENTILATOR
FDA Adverse Event
Malfunction
·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·April 13, 2017
NEWPORT
FDA Adverse Event
Malfunction
·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·May 16, 2017
AFX SYSTEM
FDA Adverse Event
Injury
·ENDOLOGIX, INC.·Product code MIH·May 2, 2013
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·September 15, 2014
HIRES 90K
FDA Adverse Event
Injury
·ADVANCED BIONICS LLC·Product code MCM·May 9, 2011
Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623; CD1257-40Q/100042341, 100059535; CD1259-40/100041914, 100042338, 100059536, 100059646, 100081567; CD1259-40Q/100041931, 100042339, 100059537, 100059620, 100059626, 100078685; CD1263-40/100042948; CD1263-40Q/100042949; CD1357-40C/100080365, 100080377, 100083441; CD1357-40Q/100080389, 100080390, 100083388; CD1359-40/100078740, 100083267, 100096839; CD1359-40C/100078500, 100078969, 100079372, 100079373, 100083442, 100083443, 100117545; CD1359-40Q/100078804, 100079155, 100079413, 100083445, 100096884; CD1359-40QC/100078603, 100079145, 100079146, 100079239, 100083405, 100083444, 100117632, 100127000, 100127065; CD1363-40C/100080349; CD1363-40Q/100080317; CD1391-40C/100080756; CD1391-40QC/100080783; CD2257-40/100042337, 100059839; CD2257-40Q/100042342, 100059842; CD2259-40/100041893, 100042308, 100059794, 100059907, 100082567; CD2259-40Q/100041894, 100042309, 100059845, 100059873, 100078610; CD2263-40/100042950; CD2263-40Q/100043201; CD2357-40C/100080404, 100080413, 100083490; CD2357-40Q/100080319, 100080412, 100083492; CD2359-40/100078750, 100083466; CD2359-40C/100078651, 100079201, 100079240, 100079442, 100083501, 100083502, 100117546; CD2359-40Q/100078841, 100079109, 100083472; CD2359-40QC/100078652, 100079156, 100079157, 100079337, 100083407, 100083465, 100117580, 100127092, 100127103; CD2363-40C/100080416; CD2363-40Q/100080407; CD2391-40C/100080784; CD2391-40QC/100080744
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018