17 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ANEROID SPHYGMANOMETER WITH STETHOSCOPE, MODEL HS-50A
FDA 510(k)
FDA Class 2
·Cardiovascular
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00510211·
MicroAire®
FDA UDI
Microaire Surgical Instruments LLC·00847399005007·SST TWIST DRILL, DENTAL, 2.2mm Dia. x 49mm
LATERAL DISTAL FIBULA PLATE, XXL, 21-HOLE, LEFT
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665029185·
BACT/ALERT® SN BLOOD CULTURE BOTTLE
FDA Adverse Event
Malfunction
·BIOMERIEUX INC.·Product code MDB·January 10, 2019
BACT/ALERT® SN CULTURE BOTTLE
FDA Adverse Event
Malfunction
·BIOMERIEUX INC.·Product code MDB·December 26, 2018
LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT HOLLOW FIBRE OXYGENATOR, MODEL D902
FDA 510(k)
FDA Class 2
·Cardiovascular
LASER 20
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LOCKING SCREWS, CROSS-PIN, DIAM 2.0X10MM, (5/PACKA
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS FREIBURG·Product code JEY·September 28, 2010
REAGENT RED BLOOD CELLS BIOTESTCELL 3
FDA Adverse Event
Malfunction
·BIO-RAD MEDICAL DIAGNOSTICS GMBH·Product code KSZ·February 1, 2011
ELECTRODE, PACEMAKER, PERMANENT
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA·Product code DTB·April 10, 2013
QUICKSITE LV
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·May 27, 2008
CAPSUREFIX
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·April 12, 2011
cobas 8000 Modular Analyzer Series; Part Numbers: 1. 05964067001 cobas 8000 c 502 module
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018
Cobas 8000 Modular Analyzer Series, Model/Catalog/Part Number: 05641489001. The Cobas 8000 is a fully automated system for clinical chemistry analysis.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·December 12, 2012
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
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026