20 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SPACELABS MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS MODULE 91482 AND ACCESSORIES MODEL-91842
FDA 510(k)
FDA Class 2
·Neurology
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70609001·2D Lingualbrackets 2. Gen. 20 Brackets w. hook
Kalitec Universal Instruments
FDA UDI
Kalitec Direct LLC·B07301K0600000·Tray Lid, Universal, Blank
JOBST Confidence
FDA UDI
BSN-Jobst GmbH·04059993452422·CONFIDENCE 3/THIGH HIGH/CLOSED TOE, KNEE FUNCTI...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702250237·Elvarex 2/Thigh High/Slant-Closed Toe/outside h...
JOBST Confidence
FDA UDI
BSN-Jobst GmbH·04059993442409·CONFIDENCE 2/THIGH HIGH/CLOSED TOE, KNEE FUNCTI...
JOBST Confidence
FDA UDI
BSN-Jobst GmbH·04059993472161·CONFIDENCE 1/THIGH HIGH/CLOSED TOE, KNEE FUNCTI...
Life Instruments
FDA UDI
Life Instrument Corporation·M930706090000·Wing Blade Inserter
Kalitec Universal Instruments
FDA UDI
Kalitec Direct LLC·B07301K0602000·Tray base, 2"
Kalitec Universal Instruments
FDA UDI
Kalitec Direct LLC·B07301K0606000·Tray, Base, 6"
STS-T LITHOTRIPTER, MODEL STS-T
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MEDSTONE LITHOTRIPTOR
FDA Adverse Event
Malfunction
·HEALTHTRONICS, INC.·Product code LNS·June 12, 2017
CONFIDENCE KIT, NO NEEDLES
FDA Adverse Event
Malfunction
·DEPUY SYNTHES SPINE·Product code NDN·April 1, 2014
E360 VEMTO;ATPR
FDA Adverse Event
Malfunction
·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·April 10, 2013
ACRYSOF IQ TORIC
FDA Adverse Event
Other
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·March 18, 2011
BD PARADIGM LINK GLUCOSE MONITOR
FDA Adverse Event
Other
·NOVA BIOMEDICAL CORPORATION DIABETES PRODUCTS·Product code NBW·June 13, 2008
G7 ACETABULAR SHELL
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PBI·February 13, 2018
Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 420 mm, Item Number: 814311420
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 19, 2018
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