18 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACCESS DHEA-S REAGENT ASSAY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197534178·Weil-Blakesley Rongeur
fenest...
Toilet Support Arms
FDA UDI
Ropox A/S·05707581002533·
HARDYDISK, CARBENICILLIN, 100MCG
FDA 510(k)
FDA Class 2
·Microbiology
CD HORIZON SPINAL SYSTEM, 4.5 ROD FOR POSTERIOR APPLICATION
FDA 510(k)
FDA Class 2
·Orthopedic
PYROPLAST POWDER
FDA UDI
AMERICAN TOOTH INDUSTRIES·D772ATI100401810·PYROPLAST POWDER 1 OZ SHADE 81
C & B FORMULA
FDA UDI
AMERICAN TOOTH INDUSTRIES·D772ATI400401810·C & B FORMULA 1 OZ SHADE 81
NAMILON POWDER
FDA UDI
AMERICAN TOOTH INDUSTRIES·D772ATI200401810·NAMILON POWDER 1 OZ SHADE 81
SONA PILLOW
FDA Adverse Event
Other
·SLEEP DEVICES, INC.·Product code MYB·May 4, 2007
SONA PILLOW
FDA Adverse Event
Other
·SLEEP DEVICES, INC.·Product code MYB·June 18, 2007
ISODUR PROSTHESIS HEAD 12/14 28MM M
FDA Adverse Event
Malfunction
·AESCULAP AG AND CO. KG·Product code LPH·January 16, 2015
PROLIFT PELVIC FLOOR REPAIR
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTP·April 8, 2013
TRANSPAC IV MONITORING KIT W/ SAFESET MV
FDA Adverse Event
Other
·ICU MEDICAL INC.·Product code DRS·March 21, 2011
ENDEAVOR RX
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code NIQ·May 8, 2008
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·May 20, 2014
CD HORIZON
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·May 16, 2016
SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code MQP·October 30, 2017
Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018