17 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SURE-SCREEN AMPHETAMINE, BENZODIAZEPINE, COCAINE, METHAMPHETAMINE/MDMA, METHADONE, OPIATES, PHENCYCLIDINE & CANNABINOIDS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Dalbo®-PLUS /-Classic /-B /-Z
FDA UDI
Cendres+Métaux SA·07640166513759·Dalbo®-PLUS /-Classic /-B /-Z
Spacer disc tin
LIGAMAX-5MM ENDO CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.·Product code FZP·June 13, 2006
CRAFT DUO-VAC SUCTION UNIT AND CRAFT SUCTION UNIT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
APC PLUS ADHESIVE
FDA 510(k)
FDA Class 2
·Dental
LIGAMAX-5MM ENDO CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.·Product code FZP·June 13, 2006
LIGAMAX-5MM ENDO CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.·Product code FZP·June 13, 2006
LIGAMAX-5MM ENDO CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.·Product code FZP·June 13, 2006
LIGAMAX-5MM ENDO CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.·Product code FZP·June 13, 2006
LIGAMAX-5MM ENDO CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.·Product code FZP·June 13, 2006
APC PLUS, CLARITY, MINI UNI-TWIN, VICTORY SERIES
FDA Adverse Event
Injury
·3M UNITEK·Product code DYH·May 9, 2012
NIM-ECLIPSE® CONTROLLER
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC·Product code GWF·December 9, 2014
UNKNOWN DEPUY PINNACLE METAL LINER
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·April 10, 2013
VITALITY 2
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 12, 2011
TENDRIL SDX
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·May 27, 2008
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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