17 results · 24ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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