25 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DuoCem
FDA 510(k)
FDA Class 2
·Dental
N/A
FDA UDI
TETRA MEDICAL SUPPLY CORP.·00614138112674·ULTRALIGHT AFO BRACE, MALE LEFT
EZ-Fill Root Canal Cement
FDA UDI
ESSENTIAL DENTAL SYSTEMS, INC.·00766054000143·Root Canal Cement Powder Jar/Gel Tube
TALOS®-C HA
FDA UDI
MEDITECH SPINE, LLC·B167521608000·
Vusion CS Plus
FDA UDI
Ortho Development Corporation·00822409025534·16 mm x 8 mm x Parallel
TIDI FACEMASK
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SEEKER/SPARK ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE NEEDLE
FDA Adverse Event
Injury
·BECTON DICKINSON MEDICAL SYSTEMS·Product code MEG·November 12, 2015
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Injury
·DEXCOM, INC.·Product code QBJ·January 12, 2026
ASSURANT COBALT
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code NIO·June 11, 2013
RIATA ACTIVE FIXATION LEAD
FDA Adverse Event
Injury
·ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D·Product code LWS·January 13, 2014
OT VERIO2 METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 20, 2015
OXF UNI TIB TRAY SZ C LM PMA
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·July 1, 2019
OXF TWIN-PEG CMNTD FEM MD PMA EM MED
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·July 1, 2019
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORP.·Product code DSQ·June 6, 2014
IMPLANTABLE NEUROSTIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·November 17, 2025
ATELLICA IM HEPATITIS B SURFACE ANTIGEN II (HBSII)
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code LOM·October 19, 2018
Siemens AXIOM Artis zee/zeego systems equipped with generator A100 Plus Product Usage: Angiographic x-ray system
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·July 24, 2013
Siemens Artis zeego--Interventional Fluoroscopic X-Ray System Model Number: 10280959
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·July 10, 2019
Artis zeego, Material no. 10280959 , for angiography and whole body radiographic/fluoroscopic procedures.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·July 4, 2018