25 results · 24ms · Sources: EU EUDAMED, 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