14 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
PREFORMANCE TEMPORARY CYLINDER
FDA 510(k)
FDA Class 2
·Dental
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496060291·MARILYN 140 SHEER OPEN TOE, SIZE M, MIELE, GRAD...
Mini-Mono®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70602911·Mini-Mono-Brackets Ricketts 'S' .018" 1000 Brac...
ITI DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
MFCD 118
FDA 510(k)
FDA Class 2
·Radiology
PRECISION MONTAGE MRI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 14, 2024
HEARTSTART ONSITE
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·April 11, 2013
PENTA
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·August 25, 2014
SELECT SECURE
FDA Adverse Event
Death
·MEDTRONIC, INC.·Product code NVN·April 15, 2011
CONFIDA BRECKER CURVE GUIDEWIRE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code DQX·June 5, 2025
UNKNOWN VALVE/SHUNT
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROSURGERY·Product code JXG·December 9, 2018
UNKNOWN VALVE/SHUNT
FDA Adverse Event
Injury
·MEDTRONIC NEUROSURGERY·Product code JXG·December 9, 2018
UNKNOWN VALVE/SHUNT
FDA Adverse Event
Injury
·MEDTRONIC NEUROSURGERY·Product code JXG·December 9, 2018
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024