14 results
·
19ms
·
Sources: EU EUDAMED, US FDA
PROPHY PASTE
FDA 510(k)
FDA Class 1
·Dental
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR77714011·Micro Sprint Bracket McLaugh/Benn/Trev. .022" m...
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR77714010101·Micro Sprint Bracket McLaugh/Benn/Trev. .022" m...
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR77714010051·Micro Sprint Bracket McLaugh/Benn/Trev. .022" m...
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR77714011001·Micro Sprint Bracket McLaugh/Benn/Trev. .022" m...
ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1
FDA 510(k)
FDA Class 2
·Clinical Chemistry
X3C 2200 DIGITAL RADIOGRAPHIC SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
CAREFUSION
FDA Adverse Event
Malfunction
·CAREFUSION·Product code LSZ·February 6, 2016
ASR ACETABULAR CUPS 56
FDA Adverse Event
Injury
·DEPUY INTL., LTD - 8010379·Product code KWA·April 24, 2014
10 LEAD ECG TRUNK AAMI/IEC 2M
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MHX·September 27, 2012
VITALITY
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 27, 2010
SENSORMEDICS
FDA Adverse Event
Malfunction
·CAREFUSION·Product code LSZ·May 12, 2011
Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·April 30, 2025
GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is used for monitoring hospital patients respiration, ventilation, and gas exchange status.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·June 25, 2014