12 results
·
18ms
·
Sources: EU EUDAMED, US FDA
X-RAY REMOTE CONTROL TABLE
FDA 510(k)
FDA Class 2
·Radiology
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR77716011·Micro Sprint Bracket McLaugh/Benn/Trev. .022" m...
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR77716010051·Micro Sprint Bracket McLaugh/Benn/Trev. .022" m...
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR77716010101·Micro Sprint Bracket McLaugh/Benn/Trev. .022" m...
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR77716011001·Micro Sprint Bracket McLaugh/Benn/Trev. .022" m...
ANALYZER, SODIUM/POTASSIUM NOVA L
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Ultraxx Nephrostomy Balloon Catheter
FDA 510(k)
FDA Unclassified
·Unknown
8015 ALARIS SYSTEM PC UNIT
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·January 11, 2021
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·April 24, 2014
CLEARCOUNT SMARTSPONGE LAP SPONGES
FDA Adverse Event
Malfunction
·MEDLINE INDUSTRIES·Product code GDY·September 26, 2012
VITALITY 2
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 27, 2010
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