11 results
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19ms
·
Sources: EU EUDAMED, US FDA
BIOPSY NEEDLE GUIDE KIT, STERILE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Mini-Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78715031·Mini Sprint Bracket Roth .018" mand. 4 left w. ...
Mini-Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78715031001·Mini Sprint Bracket Roth .018" mand. 4 left w. ...
Mini-Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78715030101·Mini Sprint Bracket Roth .018" mand. 4 left w. ...
Mini-Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78715030051·Mini Sprint Bracket Roth .018" mand. 4 left w. ...
Reprocessed CristaCath Diagnostic Electrophysiology Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
SYSTEM, TOMOGRAPHY, COMPUTED EMISSION
FDA 510(k)
FDA Class 2
·Radiology
TRILOGY 200
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code CBK·April 16, 2014
SPIRIT SELECT
FDA Adverse Event
CARROLL HOSPITAL GROUP INC.·Product code FNL·October 8, 2010
TM SHELL WITH MULTI HOLES
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code KWZ·December 6, 2012
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015