15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DYNESYS SPINAL SYSTEM WITH HA COATED SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70606381·Sprint II Bracket Roth .018" 200 Brackets
RESPONDER 3000
FDA 510(k)
FDA Class 3
·Cardiovascular
NEUROPLUS, MODEL A10040, A10041, A10042, A10043
FDA 510(k)
FDA Class 2
·Neurology
METASUL INSERT KK/28
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LPH·February 17, 2026
METASUL BALL HEAD 28/0MM
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LPH·February 17, 2026
INRATIO
FDA Adverse Event
Malfunction
·HEMOSENSE, INC.·Product code JPA·October 22, 2007
INRATIO
FDA Adverse Event
Malfunction
·HEMOSENSE, INC.·Product code JPA·March 9, 2007
INRATIO
FDA Adverse Event
Malfunction
·HEMOSENSE, INC.·Product code JPA·November 5, 2007
INRATIO
FDA Adverse Event
Malfunction
·HEMOSENSE, INC.·Product code JPA·July 16, 2007
ALARIS PUMP MODULE ADMINISTRATION SET
FDA Adverse Event
Malfunction
·CAREFUSION CORPORATION·Product code FPA·March 27, 2013
DEPUY ASR XL FEM IMP SIZE 43
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·April 6, 2011
ULTRAPRO MESH
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·June 13, 2008
Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018