26 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EMU-GRAPH 4 EMULATOR, MODEL CI 144
FDA 510(k)
FDA Class 2
·General Hospital
N/A
FDA UDI
GEORGE TIEMANN & CO.·B582083650·RETRACTOR, ALL TYPES
PERMLASTIC 3
FDA 510(k)
FDA Class 2
·Dental
ORTHOPHOS DS/DC CEPH, ORTHOPHOS 5/PLUS/CD
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 9, 2025
UNKNOWN ACETABULAR SHELL
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code KWA·September 6, 2018
SIRIUS HIP STEM 34-C
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDG·October 10, 2019
RESERVOIR 3ML
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·April 29, 2013
CAPSURE SENSE
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·May 10, 2011
GE OEC 9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·July 28, 2008
REGEN/RNGLC+ LTD 52MM SZ 23
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LZO·December 19, 2019
Femoral Nail, LEFT T2 GTN ¿12x360 mm, Product Number 18501236S
FDA Enforcement
Class II
·Terminated·Stryker GmbH·July 18, 2018
Femoral Nail, A/R T2 Femur ¿12x360 mm, Product Number 18251236S
FDA Enforcement
Class II
·Terminated·Stryker GmbH·July 18, 2018
LARGE EX-FIX COMBINATION CLAMP MR-CONDITIONAL
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018
SELDRILL-SCHANZSCR Ø5 L200/80 SST
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018
TAPERLC BMPC LAT 9.0X137 12/14
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JDI·August 20, 2019
LARGE EX-FIX 11MM CRBN FBR ROD 250MM / MR-CONDITIONAL
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018
LARGE EX-FIX 11MM CRBN FBR ROD 300MM / MR-CONDITIONAL
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018
DELTA CER FM HD 036/-4MM 12/14
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·January 7, 2019
MLRY-HD 3HOLE RLC SHL 60MM/L23
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·January 7, 2019