9 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TAS ANALYZER, MODEL 1009
FDA 510(k)
FDA Class 2
·Hematology
Trinity Acetabular Hip System
FDA UDI
CORIN LTD·05056139236334·Charnley Frame
PACEMAKER, OVALITH-D CARDIAC
FDA 510(k)
FDA Class 3
·Cardiovascular
PATHWAY AVID
FDA 510(k)
FDA Class 2
·Orthopedic
PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code MEH·October 15, 2025
CREATININE RGT (CR-S) KIT
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code CGX·March 5, 2013
CONCERTO CRT-D DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·February 15, 2011
SPRINT QUATTRO SECURE S
FDA Adverse Event
Injury
·MPRI·Product code LWS·August 8, 2014
Breast Pack, part number AMS3238(A Breast Pack, part number AMS4419(A Breast Pack, part number AMS4419(B Breast Pack, part number AMS5750 Breast Pack, part number AMS5750(A Breast Pack, part number AMS6120 Breast Pack, part number PSS1784(B Breast Pack, part number PSS2272(A
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017