23 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COLLAGEN TENDON SHEET-DDI (CTS-DDI)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ORTHOFIX
FDA UDI
ORTHOFIX SRL·18059015374346·STANDARD LOCKING SCREW L30.0MM D4.0MM
OsteoMed
FDA UDI
OSTEOMED LLC·00845694015844·Temporary Condyle Attachment (TCA)
ORTHOFIX
FDA UDI
ORTHOFIX SRL·18059015373844·STANDARD LOCKING SCREW L30.0MM D4.0MM STERILE
Mariner Outrigger
FDA UDI
Seaspine Orthopedics Corporation·10889981161545·Z-Rod, Dia. 6.0mm, Co-Cr, 300mm
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702251715·Elvarex 2/Thigh High/Slant, Open Toe, E-Version...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702898200·ELVAREX FORTE 3/KNEE HIGH/SLANT-CLOSED TOE/DOTT...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702537079·Elvarex 1/Thigh High/Profile-Slant-Closed Toe/D...
SIMPLANT 2011
FDA 510(k)
FDA Class 2
·Radiology
STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
LOGIC FEMORAL PS POR RIGHT SZ 2
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·February 10, 2025
LOGIC CR FEMORAL POR, LEFT, SZ 3.5
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·December 11, 2024
QUICK FLEX LV LEAD
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC. CRMD·Product code NIK·January 13, 2014
PINNACLE 300 ACET CUP 56MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·May 31, 2013
ENDO GIA UNIVERSAL XL
FDA Adverse Event
Injury
·UNITED STATES SURGICAL·Product code GDW·June 15, 2011
VICRYL PLUS POLYGLACTIN 910 SUTURE UNKNOWN PROD
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·November 15, 2017
VICRYL PLUS POLYGLACTIN 910 SUTURE UNKNOWN PROD
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·November 15, 2017
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·April 26, 2023
COOK® MULTI-USE HOLMIUM LASER FIBER
FDA Adverse Event
Injury
·COOK INC·Product code GEX·December 7, 2015
Change Healthcare Cardiology Hemo. Versions 14.2, 14.1.1, 14.2, 14.3, 14.3.2, 14.3, 15.0.1, 15.1.
FDA Enforcement
Class II
·Ongoing·CHANGE HEALTHCARE CANADA COMPANY·October 23, 2024