132 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DRI TM Tricyclics Serum Tox Assay
FDA 510(k)
FDA Class 2
·Clinical Toxicology
RIGIDFIX
FDA UDI
DEPUY MITEK, LLC·10886705003334·RIGIDFIX TIBIAL ROD Soft Tissue Only 7.5mm, 20-...
MED-TEC COMPENSATOR BLOCK CUTTER SOFTWARE
FDA 510(k)
FDA Class 2
·Radiology
AAP RADIUS SET 2.5
FDA 510(k)
FDA Class 2
·Orthopedic
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·October 30, 2014
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·August 5, 2011
GYNECARE PROLIFT TOTAL PELVIC FLOOR REPAIR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTP·July 9, 2013
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 24, 2024
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·May 19, 2022
COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·May 19, 2022
COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·May 19, 2022
COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·May 19, 2022
COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·May 19, 2022
COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·May 19, 2022
COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·May 19, 2022
COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DTK·May 9, 2022
COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·May 19, 2022
COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·August 30, 2023