132 results · 31ms · Sources: EU EUDAMED, 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