889 results · 23ms · Sources: EU EUDAMED, US FDA

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b-ONE MOBIO Total Knee System

FDA 510(k)
FDA Class 2 ·Orthopedic

HI-ART SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

MYSAFETY SYRINGE

FDA 510(k)
FDA Class 2 ·General Hospital

TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC·Product code NIQ·October 23, 2008

CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code DYE·August 16, 2011

EASYTRAK 2

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code OJX·July 9, 2013

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

BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code GIM·May 26, 2026

BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code GIM·May 1, 2026

BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code GIM·April 28, 2026

BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code GIM·March 11, 2026

BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code GIM·May 12, 2026

BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code GIM·May 15, 2026

BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code GIM·February 5, 2026

BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code GIM·May 14, 2026

BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code GIM·February 6, 2026

BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code GIM·May 12, 2026

BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code GIM·May 1, 2026

BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code GIM·February 23, 2026