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

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AGFA COMPUTED RADIOGRAPHY SYSTEM WITH NX2.X WORKSTATIONS

FDA 510(k)
FDA Class 2 ·Radiology

KMEDIC

FDA UDI
TELEFLEX INCORPORATED·24026704292817·

Key Surgical K-Wires and Steinmann Pins

FDA UDI
KEY SURGICAL, INC.·00849771012559·K-Wires, Single trocar, .045-inch (1.1mm) diame...

NA

FDA UDI
KEY SURGICAL, INC.·10849771049132·K-Wires, Single trocar, .045-inch (1.1mm) diame...

Genius Total Knee System

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215021528·

GOLDFINGER DEVICE

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

MODIFICATION TO THE EMIT II PLUS COCAINE METABOLITE ASSAY

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·March 26, 2025

INFINION 16

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 27, 2019

DEPUY ASR XL FEM IMP SIZE 49

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KWA·April 22, 2013

STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F/4.0MM INTRODUCER SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - CORK·Product code DTK·April 27, 2011

GE OEC 6800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·July 10, 2008

TOSOH HLC-723G8 ANALYZER

FDA Adverse Event
Malfunction ·TOSOH CORPORATION·Product code LCP·December 20, 2017

TOSOH HLC-723G8 ANALYZER

FDA Adverse Event
Malfunction ·TOSOH CORPORATION·Product code LCP·December 15, 2017

TOSOH HLC-723G8 ANALYZER

FDA Adverse Event
Malfunction ·TOSOH CORPORATION·Product code LCP·December 20, 2017

TOSOH HLC-723G8 ANALYZER

FDA Adverse Event
Malfunction ·TOSOH CORPORATION·Product code LCP·December 11, 2017

TOSOH HLC-723G8 ANALYZER G8

FDA Adverse Event
Injury ·TOSOH CORPORATION·Product code LCP·January 5, 2016

TOSOH HLC-723G8 ANALYZER G8

FDA Adverse Event
Injury ·TOSOH CORPORATION·Product code LCP·January 3, 2017

TOSOH HLC-723G8 ANALYZER G8

FDA Adverse Event
Malfunction ·TOSOH CORPORATION·Product code LCP·April 16, 2018

BARD Dynamic Tip Steerable, Product Number 6DYNTP001;

FDA Enforcement
Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026