18 results · 22ms · Sources: EU EUDAMED, US FDA

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X-spine Pedicle Screw System

FDA 510(k)
FDA Class 2 ·Orthopedic

HairCheck-DT (Cocaine)

FDA UDI
Quest Diagnostics·00868586000216·HairCheck-DT (Cocaine) is an ELISA test kit use...

Simpact Tri-Fin

FDA UDI
Life Spine, Inc.·00190837062897·12mm Drill, Cannulated

KRYSTALRAD 660 DIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

MODIFICATION TO: LIFESTENT VALEO BILIARY STENT SYSTEM

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

ONE TOUCH ULTRA

FDA Adverse Event
Malfunction ·LIFESCAN, INC.·Product code CFR·March 18, 2002

ACCU-CHEK COMPACT TEST DRUM

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·March 10, 2009

LIFESTENT VALEO BILIARY STENT

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code FGE·December 29, 2009

SPECTRA WAVEWRITER

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·February 10, 2025

LIFESTENT VALEO BILIARY STENT

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code FGE·December 29, 2009

LIFESTENT VALEO VASCULAR STENT

FDA Adverse Event
Injury ·BARD PERIPHERAL VASCULAR, INC.·Product code FGE·August 9, 2010

STEM: AMISTEM H HA COATED LAT STEM SIZE 5

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·November 13, 2018

VALEO VASCULAR STENT

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code FGE·September 3, 2010

STEM: AMISTEM H HA COATED LAT STEM SIZE 5

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·May 12, 2022

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011

URETEX SUP URETHRAL SUPPORT SYSTEM

FDA Adverse Event
Injury ·SOFRADIM PRODUCTION·Product code OTN·May 24, 2013

VERSACARE

FDA Adverse Event
Malfunction ·HILL-ROM RITTER·Product code FNL·September 10, 2008

Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024