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

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Dr’s Finder NEO

FDA 510(k)
FDA Unclassified ·Unknown

VICOR PD2I ANALYZER

FDA 510(k)
FDA Class 2 ·Cardiovascular

RAPID GENOTYPING ASSAY -CYP2C9 & VKORC1, MODEL CATALOG NO. 006+0203 GACTGA

FDA 510(k)
FDA Class 2 ·Hematology

GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/11 MM L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·January 30, 2019

PORTEX BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE

FDA Adverse Event
Malfunction ·SMITH MEDICAL INTERNATIONAL LTD.·Product code JOH·May 24, 2013

INFUSO.R.

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 22, 2011

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 15, 2014

CANCER ANTIGEN 125

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LTK·October 3, 2013

APPROACH CTO MICROWIRE WIRE GUIDE

FDA Adverse Event
Injury ·Product code DQX·May 21, 2021

APPROACH CTO MICROWIRE WIRE GUIDE

FDA Adverse Event
Injury ·COOK INC·Product code DQX·December 28, 2021

INVISION¿ TOTAL ANKLE SYSTEM

FDA Adverse Event
Injury ·WRIGHT MEDICAL TECHNOLOGY INC·Product code HSN·July 18, 2022

APPROACH CTO MICROWIRE WIRE GUIDE

FDA Adverse Event
Malfunction ·COOK INC·Product code DQX·October 17, 2023

APPROACH CTO MICROWIRE WIRE GUIDE

FDA Adverse Event
Malfunction ·COOK INC·Product code DQX·October 3, 2023

APPROACH CTO MICROWIRE WIRE GUIDE

FDA Adverse Event
Injury ·COOK INC·Product code DQX·October 31, 2023

Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781342 781377

FDA Enforcement
Class II ·Completed·Philips North America Llc·September 15, 2021