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

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SURGIVISIO Device

FDA 510(k)
FDA Class 2 ·Radiology

24M - 16 person Class A First Aid/Burn Kit

FDA UDI
Certified Safety Manufacturing, Inc.·00766588206271·24M - 16 person Class A First Aid/Burn Kit

MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-GATIFLOXACIN

FDA 510(k)
FDA Class 2 ·Microbiology

TOSHIBA 1.5T QD HEAD COIL

FDA 510(k)
FDA Class 2 ·Radiology

INTROCAN SAFETY®

FDA Adverse Event
Malfunction ·B BRAUN MELSUNGEN AG·Product code DYB·April 11, 2025

INTROCAN SAFETY®

FDA Adverse Event
Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·April 8, 2025

INTROCAN SAFETY®

FDA Adverse Event
Injury ·B BRAUN MELSUNGEN AG·Product code FOZ·April 1, 2025

8800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·October 31, 2008

CYPHER SIROLIMUS-ELUTING CORONARY STENT

FDA Adverse Event
Injury ·CORDIS LLC (PR)·Product code NIQ·August 23, 2011

IMPAX CV REPORTING

FDA Adverse Event
Malfunction ·AGFA HEALTHCARE CORP·Product code LLZ·July 8, 2013

INTROCAN SAFETY®

FDA Adverse Event
Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·March 20, 2025

BD MAX¿ ENTERIC VIRAL PANEL

FDA Adverse Event
Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code PCH·February 23, 2024

INTROCAN SAFETY®

FDA Adverse Event
Injury ·B BRAUN MELSUNGEN AG·Product code FOZ·April 10, 2025

INTROCAN SAFETY®

FDA Adverse Event
Injury ·B BRAUN MELSUNGEN AG·Product code DYB·March 18, 2026

Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxial set consisting of an outer catheter, curved-tip metal cannula, and a tapered-tip inner needle

FDA Enforcement
Class II ·Terminated·Cook Inc.·November 24, 2021

BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

FDA Enforcement
Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020