17 results · 31ms · Sources: EU EUDAMED, US FDA

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Introcan Safety IV Catheter

FDA 510(k)
FDA Class 2 ·General Hospital

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

INTROCAN SAFETY®

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

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

VariAx

FDA UDI
Stryker GmbH·37613153067789·LOCKING PEGS

EON CALCIUM REGENT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-PENICILLIN

FDA 510(k)
FDA Class 2 ·Microbiology

8800

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

SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code MDS·July 14, 2011

IMPAX CV REPORTING

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

BD MICROLANCE¿ 3 NEEDLES

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·March 3, 2023

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 Hip Cement Spacer Mold with Insert, 52 MM, Silicone, Sterile, Item 431182.

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

BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 135 MM, Silicone, Sterile, Item 431191.

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