29 results · 26ms · Sources: EU EUDAMED, US FDA

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PENTAX Medical Video Bronchoscope EB11-J10

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

B.BRAUN

FDA UDI
B.Braun Avitum AG·04046963711160·DIALYSING LINE FUTURA (US)

GEN4 DIGITAL

FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828128018·GEN4 DIGITAL

PROLITE VL PULSED LIGHT SYSTEM

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

BODY ANALYSIS SCALE, MODEL BG 17

FDA 510(k)
FDA Class 2 ·Cardiovascular

VIDAS ESTRADIOL II

FDA Adverse Event
Malfunction ·BIOMERIEUX SA·Product code CHP·January 21, 2021

VIDAS ESTRADIOL II

FDA Adverse Event
Malfunction ·BIOMERIEUX SA·Product code CHP·January 21, 2021

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 5, 2025

SONICATOR PLUS 992

FDA Adverse Event
Injury ·METTLER ELECTRONICS CORP.·Product code IPF·October 23, 2008

FORTIFY DR, DF-4 CONNECTOR

FDA Adverse Event
Death ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·August 12, 2011

MINICAP TRANSFER SET

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·July 8, 2013

BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·May 11, 2023

NEEDLE SPINAL S/SU 25GA 3-1/2IN QUINCKE

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code BSP·August 5, 2025

130° RADIOLUCENT TARGETING ARM

FDA Adverse Event
Malfunction ·ARTHREX, INC.·Product code HSB·October 17, 2025

VIDAS SARS-COV-2 IGG

FDA Adverse Event
Malfunction ·BIOMERIEUX SA·Product code QKO·November 17, 2020

VIDAS SARS-COV-2 IGG

FDA Adverse Event
Malfunction ·BIOMERIEUX SA·Product code QKO·January 21, 2021

AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-US

FDA Enforcement
Class II ·Ongoing·Fresenius Medical Care Holdings, Inc.·August 3, 2022

BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 17 X 165 MM, 64 MM, Silicone, Sterile, Item 431217.

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

BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 51 MM, Silicone, Sterile, Item 431209.

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

BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 43 MM, Silicone, Sterile, Item 431207.

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