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

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Boomerang™ Anterior Cervical Plate System

FDA 510(k)
FDA Class 2 ·Orthopedic

VIDAS® ESTRADIOL II

FDA Adverse Event
Malfunction ·BIOMERIEUX SA·Product code CHP·October 12, 2018

VIDAS® ESTRADIOL II

FDA Adverse Event
Malfunction ·BIOMERIEUX SA·Product code CHP·October 12, 2018

VIDAS® ESTRADIOL II

FDA Adverse Event
Malfunction ·BIOMERIEUX SA·Product code CHP·October 12, 2018

SAS FLUALERT A&B, SAS INFLUENZA A TEST

FDA 510(k)
FDA Class 2 ·Microbiology

OPTIMA CT660

FDA 510(k)
FDA Class 2 ·Radiology

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·May 23, 2023

VIDAS® ESTRADIOL II

FDA Adverse Event
Malfunction ·BIOMERIEUX SA·Product code CHP·July 23, 2019

VIDAS® ESTRADIOL II

FDA Adverse Event
Injury ·BIOMERIEUX SA·Product code CHP·July 23, 2019

SHILEY

FDA Adverse Event
Injury ·MMJ SA DE CV (USD)·Product code BTR·June 15, 2021

BAB FLEXIBLE FABRIC BANDAGES

FDA Adverse Event
Injury ·JOHNSON & JOHNSON CONSUMER INC·Product code KGX·January 21, 2020

INFUSE

FDA Adverse Event
Injury ·MEDTRONIC·Product code NEK·October 6, 2008

PALINDROME 23/40 KIT W/SLOT

FDA Adverse Event
Malfunction ·COVIDIEN·Product code MSD·June 10, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011

VENTED AUTOFEED HUMIDIFICATION CHAMBER

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·October 10, 2019

GALAXY G3 MINI 2MM X 3CM

FDA Adverse Event
Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·August 18, 2020

Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13; Shoulder Arthroplasty

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

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