13 results · 25ms · Sources: EU EUDAMED, US FDA

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CARDIOSMART ST

FDA 510(k)

LateralALIF

FDA UDI
Nuvasive, Inc.·00887517840103·ALIF Pin, 100mm Anchoring

GEM Premier 5000

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

CORDIS STEERABLE GUIDEWIRE

FDA 510(k)
FDA Class 2 ·Cardiovascular

BD FACSCALIBUR¿ FLOW CYTOMETER

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·January 31, 2023

DURATA STS OPTIM ACTIVE FIXATION

FDA Adverse Event
Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·February 21, 2013

HOMECHOICE CYCLER-REFURBISHED

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·January 30, 2011

PROGRASP FORCEPS INSTRUMENT

FDA Adverse Event
Injury ·INTUITIVE SURGICAL,INC.·Product code NAY·August 1, 2014

BD FACSCALIBUR FLOW CYTOMETER

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·March 31, 2023

BD FACSCALIBUR¿ FLOW CYTOMETER

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·March 31, 2023

BD FACSCALIBUR¿ FLOW CYTOMETER

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·January 20, 2023

BD FACSCALIBUR¿ FLOW CYTOMETER

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·July 24, 2023

BIOMET 3i, PROVIDE IMPRESSION COPINGS, Catalog # PIC484, PIC484H, PIC485, PIC485H, PIC654, PIC654H, PIC655, and PIC655H BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.

FDA Enforcement
Class II ·Terminated·Biomet 3i, LLC·January 13, 2016