18 results · 20ms · Sources: EU EUDAMED, US FDA

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CUTTER CAST 7

FDA 510(k)
FDA Class 1 ·Physical Medicine

CS-76 AND/OR CRYOCARE I

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

MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDIC, INC.·Product code KWP·October 30, 2014

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·September 14, 2017

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·December 17, 2014

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·January 10, 2018

GEMSTAR PAIN MGE SNG

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·February 18, 2014

HYPERFORM OCCLUSION BALLOON SYSTEM

FDA Adverse Event
Malfunction ·EV3 NEUROVASCULAR·Product code MJN·October 3, 2012

ENDOPATH** XCEL* BLADELESS TROCAR WITH STABILITY SLEEVE

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·July 27, 2010

BD TRUCOUNT TUBES

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·July 13, 2021

BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES

FDA Adverse Event
Malfunction ·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·May 20, 2024

BD TRUCOUNT TUBES

FDA Adverse Event
Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code GKZ·July 15, 2021

BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES

FDA Adverse Event
Malfunction ·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·November 30, 2023

BD TRUCOUNT TUBES

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·August 24, 2020

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·April 27, 2020

BD TRUCOUNT¿ TUBES

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·May 2, 2025

GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is used for monitoring hospital patients respiration, ventilation, and gas exchange status.

FDA Enforcement
Class II ·Terminated·GE Healthcare, LLC·June 25, 2014