14 results · 23ms · Sources: EU EUDAMED, US FDA

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PRO-TOE Hammertoe Fixation System

FDA 510(k)
FDA Class 2 ·Orthopedic

OSS™ Orthopedic Salvage System

FDA UDI
Biomet Orthopedics, LLC·00880304674905·

MODIFIED CONCENTRIC RETRIEVER, MODEL 90039

FDA 510(k)
FDA Class 2 ·Cardiovascular

VTS1000

FDA 510(k)
FDA Class 1 ·General Hospital

PEN NDL 31G 8MM 90 COUNT MAIL ORDER ONLY

FDA Adverse Event
Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·February 3, 2021

CPS TRANSVERSE PIN 6PK 32MM

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KRO·October 23, 2019

CPS SM SHT SPDL W PINS 400LBF

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWA·October 23, 2019

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 8, 2014

SPRINT QUATTRO SECURE

FDA Adverse Event
Malfunction ·MPRI·Product code NVY·June 7, 2013

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·July 6, 2011

CPS SHORT ANCHOR PLUG 16MM

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWA·June 2, 2019

CPS SM SHT SPDL W PINS 600LBF

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code MBF·August 28, 2024

ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

FDA Enforcement
Class II ·Ongoing·Elekta, Inc.·December 13, 2023

Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)

FDA Enforcement
Class II ·Ongoing·Medtronic Inc.·November 29, 2017