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

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Ilumien Optis, Optis Integrated, Optis Mobile

FDA 510(k)
FDA Class 2 ·Radiology

CoRoent

FDA UDI
Nuvasive, Inc.·00887517578051·CoRoent Ant TLIF PEEK, 8x13x32mm 0°

Vanguard® SSK Knee System

FDA UDI
Biomet Orthopedics, LLC·00880304440333·

AGILE NAIL

FDA UDI
ORTHOFIX SRL·18054242519010·SHORT SCREWDRIVER

SYNTHES XRL

FDA 510(k)
FDA Class 2 ·Orthopedic

DUKAL SURGICAL DRAPE; FENESTRATED DUKAL SURGICAL DRAPE

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

UPJ OCCLUSION BALLOON CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code EZL·December 6, 2021

LOW PRESSURE BLACK MAX HANDPIECE

FDA Adverse Event
Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBB·October 17, 2014

AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

FDA Adverse Event
Malfunction ·CARROLL HEALTHCARE·Product code FNL·June 21, 2013

CAPSUREFIX

FDA Adverse Event
Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 28, 2011

UPJ OCCLUSION BALLOON CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code EYB·July 2, 2024

UPJ OCCLUSION BALLOON CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code EZL·February 28, 2022

UPJ OCCLUSION BALLOON CATHETER

FDA Adverse Event
Injury ·COOK INC·Product code EZL·July 8, 2022

PEN NDL 32G 4MM PRO 100 BOX 1200 US

FDA Adverse Event
Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMI·July 30, 2021

BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT)

FDA Adverse Event
Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·October 25, 2023

BD PEN NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·February 23, 2021

UPJ OCCLUSION BALLOON CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code EZL·January 15, 2021

MCK Maximum Congruent Knee System, BIOMET FINNED PRI STEM 40MM; 80 x 10MM; 80 x 12.5 MM; 80 x 15 MM Knee joint replacement prostheses components include femoral, tibial, and patellar components.

FDA Enforcement
Class III ·Terminated·Biomet, Inc.·June 17, 2015