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

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Vantage Titan 1.5T, V3.1, MRT-1510

FDA 510(k)
FDA Class 2 ·Radiology

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04051526768512·GENUMEDI PSS GREEN VII

OSS™ Orthopedic Salvage System

FDA UDI
Biomet Orthopedics, LLC·00880304239487·

Oticon

FDA UDI
Oticon A/S·05707131289148·H11V2 TI, MINIRITE 312 WL CBE

HNM MEDICAL

FDA UDI
HNM STAINLESS, LLC.·00842962104866·FULL RADIUS BLADE, 4.5MM, LONG, S

Capsule Polishers

FDA UDI
AURORA SURGICAL, LLC·08175700153089·Kratz Capsule Scrubber, 27g, Angled 1mm Sandbla...

Flexion Gap Tensioner

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215057053·

FORA GW 9014 TELEHEALTH GATEWAY/TD-9014 TELEHEALTH GATEWAY

FDA 510(k)
FDA Class 2 ·Cardiovascular

FEMTEC LASER SYSTEM FOR CAPSULOTOMY

FDA 510(k)
FDA Class 2 ·Ophthalmic

HNM MEDICAL

FDA UDI
HNM STAINLESS, LLC.·00842962102879·DISPOSABLE ARTHROSCOPIC 4.5mm FULL RADIUS SHAVE...

OSS RS AXLE

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KRO·August 3, 2023

OSS POLY LOCK PIN

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JDI·August 3, 2023

OSS REINFORCED YOKE

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KRO·August 3, 2023

PRODIGY AUTOCODE

FDA Adverse Event
Injury ·OK BIOTECH CO., LTD.·Product code NBW·September 2, 2016

X-SUIT NIR COVERED BILIARY METALLIC STENT

FDA Adverse Event
Malfunction ·MEDINOL LTD.·Product code FGE·December 27, 2017

DEPUY

FDA Adverse Event
Injury ·DEPUY·Product code JDI·April 15, 2013

CONSOLE, ROTAFLOW

FDA Adverse Event
Malfunction ·MAQUET·Product code KFM·June 24, 2011

KINETRA

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·September 5, 2008

Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

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