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