15 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MEDICAL ELECTRONICS-PRINTER CLOCK
FDA 510(k)
FDA Class 1
·Cardiovascular
DD cube ONE ML
FDA UDI
Dental Direkt GmbH·EDDIG8320121·DD cube ONE® ML are dental mill blanks made fro...
LINK Endo-Model EVO Knee System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575267712·Femoral component, cemented, CoCrMo, UHMWPE, st...
Continuum® Trilogy®
FDA UDI
Zimmer, Inc.·00889024153714·
Continuum® Trilogy®
FDA UDI
Zimmer, Inc.·00889024153691·
Continuum® Trilogy®
FDA UDI
Zimmer, Inc.·00889024153707·
HOMOCYSTEINE MICROTITER PLATE ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TRINICA(R) ANTERIOR CERVICAL PLATE SYSTEM, TRINICA(R) SELECT ANTERIOR CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ATS 1200 TOURNIQUET SYSTEM
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL·Product code KCY·March 7, 2014
ASR UNI FEMORAL IMPL SIZE 43
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·November 14, 2012
ENDO GIA II 60-3.5 SULU
FDA Adverse Event
Injury
·USSC PUERTO RICO·Product code GDW·September 8, 2010
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·August 23, 2017
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·August 23, 2017
EV3 Pipeline Flex Embolization Device with Flex Shield Technology
FDA Enforcement
Class I
·Ongoing·Micro Therapeutics Inc,·September 15, 2021
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024