32 results
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37ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PATIENT-SPECIFIC VANGUARD FEMORAL COMPONETS
FDA 510(k)
FDA Class 2
·Orthopedic
Novo Surgical Inc.
FDA UDI
NOVO SURGICAL, INC.·00842331139581·probe w/ eye, stainless steel, 5 1/2" (14.0 cm)
Clear Readers
FDA UDI
Diversified Products, Inc.·00842894121696·
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776186258·SUPERCUT METZ SCS CVD DEL
SAV
FDA UDI
Diversified Products, Inc.·00037741210214·
Orthopaedic Surgical Instruments
FDA UDI
CITIEFFE SRL·08056711921167·
Tissue Holder
FDA UDI
KATENA PRODUCTS, INC.·00841668112847·BARRON ARTIFICIAL ANTERIOR CHAMBER
SAV
FDA UDI
Diversified Products, Inc.·00842894114247·
Clear Readers
FDA UDI
Diversified Products, Inc.·00842894113547·
PINS AND WIRES
FDA 510(k)
FDA Class 2
·Orthopedic
OPUS MAGNUM ANCHOR & INSERTER
FDA 510(k)
FDA Class 2
·Orthopedic
COBAS 8000 CORE UNIT
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·April 15, 2019
ZIMMER TM REVERSE GLENOSPHERE
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code HSD·April 26, 2013
8800
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS (INDIA) PRIVATE, LTD.·Product code JAA·April 20, 2011
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code NIQ·August 7, 2008
EVOLUT R TRANSCATHETER AORTIC VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·September 13, 2021
REZUM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·July 27, 2022
Syngo.via and Syngo.x ; a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·June 10, 2015
Syngo.via picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 28, 2016
Syngo.x picture archiving and communication system Syngo.x is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 28, 2016