15 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Alere Afinion HbA1c, Alere Afinion AS100 Analyzer
FDA 510(k)
FDA Class 2
·Hematology
OSS™ Orthopedic Salvage System
FDA UDI
Biomet Orthopedics, LLC·00880304674325·
Elements Connect
FDA UDI
META SYSTEMS CO., LTD.·08809455601952·Elements Connect Charging Base
ProLift
FDA UDI
Life Spine, Inc.·00190837138394·
ProLift
FDA UDI
Life Spine, Inc.·00190837138318·
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100257·CHU ASPIRATING SPECULUM SOLID
RESOLUTION 360 CLIP
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code PKL·December 2, 2024
EASYVIZ, EASYVIZ SYSTEM, EASYVIZ PACS SYSTEM, EASYVIZ IMAGE AND DATA MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ATTAIN ABILITY
FDA Adverse Event
Injury
·MPRI·Product code OJX·June 7, 2013
PRECISE PRO RX CAROTID STENT SYSTEM
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIM·July 6, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 10, 2008
Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 20, 2013
Precise Treatment Table. To be used as part of radiation therapy treatment process.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 17, 2013
All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 12, 2014