33 results
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31ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SMARTPILOT VIEW MODEL MK04500
FDA 510(k)
FDA Class 2
·Anesthesiology
NexxZr™ / W-98-12-UT-A350-ML
FDA UDI
SAGEMAX BIOCERAMICS, INC·00842271138538·
SMART PORT LABEL P. N. 103035 REV. A
FDA Adverse Event
Injury
·ANGIODYNAMICS·Product code LJS·July 17, 2015
Mariner Deformity
FDA UDI
Seaspine Orthopedics Corporation·10889981297077·Coronal Bender, Right, 5.5mm
Forefoot Screws
FDA UDI
Life Spine, Inc.·00190837020170·
RIVA Posterior Fixation System
FDA UDI
XENIX MEDICAL LLC·00840493414669·Nav Pedicle Tap, 3.5mm
AIRCARE Endotracheal Tube
FDA UDI
Well Lead Medical Co.,Ltd·00351688073559·Endotracheal Tubes without Cuff, Stylet (Oral/N...
CLARREN HELMET
FDA 510(k)
FDA Class 2
·Neurology
GUARDIAN LIMB SALVAGE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TGS UKA SYSTEM
FDA Adverse Event
Injury
·ALEXANDRIA RESEARCH TECHNOLOGIES, INC·Product code HSX·March 22, 2013
Widex
FDA UDI
Widex A/S·05706069327021·Widex mind440 M4-19 BTE (Charcoal grey (dark g ...
Widex
FDA UDI
Widex A/S·05706069328448·Widex mind330 M3-19 BTE (Charcoal grey ) Teleco...
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·July 8, 2025
SSW CARBIDE CAD CAM
FDA UDI
Ss White Burs, Inc.·D690SSWWIE10303520012·CAD/CAM CARBIDE LAZER SHARP SSWWIE-103035-20-01...
TURBOHAWK ® PERIPHERAL PLAQUE EXCISION SYSTEM
FDA Adverse Event
Injury
·EV3 INC.·Product code MCW·May 9, 2013
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·September 19, 2014
M2A MAGNUM PF CUP 62MM OD X 56MM ID
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·May 25, 2011
SLEEK OTW PTA CATHETER
FDA Adverse Event
Injury
·CLEARSTREAM TECHNOLOGIES LTD.·Product code DQY·December 13, 2023
Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese patients. Procedures that can be performed with the AXIOM Artis-zee/zeego and Q/Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee/zeego and Q/Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 6, 2017
Artis Q floor, Model Number 10848280
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022