23 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ULYSS Multi View Sinuscope
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Tasso Mini
FDA UDI
Tasso Inc.·00850038691141·
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100660·CASTROVIEJO LID SPECULUM SMALL
ADVIA Centaur® Sample Cups
FDA UDI
Siemens Healthcare Diagnostics Inc.·00630414221571·
VISIA NEURO
FDA 510(k)
FDA Class 2
·Radiology
ADVIA CHEMISTRY LIQUID SPECIFIC PROTEIN CALIBRATORS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·October 8, 2014
CAPSUREFIX NOVUS MRI
FDA Adverse Event
Injury
·MPRI·Product code NVN·June 8, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011
EAGLE EYE PLATINUM SHORT TIP
FDA Adverse Event
Injury
·VOLCANO CORPORATION·Product code OBJ·July 1, 2016
EAGLE EYE PLATINUM SHORT TIP; EAGLE EYE PLATINUM ST CATHETER
FDA Adverse Event
Injury
·VOLCANO CORPORATION·Product code OBJ·July 1, 2016
EAGLE EYE PLATINUM SHORT TIP; EAGLE EYE PLATINUM ST CATHETER
FDA Adverse Event
Injury
·VOLCANO CORPORATION·Product code OBJ·July 1, 2016
FREESTYLE LIBRE
FDA Adverse Event
Injury
·ABBOTT DIABETES CARE INC·Product code PZE·October 11, 2018
8F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS
FDA Adverse Event
Injury
·ST. JUDE MEDICAL·Product code MGB·July 8, 2009
Artis zee biplane, Model Number 10094141
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·July 31, 2019
Artis zee biplane, Model Number 10094141
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022
Artis zee/ zeego systems; Product Usage: Usage: Artis zee/ zeego systems are 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 include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. .
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·July 1, 2015
Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722223, (2) 722224, (3) 722225, (4) 722226
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024
The Artis zee / zeego Angiography System is designed as a set of components that may be combined into different configurations to provide specialized angiography systems.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·December 10, 2014
Siemens Artis zee systems; 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 include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·August 12, 2015