23 results · 25ms · Sources: EU EUDAMED, 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