34 results · 26ms · Sources: EU EUDAMED, US FDA

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VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5

FDA 510(k)
FDA Class 2 ·Cardiovascular

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450448236·

WATCH-PAT 100

FDA 510(k)
FDA Class 2 ·Anesthesiology

EVANTGARDE/ENDEAVOR POWERED WHEELCHAIR

FDA 510(k)
FDA Class 2 ·Physical Medicine

MAMMARY IMPLANT

FDA Adverse Event
Injury ·MCGHAN MEDICAL CORP.·Product code FTR·September 26, 1995

DUO-VENT CLEARLINK LUER ACTIVATED VALVE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·September 29, 2022

CLEARLINK LUER ACTIVATED VALVE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·October 31, 2022

CLEARLINK LUER ACTIVATED VALVE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·November 1, 2022

NI

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·May 5, 2023

IMMERSION HYDROBATH

FDA Adverse Event
Malfunction ·INVACARE CLEVELAND STREET·Product code ILJ·May 8, 2013

IBGSTAR BGMS

FDA Adverse Event
Injury ·AGAMATRIX·Product code NBW·September 12, 2014

MICRUS MICROCOIL SYSTEM

FDA Adverse Event
Injury ·MICRUS ENDOVASCULAR CORPORATION·Product code MJN·May 18, 2011

CLEARLINK SOLUTION ADMINISTRATION SETS

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·April 27, 2022

DUO-VENT CLEARLINK LUER ACTIVATED VALVE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·July 5, 2022

CLEARLINK SOLUTION ADMINISTRATION SETS

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·April 27, 2022

CONTINU-FLO CLEARLINK SYSTEM SOLUTION SET

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·December 29, 2022

FORTRESS INTRODUCER SHEATH SYSTEM - 6FR, 45CM

FDA Adverse Event
Malfunction ·CONTRACT MEDICAL INTERNATIONAL GMBH·Product code DYB·November 30, 2015

Brilliance iCT - Model no. 728306 Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.

FDA Enforcement
Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 25, 2018

Brilliance iCT - Model 728306 Computed Tomography X-ray systems

FDA Enforcement
Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·January 31, 2018

IVEA Product Part Number 16100 Model 500A

FDA Enforcement
Class II ·Terminated·Firefly Medical, Inc.·October 11, 2017