17 results · 23ms · Sources: EU EUDAMED, US FDA

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FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 19MM X 1

FDA 510(k)
FDA Class 2 ·Cardiovascular

EASY TOUCH

FDA 510(k)
FDA Class 2 ·General Hospital

CA 15-3 ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM

FDA 510(k)
FDA Class 2 ·Immunology

COTTON-HUIBREGTSE BILIARY STENT

FDA Adverse Event
Injury ·WILSON-COOK MEDICAL INC·Product code FGE·July 14, 2022

SCREW, UNKNOWN TYPE

FDA Adverse Event
Malfunction ·ZIMMER BIOMET SPINE INC.·Product code KWP·June 17, 2019

SCREW, UNKNOWN TYPE

FDA Adverse Event
Malfunction ·ZIMMER BIOMET SPINE INC.·Product code KWP·June 17, 2019

UNKNOWN_NEUROVASCULAR_PRODUCT

FDA Adverse Event
Death ·CONCENTRIC MEDICAL·Product code NRY·December 13, 2012

UNKNOWN_NEUROVASCULAR_PRODUCT

FDA Adverse Event
Death ·CONCENTRIC MEDICAL·Product code NRY·December 13, 2012

UNKNOWN_NEUROVASCULAR_PRODUCT

FDA Adverse Event
Death ·CONCENTRIC MEDICAL·Product code NRY·December 13, 2012

INTERLOCK?-35

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - CORK·Product code KRD·May 21, 2013

PUMP MMT-512WWL PRDGM INSULIN CL EN

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code LZG·August 15, 2008

MCA MED APPLIER

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDO·June 13, 2011

UNKNOWN_NEUROVASCULAR_PRODUCT

FDA Adverse Event
Death ·CONCENTRIC MEDICAL·Product code NRY·December 13, 2012

UNKNOWN_NEUROVASCULAR_PRODUCT

FDA Adverse Event
Death ·CONCENTRIC MEDICAL·Product code NRY·December 18, 2012

SOMATOM Edge Plus-Computed tomography system Model 1026700

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc·January 19, 2022

Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE

FDA Enforcement
Class II ·Ongoing·Electro Medical Systems SA·May 1, 2024

Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only);

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026