17 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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