16 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MONJECT STERILE 20CC SYRINGES
FDA 510(k)
FDA Class 2
·General Hospital
NAR Kit
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209110117·KIT, DOUBLE STACK IFAK - ADVANCED - CUSTOM
Shoreline ACS
FDA UDI
Seaspine Orthopedics Corporation·10889981177621·7mm, 3-Hole Threaded Anterior Plate
ARTHREX INTERFERENCE SCREW-ROUNDED HEAD SCREWS, FULL THREADED SCREWS, SHEATHED CANNULATED INTERFERENCE SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
Express SD Biliary Monorail Premounted Stent System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EXPRESS SD RENAL/BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 22, 2025
EXPRESS SD RENAL/BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·September 3, 2025
EXPRESS SD RENAL/BILIARY
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·January 27, 2025
EXPRESS SD RENAL/BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 12, 2025
EXPRESS SD RENAL/BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·May 13, 2026
EXPRESS SD RENAL/BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·January 22, 2025
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 6, 2014
HEARTSINE SAMARITAN 300P AND PAD PAK
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES, LTD·Product code MKJ·November 26, 2012
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 18, 2015
EXPRESS SD RENAL/BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 11, 2025
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·July 30, 2014