16 results · 25ms · Sources: EU EUDAMED, 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