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

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BSD3543W

FDA 510(k)
FDA Class 2 ·Radiology

METZENBAUM SCISSORS

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896055728·METZENBAUM SCISSORS DELICATE CURVED BLADES POWE...

Endo Carry-On Procedure Kit

FDA UDI
MEDIVATORS INC.·00677964091865·Endo Carry-On Procedure Kit

Custom Procedure Kit

FDA UDI
MEDIVATORS INC.·00677964109522·The ENDO CARRY-ON Procedure Kit contains all of...

RENASYS F/-AB ABDOMINAL WOUND DRESSING KIT

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

VERDICT-II PROPOXYPHENE

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

AUVON TENS & EMS DEVICE

FDA Adverse Event
Injury ·SHEN ZHEN AS TEC TECHNOLOGY CO LTD·Product code NUH·January 28, 2025

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 29, 2025

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 24, 2014

NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

FDA Adverse Event
Injury ·HOLOGIC·Product code MNB·July 29, 2011

ARCHITECT CA 19-9XR

FDA Adverse Event
Malfunction ·ABBOTT LABORATORIES·Product code NIG·July 1, 2013

AUVON TENS UNIT

FDA Adverse Event
Injury ·SHEN ZHEN AS TEC TECHNOLOGY CO LTD·Product code NUH·December 19, 2024

EMBLEM MRI S-ICD Model A219

FDA Enforcement
Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021