27 results · 21ms · Sources: EU EUDAMED, US FDA

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extriCARE® 3000 Negative Wound Pressure Therapy System

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

BELIMED STEAM STERILIZER, MODEL TOP 5000

FDA 510(k)
FDA Class 2 ·General Hospital

QLAB WITH FHN AND VPQ PLUG-IN

FDA 510(k)
FDA Class 2 ·Radiology

ADVANTAGE FIT ULTRA SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·November 7, 2025

ADVANTAGE FIT ULTRA SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·January 9, 2026

BD PARADIGM LINK BLOOD GLUCOSE MONITOR

FDA Adverse Event
Other ·BECTON DICKINSON·Product code NBW·July 29, 2005

ADVANTAGE FIT ULTRA SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·January 9, 2026

ADVANTAGE FIT ULTRA SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·May 23, 2025

ADVANTAGE FIT ULTRA SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·March 25, 2026

ADVANTAGE FIT ULTRA SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·October 28, 2025

LYNX ULTRA SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·December 12, 2025

LYNX ULTRA SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·September 4, 2025

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 31, 2024

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·September 19, 2023

FLEXCATH STEERABLE SHEATH

FDA Adverse Event
Malfunction ·MEDTRONIC CRYOCATH LP·Product code DRA·August 24, 2011

6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

FDA Adverse Event
Injury ·ST. JUDE MEDICAL PUERTO RICO, B.V.·Product code MGB·November 4, 2008

UNKNOWN

FDA Adverse Event
Injury ·ETHICON INC.·Product code FTL·July 11, 2013

ADVANTAGE FIT ULTRA SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·April 15, 2026

NI

FDA Adverse Event
Injury ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·February 18, 2020

INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code PKL·June 13, 2023