21 results · 22ms · Sources: EU EUDAMED, US FDA

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Bonine Acupressure Bands

FDA 510(k)
FDA Unclassified ·Unknown

Phasix

FDA UDI
Davol Inc.·00801741161278·Phasix ST Mesh with Echo 2 Positioning System, ...

BIOREHAB SYSTEM

FDA 510(k)
FDA Class 2 ·Neurology

CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLORIDOMETER, CHLORIDE COULOMETRIC

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

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

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

BD BACTO¿ TRYPTIC SOY BROTH

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code JSG·May 25, 2022

TERUMO CDI 500 BLOOD PARAMETER MONITOR

FDA Adverse Event
Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·August 10, 2011

SEGURA

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FFL·October 15, 2008

SELOX ST 60

FDA Adverse Event
Injury ·BIOTRONIK SE & CO. KG·Product code NVN·July 8, 2013

ADVANTAGE FIT ULTRA SYSTEM

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

DEKA MOTUS AZ

FDA Adverse Event
Malfunction ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·March 8, 2024

injeTAK Adjustable Tip Needles Needle Sheath diameter 6Fr with 35-50cm in length Stainless-stell needle cannula is 25 gauge

FDA Enforcement
Class II ·Ongoing·Labories Medical Technologies·May 10, 2023

Model Number L211 PROPONENT DR SL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025