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

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MRCAT Head & Neck

FDA 510(k)
FDA Class 2 ·Radiology

PILLING

FDA UDI
TELEFLEX INCORPORATED·24026704514933·BRAUN EPISIOTOMY SCISSORS 8"

24M - RJ Corman - Metal

FDA UDI
Certified Safety Manufacturing, Inc.·00766588140810·24M - RJ Corman - Metal

PMT® Halo Systems

FDA UDI
PMT CORPORATION·00650551114208·HALO, CTLSO VEST SMALL, LAMBSWOOL LINER, 1211-1...

BD INTEGRA

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code MEG·January 2, 2025

BD INTEGRA

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code MEG·November 24, 2024

Instant 20s Indicator

FDA 510(k)
FDA Class 2 ·General Hospital

AKTINA MEDICAL PHYSICS RADIATION THERAPY WEDGES

FDA 510(k)
FDA Class 2 ·Radiology

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 7, 2025

MAYFIELD MODIFIED SKULL CLAMP

FDA Adverse Event
Other ·INTEGRA, CINCINNATI·Product code HBL·July 19, 2011

LIGASURE V SEALER/DIVIDER

FDA Adverse Event
Malfunction ·COVIDIEN MEDICAL PRODUCTS (SHANGHAI) MAN·Product code GEI·October 30, 2014

TALENT THORACIC

FDA Adverse Event
Death ·MEDTRONIC CARDIOVASCULAR·Product code MIH·July 9, 2013

Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019

18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017