14 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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