18 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Pentaflush
FDA 510(k)
FDA Class 2
·General Hospital
NA
FDA UDI
Synthes GmbH·10886982153708·4.5MM CORTEX SCREW 80MM
PMT® Halo Systems
FDA UDI
PMT CORPORATION·00650551114192·HALO, CTLSO VEST SMALL, LAMBSWOOL LINER, 1211-1...
10PW - RJ Corman - Poly White
FDA UDI
Certified Safety Manufacturing, Inc.·00766588140803·10PW - RJ Corman
HONOUR™ Spacer System
FDA UDI
NEXXT SPINE, LLC·00889929003084·Cervical PEEK, 6°, 14mm W x 12mm D x 8mm H
BD INTEGRA
FDA Adverse Event
Injury
·BECTON DICKINSON MEDICAL SYSTEMS·Product code MEG·December 23, 2024
HONOUR™ Spacer System
FDA UDI
NEXXT SPINE, LLC·00889929003091·Cervical PEEK, 0°, 12x14x8
HONOUR™ Spacer System
FDA UDI
NEXXT SPINE, LLC·00889929003107·Cervical PEEK, 10°, 14mm W x 12mm D x 8mm H
APEX ADULT HOLLOWE FIBER OXYGENATOR
FDA 510(k)
FDA Class 2
·Cardiovascular
Dentis s-Clean s-Line Mini
FDA 510(k)
FDA Class 2
·Dental
INNER SHAFT FOR EXTRACTION SCREWDRIVER
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HXX·September 2, 2014
LIMELIGHT
FDA Adverse Event
Other
·CUTERA·Product code GEX·July 19, 2011
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·COCHLEAR LTD .·Product code MCM·October 30, 2014
GYNECARE TVT RETROPUBIC SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 9, 2013
CR TIBIAL INSERT SZ 2, 9MM, SLOPE +
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·May 31, 2024
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
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021