13 results
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36ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Explorer TO System
FDA 510(k)
FDA Class 2
·Orthopedic
Bernafon
FDA UDI
Bernafon AG·05711584114414·CO9 B 105, 2.4G NFM SABE/MAC CAPTO 9 GPL
Unity
FDA UDI
DIOMEDICAL CO.,LTD.·08800039821643·SIJ Lag ScrewOD12.5xL40
EXPERIENCE®
FDA UDI
Gc Orthodontics America Inc.·D78821254000201·EXPERIENCE Mini MBT 022/U4 UNIV-7T 0A
BLY-501 ADAPTOR
FDA 510(k)
FDA Class 2
·Cardiovascular
S-MINI IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 6, 2025
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX¿ SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·September 22, 2021
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS LLC (PR)·Product code NIQ·October 27, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2011
INSIGNIA
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·July 9, 2013
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
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023