12 results
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19ms
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Sources: EU EUDAMED, US FDA
Solero Microwave Tissue Ablation (MTA) System and Accessories
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PROGRESS GUIDE WIRE FAMILY, PILOT GUIDE WIRE FAMILY
FDA 510(k)
FDA Class 2
·Cardiovascular
FRIALOC DENTAL 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
SYNCHROMED II
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·October 23, 2008
NC QUANTUM APEX PTCA DILATATION CATHETER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·August 16, 2011
COGNIS
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 9, 2013
I-STAT CHEM8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JGS·March 16, 2022
VASOVIEW HEMOPRO 2
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR LLC·Product code GEI·January 5, 2022
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
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