11 results
·
28ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
LiverMultiScan v5 (LMSv5)
FDA 510(k)
FDA Class 2
·Radiology
Agile Esophageal OTW Stent System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
APATIGHT HA-BONE GRAFT SUBSTITUTE
FDA 510(k)
FDA Class 2
·Orthopedic
AGILE ESOPHAGEAL
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code ESW·December 26, 2024
AGILE ESOPHAGEAL
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code ESW·December 26, 2024
AGILE ESOPHAGEAL
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code ESW·February 14, 2025
IMAGER II
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code DQO·October 28, 2008
AMPLATZER SEPTAL OCCLUDER
FDA Adverse Event
Injury
·AGA MEDICAL CORPORATION·Product code MLV·August 17, 2011
GYNECARE PROLIFT POSTERIOR PELVIC FLOOR REPAIR SYSTEM
FDA Adverse Event
Injury
·ETHICON SARL·Product code OTP·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