11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ID-500 iRestore Hair Growth System
FDA 510(k)
FDA Class 2
·Physical Medicine
ORTHODONTIC CERAMIC BRACKETS
FDA 510(k)
FDA Class 2
·Dental
ORTHOSONIX ENERGEX
FDA 510(k)
FDA Class 2
·Physical Medicine
VIDEO MEDIASTINOSCOPE
FDA Adverse Event
Injury
·KARL STORZ SE & CO. KG·Product code EWY·December 21, 2021
VIDEO MEDIASTINOSCOPE
FDA Adverse Event
Injury
·KARL STORZ SE & CO. KG·Product code EWY·December 21, 2021
VIDEO MEDIASTINOSCOPE
FDA Adverse Event
Injury
·KARL STORZ SE & CO. KG·Product code EWY·December 21, 2021
VIDEO MEDIASTINOSCOPE
FDA Adverse Event
Injury
·KARL STORZ SE & CO. KG·Product code EWY·December 21, 2021
CS100
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·August 4, 2014
RADIAL JAW¿ 4
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - COSTA RICA·Product code FCL·August 16, 2011
EASYTRAK
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·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