9 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MAMMOVISTA B.smart
FDA 510(k)
FDA Class 2
·Radiology
Bernafon
FDA UDI
Bernafon AG·05711584114247·CZ5 B 105, 2.4G NFM MSIL/MAC CORAL 5 GPL
SoloPace Fusion Sterile Pack
FDA UDI
SOLO PACE INC.·00850056280044·
CLEARMEDICAL/HENTLEIGH DEEP VEIN THROMBOSIS (DVT) GARMENT
FDA 510(k)
FDA Class 2
·Cardiovascular
WIS1000
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SMARTSET HV BONE CEMENT 40G
FDA Adverse Event
Injury
·DEPUY CMV·Product code LOD·October 24, 2008
UNKNOWN ZIMMER ACETABULAR LINER
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JDI·August 11, 2011
MEDTRONICS
FDA Adverse Event
Injury
·MEDTRONICS NEUROSURGICAL·Product code LGW·July 1, 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