9 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Vision Monitor- MonCvONE
FDA 510(k)
FDA Class 2
·Neurology
NA
FDA UDI
DEPUY (IRELAND)·10603295281573·Marathon XLPE Cemented Cup 36mm Pusher Head
ANKLE TRAUMA SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SAFE'SOUND LUER LOCK PASSIVE DEVLIVERY SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
RECONSTRUCTION NAIL R2.0, TI, LEFT T2 RECON Ø11X360 MM X 125°
FDA Adverse Event
Injury
·STRYKER TRAUMA KIEL·Product code HSB·July 23, 2018
RADIAL JAW¿ 4
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - COSTA RICA·Product code FCL·August 16, 2011
PLM A+ PLATINUM MODU
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·August 4, 2014
INGENIO
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