10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AliveCor QT Service
FDA 510(k)
FDA Class 2
·Cardiovascular
Bernafon
FDA UDI
Bernafon AG·05711584114407·AN3, BTE UP 2.4G NFM MAC ALTENA 3 GPL
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704514445·
Sklar®
FDA UDI
SKLAR CORPORATION·10649111366291·GILLIES NH 6" TC
SE-100 VACUUM ERECTION DEVICE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MICROFRANCE(R) WORMALD VASCULAR CLAMP
FDA 510(k)
FDA Class 2
·Cardiovascular
REDUCTION FORCEPS WITH SERRATED JAW-RATCHET 144MM
FDA Adverse Event
Malfunction
·SYNTHES TUTTLINGEN·Product code HTD·October 30, 2014
BIOPSY INSTRUMENT
FDA Adverse Event
Injury
·ANGIOTECH, MEDICAL DEVICE TECHNOLOGIES·Product code KNW·August 11, 2011
INCEPTA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·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