12 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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CloudCath Peritoneal Dialysis Drain Set Monitoring System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Bernafon
FDA UDI
Bernafon AG·05711584114322·AN7, BTE UP 2.4G NFM MAC ALTENA 7 GPL
OSTEOSPRING FOOTJACK SUBTALAR IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
REPROCESSED COMPRESSION LIMB SLEEVES
FDA 510(k)
FDA Class 2
·Cardiovascular
8CH INFINITY DBS LEAD KIT, 40CM, 1.5, B
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code MHY·October 25, 2018
FLUENCY PLUS VASCULAR STENT GRAFT
FDA Adverse Event
Death
·ANGIOMED GMBH & CO. MEDIZINTECHNIK KG·Product code PFV·November 4, 2019
FLUENCY PLUS VASCULAR STENT GRAFT
FDA Adverse Event
Injury
·ANGIOMED GMBH & CO. MEDIZINTECHNIK KG·Product code PFV·October 30, 2019
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2011
PULSE GEN MODEL 102
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·October 24, 2008
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·July 9, 2013
DEKA SMARTPERIO
FDA Adverse Event
Injury
·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code NVK·December 11, 2024
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