8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser Fiber, Flexiva Pulse ID TracTip Laser Fiber
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
B.BRAUN
FDA UDI
B.Braun Avitum AG·04046963711139·H.E.L.P.® Plasmat® Futura Treatment Kit
SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E
FDA 510(k)
FDA Class 2
·Anesthesiology
NOVABONE MACROPOR-SI+ - BIOACTIVE BONE GRAFT
FDA 510(k)
FDA Class 2
·Orthopedic
COMPLETE MULTIPURPOSE
FDA Adverse Event
Injury
·Product code LPN·October 23, 2008
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·August 12, 2011
FINELINE II
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVN·July 8, 2013
ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017 S 2000 system 10441730 S 3000 system 10441701 S 1000 system 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.·August 5, 2015