7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Arthrex Beveled FT Screws
FDA 510(k)
FDA Class 2
·Orthopedic
TAKE ONE BITE MODIFIED
FDA 510(k)
FDA Class 2
·Dental
PARKER 500
FDA 510(k)
FDA Class 2
·Physical Medicine
LINOX SMART S 65
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NVY·October 29, 2014
MINICAP EXTD LIFE TRANS SET W/TWIST CLAMP-EX SHORT
FDA Adverse Event
Death
·BAXTER HEALTHCARE·Product code KDJ·October 24, 2008
ENTERRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LNQ·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