9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LTJ Screws and Washer
FDA 510(k)
FDA Class 2
·Orthopedic
Radius Plate PROlock, Wide
FDA UDI
I.T.S. GmbH·09120034304286·Radius Plate PROlock, Wide, 8-Hole, Left
FORCETRIAD ELECTROSURGICAL GENERATOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FRESENIUS PRIMING SET WITH NEEDLES ACCESS PORT, MODEL 04-9002-9
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EMERGE?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·October 29, 2014
ENDOPATH XCEL BLADELESS TROCAR WITH STABILITY SLEEVE-12 MM DIAMETER,100MM LENGTH
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code GCJ·October 21, 2008
R SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·July 11, 2011
ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·July 9, 2014
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