7 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HCMI X-RAY HIGH REQUENCY CHIROPRACTIC RADIOGRAPHIC
FDA 510(k)
FDA Class 2
·Radiology
GEMINUS FOSSA SPECIFIC PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·November 4, 2014
BRILLIANCE 64
FDA Adverse Event
PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.·Product code JAK·July 29, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 12, 2013
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018