7 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INNOVASIVE 2.8MM AND 3.5MM ROC EZ SUTURE BONE FASTENER
FDA 510(k)
FDA Class 2
·Orthopedic
INTERPLATE INTERBODY FUSION DEVICE, MODELS C, CGC, L AND LGC
FDA 510(k)
FDA Class 2
·Orthopedic
Anatotemp Anatomic Dental Implant Healing Abutment
FDA 510(k)
FDA Class 2
·Dental
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·February 21, 2013
FIXODENT DENTURE ADHESIVE, VERSION UNK (CALCIUM ZINC GANTREZ SALT 33 PERCENT CEL
FDA Adverse Event
Other
·PROCTER & GAMBLE MANUFACTURING CO.·Product code KOO·January 24, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 31, 2014
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020