14 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Dental Zirconia Ceramic
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 21, 2025
Darby Dental Supply, LLC
FDA UDI
DARBY DENTAL SUPPLY, LLC·00889813034347·K-Type Files 21MM #15
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B167312508110·
TALOS® HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B167322508110·
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197494496·Micro Scissors
45° an...
Dynamyx Digital Pathology Software
FDA 510(k)
FDA Class 2
·Pathology
cobas u 701 microscopy analyzer
FDA 510(k)
FDA Class 2
·Hematology
LIGAMAX-5MM ENDO CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code FZP·December 2, 2008
ARTICULEZE M 28MM 5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·September 16, 2011
CUSTOM DEFINED PRODUCT
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DXO·July 29, 2013
Dr. Newman Surgical Procedure Pack, kit numbers PSS1689 PSS1689(A convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
Applied Medical Technology, Inc., NutraGlide, 5 f - 6F x 55 Nasal Feeding Tube with Stylet and ENfit, REF NFT-05055-I
FDA Enforcement
Class II
·Completed·Applied Medical Technology Inc·November 19, 2025
BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 51 MM, Silicone, Sterile, Item 431209.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020