10 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IPD Dental Implant Abutments
FDA 510(k)
FDA Class 2
·Dental
Spud
FDA UDI
KATENA PRODUCTS, INC.·00841668101216·FRANCIS FOREIGN BODY SPUD
SacroFuse
FDA UDI
SPINEFRONTIER, INC.·00190361029311·Ø14mm X 70mm Hybrid Fusion Screw, Gen II
CHAIRSIDE ATTACHMENT PROCESSING MATERIAL
FDA 510(k)
FDA Class 2
·Dental
RANDOX METHADONE ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 28, 2025
COLIBRI
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HWE·November 10, 2014
ASR ACETABULAR CUPS 54
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·September 9, 2011
2MM FLUTED BALL, STANDARD
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 17, 2013
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021