11 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B)
FDA 510(k)
FDA Class 2
·Physical Medicine
SYNTHES 3.5MM TITANIUM LCP PROXIMAL TIBIA PLATES
FDA 510(k)
FDA Class 2
·Orthopedic
Straumann BLX Gold Abutments
FDA 510(k)
FDA Class 2
·Dental
TERA HARZ CLEAR
FDA Adverse Event
Injury
·GRAPHY INC.·Product code NXC·June 16, 2025
TERA HARZ CLEAR
FDA Adverse Event
Injury
·GRAPHY INC.·Product code NXC·June 16, 2025
TERA HARZ CLEAR
FDA Adverse Event
Injury
·GRAPHY INC.·Product code NXC·June 16, 2025
GRANUFLO
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·October 22, 2014
PAIN EAST TOPICAL ANESTHETIC SKIN REFRIGERANT
FDA Adverse Event
Injury
·GEBAUER CO.·Product code MLY·August 12, 2011
FENESTRATED BIPOLAR FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·July 16, 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
CODMAN Disposable Perforator, 14mm. Cranial perforator.
FDA Enforcement
Class I
·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025