16 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Powder free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue)
FDA 510(k)
FDA Class 1
·General Hospital
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112915·CORNEAL TREPHINE BLADE7.5MM
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112496·BARRON VACUUM TREPHINE 7.5MM
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113349·PHACO KNIFE 3.2MM ANGLED (BX/5)
NICHOLS ADVANTAGE CHEMILUMINESCENCE HELICOBACTOR PYLORI IGG ANTIBODIES IMMUNOASSAY
FDA 510(k)
FDA Class 1
·Microbiology
NATURAL-KNEE II PATELLOFEMORAL JOINT PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·January 10, 2024
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 29, 2025
UNKNOWN
FDA Adverse Event
Malfunction
·UNKNOWN·Product code LJT·October 11, 2008
GORE TAG THORACIC ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·August 4, 2011
ZOLL
FDA Adverse Event
Injury
·ZOLL MEDICAL CORP.·Product code MKJ·July 2, 2013
ARTICUL/EZE BALL 32 +9 BL
FDA Adverse Event
Malfunction
·DEPUY INTERNATIONAL LTD - 8010379·Product code JDI·February 13, 2024
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·September 9, 2022
ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code NIU·June 7, 2023
GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code PFV·October 26, 2023
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