39 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL )
FDA 510(k)
FDA Class 2
·Microbiology
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113356·CLEAR CORNEA KNIFE 2.8MM (BX/5)
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113301·STAB KNIFE 45 DEGREE (BX/5)
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113363·CLEAR CORNEA KNIFE 3.0MM (BX/5)
SIGMA DELTA
FDA 510(k)
FDA Class 2
·Anesthesiology
GLOVETEX POWDER FREE LATEX EXAMINATION GLOVES, NON STERILE (PROTEIN CONTENT LABELING CLAIM 50UG/G OR LESS)
FDA 510(k)
FDA Class 1
·General Hospital
NOBELACTIVE TIULTRA NP 3.5X13MM
FDA Adverse Event
Injury
·NOBEL BIOCARE AB·Product code DZE·May 31, 2021
NOBELACTIVE TIULTRA NP 3.5X13MM
FDA Adverse Event
Injury
·NOBEL BIOCARE AB·Product code DZE·May 31, 2021
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code QJR·August 28, 2020
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 29, 2025
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Injury
·TANDEM DIABETES CARE·Product code QFG·July 8, 2021
L-CATH PICC S/L 26GA (1.9F) 0.60MM X 30CM
FDA Adverse Event
Malfunction
·Product code LJS·November 11, 2024
PALACOS BONE CEMENT
FDA Adverse Event
Injury
·BIOMET INC.·Product code LOD·October 21, 2008
PELVOCOL 2CM X 7CM 1.0MM
FDA Adverse Event
Injury
·COVIDIEN·Product code FTL·June 21, 2013
HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES, INC.·Product code LWR·August 4, 2011
ORISE PROKNIFE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 13, 2025
SPYSCOPE DS II ACCESS & DELIVERY CATHETER
FDA Adverse Event
Death
·BOSTON SCIENTIFIC CORPORATION·Product code FBN·November 5, 2024
TECNIS IOL
FDA Adverse Event
Injury
·AMO MANUFACTURING NETHERLANDS·Product code POE·August 7, 2023
MONOFOCAL IOL
FDA Adverse Event
Injury
·AMO PUERTO RICO MFG. INC.·Product code HQL·March 14, 2024
FLEXIMA PLUS BILIARY
FDA Adverse Event
Death
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·November 5, 2024