28 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY
FDA 510(k)
FDA Class 2
·Immunology
BCI
FDA UDI
ICU MEDICAL, INC.·35019517062179·
MALLORY HEAD HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304225114·
Exergen Temporal Scanner
FDA UDI
EXERGEN CORPORATION·10834098000195·TAT5000S-TTL Oral Calibration - Fahrenheit
ICU Medical
FDA UDI
ICU MEDICAL, INC.·00840619043797·TD Torque-Line Catheter, 8F, 5 Lumen, 110 cm, R...
HERO GRAFT
FDA 510(k)
FDA Class 2
·Cardiovascular
G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE
FDA 510(k)
FDA Class 2
·Hematology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 23, 2024
PERSONA® Vivacit-E®
FDA UDI
Zimmer, Inc.·00889024237230·
PERSONA® Vivacit-E®
FDA UDI
Zimmer, Inc.·00889024237162·
PERSONA® Vivacit-E®
FDA UDI
Zimmer, Inc.·00889024237223·
PERSONA® Vivacit-E®
FDA UDI
Zimmer, Inc.·00889024237179·
PERSONA® Vivacit-E®
FDA UDI
Zimmer, Inc.·00889024237209·
PERSONA® Vivacit-E®
FDA UDI
Zimmer, Inc.·00889024237186·
PERSONA® Vivacit-E®
FDA UDI
Zimmer, Inc.·00889024237193·
PERSONA® Vivacit-E®
FDA UDI
Zimmer, Inc.·00889024237216·
INVICTUS
FDA Adverse Event
Injury
·ALPHATEC SPINE, INC.·Product code NKB·November 21, 2024
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·May 22, 2013
SPRINT FIDELIS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·June 14, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 2, 2015