211 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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AVC A/H5N1 FLU TEST
FDA 510(k)
FDA Class 2
·Microbiology
AMECATH CVC AND AMECATH PRESSURE CVC SHORT TERM SINGLE AND MULTI-LUMEN CATHERIZATION KITS
FDA 510(k)
FDA Class 2
·General Hospital
ELEGANCE FERRITIN ELISA
FDA 510(k)
FDA Class 2
·Immunology
ELEGANCE TSH ELISA
FDA 510(k)
FDA Class 2
·Clinical Chemistry
THERASOM-CAST
FDA 510(k)
FDA Class 2
·Dental
CLAMPLESS VALVED CATHETER-PICC (CVC-PICC)
FDA 510(k)
FDA Class 2
·General Hospital
CLAMPLESS VALVED CATHETER - TUNNELED (CVC-T)
FDA 510(k)
FDA Class 2
·General Hospital
CLAMPLESS VALVED CATHETER - MIDLINE (CVC-ML)
FDA 510(k)
FDA Class 2
·General Hospital
Tyvek(R) Roll with CI for STERLINKTM Sterilizer
FDA 510(k)
FDA Class 2
·General Hospital
STERLINK FPS-15s Plus sterilizer with STERPACK plus cassette
FDA 510(k)
FDA Class 2
·General Hospital
KONICA SRX-101 AUTOMATIC X-RAY FILM PROCESSOR
FDA 510(k)
FDA Class 2
·Radiology
KONICA QX-70 AUTOMATIC X-RAY FILM PROCESSOR
FDA 510(k)
FDA Class 2
·Radiology
BIOSPHERE SUTURE ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
BIOASBSORBABLE MINI-SCREW SUTURE ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
BONE SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)
FDA 510(k)
FDA Class 2
·General Hospital
STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette
FDA 510(k)
FDA Class 2
·General Hospital
VIFS
FDA 510(k)
FDA Class 2
·Radiology
STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)
FDA 510(k)
FDA Class 2
·General Hospital
STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer; Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)
FDA 510(k)
FDA Class 2
·General Hospital