211 results · 22ms · Sources: EU EUDAMED, US FDA

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