1,512 results · 26ms · Sources: EU EUDAMED, US FDA

SentEP

FDA 510(k)
FDA Class 2 ·Radiology

FACTOR

FDA 510(k)
FDA Class 2 ·Hematology

VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 ug/mL)

FDA 510(k)
FDA Class 2 ·Microbiology

CHAMELEON LIGHT/CHEMICAL CURE GLASS IONOMER

FDA 510(k)
FDA Class 2 ·Dental

KOGENT SPETZLER LIGHTED SUCTION TUBES

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHED

FDA 510(k)
FDA Class 2 ·Hematology

LDH (OPTIMIZED) REAGENT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

INFINITECH LIGHTED INFUSION CANNULA

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

YOUNG D'GRANULATOR

FDA 510(k)
FDA Class 2 ·Dental

Solidity Vertebral Body Replacement

FDA 510(k)
FDA Class 2 ·Orthopedic

LAKE CATHETER CARE KIT

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

WARMTOUCH PLASTIC WARMING COVER

FDA 510(k)
FDA Class 2 ·Cardiovascular

STORZ COMPUSCAN 68K

FDA 510(k)
FDA Class 2 ·Radiology

VITEK 2 GRAM POSITIVE AMOXICILLIN FOR STREPTOCOCCUS PNEUMONIAE

FDA 510(k)
FDA Class 2 ·Microbiology

3400E series; E5400 series; E6400 series; Sundazzler series

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

ALBUMIN (BCG) REAGENT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

BIDIRECTIONAL DOPPLER W/WAVEFORM DISPLAY

FDA 510(k)
FDA Class 2 ·Cardiovascular

VIDAS CA 125 II ASSAY

FDA 510(k)
FDA Class 2 ·Immunology

VITEK 2 AST-GN PIPERACILLIN/TAZOBACTAM

FDA 510(k)
FDA Class 2 ·Microbiology

VIDAS D-DIMER NEW (DD2) ASSAY MODEL#30 442

FDA 510(k)
FDA Class 2 ·Hematology