304 results · 21ms · Sources: EU EUDAMED, US FDA

Access PCT

FDA 510(k)
FDA Class 2 ·Microbiology

Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set

FDA 510(k)
FDA Class 2 ·Microbiology

DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls

FDA 510(k)
FDA Class 2 ·Microbiology

Access PCT, Access PCT Calibrators

FDA 510(k)
FDA Class 2 ·Microbiology

Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission

FDA classification
FDA Class 2 ·Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission

EMISSION TOMOGRAPHY CAROUSEL

FDA 510(k)
FDA Class 2 ·Radiology

A.S.D. SAFETY TROCAR

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

CTF SYSTEMS INC, WHOLE-CORTEX MEG SYSTEM (WITH OPTIONAL EEG SUBSYSTEM)

FDA 510(k)
FDA Class 2 ·Neurology

SLEEP SYSTEM FOR CLINICS & RESEARCH

FDA 510(k)
FDA Class 2 ·Anesthesiology

CLIMAX

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

OMEGA WHOLE-CORTEX MFG SYSTEM, MODELS OMEGA 151, OMEGA 275

FDA 510(k)
FDA Class 2 ·Neurology

AIXPLORER

FDA 510(k)
FDA Class 2 ·Radiology

Suture, Nonabsorbable, Synthetic, Polypropylene

FDA Pre-Market Approval
FDA Class 2 ·GORE-TEX(R) SUTURE

Suture, Nonabsorbable, Synthetic, Polypropylene

FDA Pre-Market Approval
FDA Class 2 ·GORE-TEX SUTURE WITH PLEDGETS

TransFix/EDTA Vacuum Blood Collection Tubes

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

DoubleChek DC-1001

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

MEDCARE SUTURE SCISSORS (SUTURE/GAUZE WEIGHT)

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

Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC MACH40

FDA 510(k)
FDA Class 2 ·Radiology

KIDNEY PERFUSION MACHINE

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

THE MAX SYSTEM, MODEL: BASIC, 1000,2000 AUDIOMETER

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat