28 results · 19ms · Sources: EU EUDAMED, US FDA

DermaSensor

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

Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer

FDA classification
FDA Class 2 ·Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer

CINEMAC QAS

FDA 510(k)
FDA Class 2 ·Radiology

NABI CRP-Q.S. TEST

FDA 510(k)
FDA Class 2 ·Immunology

NABI RF-Q.S. TEST

FDA 510(k)
FDA Class 2 ·Immunology

FERRITIN CONTROLS CODE QAS.104

FDA 510(k)
FDA Class 2 ·Immunology

QUANTITATIVE BLOOD POOL SPECT (QBS)

FDA 510(k)
FDA Class 2 ·Radiology

CODE QAS 103 ANTI-DNA CONTROLS

FDA 510(k)
FDA Class 2 ·Immunology

BPCARD

FDA 510(k)
FDA Class 2 ·Cardiovascular

SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

SENSAIRE DIAGNOSTIC SPIROMETER

FDA 510(k)
FDA Class 2 ·Anesthesiology

SPIROCARD

FDA 510(k)
FDA Class 2 ·Anesthesiology

EKGCARD SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

QRS Dental Implants System

FDA 510(k)
FDA Class 2 ·Dental

MODIFICATION TO: BPCARD, MODEL Z-7000-0700

FDA 510(k)
FDA Class 2 ·Cardiovascular

CARDS Q.S. HCG OR CONCISE PERFORMANCE PLUS HCG

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

QUANTIM 2000I DIGITAL IMAGE ANALYSIS SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

CARDS Q.S. HCG SERUM/URINE;CONCISE PERFORMANCE PLUS HCG-COMBO

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

CARDS Q.S. HCG-URINE; AND CONCISE PERFORMANCE PLUS HCG-URINE

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ORBIT

FDA 510(k)
FDA Class 2 ·Anesthesiology