Instrumentation For Clinical Multiplex Test Systems

FDA classification

FDA Class 2 ·Instrumentation For Clinical Multiplex Test Systems

Micro Total Analysis Instrument System

FDA classification

FDA Class 2 ·Micro Total Analysis Instrument System

Implantable Radio Frequency Transponder System

FDA classification

FDA Class 2 ·Implantable Radio Frequency Transponder System

Laparoscope And Accessories, Gynecologic, Reprocessed

FDA classification

FDA Class 2 ·Laparoscope And Accessories, Gynecologic, Reprocessed

Radiological Software Device To Predict Future Breast Cancer Risk

FDA classification

FDA Class 2 ·Radiological Software Device To Predict Future Breast Cancer Risk

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

Self-Fitting Air-Conduction Hearing Aid, Over The Counter

FDA classification

FDA Class 2 ·Self-Fitting Air-Conduction Hearing Aid, Over The Counter

ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - ASA (RPFA-ASA)

FDA 510(k)

FDA Class 2 ·Hematology

ASA ORAL APPLIANCES

FDA 510(k)

FDA Class 2 ·Dental

SnugFit ASA Extension

FDA 510(k)

FDA Class 2 ·Orthopedic

ASA LASER SH1

FDA 510(k)

FDA Class 2 ·Physical Medicine

LASERMATIC SURGILASER MODEL 5050

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ETEST TOBRAMYCIN 0.016-256 UG/ML AND 0.064-1024 UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology

ETEST MOXIFLOXACIN 0.002-32 UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology

ETEST Telavancin (TLA) (0.002-32 ug/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

ETEST TELAVANCIN IN 0.002-32 UG/ML AND 0.016-256 UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology

CHROMID CARBA agar (CARB)

FDA 510(k)

FDA Class 2 ·Microbiology

RAPIDEC CARBA NP

FDA 510(k)

FDA Class 2 ·Microbiology

Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm

FDA classification

FDA Class 2 ·Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm

Allergan Botox Needle Electrode

FDA 510(k)

FDA Class 2 ·Physical Medicine