Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·GELFLEX(R) (DIMEFILCON A) CONTACT LENS

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SENOGRAPHE DS & 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SENOGRAPHE 2100D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·SENSITITRE

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·SENSITITRE

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·THE SOFT RINSE SYSTEM

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·GEMS SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Cytokeratin Fragments 21-1 Eia Kit

FDA classification

FDA Class 2 ·Cytokeratin Fragments 21-1 Eia Kit

Uranyl Acetate/Zinc Acetate, Sodium

FDA classification

FDA Class 2 ·Uranyl Acetate/Zinc Acetate, Sodium

Alpha-1-Antitrypsin, Fitc, Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Alpha-1-Antitrypsin, Fitc, Antigen, Antiserum, Control

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

Automated Radiological Image Processing Software

FDA classification

FDA Class 2 ·Automated Radiological Image Processing Software

Electrosurgical Generator (ES-100); Electrosurgical Generator (ES-300)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BIOPRO POLAR HEAD

FDA 510(k)

FDA Class 2 ·Orthopedic

ACUTE CARDIAC CARE SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

SMOKE EATER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

OMNISOUND THERAPY UNIT

FDA 510(k)

FDA Class 2 ·Physical Medicine

ESCOTEK EST 220 INTERFERENCE THERAPY UNIT

FDA 510(k)

FDA Class 2 ·Physical Medicine

TNS MK I STIMULATOR

FDA 510(k)

FDA Class 2 ·Neurology