Laser Cap, Model: Hat-01

FDA 510(k)

FDA Class 2 ·Physical Medicine

Upper Arm Blood Pressure Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

Oximeter (Model: JZK-301,JZK-303,JZK-305,JZK-307)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Alkaline Picrate, Colorimetry, Creatinine

FDA classification

FDA Class 2 ·Alkaline Picrate, Colorimetry, Creatinine

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·PALACOS E-FLOW (OSTEOPAL) BONE CEMENT

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SELENIA DIMENSIONS 2D MOBILE FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION® Spacers, COALITION AGX™ Spacers, INDEPENDENCE® Spacers, FORTIFY®-R Corpectomy Spacers, FORTIFY® I-R Corpectomy Spacers, XPand®-R Corpectomy Spacers, NIKO® Corpectomy Spacers, MONUMENT™ Spacers, ALTERA™ Spacers, MAGNIFY™ Spacers, InterContinental® Plate-Spacer

FDA 510(k)

FDA Class 2 ·Orthopedic

Ventilator, Continuous, Minimal Ventilatory Support, Home Use

FDA classification

FDA Class 2 ·Ventilator, Continuous, Minimal Ventilatory Support, Home Use

Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed

FDA classification

FDA Class 2 ·Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed

Implant, Endosseous, Orthodontic

FDA classification

FDA Class 2 ·Implant, Endosseous, Orthodontic

Catheter, Biliary, Reprocessed

FDA classification

FDA Class 2 ·Catheter, Biliary, Reprocessed

Digital Pathology Image Viewing And Management Software

FDA classification

FDA Class 2 ·Digital Pathology Image Viewing And Management Software

Control Material, Blood Circulating Epithelial Cancer Cell

FDA classification

FDA Class 2 ·Control Material, Blood Circulating Epithelial Cancer Cell

Cervical Intraepithelial Neoplasia (Cin) Test System

FDA classification

FDA Class 2 ·Cervical Intraepithelial Neoplasia (Cin) Test System

System, Peritoneal, Automatic Delivery, Exempt

FDA classification

FDA Class 2 ·System, Peritoneal, Automatic Delivery, Exempt

Automated Digital Image Manual Interpretation Microscope

FDA classification

FDA Class 2 ·Automated Digital Image Manual Interpretation Microscope

Whole Slide Imaging System

FDA classification

FDA Class 2 ·Whole Slide Imaging System

Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis

FDA classification

FDA Class 2 ·Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis