TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE, THERAPON, TRY-IN, BURNOUT, TRY-IN & BURNOUT

FDA 510(k)

FDA Class 2 ·Dental

Polibond

FDA 510(k)

FDA Class 2 ·Dental

ICE Ceramics, ICE Stains, Fresco

FDA 510(k)

FDA Class 2 ·Dental

Prettau, ICE, Z-White zirconia blanks

FDA 510(k)

FDA Class 2 ·Dental

Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral Tissue

FDA 510(k)

FDA Class 2 ·Dental

Color Liquid, Vita Liquid

FDA 510(k)

FDA Class 2 ·Dental

ZIRKONZAHN.Implant-Planner, ZIRKONZAHN.Implant-Planner Practice, CAD/CAM STL Converter, CAD/CAM Z-Tray

FDA 510(k)

FDA Class 2 ·Radiology

ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA

FDA 510(k)

FDA Class 2 ·Dental

CleanCart A, CleanCart C, AK 98 Hemodialysis Machine

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·BAK INTERBODY FUSION SYSTEM

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·BAK VISTA INTERBODY FUSION CAGE

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·BAK INTERBODY FUSION SYSTEM

AXYA MEDICAL INC, BONE ANCHOR SYSTEM AND KIT- (BAK)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Blue Beacon Submucosal Injectable Solution

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Single Use MultiClip Device

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Embrella Endoscopic Distal Attachment

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Sterile Repositionable Hemostasis Clipping Device

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Single-use Video Pancreaticobiliary Scope, PB Digital Controller

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Segmented Esophageal Stent System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Sphincterotome / short-wire compatible, Sterile Sphincterotome

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology