GC CERVICAL CEMENT

FDA 510(k)

FDA Class 2 ·Dental

FUJI II LC

FDA 510(k)

FDA Class 2 ·Dental

76 EMA LINING CEMENT

FDA 510(k)

FDA Class 2 ·Dental

SURFLEX F

FDA 510(k)

FDA Class 2 ·Dental

FUJI CAP II CAPSULE & APPLIER

FDA 510(k)

FDA Class 2 ·Dental

LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Q-Rejuvalight Pro Facewear (Model: P19-0023)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CurrentBody Skin™ Led Hair Regrowth(Model: MZ-07)

FDA 510(k)

FDA Class 2 ·Physical Medicine

Cold Sore Device (Model: QPZ-01)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LED Lip Perfector, model: ZC-05

FDA 510(k)

FDA Class 2 ·Physical Medicine

Infrared Heat (Model: E0221)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P); Full HD Visualization Endoscopic Image Processor (HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D); Endoscopic Image Processor (HDVS-S100A, HDVS-S100D))

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Biliary Catheter For Irrigation And Contrast Injection, Exempt

FDA classification

FDA Class 2 ·Biliary Catheter For Irrigation And Contrast Injection, Exempt

VivoSight Dx Topical OCT System

FDA 510(k)

FDA Class 2 ·Radiology

Arc Endocuff Glide AEG110 & AEG120

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VITROS Immunodiagnostic Products CEA Reagent Pack

FDA 510(k)

FDA Class 2 ·Immunology

CENTRAFIX EXTERNAL FIXATOR

FDA 510(k)

FDA Class 2 ·Orthopedic

Flexi-Seal PROTECT Fecal Management System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology