GC E-LIGHT

FDA 510(k)

FDA Class 2 ·Dental

Focus Cap

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GCE Zen-O Portable Oxygen Concentrator

FDA 510(k)

FDA Class 2 ·Anesthesiology

KLEIN CORK(TM)

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

MEDIFLEX INJECTION CAP

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

BETA-CAP II ADAPTER

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

KLEIN CONNECTOR(TM)

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

CUSTOM I.T.E. HEARING AIDS CE-5, CE-6, CE-7

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

DEVON COOL FACE

FDA 510(k)

FDA Class 1 ·General Hospital

VINYL ICE BAG

FDA 510(k)

FDA Class 1 ·General Hospital

ICE BAG, VINYL

FDA 510(k)

FDA Class 1 ·General Hospital

SAV-A-LIMB

FDA 510(k)

FDA Class 1 ·General Hospital

PQ1

FDA 510(k)

FDA Class 2 ·Dental

SPECTACLE PRESCRIPTION LENSES

FDA 510(k)

FDA Class 1 ·Ophthalmic

ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality Control

FDA 510(k)

FDA Class 2 ·Microbiology

Atellica IM High-Sensitivity Troponin I (TNIH)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ADVIA Centaur Enhanced Liver Fibrosis (ELF)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ADVIA Centaur High-Sensitivity Troponin I (TNIH)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ADVIA CENTAUR TESTOSTERONE (TSTO)

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

MDI MII ONE-PIECE IMPLANT, 2.9MM

FDA 510(k)

FDA Class 2 ·Dental