PHYSIO HAB

FDA 510(k)

FDA Class 2 ·Physical Medicine

CK-B RIA KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BREATHING CIRCUIT, DISPOSABLE

FDA 510(k)

FDA Class 1 ·Anesthesiology

CARDIO CK-B RIA KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MARCHON/MARCOLIN SUNGLASSES

FDA 510(k)

FDA Class 1 ·Ophthalmic

MARCHON/MARCOLIN EYEGLASSES

FDA 510(k)

FDA Class 1 ·Ophthalmic

Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)

FDA 510(k)

FDA Class 2 ·General Hospital

ALLERSHARP ALLERGY SKIN TESTER

FDA 510(k)

FDA Class 2 ·General Hospital

ULTROSPEC K KINETICS SPECTROPHOTOMETER

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

DELFIA DIGOXIN

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

BK-A; BK-B; BK-IS SEALING CAP

FDA 510(k)

FDA Class 2 ·Cardiovascular

CK-TOTAL/CK-B (NAC) BIOLUMIN. ASSAY KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MVision AI Segmentation

FDA 510(k)

FDA Class 2 ·Radiology

SAGIPLAN, SAGIPLAN PROSTATE MODULE ADD ON, SAGIPLAN INCLUDING PROSTATE MODULE

FDA 510(k)

FDA Class 2 ·Radiology

HDRPLUS, ADD IN PROSTATE MODULE FOR HDRPLUS

FDA 510(k)

FDA Class 2 ·Radiology

FLEXIPLAN BRACHYTHERAPY TREATMENT PLANNING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

FLEXITRON

FDA 510(k)

FDA Class 2 ·Radiology

APPLICATORS FOR AFTERLOADING BRACHYTHERAPY

FDA 510(k)

FDA Class 2 ·Radiology

FLEXIPLAN 3D AND 3D+

FDA 510(k)

FDA Class 2 ·Radiology