SERODIA ATG

FDA 510(k)

FDA Class 2 ·Immunology

ATG/SM-OSA APPLIANCES

FDA 510(k)

FDA Class 2 ·Dental

ASSERACHROM B-TG KIT

FDA 510(k)

FDA Class 2 ·Hematology

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·ACHILLES EXPRESS ULTRASONOMETER

BTG SMARTEST GLUCOSE TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GYREX PRIMA 1TG 1.0T MRI SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

EkoSonic Endovascular System with Control Unit 4.0

FDA 510(k)

FDA Class 2 ·Cardiovascular

EkoSonic Endovascular Device with Control Unit 4.0

FDA 510(k)

FDA Class 2 ·Cardiovascular

EkoSonic Endovascular Device

FDA 510(k)

FDA Class 2 ·Cardiovascular

EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT

FDA 510(k)

FDA Class 2 ·Cardiovascular

EkoSonic Endovascular System

FDA 510(k)

FDA Class 2 ·Cardiovascular

EKOS ultrasound EVD Device, EVD Control Unit

FDA 510(k)

FDA Class 2 ·Neurology

Opera Lebody (Gold), Opera Lebody (Zafiro)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Tester, Pacemaker Electrode Function

FDA Pre-Market Approval

FDA Class 2 ·ATA SOFTWARE CARTRIDGE (SWM 1000 I-KTB.0.U)

Disposable Cytology Brush BC-202D/203D Series

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Single Use Cytology Brush BC-205D

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSH

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

CYTOLOGY BRUSH

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MICROBIOLOGY SPECIMEN BRUSH

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Pulmonary Cytology Brush

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat