Lifetech Cardio Model 8301 Temporary Pacemaker

FDA 510(k)

FDA Class 2 ·Cardiovascular

Diode laser Treatment System (K18)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LED Light Therapy Mask (G15, G15P, G15K, G11P, G11, G10, G13, G14, G17, VISO, PRANA, Chin2Chest, BBL-FACEMASK)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle

FDA 510(k)

FDA Class 2 ·General Hospital

Biodegradable Medical surgical mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Medical surgical mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORING

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEDISIGN BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241

FDA 510(k)

FDA Class 2 ·General Hospital

ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODELS 14-5511-01, 14-5506-01 AND 14-5507-01

FDA 510(k)

FDA Class 2 ·Immunology

Sacroiliac Joint Guidewire Placement Device

FDA classification

FDA Class 2 ·Sacroiliac Joint Guidewire Placement Device

ACIES

FDA 510(k)

FDA Class 2 ·Radiology

BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·CSI COLOURS CONTACT LENSES

ACTHK-PR RIA KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BCI WW1021 PC APPLICATION

FDA 510(k)

FDA Class 2 ·Cardiovascular

BCI WW1030 PULSE OXIMETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

BCI 3180 PULSE OXIMETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

SHARPS CONTAINER 18 GALLON

FDA 510(k)

FDA Class 2 ·General Hospital