SMART WAVE GS100

FDA 510(k)

FDA Class 2 ·Physical Medicine

MDX 2000, DIGITAL ANALYZER

FDA 510(k)

FDA Class 2 ·Hematology

Alinity m BKV

FDA 510(k)

FDA Class 2 ·Microbiology

cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit

FDA 510(k)

FDA Class 2 ·Microbiology

Laser, Ophthalmic

FDA Pre-Market Approval

FDA Class 2 ·HYPERION LTK SYSTEM

Laser, Ophthalmic

FDA Pre-Market Approval

FDA Class 2 ·HYPERION LTK SYSTEM

MEGATECH SCIENTIFIC FACE MASK

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BIOLAND BLOOD PRESSURE MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25E

FDA 510(k)

FDA Class 2 ·General Hospital

Forehead Thermometer, models AOJ-F101, AOJ-F102, AOJ-F103, AOJ-F104 AOJ-F105, AOJ-F106, AOJ-F107

FDA 510(k)

FDA Class 2 ·General Hospital

SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator

FDA 510(k)

FDA Class 2 ·Anesthesiology

Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y)

FDA 510(k)

FDA Class 2 ·General Hospital

GaiaBone Bioabsorbable Bone Graft

FDA 510(k)

FDA Class 2 ·Orthopedic

Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F and AOJ-30G

FDA 510(k)

FDA Class 2 ·Cardiovascular

Wrist Blood Pressure Monitor, models AOJ-35A, AOJ-35B, AOJ-35C, AOJ-35D, AOJ-35E

FDA 510(k)

FDA Class 2 ·Cardiovascular

Infrared Thermometer, models AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F, AOJ-20H, AOJ-20M, AOJ-20T, AOJ-20R and AOJ-20Y

FDA 510(k)

FDA Class 2 ·General Hospital

APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR INSTRUMENT WITH SDS SOFTWARE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Intrelief

FDA 510(k)

FDA Class 2 ·Neurology

HARDCOVER CONDOMS MALE LATEX CONDOMS, (WITH SPERMICIDE)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MALE NATURAL RUBBER LATEX CONDOM (WITH LUBRICATION)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology