FOUNDATION SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

POTABLE AIR MASSAGER PUTIFINO, MODEL AM-7

FDA 510(k)

FDA Class 2 ·Physical Medicine

ADIN DENTAL IMPLANTS SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda Kit

FDA 510(k)

FDA Class 2 ·Immunology

TEVADAPTOR; CONNECTING SET W/ ULTRASITE INJECTION SITE, SPIKE PORT ADAPTOR SET W/ ULTRASITE INJECTION SITE

FDA 510(k)

FDA Class 2 ·General Hospital

External Counterpulsation System

FDA 510(k)

FDA Class 2 ·Cardiovascular

ASAHI REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LX

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DCM Kyphoplasty System

FDA 510(k)

FDA Class 2 ·Orthopedic

dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T

FDA 510(k)

FDA Class 2 ·Radiology

Xenta Drug Screen Cup, Xenta Drug Screen Dipcard

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ZEST NASAL MASK

FDA 510(k)

FDA Class 2 ·Anesthesiology

RESPIRATORY HUMIDIFIER, MODEL HC150

FDA 510(k)

FDA Class 2 ·Anesthesiology

IPL + Diode Laser Machine

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

XBit Series Digital Color Doppler Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

Hair Removal Device (Model: IPL-D26, IPL-D19)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Elastic Impression Material

FDA 510(k)

FDA Class 2 ·Dental

VACCESS 3000 SINGLE LUMEN JUGULAR CANNULA-CATH

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CG-6108 ARRHYTHMIA ECG EVENT RECORDER

FDA 510(k)

FDA Class 2 ·Cardiovascular

MERITS HEALTH PRODUCTS PROFIL Q601 SERIES OXYGEN FILLING ACCESSORY

FDA 510(k)

FDA Class 2 ·Anesthesiology