Patient Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

IPL Hair Removal Device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Electrocardiograph: SE-1200 Pro and SE-1201 Pro

FDA 510(k)

FDA Class 2 ·Cardiovascular

Sharps Needle Destruction Device

FDA Pre-Market Approval

FDA Class 2 ·NEEDLE-EASE MODEL 3500

Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens (HPM38)

FDA 510(k)

FDA Class 2 ·Ophthalmic

Radiofrequency Generator System, Cura RF Electrode

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Minimally Invasive Prostate Surgery Navigation System

FDA 510(k)

FDA Class 2 ·Radiology

Bone Marrow Biopsy Needle

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

INTELEPACS, MODEL VERSION 3.X.X

FDA 510(k)

FDA Class 2 ·Radiology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·TITAN AND TITAN XL PTCA DILATATION CATHETERS

IAFP MUELLER HINTON AGAR

FDA 510(k)

FDA Class 2 ·Microbiology

IAFP MUELLER HINTON AGAR W/HEMO. W/CVA ENRICHMENT

FDA 510(k)

FDA Class 2 ·Microbiology

IAFP MUELLER HINTON AGAR W/5% SHEEP BLOOD

FDA 510(k)

FDA Class 2 ·Microbiology

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·OSTEOSPACE

Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S DB, UI20S RE, UI20S PW, UI20S GP,UI20 WH, UI20 GR, UI20 BS, UI20 MP, UI20 BL, UI20 PN, UI20 BR, UI20WG, UI20S WH, UI20S GR, UI20S BS, UI20S MP)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 CB, MI01 GR, MI01 PP, MI01 RM, MI01 WG, MI01 WH, MI01 BK;UI04S PP, UI04S BU, UI04S WH, UI04S PN)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery