DELTEX MEDICAL CARDIOQ EDM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Scope ProTech

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EDWARDS AQUARIUS SYSTEM, MODEL GE-F098-00

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LUBREASE FEMALE LUBRICANT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MSA100BT Peak Flow Meter

FDA 510(k)

FDA Class 2 ·Anesthesiology

IPL Therapy Machine

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Diode laser therapy device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PDT-FACE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)

FDA 510(k)

FDA Class 2 ·Radiology

Picosecond Laser System (Model PS10-A and PS10-B)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TinniLogic Mobile Tinnitus Management Device

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable Endoscopic Linear Cutter Stapler and Reloads

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

FDA 510(k)

FDA Class 2 ·Dental

IVYLASER Diode laser hair removal system (IVY-HR-Alloy)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Dental Glass Ceramics Blocks

FDA 510(k)

FDA Class 2 ·Dental

IVYLASER Handhold Hair Removal Machine

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Diode laser system (Night Universe; Predator)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Youha electric breast pump

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology