ProSeal™ Closed System Administration Set

FDA 510(k)

FDA Class 2 ·General Hospital

ProSeal™ Injector Plus (Model no. 421050)

FDA 510(k)

FDA Class 2 ·General Hospital

AT-Patch ECG Analysis System

FDA 510(k)

FDA Class 2 ·Cardiovascular

SAGITTILT

FDA 510(k)

FDA Class 2 ·Radiology

RIA LATEX CONDOM & RIA COLOR CONDOMS (RED, GREEN, BLUE, ORANGE, PURPLE AND BLACK)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

IH Implant System

FDA 510(k)

FDA Class 2 ·Dental

SHILLA GROWTH GUIDANCE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

VESOFLOW PLUS DVT COMPRESSION DEVICE

FDA 510(k)

FDA Class 2 ·Cardiovascular

Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302)

FDA 510(k)

FDA Class 2 ·Physical Medicine

UNICON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER FOR DAILY WEAR

FDA 510(k)

FDA Class 2 ·Ophthalmic

INSIGHT DISCOVERY

FDA 510(k)

FDA Class 2 ·Physical Medicine

NATURALASE DIODE LASER FAMILY NATURALASE MODEL NL980, NATURALASE DIODE LASER FAMILY NATURALASE NL810

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CD HORIZON SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

LIPOcel

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

UNIMARK HCG COMBO PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Oscar 15 & Oscar 15i

FDA 510(k)

FDA Class 2 ·Radiology

ET Abutment System

FDA 510(k)

FDA Class 2 ·Dental

EMBRYO FREEZE MEDIUM, EMBRYO THAW MEDIUM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters

FDA 510(k)

FDA Class 2 ·Cardiovascular

HYGEIA-5 OXYGEN CONCENTRATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology