OSW Aligner System

FDA 510(k)

FDA Class 2 ·Dental

Straumann® BLC and TLC Implants

FDA 510(k)

FDA Class 2 ·Dental

AMES DCA 2000 HEMOGLOBIN ALC CONTROLS

FDA 510(k)

FDA Class 2 ·Hematology

INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN ALC

FDA 510(k)

FDA Class 2 ·Hematology

DUPONT DIMENSION(R) ETHYL ALCOHOL(ALC) METHOD

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DETERMIN HEMOGLOBIN ALC/HI PERF LIQ CHROMATOGRAPHY

FDA 510(k)

FDA Class 2 ·Hematology

KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE ALCOHOL (ALC)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ACA ETHYL ALCOHOL (ALC) ANALYTICAL TEST PACKS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

S- TEST HEMOGLOBIN ALC (HBA1C), MODEL RC0023

FDA 510(k)

FDA Class 2 ·Hematology

NEEDLE BARN STICK STOPPER WITH SAFETY CAP, IN KIT WITH STERILE FIELD DRAPE

FDA 510(k)

FDA Class 2 ·General Hospital

Endophys Pressure Sensing Sheath Kit

FDA 510(k)

FDA Class 2 ·Cardiovascular

MatriStem UBM Pericardial Patch

FDA 510(k)

FDA Class 2 ·Cardiovascular

VACUUM CUP (004SD)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Drakon™ and Sequre® Microcatheters

FDA 510(k)

FDA Class 2 ·Cardiovascular

SWIFT DELIVERY PRODUCT #002-VAC EX CUP W/VAC REL VALVE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SWIFT DELIVERY PRODUCT #300

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SWIFT LOW PROFILE CUP (PRO CUP)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

125-IMPLANT SEEDS, MODEL STM1250

FDA 510(k)

FDA Class 2 ·Radiology

Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Drakon and Sequre Microcatheters

FDA 510(k)

FDA Class 2 ·Cardiovascular