Bose Hearing Aid

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

BHA100 Series Braun Clear Hearing Aid

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MDHearingAid app, MDHearingAid Smart hearing aids

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Cartiva SCI Disposable Instrumentation Set

FDA 510(k)

FDA Class 2 ·Orthopedic

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT IMX(R) HAVAB(R)-M

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT HAVAB-M 7180/ HAVAB-M EIA 9843/IMX HAVAB-M 2263

GALEMED PEAK FLOW METER, MODELS 3751/3752

FDA 510(k)

FDA Class 2 ·Anesthesiology

DIGORA

FDA 510(k)

FDA Class 2 ·Radiology

CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

INION CPS BSSO SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

CARESCAPE MONITOR B650

FDA 510(k)

FDA Class 2 ·Cardiovascular

CRANEX BASEX D OR CRANEX EXCEL D

FDA 510(k)

FDA Class 2 ·Dental

PLLA PIN

FDA 510(k)

FDA Class 2 ·Orthopedic

ELEKTA OY

FDA 510(k)

FDA Class 2 ·Neurology

BIOCUFF, MODELS 225718, 225728, 225736, 235718, 235728, 235736

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION TO: 1.5 BONE FIXATION KIT, MODELS BXS6114, BXS6214

FDA 510(k)

FDA Class 2 ·Orthopedic

LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM CALIBRATION SET B, NORTROL AND ABTROL

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

BIOSORBPDX BIOABSORBABLE FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIGH CONTROLS

FDA 510(k)

FDA Class 2 ·Immunology