BA310 Abutment, BIA310 Implant/Abutment

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ELIBRA DYNAMIC KNEE BALANCER

FDA 510(k)

FDA Class 2 ·Neurology

Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System / Wide implant, 4mm, with abutment, 14 mm

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT ARCHITECT AFP FOR THE ARCHITECT I2000SR ANALYZER

PRE-POWDERED NITRILE EXAMINATION GLOVES

FDA 510(k)

FDA Class 2 ·Orthopedic

EXTRA-ORAL, ADDITIVE COMPUTER AIDED MANUFACTURE AND CURING SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

TELEX TDR-7AA BINAURAL HEAR AID/WIRELESS FM REC

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MICS INTERVENTION AID, CATALOG # MICS-MIA AND MICS-MIAS

FDA 510(k)

FDA Class 2 ·Radiology

OPTIK-AIDS/OPTIC-SHOP THERMAL/THERMA PRO LENS CASE

FDA 510(k)

FDA Class 2 ·Ophthalmic

TELEX TDR-4AA MONAURAL HEAR AID/WIRELESS FM REC

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

BEHIND-THE-EAR HEARING AID MODEL 404 PP-PC

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SURGIDYNE VARIDYNE, MODEL 140-2I & MODEL 140-2ID

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AUDIOMETER AI1, ME1 AND SA1 & MASTER HEARING AID

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·RAPIDSCREEN RS-2000

Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

STARKEY MA-3 AIR CONDUCTION COMBINATION HEARING AID/TINNITUS MASKER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

DIGITAL LGOB PROCEDURE USING RESOUND, DIGITAL 5000 SERIES HEARING AIDS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

PACE*AID 10 A -PAD 10A- PACEMAKER OUTPUT DISPLAY &

FDA 510(k)

FDA Class 2 ·Cardiovascular

METAVOX MV-1000 AUDITORY TRAINER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat