POLY PISTON

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ACS DIGOXIN IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

HI SONIC 2000 DIGITAL HEARING INSTRUMENT

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

INNOFLUOR(TM) THEOPHYLLINE CALIBRATOR SET

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

TECHNICON RA-PHENOBARBITAL

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

KARL STORZ RHINO-PHARYNGO-LARYNGO-FIBERSCOPE, BIOPSY, GRASPING FORCEPS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

SINUSCOPE AND BACCESSORIES

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100, Bronchovideoscope Olympus BF-1TH1100

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

DIEGO ELITE DRILL

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Cochlear™ Osia® System; Cochlear™ Osia® OSI300 Implant; Cochlear™ Magnet Cassette; Cochlear™ Non-Magnetic Cassette; Cochlear™ Osia® 2(I) Sound Processor; Cochlear™ Osia® Fitting Software 2; Cochlear™ Osia® Smart App

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Ponto 5 Mini

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

IMMPULSE T4 ASSAY REAGENTS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CEDIA Heroin Metabolite (6-AM) assay

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MODEL 210 IMPEDANCE SYSTEM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

CELL-MATE(TM) MASS CYTOLOGY-CELLULAR RETRIEVAL SYST

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

TINNITUS AID, MODEL S244

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

IMMITTANCE METER, MODEL AE-105D/S

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Cordelle II Sound Processor

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat