Captura Disposable Bronchoscope Biopsy Forceps

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MDHearingAid app, MDHearingAid Smart hearing aids

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Ambu® aScope™ 5 Broncho 2.7/1.2, Ambu® aScope™ 5 Broncho 4.2/2.2, Ambu® aBox™ 2

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

LIAISON PLEX Gram-Positive Blood Culture Assay

FDA 510(k)

FDA Class 2 ·Microbiology

Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC, or Breakpoint Susceptibility System with Imipenem-relebactam in the dilution, range of 0.03/4-128-4ug/ml (Haemophilus influenzae)

FDA 510(k)

FDA Class 2 ·Microbiology

SIMPLEXA HSV 1&2 DIRECT

FDA 510(k)

FDA Class 2 ·Microbiology

QIAstat-Dx Meningitis/Encephalitis (ME) Panel

FDA 510(k)

FDA Class 2 ·Microbiology

SAS SALMONELLA H Z42 ANTISERUM

FDA 510(k)

FDA Class 2 ·Microbiology

ETEST FOR CEFTAZIDIME

FDA 510(k)

FDA Class 2 ·Microbiology

Acclarent Aera Eustachian Tube Balloon Dilation System

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Baha 5 Power Sound Processor

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

VIDAS TOXOPLASMA GONDII IGM ASSSAY

FDA 510(k)

FDA Class 2 ·Microbiology

BIOPLEX 2200 SYSTEM TORC IGG KIT, CALIBRATOR SET AND CONTROL SET

FDA 510(k)

FDA Class 2 ·Microbiology

D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT

FDA 510(k)

FDA Class 2 ·Microbiology

VISION SCIENCES ENDOSHEATH SYSTEM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

HERPES HOMINUS I-COMPLE FIX ANTIGEN & NEGATIVE CLT

FDA 510(k)

FDA Class 2 ·Microbiology

SAS SALMONELLA H L,W ANTISERUM

FDA 510(k)

FDA Class 2 ·Microbiology

IMMULITE TOXOPLASMA QUANTITATIVE IGG

FDA 510(k)

FDA Class 2 ·Microbiology

CARDS O.S. MONO

FDA 510(k)

FDA Class 2 ·Immunology

ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL

FDA 510(k)

FDA Class 2 ·Microbiology