InsightersTM Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0; InsightersTM Single-use Bronchoscope/Insight Bimodel-Integral iS-B22A 5.5 /2.6; InsightersTM Single-use Bronchoscope/Insight Bimodel-Integral iS-B26A 6.0/3.0; InsightersTM Insight Workstation iS-PF1.

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ALP IFCC Gen.2

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SENTIO MMG Gen 2

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ANNE View, Central Hub

FDA 510(k)

FDA Class 2 ·Cardiovascular

AERO-GEN NUBULIZER SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

GENESIS (MS-P02-GEN)

FDA 510(k)

FDA Class 2 ·Physical Medicine

NEUROMATE FRAMELESS GEN II

FDA 510(k)

FDA Class 2 ·Neurology

<GEN>SINGLE LUMEN NEEDLE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Disposable Endobronchial Blocker Tube

FDA 510(k)

FDA Class 2 ·Anesthesiology

Disposable Double Lumen Endobronchial Tube

FDA 510(k)

FDA Class 2 ·Anesthesiology

PROFAST+ ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

PRODESSE PROFLU+ ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

CELL GEN LASER, MODEL CG-4000

FDA 510(k)

FDA Class 2 ·Physical Medicine

PERITONE DISPOSAL SHEATH - RUBBER AND VINYL

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

PRODESSE PROFAST+ ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

APTIMA COMBO 2 ASSAY (PANTHER SYSTEM)

FDA 510(k)

FDA Class 2 ·Microbiology

PRO HMPV+ ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

PERITONE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

PRODESSE PROADENO

FDA 510(k)

FDA Class 2 ·Microbiology

PROFLU+ ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology