Route 92 Medical Full Length 088 Access System

FDA 510(k)

FDA Class 2 ·Cardiovascular

6F Wallaby Long Sheath

FDA 510(k)

FDA Class 2 ·Cardiovascular

NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

GREENLEAF EVAL SYSTEM/ GREENLEAF SOLOSYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard Profile

FDA 510(k)

FDA Class 2 ·Cardiovascular

HAL for Medical Use(Lower Limb type)

FDA 510(k)

FDA Class 2 ·Physical Medicine

PATH BGC

FDA 510(k)

FDA Class 2 ·Cardiovascular

INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Zoom System

FDA 510(k)

FDA Class 2 ·Cardiovascular

REWALK

FDA 510(k)

FDA Class 2 ·Physical Medicine

Next Generation Access Platform

FDA 510(k)

FDA Class 2 ·Cardiovascular

Route 92 Medical 070 Access System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Wallaby 017 Micro Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

MICROPLEX COIL SYSTEM- COSMOS

FDA 510(k)

FDA Class 2 ·Cardiovascular

NEURO SCAN MEDICAL SYSTEMS, MODELS 302L MEDICOR (LABORATORY) AND 302P ADVANTAGE 3000 (PORTABLE)

FDA 510(k)

FDA Class 2 ·Physical Medicine

DISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND REUSABLE MONOPOLAR NEEDLE

FDA 510(k)

FDA Class 2 ·Physical Medicine

ReWalk P6.0

FDA 510(k)

FDA Class 2 ·Physical Medicine

REMUSK MP

FDA 510(k)

FDA Class 2 ·Orthopedic

XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059

FDA 510(k)

FDA Class 2 ·Physical Medicine

EMG RECORDING ELECTRODE ASSEMBLY

FDA 510(k)

FDA Class 2 ·Physical Medicine