ShapeIT (SI014135)

FDA 510(k)

FDA Class 2 ·Cardiovascular

PDO Absorbable Punctum Plug

FDA 510(k)

FDA Unclassified ·Unknown

OrthoButton CL

FDA 510(k)

FDA Class 2 ·Orthopedic

Sirius Max Dental Diode Curing Light

FDA 510(k)

FDA Class 2 ·Dental

Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub

FDA 510(k)

FDA Class 2 ·Cardiovascular

WR19 System

FDA 510(k)

FDA Class 2 ·Neurology

SILKAIR LOW AIRLOSS THERAPY

FDA 510(k)

FDA Class 2 ·Physical Medicine

FlowGuide (FG60F); GuidionShort (GS60F)

FDA 510(k)

FDA Class 2 ·Cardiovascular

NANOLITE SKIN CARE SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ExSpiron 1Xi

FDA 510(k)

FDA Class 2 ·Anesthesiology

Flexset System

FDA 510(k)

FDA Class 2 ·Neurology

Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

ReCross

FDA 510(k)

FDA Class 2 ·Cardiovascular

Wearable Device, Wearable Package

FDA 510(k)

FDA Class 2 ·Cardiovascular

CLEAN ROOM WHEELCHAIR

FDA 510(k)

FDA Class 1 ·Physical Medicine

RiverLon (Nylon) Suture

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set

FDA 510(k)

FDA Class 2 ·Neurology

HS Fiber

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves

FDA 510(k)

FDA Class 2 ·Neurology

SPIRAL FLOW PERIPHERAL VASCULAR GRAFT

FDA 510(k)

FDA Class 2 ·Cardiovascular