RADIODEXTER VERSION 1.0, DEXTROSCOPE, MODEL MK10 AND DEXTROBEAM, MODEL MK3

FDA 510(k)

FDA Class 2 ·Radiology

SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)

FDA 510(k)

FDA Class 2 ·General Hospital

AeviceMD

FDA 510(k)

FDA Class 2 ·Cardiovascular

ProSeal™ Vented Universal Vial Adaptor

FDA 510(k)

FDA Class 2 ·General Hospital

RhythmAnalytics

FDA 510(k)

FDA Class 2 ·Cardiovascular

VIZDEXTER VERSION 2.0; DEXTROSCOPE MK8; DEXTROBEAM MK3

FDA 510(k)

FDA Class 2 ·Radiology

Us2.v2

FDA 510(k)

FDA Class 2 ·Radiology

ProSeal™ Closed System drug Transfer Device (CSTD)

FDA 510(k)

FDA Class 2 ·General Hospital

ProSeal™ Closed System Administration Set

FDA 510(k)

FDA Class 2 ·General Hospital

ProSeal™ Injector Plus (Model no. 421050)

FDA 510(k)

FDA Class 2 ·General Hospital

iSR’obot Mona Lisa 2.0

FDA 510(k)

FDA Class 2 ·Radiology

Merit RadialFlo Arterial Catheter

FDA 510(k)

FDA Class 2 ·General Hospital

iRAD

FDA 510(k)

FDA Class 2 ·Radiology

ClearColor 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens, Aryan Color 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens

FDA 510(k)

FDA Class 2 ·Ophthalmic

Safety Subcutaneous Infusion Set

FDA 510(k)

FDA Class 2 ·General Hospital

Monarch Airway Clearance System

FDA 510(k)

FDA Class 2 ·Anesthesiology

BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software

FDA 510(k)

FDA Class 2 ·Cardiovascular

Maximus System

FDA 510(k)

FDA Class 2 ·Anesthesiology

Quantum Mitohormesis (QMT) (M2101)

FDA 510(k)

FDA Class 2 ·Physical Medicine

ToxiSeal™ Vial Adaptor

FDA 510(k)

FDA Class 2 ·General Hospital