SPIRACLE TECHNOLOGY - MODEL 302 OX INHALATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

OES ELITE Telescopes, Protective Tube

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

RESPAIDE

FDA 510(k)

FDA Class 2 ·Anesthesiology

CPR Face Shield

FDA 510(k)

FDA Class 2 ·Anesthesiology

F&P Optiflow Flow Diverter

FDA 510(k)

FDA Class 2 ·Anesthesiology

VALVE, EXHALATION BE 115-4, 115-5

FDA 510(k)

FDA Class 2 ·Anesthesiology

EMS MOUTH TO MASK RESUSCITATORS

FDA 510(k)

FDA Class 2 ·Anesthesiology

PROTECTAIDE CPR PROTECTION PACK

FDA 510(k)

FDA Class 2 ·Anesthesiology

AUDIBLE PRESSURE RELEASE VALVE WITH HUMIDIFIER ADAPTER / AND OXYGEN NIPPLE

FDA 510(k)

FDA Class 2 ·Anesthesiology

RESCUE BREATHER

FDA 510(k)

FDA Class 2 ·Anesthesiology

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, ENPULSE E1 IPG, ENPULSE E2 IPG,KAPPA D (KAPPA 700) IPG, KAP

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADAPTA,VERSA,SENSIA IPG,ADVISA DR IPG,ADVISA DR MRI IPG,AT500 DDDRP PACING SYSTEM IPG, ENPULSE E2 IPG,ENPULSE E2 IPG,KAP

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENTRUST ICD,INTRINSIC 30 ICD, INTRINSIC ICD,MARQUIS DR ICD,MARQUIS VR ICD,MAXIMO DR ICD, KAPPA DR(KAPPA 700/600)IPG, KAP

PATIENT EXAMINATION GLOVES

FDA 510(k)

FDA Class 1 ·General Hospital

RADIOPAQUE BONE CEMENT

FDA 510(k)

FDA Class 2 ·Orthopedic

SMARTSCORE 3.5; SMARTSCORE 4.0; SMARTSCORE 4.5

FDA 510(k)

FDA Class 2 ·Radiology

FIDIS CELIAC

FDA 510(k)

FDA Class 2 ·Immunology

AIRLIFE INFANT NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

HBP-1120

Basic UDI-DI

EU MDR · Eu Md Class 2a ·OMRON Healthcare Co., Ltd.·1 device

HBP-1320

Basic UDI-DI

EU MDR · Eu Md Class 2a ·OMRON Healthcare Co., Ltd.·1 device