INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL PULMONARY RESUSCITATOR WITH RUBBER COMPRESSION BAG

FDA 510(k)

FDA Class 2 ·Anesthesiology

TERUMO HOLLOW OXYGENATOR CIRCUIT

FDA 510(k)

FDA Class 2 ·Cardiovascular

SPUR ADULT WITH OPEN RESERVOIR SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

POCKET BVM

FDA 510(k)

FDA Class 2 ·Anesthesiology

OEMEDIC INTERNATIONAL INC. BESMED SINGLE USE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK & RESERVOIR

FDA 510(k)

FDA Class 2 ·Anesthesiology

SIEMENS-ELEMA AB AGA REVIVATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

DISPOSABLE MANUAL RESUSCITATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

DISPO-BAG MANUAL RESUSCITATOR, DISPOSABLE ADJUSTABLE PEEP VALVE, DISPOSABLE FIXED PEEP VALVE

FDA 510(k)

FDA Class 2 ·Anesthesiology

ARTERIAL BLOOD FILTER ELECTRO. AIR* STAR 40 AND 20

FDA 510(k)

FDA Class 2 ·Cardiovascular

STAT BLUE DISPOS. MANUAL RESUSCITATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

AULD BAGGER KIT

FDA 510(k)

FDA Class 2 ·Anesthesiology

BAGRIGHT RESUSCITATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

AFFINITY PIXIE ARTERIAL FILTER WITH BALANCE BIOSURFACE

FDA 510(k)

FDA Class 2 ·Cardiovascular

MERCURY CPR (COMPLETE PERSONAL RESUSCIATOR) BAG WITH EXPANDABLE RESERVOIR

FDA 510(k)

FDA Class 2 ·Anesthesiology

RESPOSABLE INFANT RESUSCITATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·KRONOS LV-T CRT-D

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·STRATOS LV/LV-T

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ACTROS, AXIOS, BA03, CYLOS, DROMOS, KAIROS, PHILOS, PHILOS II, AND PROTOS FAMILIES OF PULSE GENERATORS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CARDIAC AIRBAG AND BELOS FAMILIES OF ICDS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·LUMOS ICDS/XELOS DR-T ICD/LEXOS ICDS