Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS RX COMET CORONARY DILATION CATHETER

629V SPIROMETER, PULMONARY FUNCTION ANALYZER

FDA 510(k)

FDA Class 2 ·Anesthesiology

CIDEX FORMULA 7* LONG-LIFE ACTIVATED DIALDEHYDE

FDA 510(k)

FDA Class 2 ·General Hospital

BARRIER DRAPE SHEET WITH SYMETRY FABRIC

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AUTO IMPEDANCE METER AE105 & AE106 W/AUDIOMETER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

BARRIER SAF-TE HYDROGEL DRAPE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BARRIER* EXTRA PROTECTION PLUS FACE MASK

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AE1162 CLINICAL/DIAGNOSTIC AUDIOMETER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

J-VAC BULB SUCTION RESERVOIR

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

PLOTTER MODEL (MP100)

FDA 510(k)

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·BAYER IMMUNO 1 SYSTEM

Disposable PVC Resuscitator, Disposable PEEP Valve, Disposable Manometer

FDA registration

ASIA CONNECTION CO., LTD.·3 products·🇹🇼 Taiwan

QUADROX-iD Diffusion Membrane Oxygenators with Holding Clamp.

FDA registration

MAQUET CARDIOPULMONARY GmbH·3 products·🇩🇪 Germany

QUADROX-i Pediatric Micorporous Membrane Oxygenator with and without integrated Arterial Filter with SOFTLINE Coating or

FDA registration

Sterigenics Belgium Petit Rechain S.A.·3 products·🇧🇪 Belgium

QUADROX-i Neonatal Micorporous Membrane Oxygenator with and without integrated Arterial Filter with SOFTLINE Coating or

FDA registration

Sterigenics Belgium Petit Rechain S.A.·3 products·🇧🇪 Belgium

PVC Resuscitator and Accessories

FDA registration

FOREMOUNT ENTERPRISE CO., LTD.·3 products·🇹🇼 Taiwan

QUADROX-i Small Adult Microporous Membrane Oxygenator with or without Arterial Filter with BIOLINE Coating

FDA registration

Sterigenics Belgium Petit Rechain S.A.·3 products·🇧🇪 Belgium

Affinity Fusion™ Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance™ Biosurface

FDA registration

MEDTRONIC PERFUSION SYSTEMS·3 products·🇺🇸 United States

PVC Resuscitator and Accessories

FDA registration

EXIN MEDICAL TECHNOLOGY COMPANY, LLC·3 products·🇺🇸 United States

QUADROX-i Microporous Membrane Oxygenator w and w/o Arterial Filter with holding clamp

FDA registration

Sterigenics Belgium Petit Rechain S.A.·3 products·🇧🇪 Belgium