MICROMED QRS CARD

FDA 510(k)

FDA Class 2 ·Cardiovascular

Quantitative Electrocardiographic Detector (QED 2000)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval

FDA Class 3 ·DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM

Prosthesis, Hip, Semi-Constrained, Ceramic-On-Metal Articulation

FDA Pre-Market Approval

FDA Class 3 ·DEPUY PINNACLE COMPLETE ACETABULAR HIP SYSTEM

NES Nederland B.V.

Importer

🇳🇱 Netherlands

Disposable ECMO Set

Basic UDI-DI

EU MDR · Eu Md Class 2a ·CHINABRIDGE (SHENZHEN) MEDICAL TECHNOLOGY CO., LTD.·3 devices

PSA Prostate Specific Antigen Semi-Quantitative Ultra Rapid Test Device (Whole Blood/Serum/Plasma)

Basic UDI-DI

EU IVDD · Eu Ivd Annex 2 List B ·Abon Biopharm(Hangzhou) Co., Ltd·1 device

SILICONE INFANT 280ML RESUSCITATOR W/ POP-OFF 40 CMH2O (ALL IN ONE-INTAKE VALVE)

Basic UDI-DI

EU MDD · Eu Md Class 2a ·Besmed Health Business Corp.·1 device

SILICONE CHILD 500ML RESUSCITATOR W/ POP-OFF 40 CMH2O (ALL IN ONE-INTAKE VALVE)

Basic UDI-DI

EU MDD · Eu Md Class 2a ·Besmed Health Business Corp.·1 device

SILICONE ADULT 1600ML RESUSCITATOR W/O POP-OFF (ALL IN ONE-INTAKE VALVE)

Basic UDI-DI

EU MDD · Eu Md Class 2a ·Besmed Health Business Corp.·1 device

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·PD-L1 IHC 22C3 pharmDx

Novanta Europe GmbH

Authorized representative

🇩🇪 Germany·1 Manufacturer

Tempus LS-Manual

FDA registration

Philips Electronics Ltd·4 products·🇨🇦 Canada

Vyntus CPX / Vyntus ECG

FDA registration

Jaeger Medical America Inc.·4 products·🇺🇸 United States

OMRON HEALTHCARE Co., Ltd. Matsusaka Factory

FDA registration

OMRON HEALTHCARE Co., Ltd. Matsusaka Factory·4 products·🇯🇵 Japan

TEMPUS LS-MANUAL

FDA registration

REMOTE DIAGNOSTIC TECHNOLOGIES LTD.·4 products·🇬🇧 United Kingdom

TEMPUS LS - MANUAL

FDA registration

SCHILLER AG·4 products·🇨🇭 Switzerland

Amphenol Medical Technologies (Dongguan) Co., Ltd.

FDA registration

Amphenol Medical Technologies (Dongguan) Co., Ltd.·4 products·🇨🇳 China

Paceart Optima System 1.6 with Analytics

FDA registration

MEDTRONIC, INC.·4 products·🇺🇸 United States

KATECHO LLC

FDA registration

KATECHO LLC·4 products·🇺🇸 United States