ABL9

FDA registration

Radiometer Minneapolis·1 product·🇺🇸 United States

Rapidpoint 400/405/500 systems Pleural Fluid

FDA registration

SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD·1 product·🇬🇧 United Kingdom

800 SERIES

FDA registration

SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD·1 product·🇬🇧 United Kingdom

EasyBloodGas

FDA registration

MEDICA CORP.·1 product·🇺🇸 United States

JJX Siemens RapidLab High Glucose Control

FDA registration

BIONOSTICS, INC.·1 product·🇺🇸 United States

Blood Gases/ PCO2, PO2 Analysis Products

FDA registration

PHOENIX DIAGNOSTICS, INC.·1 product·🇺🇸 United States

Rapidpoint 400/405/500 systems Pleural Fluid

FDA registration

Siemens Healthcare Diagnostics Inc.·1 product·🇺🇸 United States

i-STAT G3+ cartridge

FDA registration

ABBOTT POINT OF CARE INC.·1 product·🇺🇸 United States

Stat Profile Prime ABG Blood Gas Analyzer

FDA registration

Nova Biomedical Corporation·1 product·🇺🇸 United States

800 SERIES

FDA registration

Siemens Healthcare Diagnostics Inc·1 product·🇺🇸 United States

Analyzer

FDA registration

Diamond Diagnostics Inc.·1 product·🇭🇺 Hungary

Stat Profile Prime Plus

FDA registration

NOVA BIOMEDICAL CORPORATION·1 product·🇺🇸 United States

248 BG System

FDA registration

SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD·1 product·🇬🇧 United Kingdom

Cleaning Solution 1 and Cleaning Solution 2 (C1/C2)

FDA registration

Fisher Diagnostics·1 product·🇺🇸 United States

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED NC EXPRESS PLUS PTCA CATHETER

BOOMERANG WIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

Play and Joy Water-Based Lubricant, model PJ-LBS201-35

FDA registration

INNOVEMED BIO-TECH CO., LTD.·1 product·🇹🇼 Taiwan

Tianjin Zhengtian Medical Instrument Co., Ltd.

Manufacturer

🇨🇳 China·8473 Basic UDI-DIs·8473 Devices·1 Importer·UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş., UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş., TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş., UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş., TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş., TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş., TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş., UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş., TÜV Rheinland LGA Products GmbH, and TÜV Rheinland LGA Products GmbH

AFINION ANALYZER

FDA 510(k)

FDA Class 2 ·Hematology

AFINION HBALC

FDA 510(k)

FDA Class 2 ·Hematology