Predo Care

FDA registration

PREDO SAGLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI·1 product·🇹🇷 Türkiye

Mixer

FDA registration

JOLINE GMBH & CO. KG·1 product·🇩🇪 Germany

Ambra PACS

FDA registration

DICOM Grid (dba Ambra Health)·1 product·🇺🇸 United States

Ambra Mobile Application

FDA registration

DICOM Grid (dba Ambra Health)·1 product·🇺🇸 United States

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD AND EVERA XT VR ICD

FDA Pre-Market Approval

BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D

Plastic Electromechanic Company Plus

FDA registration

Plastic Electromechanic Company Plus·1 product·🇹🇳 Tunisia

Electrode, electrocardiograph

FDA registration

Plastic Electromechanic Company Plus·1 product·🇹🇳 Tunisia

Folysil Silicone Catheter

FDA registration

ADHE-ELS INTERNATIONAL·1 product·🇹🇳 Tunisia

Electrode, electrocardiograph

FDA registration

Plastic Electromechanic Company MEDICAL DEVICE·1 product·🇹🇳 Tunisia

X-Flow

FDA registration

ADHE-ELS INTERNATIONAL·1 product·🇹🇳 Tunisia

Medipeds

FDA registration

Gildan Hosiery Rio Nance·1 product·🇭🇳 Honduras

OPUS TROPONIN I (CTN) TEST MODULES

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TITANIUM CANNULATED TIBIAL NAIL (TI CTN)

FDA 510(k)

FDA Class 2 ·Orthopedic

ALPHATEC FEMORAL TROCHANTERIC NAIL (FTN) SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

SUNGLASSES

FDA registration

JIANSHI INDUSTRAL LIMITED·1 product·🇨🇳 China

Toothpaste

FDA registration

BSD PRODUCT DESIGN INC.·1 product·🇹🇼 Taiwan

SUN GLASSES

FDA registration

HANGZHOU GREATSTAR INDUSTRIAL CO., LTD·1 product·🇨🇳 China

Biothread Dental Implant Systems

FDA registration

MEDIMECCA CO LTD·2 products·🇰🇷 South Korea

ZEESAN, SARS-CoV-2 Variant B.1.617 Identification Kit (Sanity 2), 24 Tests/Kit, 48 Tests/Kit

FDA registration

XIAMEN ZEESAN BIOTECH CO., LTD·1 product·🇨🇳 China