GEM Premier 5000 PAK

FDA registration

INSTRUMENTATION LABORATORY CO.·4 products·🇺🇸 United States

GEM Premier 5000 PAK

FDA registration

INSTRUMENTATION LABORATORY CO. - Devens·4 products·🇺🇸 United States

GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation)

FDA 510(k)

FDA Class 2 ·Hematology

Instrument, Hematocrit, Automated

FDA classification

FDA Class 2 ·Instrument, Hematocrit, Automated

Signature Personalized Patient Care System

FDA registration

MATERIALISE N.V.·5 products·🇧🇪 Belgium

Signature

FDA registration

Paragon Medical Inc.·1 product·🇺🇸 United States

Signature Personalized Patient Care System

FDA registration

Materialise USA, LLC.·5 products·🇺🇸 United States

Signature Personalized Patient Care System

FDA registration

Materialise Ukraine, Rep. office·5 products·🇺🇦 Ukraine

High Metabolite QUALICHECK

FDA registration

Radiometer Solutions Sp. z o.o.·1 product·🇵🇱 Poland

Signature Personalized Patient Care System

FDA registration

Materialise Sdn Bhd·5 products·🇲🇾 Malaysia

SIGNATURE PLANNER / SIGNATURE GUIDES

FDA registration

BIOMET, INC.·5 products·🇺🇸 United States

RADIOMETER MEDICAL APS

FDA registration

RADIOMETER MEDICAL APS·1 product·🇩🇰 Denmark

B-P TOTAL HIP SYSTEM

FDA UDI

Synovo Production·00814193024220·B-P MODULAR EXTENSION W/ULTRACOAT - 15 MM X 100 MM

Elecsys CYFRA 21-1 CalSet

FDA registration

ROCHE DIAGNOSTICS GMBH·3 products·🇩🇪 Germany

Shanghai Caremate Medical Device Co. Ltd

FDA registration

Shanghai Caremate Medical Device Co. Ltd·1 product·🇨🇳 China

MODIFICATION TO: SATELLITE SPINAL SYSTEM

FDA 510(k)

FDA Class 3 ·Unknown

ACUPULSE 30/40 ST CO2 LASER SYSTEM AND ACUPULSE 40WG CO2 LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar

FDA classification

FDA Class 3 ·Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar

SUCTION COLLECTION BAG 2000ML (INCLUDING TUBE) - 160 203 9

FDA registration

PLASTI-MED PLASTIK MEDIKAL URUNLER SAN. VE TIC. LTD. STI.·1 product·🇹🇷 Türkiye

Powered Laser Surgical Instrument

FDA classification

FDA Class 2 ·Powered Laser Surgical Instrument