Model 8101AA/8101AP Sensors, Model 8102AA/8102AP Sensors, Model 8100Q2 Sensor, Model 8101Q2 Sensor, Model 8102Q2 Sensor

FDA registration

NONIN MEDICAL, INC.·2 products·🇺🇸 United States

RAS-45 Neo

FDA registration

MASIMO CORPORATION·2 products·🇺🇸 United States

SmartMonitor 2PS

FDA registration

CIRCADIANCE·2 products·🇺🇸 United States

SmartMonitor 2 Professional Series (PS)

FDA registration

CIRCADIANCE·2 products·🇺🇸 United States

StrykerSustainability (GP) - Reprocessed RD SET Pulse Oximeter Sensor

FDA registration

Isomedix Operations Inc.·2 products·🇺🇸 United States

ORTA MEDICAL

FDA registration

ORTA MEDICAL LTD·2 products·🇮🇱 Israel

Model 9843

FDA registration

NONIN MEDICAL, INC.·2 products·🇺🇸 United States

RAS-45 Neo

FDA registration

MASIMO CORPORATION·2 products·🇺🇸 United States

RAS-45

FDA registration

MASIMO CORPORATION·2 products·🇺🇸 United States

PulseLavage AB

Manufacturer

🇸🇪 Sweden·5 Basic UDI-DIs·5 Devices·UDEM Adriatic d.o.o., UDEM Adriatic d.o.o., and Eurofins Electric & Electronics Finland Oy

Shenzhen Zijian Biotechnology Co., Ltd

Manufacturer

🇨🇳 China·287 Basic UDI-DIs·368 Devices·SGS Belgium NV and CeCert Sp. z o.o.

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·Elecsys Anti-HBs; PreciControl Anti-HBs; Anti-HBs CalCheck

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SELECTED FAMILIES OF ICD'S, ENTRUST FAMILY,INTRINSIC FAMILY,ONYX, MAXIMO FAMILY, MARQUIS FAMILY,GEM III FAMILY,GEM II FA

Single-Use Internal Condom

FDA Pre-Market Approval

FDA Class 2 ·REALITY FEMALE CONDOM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·CYPHER SIROLIMUS-ELUTING CORONARY STENT ON THE RAPTOR OVER-THE WIRE DELIVERY

Single-Use Internal Condom

FDA Pre-Market Approval

FDA Class 2 ·REALITY FEMALE CONDOM

Tecnoclínic SA

Manufacturer

🇪🇸 Spain·25 Basic UDI-DIs·83 Devices·ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', and ISTITUTO SUPERIORE DI SANITA'

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·COBAS TAQMAN HCV TEST V2.0 FOR USE WITH THE HIGH PURE SYSTEM

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·IPAFLUOROFOCON A AND B

Hydrozid Precise

FDA registration

BIBAWO MEDICAL A/S·1 product·🇩🇰 Denmark