4,549 results · 42ms · Sources: EU EUDAMED, US FDA

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval
FDA Class 3 ·DIMENSION FPSA FLEX REAGENT CARTRIDGE AND DIMENSION T/F PSA CALIBRATOR FOR DIMENSION RXL AND XPAND SYSTEMS

System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)

FDA classification
FDA Class 2 ·System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)

Insufflator, Endoscopic Vessel Harvesting

FDA classification
FDA Class 2 ·Insufflator, Endoscopic Vessel Harvesting

ZENA MAX HSV Type 1/2 Real Time PCR Detection Kit

Basic UDI-DI
EU IVDD · Eu Ivd General ·Advanced Molecular Diagnostics Ltd·1 device

SV-Systems Oy

Importer
🇫🇮 Finland·2 Manufacturers

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·MULTI-LINK Vision/ MULTI-LINK Mini Vision Coronary Stent System, MULTI-LINK 8/ 8 SV/ 8 LL Coronary Stent System

ENERPEEL SA

Basic UDI-DI
EU MDD · Eu Md Class 2a ·GENERAL TOPICS SRL·1 device

Stent Application System

Basic UDI-DI
EU MDR · Eu Md Class 1 ·G-FLEX FLEXIBLE INSTRUMENTS EUROPE·4 devices

ENERPEEL SA-15

Basic UDI-DI
EU MDD · Eu Md Class 2a ·GENERAL TOPICS SRL·1 device

Herpes Simplex Virus (HSV) II Nucleic Acid Detection Kit (Fluorescence PCR Method)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Suzhou TianLong Biotechnology Co., Ltd.·1 device

Herpes Simplex Virus (HSV) II Nucleic Acid Detection Kit (Fluorescence PCR Method)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Suzhou TianLong Biotechnology Co., Ltd.·1 device

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·Multi-Link Vision RX Coronary Stent System, Multi-Link Mini Vision RX Coronary Stent System, Multi-Link 8/8SV/8LL Corona

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

Pacing System Analyzer

FDA classification
FDA Class 2 ·Pacing System Analyzer

PS Product Services GmbH

Importer
🇩🇪 Germany·2 Manufacturers

Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1

FDA classification
FDA Class 2 ·Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1

Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2

FDA classification
FDA Class 2 ·Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA classification
FDA Class 2 ·Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers