4,549 results
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42ms
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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
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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