20 results · 8ms · Sources: EU EUDAMED, US FDA

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Software Device To Aid In The Prediction Or Diagnosis Of Sepsis

FDA classification
FDA Class 2 ·Software Device To Aid In The Prediction Or Diagnosis Of Sepsis

ASK-300

FDA 510(k)
FDA Class 2 ·Cardiovascular

ASK System

FDA 510(k)
FDA Class 2 ·Orthopedic

TOTIM Patient Cushion Immobilization System

FDA 510(k)
FDA Class 2 ·Radiology

BAK-ON SP PORCELAIN ALLOY

FDA 510(k)
FDA Class 2 ·Dental

MODIFICATION TO BONE ANCHOR AND KIT (BAK)

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

CleanCart A, CleanCart C, AK 98 Hemodialysis Machine

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

AXYA MEDICAL INC, BONE ANCHOR SYSTEM AND KIT- (BAK)

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody Fusion System, InFix Anterior Lumbar System, TraXis Vertebral Body Replacement (Ti and VUE)

FDA 510(k)
FDA Class 2 ·Orthopedic

MODIFICATION TO AXYA MEDICAL, INC. BONE ANCHOR SYSTEM AND KIT (BAK)

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

CENTROX, RELIANT, ULTROX, AS-D+, AS-E, AS-G, AS-J, AS-K AND AS-L

FDA 510(k)
FDA Class 2 ·Anesthesiology

Microfilter, Blood Transfusion

FDA classification
FDA Class 2 ·Microfilter, Blood Transfusion

Complement C1q, Antigen, Antiserum, Control

FDA classification
FDA Class 2 ·Complement C1q, Antigen, Antiserum, Control

Sars-Cov-2 Serology Test

FDA classification
FDA Class 2 ·Sars-Cov-2 Serology Test

Non-Sars Coronavirus Multiplex Nucleic Acid Assay

FDA classification
FDA Class 2 ·Non-Sars Coronavirus Multiplex Nucleic Acid Assay

Respiratory Specimen Nucleic Acid Sars-Cov-2 Test

FDA classification
FDA Class 2 ·Respiratory Specimen Nucleic Acid Sars-Cov-2 Test

Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens

FDA classification
FDA Class 2 ·Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens

Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

FDA classification
FDA Class 2 ·Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings

FDA classification
FDA Class 2 ·Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings

Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings

FDA classification
FDA Class 2 ·Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings