132 results · 45ms · Sources: EU EUDAMED, US FDA

Uric Acid Test System For At Home Prescription Use

FDA classification
FDA Class 1 ·Uric Acid Test System For At Home Prescription Use

Blanket, Neonatal Phototherapy

FDA classification
FDA Class 2 ·Blanket, Neonatal Phototherapy

Radioimmunoassay, Digoxin (125-I), Goat Antibody, Anion Exchange, Resin Sep.

FDA classification
FDA Class 2 ·Radioimmunoassay, Digoxin (125-I), Goat Antibody, Anion Exchange, Resin Sep.

Mask, Surgical, Eua Authorized

FDA classification
FDA Not Classified ·Mask, Surgical, Eua Authorized

Electrode, Pacing And Cardioversion, Temporary, Epicardial

FDA classification
FDA Class 2 ·Electrode, Pacing And Cardioversion, Temporary, Epicardial

System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen

FDA classification
FDA Class 2 ·System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen

Reprocessed Bronchoscope

FDA classification
FDA Class 2 ·Reprocessed Bronchoscope

Catheter, Intravascular, Plaque Morphology Evaluation

FDA classification
FDA Class 2 ·Catheter, Intravascular, Plaque Morphology Evaluation

Wearable Automated External Defibrillator

FDA classification
FDA Class 3 ·Wearable Automated External Defibrillator

Cannula, Trocar, Ophthalmic

FDA classification
FDA Class 1 ·Cannula, Trocar, Ophthalmic

Intraoperative Orthopedic Strain Sensor

FDA classification
FDA Class 2 ·Intraoperative Orthopedic Strain Sensor

Ppg Sensor Wearable For Hypercoagulation Detection And Covid-19 Screening

FDA classification
FDA Not Classified ·Ppg Sensor Wearable For Hypercoagulation Detection And Covid-19 Screening

System, Suction, Lipoplasty

FDA classification
FDA Class 2 ·System, Suction, Lipoplasty

Reagents And Transportation Supplies, Sodium Citrate Blood Specimen Collection Tube

FDA classification
FDA Not Classified ·Reagents And Transportation Supplies, Sodium Citrate Blood Specimen Collection Tube

Infant Positioner, Rx, Use In Highly Monitored Setting

FDA classification
FDA Class 1 ·Infant Positioner, Rx, Use In Highly Monitored Setting

Shoulder Arthroplasty Implantation System

FDA classification
FDA Class 2 ·Shoulder Arthroplasty Implantation System

Knee Arthroplasty Implantation System

FDA classification
FDA Class 2 ·Knee Arthroplasty Implantation System

Pediatric/Child Facemask

FDA classification
FDA Class 2 ·Pediatric/Child Facemask

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