Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use

FDA classification

FDA Class 2 ·Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use

Prostate-Specific Antigen (Psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers

FDA classification

FDA Class 2 ·Prostate-Specific Antigen (Psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers

Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter

FDA classification

FDA Class 2 ·Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter

Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use

FDA classification

FDA Class 2 ·Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use

Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna

FDA classification

FDA Class 2 ·Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna

Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus

FDA classification

FDA Class 2 ·Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus

Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment

FDA classification

FDA Class 2 ·Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment

Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices

FDA classification

FDA Class 2 ·Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices

Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

FDA classification

FDA Class 2 ·Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs)

FDA classification

FDA Class 2 ·Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs)

Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss

FDA classification

FDA Class 2 ·Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss

Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs

FDA classification

FDA Class 2 ·Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs

Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users

FDA classification

FDA Class 2 ·Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users

Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed

FDA classification

FDA Class 2 ·Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed

Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea

FDA classification

FDA Class 2 ·Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea

Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna

FDA classification

FDA Class 2 ·Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna

Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue

FDA classification

FDA Class 2 ·Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue

Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation

FDA classification

FDA Class 2 ·Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation

Respirator, N95, For Use By The General Public In Public Health Medical Emergencies

FDA classification

FDA Class 2 ·Respirator, N95, For Use By The General Public In Public Health Medical Emergencies

Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed

FDA classification

FDA Class 2 ·Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed