Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)

FDA classification

FDA Class 2 ·Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)

Software Algorithm Device To Assist Users In Digital Pathology

FDA classification

FDA Class 2 ·Software Algorithm Device To Assist Users In Digital Pathology

Radiological Software Device To Predict Future Breast Cancer Risk

FDA classification

FDA Class 2 ·Radiological Software Device To Predict Future Breast Cancer Risk

Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor

FDA classification

FDA Class 2 ·Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor

Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety

FDA classification

FDA Class 2 ·Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety

Device To Detect Microbial Colonization Directly From Clinical Specimens.

FDA classification

FDA Class 2 ·Device To Detect Microbial Colonization Directly From Clinical Specimens.

Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission

FDA classification

FDA Class 2 ·Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission

Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions

FDA classification

FDA Class 2 ·Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions

Over-The-Counter Device To Assess Risk Of Sleep Apnea

FDA classification

FDA Class 2 ·Over-The-Counter Device To Assess Risk Of Sleep Apnea

Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)

FDA classification

FDA Class 2 ·Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)

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

Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation

FDA classification

FDA Class 2 ·Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation

Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.

FDA classification

FDA Class 2 ·Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.

Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens

FDA classification

FDA Class 2 ·Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens

Mobile / Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera

FDA classification

FDA Class 2 ·Mobile / Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera

Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature

FDA classification

FDA Class 2 ·Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature

Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens

FDA classification

FDA Class 2 ·Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens

Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness

FDA classification

FDA Class 2 ·Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness

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

Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection

FDA classification

FDA Class 2 ·Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection