60 results · 11ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid

FDA classification
FDA Class 2 ·Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid

Colon Computed Tomography System, Computer Aided Detection

FDA classification
FDA Class 2 ·Colon Computed Tomography System, Computer Aided Detection

Self-Fitting Air-Conduction Hearing Aid, Prescription

FDA classification
FDA Class 2 ·Self-Fitting Air-Conduction Hearing Aid, Prescription

Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid

FDA classification
FDA Class 2 ·Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid

Calibrator, Hearing Aid / Earphone And Analysis Systems

FDA classification
FDA Class 2 ·Calibrator, Hearing Aid / Earphone And Analysis Systems

Hearing Aid, Air-Conduction, Over The Counter

FDA classification
FDA Class 1 ·Hearing Aid, Air-Conduction, Over The Counter

Lung Computed Tomography System, Computer-Aided Detection

FDA classification
FDA Class 2 ·Lung Computed Tomography System, Computer-Aided Detection

Peripheral Electromagnetic Field (Pemf) To Aid Wound Healing

FDA classification
FDA Class 3 ·Peripheral Electromagnetic Field (Pemf) To Aid Wound Healing

Hearing Aid, Air-Conduction With Wireless Technology, Prescription

FDA classification
FDA Class 2 ·Hearing Aid, Air-Conduction With Wireless Technology, Prescription

Calibrator For Alpha-Fetoprotein In Mid-Pregnancy Maternal Serum

FDA classification
FDA Class 3 ·Calibrator For Alpha-Fetoprotein In Mid-Pregnancy Maternal Serum

Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure

FDA classification
FDA Class 1 ·Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure

Ir Laser Illuminator With Alignment Aid/Night Vision System

FDA classification
FDA Not Classified ·Ir Laser Illuminator With Alignment Aid/Night Vision System

Self-Fitting Air-Conduction Hearing Aid, Over The Counter

FDA classification
FDA Class 2 ·Self-Fitting Air-Conduction Hearing Aid, Over The Counter

Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter

FDA classification
FDA Class 2 ·Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter

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

Aids, Speech Training For The Hearing Impaired (Ac-Powered And Patient-Contact)

FDA classification
FDA Unclassified ·Aids, Speech Training For The Hearing Impaired (Ac-Powered And Patient-Contact)

Aids, Speech Training For The Hearing Impaired (Battery-Operated Or Non-Patient)

FDA classification
FDA Unclassified ·Aids, Speech Training For The Hearing Impaired (Battery-Operated Or Non-Patient)

Software-Aided Adjunctive Diagnostic Device For Use By Healthcare Providers In Skin Wound Assessment.

FDA classification
FDA Class 2 ·Software-Aided Adjunctive Diagnostic Device For Use By Healthcare Providers In Skin Wound Assessment.

Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer

FDA classification
FDA Class 2 ·Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer

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