434 results · 50ms · Sources: EU EUDAMED, US FDA

Burr, Corneal, Manual

FDA classification
FDA Class 1 ·Burr, Corneal, Manual

Modified Version Of Another Manufacturer’S Fda-Authorized Test Within Scope Described In Preamble To Ldt Final Rule

FDA classification
FDA Not Classified ·Modified Version Of Another Manufacturer’S Fda-Authorized Test Within Scope Described In Preamble To Ldt Final Rule

Hoe, Periodontic

FDA classification
FDA Class 1 ·Hoe, Periodontic

Rongeur, Cystoscopic, Hot

FDA classification
FDA Class 2 ·Rongeur, Cystoscopic, Hot

Device, Pasteurization, Hot Water

FDA classification
FDA Class 2 ·Device, Pasteurization, Hot Water

Bottle, Hot/Cold Water

FDA classification
FDA Class 1 ·Bottle, Hot/Cold Water

Lead, Atomic Absorption

FDA classification
FDA Class 2 ·Lead, Atomic Absorption

Antisera, Neutralization, Poliovirus 1-3

FDA classification
FDA Class 1 ·Antisera, Neutralization, Poliovirus 1-3

Pack, Hot Or Cold, Disposable

FDA classification
FDA Class 1 ·Pack, Hot Or Cold, Disposable

Pack, Hot Or Cold, Reusable

FDA classification
FDA Class 1 ·Pack, Hot Or Cold, Reusable

Ldt, Approved By Nys Clep

FDA classification
FDA Not Classified ·Ldt, Approved By Nys Clep

Pack, Hot Or Cold, Water Circulating

FDA classification
FDA Class 2 ·Pack, Hot Or Cold, Water Circulating

Ldt, Unmet Need Within An Integrated Healthcare System

FDA classification
FDA Not Classified ·Ldt, Unmet Need Within An Integrated Healthcare System

Ivd Offered As Ldt, First Marketed Before May 6, 2024, Not Modified Beyond Scope Described In Preamble To Ldt Final Rule

FDA classification
FDA Not Classified ·Ivd Offered As Ldt, First Marketed Before May 6, 2024, Not Modified Beyond Scope Described In Preamble To Ldt Final Rule

Laparoscope, General & Plastic Surgery

FDA classification
FDA Class 2 ·Laparoscope, General & Plastic Surgery

Arthroscope

FDA classification
FDA Class 2 ·Arthroscope

Electrosurgical, Cutting & Coagulation & Accessories

FDA classification
FDA Class 2 ·Electrosurgical, Cutting & Coagulation & Accessories

Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates

FDA classification
FDA Class 2 ·Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates

System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates

FDA classification
FDA Class 2 ·System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates

Ldt, Non-Molecular Antisera For Rare Rbc Antigens When There Is No Alternative Ivd

FDA classification
FDA Not Classified ·Ldt, Non-Molecular Antisera For Rare Rbc Antigens When There Is No Alternative Ivd