SMR Reverse Liner

FDA 510(k)

FDA Class 2 ·Orthopedic

CRONO SUPER PID

FDA 510(k)

FDA Class 2 ·General Hospital

DRSplus

FDA 510(k)

FDA Class 2 ·Ophthalmic

Filbloc

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Galaxy UNYCO System

FDA 510(k)

FDA Class 2 ·Orthopedic

Implant, Endosseous, Orthodontic

FDA classification

FDA Class 2 ·Implant, Endosseous, Orthodontic

Cream For X-Ray Attenuation

FDA classification

FDA Class 2 ·Cream For X-Ray Attenuation

Auto-Antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/Prothrombin Complex

FDA classification

FDA Class 2 ·Auto-Antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/Prothrombin Complex

Respirator, Surgical

FDA classification

FDA Class 2 ·Respirator, Surgical

Compression-Based Airway Clearance Device

FDA classification

FDA Class 2 ·Compression-Based Airway Clearance Device

Saline, Vascular Access Flush

FDA classification

FDA Class 2 ·Saline, Vascular Access Flush

Heparin, Vascular Access Flush

FDA classification

FDA Class 2 ·Heparin, Vascular Access Flush

Water, Vascular Access Flush

FDA classification

FDA Class 2 ·Water, Vascular Access Flush

Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside

FDA classification

FDA Class 2 ·Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside

Single-Use Internal Condom

FDA classification

FDA Class 2 ·Single-Use Internal Condom

Cardiovascular Machine Learning-Based Notification Software

FDA classification

FDA Class 2 ·Cardiovascular Machine Learning-Based Notification Software

Orthodontic Led Accessory

FDA classification

FDA Class 2 ·Orthodontic Led Accessory

System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection

FDA classification

FDA Class 2 ·System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection

System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection

FDA classification

FDA Class 2 ·System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection

Powered Light Based Non-Laser Surgical Instrument With Thermal Effect

FDA classification

FDA Class 2 ·Powered Light Based Non-Laser Surgical Instrument With Thermal Effect