We have experience working with a broad range of Class I and Class II medical devices across various FDA medical device panels, including software-based devices, medical imaging devices, and traditional medical devices.

General & Plastic Surgery Devices

• Surgical camera (Class I)
• Bipolar forceps (Class II)
• Surgical facemasks, gowns, gloves (Class II)
• Powered muscle stimulator for muscle conditioning (Class II)

Anesthesiology Devices

• Nebulizer (Class II)

Orthopedics Devices

• Bone Void Fillers (Class II)

Physical Medicine Devices

• Manual Wheelchair (Class I)
• Spinal Decompression Devices (Class II)

Gastroenterology / Urology Devices

• Foley catheters (Class II)

Hematology Devices

• PRP Tube (Class II)

Neurology Devices

• In situ polymerizing peripheral nerve cap
• Balloon Catheter (Class II)

Obstetrics / Gynecology Devices

• Personal Lubricant (Class II)

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