Experience

FDA Experience by Medical Device Panel

General & Plastic Surgery

  • Surgical camera (Class I)
  • Bipolar forceps (Class II)
  • Surgical facemasks, gowns, gloves (Class II)

Anesthesiology

  • Nebulizer (Class II)

Orthopedics

  • Bone Void Fillers (Class II)

Physical Medicine

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

Gastroenterology / Urology

  • Foley catheters (Class II)

Hematology

  • PRP Tube (Class II)

Neurology

  • Balloon Catheter (Class II)

Obstetrics / Gynecology

  • Personal Lubricant (Class II)
Panels and device classifications overview
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