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Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence

FDA product code PWJ · Class 2 · Obstetrics/Gynecology

25

Registered devices

9

Adverse events

0

Recalls

5

510(k) clearances

Devices with this code

Transvaginal 4.0 mm Introducer — Caldera Medical, Inc.Transobturator Helical, Right Introducer — Caldera Medical, Inc.Transobturator Helical, Left Introducer — Caldera Medical, Inc.Transobturator Helical, Left Introducer — Caldera Medical, Inc.Desara Blue TVez 2.7 — Caldera Medical, Inc.Desara TVez 2.7 — Caldera Medical, Inc.Transvaginal 3.2 mm Introducer — Caldera Medical, Inc.Desara One — Caldera Medical, Inc.Transobturator Inside-Out, Left 3.2 mm Introducer — Caldera Medical, Inc.Transobturator Inside-Out, Right Introducer — Caldera Medical, Inc.Transobturator Inside-Out, Right 3.2 mm Introducer — Caldera Medical, Inc.Transobturator Hook Introducer — Caldera Medical, Inc.Winged Guide Accessory — Caldera Medical, Inc.Desara TVez 3.0 — Caldera Medical, Inc.Desara Blue TVez 3.0 — Caldera Medical, Inc.Desara Blue TVez 3.0 — Caldera Medical, Inc.Transobturator Large Helical, Left Introducer — Caldera Medical, Inc.Desara TVez 3.0 — Caldera Medical, Inc.Desara Blue TVez 2.7 — Caldera Medical, Inc.Desara One — Caldera Medical, Inc.Transobturator Helical, Right Introducer — Caldera Medical, Inc.Desara TVez 2.7 — Caldera Medical, Inc.Transobturator Large Helical, Right Introducer — Caldera Medical, Inc.Suprapubic Introducer — Caldera Medical, Inc.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.