Prevelle Silk

No FDA recalls found in the data synced 22 Oct 2026.

Trade Name

Hylaform (Hylan B Gel)

Generic Name

Implant, dermal, for aesthetic use

PMA Number

P030032 ↗

FDA Product Code

LMH

Device Class

Class III

Advisory Committee

General, Plastic Surgery

FDA Decision

APWD Approval withdrawn

• S-1150 Pleur-Evac Sahara Plus Continuous Reinfusion Autotransfusion System

  Class II

  FDA 510(k) K031554 Active Cleared 25 Jul 2003

• Radlite Tissue Retractor System

  Class II

  FDA 510(k) K022989 Active Cleared 25 Nov 2002

• Monodek Synthetic Absorbable Surgical Suture

  Class II

  FDA 510(k) K030212 Active Cleared 27 Mar 2003

• Saph-Loop Ligating Loop

  Class II

  FDA 510(k) K022410 Active Cleared 20 Aug 2002