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Scalpel, One-Piece

FDA product code GDX · Class 1 · General, Plastic Surgery

642
Registered devices
127
Adverse events
6
Recalls
26
510(k) clearances

Devices with this code

Swann Morton Ltd. — SWANN-MORTON LIMITEDSTERiLANCE — Sterilance Medical (Suzhou) Inc.Medicon — Medicon eG. Chirurgiemechaniker-GenossenschaftBard-Parker ® Disposable Scalpels — ASPEN SURGICAL PRODUCTS, INC.Gimmi — Gimmi GmbHSURGISTAR — SURGISTAR, INC.Swann Morton Ltd. — SWANN-MORTON LIMITEDSwann Morton Ltd. — SWANN-MORTON LIMITEDMedicon — Medicon eG. Chirurgiemechaniker-GenossenschaftScalpel — Treace Medical Concepts, Inc.CUTFIX — Aesculap AGSURGISTAR — SURGISTAR, INC.Swann Morton Ltd. — SWANN-MORTON LIMITEDSwann Morton Ltd. — SWANN-MORTON LIMITEDSURGISTAR — SURGISTAR, INC.Integra® Miltex® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONSURGISTAR — SURGISTAR, INC.FEATHER DISPOSABLE SCALPEL SAFESHIELD SCALPEL — FEATHER SAFETY RAZOR CO., LTD.Surgistar — SURGISTAR, INC.SANDEL — Ansell Sandel Medical Solutions LLCSwann Morton Ltd. — SWANN-MORTON LIMITEDSwann Morton Ltd. — SWANN-MORTON LIMITEDSURGISTAR — SURGISTAR, INC.Swann Morton Ltd. — SWANN-MORTON LIMITED

Recent recalls

DateFirmReason
2017-11-06Southmedic, Inc.Scalpels lot contains non-sterile products labeled as sterile.
2015-08-18Zien Medical Technologies, IncCracks were discovered in the PET tray of a small population of sterile product. These cracks create a risk of loss of sterile barrier for the product. Sampling
2013-02-07Myco Medical Supplies IncPouch labeling/printing errors and defective packaging resulting in possible compromised sterility.
2010-09-03Southmedic, Inc.Scalpels labeled as sterile have the potential to be unsealed and therefore not sterile.
2010-09-03Southmedic, Inc.Scalpels labeled as sterile have the potential to be unsealed and therefore not sterile.
2010-09-03Southmedic, Inc.Scalpels labeled as sterile have the potential to be unsealed and therefore not sterile.

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