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Scalpel, One-Piece
FDA product code GDX · Class 1 · General, Plastic Surgery
657
Registered devices
133
Adverse events
6
Recalls
26
510(k) clearances
Devices with this code
SURGISTAR — SURGISTAR, INC.SANDEL — Ansell Sandel Medical Solutions LLCSwann Morton Ltd. — SWANN-MORTON LIMITEDBard-Parker ® Disposable Scalpels — ASPEN SURGICAL PRODUCTS, INC.McKesson — MCKESSON MEDICAL-SURGICAL INC.index Asurity — Sterilance Medical (Suzhou) Inc.SURGISTAR — SURGISTAR, INC.Swann Morton Ltd. — SWANN-MORTON LIMITEDKendall — Cardinal Health 200, LLCAESCULAP — Aesculap AGSklar® — SKLAR CORPORATIONBard-Parker ® Disposable Scalpels — ASPEN SURGICAL PRODUCTS, INC.index Asurity — Sterilance Medical (Suzhou) Inc.SURGISTAR — SURGISTAR, INC.Medicon — Medicon eG. Chirurgiemechaniker-GenossenschaftSURGISTAR — SURGISTAR, INC.Devon — Cardinal Health 200, LLCSklar® — SKLAR CORPORATIONAESCULAP — Aesculap AGMedline — MEDLINE INDUSTRIES, INC.Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.SURGISTAR, INC. — SURGISTAR, INC.SURGISTAR — SURGISTAR, INC.AESCULAP — Aesculap AG
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-11-06 | Southmedic, Inc. | Scalpels lot contains non-sterile products labeled as sterile. |
| 2015-08-18 | Zien Medical Technologies, Inc | Cracks 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 |
| 2013-02-07 | Myco Medical Supplies Inc | Pouch labeling/printing errors and defective packaging resulting in possible compromised sterility. |
| 2010-09-03 | Southmedic, Inc. | Scalpels labeled as sterile have the potential to be unsealed and therefore not sterile. |
| 2010-09-03 | Southmedic, Inc. | Scalpels labeled as sterile have the potential to be unsealed and therefore not sterile. |
| 2010-09-03 | Southmedic, Inc. | Scalpels labeled as sterile have the potential to be unsealed and therefore not sterile. |
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