Home › Device types › GDZ
Handle, Scalpel
FDA product code GDZ · Class 1 · General, Plastic Surgery
1,793
Registered devices
131
Adverse events
13
Recalls
16
510(k) clearances
Devices with this code
comknife® — Beijing Bohai Kangyuan Medical Devices Co., Ltd.comknife® — Beijing Bohai Kangyuan Medical Devices Co., Ltd.BR Surgical, LLC — BR Surgical, LLCPDT, Inc. — PDT, INC.Integra® Miltex® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONAdler Instrument Company — Adler, Inc.Salvin Dental Specialties — SALVIN DENTAL SPECIALTIES, LLCSymmetry Surgical — ASPEN SURGICAL PRODUCTS, INC.Life Instruments — Life Instrument CorporationRZ Medizintechnik GmbH — RZ-Medizintechnik GmbHSymmetry Surgical — ASPEN SURGICAL PRODUCTS, INC.Salvin 6 Way Adjustable Angled Scalpel Handle — SALVIN DENTAL SPECIALTIES, LLCSalvin Dental Specialties — SALVIN DENTAL SPECIALTIES, LLCSurtex — SURTEX INSTRUMENTS LTD.Salvin Safety Ejector Scalpel Handle — SALVIN DENTAL SPECIALTIES, LLCcomknife® — Beijing Bohai Kangyuan Medical Devices Co., Ltd.Sklar® — SKLAR CORPORATIONcomknife® — Beijing Bohai Kangyuan Medical Devices Co., Ltd.FuzeFix Large — FUSION ORTHOPEDICS, LLCGen2 — SURGIX MEDICAL LLCMILLENNIUM — Avalign Technologies, Inc.AESCULAP — Aesculap AGcomknife® — Beijing Bohai Kangyuan Medical Devices Co., Ltd.Millennium — Avalign Technologies, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-12-03 | Sklar Instruments | Reports of various packaging issues that may result in a breach of the sterile barrier. |
| 2024-02-23 | MEDLINE INDUSTRIES, LP - Northfield | Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. |
| 2022-09-02 | Steris Corporation | The scalpel holder may separate from the handle for certain lots. If the tip falls off during use, it could fall into the patient's mouth which may result in a |
| 2016-03-11 | Integra York PA, Inc | One lot of self-lock chisel blade handles have a wider slot that holds the chisel blade that may result in the inability to firmly secure the blade in the handl |
| 2014-09-26 | Teleflex Medical | The knife handles slot depth is out of specification, so blades may not fit on the handles properly. |
| 2014-06-24 | Bard Access Systems | Potential for inadvertent scalpel stick injury involving the safety scalpel. |
| 2013-11-12 | Ansell Sandel Medical Industries LLC | Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the |
| 2013-11-12 | Ansell Sandel Medical Industries LLC | Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the |
| 2013-11-12 | Ansell Sandel Medical Industries LLC | Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the |
| 2013-11-12 | Ansell Sandel Medical Industries LLC | Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.