Home › Device types › MDM
Instrument, Manual, Surgical, General Use
FDA product code MDM · Class 1 · General, Plastic Surgery
0
Registered devices
4,185
Adverse events
77
Recalls
44
510(k) clearances
Devices with this code
Comedone Extractor — SONTEC INSTRUMENTS, INC.SteriBest — Mastel Surgical Inc.Arthrex® — ARTHREX, INC.Integra® Jarit® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONN/A — GEORGE TIEMANN & CO.RZ Medizintechnik GmbH — RZ-Medizintechnik GmbHBatrik Green Padlock Security Tags — Batrik Medical Manufacturing IncELMED — ELMED INCORPORATEDMSI — Modern Surgical Instruments LLCFENTEX — FENTEX medical GmbHTSI — TEDAN SURGICAL INNOVATIONS, L.L.C.MSI Precision Specialty Instruments — Med Saver, Inc.HU-FRIEDY — HU-FRIEDY MFG. CO., LLCMarina Medical — MARINA MEDICAL INSTRUMENTS, INC.Mastel Surgical — INTERNATIONAL SURGICAL PRODUCTS INCPRINCETON — Princeton Medical Group, Inc.Integra® Jarit® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONSklar — SKLAR CORPORATIONAmerican Medicals — American MedicalsTrigon — NVision Biomedical Technologies, Inc.Power Dental USA — Power Dental U.S.A. Inc.Instrument Protectors — Batrik Medical Manufacturing IncNovo Surgical Inc. — NOVO SURGICAL, INC.American Medicals — American Medicals
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-09-07 | Healthmark Industries Co., Inc. | Labeling not compliant with 21 CFR 801 and steam sterilization IFU has been updated. |
| 2025-03-03 | MEDLINE INDUSTRIES, LP - Northfield | There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. |
| 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. |
| 2024-01-31 | Technicality Inc. | The Ring on the Trump Needle Guide can detach when excessive pressure is applied. |
| 2024-01-30 | Applied Medical Resources Corp | Their is the potential that Universal Clip applier may not load clip after the trigger is actuated. |
| 2024-01-30 | Applied Medical Resources Corp | Their is the potential that Universal Clip applier may not load clip after the trigger is actuated. |
| 2022-11-17 | MEDLINE INDUSTRIES, LP - Northfield | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. |
| 2022-11-08 | ENDO Pharmaceuticals Solutions, Inc. | No expiration dates printed on the packaging |
| 2022-11-02 | Arthrex, Inc. | The devices may be packaged with the wrong reamer size. |
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