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Camera, Surgical And Accessories
FDA product code KQM · Class 1 · General, Plastic Surgery
1,090
Registered devices
783
Adverse events
14
Recalls
18
510(k) clearances
Devices with this code
EndoVue — Nds Surgical Imaging LLCOptik View — LINDEN GROUP CORPORATION, THENA — Conmed CorporationSONY — SONY CORPORATIONfutudent — Novocam Medical Innovations OyOptik View — LINDEN GROUP CORPORATION, THECS 7600 Hygienic Sheath — CARESTREAM HEALTH, INC.TIDISHIELD — TIDI PRODUCTS, LLCHygienic Sleeves Ear Cones — CARESTREAM HEALTH, INC.CONMED — Conmed CorporationILO — ILO electronic GmbHEzCam — Dentall co.,Ltd.Beacon — Shenzhen Beacon Display Technology Co., Ltd.ImageCam 3 (Adapt.: CSO) — OCULUS Optikgeräte Gesellschaft mit beschränkter HaftungImageCam 3 (Adapt.: Topcon SL-2E) — OCULUS Optikgeräte Gesellschaft mit beschränkter HaftungBeacon — Shenzhen Beacon Display Technology Co., Ltd.EndoVue — Nds Surgical Imaging LLCAED ENDOPRO® PRIMO SERIES CAMERA — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.Endovue — Nds Surgical Imaging LLCRadiance — Nds Surgical Imaging LLCNDS — PENTAX OF AMERICA, INC.N/A — PENTAX OF AMERICA, INC.Accu-Beam — TRANSAMERICAN TECHNOLOGIES INTERNATIONALLifeVue — Nds Surgical Imaging LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-05-23 | Steris Corporation | This is a sub-recall of event RES 96885. The supplier identified that during their manufacturing process for a limited batch of MNA-6x0 (adapter) components the |
| 2024-06-04 | Baxter Healthcare Corporation | Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction due to customer reports of thermal skin injuries when using the iLED 7 surgical lig |
| 2023-12-20 | Barco N.V. | Barco became aware of a problem with I2C cables in the manufacturing process of a limited batch of MDSC-85xx NXF products. The functionality of the built-in MN |
| 2015-05-28 | Barco Inc. | User settings were no longer on the monitor's memory after these systems were powered off and back on. |
| 2015-03-05 | Sony Latin America | Monitor has either not turned on or has lost image during clinical use. |
| 2013-03-18 | Linvatec Corp. dba ConMed Linvatec | The VP1600 HD Still Capture Image System is recalled due to an anomaly between the software code in the VP1600 console and the communications interface for vari |
| 2010-10-25 | Mako Surgical Corporation | MAKO Surgical Corporation recalled ONE infra-red camera MAKO PN 204854 which was a component of their RIO Robotic Arm Interactive Orthopedic System with SSN P7- |
| 2010-09-17 | Linvatec Corp. dba ConMed Linvatec | If the VHM Arm is left in the locked position, the gas spring can lose pressure and releasing the lock can result in a sudden downward movement. |
| 2010-02-23 | Linvatec Corp. dba ConMed Linvatec | ConMed Linvatec, Endoscopy Division, dba. ConMed Linvatec, Largo, Florida is recalling five products: (1.) Video Cart Premium 120 VAC (VP6501), (2.) Video Cart |
| 2010-02-23 | Linvatec Corp. dba ConMed Linvatec | ConMed Linvatec, Endoscopy Division, dba. ConMed Linvatec, Largo, Florida is recalling five products: (1.) Video Cart Premium 120 VAC (VP6501), (2.) Video Cart |
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