Camera, Surgical And Accessories
FDA product code KQM · Class I (low risk) · 21 CFR 878.4160 · General, Plastic Surgery
18510(k) clearances
0PMA approvals
14recalls
Manufacturers
- Medline Industries, LP 3
- Technology For Imaging, Inc. 2
- M.P. Video, Inc. 2
- Sony Medical Electronics Co. 2
- Janin Group, Inc. 1
- The Anspach Effort, Inc. 1
- Hydro-Med Products, Inc. 1
- Video-Medical Devices, Ltd. 1
- Kamiya Tsusan Kaisha, Ltd. 1
- Vistek Corp. 1
- Concept, Inc. 1
- Sony Corp. of America 1
- Jedmed Instrument Co. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K900160 | Adaptor: Kaps Cine to Moeller BeamsplitterKQM · Traditional | Jedmed Instrument Co. | 01/24/1990SE |
| K890826 | Sony Video Graphic Printer UP-850KQM · Traditional | Sony Corp. of America | 03/14/1989SE |
| K885042 | Sony Trinitron Color Video Monitor PVM-1343MDKQM · Traditional | Sony Medical Electronics Co. | 12/22/1988SE |
| K882958 | Sony Video Printers, Up SeriesKQM · Traditional | Sony Medical Electronics Co. | 08/04/1988SE |
| K882924 | Medicam MC-7 and RP-7 Surgical CamerasKQM · Traditional | M.P. Video, Inc. | 07/26/1988SE |
| K873419 | Video Printer SystemKQM · Traditional | Technology For Imaging, Inc. | 11/02/1987SE |
| K871595 | Surgical Camera AccessoriesKQM · Traditional | M.P. Video, Inc. | 05/07/1987SE |
| K863800 | Endoscopic Video CameraKQM · Traditional | Technology For Imaging, Inc. | 10/14/1986SE |
| K860904 | Video Printer, Model 3200KQM · Traditional | Medline Industries, Inc. | 03/28/1986SE |
| K850749 | Concept Video Imaging SystemKQM · Traditional | Concept, Inc. | 05/20/1985SE |
| K843806 | VIS-1000 Video SystemKQM · Traditional | Vistek Corp. | 12/12/1984SE |
| K843295 | Med. Dynamics High Resolution Solid STKQM · Traditional | Medline Industries, Inc. | 12/12/1984SE |
| K843294 | Med. Dynamics Satican Video Camera 5410KQM · Traditional | Medline Industries, Inc. | 12/12/1984SE |
| K832342 | Endoscopic Camera TV W/AudioKQM · Traditional | Kamiya Tsusan Kaisha, Ltd. | 09/12/1983SE |
| K820626 | Opti-DiscKQM · Traditional | Video-Medical Devices, Ltd. | 04/09/1982SE |
| K812405 | Sterile TV Camera & Cord CoverKQM · Traditional | Hydro-Med Products, Inc. | 10/20/1981SE |
| K811717 | Gator DrapesKQM · Traditional | The Anspach Effort, Inc. | 07/20/1981SE |
| K810512 | Mediseal Camera CoversKQM · Traditional | Janin Group, Inc. | 03/13/1981SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1361-2026 Class II | Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-HThis is a sub-recall of event RES 96885. The supplier identified that during their manufacturing process for… | Steris Corporation | 05/23/2025Open, Classified |
| Z-2313-2024 Class II | VidiaPort carrying arm, mount for auxiliary products, model numbers: a) 4028110 (Ceiling…Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction due to customer reports of… | Baxter Healthcare Corporation | 06/04/2024Open, Classified |
| Z-0979-2024 Class II | Barco MDSC-8527 NXF, Part Number K9352421Barco became aware of a problem with I2C cables in the manufacturing process of a limited batch of MDSC-85xx… | Barco N.V. | 12/20/2023Open, Classified |
| Z-0227-2016 Class II | Surgical Display, Model No. MDSC-2224 (24 inch), Model No. MDSC-2226 (26 inch) and Model…User settings were no longer on the monitor's memory after these systems were powered off and back on. | Barco Inc. | 05/28/2015Terminated |
| Z-1514-2015 Class II | Sony Medical Monitor LMD-1951MD 19 inchMonitor has either not turned on or has lost image during clinical use. | Sony Latin America | 03/05/2015Terminated |
| Z-1340-2013 Class II | Ref: VP1600 HD Still Capture System ConMed Linvatec . Captures, stores and transfers…The VP1600 HD Still Capture Image System is recalled due to an anomaly between the software code in the… | Linvatec Corp. dba ConMed Linvatec | 03/18/2013Terminated |
| Z-2232-2011 | MAKO PN 204588 Camera 204588 Label With Camera Stand Number ***PN 200294 SN CAM XXX…MAKO Surgical Corporation recalled ONE infra-red camera MAKO PN 204854 which was a component of their RIO… | Mako Surgical Corporation | 10/25/2010Terminated |
| Z-1893-2011 | ***REF VP6528***Qty 1***Articulating Arm, Secondary Flat Panel***RX Only***See…If the VHM Arm is left in the locked position, the gas spring can lose pressure and releasing the lock can… | Linvatec Corp. dba ConMed Linvatec | 09/17/2010Terminated |
| Z-0851-2011 | Video Cart, 120 VAC product labeling is as follows: REF, VP8500, QTY1, Video Cart, 120…ConMed Linvatec, Endoscopy Division, dba. ConMed Linvatec, Largo, Florida is recalling five products: (1.)… | Linvatec Corp. dba ConMed Linvatec | 02/23/2010Terminated |
| Z-0850-2011 | Video Cart Articulating Arm product labeling is as follows: REF, VP6504, QTY1, Video…ConMed Linvatec, Endoscopy Division, dba. ConMed Linvatec, Largo, Florida is recalling five products: (1.)… | Linvatec Corp. dba ConMed Linvatec | 02/23/2010Terminated |
| Z-0849-2011 | Video Cart Multi-Specialty product labeling is as follows: REF, VP6502, QTY1, Video Cart…ConMed Linvatec, Endoscopy Division, dba. ConMed Linvatec, Largo, Florida is recalling five products: (1.)… | Linvatec Corp. dba ConMed Linvatec | 02/23/2010Terminated |
| Z-0848-2011 | Video Cart, Premium 120V product labeling is as follows: REF, VP6501, QTY1, Video Cart…ConMed Linvatec, Endoscopy Division, dba. ConMed Linvatec, Largo, Florida is recalling five products: (1.)… | Linvatec Corp. dba ConMed Linvatec | 02/23/2010Terminated |
| Z-0847-2011 | The Power Cord Reel is labeled as follows: REF, VP6547, QTY1, POWER CORD REEL, Rx ONLY.…ConMed Linvatec, Endoscopy Division, dba. ConMed Linvatec, Largo, Florida is recalling five products: (1.)… | Linvatec Corp. dba ConMed Linvatec | 02/23/2010Terminated |
| Z-2458-2008 | ConMed Linvatec Surgical Video Cart, Catalogue Number: VP8500The recall was initiated because ConMed Linvatec has determined there is a possibility the wheel caster(s)… | Conmed Linvatec Endoscopy Division | 10/31/2007Terminated |