Home › Device types › FST
Light, Surgical, Fiberoptic
FDA product code FST · Class 2 · General, Plastic Surgery
493
Registered devices
313
Adverse events
12
Recalls
45
510(k) clearances
Devices with this code
Integra® — INTEGRA LIFESCIENCES (IRELAND) LIMITEDVISION LED — AvanteIntegra® — INTEGRA LIFESCIENCES (IRELAND) LIMITEDNA — Medos International SàrlVu — Medical Illumination International Inc.SYSTEM TWO LED — Medical Illumination International Inc.Vu — Medical Illumination International Inc.Vu — Medical Illumination International Inc.Vu — Medical Illumination International Inc.SYSTEM TWO LED — Medical Illumination International Inc.Sunoptic Technologies — SUNOPTIC TECHNOLOGIES LLCMI Product Line — Medical Illumination International Inc.VS3 Bifurcated Light Cable for MMS — VISIONSENSE LTD.VistOR MS LED — Medical Illumination International Inc.SYSTEM TWO LED — Medical Illumination International Inc.Integra® — INTEGRA LIFESCIENCES (IRELAND) LIMITEDMaXcess — Nuvasive, Inc.Arthrex® — ARTHREX, INC.Integra® — INTEGRA LIFESCIENCES (IRELAND) LIMITEDMAXX LUXX LED — AvanteMI Product Line — Medical Illumination International Inc.PILLING — TELEFLEX INCORPORATEDSnowden-Pencer — STERIS CORPORATIONInvuity® Fiber Optic Cable — INVUITY, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2014-11-26 | Steris Corporation | STERIS has learned that groups of LED lights (modules) contained within the vLED light head may illuminate inconsistently. |
| 2012-04-09 | Gulf Fiberoptics, Inc. | The GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink falls outside of the firm's 510k due to light transmitting fiber material difference. |
| 2011-10-10 | Integra LifeSciences Corp. | Headlight assembly (module) may become loose and separate from the headband assembly |
| 2011-10-10 | Integra LifeSciences Corp. | Headlight assembly (module) may become loose and separate from the headband assembly |
| 2011-10-10 | Integra LifeSciences Corp. | Headlight assembly (module) may become loose and separate from the headband assembly |
| 2011-10-10 | Integra LifeSciences Corp. | Headlight assembly (module) may become loose and separate from the headband assembly |
| 2011-10-10 | Integra LifeSciences Corp. | Headlight assembly (module) may become loose and separate from the headband assembly |
| 2011-10-10 | Integra LifeSciences Corp. | Headlight assembly (module) may become loose and separate from the headband assembly |
| 2011-10-10 | Integra LifeSciences Corp. | Headlight assembly (module) may become loose and separate from the headband assembly |
| 2011-10-10 | Integra LifeSciences Corp. | Headlight assembly (module) may become loose and separate from the headband assembly |
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