Home › Device types › FST
Light, Surgical, Fiberoptic
FDA product code FST · Class 2 · General, Plastic Surgery
482
Registered devices
312
Adverse events
12
Recalls
45
510(k) clearances
Devices with this code
MAXX LUXX LED — AvanteNICO Myriad — NICO CORPORATIONCONMED — Conmed CorporationFiberoptic Cable — BLACK & BLACK SURGICAL, INC.Vu-E — Medical Illumination International Inc.Vu — Medical Illumination International Inc.NA — Medos International SàrlMAXX LUXX LED — AvanteHeadlight Cable — BLACK & BLACK SURGICAL, INC.SYSTEM TWO LED — Medical Illumination International Inc.Vu — Medical Illumination International Inc.Fiber Optic Light Guide — ESCALON MEDICAL CORP.MAXX LUXX LED — AvanteVistor PRO LED — Medical Illumination International Inc.VistOR MS LED — Medical Illumination International Inc.SYSTEM TWO LED — Medical Illumination International Inc.Snowden-Pencer — STERIS CORPORATIONIntegra® — INTEGRA LIFESCIENCES (IRELAND) LIMITEDSYSTEM TWO LED — Medical Illumination International Inc.Integra® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONOMNI — SANTA BARBARA IMAGING SYSTEMS, INC.Spetzler™ Lighted Suction Tube, 5 French, 120mm long — KATALYST SURGICAL LLCVistOR MS LED — Medical Illumination International Inc.Spetzler Lighted Suction Tube, 7 French, 140mm, Storz Connector — KATALYST SURGICAL LLC
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 |
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.