Panels › General, Plastic Surgery › Product code FST · Class 2
Light, Surgical, Fiberoptic
Regulation 878.4580
0510(k)s in 12 months (45 all time)
0recalls in 12 months (12 all time)
10recalls that name a 510(k)
Top companies in FST
| Company | 510(k)s | Recalls |
|---|---|---|
| Integra LifeSciences Corp. | 0 | 9 |
| Advanced Surgical Products, Inc. | 5 | 0 |
| Cuda Products Co. | 3 | 0 |
| STERIS Corporation | 2 | 1 |
| Gulf Medical Fiberoptics | 1 | 1 |
| Invuity, Inc. | 2 | 0 |
| Medical Illumination International, Inc. | 2 | 0 |
| Sensormed | 2 | 0 |
| Bfw, Inc. | 1 | 0 |
| Cogent Light Technologies, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 7, 2015 | Steris Corporation Harmony vLED Surgical Lighting System, one unit packaged per box
The Harmony vLED Surgical Lighting System is a variable pattern, variable intensity surgical lighting fixture designed to provide visib Terminated |
FST | K100395 |
| Jul 18, 2012 | Gulf Fiberoptics, Inc. GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink.
GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink is used to transmit light. Terminated |
FST | None listed |
| Jan 20, 2012 | Gulf Medical Fiberoptics, Inc. Surgical Headlight labeled in part *Gulf Medical Fiberoptics*OLDSMAR, FLORIDA U.S.A.* Model Numbers: GMF-H001, GMF-H100, GMF-H101, GMF-H102, GMF-H103, GMF-H104, GMF-H105, and GMF-H106. The Surgical He Terminated |
FST | K061690 |
| Jan 11, 2012 | Integra LifeSciences Corp. UltraLite Headlight module-grey
Model: 001328
Product Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity light source for surgical site illumination. Terminated |
FST | K864380 |
| Jan 11, 2012 | Integra LifeSciences Corp. Mark II Headlight module-black with short linkage
Model: 001380LXSL
Product Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity light source for surgi Terminated |
FST | K864380 |
| Jan 11, 2012 | Integra LifeSciences Corp. Mark II Headlight module-black
Model: 001380LX
Product Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity light source for surgical site illumination. Terminated |
FST | None listed |
| Jan 11, 2012 | Integra LifeSciences Corp. Luxtec UltraLite Headlight System sweatband with short linkage
Model: AXI385BIFSL
Product Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity light sou Terminated |
FST | K864380 |
| Jan 11, 2012 | Integra LifeSciences Corp. Luxtec UltraLite Headlight System sweatband
Model: AXI385BIF
Product Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity light source for surgical site Terminated |
FST | K864380 |
| Jan 11, 2012 | Integra LifeSciences Corp. Luxtec UltraLite Headlight System with short linkage
Model: AX 1375BIFSL
Product Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity light source for s Terminated |
FST | K864380 |
| Jan 11, 2012 | Integra LifeSciences Corp. Luxtec UltraLite Headlight System Headband
Model: AXI375BIF
Product Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity light source for surgical site Terminated |
FST | K864380 |
| Jan 11, 2012 | Integra LifeSciences Corp. Luxtec UltraLite Headlight System with 9ft premium bifurcated cable
Model: AX2100BIF
Product Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity light Terminated |
FST | K864380 |
| Jan 11, 2012 | Integra LifeSciences Corp. Luxtec UltraLite Pro Headlight with 9ft bifurcated cable
Model: AX2000BIF
Product Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity light source for s Terminated |
FST | K864380 |
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