FDA Device Intelligence
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Lamp, Surgical

FDA product code FTD · Class 2 · General, Plastic Surgery

2,340
Registered devices
1,238
Adverse events
49
Recalls
29
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2024-06-04Baxter Healthcare CorporationBaxter Healthcare Corporation is issuing an Urgent Medical Device Correction due to customer reports of thermal skin injuries when using the iLED 7 surgical lig
2024-06-04Baxter Healthcare CorporationBaxter Healthcare Corporation is issuing an Urgent Medical Device Correction due to customer reports of thermal skin injuries when using the iLED 7 surgical lig
2023-11-08Getinge Usa Sales IncA potential for a light system to fall in the operating room.
2023-11-08Getinge Usa Sales IncA potential for a light system to fall in the operating room.
2023-11-08Getinge Usa Sales IncA potential for a light system to fall in the operating room.
2023-11-08Getinge Usa Sales IncA potential for a light system to fall in the operating room.
2023-11-08Getinge Usa Sales IncA potential for a light system to fall in the operating room.
2023-11-08Getinge Usa Sales IncA potential for a light system to fall in the operating room.
2019-05-28Maquet Cardiovascular Us Sales, LlcPotential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during
2019-05-28Maquet Cardiovascular Us Sales, LlcPotential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.