328 results
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38ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LED SPA
FDA registration
LED SPA·1 product·🇮🇹 Italy
SURTRON
FDA UDI
LED SPA·08033638321102·SURTRON device model 80D is an ElectroSurgical ...
SURTRON
FDA UDI
LED SPA·08033638321140·SURTRON device model 200 is an ElectroSurgical ...
SURTRON
FDA UDI
LED SPA·08033638321164·SURTRON device model 160HF is an ElectroSurgica...
SURTRON
FDA UDI
LED SPA·08033638321133·SURTRON device model 160 is an ElectroSurgical ...
SURTRON
FDA UDI
LED SPA·08033638321911·SURTRON device model 400HP is an ElectroSurgica...
FLEXIBLE BAYONET DRILL Ø 3.2 MM SHAFT L 56
FDA Adverse Event
Malfunction
·HPF S.P.A.·Product code LXH·June 16, 2017
ILET BIONIC PANCREAS
FDA Adverse Event
Malfunction
·BETA BIONICS INC.·Product code QFG·November 13, 2025
Quasar MD is an infrared LED lamp that is labeled in part: "***QUASAR MD***Bringing the Spa Home***Radiant and Youthful Skin***QUASAR MD INCLUDES***QUASAR MD***USER MANUAL***12 VOLT POWER SUPPLY***1 OZ PURE SILK SERUM***Made in the USA.***Five year warranty***" The product emits energy in the near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature. This device may be used to provide temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm. This device may temporarily increase local blood circulation, and may be used to promote relaxation of the muscle tissue.
FDA Enforcement
Class II
·Terminated·Quasar Bio-Tech, Inc. dba Silver Bay LLC·December 19, 2012
LIGHTSCOPE RECTO MAXI LED AND BULB STERILE
FDA Adverse Event
Malfunction
·THD SPA·Product code FER·November 25, 2020
MPACT FLEXIBLE BAYONET DRILL Ø 3.2 MM SHAFT L 56
FDA Adverse Event
Malfunction
·HPF S.P.A.·Product code LXH·June 28, 2017
RADIOFREQUENCY FACIAL TREATMENT
FDA Adverse Event
Injury
·UNK·Product code GEI·July 6, 2022
SPACEOAR VUE SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code OVB·September 20, 2024
NV GXL LNR, +5 LAT 32MM ID, GROUP 3 CUPS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·October 3, 2023
OXYLIGHT
FDA Adverse Event
Injury
·RAJA TRADING COMPANY, INC.·Product code GEX·December 10, 2020
DEKA SMARTXIDE DOT
FDA Adverse Event
Injury
·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·August 7, 2019
DEKA SMARTXIDE DOT
FDA Adverse Event
Injury
·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·August 7, 2019
IONIXLIGHT (OR OXYLIGHT)
FDA Adverse Event
Injury
·RAJA TRADING COMPANY, INC.·Product code NFO·October 6, 2020
Quasar MD is an infrared LED lamp that is labeled in part: "***QUASAR MD***Bringing the Spa Home***Radiant and Youthful Skin***QUASAR MD INCLUDES***QUASAR MD***USER MANUAL***12 VOLT POWER SUPPLY***1 OZ PURE SILK SERUM***Made in the USA.***Five year warranty***" The product emits energy in the near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature. This device may be used to provide temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm. This device may temporarily increase local blood circulation, and may be used to promote relaxation of the muscle tissue.
FDA Recall
Terminated
·Quasar Bio-Tech, Inc. dba Silver Bay LLC·Product code ILY·October 25, 2012
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·May 31, 2022