26 results
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51ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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X-Laser Laser Light Show projector models Aurora, Caliente Aurora, PSX-400, Mobile Beat Max, Mobile Beat Max MKII, X-Beam, Hawk 500 High-power laser light show projector.
FDA Recall
Terminated
·X-Laser Llc·Product code REA·July 24, 2017
X-Laser Laser Light Show projector models Aurora, Caliente Aurora, PSX-400, Mobile Beat Max, Mobile Beat Max MKII, X-Beam, Hawk 500 High-power laser light show projector.
FDA Enforcement
Class II
·Terminated·X-Laser Llc·September 20, 2017
Biomet Vanguard(TM) DCM PS Plus 16mm x 63/67mm Tibial Bearing (REF. 183726), ARCOM UHMWPE, sterile, Biomet Orthopedics, Inc., Warsaw, IN. A knee prosthesis intended for single use implantation to replace the articular portions of the knee joint.
FDA Recall
Terminated
·Biomet, Inc.·Product code JWH·September 22, 2008
Summus Medical Laser, LLC
FDA registration
Summus Medical Laser, LLC·1 product·🇺🇸 United States
CUREWAVE LASERS LLC
FDA registration
CUREWAVE LASERS LLC·1 product·🇺🇸 United States
SWL, Silver, labeled, US
FDA UDI
STELLAR LASERS LLC·B3926001100·The Scalar Wave Laser System is indicated for t...
Probe, 780 IR, labeled, US
FDA UDI
STELLAR LASERS LLC·B3926001300·The Scalar Wave Laser System is indicated for t...
Probe, 650 Red, labeled, US
FDA UDI
STELLAR LASERS LLC·B3926001200·The Scalar Wave Laser System is indicated for t...
SWL, Violet, labeled, US
FDA UDI
STELLAR LASERS LLC·B3926001000·The Scalar Wave Laser System is indicated for t...
Probe, 405 Blue-Vio, labeled, US
FDA UDI
STELLAR LASERS LLC·B3926001400·The Scalar Wave Laser System is indicated for t...
Platinum
FDA UDI
SUMMUS MEDICAL LASER, LLC·B679SLP40·Light weight (~3 Kg.) and portable therapeutic ...
Platinum
FDA UDI
SUMMUS MEDICAL LASER, LLC·B679KP10·Therapeutic medical laser device indicated for ...
Platinum
FDA UDI
SUMMUS MEDICAL LASER, LLC·B679SLP10·Light weight (~3 Kg.) and portable therapeutic ...
Platinum
FDA UDI
SUMMUS MEDICAL LASER, LLC·B679SLH10·Light weight (~2 Kg.) and portable therapeutic ...
Platinum
FDA UDI
SUMMUS MEDICAL LASER, LLC·B679KP40·Therapeutic medical laser device indicated for ...
Platinum
FDA UDI
SUMMUS MEDICAL LASER, LLC·B679SLP4H0·Light weight (~2.5 Kg.) and portable therapeuti...
Platinum
FDA UDI
SUMMUS MEDICAL LASER, LLC·B679SLP30·Light weight (~2 Kg.) and portable therapeutic ...
Platinum
FDA UDI
SUMMUS MEDICAL LASER, LLC·B679KP30·Therapeutic medical laser device indicated for ...
Platinum
FDA UDI
SUMMUS MEDICAL LASER, LLC·B679KGH10·Therapeutic medical laser device indicated for ...
PINNACLE 3
FDA Adverse Event
Malfunction
·ADAC LABORATORIES·Product code IYE·March 7, 2000