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U.S. Department of Health and Human Services

510(K) Premarket Notification
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lyher® urine multi-drug test kit(cup), lyher® urine multi-drug test kit(cassette), lyher® urine multi-drug test kit(dipcard) Hangzhou Laihe Biotech Co., Ltd. k232597 01/09/2024
encor enspire™breast biopsy system (e4115, e4230); encor™ breast biopsy driver (drencor); encor™ mri breast biopsy driver (drencormr); encor™ breast biopsy driver probes (ecp017g, ecp017gv, ecp0110g, ecp0110gv, ecp0112g, ecp0112gv); encor™ mri breast biopsy probes (ecpmr017g, ecpmr0110g, ecpmr0110g SenoRx, Inc. k233220 10/27/2023
millipede 088 access catheter Perfuze Ltd. k233648 12/14/2023
mjolnir pro. (multi–electrode plasma) Shenzhen Leaflife Technology Co., Ltd k233760 02/20/2024
biofeedback nerve and muscle stimulator Shenzhen Konmed Technology Co.,Ltd. k220161 07/20/2022
violet nitrile powder-free patient examination glove, non sterile One Glove Industrial SDN BHD k220429 05/13/2022
angioguard xp emboli capture guidewire, angioguard rx emboli capture guidewire Cordis Corporation k220654 04/06/2022
led curing light Foshan COXO Medical Instrument Co., Ltd. k220826 12/08/2022
actera™ hip system Conformis Inc. k221104 08/04/2022
acuson juniper diagnostic ultrasound system and acuson juniper select diagnostic ultrasound system Siemens Medical Solutions USA, Inc. k221190 08/16/2022

*   The maximum 500 records meeting your search criteria returned. Please narrow your search.
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