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U.S. Department of Health and Human Services

510(K) Premarket Notification
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syngo.via rt image suite Siemens Medical Solutions USA, Inc. k201444 08/13/2020
renew xr handpiece, renew xr handpiece 34cm, renew xr handpiece 42cm, renew xr handpiece 25cm, ratcheted renew xr handpiece 34cm Microline Surgical, Inc. k201884 10/21/2020
the aio solution 3.0 Orfit Industries NV k202068 08/14/2020
largan db / db color (ocufilcon d) daily wear soft (hydrophilic) contact lens, largan db / db color (ocufilcon d) daily wear soft (hydrophilic) contact lens for astigma, largan db / db color (ocufilcon d) daily wear soft (hydrophilic) contact lens for presbyo Largan Medical Co., Ltd. k202129 04/01/2021
instylla delivery kit Instylla, Inc. k202544 01/07/2021
vycor medical viewsite brain access system (“vbas”) and vbas with alignment clip (“vbas ac”) (together the “vbas family”) Vycor Medical INC. k202694 01/14/2021
infrared thermometer models: dt-8806s, dt-8807s Shenzhen Everbest Machinery Industry Co., LTD k203170 04/16/2021
heartflow analysis HeartFlow, Inc. k203329 01/08/2021
disposable medical face mask Guangzhou Mei Yi Kang Medical Technology CO., LTD. k203646 04/22/2021
polaris spinal system Zimmer Biomet Spine, Inc k210275 04/02/2021

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