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U.S. Department of Health and Human Services

510(K) Premarket Notification
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510(K)
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powder free black nitrile examination gloves, non-sterile, tested for use with chemotherapy drugs and fentanyl resistant WRP Asia Pacific SDN BHD k210330 03/04/2022
ultrasonic surgical & electrosurgical generator Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. k210488 10/25/2021
sublime radial access 018 rx dilatation catheter Creagh Medical Ltd. (a wholly owned subsidiary of Surmodics, k211044 06/16/2021
magnetos easypack putty Kuros Biosciences B.V. k211201 09/02/2021
3° anterior cervical plating system, reliant anterior cervical plating system, unity lumbosacral fixation system, hallmark anterior plate system, newbridge laminoplasty fixation system, cetra anterior cervical plate system Orthofix US LLC k211712 02/11/2022
catalyst r1 reverse shoulder system Catalyst OrthoScience, Inc. k211991 07/28/2021
terragene bionova scbi (bt96), terragene bionova reader incubators (ic10/20frlcd, mini-bio), terragene chemdye (cd42), terragene cintape (ct40) Plasmapp Co., Ltd. k212193 10/22/2021
non absorbable surgical nylon suture Shandong Haidike Medical Product Co., Ltd. k212603 12/22/2021
disposable powder free polyethylene examination gloves Mastermax Plastic (Huizhou) LTD k212699 05/31/2022
micro-current facial cold and hot service (model: tpml-100) Li-Tek Electronics Technology C0., Ltd k213039 05/25/2022

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