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U.S. Department of Health and Human Services

510(k) Premarket Notification

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11 to 20 of 500 Results *
Decision Date To: 07/22/2019
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sterile high-pressure angiographic syringes for single-use Shenzhen Boon Medical Supply Co., Ltd K192657 08/07/2020
concorde models concorde us and concorde st soft tissue biopsy devices TransMed7, LLC K201244 08/07/2020
cupid brand male natural rubber latex condoms (plain (banana) , plain (strawberry), dotted , multi-textured (dotted+contoured + ribbed)) CUPID Limited K201067 08/07/2020
fountain valvetip infusion catheter Merit Medical Systems, Inc K193082 08/07/2020
vidavision VIDA Diagnostics Inc. K200990 08/07/2020
x-ray flat panel detectors (careview 1800cwe /careview 1500cwe) CareRay Digital Medical System Co., Ltd. K201932 08/07/2020
carboclear® pedicle screw system, carboclear® ii pedicle screw system CarboFix Orthopedics Ltd. K201926 08/07/2020
k2m navigation instruments K2M, Inc. K201006 08/07/2020
medina anterior cervical plate system Alliance Partners, LLC K201521 08/06/2020
tk safety needle Anhui Tiankang Medical Technology Co., Ltd. K191644 08/06/2020

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