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U.S. Department of Health and Human Services

510(k) Premarket Notification

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91 to 100 of 500 Results *
Decision Date To: 07/22/2019
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depuy corail amt hip prosthesis DePuy Orthopaedics, Inc. K192946 11/26/2019
peridot intervertebral body fusion system GBS Commonwealth Co., Ltd. K192026 11/26/2019
arix cannulated screw system Jeil Medical Corporation K192417 11/26/2019
fibertak button Arthrex Inc. K191426 11/26/2019
streamline mis spinal fixation system Pioneer Surgical Technology, Inc. K192396 11/26/2019
advocate pta catheter Merit Medical Systems Inc. K192907 11/26/2019
depuy synthes trauma screws Synthes (USA) Products LLC / DePuy Orthopaedics Inc K192745 11/26/2019
neuroone cortical electrode NeuroOne, Inc. K192764 11/26/2019
simplexa vzv swab direct, simplexa vzv positive control pack DiaSorin Molecular LLC K192376 11/26/2019
etest delafloxacin (dfx) (0.002-32 µg/ml) BioMerieux SA K192738 11/26/2019

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