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U.S. Department of Health and Human Services

510(K) Premarket Notification
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flexible sensor-ureterorenoscopes boa vision ef, flexible sensor-ureterorenoscopes cobra vision ef Richard Wolf Medical Instruments Corporation k183188 05/03/2019
lc glossfill xr S&C Polymer Silicon- und Composite Spezialitaeten GmbH k182778 04/22/2019
klassic knee system - sombrero patella with standard poly, klassic knee system - sombrero patella with e-link poly Total Joint Orthopedics, Inc. k190280 03/15/2019
zimmer segmental system proximal femoral component Zimmer, Inc. k183136 01/30/2019
t-plus Wintecare SA k181893 01/29/2019
stratafix symmetric pds plus knotless tissue control devices, stratafix spiral pds plus knotless tissue control devices, stratafix spiral monocryl plus knotless tissue control devices, stratafix spiral monocryl knotless tissue control devices Ethicon, Inc. k182873 01/10/2019
reusable blood pressure cuff, disposable blood pressure cuff Shenzhen Caremed Medical Technology Co., Ltd. k182433 12/17/2018
carboclear® pedicle screw system CarboFix Orthopedics Ltd. k182377 09/27/2018
5cm tag applicator, 7cm tag applicator, 10 cm tag applicator, 5 cm tag applicator (10 pack), 7cm tag applicator (10 pack), 10cm tag applicator (10 pack), localizer surgical probe, localizer surgical probe (5 pack) Health Beacons, Inc. k181692 09/25/2018
firebird® spinal fixation systems: firebird system; firebird deformity system; firebird® nxg spinal fixation system; phoenix® minimally invasive spinal fixation system; phoenix® cdx™ minimally invasive spinal fixation system; janus® midline fixation screw; janus® fenestrated screw Orthofix Inc. k180179 08/24/2018

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