FDA 510(k) Applications Received During August, 2020

FDA 510(k) Number Submission Date Device Name Applicant Contact
K202256 08/10/2020 3Shape Implant Studio 3Shape Medical A/S Jenny Axel
K202276 08/11/2020 BracePaste Band and Build LC American Orthodontics Andre Leak
K202347 08/18/2020 UNIFUSE Infusion System with Cooper Wire AngioDynamics, Inc. Brandon M. Brackett
K202252 08/10/2020 ASAHI Corsair Armet 18 Microcatheter (Model: CSAR060-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR090-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR110-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR135-18N), Asahi Intecc Co., Ltd. Yasuyuki Kawahara
K202224 08/07/2020 SpaceOAR System Boston Scientific Corporation Jeanne OToole
K202406 08/21/2020 Butterfly iQ Ultrasound System Butterfly Network, Inc. Brian Sawin
K202235 08/07/2020 ArtPIX DRF CMT Medical Technologies Ltd Dror Wertman
K202499 08/31/2020 Diamond Digital Sleep Orthotic (DDSO) Diamond Orthotic Laboratory Matt Rago
K202335 08/17/2020 Ambra ProViewer Dicom Grid, Inc, dba Ambra Health Patrice Nedelec
K202394 08/21/2020 EOSedge EOS imaging Bernard Ismael
K202160 08/03/2020 Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound System, Sonosite X-Porte Ultrasound System, Sonosite Edge II Ultrasound System, Sonosite Maxx Ultrasound System FUJIFILM SonoSite Inc. Anoush Frankian
K202238 08/07/2020 SIGNA Artist GE Healthcare (Tianjin) Company Limited Qiang Ding
K202354 08/19/2020 Surgical Mask-Model Number CW01 Hunan Heng Chang Pharmaceutical Co., Ltd. Tao Jingfeng
K202182 08/04/2020 ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing Imperative Care Inc. Jake Wolenberg
K202176 08/04/2020 Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes Medical Components Inc. (Dba Medcomp) Courtney Nix
K202328 08/17/2020 CD Horizon Spinal System Medtronic Sofamor Danek USA, Inc. Venkata Sandeep Manne
K202318 08/17/2020 Marathon Flow Directed Micro Catheter Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Elizabeth Campion
K202297 08/13/2020 Aline Ablation Intelligence Mirada Medical Ltd David Clafton
K202192 08/05/2020 STRUXXURE«-L and STRUXXURE«-A Plate System Nexxt Spine LLC Andy Elsbury
K202251 08/10/2020 Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JET 7MAX) Penumbra, Inc. Anush Puvvada
K202216 08/06/2020 EPIQ Series Diagnostic Ultrasound Systems Philips Ultrasound, Inc. Colin S. Jacob
K202286 08/12/2020 Tulsa-Pro System Profound Medical Inc Goldy Singh
K202169 08/03/2020 Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22 Qura S.r.l Raffaella Tommasini
K202287 08/12/2020 Ran-Flex-B Bone Marrow Aspiration Needle Ranfac Corporation Eric Kreuz
K202153 08/03/2020 Responsive Arthroscopy Suture Anchor System Responsive Arthroscopy LLC Douglas Korhs
K202399 08/21/2020 OrthoButton FL Riverpoint Medical Amanda Cole
K202242 08/10/2020 HS Fiber Riverpoint Medical, LLC Edwin Anderson
K202215 08/06/2020 cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit Roche Molecular Systems, Inc. Rita Hoady
K202197 08/05/2020 Astopad Patient Warming System Stihler Electronic GmbH Jens- Peter Weege
K202227 08/07/2020 ArtusÖ cervical plate system Ulrich GmbH & Co. KG Christoph Ulrich
K202463 08/27/2020 Disposable Surgical Mask Unisources Group LLC Henry Shen
K202187 08/04/2020 FLEX Vessel Prep System VentureMed Group, Inc. Jill Schweiger
K202360 08/19/2020 Ziehm Vision RFD 3D Ziehm Imaging GmbH Stefan Fidler


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