FDA 510(k) Applications Received During July, 2020

FDA 510(k) Number Submission Date Device Name Applicant Contact
K201966 07/15/2020 7D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5.5 mm - 150 mm, 7D Surgical Flex Array 7D Surgical Inc. Daniel Zisind
K201834 07/02/2020 HI-TORQUE PROCEED Guide Wire Family Abbott Vascular Charlotte Pullman
K201948 07/13/2020 AcroDTI Visualizer AcroViz Inc. Yung-Chin Hsu
K202099 07/29/2020 AOS GalileoÖ Trochanteric Nail System Advanced Orthopaedic Solutions, Inc. Jolie Krance
K202124 07/31/2020 Aesculap PAS-Port Proximal Anastomosis System Aesculap Inc. Sierra Mertz
K202036 07/23/2020 Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal Alcon Laboratories, Inc. Sherri Lakota
K201830 07/02/2020 ANSER Clavicle Pin Baat Medical Products BV Teake Bulstra
K202008 07/21/2020 Disposable Vinyl Glove Best Care Trading Co., LTD Chongfeng Zhao
K201833 07/02/2020 BiPad Hand Activated, Disposable Bipolar Electrocautery Cords BiPad Surgical, Inc. Louis Cornacchia
K202050 07/24/2020 Cranial 4Pi Immobilization Brainlab AG Chiara Cunico
K201871 07/07/2020 Surgical Mask C & S Paper Yunfu Co., Ltd. Xu Zhiming
K201992 07/17/2020 Caption Guidance Caption Health Sam Surette
K201926 07/10/2020 CarboClear« Pedicle Screw System, CarboClear« II Pedicle Screw System CarboFix Orthopedics Ltd. Hila Wachsler-Avrahami
K201933 07/13/2020 ImagenSPECT 3.0 Cardiovascular Imaging Technologies James A. Case
K201932 07/13/2020 X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe) CareRay Digital Medical System Co., Ltd. Leilei Li
K201898 07/02/2020 Clear Guide SCENERGY Clear Guide Medical Jack Kent
K201859 07/06/2020 Porcine Mineral Collagen Composite Moldable Collagen Matrix, Inc. Gloria Zuclich
K201849 07/06/2020 eNAT molecular collection and preservation medium Copan Italia S.p.A. Elena Simeonato
K201851 07/06/2020 EXULT Femoral component trial - Left, EXULT Femoral component trial - Right Corentec Co., Ltd Sungwon Yang
K201805 07/01/2020 VersaOne Reusable Positioning Trocar System Covidien Stephanie Wilde
K201952 07/14/2020 CrossGlide ETS Plus CrossBay Medical Piush Vidyarthi
K201831 07/02/2020 CONFIDENCE Spinal Cement System DePuy Spine, Inc. Sergio M. Cordeiro
K201959 07/14/2020 DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System DePuy Synthes Stacey Bonnell
K202012 07/21/2020 Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System Devicor Medical Products, Inc. Gwendolyn P. Payne
K202156 07/27/2020 DIAMOND-5A/6A/8A DRGEM Corporation Ki-Nam Yang
K201979 07/16/2020 Cervical Plate System Eminent Spine, LLC Stephen Courtney
K202116 07/30/2020 EzDent-i/ E2/ Prora View/ Smart M Viewer Ewoo soft Co., Ltd. Young Seok Kim
K202130 07/31/2020 FUJIFILM Video Laparoscope Fujifilm Corporation Randy Vader
K201960 07/14/2020 SpaceFlex Knee - 80mm Size G21 S.r.l Filippo Foroni
K201961 07/14/2020 IlluminOss Photodynamic Bone Stabilization System IlluminOss Medical, Inc. Robert Rabiner
K201981 07/16/2020 Magicore System InnoBioSurg Co., Ltd. Bo-Yeon Lim
K201938 07/13/2020 LZI Fentanyl II Enzyme Immunoassay Lin-Zhi International, Inc. Bernice Lin
K202007 07/21/2020 LZI Oxycodone III Enzyme Immunoassay Lin-Zhi International, Inc. Bernice Lin
K201995 07/20/2020 CUBEScan BioCon-1100 Mcube Technology Co., Ltd. Hye-Ri Choi
K202022 07/22/2020 GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS (Vitamin E Highly Crosslinked UHMWPE) Medacta International SA Stefano Baj
K201829 07/02/2020 SensiCare PI Evolution Surgical Glove (Tested for Use with Chemotherapy Drugs) Medline Industries, Inc. Jennifer Mason
K201883 07/08/2020 6.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP Biocomposite Anchor Medos International SARL Elizabeth Messana
K201907 07/09/2020 ClariVein IC Merit Medical Systems, Inc. Michaela Rivkowich
K201807 07/01/2020 ANCORIS MiEGmbH Thomas Kuehl
K202072 07/27/2020 MindsEye Expandable Port Minnetronix Neuro, INC. Matt Adams
K201854 07/06/2020 CAPOGEN Laser Cap Nature Incredible Inc John Lee
K201837 07/02/2020 UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge NeoTract, Inc. Brian Gall
K201850 07/06/2020 Vector Hammertoe Correction System Nvision Biomedical Technologies, Inc Diana Langham
K201841 07/02/2020 EyeBOX Oculogica, Inc. Rosina Samadani
K201920 07/10/2020 Endoscope Reprocessor OER-Elite Olympus Medical Systems Corp. Toshiyuki Nakajima
K202068 07/27/2020 The AIO Solution 3.0 Orfit Industries NV Eddy Marivoet
K201909 07/09/2020 RxSight Contact Lens RxSight, Inc. Maureen O'Connell
K202064 07/27/2020 Admiral ACP System SeaSpine Orthopedics Corporation Aly Alvarez
K202014 07/21/2020 Magnetom Aera, Magnetom Skyra, Magnetom Prisma/Prisma fit Siemens Medical Solutions USA, Inc. Andrew Turner
K201953 07/14/2020 OMNI PLUS Surgical System Sight Sciences, Inc. Edward J. Sinclair
K201951 07/13/2020 Cemented Origin Hip Stem Signature Orthopaedics Pty Ltd. Declan Brazil
K201916 07/10/2020 Inspire 6M Hollow Fiber oxygenator, Inspire 7M Hollow Fiber oxygenator, Inspire 8M Hollow Fiber oxygenator Sorin Group Italia S.r.l Luigi Vecchi
K201900 07/08/2020 3D GraftRasp System SurGenTec Andrew Shoup
K201944 07/13/2020 DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm) Synthes (USA) Products, LLC Prem Pisupati
K201958 07/14/2020 ETD Family of Electrotherapy Devices TheraSigma, LLC Jim Klett
K202108 07/30/2020 External Counterpulsation System, Soulaire Vamed Medical Instrument Co., Ltd. Ji Ma
K202143 07/31/2020 Dynex Micro Vilex, LLC Joyce Thacker
K202054 07/24/2020 Dynex Ring Fixation System, Diametrix Ring Fixation System Vilex, LLC Joyce Thacker
K201856 07/06/2020 Provicol QM Aesthetic VOCO GmbH M. Th. Plaumann


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