510(k) Clearances in 2020 — Page 20

2,923 510(k) clearances total

Browse FDA 510(k) clearances granted in 2020. RegDataLab tracks 2,923 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2020 (page 20 of 59)
510(k) clearancesDetails
K202238 — SIGNA ArtistGe Healthcare (Tianjin) Company Limited Sep 4, 2020
K201537 — Protective Face Mask for Medical UseShandong Shengquan New Material Co., Ltd. Sep 4, 2020
K193655 — MSLS6QF TENS/PMS DeviceSelf Doctor Care, LLC Sep 4, 2020
K201517 — Plain Surgical MaskAok Tooling Limited Sep 4, 2020
K201134 — Arthrex NanoScope SystemArthrex, Inc. Sep 4, 2020
K200835 — 3M Tegaderm CHG Chlorhexidine Gluconate Gel Pad3M Company Sep 4, 2020
K193439 — MEBO Wound DressingMebo Life Science, Inc. Sep 4, 2020
K202197 — Astopad Patient Warming SystemStihler Electronic GmbH Sep 4, 2020
K192452 — LyograftB. Bruan Surgical, SA Sep 3, 2020
K202499 — Diamond Digital Sleep Orthotic (DDSO)Diamond Orthotic Laboratory Sep 3, 2020
K193599 — BOUNDER 300 Power Wheelchair, BOUNDER Plus 300 Power Wheelchair, BOUNDER 450 Power Wheelchair, BIG BOUNDER 600 Power Wheelchair, BIG BOUNDER 1000 Power Wheelchair21St Century Scientific, Inc. Sep 3, 2020
K201203 — Cliq AspiratorAnest Iwata Sparmax Co., Ltd. Sep 3, 2020
K202235 — ArtPIX DRFCmt Medical Technologies, Ltd. Sep 3, 2020
K200212 — Reprocessed Advisor HD Grid Mapping Catheter, Sensor EnabledInnovative Health, LLC Sep 3, 2020
K201769 — Cavetto [MAX] Cervical Cage SystemNeurostructures, Inc. Sep 3, 2020
K200641 — HaloGUARD Protective Disc with CHGAttwill Medical Solutions Sep 3, 2020
K201591 — Flat Panel DetectorKa Imaging, Inc. Sep 3, 2020
K201336 — DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mmSynthes (USA) Products, LLC Sep 3, 2020
K201211 — 3MP Color LCD Monitors C32S+, C32SP+; 3MP Monochrome LCD Monitors G32S+, G32SP+Shenzhen Beacon Display Technology Co., Ltd. Sep 3, 2020
K201966 — 7D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5.5 mm - 150 mm, 7D Surgical Flex Array7D Surgical, Inc. Sep 3, 2020
K201900 — 3D GraftRasp SystemSurgentec Sep 3, 2020
K200102 — MIS Dental Implant SystemDentsply Sirona Sep 3, 2020
K201074 — Delta III LithotripterDornier Medtech America, Inc. Sep 3, 2020
K192111 — Biodegradable Nitrile Examination Powder Free Glove, GreenTop Glove Sdn. Bhd. Sep 3, 2020
K201522 — Arthrex Syndesmosis TightRope XP Buttress Plate Implant SystemArthrex, Inc. Sep 3, 2020
K202176 — Symetrex LTHD Catheter, Symetrex LTHD Catheter with SideholesMedical Components, Inc. (Dba MedComp) Sep 3, 2020
K193618 — ExactechGPS SystemBlue Ortho Sep 2, 2020
K192830 — Bright Temporary C&BDmp Dental Industry S.A. Sep 2, 2020
K200462 — EtchPro Etching GelBelport Company, Inc., Gingi-Pak Sep 2, 2020
K202216 — EPIQ Series Diagnostic Ultrasound SystemsPhilips Ultrasound, Inc. Sep 2, 2020
K202169 — Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22Qura S.R.L Sep 2, 2020
K202182 — ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration TubingImperative Care, Inc. Sep 2, 2020
K200812 — VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE CatheterPhilips Image Guided Therapy Corporation Sep 2, 2020
K202215 — cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control KitRoche Molecular Systems, Inc. Sep 2, 2020
K200833 — RX-1 Rhythm Express Remote Cardiac Monitoring SystemVivaQuant, Inc. Sep 2, 2020
K200516 — OCT-Camera ID 21101A3Optomedical Technologies GmbH Sep 2, 2020
K200827 — LOCATOR R-TxIvory Super Holdco, Incp. Sep 2, 2020
K201552 — ApolloVue S100 Image SystemApollo Medical Optics, Ltd. Sep 2, 2020
K201677 — Arthrex Mesh PlatesArthrex, Inc. Sep 2, 2020
K200503 — ATL AnchorsInternational Life Sciences Sep 2, 2020
K201765 — SmartHDM-510 SystemMesa Laboratories, Inc. Sep 2, 2020
K202124 — Aesculap PAS-Port Proximal Anastomosis SystemAesculap, Inc. Sep 2, 2020
K193405 — Simplant Digital GuideDentsply Sirona Sep 2, 2020
K201277 — Oral-B Dry Mouth Oral RinseThe Procter & Gamble Company Sep 2, 2020
K192704 — Endofresh Digestive Endoscopy SystemHuizhou Xzing Technology Co., Ltd. Sep 2, 2020
K200916 — Patient Administration SetCyclomedica Australia Pty, Ltd. Sep 1, 2020
K200724 — VICTUS Femtosecond Laser PlatformTechnolas Perfect Vision GmbH Sep 1, 2020
K201920 — Endoscope Reprocessor OER-EliteOlympus Medical Systems Corp. Sep 1, 2020
K193424 — Resolution 360™ ULTRA ClipBoston Scientific Corporation Sep 1, 2020
K202160 — 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 SystemFUJIFILM Sonosite, Inc. Sep 1, 2020
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