510(k) Clearances in 2020

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 1 of 59)
510(k) clearancesDetails
K202267 — Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge NeedlesIsoray Medical, Inc. Dec 31, 2020
K202681 — Promisemed Covered Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd. Dec 31, 2020
K201342 — HANAROSTENT Trachea/Bronchium (CCC)M.I.Tech Co., Ltd. Dec 31, 2020
K202322 — Sim&SizeSim&Cure Dec 31, 2020
K201239 — NuEra Tight Family, EMS ModelBios S.R.L. Dec 31, 2020
K202706 — Surgical Gown (Sterile), Surgical Gown (Non-sterile)B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. Dec 31, 2020
K202615 — Nordiwell Medical Face MaskChangzhou Combat Protective Equipment Co., Ltd. Dec 31, 2020
K202038 — CryoTreQVitreQ BV Dec 30, 2020
K201776 — Foley Balloon Catheter for UrologyApollon Co., Ltd. Dec 30, 2020
K203166 — PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound Upper GI Video Scope EG36-J10UR, PENTAX Medical Ultrasound Upper GI Video Scope EG38-J10UT, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10UPentax Of America, Inc. Dec 30, 2020
K202372 — Upper Arm Electronic Blood Pressure MonitorConmo Electronic Company Limited Dec 30, 2020
K203239 — Arthrex Low Profile ScrewsArthrex, Inc. Dec 30, 2020
K201754 — JianYu Surgical MaskJiangsu Jianyu Health Medical Co., Ltd. Dec 30, 2020
K202268 — CrossRoads Tray SystemCrossroads Extremity Systems, LLC Dec 30, 2020
K202690 — Remunity Pump for Remodulin (treprostinil) InjectionDeka Research And Development Dec 30, 2020
K193159 — NeuroAmp II, NeuroAmp II.5sCorscience GmbH & Co. KG Dec 30, 2020
K202940 — First Relief v1Dyansys, Inc. Dec 29, 2020
K202699 — E-Cath STIM acc. TsuiPAJUNK GmbH Medizintechnologie Dec 29, 2020
K202456 — M5 RecorderGlobal Instrumentation, LLC Dec 29, 2020
K203137 — Venue FitGE Medical Systems Ultrasound And Primary Care Diagnostics Dec 29, 2020
K203219 — Trevo XP ProVue Retriever and Trevo NXT™ ProVue RetrieverStryker Neurovascular Dec 29, 2020
K203511 — Baby Gorilla/Gorilla Plating SystemParagon 28, Inc. Dec 29, 2020
K203508 — BriefCaseAidoc Medical , Ltd. Dec 29, 2020
K202455 — Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 Ultrasonic Diagnostic SystemsSupersonic Imagine Dec 29, 2020
K200965 — XR-MX/1000Karl Storz Endoscopy America, Inc. Dec 29, 2020
K200970 — Self-Contained Biological IndicatorTrue Indicating, LLC Dec 28, 2020
K200458 — Tailored-C Cervical Interbody Fusion SystemBespoke Technologies Dec 28, 2020
K200321 — Novaerus NV1050Novaerus Us, Inc. Dec 28, 2020
K201781 — Uni-FuZe-P Bone PuttyZavation Medical Products, LLC Dec 28, 2020
K203062 — Optiflux Series of Dialyzers F160NR, F180NR, F200NRFresenius Medical Care Renal Therapies Group, LLC Dec 28, 2020
K202730 — Quadra-PMedacta International S.A. Dec 28, 2020
K202248 — Attune Revision Sleeve LPS Femoral AdaptorsDepuy Ireland UC Dec 28, 2020
K200968 — ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39RInsung Medical Co., Ltd. Dec 28, 2020
K201800 — Portable Dental X-ray (NR-F350, CS 2400P, CS 2300P, R2 Port-X)Nanoray Co., Ltd. Dec 28, 2020
K202454 — Smart SPACE Shoulder SystemTechmah Medical, LLC Dec 28, 2020
K193419 — MBT SepsityperBruker Daltonik GmbH Dec 27, 2020
K201747 — 8-CH Electroencephalography AmplifierHipposcreen Neurotech Corp. Dec 27, 2020
K202485 — ImPACT Version 4Impact Applications, Inc. Dec 25, 2020
K200422 — Image Quality Analyzer (IQA)Visionquest Biomedical, Inc. Dec 24, 2020
K203544 — UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and AccessoriesLumenis, Ltd. Dec 24, 2020
K200426 — Acute Dual Lumen Hemodialysis CatheterHealth Line International Corporation Dec 24, 2020
K202353 — SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging SystemShantou Institute Of Ultrasonic Instruments Co., Ltd. (Siui) Dec 23, 2020
K203257 — LUBi Water Based Personal LubricantBoya Biotechnology Co., Ltd. Dec 23, 2020
K203540 — Bridge Occlusion BalloonSpectranetics, Inc. Dec 23, 2020
K203467 — WishBone Medical Plate and Screw SystemWishbone Medical, Inc. Dec 23, 2020
K202526 — OmniTom EliteNeurologica Corporation, A Subsidiary Of Samsung Electronics Dec 23, 2020
K193670 — SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube SetQuanta Dialysis Technologies, Ltd. Dec 23, 2020
K200631 — DeRoyal Temperature Monitoring ProbeDeroyal Industries, Inc. Dec 23, 2020
K202637 — F3D Corpectomy SystemCorelink, LLC Dec 23, 2020
K202237 — Locking deviceHangzhou AGS MedTech Co., Ltd. Dec 23, 2020
Page 1 of 59 Next →