510(k) Clearances in 2021 — Page 52

3,023 510(k) clearances total

Browse FDA 510(k) clearances granted in 2021. RegDataLab tracks 3,023 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2021 (page 52 of 61)
510(k) clearancesDetails
K210262 — Biograph Vision Quadra PET/CT SystemSiemens Medical Solutions USA, Inc. Mar 3, 2021
K203576 — FORZA Ti Spacer SystemOrthofix, Inc. Mar 3, 2021
K210277 — 3M Attest Rapid Readout Biological Indicator, 12953M Company Mar 3, 2021
K203764 — TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal PlatformImperative Care, Inc. Mar 3, 2021
K210280 — Geistlich Mucograft®, Geistlich Mucograft® SealGeistlich Pharma AG Mar 3, 2021
K201674 — Cultura Collection and Transport SystemMerit Medical Systems, Inc. Mar 3, 2021
K210293 — AtriClip LAA Exclusion SystemAtriCure, Inc. Mar 3, 2021
K202879 — EOGas 4 Endo-SteriTest RRBIAndersen Sterilizers, Inc. Mar 3, 2021
K210316 — Mars 1417X Wireless Digital Flat Panel DetectorIray Technology Taicang , Ltd. Mar 3, 2021
K202316 — Medical mask (Model: KKF-1A)Han Zhaoqing Sporting Goods Company Limited Mar 3, 2021
K203807 — Ponto Bone Anchored Hearing System, MONO Surgery KitOticon Medical AB Mar 3, 2021
K210010 — GMK Revision & Hinge Extension - TiNbN CoatingMedacta International S.A. Mar 2, 2021
K203086 — X-PLO2RBelluscura, LLC Mar 2, 2021
K201422 — Arisure Closed System Drug Transfer Device (CSTD)Yukon Medical, LLC Mar 2, 2021
K202166 — Senhance Surgical SystemTransenterix, Inc. Mar 2, 2021
K210266 — OverStitch Sx Endoscopic Suturing SystemApollo Endosurgery, Inc. Mar 2, 2021
K202889 — Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices Mar 2, 2021
K202214 — IFM Surgical Mask Model SM3Fssc, LLC Mar 2, 2021
K201965 — SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd. Mar 2, 2021
K210314 — Mars1717X Wireless Digital Flat Panel DetectorIray Technology Taicang , Ltd. Mar 2, 2021
K202356 — Powder free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue)Kanglongda Vietnam Protection Technology Company Limited Mar 2, 2021
K203394 — PleuraFlow System with FlowGlideClearflow, Inc. Mar 2, 2021
K202113 — Ceragem Automatic Thermal Massager, Model CGM-MB-1901Ceragem Co., Ltd. Mar 2, 2021
K203755 — Shoulder System - TiNbN CoatingMedacta International S.A. Mar 2, 2021
K203617 — MaxFOV 2Ge Medical Systems, LLC Mar 2, 2021
K201852 — Surgical Mask-Model Number: Ear Loop, Flat-PleatedHuizhou Foryou Medical Devices Co., Ltd. Mar 2, 2021
K203653 — MRI PPG Patient CableIvy Biomedical Systems, Inc. Mar 2, 2021
K210550 — VALO Grand Corded and Accessory LensesUltradent Products, Inc. Mar 1, 2021
K202743 — Med-Link Temp-pulse OximeterShenzhen Med-Link Electronics Tech Co., Ltd. Mar 1, 2021
K201927 — Getinge GSS610N Series Steam SterilizerMaquet GmbH Mar 1, 2021
K203358 — Solitaire X Revascularization DeviceMicro Therapeutics, Inc. D/B/A Ev3 Neurovascular Mar 1, 2021
K201533 — Avinent Biomimetic Coral and Ocean-Iceberg Sterilization CassettesAvinent Implant System S.L.U. Mar 1, 2021
K202678 — OMNI Surgical SystemSight Sciences, Inc. Mar 1, 2021
K202776 — Fingertip pulse oximeterShenzhen Lepu Intelligent Medical Equipment Co., Ltd. Mar 1, 2021
K202037 — imani i2Imani Co. Mar 1, 2021
K210271 — NuVasive Modulus ALIF SystemNu Vasive, Incorporated Mar 1, 2021
K203275 — Recon Support CatheterC.R. Bard, Inc. Mar 1, 2021
K202402 — Nitrile Examination Gloves (Blue, Violet Blue, White)Jiangsu Tianshuo Medical Products Co., Ltd. Mar 1, 2021
DEN200022 — Analytic for Hemodynamic Instability (AHI)Fifth Eye, Inc. Mar 1, 2021
K201644 — QardioCoreQardio, Inc. Feb 28, 2021
K202111 — Medical infrared forehead thermometerHunan Honggao Electronic Technolofy Co., Ltd. Feb 26, 2021
K201968 — SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd. Feb 26, 2021
K201104 — AsoAlignerAso International Manila, Inc. Feb 26, 2021
K203651 — CuptimizeCuptimize, Inc. Feb 26, 2021
K202956 — Erisma LP Navigated InstrumentsClariance, Sas Feb 26, 2021
K203510 — IPL Hair removalShenzhen Weikai Technology Co.,Ltd Feb 26, 2021
K201387 — Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc. Feb 26, 2021
DEN200017 — Q-CollarQ30 Sports Science, LLC Feb 26, 2021
K210323 — Indigo Aspiration System - Lightning Aspiration TubingPenumbra, Inc. Feb 26, 2021
K202702 — FLARE Single-Use Surgical Laser FiberRealton (Suzhou) Medical Technology Co., Ltd. Feb 26, 2021
← Previous Page 52 of 61 Next →