510(k) Clearances in 2021 — Page 42

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 42 of 61)
510(k) clearancesDetails
K203749 — Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter CableAmbu A/S May 3, 2021
K210675 — EasyWhipWinter Innovations, Inc. May 3, 2021
K201949 — Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 SeriesNihon Kohden Corporation May 2, 2021
K202430 — Kerecis ReconstructKerecis Limited May 2, 2021
K210993 — CereLink ICP MonitorIntegra Lifesciences Production Corporation Apr 30, 2021
K203165 — Disposable Ureteral Access SheathSuzhou Beyo Medical Technology Co., Ltd. Apr 30, 2021
K210061 — ProLift Lateral HELO FixatedLife Spine, Inc. Apr 30, 2021
K203580 — ArtiSential Laparoscopic Instruments-ElectrodesLivsmed, Inc. Apr 30, 2021
K203267 — The BioBrace ImplantBiorez, Inc. Apr 30, 2021
K203601 — Innova Nasal Non-Vented MaskSleepnet Corporation Apr 30, 2021
K211013 — FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24Inari Medical, Inc. Apr 30, 2021
K210647 — SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheterVascular Solutions, LLC Apr 30, 2021
K203699 — syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc. Apr 30, 2021
K210637 — CD Horizon™ Spinal SystemMedtronic Apr 30, 2021
K203786 — MAC 7 - Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc. Apr 30, 2021
K210290 — JACE Medical Thoracic Plating SystemJace Medical, LLC Apr 30, 2021
K210001 — HYPER AiRShanghai United Imaging Healthcare Co., Ltd. Apr 30, 2021
K210919 — AcuityDReRadmedix, LLC Apr 30, 2021
K210247 — OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma Apr 30, 2021
K201024 — Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC Apr 29, 2021
K210944 — Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs (Blue)Harbour Health, LLC Apr 29, 2021
K203454 — Infrared ThermometerShandong Zhushi Pharmaceutical Group Co., Ltd. Apr 29, 2021
K210605 — 3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation3M Company Apr 29, 2021
K202457 — M1 Surgical Face MaskCHISON Medical Technologies Co., Ltd. Apr 29, 2021
K202619 — KardiFlex PTCA Balloon Dilatation CatheterMedcaptain Life Science Co., Ltd. Apr 29, 2021
K202987 — Rescue Pulmonary Grasping ForcepsAnrei Medical (Hangzhou) Co., Ltd. Apr 29, 2021
K210981 — Pure Vu SystemMotus GI Medical Technologies , Ltd. Apr 29, 2021
K203532 — BI-MENTUM™ ALTRX® Dual Mobility LinerDepuy Ireland UC Apr 28, 2021
K210601 — Plato 17 MicrocatheterScientia Vascular, LLC Apr 28, 2021
K203277 — Electrosurgical Generator ESG-410, Foot Switches, PK Cutting ForcepsOlympus Winter & Ibe GmbH Apr 28, 2021
K203535 — TriniasShimadzu Corporation Medical Systems Apr 28, 2021
K210985 — 1717FCCRayence Co., Ltd. Apr 28, 2021
K202757 — CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50 Automatic Blood Pressure MonitorContec Medical Systems Co.,Ltd Apr 28, 2021
K203436 — Disposable Nitrile Examination GlovesShandong Zhushi Pharmaceutical Group Co., Ltd. Apr 28, 2021
K200391 — MPACT ExtensionMedacta International S.A. Apr 28, 2021
K210925 — Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser Fiber, Flexiva Pulse ID TracTip Laser FiberBoston Scientific Apr 28, 2021
K203451 — TCL3 Motion Tracking SystemTracinnovations Aps Apr 28, 2021
K210278 — Titan SGSStandard Bariatrics Apr 28, 2021
K210982 — AMX NavigateGe Medical Systems, LLC Apr 28, 2021
K210020 — Medical MaskZhende Medical Co., Ltd. Apr 28, 2021
K210621 — Oral/Enteral SyringeNingbo Tianyi Medical Appliance Co., Ltd. Apr 28, 2021
K210242 — Astroglide X Silicone Personal LubricantBiofilm, Inc. Apr 28, 2021
K211072 — Safety Trocar CannulaBoston Scientific Corporation Apr 27, 2021
K210660 — Stone Retrieval Balloon CatheterAnrei Medical (Hangzhou) Co., Ltd. Apr 27, 2021
K210964 — Resonic Rapid Acoustic Pulse DeviceSoliton, Inc. Apr 27, 2021
K203121 — Responsive Arthroscopy Thunderbolt SystemResponsive Arthroscopy, LLC Apr 27, 2021
K191951 — Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ DeviceAvazzia, Inc. Apr 27, 2021
K203240 — AccelX AbutmentsIntegrated Dental Systems, LLC Apr 27, 2021
K203098 — STARband, STARlight, St. Louis BandOrthomerica Products, Inc. Apr 27, 2021
K210609 — AQUASPLASH (Polymacon) Soft (Hydrophilic) Daily Wear Contact LensVp Optics Apr 27, 2021
← Previous Page 42 of 61 Next →