510(k) Clearances — Page 136

176,223 clearances total

Browse all FDA 510(k) medical device clearances. RegDataLab tracks 176,223 clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances (page 136 of 3,525)
ClearancesDetails
K242300 — MI View&GOSiemens Medical Solutions USA, Inc. Aug 30, 2024
K241386 — Heyman Packing Applicator Set (GM11004580)Varian Medical Systems, Inc. Aug 30, 2024
K241823 — ToxiSeal™ Vial AdaptorEpic Medical Pte. , Ltd. Aug 30, 2024
K233107 — Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5Canon Medical Systems Corporation Aug 30, 2024
K242249 — Conformity Stem Extension LineUnited Orthopedic Corporation Aug 30, 2024
K241318 — Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA)Adaptiiv Medical Technologies, Inc. Aug 30, 2024
K241847 — Imbio PHA (4.0.0)Imbio, Inc. Aug 30, 2024
K241518 — Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0 with StimGuide Pro); Horizon® 3.0 TMS Therapy System (Horizon 3.0)The Magstim Company Limited Aug 30, 2024
K241585 — uMI PanoramaShanghai United Imaging Healthcare Co., Ltd. Aug 30, 2024
K241583 — VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-SP-01, VC-CH-01)Remington Medical, Inc. Aug 30, 2024
K241051 — Vave Wireless Ultrasound SystemVave Health, Inc. Aug 30, 2024
K241662 — Ultrasound Transducer CoverVitrolife Sweden AB Aug 30, 2024
K241326 — Cadence Ankle PSI System3D Systems, Inc. Aug 30, 2024
K240003 — Velmeni for Dentists (V4D)Velmeni, Inc. Aug 30, 2024
K232441 — Unipro (K-UNIPRO-US)Tenscare, Ltd. Aug 30, 2024
K241957 — Talee, Talee PostOpInvent Medical USA, LLC Aug 30, 2024
K231969 — BASEN Wearable Breast Pump (Model: YM-801, YM-803, YM-805, YM-806, YM-808)Dongguanshi Yiyingmei Technology Co., Ltd. Aug 30, 2024
K241256 — JetBoots PRO PlusTherabody, Inc. Aug 30, 2024
K233826 — KosmosEchoNous, Inc. Aug 29, 2024
K241400 — SkinPen Precision Elite SystemCrown Aesthetics Aug 29, 2024
K242346 — Grass® MR Conditional/CT Cup ElectrodesNatus Manufacturing Limited Aug 29, 2024
K241881 — IPL Hair Removal Device (JM-843, JM-865, JM-638)Shenzhen Junmei Technology Co., Ltd. Aug 29, 2024
K242296 — VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture Anchor (ATP003-M); VersaLat™ Ti Suture Anchor (ADP021-TI); VersaLat™ Suture Anchor (ADP021-PK)Ortho-Design (Pty), Ltd. Aug 29, 2024
K240105 — Navigator (FMNVG15); Navigator XL (FMNVX06)Forcemech International, LLC Aug 29, 2024
K242280 — Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioactive Bone Graft Substitute, Vitoss BBTrauma® Bioactive Bone Graft Substitute,Vitoss® BA2X Bioactive Bone Graft Substitute, Vitoss® Bioactive Bone Graft Substitute Pack,Vitoss® Bioactive Bone Graft Substitute, Vitoss® Foam Bone Graft Substitute, Vitoss® Bone Graft Substitute Filled Canister, Vitoss® Bone Graft Substitute, Vitoss® Bone Graft Substitute - Synthetic Cancellous ChipsStryker Spine Aug 29, 2024
K220908 — Ensol EnTM Specimen Collection and Transport SystemEnsol Biosciences, Inc. Aug 29, 2024
K241227 — RHYTHMIA HDx™ Mapping SystemBoston Scientific Corporation Aug 29, 2024
K242243 — Target Detachable CoilsStryker Neurovscular Aug 29, 2024
K240545 — GenaCheck™ Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS/S/M/L/XL)Genabio Diagnostics, Inc. Aug 28, 2024
K240078 — Fogarty Thru-Lumen Embolectomy CatheterEdwards Lifesciences, LLC Aug 28, 2024
K241932 — OSSIOfiber® Compression StapleOSSIO , Ltd. Aug 28, 2024
K241943 — Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented MaskSleepnet Corporation Aug 28, 2024
K241913 — da Vinci Handheld CameraIntuitive Surgical Operations, Inc. Aug 28, 2024
K241457 — Vista BC PuttyInter-Med, Inc. Aug 28, 2024
DEN230067 — Chronos®Germitec Aug 28, 2024
K233827 — OxiWearOxiwear, Inc. Aug 28, 2024
K242316 — Safety LancetNingbo Medsun Medical Co., Ltd. Aug 28, 2024
K241557 — Cercon® yo MLDentsply Sirona Aug 28, 2024
K241534 — VITROS Immunodiagnostic Products Syphilis Reagent PackOrtho Clinical Diagnostics Aug 28, 2024
K233816 — REDEMPTION Charcot Plating SystemVilex, LLC Aug 28, 2024
K232991 — BT-1000Bistos Co., Ltd. Aug 28, 2024
K241517 — Q Guidance System; Mako Spine System;Stryker Leibinger GmbH & Co KG Aug 27, 2024
K241228 — TENSWaveZynex Medical Officer Aug 27, 2024
K241241 — Z1 Cemented Hip SystemOrchard Medical Development, LLC Aug 27, 2024
K242537 — BracePaste Fluoride SealantAmerican Orthodontics Corp. Aug 27, 2024
K241523 — injeTAK Adjustable Tip Needle (DIS199; DIS201)Laborie Medical Technologies, Corp. Aug 27, 2024
K241787 — CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring SystemAscensia Diabetes Care U.S., Inc. Aug 27, 2024
K241684 — Overjet Charting AssistOverjet, Inc. Aug 27, 2024
K233846 — Vitrification Solution Set and Warming Solution SetEcmpc, LLC Aug 27, 2024
K234151 — Isolator Synergy EnCapture Ablation System (EMH)AtriCure, Inc. Aug 27, 2024
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