510(k) Clearances

174,759 clearances total

K232865 — Magseed Pro Magnetic Marker SystemEndomagnetics Ltd., Fri Jun 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240927 — Access ThyroglobulinBeckman Coulter, Inc. Fri Jun 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240215 — BLUE 400; BLUE 400 SCarl Zeiss Meditec, AG Fri Jun 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241608 — nordicMEDiVANordicneurolab AS Fri Jun 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233823 — Ultrasonic Fetal DopplerShenzhen Jamr Technology Co., Ltd. Fri Jun 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241204 — TopCEM-Veneer Light Cure Veneer CementRizhao Huge Biomaterials Company, Ltd. Fri Jun 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240164 — NovaLine SP-C35 Transducer Protector (956007)Bain Medical Equipment (Guangzhou) Co., Ltd. Fri Jun 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240892 — XSense Cryoablation System with CryoprobesIceCure Medical , Ltd. Fri Jun 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241406 — LavieenWontech Co., Ltd. Fri Jun 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233637 — Cordis BRITECROSS Support CatheterCordis US Corp Fri Jun 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240893 — ARTFX MEDICAL Cervical PEEK CagesArtfx Medical Fri Jun 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241540 — NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound CatheterBiosense Webster, Inc. Fri Jun 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240320 — Patient Monitor (RespArray)Edan Instruments, Inc. Fri Jun 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241154 — Electric Wheelchair (YFWB-63)If Health (Xiamen) Intelligent Technology Co.,Ltd Fri Jun 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240938 — The Optimotion™ Blue Plus Knee SystemOptimotion Implants, LLC Thu Jun 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241212 — MagnetOs Easypack PuttyKuros Biosciences Thu Jun 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241542 — 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD)3M Company Thu Jun 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
DEN230055 — FSYX™ Ocular Pressure Adjusting Pump (FSYX™ OPAP) SystemBalance Ophthalmics, Inc. Thu Jun 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241520 — Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal 3 Full Face Non-Vented Mask; Veraseal 3 Full Face AAV Non-Vented MaskSleepnet Corporation Thu Jun 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233762 — SteroScope® Sterilization Technology SystemIdeate Medical, Inc. Thu Jun 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233357 — EsoCool Thermal Regulation CatheterNuvaira, Inc. Thu Jun 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240381 — CATALYSTEM Femoral StemsSmith & Nephew, Inc. Thu Jun 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240327 — UNIKO PointCloud™ Knee InstrumentsUnik Orthopedics, Inc. Thu Jun 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241509 — TENS&EMS units (SM9109A, SM9109B)Plexus Yoga, LLC Dba Chirp Thu Jun 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240823 — els extra low shrinkage® composite & els extra low shrinkage® flowSaremco Dental AG Thu Jun 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233983 — Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D97130F5); Swan-Ganz Pacing Thermodilution TD Catheter (D200F7); Chandler Transluminal V-Pacing Probe (D98100)Edwards Lifesciences Thu Jun 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240717 — 3M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E3M Company Thu Jun 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240564 — NuFACE® FIX+Carol Cole Company Dba Nuface® Thu Jun 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
DEN240016 — Xpert HCV; GeneXpert Xpress SystemCepheid Thu Jun 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241553 — Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic CoatingEximo Medical, Ltd. Thu Jun 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240853 — Pathfinder® CR SystemNeptune Medical, Inc. Thu Jun 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241506 — Annabella Double Breast Pump (ADO-US23-1000)Annabella Tech Thu Jun 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233398 — Faros Surgical SystemOertli Instrumente AG Thu Jun 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232987 — FlowArt Valve for Vial AccessAsset Medikal Tasarim Sanayi VE Ticaret A.S. Wed Jun 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232829 — Versalock Rib and Sternum Plates SystemGM Dos Reis Industria e Comercio Ltda. Wed Jun 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233579 — SC1 Handheld Ultrasound Imaging system (Model: SC1)Fcu Co., Ltd. Wed Jun 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233380 — TRIDENT Mobile Fluoroscopy SystemDornier Medtech America Wed Jun 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241133 — Magnifico Open (100009900); Magnifico MSK ( 100009910)Esaote, S.p.A. Wed Jun 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K222771 — Sample Preservative FluidHangzhou Bioer Technology Co., Ltd. Wed Jun 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233840 — Endoscopic Fluorescence Camera System (DPM-ENDOCAM-03PF)Zhuhai Dipu Medical Technology Co., Ltd. Wed Jun 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K234059 — Forma Medical Optimal Plating SystemForma Medical, Inc. Wed Jun 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233413 — Ultraphon Chemical Indicator (TRO-T and TRO-B)True Indicating, LLC Wed Jun 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241507 — ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK)Aln S.A.R.L. Wed Jun 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240875 — Unity Knee PS-C Tibial InsertCorin U.S.A. Limited Wed Jun 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233354 — WVSM Pro (Series) (500-0030-XX)Athena Gtx, Inc. Wed Jun 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240824 — Disposable Medical Nitrile Examination Gloves (Non sterile) (QN-N001, QN-N002, QN-N003, QN-N004, QN-N005)Ningxia Qiaoen Medical Technology Co., Ltd. Tue Jun 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233368 — Allograft Delivery Device (OFAC-C)Bioventus, LLC Tue Jun 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233006 — MyndMove, MyndMove 2.0Myndtec, Inc. Tue Jun 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232111 — NeoBeat, NeoBeat MiniLaerdal Medical AS Tue Jun 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240582 — VEA Align; spineEOSEos Imaging Tue Jun 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
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