510(k) Clearances — Page 147

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 147 of 3,525)
ClearancesDetails
K241212 — MagnetOs Easypack PuttyKuros Biosciences Jun 27, 2024
K240717 — 3M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E3M Company Jun 27, 2024
K233357 — EsoCool Thermal Regulation CatheterNuvaira, Inc. Jun 27, 2024
K240381 — CATALYSTEM Femoral StemsSmith & Nephew, Inc. Jun 27, 2024
K240327 — UNIKO PointCloud™ Knee InstrumentsUnik Orthopedics, Inc. Jun 27, 2024
K241509 — TENS&EMS units (SM9109A, SM9109B)Plexus Yoga, LLC Dba Chirp Jun 27, 2024
K240823 — els extra low shrinkage® composite & els extra low shrinkage® flowSaremco Dental AG Jun 27, 2024
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 Jun 27, 2024
K240564 — NuFACE® FIX+Carol Cole Company Dba Nuface® Jun 27, 2024
DEN240016 — Xpert HCV; GeneXpert Xpress SystemCepheid Jun 27, 2024
K233579 — SC1 Handheld Ultrasound Imaging system (Model: SC1)Fcu Co., Ltd. Jun 26, 2024
K241133 — Magnifico Open (100009900); Magnifico MSK ( 100009910)Esaote, S.P.A. Jun 26, 2024
K222771 — Sample Preservative FluidHangzhou Bioer Technology Co., Ltd. Jun 26, 2024
K233354 — WVSM Pro (Series) (500-0030-XX)Athena Gtx, Inc. Jun 26, 2024
K233380 — TRIDENT Mobile Fluoroscopy SystemDornier Medtech America Jun 26, 2024
K232829 — Versalock Rib and Sternum Plates SystemGM Dos Reis Industria E Comercio Ltda. Jun 26, 2024
K232987 — FlowArt Valve for Vial AccessAsset Medikal Tasarim Sanayi VE Ticaret A.S. Jun 26, 2024
K233840 — Endoscopic Fluorescence Camera System (DPM-ENDOCAM-03PF)Zhuhai Dipu Medical Technology Co., Ltd. Jun 26, 2024
K234059 — Forma Medical Optimal Plating SystemForma Medical, Inc. Jun 26, 2024
K233413 — Ultraphon Chemical Indicator (TRO-T and TRO-B)True Indicating, LLC Jun 26, 2024
K241507 — ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK)Aln S.A.R.L. Jun 26, 2024
K240875 — Unity Knee PS-C Tibial InsertCorin U.S.A. Limited Jun 26, 2024
K240824 — Disposable Medical Nitrile Examination Gloves (Non sterile) (QN-N001, QN-N002, QN-N003, QN-N004, QN-N005)Ningxia Qiaoen Medical Technology Co., Ltd. Jun 25, 2024
K233006 — MyndMove, MyndMove 2.0Myndtec, Inc. Jun 25, 2024
K233368 — Allograft Delivery Device (OFAC-C)Bioventus, LLC Jun 25, 2024
K232640 — Venowave VW5Thermabright Jun 25, 2024
K232111 — NeoBeat, NeoBeat MiniLaerdal Medical AS Jun 25, 2024
K240582 — VEA Align; spineEOSEos Imaging Jun 25, 2024
K241158 — ASAHI Veloute; ASAHI Veloute C3; ASAHI Tellus; ASAHI Tellus C3Asahi Intecc Co., Ltd. Jun 25, 2024
K241035 — PMT Posterior Cervical Stabilization System (PCSS)Providence Medical Technology, Inc. Jun 25, 2024
K241120 — Intense pulsed light therapy apparatus (FDA01, FDA02, FDA03, FDA04S, FDA05S, FDA06, FDA06S, FDA07, FDA07S, FDA08, FDA09S, FDA10S)Qiaocheng LI (Dongguan) Medical Instruments Co., Ltd. Jun 24, 2024
K240259 — APEX 3D Total Ankle Replacement SystemParagon 28, Inc. Jun 24, 2024
K233123 — SILKROHironic Co., Ltd. Jun 24, 2024
K233630 — Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse Deflection); Ambu® aBox™ 2Ambu A/S Jun 24, 2024
K241144 — Picosecond Nd:YAG Laser (PICOCAREMAJESTY)Wontech Co., Ltd. Jun 24, 2024
K233204 — Philips IntelliSite Pathology Solution 5.1Philips Medical Systems Nederland B.V. Jun 24, 2024
K232952 — Copran ZriWhitepeaks Dental Solutions GmbH Jun 24, 2024
K233288 — NLZ Built-In Motor SystemNakanishi, Inc. Jun 24, 2024
K233196 — Medihub ProstateJLK, Inc. Jun 21, 2024
K241476 — ToxiSeal™ Vial Adaptor with External Flip BalloonEpic Medical Pte. , Ltd. Jun 21, 2024
K233326 — Merge Hemo, Model RCSV2Merge Healthcare Incorporated Jun 21, 2024
K240862 — Medicom Sterilization WrapMedicom Group, Inc. Jun 21, 2024
K241459 — MOTUS PRO FamilyEl.En S.P.A. Jun 21, 2024
K233259 — XerosynXerothera, Inc. Jun 21, 2024
K240649 — Ice Cooling IPL Hair Removal Device (UI07 BR, UI07 DB, UI07 BL, UI07 GP, UI07 PN, UI07 RE, UI07 WH, UI07 PW, UI20 BR, UI20 DB, UI20 BL, UI20GP, UI20 PN, UI20 RE, UI20 WH, UI20 PW)Shenzhen Ulike Smart Electronics Co., Ltd. Jun 21, 2024
K234155 — Nimbl (model PD08-N1)Tactile Medical Jun 21, 2024
K241117 — M6-C™ Single Use, Disposable InstrumentationSpinal Kinetics / Orthofix / Seaspine Jun 21, 2024
K233240 — GERDX-SystemG-Surg GmbH Jun 21, 2024
K240465 — O-arm O2 Imaging SystemMedtronic Navigation, Inc. Jun 21, 2024
K241519 — Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc. Jun 21, 2024
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