510(k) Clearances — Page 151

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 151 of 3,525)
ClearancesDetails
K240657 — ArtiSential Laparoscopic Instruments-Electrodes (AMHD01-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01S-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01L-LH); ArtiSential Laparoscopic Instruments-Electrodes (5AMHD01-LH); ArtiSential Laparoscopic Instruments-Electrodes (5AMHD01S-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01-FH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01S-FH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01L-Livsmed, Inc. Jun 6, 2024
K240202 — Conical Platform Dental Implants SystemNoris Medical , Ltd. Jun 6, 2024
K240965 — CORTRAK* 2 Enteral Access System (20-0950)Avanos Medical, Inc. Jun 6, 2024
K240951 — Invictus Robotic Navigation InstrumentsAlphatec Spine Jun 6, 2024
K232968 — Grande Medical Masks, Model SF-600Golden Grande Corp. Jun 6, 2024
K233824 — Swan-Ganz catheterEdwards Lifesciences, LLC Jun 6, 2024
K240963 — Spinal SystemTeslake, Inc. Jun 6, 2024
K241304 — WaveSense Jazz Blood Glucose Monitoring SystemAgamatrix Jun 6, 2024
K233094 — Wellead® Latex Foley CatheterWell Lead Medical (Hainan) Co., Ltd. Jun 6, 2024
K240948 — TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform SupportImperative Care, Inc. Jun 6, 2024
K232774 — Wearable Breast Pump,Model S18Ningbo Dearevery Electronic Technology Co., Ltd. Jun 6, 2024
K240603 — Ti-Base & Master FixArum Dentistry Co., Ltd. Jun 5, 2024
K233008 — Cannulated Headless Bone ScrewsAap Implantate AG Jun 5, 2024
K240187 — Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc. Jun 5, 2024
K240211 — VELYS Robotic-Assisted SolutionDepuy Ireland UC Jun 5, 2024
K241262 — Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc. Jun 5, 2024
K240358 — ShockPhysio Mobile (model SW3200 Basic)Shenzhen Dongdixin Technology Co., Ltd. Jun 5, 2024
K240648 — Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE)Radiant Innovation, Inc. Jun 5, 2024
K240008 — Mobility Scooter (W3331)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd Jun 5, 2024
K233971 — Arthrex AlloSync PushLock Suture AnchorArthrex, Inc. Jun 4, 2024
K240100 — SAM Model 9-10000Snap Diagnostics, LLC Jun 4, 2024
K240222 — Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024)Aesthetic Technology, Ltd. Jun 4, 2024
K240463 — Slow Wave DS8 (SWDS802)Slow Wave, Inc. Jun 4, 2024
K241258 — Ingenix Spinal SystemIngenium Spine Jun 4, 2024
K240627 — LIAISON PLEX Yeast Blood Culture AssayLuminex Corporation Jun 4, 2024
K240877 — Monteris Medical NeuroBlate SystemMonteris Medical, Jun 4, 2024
K232773 — da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc. Jun 4, 2024
K232820 — HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806)Owens & Minor (O&M) Halyard, Inc. Jun 4, 2024
K240505 — Eminent Spine SI Screw SystemEminent Spine, LLC Jun 4, 2024
K234032 — Hudson RCI Dri-Tech Breathing Circuits; HUD99035/Dri-Tech Adult Circuit; HUD99035KIT/Dri-Tech Adult Circuit Kit; HUD99098KIT/Single Limb Adult Dri-Tech Kit; HUD99098KITF/Single Limb Adult Dri-Tech Filter Kit; HUD900/Dri-Tech Ventilator Accessory; HUD901/Dri-Tech Ventilator Accessory Extension LineMedline Industries, LP Jun 4, 2024
K240947 — TENSOR® Suture Button SystemGlobus Medical, Inc. Jun 3, 2024
K241259 — Amplatz Goose Neck Snare KitMedtronic, Inc. Jun 3, 2024
K240617 — Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS)Olympus Medical Systems Corp. Jun 3, 2024
K240598 — Maestro System (REF100)Moon Surgical Jun 3, 2024
K240834 — EcoFit® short stem cementless cpTiImplantcast GmbH Jun 3, 2024
K240251 — ANNE ChestSibel Health, Inc. Jun 3, 2024
K233751 — Milieve (YPS-301BD)Soterix Medical, Inc. Jun 3, 2024
K231291 — Perforated BasketsRichard Wolf Medical Instruments Corporation Jun 3, 2024
K233587 — LOCATOR Angled Abutment (Various)Zest Anchors, LLC Jun 3, 2024
K232821 — S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. May 31, 2024
K232943 — Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space SyringeSmiths Medical Asd, Inc. May 31, 2024
K240912 — Dental Zirconia Block (Models HT-plus, ST, SHT, UT, 3D-Pro)Anhui Miisen Intelligence Technology Co., Ltd. May 31, 2024
K240969 — IPL Hair Removal (SL-B287, SL-B329, SL-B301-1, SL-B328)Shenzhen Semlamp Intelligent Technology Co., Ltd. May 31, 2024
K240281 — Bone Suppression SoftwareKonica Minolta, Inc. May 31, 2024
K241248 — Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1)Spectrum Medical S.R.L. May 31, 2024
K232080 — Puracyn® Plus Antimicrobial Irrigation SolutionInnovacyn, Inc. May 31, 2024
K220062 — QIAstat-Dx Gastrointestinal Panel 2QIAGEN GmbH May 31, 2024
K240913 — Electric Wheelchair (HBLD3-B); Electric Wheelchair (HBLD3-E)Shanghai Hubang Intelligent Rehabilitation Equipment Co.,Ltd May 31, 2024
K233591 — StylusDegania Silicone , Ltd. May 31, 2024
K232738 — BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002)Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla May 31, 2024
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