510(k) Clearances — Page 145

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 145 of 3,525)
ClearancesDetails
K240527 — HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6)Devicor Medical Products, Inc. Jul 10, 2024
K232177 — Lightin System, Lightin, Lightin GeneratorSolmedix Co., Ltd. Jul 10, 2024
K233628 — AOS Interstitial Templates, Needles, and AccessoriesAlpha-Omega Services, Inc. Jul 10, 2024
K241683 — Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031404020 ); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031406020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031408020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031410020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031412020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031415020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H749390314Boston Scientific Corporation Jul 10, 2024
K240614 — Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHSOticon Medical AB Jul 10, 2024
K232551 — EM-07 Cordless Endo MotorForum Engineering Technologies (96) , Ltd. Jul 9, 2024
K241372 — Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™ABBOTT MEDICAL Jul 9, 2024
K241316 — Zirconia BlockHunan Hualian Special Ceramics Co., Ltd. Jul 9, 2024
K233937 — OW100SSoftwave/Trt, LLC Jul 9, 2024
K241343 — IPL Hair Removal Device (LS-T121, LS-T121A, LS-T121B, LS-T121C, LS-T130, LS-T130A, LST130B, LS-T133, LS-T135, LS-T136, LS-T137, LS-T134, LS-T138, LS-T139, LS-T140)Shenzhen Lescolton Electrical Appliance Co., Ltd. Jul 9, 2024
K240966 — Prima Plus Conical Implant SystemKeystone Dental, Inc. Jul 9, 2024
K241019 — aprevo® TLIF-C Articulating SystemCarlsmed Jul 9, 2024
K240610 — deepLiveDamae Medical Jul 9, 2024
K240502 — da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc. Jul 8, 2024
K233584 — RhythmStar SystemRhythMedix, LLC Jul 8, 2024
K241293 — LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC Jul 8, 2024
K241111 — AMT Suture PasserApplied Medical Technology, Inc. Jul 5, 2024
K240252 — UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniCel DxH 690T Coulter Cellular Analysis SystemBeckman Coulter, Inc. Jul 5, 2024
K241305 — LifeRay Intraoral Handheld X-ray SystemLucas Lifecare Jul 5, 2024
K240120 — Merlexi Craft Bariatric series of manual wheelchairsTurbo Wheelchair Co., Inc. Jul 5, 2024
K241625 — Anatase Navi Disposable InstrumentRemex Medical Corp. Jul 5, 2024
K234082 — STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104); APTIMAX™ Instrument Tray for ULTRA GI™ Cycle (011077)Advanced Sterilization Products Jul 5, 2024
K234084 — STERRAD™ Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator (CI) Tape (14202NL); STERRAD VELOCITY™ Biological Indicator (BI) (43210) (60 count); STERRAD VELOCITY™ Biological Indicator (BI) (43210-30)(30 count); STERRAD VELOCITY™ Reader (43220); ULTRA GI™ Process Challenge Device (PCD) (43400)(30 count)Advanced Sterilization Products, Inc. Jul 5, 2024
K241660 — SiOxD® Wound MatrixSioxmed, LLC Jul 5, 2024
K241649 — DUO1 and DUO2Zinnovi, Inc. Jul 5, 2024
K241284 — da Vinci Surgical System (IS5000)Intuitive Surgical, Inc. Jul 3, 2024
K241606 — Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm Length (HAR1136)Stryker Sustainability Solutions Jul 3, 2024
K241129 — Upper Arm Electronic Blood Pressure MonitorShenzhen Goodlymed Technology Co., Ltd. Jul 3, 2024
K241508 — SKOUT® systemIterative Scopes, Inc. Jul 3, 2024
K241629 — ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L)Ethicon Endo-Surgery, LLC Jul 3, 2024
K240996 — Access Thyroglobulin Antibody IIBeckman Coulter, Inc. Jul 3, 2024
K241577 — Iconix® AnchorRiverpoint Medical Jul 3, 2024
K240009 — iQFlex ProFirst Source, Inc. Jul 3, 2024
K240987 — Access sTfRBeckman Coulter, Inc. Jul 3, 2024
K240946 — Gastric AlimetryAlimetry , Ltd. Jul 3, 2024
K241615 — Transducer Probe CoverHony Medical Co., Ltd. Jul 3, 2024
K241600 — DermablateAsclepion Laser Technologies GmbH Jul 3, 2024
K241371 — VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500)Olympus Medical Systems Corporation Jul 3, 2024
K241277 — OSSIOfiber® Threaded Trimmable Fixation NailOSSIO , Ltd. Jul 3, 2024
K241591 — Blue EyeThe Standard Co., Ltd. Jul 3, 2024
K233574 — Total Wrist Arthroplasty System (TWA)Skeletal Dynamics Jul 3, 2024
K240052 — Disposable Enteral Feeding SetsBeijing L&Z Medical Technology Development Co., Ltd. Jul 3, 2024
K240736 — SMART Bun-Yo-Matic X-RayDisior, Ltd. Jul 2, 2024
K240555 — Tyto Insights for Crackles DetectionTyto Care , Ltd. Jul 2, 2024
K234074 — Next Generation Access CatheterBalt USA, LLC Jul 2, 2024
K240915 — ZIEN IO Intraosseous Access SystemZien Medical Technologies, Inc. Jul 2, 2024
K233626 — AOS Marker Seeds (SMG0242-025)Alpha-Omega Services, Inc. Jul 2, 2024
K234083 — Next Generation Aspiration Catheter; Balt Aspiration Tubing SetBalt USA, LLC Jul 2, 2024
K240930 — Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Violet Blue; Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- BlueSri Trang Gloves Thailand (Public Company Limited) Jul 2, 2024
K233415 — DELTAWAVE Nasal Pillows SystemRemsleep Holdings Jul 2, 2024
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