510(k) Clearances — Page 135
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K241011 — Mako Total Knee Application | Mako Surgical Corp. Tue Jun 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240111 — Venue | GE Medical Systems Ultrasound and Primary Care Diagnostics Mon Jun 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241399 — Indigo® Lightning Flash Aspiration System Select + Catheter | Penumbra, Inc. Mon Jun 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233767 — OmniTom Elite | Neurologica Corporation Mon Jun 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240644 — Medical Diode Laser (S1Pro) | Wuhan Pioon Technology Co., Ltd. Mon Jun 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240106 — Histofreezer V | Cryoconcepts LP Mon Jun 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232911 — KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [positive deflection] (11278A2), KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [contra-positive deflection] (11278AU1) | Karl Storz Endovision, Inc. Mon Jun 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240108 — Wrap Accessory Electrodes (GMX-ABSBELT01; GMX-ABSBELT02; GMX-WRIST01; GMX-ELBOW01; GMX-LEG01, GMX-ANKLE01, GMX-KNEE01; GMX-FOOT PAD01; GMX-GLOVES01; SHOULDER01; GMX-NCK01) | Gymmax Technology Shenzhen Co., Ltd. Mon Jun 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234106 — Venue Fit | GE Medical Systems Ultrasound and Primary Care Diagnostics Mon Jun 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240283 — BubbleView Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR); ViewHub® Video Processor (S13, S13-T, S13-N, S13-S) | MacroLux Medical Technology Co., Ltd. Mon Jun 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240053 — Venue Go | GE Medical Systems Ultrasound and Primary Care Diagnostics Mon Jun 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240206 — Venue Sprint | GE Medical Systems Ultrasound and Primary Care Diagnostics Mon Jun 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232969 — Disposable Hemostatic Clips | Ningbo Xinwell Medical Technology Co., Ltd. Fri Jun 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232035 — Impala | AliveCor, Inc. Fri Jun 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232806 — HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask (48388) | Owens & Minor (O&M) Halyard, Inc. Fri Jun 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241069 — iLoop Interventional Coil 0.55T | Noras Mri Products GmbH Fri Jun 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240570 — IPD Dental Implant Abutments | Implant Protesis Dental 2004, S.L. Fri Jun 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240672 — Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ( ZD-HT-PLUS, ZD-ST, ZD-SHT, ZD-HT-C, ZD-ST-C, ZD-SHT-C, ZD-UT-C, ZD-ST-ML, ZD-SHT-ML, ZD-UT-ML, ZD-3D-Pro-ML, ZD-4D-Pro-ML) | Zhejiang Zahndent Biotechnology Co., Ltd. Fri Jun 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241038 — Cardiac CT Function Software Application | Circle Cardiovascular Imaging Fri Jun 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232963 — VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL) | bioMerieux, Inc. Fri Jun 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234042 — EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100) | Ever Fortune.Ai, Co., Ltd. Fri Jun 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240972 — Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC) | Surgical Instrument Service and Savings, Inc. Fri Jun 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231010 — Corvair | AliveCor, Inc. Fri Jun 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234099 — Select Hybrid Personal Lubricant, and Select Pure Silicone Personal Lubricant | Select Labs, LLC Fri Jun 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232625 — Steriking® Pouch for Robotic Instruments | Wipak OY Fri Jun 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241423 — Access Thyroglobulin | Beckman Coulter, Inc. Fri Jun 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240832 — Blood Pressure Monitor (BBZ32-AA01) | Guangdong Transtek Medical Electronics Co., Ltd. Fri Jun 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232816 — Electrocardiograph, model: ECG301 | Shenzhen LE Medical Technology Co., Ltd. Fri Jun 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232837 — Uro-G HD Flexible Cystoscope | Uroviu Corporation Fri Jun 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232804 — FibriCheck | Qompium NV Fri Jun 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233825 — Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter | Innovative Health Fri Jun 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233861 — Libre Rio Continuous Glucose Monitoring System | Abbott Diabetes Care Fri Jun 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240662 — Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q Instruments; Mesa 2 Q Instruments; Q Pedicle Preparation Instruments; Q S2AI Drills; Q Handles; Consolidated Operating Room Equipment (CORE) 2 Console; Electric System 6 Dual Trigger Rotary Handpiece | Stryker Leibinger GmbH & Co KG Thu Jun 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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. Thu Jun 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233824 — Swan-Ganz catheter | Edwards Lifesciences, LLC Thu Jun 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240951 — Invictus Robotic Navigation Instruments | Alphatec Spine Thu Jun 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240202 — Conical Platform Dental Implants System | Noris Medical , Ltd. Thu Jun 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240965 — CORTRAK* 2 Enteral Access System (20-0950) | Avanos Medical, Inc. Thu Jun 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232968 — Grande Medical Masks, Model SF-600 | Golden Grande Corp. Thu Jun 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240963 — Spinal System | Teslake, Inc. Thu Jun 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241304 — WaveSense Jazz Blood Glucose Monitoring System | Agamatrix Thu Jun 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233094 — Wellead® Latex Foley Catheter | Well Lead Medical (Hainan) Co., Ltd. Thu Jun 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240948 — TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support | Imperative Care, Inc. Thu Jun 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232774 — Wearable Breast Pump,Model S18 | Ningbo Dearevery Electronic Technology Co., Ltd. Thu Jun 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240603 — Ti-Base & Master Fix | Arum Dentistry Co., Ltd. Wed Jun 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233008 — Cannulated Headless Bone Screws | Aap Implantate AG Wed Jun 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240187 — Tapered Pro Conical Implant System | BioHorizons Implant Systems, Inc. Wed Jun 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240211 — VELYS Robotic-Assisted Solution | Depuy Ireland UC Wed Jun 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241262 — Baby Gorilla/Gorilla Plating System; Monster Screw System | Paragon 28, Inc. Wed Jun 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240358 — ShockPhysio Mobile (model SW3200 Basic) | Shenzhen Dongdixin Technology Co., Ltd. Wed Jun 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |