510(k) Clearances — Page 172
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K231918 — Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter | Koru Medical Systems Fri Nov 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232382 — Control-IQ Technology | Tandem Diabetes Care, Inc. Fri Nov 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232186 — LOGIQ e | Ge Medical Systems Ultrasound and Primary Care Diagnostic, Fri Nov 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231254 — GripTract-GI Endoscopic Tissue Manipulator | Actuated Medical, Inc. Fri Nov 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232266 — Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Better Care Plastic Technology Co., Ltd. Fri Nov 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231440 — Combo Electrotherapy Device | Shenzhen Roundwhale Technology Co. , Ltd. Fri Nov 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230343 — ProSeal Closed System Administration Set | Epic Medical Pte. , Ltd. Fri Nov 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230100 — SCIZER (SC1-M410) | Classys, Inc. Fri Nov 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232380 — t:slim X2 Insulin Pump with Interoperable Technology | Tandem Diabetes Care, Inc. Fri Nov 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232113 — Halcyon, Ethos Radiotherapy System | Varian Medical Systems, Inc. Fri Nov 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231569 — ManaFlexx 2 (model: MF002-RX, MF002-OTC) | Manamed, Inc. Fri Nov 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231182 — Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System | Zoll Circulation, Inc. Fri Nov 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230800 — XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50 | GEMSS HEALTHCARE CO., LTD. Thu Nov 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233056 — EpiZact | Guidestar Medical Devices Thu Nov 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232532 — Nd:Yag Laser Therapy Systems | Beijing Unt Technology Co., Ltd. Thu Nov 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232029 — VersaWrap Nerve Protector | Alafair Biosciences, Inc. Thu Nov 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232345 — ATEC Posterior Navigated Disc Prep Instruments | Alphatec Spine, Inc. Thu Nov 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233062 — BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx | Vivachek Biotech (Hangzhou) Co., Ltd. Thu Nov 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233518 — BASE290 LED Curing Light | Handpiece Headquarters Thu Nov 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233407 — AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH2); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2); AtriClip PRO-V LAA Exclusion System (PROV); AtriClip Flex-V LAA Exclusion System with preloaded V Clip (ACHV) | AtriCure, Inc. Thu Nov 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232725 — Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor | Suzhou Endophix Co., Ltd. Thu Nov 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232076 — Fibercure | Lumendo AG Thu Nov 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230326 — ENFit to ENFit Extension Sets | Vesco Medical Thu Nov 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232176 — STELLAR Knee | Polarisar, Inc. Thu Nov 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231414 — CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009) | Chalice Medical , Ltd. Wed Nov 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233502 — TERA HARZ II | Graphy, Inc. Wed Nov 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230927 — OptiMesh Multiplanar Expandable Interbody Fusion System | Spineology, Inc. Wed Nov 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233402 — Bard 3DMax Mesh | Davol Inc., Subsidiary of C. R. Bard, Inc. Wed Nov 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232730 — Aventus Thrombectomy System | Inquis Medical Wed Nov 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232880 — Inzii Ripstop Redeployable Retrieval System | Applied Medical Resources Corporation Wed Nov 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231362 — OCS Heart Leukocyte Depleting Filter | TransMedics, Inc. Tue Oct 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232099 — Neodent Implant System - GM Zygomatic Implant System | JJGC Indústria e Comércio de Materiais Dentários S.A. Tue Oct 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231238 — Ultravision2 System | Alesi Surgical, Ltd. Tue Oct 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232321 — FlexCath Contour Steerable Sheath | Medtronic, Inc. Tue Oct 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231629 — 091 Balloon Guide Catheter | Eosolutions, Corp. Tue Oct 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230352 — Tornier Humeral Nail and Tornier Long Humeral Nail | Tornier, Inc. Tue Oct 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231243 — Finger Clip Pulse Oximeter | Guangdong Genial Technology Co., Ltd. Tue Oct 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233320 — LINQ II Insertable Cardiac Monitor (LNQ22) | Medtronic, Inc. Tue Oct 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230814 — VRNT | Cognifisense, Inc. Tue Oct 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230328 — Speedboat Flush SB1 Instrument | Creo Medical, Ltd. Tue Oct 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232294 — HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta Advanced Monitor (Smart Recovery); HemoSphere Alta Advanced Monitor (Cardiac); HemoSphere Alta Advanced Monitor (All-on-One) | Edwards Lifesciences, LLC Tue Oct 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231868 — Electric Wheelchair (Robooter E40), Model name: BBR-E40-01 | Shanghai Bangbang Robotics Co., Ltd. Tue Oct 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231298 — Ultravision2 System Integrated Monopolar L-Hook (H/S) | Alesi Surgical, Ltd. Tue Oct 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230083 — SAFIRA | Medovate Limited Tue Oct 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230602 — Hudson RCI® TurboMist Nebulizer System | Medline Industries, LP Tue Oct 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231947 — EVOLUTION® Cement Keel | Microport Orthopedics, Inc. Tue Oct 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232318 — VICTORY Lumbar Plate System | Globus Medical, Inc. Tue Oct 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232310 — Sensititre 20-24 hour Haemophilus influenzaelStreptococcus pneumoniae MIC or Breakpoint Susceptibility System with Ceftolozane-tazobactam in the dilution range of 0.03/4-64/4ug/ml | Thermo Fisher Scientific Tue Oct 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231340 — Renova Spine Balloon Catheter | Biopsybell S.R.L. Mon Oct 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231378 — Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0 | Insightec, Ltd. Mon Oct 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |