510(k) Clearances — Page 155
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K233483 — FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration) | Cardio Flow Inc., Thu Feb 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231514 — Azure | Daeshin Enterprise Co., Ltd. Wed Feb 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240427 — airVata | Gelb Practice Solutions, Inc. Wed Feb 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233678 — Radiography 7000 M | Philips Medical Systems Dmc GmbH Wed Feb 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231855 — QOCA® image Smart RT Contouring System | Quanta Computer, Inc. Tue Feb 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231134 — VerteLoc Spinal System | Signature Orthopaedics Pty, Ltd. Tue Feb 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234048 — M.U.S.T. Pedicle Screw System - Extension | Medacta International S.A. Tue Feb 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231990 — Apex Locator | Cefla S.C. Tue Feb 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233954 — Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu | B&E Korea Co., Ltd. Tue Feb 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233661 — Transorb Self-Gripping Resorbable Mesh | Sofradim Production Tue Feb 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232082 — EXPD 4343S | DRTECH Corporation Tue Feb 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233959 — EPi-Ease Epicardial Access Device (EAS) | AtriCure, Inc. Tue Feb 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234123 — Easi-Vue® embolic microspheres System | Abk Biomedical, Inc. Tue Feb 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233788 — EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound, LLC Tue Feb 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233740 — Black Nitrile Powder Free Patient Examination Glove, Non Sterile | W.A. Rubbermate Co., Ltd. Tue Feb 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233260 — Univers Revers CA Head and Adapter | Arthrex, Inc. Mon Feb 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233217 — Mimics Cardiac Planner | Materialise NV Mon Feb 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233401 — Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile) | Eieling Technology Limited Mon Feb 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233134 — I.T.S. INS Proximal Femur Nail | I.T.S. GmbH Mon Feb 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232003 — Endoscopic Video Image Processor, Single-Use Video Hysteroscope | Guangzhou Red Pine Medical Instrument Co., Ltd. Mon Feb 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233040 — EMS/TENS Massager Device | Shenzhen Imdk Medical Technology Co., Ltd. Mon Feb 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233533 — NerveTape | Biocircuit Technologies, Inc. Mon Feb 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233092 — Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W) | Chongqing Rob Linka Science and Technology Co., Ltd. Mon Feb 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233667 — Facial Toning device (UIC-189); Facial Toning device (UIC-589) | Body Trim Industrial Co., Ltd. Mon Feb 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232674 — PainFreeze II | Nuance Medical, LLC Mon Feb 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231468 — SCOUT MD Surgical Guidance System | Merit Medical System, Inc. Mon Feb 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233635 — SPY Cystoscope/Hysteroscope | Stryker Endoscopy Mon Feb 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240098 — DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) | STERIS Corporation Fri Feb 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234037 — CATS-L Tonometer Prism | Cats Tonometer, LLC Fri Feb 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233464 — WSA Self-Fitting Hearing Aid Gen 2 | Wsaud A/S Fri Feb 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232473 — Infrared Thermometer: Model YJ600 | Zhuhai Yueja Medical Device Technology Co., Ltd. Fri Feb 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233638 — VERZA High Speed Drills | Globus Medical, Inc. Fri Feb 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232072 — AMICA-GEN AGN-H-1.3, AMICA-GEN AGN 3.3, AMICA-PROBE 17G & 18G | H.S Hospital Service S.P.A Fri Feb 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240066 — Fine Osteotomy | Bodycad Laboratories, Inc. Fri Feb 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240072 — Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested For Use With Chemotherapy Drugs and Fentanyl Citrate | Luliang Hongruida Health Protection Technology Co., Ltd. Fri Feb 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231355 — Aurora | Ensodata Fri Feb 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231733 — Neteera 130H-Plus Vital Sign Monitoring Sensor | Neteera Technologies , Ltd. Fri Feb 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233631 — ZapStim Controller Application (Z1023) | Revital Lab, Inc. Fri Feb 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234034 — VenaCore Thrombectomy Catheter (46-101) | Inari Medical, Inc. Fri Feb 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240084 — V-STRUT® Vertebral Implant | Hyprevention Fri Feb 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231536 — eQUANT System | Avails Medical, Inc. Thu Feb 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233024 — Alma Harmony | Alma Lasers, Inc. Thu Feb 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232644 — neuro42 MRI System | Neuro42, Inc. Thu Feb 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231662 — Aid-U | Iaid Thu Feb 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231575 — Vecttor VT-300 | Artaflex, Inc. Thu Feb 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232854 — Leksell GammaPlan (LGP) | Elekta Solutions AB Thu Feb 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233504 — Lexa MINI (RIS-303, RIS-305) | W&H Sterilization S.R.L. Thu Feb 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233080 — HealthFLD | Nano-X AI , Ltd. Thu Feb 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231913 — T-FIT | Techwin Co., Ltd. Thu Feb 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240069 — Endolumik Gastric Calibration Tube M Series (EGCT36M); Endolumik Gastric Calibration Tube M Series (EGCT40M) | Endolumik Thu Feb 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |