510(k) Clearances — Page 119
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K241010 — HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors | Depuy Mitek Wed Sep 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241362 — Pounce XL Thrombectomy System (PTS-1011-7F135) | Surmodics,Inc. Wed Sep 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241954 — SonoBlock; SonoBlock II | PAJUNK GmbH Medizintechnologie Wed Sep 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232559 — C&B NFH Hybrid | Arum Dentistry Co., Ltd. Wed Sep 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241161 — Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound Imaging System (LK128C); Ultrasound Imaging System (LK128M); Ultrasound Imaging System (LK128PA); Ultrasound Imaging System (LK128E); Ultrasound Imaging System (LU700C); Ultrasound Imaging System (LU700L); Ultrasound Imaging System (LU710L); Ultrasound Imaging System (LU710LH); Ultrasound Imaging System (LU710C); Ultrasound Imaging System (LU710M); Ultrasound Imaging System (LU710PA); Ultrasound Imaging | Leltek, Inc. Wed Sep 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241004 — Wearable Breast Pump (ABP-1508PRO, ABP-1506, ABP-1306, ABP-1306 PRO, M1, M3, M8, M5, M6, K1, K2, K3, K5, ABP-1306PLUS, ABP-1308, M2) | Huizhou Lvb Maternal and Infant Supplies Co., Ltd. Wed Sep 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241638 — 8mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 Stapler; 8mm SureForm 30 Reloads | Intuitive Surgical, Inc. Tue Sep 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240094 — LumiNE US; Lumi | Augmedit B.V. Tue Sep 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240990 — Mobility Scooter | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd Tue Sep 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241609 — Tornier Humeral Reconstruction System (Tornier HRS) | Stryker Corporation (Tornier, Inc.) Tue Sep 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241214 — ProPel SG3 Surgical Gown | Standard Textile Co., Inc. Tue Sep 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234064 — Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Siemens Systems) (10135936); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for GE Systems) (10135910) | Surgical Instrument Service and Savings, Inc. Tue Sep 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242612 — Option ELITE Vena Cava Filter System (352506070E 352506100E) | Argon Medical Devices, Inc. Tue Sep 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240266 — Latex Examination Glove Powder Free (Ocean Blue and Natural White) | Sri Trang Gloves (Thailand) Public Company Limited Mon Sep 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240233 — Pitkar Spinal Pedicle Screw System | S.H.Pitkar Orthotools Pvt. , Ltd. Mon Sep 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241678 — TENS & EMS Stimulator (MHD-1083) | Shenzhen Minghuangda Electronics Co., Ltd. Mon Sep 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242394 — Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF) | Rayence Co., Ltd. Mon Sep 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241205 — Ice Cooling IPL Hair Removal Device (Y6S GR, Y6S GA,Y6S GT, Y6S JU, Y6S JM, Y6S MU, Y6S OG, Y6S CH,Y6S PN,Y6S NK, Y6S PG, Y6S TG, Y6S OE) | Shenzhen Ulike Smart Electronics Co., Ltd. Mon Sep 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242042 — TriALTIS Spine System | Medos International SARL Mon Sep 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242349 — FoLix | Lumenis Be, Ltd. Mon Sep 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240697 — See-Mode Augmented Reporting Tool, Thyroid (SMART-T) | See-Mode Technologies Pte, Ltd. Mon Sep 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241681 — Overjet Image Enhancement Assist | Overjet, Inc. Mon Sep 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240791 — ADAS 3D | Adas3D Medical S.L. Mon Sep 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240486 — PM2 System and ECGuide Connector | Piccolo Medical, Inc. Sun Sep 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241976 — nextaro® va, 15mm, 5µm | Sfm Medical Devices GmbH Fri Sep 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240411 — uAI Portal | Shanghai United Imaging Intelligence Co., Ltd. Fri Sep 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231667 — Withings Sleep Rx | Withings Fri Sep 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242415 — TMC Compression Implant System | Treace Medical Concepts Fri Sep 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233900 — Nordica PV Cryo Mapping Catheter | Synaptic Medical Corporation Fri Sep 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234044 — ACS® LD FB Knee System | Implantcast GmbH Fri Sep 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241672 — COPRO 3 | Amt Engineering Co., Ltd. Fri Sep 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233974 — Mucosal Impedance Measurement System | Alandra Medical Sapi DE CV Fri Sep 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233911 — VISULAS combi | Carl Zeiss Meditec, AG Fri Sep 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241164 — IB3D PL Spinal System | Medicrea International S.A.S. (Medtronic) Fri Sep 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232996 — Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF) | Shanghai Iatrical-Ti Technologies CO , Ltd. Fri Sep 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241427 — Access Syphilis | Beckman Coulter, Inc. Fri Sep 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232543 — MSC SFM | Yocon Biology Technology Company Fri Sep 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241415 — Orchid Safety Release Valve | Linear Health Sciences, LLC Fri Sep 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240600 — SafeCross Vascular Introducer System (4001) | East End Medical I, LLC Fri Sep 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234035 — COSINE Spacer | Globus Medical, Inc. Fri Sep 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241552 — MENTOR MemoryGel Enhance Single Use Gel Sizer | Mentor Worldwide, LLC Fri Sep 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241693 — FemChec Controlled Saline-Air Device (FCD-250) | Femasys, Inc. Fri Sep 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241579 — DD Hybridlayer (multicolored zirconia) | Dental Direkt GmbH Fri Sep 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233921 — Luvis Chair (LC700C) | Dentis Co., Ltd. Fri Sep 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233806 — T2 Plus | Osstem Implant Co., Ltd. Fri Sep 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240203 — URUS System (DMG-SU100/URUS); URUS System (DMG-SU100R/URUS); URUS System (VP-100/Video Processor) | Dyne Medical Group, Inc. Thu Sep 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242390 — Novum IQ Syringe Pump (40800BAXUS) | Baxter Healthcare Corporation Thu Sep 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241605 — Adaptix PEEK Interbody System with Nanotechnology; Capstone Control PEEK Spinal System with Nanotechnology | Nanovis, LLC Thu Sep 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241721 — Electric wheelchair (N3901) | Zhejiang Richall Medical Technology Co., Ltd. Thu Sep 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231566 — ICX-Implant System | Medentis Medical GmbH Thu Sep 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |