510(k) Clearances — Page 144
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K232105 — APTUS Foot System 2.8-3.5 | Medartis AG Fri Apr 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240534 — Bio-Medicus Life Support Catheter and Introducer | Medtronic, Inc. Fri Apr 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240781 — SKOUT® system | Iterative Scopes, Inc. Fri Apr 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232259 — Patriot-SI Posterior Implant System | Spinal Simplicity, LLC Fri Apr 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240162 — LIFEPAK® 35 AC Power Adapter (41335-000001) | Stryker Physio-Control Fri Apr 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233046 — Electrical Neuromuscular Stimulator, Cure Trio | Oriental Inspiration Limited Fri Apr 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233737 — ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) | Ulrich GmbH & Co. KG Fri Apr 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234092 — SafeOp 3: Neural Informatix Systeem | Alphatec Spine, Inc. Fri Apr 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233850 — Difiney Anti Snoring Device | Fissiontech, LLC Thu Apr 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240155 — Cochlear Osia System | Cochlear Americas Thu Apr 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232325 — RAYSCAN a-Expert | Ray Co., Ltd. Thu Apr 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233924 — EMBOGUARD Balloon Guide Catheter | Neuravi Limited Thu Apr 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232627 — HotDog Warming Mattress + Return Electrode | Augustine Temperature Management, LLC Thu Apr 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240258 — Disposable Medical Face Mask (M643BE) | Makrite Industries, Inc. Thu Apr 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240046 — Ethylene Oxide Sterilization Supplier Change for MPO Hips | Microport Orthopedics Thu Apr 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234098 — Mobility Scooter (C4+) | Yongkang Yile Vehicle Co., Ltd. Thu Apr 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240085 — zLOCK Lumbar Facet Fixation System | Zygofix , Ltd. Thu Apr 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230233 — Prospera Spectruum Negative Pressure Wound Therapy System | Deroyal Industries, Inc. Thu Apr 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232238 — Goyo Mouthpiece S | Dimedikorea Wed Apr 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240484 — MSFX Mikron Cervical Anterior Plate System | Mikron Makina Sanayi VE Ticaret Ltd. Sti. Wed Apr 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231646 — Carilex VT¿200-i NX | Carilex Medical, Inc. Wed Apr 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240032 — Celerity Chemical Indicator for enspire 3000 CLCSPS | STERIS Corporation Wed Apr 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240519 — Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens | Innova Vision, Inc. Wed Apr 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240039 — Enteral Feeding Sets | Hangzhou Primecare Medical Co., Ltd. Wed Apr 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240057 — TraumaGuard Intra-abdominal Pressure Sensing System | Sentinel Medical Technologies, LLC Wed Apr 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233863 — TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating System (1st Met Osteotomy Plate), TriMed ASET Foot Plating System (H-Plate), TriMed ASET Foot Plating System (Talonavicular Plate), TriMed ASET Foot Plating System (Calcaneal Slide Osteotomy Plate), TriMed ASET Foot Plating System (Evans Osteotomy Plate), TriMed ASET Foot Plating System (Medial Column Fusion Plate), TriMed ASET Foot Plating System (Straight Plate), TriMed ASET Foot Plating System (T- | TriMed, Inc. Wed Apr 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233186 — uOmnispace.MR | Shanghai United Imaging Healthcare Co., Ltd. Wed Apr 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233962 — ReBorn (1050nm) | Lightfective , Ltd. Tue Apr 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232256 — Alcantara Thoracolumbar Plate System | Camber Spine Technologies, LLC Tue Apr 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240748 — nextaro® v, 20/20 | Sfm Medical Devices GmbH Tue Apr 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232202 — Aperio GT 450 DX | Leica Biosystems Imaging, Inc. Tue Apr 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232133 — Co2 Laser System, Models: PureLase And VanLase | Cpmt Laser (Canadian Pioneer Medical Technology Corporation) Tue Apr 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233886 — Ambu® aScope Duodeno 2, Ambu® aBox 2 | Ambu A/S Tue Apr 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232208 — Sectra Digital Pathology Module (Version 3.3) | Sectra AB Tue Apr 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223113 — Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments | Medentika GmbH Mon Apr 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233411 — Folysil Silicone Catheter | Coloplast Corp. Mon Apr 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240205 — Ez Catch Auto; Ez Catch YR; Ez Catch TR | Veol Medical Technologies Pvt , Ltd. Mon Apr 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232926 — Novalung ultimate kit (US) | Fresenius Medical Care Renal Therapies Group, LLC Mon Apr 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232904 — Access Ostase | Beckman Coulter Mon Apr 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240884 — Glide (91000-GL-X) | Infinite Biomedical Technologies, LLC Mon Apr 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240773 — VisAble.IO | Techsomed Mon Apr 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232175 — XN Knee Prosthesis System | Beijing Chunlizhengda Medical Instruments Co., Ltd. Sun Apr 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240452 — Ceramic Femoral Head | Microport Orthopedics, Inc. Fri Apr 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222766 — Disposable Extension Set | Shandong Ande Healthcare Apparatus Co., Ltd. Fri Apr 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233624 — HCG One Step Pregnancy Test Strip OTC, HCG One Step Pregnancy Test Strip Rx, HCG One Step Pregnancy Test Midstream OTC, HCG One Step Pregnancy Test Midstream Rx | Hangzhou Aichek Medical Technology Co., Ltd. Fri Apr 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233034 — Mobility+ Enteral Feeding System OTC | Rockfield Medical Fri Apr 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240238 — Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation Fri Apr 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232200 — Disposable Injection Needles | Ningbo Xinwell Medical Technology Co., Ltd. Fri Apr 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240703 — Fine Osteotomy | Bodycad Laboratories, Inc. Fri Apr 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240419 — UltraThineer Zirconia Slurry (5Y-B) | Boston Micro Fabrication Fri Apr 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |