510(k) Clearances — Page 177
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K223126 — SurgiAid® Collagen Wound Dressing | Maxigen Biotech, Inc. Wed Oct 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232574 — VASSALLO GT Crossing14 | Filmec Co. , Ltd. Wed Oct 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232578 — VASSALLO GT 018 G12; VASSALLO GT 018 G30 | Filmec Co. , Ltd. Wed Oct 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233233 — EMPHASYS Femoral Stems | Depuy Ireland UC Wed Oct 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231050 — Arm Blood Pressure Monitor | Alicn Medical Shenzhen, Inc. Wed Oct 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232070 — Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black, Green) | Better Care Plastic Technology Co., Ltd. Wed Oct 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230116 — Vital Spinal Fixation System | Zimvie Spine (Zimmer Biomet Spine, Inc.) Wed Oct 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232460 — Disposable electrosurgical pencil (MD1000) | Shenzhen Mecun Medical Supply Co., Ltd. Wed Oct 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222025 — G4Derm / G4Derm Plus Synthetic Wound Matrix | Gel4med, Inc. Wed Oct 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230618 — MegaGen Dental Implant Systems Portfolio - MR Conditional | Megagen Implant Co., Ltd. Wed Oct 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232090 — JO Coconut Hybrid Warming Personal Lubricant | CC Wellness, LLC Wed Oct 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232499 — IPL Hair Removal Device (LS-T106, LS-T107, LS-T108) | Shenzhen Lescolton Electrical Appliance Co., Ltd. Wed Oct 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230220 — NeuViz 128 Multi-Slice CT Scanner System | Neusoft Medical Systems Co., Ltd. Wed Oct 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232981 — Synq Software Version 1.3 | Synaptive Medical, Inc. Wed Oct 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232344 — Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR | GE Medical Systems SCS Wed Oct 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230148 — Vlab | Dormotech Medical, Ltd. Wed Oct 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230897 — Anterion | Heidelberg Engineering GmbH Wed Oct 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230916 — WeSensor | Picopack, Inc. Tue Oct 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232471 — Vy Spine VyLam Laminoplasty System | Vy Spine, LLC Tue Oct 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232775 — ID NOW Influenza A & B 2 | Abbott Diagnostics Scarborough, Inc. Tue Oct 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230961 — Zeus Spinal System | Shanghai Sanyou Medical Co, Ltd. Tue Oct 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231658 — VEOS Spinal Fixation System | Spineway Tue Oct 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231413 — IPD Dental Implant Abutments | Implant Protesis Dental 2004, S.L. Tue Oct 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230130 — Micromate Navi+ | Isys Medizintechnik GmbH Tue Oct 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223027 — NeuroTrigger Basic (NTB) | Neurotrigger Tue Oct 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232341 — CarboClear® Pedicle Screw System | CarboFix Orthopedics , Ltd. Tue Oct 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232044 — Invictus Robotic Navigation Instruments | Alphatec Spine, Inc. Fri Oct 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230091 — THE Cover | Purgo Biologics, Inc. Fri Oct 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230265 — MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System | Infobionic, Inc. Fri Oct 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232411 — JuggerKnot Soft Anchor OC | Riverpoint Medical, LLC Fri Oct 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223802 — accufit | Mettler Electronics Corporation Fri Oct 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232787 — ScanNav Anatomy Peripheral Nerve Block | Intelligent Ultrasound Limited Fri Oct 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232056 — IPL Hair Removal Device, Model(s): PB1, PB2, PB3, PB4, TM002 | Dongguan Lide Electric Appliance Co., Ltd. Fri Oct 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232492 — 2.7 mm GRYPHON Flex Knotless PEEK Anchor; 2.7 mm GRYPHON Flex Knotless Biocomposite Anchor | Medos International SARL Fri Oct 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232760 — Swoop® Portable MR Imaging System® | Hyperfine, Inc. Fri Oct 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232755 — Arthrex FiberTape and TigerTape Cerclage Sutures | Arthrex, Inc. Fri Oct 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223905 — Vivio® LVEDP System | Avicena, LLC Fri Oct 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN220087 — Edison System | HistoSonics, Inc. Fri Oct 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232276 — Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20 | Oxoid Limited (Part of Thermo Fisher Scientific) Fri Oct 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232407 — Cautery Protective Actuation System (CPAS) | Safer Surgeries Medical Devices, LLC Fri Oct 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232480 — ProtekDuo Veno-Venous Cannula Sets | Cardiacassist, Inc. Fri Oct 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230853 — EARP Nerve Cuff Electrode | Nvision Biomedical Technologies, Inc. Fri Oct 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231300 — Nutricair Enteral Syringe with ENFit | Cair Lgl Fri Oct 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231863 — ProBeam 360° Proton Therapy System v2.0 (Multiroom) | Varian Medical Systems, Inc. Fri Oct 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232173 — Ascend VBR System, Ascend NanoTec VBR System | Alphatec Spine, Inc. Fri Oct 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231603 — Standard Staple-Line Reinforcement (SSLR23) | Standard Bariatrics, Inc. Fri Oct 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232055 — Vial Adapter | Shanghai Lingfu Technology Co., Ltd. Fri Oct 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230777 — Patient Examination Gloves | 3A Glove Sdn. Bhd. Fri Oct 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223926 — VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box | Medimaging Integrated Solution, Inc (Miis) Fri Oct 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221777 — Disposable Sterile Syringe | Weihai Shengjie Medical Technology Co., Ltd. Fri Oct 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |