510(k) Clearances — Page 180
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K230925 — Disposable Injection Needle AF series | Alton (Shanghai) Medical Instruments Co., Ltd. Wed Sep 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231007 — CEDIA Heroin Metabolite (6-AM) Assay | Microgenics Corporation Wed Sep 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223496 — Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons® Tapered Internal, MIS® C1 Implant Systems | Prismatik Dentalcraft, Inc. Tue Sep 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K213517 — Access Thyroglobulin Antibody II | Beckman Coulter, Inc. Tue Sep 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231971 — DEKA PHYSIQ 360 | El.En S.P.A. Tue Sep 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232336 — ES Series V2 | E-Scopics Tue Sep 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232233 — Invisalign System with Mandibular Advancement Featuring Occlusal Blocks | Align Technology, Inc. Tue Sep 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230884 — AVVIGO'+ Multi-Modality Guidance System | Boston Scientific Corporation Tue Sep 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN220026 — VasQ | Laminate Medical Technologies , Ltd. Tue Sep 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230252 — OFIX MIS App | Orthofix US, LLC Tue Sep 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K220396 — EasyStat 300 | Medica Corporation Tue Sep 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230513 — Arthrex Univers Apex OptiFit Humeral Stem | Arthrex, Inc. Tue Sep 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232617 — ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. Tue Sep 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230398 — MedCAD® AccuPlate® 3DTi Patient-Specific Plating System | Medcad Tue Sep 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221052 — Self-Fitting hearing aids | Huizhou Jinghao Medical Technology Co., Ltd. Mon Sep 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230825 — Smileyscope System (Therapy Mode) | Smileyscope Holding, Inc. Mon Sep 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230778 — EndoCore | Praxis Medical, LLC Mon Sep 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232097 — IdentiTi ALIF Interbody Systems | Alphatec Spine, Inc. Mon Sep 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231888 — BD Texium Needle-Free Syringe | Care Fusion Mon Sep 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231928 — EFAI RTSUITE CT HCAP-Segmentation System | Ever Fortune.Ai, Co., Ltd. Mon Sep 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231739 — Cervical Spine Truss System (CSTS) | 4Web Medical, Inc. Mon Sep 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223933 — Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws | Exactech, Inc. Mon Sep 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231891 — Virtue Male Sling System with Alexis Wound Retractor Convenience Kit | Coloplast Mon Sep 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231977 — PEACH 2, PEACH 2 Duo, PEACH 2 go | Foreo, Inc. Mon Sep 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230857 — TiLink-P SI Joint Fusion System | SurGenTec, LLC Mon Sep 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230184 — Holter ECG and ABP System | Edan Instruments, Inc. Mon Sep 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K220265 — ADVIA Centaur® NT-proBNPII (PBNPII) | Siemens Healthcare Diagnostics, Inc. Sun Sep 24 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223919 — B.Light Clear Evo and B.Light Restore Evo | Bemer Int AG Sat Sep 23 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222778 — Osstem Implant System | Osstem Implant Co., Ltd. Sat Sep 23 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231092 — T-SHAPE 2 | B&M S.R.L. Marketing Nel Benessere Fri Sep 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232193 — Electrically Power Wheelchairs (Models:YLB-W-0812-A01, YLB-W-0812-A02, YLB-W-0812-A03) | Yurob Rehabilitation Medical Co., Ltd. Fri Sep 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K220179 — High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors | Foshan Coxo Medical Instrument Co., Ltd. Fri Sep 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230067 — Para-Fix External Fixation System | New Paradigm Biomedical Fri Sep 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231446 — Single-Use Latex Sterile Surgical Gloves (SG100) | Fitone Latex Products Co., Ltd. Guangdong Fri Sep 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231767 — Annalise Enterprise CTB Triage Trauma | Annalise-Ai Pty , Ltd. Fri Sep 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232978 — DX. Bond V Dental Bonding Adhesive | Sino-Dentex Co., Ltd. Fri Sep 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223659 — Jazz | Ai Medical AG Fri Sep 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221817 — ALFIS Vitamin D, ALFIS-3 Analyzer | Immunostics Inc., Fri Sep 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232594 — CATHTONG II PICC Catheter | L&Z Us, Inc. Fri Sep 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232558 — UroLift 2 ATC Advanced Tissue Control System | Neotract, Inc. Fri Sep 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230350 — VISULAS yag | Carl Zeiss Meditec, Inc. Fri Sep 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231479 — TriALTIS Spine System | Medos International SARL Fri Sep 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232571 — CATHTONG II PICC Catheter | L&Z Us, Inc. Fri Sep 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231239 — Nexiva Closed IV Catheter System with NearPort IV Access | Becton Dickinson Infusion Therapy Systems, Inc. Fri Sep 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223921 — Access CEA | Beckman Coulter, Inc. Fri Sep 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231149 — qXR-CTR | Qure.Ai Technologies Fri Sep 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232224 — iLet® Dosing Decision Software | Beta Bionics, Inc. Fri Sep 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231730 — FemaSeed Intratubal Insemination | Femasys, Inc. Fri Sep 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230980 — MicroMatrix® Flex | Acell, Inc. Fri Sep 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232183 — IPL Hair Removal Device, Model(s): T1, T2, T3, T7, T10 | Shenzhen Koli Technology Co.,Ltd Fri Sep 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |