510(k) Clearances — Page 173
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K231222 — 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) | Topcon Corporation Mon Oct 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231874 — AOT & T-L Abutment | Truabutment, Inc. Mon Oct 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230457 — Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal | Empatica S.r.l. Mon Oct 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230755 — NuEra Tight RF Model OptiStream | Bios S.R.L. Mon Oct 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231836 — ClariVy Cervical IBF System | Vy Spine, LLC Mon Oct 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232145 — ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. Mon Oct 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231029 — Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs And Fentanyl | Zhonghong Pulin Medical Products Co., Ltd. Mon Oct 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231965 — Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 | GE Medical Systems Ultrasound and Primary Care Diagnostics Mon Oct 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232751 — BriefCase-Triage | Aidoc Medical , Ltd. Mon Oct 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232280 — NextAR TSA Platform | Medacta International S.A. Sun Oct 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230418 — Mighty Wire Guide Wire | Merit Medical Systems, Inc. Sat Oct 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233270 — AcuNav Crystal Ultrasound Catheter | Siemens Medical Solutions USA, Inc. Sat Oct 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232045 — MeVis Liver Suite | MeVis Medical Solutions AG Fri Oct 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231214 — LIAISON VZV IgG HT, LIAISON Control VZV IgG HT | DiaSorin, Inc. Fri Oct 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233207 — Polaris X Unidirectional Steerable Diagnostic Catheter | Boston Scientific Corporation Fri Oct 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230275 — i-STAT CG8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. Fri Oct 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K220493 — Plaxpot Multi Plasma | Gcs Co. Limited Fri Oct 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231310 — Electronic Blood Pressure Monitor | Shenzhen Jumper Medical Equipment Co., Ltd. Fri Oct 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232348 — RIGEL 3DR Standalone Anterior Cervical Interbody Fusion System | MiRus, LLC Fri Oct 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233220 — EnCor EnspireBreast Biopsy System (E4115, E4230); EnCor Breast Biopsy Driver (DRENCOR); EnCor MRI Breast Biopsy Driver (DRENCORMR); EnCor Breast Biopsy Driver Probes (ECP017G, ECP017GV, ECP0110G, ECP0110GV, ECP0112G, ECP0112GV); EnCor MRI Breast Biopsy Probes (ECPMR017G, ECPMR0110G, ECPMR0110GBT) | Senorx, Inc. Fri Oct 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K213146 — Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen | Jiangsu Rongye Technology Co., Ltd. Fri Oct 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230285 — i-STAT CG8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. Fri Oct 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231545 — hearOAE | Hearx SA (Pty) , Ltd. Fri Oct 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232393 — BluTube® Dental Unit Water Purification Cartridge (BluTube®); Model Numbers: WB180, WB90, Z3 Waterline Purification Straws, Dental Unit Water Purification Cartridge | Proedge Dental Products, Inc. Fri Oct 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231934 — GIA Stapler with Tri-Staple Technology | Covidien Fri Oct 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230826 — Modius Sleep | Neurovalens , Ltd. Fri Oct 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223541 — Cold/Hot Compression | Jkh Health Co., Ltd. Fri Oct 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231494 — CoreLink Robotic Navigation Instruments | Corelink, LLC Fri Oct 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233090 — DEKA AGAIN PRO family | El.En S.P.A. Fri Oct 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222459 — Centrix FluoroSilver Silver Diamine Fluoride 38% | Centrix, Inc. Fri Oct 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233241 — SOLACE Sacroiliac Fixation System | Ht Medical, LLC Dba Xenix Medical Fri Oct 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230854 — SwiftMR | Airs Medical, Inc. Fri Oct 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230300 — i-STAT CG8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. Fri Oct 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230490 — PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA, 4004-LPUR-NA, 4004-CABLUE-NA-INT, 4004-GREY-INT, 4004-YELLOW-INT, 4004-PSTO-INT, 4004-LPUR-INT | Dongguan Hunter Electronic Technology Co., Ltd. Fri Oct 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231761 — PodSKAN HF Diagnostic X-ray System | Skanray Technologies Limited Fri Oct 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231908 — 45 Micron Polyisoprene Condom | Suretex Limited Fri Oct 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231165 — Shina Syringe; Shina Safety Syringe | Shina Med Corporation Fri Oct 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232667 — OR3O Dual Mobility Liners | Smith & Nephew, Inc. Fri Oct 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232346 — Digital Expert Access with Remote Scanning | GE Healthcare Fri Oct 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233292 — ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress | Inomed Medizintechnik GmbH Fri Oct 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233187 — Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078) | Steris Fri Oct 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232618 — Aurora Surgiscope System | Rebound Therapeutics Corporation Fri Oct 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233318 — AXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (8mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (10mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (20mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx15mm) | Boston Scientific Corporation Fri Oct 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233234 — PressON Spinal Fixation System | Nexus Spine, LLC Thu Oct 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232500 — Lumify Diagnostic Ultrasound System | Philips Ultrasound Thu Oct 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230559 — Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260) | Medline Industries, Inc. Thu Oct 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233170 — cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L) | AtriCure, Inc. Thu Oct 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K213473 — Antimicrobial Gelling Fiber Dressing with PHMB | Advanced Medical Solutions, Ltd. Thu Oct 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231579 — MOLLI 2 | Molli Surgical, Inc. Thu Oct 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232271 — SIMDA abutment | Simda Co., Ltd. Thu Oct 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |