510(k) Clearances — Page 192
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K223670 — MESI mTablet ECG Diagnostic System, MESI mTablet ECG | Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O. Fri Jul 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231313 — Therapy Mask 3100 NC/SP | Respironics, Inc. Fri Jul 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231552 — Dia-Cem | DiaDent Group International Fri Jul 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231195 — Brainomix 360 Triage ICH | Brainomix Limited Thu Jul 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223591 — cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System | Roche Molecular Systems, Inc. Thu Jul 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231886 — SURGIVISIO Device | Ecential Robotics Thu Jul 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231261 — Altaviz Needle Kit II | Altaviz, LLC Thu Jul 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K212077 — Teleflex Rusch SoftSimplastic Foley Catheters | Teleflexmedical, Inc. Thu Jul 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231236 — IBS-B MIS Beveled Screw System | In2bones USA, LLC Thu Jul 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230838 — Cardinal Health SmartGown EDGE Breathable Surgical Gown with ASSIST Instrument Pockets | Cardinal Health200, LLC Thu Jul 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231555 — LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189)) | iSMART Developments, Ltd. Thu Jul 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231223 — MDx-Chex for BC-GN | Streck Thu Jul 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230074 — Rapid Aneurysm Triage and Notification | Ischemaview, Inc. Thu Jul 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231044 — R2P Navicross | Terumo Medical Corporation Thu Jul 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231912 — Therm-X | Zenith Technical Innovations Thu Jul 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231221 — MDx-Chex for BC-GP | Streck Thu Jul 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231038 — Global Hypoperfusion Index (GHI) Algorithm | Edwards Lifesciences, LLC Wed Jul 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231787 — ecoFIX® | Science & Bio Materials (S.B.M.) Sas Wed Jul 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222874 — CarboClear Cervical Cage System, CarboClear Cervical VBR System | Carbofix Orthpedics , Ltd. Wed Jul 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K220765 — HS Fiber Cerclage | Riverpoint Medical, LLC Wed Jul 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231922 — DEPUY SYNTHES MAXFRAME AUTOSTRUT System | DePuy Synthes Wed Jul 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231572 — uMI Panorama | Shanghai United Imaging Healthcare Co., Ltd. Wed Jul 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222994 — Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B | Shenzhen AOJ Medical Technology Co., Ltd. Wed Jul 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231172 — ApolloKnee | Corin U.S.A. Limited Wed Jul 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231900 — A-TAP (previously called Arthrotap) | Elcam Medical Acal Tue Jul 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231924 — EZ-IO Intraosseous Vascular Access System | Teleflex Medical Tue Jul 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231621 — Reprocessed ViewFlex Xtra ICE Catheter (D087031) | Stryker Sustainability Solutions Tue Jul 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221605 — Emit® II Plus Buprenorphine Assay | Siemens Healthcare Diagnostics, Inc. Tue Jul 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230365 — Sonio Detect | Sonio Tue Jul 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231878 — Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101, Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101, Vision1 Imaging Console and Display System, PN VIS101 | STERIS Corporation Tue Jul 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230540 — Patient Specific Planning Solution 3D Bone Models | Biomet Manufacturing Corp Tue Jul 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230913 — ANDI | Imeka Solutions, Inc. Tue Jul 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230576 — IDENTIFY | Varian Medical Systems, Inc. Tue Jul 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230730 — Apyx | Escala Medical Tue Jul 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231275 — Exceed Biplanar Expandable Interbody System | Spine Wave, Inc. Tue Jul 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K213536 — DEKA ACE Pump System | Deka Research and Development Tue Jul 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222438 — A-LYTE® Integrated Multisensor (IMT Na K Cl) | Siemens Healthcare Diagnostics, Inc. Tue Jul 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223473 — ME-APDS; MAGENTIQ-COLO | Magentiq Eye, Ltd. Tue Jul 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230455 — Enamel Coating Resin | Rizhao Huge Biomaterials Company, Ltd. Tue Jul 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231577 — MOBILETT Impact | Siemens Medical Solutions Tue Jul 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231523 — EsCom250 | Spident Co., Ltd. Mon Jul 24 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230333 — Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800) | Kettenbach GmbH & Co. KG Mon Jul 24 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223752 — Black Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Chloroquine, Cyclosporin A, Retrovir, Gastric Acid and Fentanyl | Central Medicare Sdn Bhd Mon Jul 24 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223322 — Argus Cognitive ReVISION Software | Argus Cognitive, Inc. Mon Jul 24 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223347 — UltraSight AI Guidance | Ultrasight, Inc. Mon Jul 24 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230931 — Atlan | Drägerwerk AG Co. Kgaa Sun Jul 23 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221327 — BD Alaris Pump Infusion Sets | Care Fusion Fri Jul 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231848 — Triever20 Curve (21-201) | Inari Medical, Inc. Fri Jul 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221319 — BD Alaris Pump Epidural Infusion Set | Care Fusion Fri Jul 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223499 — Three Way Stop Cock | M/S Romsons International Fri Jul 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |