510(k) Clearances — Page 195
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K223426 — ECHELON Synergy MRI system | Fujifilm Healthcare Corporation Thu Jul 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231351 — Chondral Quant | Siemens Medical Soultions USA, Inc. Thu Jul 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231709 — AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4 | Radmedix, LLC Wed Jul 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223631 — Comprehensive Segmental Revision System(SRS) | Biomet Orthopedics Wed Jul 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223808 — Zavation Navigation Instrument System | Zavation Medical Products, LLC Wed Jul 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231241 — NanoHive Medical Lumbar Interbody System | NanoHive Medical, LLC Wed Jul 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231035 — FusedCO Algorithm | Edwards Lifesciences, LLC Wed Jul 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231714 — Graftys Quickset | Graftys Wed Jul 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230532 — RADx Intraoral Appliance for Snoring and Sleep Apnea | Achaemenid, LLC Wed Jul 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230823 — AusculThing ACC | Ausculthing OY Wed Jul 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231386 — Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste | Orthocon, Inc. Tue Jul 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231711 — microINR System | Iline Microsystems, S.L. Tue Jul 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230427 — CUSA Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation Tue Jul 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230307 — Dentis i-Clean System | Dentis Co., Ltd. Tue Jul 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231925 — MINIMA S System | Lima Corporate S.P.A. Tue Jul 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231528 — Bonalive Orthopedics granules | Bonalive Biomaterials, Ltd. Tue Jul 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230942 — SPIRA® Posterior Lumbar Spacers | Camber Spine Technologies Tue Jul 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221137 — Play and Joy Water-Based Lubricant | Innovemed Bio-Tech Co., Ltd. Tue Jul 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231735 — NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody System; NuVasive CoRoent Small Interlock System; NuVasive CoRoent Small Interlock II System; NuVasive CoRoent Small Ti-C System; NuVasive Cohere Cervical Interbody System | Nu Vasive, Incorporated Tue Jul 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230680 — Anthogyr Surgical Cassettes | Anthogyr Tue Jul 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K220646 — Play&Joy InvisiLube Lubricant Capsule | Innovemed Bio-Tech Co., Ltd. Mon Jul 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221307 — Edge Upper Cervical System | Spinal Simplicity, LLC Mon Jul 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231387 — Endofill | Lumendo AG Mon Jul 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222666 — X-View 3D Pan/X-View 2D Pan | Trident S.R.L Mon Jul 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231091 — AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. Mon Jul 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223683 — EnteraLoc Flow | Vonco Products Mon Jul 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231701 — Ziehm Vision RFD 3D | Ziehm Imaging GmbH Mon Jul 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223724 — MOZI TPS | Manteia Technologies Co., Ltd. Mon Jul 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223213 — Tandem Mobi Insulin Pump with Interoperable Technology | Tandem Diabetes Care, Inc. Mon Jul 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231412 — CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S) | Biosense Webster, Inc. Mon Jul 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231312 — PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto ID | Biosense Webster, Inc. Mon Jul 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223578 — T3 Platform software | Etiometry, Inc. Fri Jul 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223382 — AeviceMD | Aevice Health Pte. , Ltd. Fri Jul 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231844 — ProMIS Fixation System | Premia Spine, Ltd. Fri Jul 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230080 — Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Blood | Yangzhou Medline Industry, Co., Ltd. Fri Jul 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230932 — ANDORATE® Valve Kit | Ga Health Company Limited Fri Jul 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230804 — Complement Kit Cases | JJGC Indústria e Comércio de Materiais Dentários S.A. Fri Jul 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231253 — Overture Orthopaedics Patellofemoral System | Overture Resurfacing, Inc. Fri Jul 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN220058 — BT-001 | Better Therapeutics Fri Jul 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222707 — IH Implant System | Sewonmedix, Inc. Fri Jul 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231668 — Spine CAMP (1.1) | Medical Metrics, Inc. Fri Jul 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223388 — Invia® Integrated Dressing | Medela AG Fri Jul 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231318 — Electromagnetic Stimulator Device(Model EM Contouring and Tesla Duet) | Beijing Adss Development Co., Ltd. Fri Jul 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223448 — Bladder Scanner Model: BVT02 | Xuzhou Kaixin Electronic Instrument Co., Ltd. Fri Jul 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232011 — Cleo | American Orthodontics Fri Jul 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223806 — VERTICALE® Triangular Fixation System | Silony Medical GmbH Thu Jul 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231339 — Tyber Medical Pin and Wire System (various) | Tyber Medical, LLC Thu Jul 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223780 — Lumos 3DX | 3Dio Thu Jul 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221056 — ARGUS PB-3000 | Schiller AG Thu Jul 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231003 — Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC) | Guangdong Optomedic Technologies, Inc. Thu Jul 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |