| K240430 — Otoport Pro | Otodynamics, Ltd. Fri Mar 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233748 — CIARTIC Move (VB10) | Siemens Medical Solutions USA, Inc. Fri Mar 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233881 — ivWatch® Model 400 | Ivwatch, LLC Fri Mar 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233814 — 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M Attest Auto-reader (490); 3M Attest Auto-reader (490H); 3M Attest Mini Auto-reader (490M) | 3M Company Fri Mar 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232327 — Endorail | Endostart S.R.L. Fri Mar 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232610 — da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation | Intuitive Surgical, Inc. Thu Mar 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231850 — QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments | Globus Medical, Inc. Thu Mar 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232567 — Myriad SPECTRA Light Source | Nico Corporation Thu Mar 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233853 — LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub | Philips Medical Systems Nederland B.V. Thu Mar 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232301 — Define RF Microneedling System | Aesthetic Management Partners Thu Mar 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233958 — hekaDrill | Zethon, Ltd. Thu Mar 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233542 — Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile Hip Software; Q Guidance System | Stryker Leibinger GmbH & Co KG Thu Mar 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232803 — NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E) | Nxstage Medical, Inc. Thu Mar 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232980 — SpermAlign Sperm Separation Device | Cytoswim, Ltd. Thu Mar 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231529 — CloudPoint FastDesign Chairside | Prismatik Dentalcraft, Inc. Thu Mar 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233070 — Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N) | Chongqing Rob Linka Science and Technology Co., Ltd. Wed Mar 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233968 — CINA-iPE | Avicenna.Ai Wed Mar 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233949 — ACCORD Cable System | Smith & Nephew, Inc. Wed Mar 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233952 — DEKA ACE Pump System | Deka Research and Development Wed Mar 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234008 — CERAMENT G | Bonesupport AB Wed Mar 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234055 — DEKA Loop | Deka Research and Development Wed Mar 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232022 — CAS-One IR | Cascination AG Wed Mar 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233466 — Edison System | HistoSonics, Inc. Wed Mar 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233946 — IMMULITE® 2000 BR-MA | Siemens Healthcare Diagnostics Products, Ltd. Wed Mar 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233136 — Hygeia Express Powered Breast Pump | Hygeia II Medical Group, Inc. Wed Mar 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233930 — MRCP+ version 2 (MRCP+ v2) | Perspectum Wed Mar 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233592 — BioPoly Radial Head Implant | BioPoly, LLC Wed Mar 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234002 — ICEfx Cryoablation System (FPRCH8000-02) | Boston Scientific Wed Mar 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240132 — EmoLED (v. 2-USA) | Emoled, Srl Tue Mar 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240424 — Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix | Collagen Matrix, Inc. Tue Mar 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240416 — Tranquil-C Interbody System | Nexus Spine, LLC Tue Mar 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231849 — MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483 | Baxter Healthcare Tue Mar 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240497 — Smartxide Tetra Pro | El.En S.P.A. Tue Mar 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232564 — Align Studio | Laon Medi, Inc. Tue Mar 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233381 — DRX-Evolution Plus System | Carestream Health, Inc. Tue Mar 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234000 — VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL) | bioMerieux, Inc. Mon Mar 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231789 — Pain Therapy Device (Model: P.T.S-VI, P.T.S-VII) | Guangzhou Xinbo Electronic Co., Ltd. Mon Mar 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233724 — 28mm/38D MDM X3 Insert for MDM Liner | Howmedica Osteonics Corp., Dba Stryker Orthopaedics Mon Mar 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232140 — OTS Hip | Ortoma AB Mon Mar 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233912 — ARIX Cannulated Screw System | Jeil Medical Corporation Mon Mar 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233922 — SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; NWT CAN SLIM LED CORD G3 SHORT; NWT CAN SLIM LED CORD G3 LONG | Satelec - Acteon Group Mon Mar 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234015 — Caphosol® Artifical Saliva (32 doses sachet box) | Eusa Pharma (Uk) Limited Mon Mar 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231864 — Fiber Optic Brushless Electronic Micromotor, model: iM100 | Codent Technical Industry Co., Ltd. Mon Mar 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231758 — NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2) | Luminex Molecular Diagnostics, Inc. Mon Mar 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233083 — Osteon Precision Milled Suprastructure | Implant Solutions Pty Ltd (Aka Osteon Medical) Sat Mar 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233899 — Knee+ | Pixee Medical Fri Mar 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231056 — Esperance Distal Access Catheter | Wallaby Medical Fri Mar 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233649 — ALGO Pro Newborn Hearing Screener (ALGO Pro) | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) Fri Mar 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233421 — RESCAN 700 | Carl Zeiss Meditec, AG Fri Mar 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233359 — DOMINION Expandable Corpectomy System | Astura Medical Fri Mar 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |