| K232615 — LumiMARK Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK Biopsy Site Marker (LM0215R (Rose shape)) | Devicor Medical Products, Inc. Jan 12, 2024 |
| K231684 — Quick - Radius Disposable Set | GM Dos Reis Industria E Comercio Ltda. Jan 12, 2024 |
| K232990 — ATOMIC Nitinol Fixation System | Rmr Ortho, LLC Jan 12, 2024 |
| DEN220040 — Fibresolve | Imvaria, Inc. Jan 12, 2024 |
| K232170 — Ti Link Abutment | Izenimplant Co., Ltd. Jan 12, 2024 |
| DEN230008 — DermaSensor | Dermasensor, Inc. Jan 12, 2024 |
| DEN230015 — Osteoboost Belt | Bone Health Technologies, Inc. Jan 12, 2024 |
| K233144 — ClearPoint Bone Screw Fiducials | ClearPoint Neuro, Inc. Jan 12, 2024 |
| K232032 — PROBEAT-FR | Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha Jan 12, 2024 |
| K231315 — Velox Power Chair | Velox Manufacturing, Inc. Jan 12, 2024 |
| K233141 — SmartFrame OR | ClearPoint Neuro, Inc. Jan 12, 2024 |
| K222783 — MD Mattress Suture Placement Device | Lsi Solutions, Inc. Jan 12, 2024 |
| K231558 — SMB Luer lock disposable syringe | Smb Corporation Of India Jan 12, 2024 |
| K233694 — Meridian Interbody System; WaveForm A Interbody System | SeaSpine Orthopedics Corporation Jan 12, 2024 |
| K233125 — Zirconia Block | Hangzhou Ivista Medical Devices Co., Ltd. Jan 12, 2024 |
| K233677 — Biograph VK10 | Siemens Medical Solutions USA, Inc. Jan 12, 2024 |
| K231820 — SoloSmart Injection Pen Adapter (SoloSmart®) | Biocorp Production Jan 12, 2024 |
| K233964 — GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US) | Cosmo Artificial Intelligence - Ai, Ltd. Jan 12, 2024 |
| K231774 — CoralView® Single-use Digital Flexible Ureteroscope (U10); CoralView® Single-use Digital Flexible Ureteroscope (U10-B); CoralView® Single-use Digital Flexible Ureteroscope (U10-BR); CoralView® Single-use Digital Flexible Ureteroscope (U20); CoralView® Single-use Digital Flexible Ureteroscope (U20-B); CoralView® Single-use Digital Flexible Ureteroscope (U20-BR) | MacroLux Medical Technology Co., Ltd. Jan 11, 2024 |
| K231633 — Disposable Hemoclip (AF series) | Alton (Shanghai) Medical Instruments Co., Ltd. Jan 11, 2024 |
| DEN220066 — BrainSee | Darmiyan, Inc. Jan 11, 2024 |
| K233712 — PRIMA Humeral System; PRIMA TT Glenoid | Lima Corporate S.P.A. Jan 11, 2024 |
| K222929 — ToxiSeal Vial Adapter with External Balloon | Epic Medical Pte. , Ltd. Jan 11, 2024 |
| K233616 — Clevaligner Software (V1.0.0) | Clevaligner, Ltd. Jan 11, 2024 |
| K232250 — SurgiCount+ System | Stryker Instruments Jan 11, 2024 |
| K231088 — Copper Foam Dressing (Prescription and OTC) | Roosin Medical Co., Ltd. Jan 11, 2024 |
| K232285 — U-Lite PRO | Sonoscanner Sarl Jan 11, 2024 |
| K233945 — ProxiDiagnost N90 / Precision CRF (706110, 706400) | Philips Medical Systems Dmc GmbH Jan 11, 2024 |
| K233664 — IPL Hair Removal Device (UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD,UI06 WH, UI06 MG, UI06 OB, UI06 LY,UI06 IG,) | Shenzhen Ulike Smart Electronics Co., Ltd. Jan 11, 2024 |
| K232995 — Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning, AC1001, AC1002, AC1003, AC1003, AC1004, AC1005; Electrotherapy device Electrode belt for back of body, AC2001, AC2002, AC2003, AC2004; Electrotherapy device Electrode belt for Body joints, AC3001, AC3008, AC3009, AC3010, AC3011; Electrotherapy device Electrode for Knee, AC3002, AC3004, AC3006; Electrotherapy device Electrode for Elbow, AC3003, AC3005, AC3007; Electrothe | Shenzhen Roundwhale Technology Co. , Ltd. Jan 11, 2024 |
| K233902 — Centurion Vision System (Active Sentry) (8065753057) | Alcon Laboratories, Inc. Jan 10, 2024 |
| K233364 — Axon Therapy | Neuralace Medical, Inc. Jan 10, 2024 |
| K232604 — LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit (Cassette) | Hangzhou Laihe Biotech Co., Ltd. Jan 10, 2024 |
| K232955 — Numen Coil Embolization System; NumenFR Detachment System | MicroPort NeuroTech (Shanghai) Co., Ltd. Jan 10, 2024 |
| K233903 — Zeta Cranial Navigation System (ZNS131-US) | Zeta Surgical, Inc. Jan 10, 2024 |
| K233944 — CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments | CarboFix Orthopedics , Ltd. Jan 10, 2024 |
| K232710 — Dental Cone-beam Computed Tomography | Yian Medical Technology (Haining) Co., Ltd. Jan 9, 2024 |
| K233327 — 1788 4K Camera System with Advanced Imaging Modality | Stryker Endoscopy Jan 9, 2024 |
| K232312 — GORE® PROPATEN® Vascular Graft | W. L. Gore & Associates, Inc. Jan 9, 2024 |
| K232597 — LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard) | Hangzhou Laihe Biotech Co., Ltd. Jan 9, 2024 |
| K231324 — DASI Dimensions (V1.0) | Dasi Simulations Jan 8, 2024 |
| K232106 — Air Gap Fiber | Wontech Co., Ltd. Jan 8, 2024 |
| K233615 — Electrosurgical Pads (GBS-Dm 1030ac, GBS-Db 1031ac, GBS-Dm 1030a, GBS-Db 1031a, GBS-Dm 1130ac, GBS-Db 1131ac, GBS-Dm 1130a, GBS-Db 1131a, GBS-Dm 1040ac, GBS-Db 1041ac, GBS-Dm 1040a, GBS-Db 1041a, GBS-Dm 1140ac, GBS-Db 1141ac, GBS-Dm 1140a, GBS-Db 1141a, GBS-Db 4030c, GBS-Db 4030, GBS-Db 4040c, GBS-Db 4040, GBS-Dm 1030bc, GBS-Db 1031bc, GBS-Dm 1030b, GBS-Db 1031b, GBS-Dm 1130bc, GBS-Db 1131bc, GBS-Dm 1130b, GBS-Db 1131b, GBS-Dm 1030nc, GBS-Db 1031nc, GBS-Dm 1030n, GBS-Db 1031n, GBS-Dm 1 | Baisheng Medical Co., Ltd. Jan 8, 2024 |
| K232412 — LungQ v3.0.0 | Thirona BV Jan 8, 2024 |
| K232894 — HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining (39123), HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining and Visor (39124) | Owens & Minor (O&M) Halyard, Inc. Jan 8, 2024 |
| K233444 — InkSpace Imaging Small Body Array | Inkspace Imaging, Inc. Jan 8, 2024 |
| K233035 — Electronic Muscle Stimulator (Model MP01) | Shenzhen Hengbosi Industrial Co., Ltd. Jan 8, 2024 |
| K231068 — autoSCORE | Holberg Eeg AS Jan 7, 2024 |
| K231608 — Teleport XT Microcatheter | OrbusNeich Medical (Shenzhen) Co., Ltd. Jan 7, 2024 |
| K232721 — Lifetech Cardio Temporary Pacemaker | Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. Jan 7, 2024 |