| K231871 — Radify Triage | Envisionit Deepai, Ltd. Wed Jan 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233710 — Symphion Operative Hysteroscopy System | Minerva Surgical, Inc. Wed Jan 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232732 — Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50 | Co-Innovation Biotech Co., Ltd. Wed Jan 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233783 — exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts | Peca Labs, Inc. Wed Jan 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231135 — Video Ureteroscope System | Hunan Vathin Medical Instrument Co., Ltd. Wed Jan 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232355 — Non absorbable Surgical Silk Suture | Shandong Haidike Medical Product Co., Ltd. Tue Jan 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233970 — Nephron Nitrile, Nitrile Powder-Free Examination Blue Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) | Nephron Nitrile, LLC Tue Jan 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233796 — Disposable safety lancet (Impress); Disposable safety lancet (Impress Pro); Disposable safety lancet (Lite4); Disposable blood lancet (Elite); Disposable blood lancet (Elite Pro) | SteriLance Medical (Suzhou), Inc. Tue Jan 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233293 — Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System® | Neurosigma, Inc. Tue Jan 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233512 — Rapid (6.0) | Ischemaview, Inc. Tue Jan 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231144 — Washtrays | Dentsply Sirona Tue Jan 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223266 — Hilzo Esophageal Stents | Thoracent, Inc. Tue Jan 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232062 — Uni-port | Dalim Medical Corp. Tue Jan 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231138 — Aniti-Snore Mouthguard+ | Oscimed SA Tue Jan 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223234 — Delta4 Insight | Scandidos AB Tue Jan 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232350 — Stryker Facial iD System | Stryker Craniomaxillofacial Sat Jan 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233216 — CLEWICU System | Clew Medical , Ltd. Sat Jan 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233355 — Cypris eXact Suturing System | Cypris Medical Fri Jan 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222783 — MD Mattress Suture Placement Device | Lsi Solutions, Inc. Fri Jan 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232032 — PROBEAT-FR | Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha Fri Jan 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233125 — Zirconia Block | Hangzhou Ivista Medical Devices Co., Ltd. Fri Jan 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231970 — PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video Bronchoscope EB15-S01, PENTAX Medical Mobile Processor ONE-M, PENTAX Medical Mobile Processor Plug-In ONE-Dock | Pentax of America, Inc. Fri Jan 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231371 — BEE Cervical Cage | NGMedical GmbH Fri Jan 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231558 — SMB Luer lock disposable syringe | Smb Corporation of India Fri Jan 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233964 — GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US) | Cosmo Artificial Intelligence - Ai, Ltd. Fri Jan 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232990 — ATOMIC Nitinol Fixation System | Rmr Ortho, LLC Fri Jan 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233020 — TauTona Pneumoperitoneum Assist Device (TPAD) | Tautona Group Research & Development, Co., LLC Fri Jan 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233144 — ClearPoint Bone Screw Fiducials | ClearPoint Neuro, Inc. Fri Jan 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN230008 — DermaSensor | Dermasensor, Inc. Fri Jan 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN230015 — Osteoboost Belt | Bone Health Technologies, Inc. Fri Jan 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232170 — Ti Link Abutment | Izenimplant Co., Ltd. Fri Jan 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233155 — ClearPointer Optical Navigation Wand | ClearPoint Neuro, Inc. Fri Jan 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231684 — Quick - Radius Disposable Set | GM Dos Reis Industria e Comercio Ltda. Fri Jan 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233022 — Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and Small | Owens & Minor (O&M) Halyard, Inc. Fri Jan 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233141 — SmartFrame OR | ClearPoint Neuro, Inc. Fri Jan 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233694 — Meridian Interbody System; WaveForm A Interbody System | SeaSpine Orthopedics Corporation Fri Jan 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231820 — SoloSmart Injection Pen Adapter (SoloSmart®) | Biocorp Production Fri Jan 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233520 — Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl | Anhui Powerguard Technology Co., Ltd. Fri Jan 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN220040 — Fibresolve | Imvaria, Inc. Fri Jan 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233114 — LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200) | Shenzhen Idea Light Limited Fri Jan 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232970 — Hem-o-lok® Ligating Clips | Teleflex Medical Fri Jan 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231315 — Velox Power Chair | Velox Manufacturing, Inc. Fri Jan 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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. Fri Jan 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233677 — Biograph VK10 | Siemens Medical Solutions USA, Inc. Fri Jan 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232250 — SurgiCount+ System | Stryker Instruments Thu Jan 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233712 — PRIMA Humeral System; PRIMA TT Glenoid | Lima Corporate S.P.A. Thu Jan 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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. Thu Jan 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233945 — ProxiDiagnost N90 / Precision CRF (706110, 706400) | Philips Medical Systems Dmc GmbH Thu Jan 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN220066 — BrainSee | Darmiyan, Inc. Thu Jan 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231088 — Copper Foam Dressing (Prescription and OTC) | Roosin Medical Co., Ltd. Thu Jan 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |