| K240754 — N2 | Megagen Implant Co., Ltd. Thu Mar 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234006 — AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl Test | Allsource Screening Solutions Thu Mar 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240574 — BruxZir® Radiant | Prismatik Dentalcraft, Inc. Wed Mar 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240165 — Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer | Wenzhou Longwan Medical Device Factory Wed Mar 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240743 — Peak Universal Bond | Ultradent Products, Inc. Wed Mar 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233642 — InMode RF System | InMode , Ltd. Wed Mar 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232654 — Nephron Nitrile, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemotherapy Drugs and Fentanyl) | Nephron Nitrile, LLC Wed Mar 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233375 — Tranquil-L Interbody System | Nexus Spine, LLC Wed Mar 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240537 — SMARTXIDE PRO | El.En S.P.A. Wed Mar 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240507 — NuVasive AttraX Scaffold | Nuvasive, Inc. Wed Mar 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233002 — BEED 2,5, BEED 3,8 | Excelsior Resources, LLC Wed Mar 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231974 — PATHFAST®hs-cTnI-II | Phc Corporation Wed Mar 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234090 — EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004) | Surgvision GmbH Wed Mar 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234047 — Automatic Registration | Brainlab AG Wed Mar 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234049 — Straumann® BLC and TLC Implants - Line extension | Institut Straumann AG Wed Mar 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234052 — Access Ferritin | Beckman Coulter, Inc. Wed Mar 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232125 — V-PVP | Vitromed GmbH Wed Mar 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233901 — Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006, NASA008, NASA009) | Shenzhen Desida Technology Co., Ltd. Wed Mar 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234130 — Portrait Mobile Monitoring Solution consists of: Portrait Central Viewer Application (Portrait CVAXB) Portrait Core Services (Portrait CSSXB) Portrait Clinical Alarming Unit (Portrait CAU01) Portrait Mobile Patient Monitor Hardware (Portrait HUBXB) Portrait Mobile Patient Monitor Software (Portrait HSWXB) Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) Portrait Wearable Pulse O | Ge Medical Systems Information Technologies, Inc. Wed Mar 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233146 — Blood Pressure Monitor | Shenzhen Jamr Technology Co., Ltd. Tue Mar 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232619 — MATRIX HA PEEK Cervical IBF System | Sapphire Medical Group Tue Mar 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234024 — HWJECT Auto-disable syringe | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. Tue Mar 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231719 — Medical Surgical Mask | Azur Medical Company, Inc. Tue Mar 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232682 — Pre-Sintered Zirconia Coloring Liquid | Chengdu Besmile Medical Technology Co., Ltd. Tue Mar 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240668 — Amydi-med Disposable Non-invasive EEG electrodes | Shenzhen Amydi-Med Electrics Tech Co., Ltd. Tue Mar 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231843 — ARX Viral Transport Media Collection and Transport System | Arx Sciences, Inc. Tue Mar 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233772 — Disposable Dual Action Tissue Closure Device | Mirco-Tech (Nanjing) Co., Ltd. Tue Mar 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233599 — X-Clever (ASHK100G) | Lg Electronics.Inc Mon Mar 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240515 — uNion® MAX Cervical Plate System | Ulrich Medical USA, Inc. Mon Mar 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240113 — CORIOGRAPH Knee Pre-Op Plan | Smith & Nephew, Inc. Mon Mar 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240139 — Real Intelligence CORI | Blue Belt Technologies, Inc. Mon Mar 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233660 — nCommand Lite System | Ionic Health Mon Mar 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230981 — Meriglu Topical Skin Adhesive | M/s. Meril Endo Surgery Private Limited. Sat Mar 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240112 — Light Cure Composite | Sincera Technology (Changchun) Co., Ltd. Fri Mar 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240117 — Aventus Thrombectomy System (IM-2001/IM-0002) | Inquis Medical Fri Mar 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234115 — APRO 55 Catheter | Alembic, LLC Fri Mar 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233986 — BD Phoenix Automated Microbiology System - GN Ciprofloxacin (0.01564 µg/mL) | Becton, Dickinson and Company Fri Mar 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240466 — STARband 3D | Orthomerica Products, Inc. Fri Mar 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240694 — FORMA Composite (Shade A3D) | Ultradent Products, Inc. Fri Mar 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233799 — Wrist Blood Pressure Monitor (222); Wrist Blood Pressure Monitor (222BT); Wrist Blood Pressure Monitor (W1681BL); Wrist Blood Pressure Monitor (W1681BT); Wrist Blood Pressure Monitor (W1681R) | Shenzhen Yuezhongxing Technology Co., Ltd. Fri Mar 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240441 — MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw | Depuy Mitek Fri Mar 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240454 — RESPONDER® Polysaccharide Hemostat | Starch Medical, Inc. Fri Mar 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233342 — CINA-ASPECTS | Avicenna.Ai Fri Mar 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232234 — Nouvo Safety Set | Poly Medicure Limited Fri Mar 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234104 — PICOANDY (Q-Switched Nd:YAG Laser) | Wontech Co., Ltd. Fri Mar 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230802 — Xprecia Prime Coagulation System | Universal Biosensors Pty, Ltd. Fri Mar 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233747 — Concha Sol Hearing Aids (CL-1001) | Concha Labs Fri Mar 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240539 — Vital Spinal Fixation System | Zimvie Spine (Zimmer Biomet Spine, Inc.) Fri Mar 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231856 — TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534)) | Medexel Co.,Ltd Fri Mar 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233307 — Intensity Pulsed Light Therapy System | Beijing Adss Development Co., Ltd. Fri Mar 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |