| K230148 — Vlab | Dormotech Medical, Ltd. Oct 11, 2023 |
| K230897 — Anterion | Heidelberg Engineering GmbH Oct 11, 2023 |
| K232775 — ID NOW Influenza A & B 2 | Abbott Diagnostics Scarborough, Inc. Oct 10, 2023 |
| K232471 — Vy Spine VyLam Laminoplasty System | Vy Spine, LLC Oct 10, 2023 |
| K230961 — Zeus Spinal System | Shanghai Sanyou Medical Co, Ltd. Oct 10, 2023 |
| K230916 — WeSensor | Picopack, Inc. Oct 10, 2023 |
| K231658 — VEOS Spinal Fixation System | Spineway Oct 10, 2023 |
| K231413 — IPD Dental Implant Abutments | Implant Protesis Dental 2004, S.L. Oct 10, 2023 |
| K230130 — Micromate Navi+ | Isys Medizintechnik GmbH Oct 10, 2023 |
| K223027 — NeuroTrigger Basic (NTB) | Neurotrigger Oct 10, 2023 |
| K232341 — CarboClear® Pedicle Screw System | CarboFix Orthopedics , Ltd. Oct 10, 2023 |
| K232755 — Arthrex FiberTape and TigerTape Cerclage Sutures | Arthrex, Inc. Oct 6, 2023 |
| K230091 — THE Cover | Purgo Biologics, Inc. Oct 6, 2023 |
| K232411 — JuggerKnot Soft Anchor OC | Riverpoint Medical, LLC Oct 6, 2023 |
| K223802 — accufit | Mettler Electronics Corporation Oct 6, 2023 |
| K232787 — ScanNav Anatomy Peripheral Nerve Block | Intelligent Ultrasound Limited Oct 6, 2023 |
| K232276 — Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20 | Oxoid Limited (Part Of Thermo Fisher Scientific) Oct 6, 2023 |
| K232492 — 2.7 mm GRYPHON Flex Knotless PEEK Anchor; 2.7 mm GRYPHON Flex Knotless Biocomposite Anchor | Medos International SARL Oct 6, 2023 |
| K231863 — ProBeam 360° Proton Therapy System v2.0 (Multiroom) | Varian Medical Systems, Inc. Oct 6, 2023 |
| K232760 — Swoop® Portable MR Imaging System® | Hyperfine, Inc. Oct 6, 2023 |
| K230265 — MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System | Infobionic, Inc. Oct 6, 2023 |
| K231300 — Nutricair Enteral Syringe with ENFit | Cair Lgl Oct 6, 2023 |
| K232480 — ProtekDuo Veno-Venous Cannula Sets | Cardiacassist, Inc. Oct 6, 2023 |
| K232056 — IPL Hair Removal Device, Model(s): PB1, PB2, PB3, PB4, TM002 | Dongguan Lide Electric Appliance Co., Ltd. Oct 6, 2023 |
| K223905 — Vivio® LVEDP System | Avicena, LLC Oct 6, 2023 |
| DEN220087 — Edison System | HistoSonics, Inc. Oct 6, 2023 |
| K232407 — Cautery Protective Actuation System (CPAS) | Safer Surgeries Medical Devices, LLC Oct 6, 2023 |
| K230853 — EARP Nerve Cuff Electrode | Nvision Biomedical Technologies, Inc. Oct 6, 2023 |
| K232044 — Invictus Robotic Navigation Instruments | Alphatec Spine, Inc. Oct 6, 2023 |
| K232173 — Ascend VBR System, Ascend NanoTec VBR System | Alphatec Spine, Inc. Oct 6, 2023 |
| K231603 — Standard Staple-Line Reinforcement (SSLR23) | Standard Bariatrics, Inc. Oct 6, 2023 |
| K232055 — Vial Adapter | Shanghai Lingfu Technology Co., Ltd. Oct 6, 2023 |
| K230777 — Patient Examination Gloves | 3A Glove Sdn. Bhd. Oct 6, 2023 |
| K223926 — VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box | Medimaging Integrated Solution, Inc (Miis) Oct 6, 2023 |
| K221777 — Disposable Sterile Syringe | Weihai Shengjie Medical Technology Co., Ltd. Oct 6, 2023 |
| K230144 — Denti.AI Detect | Denti.Ai Technology, Inc. Oct 6, 2023 |
| K232046 — Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection | Xeridiem Medical Devices, A Spectrum Plastics Group Company Oct 6, 2023 |
| K220451 — Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT | Randox Laboratories Limited Oct 5, 2023 |
| K232279 — LifeStyles NRL Textured Condom | Suretex Limited Oct 5, 2023 |
| K232367 — cmAngio® V1.0 | Curemetrix, Inc. Oct 5, 2023 |
| K232395 — ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD | Biomérieux Oct 5, 2023 |
| K231001 — DeepTek CXR Analyzer v1.0 | Deeptek Medical Imaging Pvt, Ltd. Oct 5, 2023 |
| K223740 — Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5) | Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd. Oct 5, 2023 |
| K230780 — MFG-05 | Zimmer Medizinsysteme GmbH Oct 5, 2023 |
| K221550 — Evidence MultiSTAT DOA Urine MultiPlex | Randox Laboratories Limited Oct 5, 2023 |
| K233044 — Tandem Mobi insulin pump with interoperable technology | Tandem Diabetes Care, Inc. Oct 5, 2023 |
| K231078 — All-Suture Anchor | Riverpoint Medical, LLC Oct 5, 2023 |
| K230070 — MESORAM® Hypodermic Needle (710301); MESORAM® Hypodermic Needle (710302); MESORAM® Hypodermic Needle (712305); MESORAM® Hypodermic Needle (712315); MESORAM® Hypodermic Needle (710303); MESORAM® Hypodermic Needle (710307); MESORAM® Hypodermic Needle (710306); MESORAM® Hypodermic Needle (712308); MESORAM® Hypodermic Needle (712318); MESORAM® Hypodermic Needle (712303); MESORAM® Hypodermic Needle (712307); MESORAM® Hypodermic Needle (712306); MESORAM® Hypodermic Needle (812400); MESORAM® | Promamedical, Inc. Oct 5, 2023 |
| K232704 — Clarius Ultrasound Scanner | Clarius Mobile Health Corp. Oct 5, 2023 |
| K230242 — OsteoCentric Dental Implant System | OsteoCentric Technologies Oct 5, 2023 |