| K231973 — PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove | Ineo Tech Sdn Bhd Sep 29, 2023 |
| K232650 — KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O Sep 29, 2023 |
| K220458 — UltraFlo-R Push Button Blood Collection Set | Innovative Medical Technologies, Inc. Sep 29, 2023 |
| K232647 — Microcatheter | Surmodics,Inc. Sep 29, 2023 |
| K230187 — Terran NM-101 | Terran Biosciences, Inc. Sep 29, 2023 |
| K232669 — TBI | Abbott Laboratories Sep 29, 2023 |
| K213403 — Aptiva CTD Essential Reagent | Inova Diagnostics, Inc. Sep 29, 2023 |
| DEN210011 — Invitae Common Hereditary Cancers Panel | Invitae Corporation Sep 29, 2023 |
| K221359 — ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM | Instrumentation Laboratory CO Sep 29, 2023 |
| K233257 — 3M ClarityAligners with Quick Attachments | 3M Company, Unitek Orthodontic Products Sep 29, 2023 |
| K230865 — PIVO Pro Needle-free Blood Collection Device | Becton Dickinson Infusion Therapy Systems, Inc. Sep 28, 2023 |
| K231013 — DNA/RNA Shield SafeCollect Saliva Collection kit | Zymo Research Sep 28, 2023 |
| K232605 — Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue® MAX + Invue Inset Anterior Cervical Plate System, and FacetFuse® Screw Fixation System | Lesspine Innovations Sep 28, 2023 |
| K232699 — Low Ejection Fraction AI-ECG Algorithm | Anumana, Inc. Sep 28, 2023 |
| K233161 — BeautiLink SA | Shofu Dental Corporation Sep 28, 2023 |
| K231837 — Brainomix 360 Triage LVO | Brainomix Limited Sep 28, 2023 |
| K231901 — Hakon, Hakon Smart | Medical San Indústria DE Equipamentos Médicos Ltda. Sep 28, 2023 |
| K231792 — VeriSafe Safety sterile syringes | Promisemed Hangzhou Meditech Co., Ltd. Sep 28, 2023 |
| K232274 — IPL hair removal device | Lumenessa Corp Sep 28, 2023 |
| K231188 — ALIGN Radial Head System | Skeletal Dynamics, Inc. Sep 28, 2023 |
| K232275 — Invictus® Spinal Fixation System | Alphatec Spine, Inc. Sep 27, 2023 |
| K231538 — FreedomFlow Orbital Circumferential Atherectomy System | Cardio Flow Inc., Sep 27, 2023 |
| K222638 — Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems | Cepheid Sep 27, 2023 |
| K230563 — EVOLUTION® Hinge Knee System | Microport Orthopedics, Inc. Sep 27, 2023 |
| K232668 — Cove Strip, OsteoCove Strip | SeaSpine Orthopedics Corporation Sep 27, 2023 |
| K214117 — Afinion HbA1c, Afinion 2 and Alere Afinion AS100 Analyzer | Abbott Diagnostics Technologies AS Sep 27, 2023 |
| K231076 — VariLift®-C Interbody Fusion System | Wenzel Spine, Inc. Sep 27, 2023 |
| K232260 — Thinline Sheath Introducer | Inneuroco, Inc. Sep 27, 2023 |
| K232596 — EndoGI S-Path Biliary Stent System | Endogi Medical, Ltd. Sep 27, 2023 |
| K231108 — Talon Transseptal Sheath | Inari Medical, Inc. Sep 27, 2023 |
| K232609 — Micro Ace Advanced Micro Access System | Merit Medical Systems, Inc. Sep 27, 2023 |
| K232167 — VySpan PCT System | Vy Spine, LLC Sep 27, 2023 |
| K232255 — EZSensor XHD | Qpix Solutions, Inc. Sep 27, 2023 |
| K232616 — Volta AF-Xplorer | Volta Medical Sep 27, 2023 |
| K231363 — Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010) | Hantech Medical Device Co., Ltd. Sep 27, 2023 |
| K230925 — Disposable Injection Needle AF series | Alton (Shanghai) Medical Instruments Co., Ltd. Sep 27, 2023 |
| K231007 — CEDIA Heroin Metabolite (6-AM) Assay | Microgenics Corporation Sep 27, 2023 |
| K230884 — AVVIGO'+ Multi-Modality Guidance System | Boston Scientific Corporation Sep 26, 2023 |
| K223496 — Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons® Tapered Internal, MIS® C1 Implant Systems | Prismatik Dentalcraft, Inc. Sep 26, 2023 |
| K232233 — Invisalign System with Mandibular Advancement Featuring Occlusal Blocks | Align Technology, Inc. Sep 26, 2023 |
| K231971 — DEKA PHYSIQ 360 | El.En S.P.A. Sep 26, 2023 |
| K213517 — Access Thyroglobulin Antibody II | Beckman Coulter, Inc. Sep 26, 2023 |
| K232336 — ES Series V2 | E-Scopics Sep 26, 2023 |
| DEN220026 — VasQ | Laminate Medical Technologies , Ltd. Sep 26, 2023 |
| K230252 — OFIX MIS App | Orthofix US, LLC Sep 26, 2023 |
| K220396 — EasyStat 300 | Medica Corporation Sep 26, 2023 |
| K230513 — Arthrex Univers Apex OptiFit Humeral Stem | Arthrex, Inc. Sep 26, 2023 |
| K232617 — ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. Sep 26, 2023 |
| K230398 — MedCAD® AccuPlate® 3DTi Patient-Specific Plating System | Medcad Sep 26, 2023 |
| K221052 — Self-Fitting hearing aids | Huizhou Jinghao Medical Technology Co., Ltd. Sep 25, 2023 |