| K242133 — Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System (IOPS®) (Guidewire Handle) | Centerline Biomedical, Inc. Oct 11, 2024 |
| K242035 — Accure Laser System | Accure Acne, Inc. Oct 11, 2024 |
| K240499 — ARTAIRA Arterial Compression Device (AACD01) | Airos Medical, Inc. Oct 11, 2024 |
| K240472 — PBM Hair Therapy Cap | Dongguan Tutamen Metalwork Co., Ltd. Oct 11, 2024 |
| K240242 — HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold) | Anhui Deepblue Medical Technology Co., Ltd. Oct 11, 2024 |
| DEN230078 — Versius Surgical System | Cmr Surgical Limited Oct 11, 2024 |
| K242389 — EyeGility Inserter for Preloaded enVista IOLs | Bausch & Lomb, Incorporated Oct 10, 2024 |
| K240992 — eMVFit (MVF-10M) | Weero Co., Ltd. Oct 10, 2024 |
| K240315 — INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05) | Siemens Healthcare Diagnostics Products GmbH Oct 10, 2024 |
| K241092 — Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT | Quanta System Spa Oct 10, 2024 |
| K241430 — EchoMeasure | Icardio.Ai Oct 10, 2024 |
| K241491 — Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid | Stryker Corporation (Tornier, S.A.S.) Oct 10, 2024 |
| K240848 — Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection); Ambu® aView 2 Advance | Ambu A/S Oct 10, 2024 |
| K241735 — ProSeal In Line Pump Set (423850) | Epic Medical Pte. , Ltd. Oct 10, 2024 |
| K230325 — GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System | Greens Surgicals Pvt. , Ltd. Oct 10, 2024 |
| K240262 — BTI Interna 3.0 Dental Implant System UnicCa® | B.T.I. Biotechnology Institute, Sl. Oct 10, 2024 |
| K233947 — KLIMT Expandable Lumbar Interbody Fusion (LIF) Cage System | Ctl Medical Corporation Oct 10, 2024 |
| K241951 — Lasya-Trinity | BLUECORE COMPANY Co., Ltd. Oct 10, 2024 |
| K242400 — Dental porcelain powder | Yilink (Tianjin) Biotechnology Co., Ltd. Oct 10, 2024 |
| K242515 — uDR 380i Pro | Shanghai United Imaging Healthcare Co., Ltd. Oct 10, 2024 |
| K240786 — AutoChamber | HeartLung Corporation Oct 10, 2024 |
| K242021 — The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Meropenem in the dilution range of 0.015 - 32 ug/ml. | Thermo Fisher Scientific Oct 9, 2024 |
| K231948 — MEDIYAG | Medicreations, LLC Oct 9, 2024 |
| K240991 — eMVFit (MVF-10M) | Weero Co., Ltd. Oct 9, 2024 |
| K242029 — TRAP EASY | H.S Hospital Service S.P.A Oct 9, 2024 |
| K240095 — CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6) | Shanghai Care US Medical Product Co., Ltd. Oct 9, 2024 |
| K241485 — TruAbutment DS; TruBase | Truabutment, Inc. Oct 9, 2024 |
| K242691 — OsteoCentric Technologies Cannulated Fasteners and Nuts | OsteoCentric Technologies Oct 9, 2024 |
| K241477 — aprevo® anterior lumbar interbody fusion device with interfixation | Carlsmed, Inc. Oct 9, 2024 |
| K241837 — Limbus Contour | Limbus Ai, Inc. Oct 9, 2024 |
| K240181 — Clavicle and Scapula System | Auxein Medical Pvt., Ltd. Oct 9, 2024 |
| K241355 — SER Pen Carain MicroSystem (MP1209SP) | Su-Ko Technologies, LLC Oct 9, 2024 |
| K242826 — ProLift Wedge Expandable Spacer System | Life Spine, Inc. Oct 8, 2024 |
| K240167 — Single-use Ureteral Access Sheath | Hunan Vathin Medical Instrument Co., Ltd. Oct 8, 2024 |
| K241756 — Nerivio; NerivioInfinity | Theranica Bio-Electronics, Ltd. Oct 8, 2024 |
| K242391 — Lucens 41 (senofilcon C) Silicone Hydrogel Soft (Hydrophilic) Contact Lens | Lucens Technology Co., Ltd. Oct 8, 2024 |
| K242267 — Gemini Medical Cage System | ZheJiang Decans Medical Devices Co., Ltd. Oct 8, 2024 |
| K240640 — Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System | Sejoy Biomedical Co., Ltd. Oct 8, 2024 |
| K240379 — TROJAN SIS Synthetic Latex Condom with Silicone Lubricant | Church & Dwight Co., Inc. Oct 8, 2024 |
| DEN230076 — Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP7460 (HEM-7371T1-AZ)); Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP5460 (HEM-7372T1-AZAZ)) | Omron Healthcare, Inc. Oct 8, 2024 |
| K242014 — Jet Flow Bulk | Meta Biomed Co., Ltd. Oct 8, 2024 |
| K240563 — Power Wheelchair (JJW-6001) | ZheJiang J&J Mobility Co., Ltd. Oct 8, 2024 |
| K241446 — Air Compression Massager (ACM-A1, ACM-A2, ACM-A3, ACM-A4) | Sichuan Qianii-Beoka Medical Technoiogy Lnc. Oct 8, 2024 |
| K240843 — GENESIS (MS-P02-GEN) | Climbing Steps, Inc. Oct 7, 2024 |
| K240980 — EPIQ Series Diagnostic Ultrasound System | Philips Ultrasound, LLC Oct 7, 2024 |
| K242457 — EARP Interbody System | Retropsoas Technologies, LLC Oct 7, 2024 |
| K242084 — EMPHASYS Acetabular Shell with RapiTite HA | Depuy Ireland UC Oct 7, 2024 |
| K242152 — SMARTeZ Elastomeric Infusion Pump (498111, 498121, 498131, 498141) | Epic Medical Pte. , Ltd. Oct 7, 2024 |
| K242208 — PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) | Primed Medical Products, Inc. Oct 7, 2024 |
| DEN240029 — Healgen Rapid Check COVID-19/Flu A&B Antigen Test | Healgen Oct 7, 2024 |