| SIGNA MAGNUS (K241242) | Ge Medical Systems, LLC | 2024-10-17 |
| EGPS Navigated Instruments (K240160) | Astura Medical | 2024-10-17 |
| Safe Secure Sterilization Pouches and Rolls (K242839) | Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. | 2024-10-16 |
| Cerebral Autoregulation Index (CAI) Algorithm (K240596) | Edwards Lifesciences | 2024-10-16 |
| xvision Spine System (K241481) | Augmedics, Ltd. | 2024-10-16 |
| AMStent® Tracheobronchial Covered Stent System (DEN230087) | Peytant Solutions, Inc. | 2024-10-16 |
| Electrically powered wheelchair (K241632) | Kunshan Hi-Fortune Health Products Co., Ltd. | 2024-10-16 |
| Alkaline Phosphatase (K240468) | Abbott Laboratories Diagnostics Division | 2024-10-16 |
| JLK-CTP (K242556) | JLK, Inc. | 2024-10-16 |
| UltraEzAir® (UEA1A) (K240114) | Dualams, Inc., Dba Airkor | 2024-10-16 |
| CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing Set (K241221) | Cerenovus, Inc. | 2024-10-16 |
| Vy Spine™ VyLam™ Laminoplasty System (K242784) | Vy Spine, LLC | 2024-10-16 |
| CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter (K241244) | Cerenovus, Inc. | 2024-10-16 |
| RELIEEV Uterine Manipulator Injector (CUMI 5.0) (K240364) | Li Medical Corporation , Ltd. | 2024-10-16 |
| Elecrtronic Blood Pressure Monitor (BP-201, BP-202, BP-203, BP-204, BP-205, BP-206) (K241613) | Shenzhen Hbcare Technology Co.,Ltd | 2024-10-16 |
| ONCOZENE Microspheres (K242794) | Varian Medical Systems, Inc. | 2024-10-16 |
| Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection); Ambu® aBox™ 2 (K240849) | Ambu A/S | 2024-10-16 |
| Stryker Steri-Shield 8 Surgical Hoods and Togas (K241272) | Stryker Instruments | 2024-10-16 |
| DenMat Bulk Fill Composite (K242097) | Den-Mat Holdings, LLC | 2024-10-15 |
| VINT (K240385) | Mediimg Corporation | 2024-10-15 |
| Denture Base Resin (PN-Denture (Red, White)) (K241673) | Shenzhen Piocreat 3D Technology Co., Ltd. | 2024-10-15 |
| Artix™ MT; Artix™ Thin-Walled Thrombectomy Sheath (K241894) | Inari Medical, Inc. | 2024-10-15 |
| SIRONA 100 Therapy Laser System (OEM's Model EVANLAS) (K231997) | Cure Point Therapeutics, Inc. | 2024-10-15 |
| Single-use Extraction Baskets (K240192) | Scivita Medical Technology Co., Ltd. | 2024-10-15 |
| TauTona Pneumoperitoneum Assist Device (TPAD) (K242536) | Tautona Group | 2024-10-15 |
| Getinge Assured MI Steam Migrating Integrator (K242795) | Steritec Products Mfg. (A Getinge Group Company) | 2024-10-15 |
| cvi42 Software Application (K242781) | Circle Cardiovascular Imaging, Inc. | 2024-10-15 |
| NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs) (K242812) | Nb Medical Company Limited | 2024-10-12 |
| Mobility Scooter (N3473) (K242387) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2024-10-11 |
| SPECTRALIS with Flex Module (K241163) | Heidelberg Engineering GmbH | 2024-10-11 |
| syngo Application Software (K241569) | Siemens Medical Solutions USA, Inc. | 2024-10-11 |
| X Sensor (Model: IOS-A15IF, HDI-15DGF) (K242778) | Qpix Solutions, Inc. | 2024-10-11 |
| ARTAIRA Arterial Compression Device (AACD01) (K240499) | Airos Medical, Inc. | 2024-10-11 |
| Hood (DH-083ST) (K242779) | Fujifilm Corporation | 2024-10-11 |
| Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System (IOPS®) (Guidewire Handle) (K242133) | Centerline Biomedical, Inc. | 2024-10-11 |
| LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293) (K241857) | Dongguan Boyuan Intelligent Technology Co.,Ltd | 2024-10-11 |
| Access Toxo IgM II (K242095) | Beckman Coulter, Inc. | 2024-10-11 |
| Spark™ Clear Aligner System (K240501) | Ormco Corporation | 2024-10-11 |
| Versius Surgical System (DEN230078) | Cmr Surgical Limited | 2024-10-11 |
| Accure Laser System (K242035) | Accure Acne, Inc. | 2024-10-11 |
| Belun Ring BLR-200 (BLR-200) (K234110) | Belun Technology Company Limited | 2024-10-11 |
| PPH Saliva Collection Kit (K240797) | Permantis Public Health | 2024-10-11 |
| HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System (K241971) | Samsung Medison Co., Ltd. | 2024-10-11 |
| HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold) (K240242) | Anhui Deepblue Medical Technology Co., Ltd. | 2024-10-11 |
| JDZygoma dental implants (K240143) | Jdentalcare Srl | 2024-10-11 |
| DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) (K242742) | STERIS Corporation | 2024-10-11 |
| Legend® Acetabular Shell (K242833) | Ortho Development Corp. | 2024-10-11 |
| Progressive Orthodontics App (K241153) | Progressive Aligners, Inc. | 2024-10-11 |
| Monotime and Optime R (K233265) | Peters Surgical | 2024-10-11 |
| PBM Hair Therapy Cap (K240472) | Dongguan Tutamen Metalwork Co., Ltd. | 2024-10-11 |
| Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter (K240826) | Sterilmed, Inc. | 2024-10-11 |
| UriSponge™ (K232565) | Copan Italia Spa | 2024-10-11 |
| QUEX ED; QUEX S (K232779) | Qx World, Ltd. | 2024-10-11 |
| ProSeal™ In Line Pump Set (423850) (K241735) | Epic Medical Pte. , Ltd. | 2024-10-10 |
| uDR 380i Pro (K242515) | Shanghai United Imaging Healthcare Co., Ltd. | 2024-10-10 |
| eMVFit (MVF-10M) (K240992) | Weero Co., Ltd. | 2024-10-10 |
| Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection); Ambu® aView™ 2 Advance (K240848) | Ambu A/S | 2024-10-10 |
| EyeGility™ Inserter for Preloaded enVista IOLs (K242389) | Bausch & Lomb, Incorporated | 2024-10-10 |
| Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT (K241092) | Quanta System Spa | 2024-10-10 |
| Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid (K241491) | Stryker Corporation (Tornier, S.A.S.) | 2024-10-10 |
| Dental porcelain powder (K242400) | Yilink (Tianjin) Biotechnology Co., Ltd. | 2024-10-10 |
| GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System (K230325) | Greens Surgicals Pvt. , Ltd. | 2024-10-10 |
| EchoMeasure (K241430) | Icardio.Ai | 2024-10-10 |
| AutoChamber (K240786) | HeartLung Corporation | 2024-10-10 |
| Lasya-Trinity (K241951) | BLUECORE COMPANY Co., Ltd. | 2024-10-10 |
| BTI Interna 3.0 Dental Implant System UnicCa® (K240262) | B.T.I. Biotechnology Institute, Sl. | 2024-10-10 |
| KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage System (K233947) | Ctl Medical Corporation | 2024-10-10 |
| INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05) (K240315) | Siemens Healthcare Diagnostics Products GmbH | 2024-10-10 |
| aprevo® anterior lumbar interbody fusion device with interfixation (K241477) | Carlsmed, Inc. | 2024-10-09 |
| TRAP EASY (K242029) | H.S Hospital Service S.P.A | 2024-10-09 |
| OsteoCentric Technologies Cannulated Fasteners and Nuts (K242691) | OsteoCentric Technologies | 2024-10-09 |
| Limbus Contour (K241837) | Limbus Ai, Inc. | 2024-10-09 |
| TruAbutment DS; TruBase (K241485) | Truabutment, Inc. | 2024-10-09 |
| 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. (K242021) | Thermo Fisher Scientific | 2024-10-09 |
| CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6) (K240095) | Shanghai Care US Medical Product Co., Ltd. | 2024-10-09 |
| eMVFit (MVF-10M) (K240991) | Weero Co., Ltd. | 2024-10-09 |
| SER Pen Carain MicroSystem (MP1209SP) (K241355) | Su-Ko Technologies, LLC | 2024-10-09 |
| MEDIYAG (K231948) | Medicreations, LLC | 2024-10-09 |
| Clavicle and Scapula System (K240181) | Auxein Medical Pvt., Ltd. | 2024-10-09 |
| TROJAN SIS Synthetic Latex Condom with Silicone Lubricant (K240379) | Church & Dwight Co., Inc. | 2024-10-08 |
| Jet Flow Bulk (K242014) | Meta Biomed Co., Ltd. | 2024-10-08 |
| Power Wheelchair (JJW-6001) (K240563) | ZheJiang J&J Mobility Co., Ltd. | 2024-10-08 |
| Gemini Medical Cage System (K242267) | ZheJiang Decans Medical Devices Co., Ltd. | 2024-10-08 |
| Air Compression Massager (ACM-A1, ACM-A2, ACM-A3, ACM-A4) (K241446) | Sichuan Qianii-Beoka Medical Technoiogy Lnc. | 2024-10-08 |
| Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System (K240640) | Sejoy Biomedical Co., Ltd. | 2024-10-08 |
| 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)) (DEN230076) | Omron Healthcare, Inc. | 2024-10-08 |
| ProLift Wedge Expandable Spacer System (K242826) | Life Spine, Inc. | 2024-10-08 |
| Nerivio; NerivioInfinity (K241756) | Theranica Bio-Electronics, Ltd. | 2024-10-08 |
| Single-use Ureteral Access Sheath (K240167) | Hunan Vathin Medical Instrument Co., Ltd. | 2024-10-08 |
| Lucens 41 (senofilcon C) Silicone Hydrogel Soft (Hydrophilic) Contact Lens (K242391) | Lucens Technology Co., Ltd. | 2024-10-08 |
| EPIQ Series Diagnostic Ultrasound System (K240980) | Philips Ultrasound, LLC | 2024-10-07 |
| SpineUs™ System (K241029) | Verdure Imaging | 2024-10-07 |
| Healgen Rapid Check COVID-19/Flu A&B Antigen Test (DEN240029) | Healgen | 2024-10-07 |
| EMPHASYS Acetabular Shell with RapiTite HA (K242084) | Depuy Ireland UC | 2024-10-07 |
| Water Container (MAJ-901); Water Container (MAJ-902) (K242357) | Olympus Medical Systems Corporation | 2024-10-07 |
| GENESIS (MS-P02-GEN) (K240843) | Climbing Steps, Inc. | 2024-10-07 |
| EARP Interbody System (K242457) | Retropsoas Technologies, LLC | 2024-10-07 |
| OvertureTi Knee Resurfacing SystemTM (K242746) | Overture Orthopaedics | 2024-10-07 |
| PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) (K242208) | Primed Medical Products, Inc. | 2024-10-07 |
| OR3O Dual Mobility System (K242375) | Smith & Nephew, Inc. | 2024-10-07 |