| K242948 — Adora DRFi (04550010) | Nrt X-Ray A/S Dec 23, 2024 |
| K242797 — OsteoFlo HydroFiber | SurGenTec, LLC Dec 23, 2024 |
| K243121 — SLT Select Fiber Delivery System and Contact Tips (models: SSRH 8-SMA; TCRH 7-SMA; FEF 2.2-SMA; CFE 0.6-SMA; SSRH 8Z-SMA; SSRH 4-SMA; SSRH 6-SMA; SSRH 9-SMA; SSRH 10-SMA; SSRH 11-SMA; SSRH 7L-SMA; TCRH 7Z-SMA; FEF 1.8-SMA; CFE 0.55-SMA; CFE 0.36-SMA; LAL 550-SMA; LAL 550Z-SMA; LAL 365-SMA; LAL 365Z-SMA; ER2; ERP2; GR2; GRP2; ER4; ERP4; GR4; GRP4; ER6; ERP6; GR6; GRP6; ER8; ERP8; GR8; GRP8; ER10; ERP10; GR10; GRP10; ER12; ERP12; GR12; GRP12; MD2.5; MD3.5; HP1.0; MTP1.5; MTP3.5; MTRG1.5; | Jiangxi Medex Technology Co., Ltd. Dec 22, 2024 |
| K243147 — LGO-Surgical Laser Fibers | Light Guide Optics International , Ltd. Dec 21, 2024 |
| K243085 — IPL Hair Removal Device (DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-P, DE03B-V, DE03B-G) | Zhuzhou Goldenhot Medical Technology Co., Ltd. Dec 21, 2024 |
| K242628 — Scooter (PS30) | Lichtmega Technology Co., Ltd. Dec 20, 2024 |
| K242953 — KIDS Arterial Filters | Sorin Group Italia S.R.L. Dec 20, 2024 |
| K243024 — Cellbrick Knee Spacer | United Orthopedic Corporation Dec 20, 2024 |
| K241394 — iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip | Andon Health Co, Ltd. Dec 20, 2024 |
| K241680 — Momcozy Wearable Breast Pump (BP311) | Shenzhen Root Innovation Technology Co., Ltd. Dec 20, 2024 |
| K242572 — TopCEM-Try in Veneer Try-in Gel | Rizhao Huge Biomaterials Company, Ltd. Dec 20, 2024 |
| K243293 — Zimmer® Persona® Personalized Knee System | Zimmer Biomet Dec 20, 2024 |
| K243308 — Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, LEPORELLO 3.5mm Olecranon Syste) | Bonebridge AG Dec 20, 2024 |
| K242530 — HF-Etchant Hydrofluoric Acid Etching Gel | Rizhao Huge Biomaterials Company, Ltd. Dec 20, 2024 |
| K233639 — SmartClip Secure Soft Tissue Marker | Elucent Medical, Inc. Dec 20, 2024 |
| K243671 — ExcelsiusGPS® Instruments | Globus Medical, Inc. Dec 20, 2024 |
| K242923 — SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230) | Envision Endoscopy Dec 20, 2024 |
| K242362 — Lightning Viewer | Nexsys Electronics Inc. Dba Medweb Dec 20, 2024 |
| K242599 — aprevo® Digital Planning | Carlsmed, Inc. Dec 20, 2024 |
| K242688 — Finiff System | Skingrab Co., Ltd. Dec 20, 2024 |
| K242929 — Fas Aligner System | Xplora 3D Europe S.L Dec 20, 2024 |
| K241888 — Single-use Balloon Dilatation Catheter | Leo Medical Co., Ltd. Dec 20, 2024 |
| K242534 — HandPICO Fractional Laser Handpiece Tip | Vydence Medical Dec 20, 2024 |
| K242644 — SENDERO MAX Delivery Catheter | Okami Medical, Inc. Dec 20, 2024 |
| K242281 — Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00622); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00820); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00822) | Arrow International, LLC (A Subsidiary Of Teleflex, Inc.) Dec 20, 2024 |
| K240435 — Alpha Dent Implants Dental Implants System | Alpha Dent Implants GmbH Dec 20, 2024 |
| K243629 — Momcozy Wearable Breast Pump (BP311); Momcozy Wearable Breast Pump (BP223); Momcozy Wearable Breast Pump (BP324); Momcozy Wearable Breast Pump (BP334); Momcozy Wearable Breast Pump (BP430) | Shenzhen Root Innovation Technology Co., , Ltd. Dec 20, 2024 |
| K243675 — InkSpace Imaging Small Body Array | Inkspace Imaging, Inc. Dec 20, 2024 |
| K242168 — Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 | GE Medical Systems Ultrasound And Primary Care Diagnostics Dec 20, 2024 |
| K241411 — Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM) | Welch Allyn, Inc. Dec 20, 2024 |
| K243911 — HPR Cordless Hygiene Handpiece | Handpiece Headquarters Dec 20, 2024 |
| K243149 — Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models) | Congruence Medical Solutions, LLC Dec 20, 2024 |
| K242529 — Tigon Medical All-Suture Anchors (ASA) | Tigon Medical Dec 20, 2024 |
| K241167 — BioSphere Putty; BioSphere MIS Putty | Synergy Biomedical Dec 20, 2024 |
| K243759 — BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack)) | Biofire Diagnostics, LLC Dec 20, 2024 |
| K241670 — Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2) | Beijing Adss Development Co., Ltd. Dec 20, 2024 |
| K243607 — Moda-flx Hemodialysis System Cartridge (102121-001 ) | Diality, Inc. Dec 20, 2024 |
| K241652 — DASH® SARS-CoV-2 & Flu A/B Test | Nuclein, LLC Dec 20, 2024 |
| K243040 — LED Light Therapy Mask (SKB-1818P,SKB-1918,SKB-1918P,SKB-1918PLUS,SKB-2318L,SKB-2318P,SKB-2318PRO,IN-FM002, SKB-2418) | Shenzhen Siken 3D Technology Development Co., Ltd. Dec 20, 2024 |
| K243440 — Electric Wheelchair (HC820N) | Yongkang Hengyi Vehicle Co., Ltd. Dec 19, 2024 |
| K243652 — Monoject Enteral Syringe with ENFit Connector (401SE); Monoject Enteral Syringe with ENFit Connector (403SE); Monoject Enteral Syringe with ENFit Connector (406SE); Monoject Enteral Syringe with ENFit Connector (412SE); Monoject Enteral Syringe with ENFit Connector (435SE); Monoject Enteral Syringe with ENFit Connector (460SE) | Cardinalhealth Dec 19, 2024 |
| K242700 — Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A, HD-73A, HD-73B, HD-116, HD-116A, HD-53A, HD-53B) | Shenzhen Nuon Medical Equipment Co., Ltd. Dec 19, 2024 |
| K242370 — Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle (3cm) (140937 (ESE103A)) | Medline Industries, LP Dec 19, 2024 |
| K243071 — Bovine Dermis Collagen Dermal Matrix | Collagen Matrix, Inc. Dec 19, 2024 |
| K241637 — Echo Intracranial Base Catheter | Stryker Neurovascular Dec 19, 2024 |
| K242954 — Integrity V500 (Integrity, Integrity with VEMP) | Vivosonic, Inc. Dec 19, 2024 |
| K243688 — Saige-Dx (3.1.0) | DeepHealth, Inc. Dec 19, 2024 |
| K243361 — Nutrifit | Vygon USA Dec 19, 2024 |
| DEN240014 — ARC-EX System | Onward Medical, Inc. Dec 19, 2024 |
| K241768 — Broadway 8 Catheter | Stryker Neurovascular Dec 19, 2024 |