| Nasal Aspirator (NS 13) (K241852) | Avita Corporation | 2024-12-31 |
| Power Wheelchair (D10, D12, D15, D17, D20, D37) (K242468) | Anhui Jbh Medical Apparatus Co., Ltd. | 2024-12-31 |
| Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (NNPM-03/ Nefes L) (K243225) | Genadyne Biotechnologies, Inc. | 2024-12-31 |
| MitraClip™ G5 Steerable Guide Catheter (SGC0801); TriClip™ G5 Steerable Guide Catheter (TSGC0801) (K243224) | ABBOTT MEDICAL | 2024-12-31 |
| Peak Flow Meter (K241338) | Chongqing Moffy Innovation Technology Co., Ltd. | 2024-12-31 |
| Electric Wheelchair (MODEL H) (K242989) | Nanjing E-Take Medical Apparatus Co., Ltd. | 2024-12-31 |
| Idys® LIF (K243670) | Clariance | 2024-12-31 |
| Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG) (K243445) | Bios S.R.L. | 2024-12-30 |
| Next Generation Access Platform (K242376) | Balt USA, LLC | 2024-12-30 |
| AF531 Oro-Nasal SE Face Mask (K243394) | Respironics, Inc. | 2024-12-30 |
| PAL Aspiration System (K242804) | Microaire Surgical Instruments, LLC | 2024-12-30 |
| 8MP Color LCD Displays C811W, C811WT, PA27 and PA27T (K233119) | Shenzhen Beacon Display Technology Co., Ltd. | 2024-12-28 |
| INNO SLA Mini Plus® Implant System (K241127) | Cowellmedi Co., Ltd. | 2024-12-27 |
| BioTraceIO Precision (2.0) (K243084) | Techsomed Medical Technologies , Ltd. | 2024-12-27 |
| OEC One ASD (K240828) | Ge Hualun Medical Systems Co. , Ltd. | 2024-12-27 |
| Elastic Impression Material (K241924) | Beijing Okvd Biological Technology , Ltd. | 2024-12-27 |
| Power Wheelchair (K242252) | Anhui Jbh Medical Apparatus Co., Ltd. | 2024-12-27 |
| TiLink-P SI Joint Fusion System (K243835) | SurGenTec, LLC | 2024-12-27 |
| FLASH EVD System (10-0002) (K242480) | 7D Surgical ULC | 2024-12-27 |
| BLUEDIAMOND IMPLANT (K241972) | Megagen Implant Co., Ltd. | 2024-12-27 |
| ProSeal™ Vented Universal Vial Adaptor (K240517) | Epic Medical Pte. , Ltd. | 2024-12-26 |
| iovera° System (K243677) | Pacira Biosciences, Inc. | 2024-12-26 |
| Diode Laser System model Dawn-S (K243037) | Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd | 2024-12-26 |
| Straumann CARES Visual and Nova Dental CAD (K233252) | Institut Straumann AG | 2024-12-26 |
| Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser System (Aurolance 980); Diode Laser System (Aurolance 810); Diode Laser System (Aurolance AM) (K243141) | Jiangxi Medex Technology Co., Ltd. | 2024-12-26 |
| FISIOWARM 7.0 (K232966) | Golden Star Srl | 2024-12-26 |
| TMC Compression Implant System (K243658) | Treace Medical Concepts | 2024-12-26 |
| RM STAR EX with RMS Needle (K243097) | Bomtech Electronics Co., Ltd. | 2024-12-26 |
| SpineAR SNAP (SyncAR Spine) (K243623) | Surgical Theater, Inc. | 2024-12-24 |
| Insulin Syringes (K242434) | Chirana T. Injecta | 2024-12-24 |
| ARTFX Trauma Bone Plate and Screw System (K242939) | Artfx Medical | 2024-12-23 |
| SACS PRO (K243177) | Elastimed , Ltd. | 2024-12-23 |
| GlassBone Granules (K242782) | Noraker | 2024-12-23 |
| NIDO Baby Magnetic Resonance Imaging System (K242573) | Jiangsu Lici Medical Device Co., Ltd. | 2024-12-23 |
| INHANCE INTACT™ (K243248) | Depuy Ireland UC | 2024-12-23 |
| Adora DRFi (04550010) (K242948) | Nrt X-Ray A/S | 2024-12-23 |
| NEO Pedicle Screw System™ (K243693) | Neo Medical SA | 2024-12-23 |
| OsteoFlo HydroFiber (K242797) | SurGenTec, LLC | 2024-12-23 |
| Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 750 ml/min) (K242735) | Belmont Medical Technologies | 2024-12-23 |
| Electrosurgical Generator (ES-100); Electrosurgical Generator (ES-300) (K240975) | Beijing Taktvoll Technology Co., Ltd. | 2024-12-23 |
| SIMEOX 200 Airway Clearance Device (K241091) | Inogen, Inc. | 2024-12-23 |
| Angiography Injector (K242143) | Shandong Int Medical Instruments Co., Ltd. | 2024-12-23 |
| Denture Base (K243103) | Riton 3D Technology Co., Ltd. | 2024-12-23 |
| Genadyne DUO NPWT (K233614) | Genadyne Biotechnologies, Inc. | 2024-12-23 |
| PanopticAI Vital Signs (K240890) | PanopticAI technologies Limited | 2024-12-23 |
| Aquilion ONE (TSX-308A/3) V1.5 (K242403) | Canon Medical Systems Corporation | 2024-12-23 |
| Noxturnal Web (K241288) | Nox Medical Ehf | 2024-12-23 |
| Bolo Button System (K242091) | Fusion Orthopedics | 2024-12-23 |
| Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe) (K241856) | Hlb Lifescience Co., Ltd. | 2024-12-23 |
| 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; (K243121) | Jiangxi Medex Technology Co., Ltd. | 2024-12-22 |
| LGO-Surgical Laser Fibers (K243147) | Light Guide Optics International , Ltd. | 2024-12-21 |
| IPL Hair Removal Device (DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-P, DE03B-V, DE03B-G) (K243085) | Zhuzhou Goldenhot Medical Technology Co., Ltd. | 2024-12-21 |
| SmartClip Secure Soft Tissue Marker (K233639) | Elucent Medical, Inc. | 2024-12-20 |
| KIDS Arterial Filters (K242953) | Sorin Group Italia S.R.L. | 2024-12-20 |
| Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 (K242168) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2024-12-20 |
| Cellbrick Knee Spacer (K243024) | United Orthopedic Corporation | 2024-12-20 |
| HF-Etchant Hydrofluoric Acid Etching Gel (K242530) | Rizhao Huge Biomaterials Company, Ltd. | 2024-12-20 |
| ExcelsiusGPS® Instruments (K243671) | Globus Medical, Inc. | 2024-12-20 |
| Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2) (K241670) | Beijing Adss Development Co., Ltd. | 2024-12-20 |
| DASH® SARS-CoV-2 & Flu A/B Test (K241652) | Nuclein, LLC | 2024-12-20 |
| Fas Aligner System (K242929) | Xplora 3D Europe S.L | 2024-12-20 |
| Scooter (PS30) (K242628) | Lichtmega Technology Co., Ltd. | 2024-12-20 |
| BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack)) (K243759) | Biofire Diagnostics, LLC | 2024-12-20 |
| BioSphere Putty; BioSphere MIS Putty (K241167) | Synergy Biomedical | 2024-12-20 |
| Single-use Balloon Dilatation Catheter (K241888) | Leo Medical Co., Ltd. | 2024-12-20 |
| Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, LEPORELLO 3.5mm Olecranon Syste) (K243308) | Bonebridge AG | 2024-12-20 |
| Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM) (K241411) | Welch Allyn, Inc. | 2024-12-20 |
| 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) (K242281) | Arrow International, LLC (A subsidiary of Teleflex, Inc.) | 2024-12-20 |
| aprevo® Digital Planning (K242599) | Carlsmed, Inc. | 2024-12-20 |
| Finiff System (K242688) | Skingrab Co., Ltd. | 2024-12-20 |
| TopCEM-Try in Veneer Try-in Gel (K242572) | Rizhao Huge Biomaterials Company, Ltd. | 2024-12-20 |
| SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230) (K242923) | Envision Endoscopy | 2024-12-20 |
| HPR Cordless Hygiene Handpiece (K243911) | Handpiece Headquarters | 2024-12-20 |
| SENDERO MAX Delivery Catheter (K242644) | Okami Medical, Inc. | 2024-12-20 |
| 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) (K243629) | Shenzhen Root Innovation Technology Co., , Ltd. | 2024-12-20 |
| Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models) (K243149) | Congruence Medical Solutions, LLC | 2024-12-20 |
| Zimmer® Persona® Personalized Knee System (K243293) | Zimmer Biomet | 2024-12-20 |
| Moda-flx Hemodialysis System™ Cartridge (102121-001 ) (K243607) | Diality, Inc. | 2024-12-20 |
| Lightning Viewer (K242362) | Nexsys Electronics Inc. Dba Medweb | 2024-12-20 |
| HandPICO Fractional Laser Handpiece Tip (K242534) | Vydence Medical | 2024-12-20 |
| InkSpace Imaging Small Body Array (K243675) | Inkspace Imaging, Inc. | 2024-12-20 |
| LED Light Therapy Mask (SKB-1818P,SKB-1918,SKB-1918P,SKB-1918PLUS,SKB-2318L,SKB-2318P,SKB-2318PRO,IN-FM002, SKB-2418) (K243040) | Shenzhen Siken 3D Technology Development Co., Ltd. | 2024-12-20 |
| Tigon Medical All-Suture Anchors (ASA) (K242529) | Tigon Medical | 2024-12-20 |
| Momcozy Wearable Breast Pump (BP311) (K241680) | Shenzhen Root Innovation Technology Co., Ltd. | 2024-12-20 |
| iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip (K241394) | Andon Health Co, Ltd. | 2024-12-20 |
| Alpha Dent Implants Dental Implants System (K240435) | Alpha Dent Implants GmbH | 2024-12-20 |
| Nutrifit (K243361) | Vygon USA | 2024-12-19 |
| Broadway 8 Catheter (K241768) | Stryker Neurovascular | 2024-12-19 |
| OviTex PRS (Long-Term Resorbable) (K243595) | TELA Bio, Inc. | 2024-12-19 |
| Quickdent Dental Implant System (K243094) | Quickdent Devices Private , Ltd. | 2024-12-19 |
| OrthoNext Platform System (K242270) | Orthofix Srl | 2024-12-19 |
| ARC-EX System (DEN240014) | Onward Medical, Inc. | 2024-12-19 |
| Bovine Dermis Collagen Dermal Matrix (K243071) | Collagen Matrix, Inc. | 2024-12-19 |
| Yushan X-Ray Flat Panel Detector (K243171) | Innocare Optoelectronics Corp. | 2024-12-19 |
| BD Vaginal Panel (K243725) | Becton, Dickinson and Company | 2024-12-19 |
| UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG) (K242908) | Shanghai Sigma High-Tech Co., Ltd. | 2024-12-19 |
| Echo Intracranial Base Catheter (K241637) | Stryker Neurovascular | 2024-12-19 |
| Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) (K243430) | Shenzhen Aozemei Technology Co., Ltd. | 2024-12-19 |
| 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) (K242700) | Shenzhen Nuon Medical Equipment Co., Ltd. | 2024-12-19 |
| IPD Dental Implant Abutments (K242819) | Implant Protesis Dental 2004, S.L. | 2024-12-19 |