| Sonix Health (K240645) | Ontact Health Co., Ltd. | 2024-11-27 |
| AirSculpt Body Contouring System (AIRS-1-SYS) (K241835) | Cellmyx | 2024-11-27 |
| C&B Ceramic; C&B Permanent; C&B Interim (K233273) | Prevest Denpro Limited | 2024-11-27 |
| Ceragem Automatic Thermal Massager (CGM-MB-1902) (K243355) | Ceragem Co., Ltd. | 2024-11-27 |
| LED Light Therapy Machine (G1, G3, G4, G6) (K242638) | Shenzhen Walton Technology Co., Ltd. | 2024-11-27 |
| RadiForce RX570; RadiForce RX570-AR (K243221) | Eizo Corporation | 2024-11-27 |
| HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System (K242444) | Samsung Medison Co., Ltd. | 2024-11-27 |
| Pelvic Floor Stimulator (Intrelief PFE) (K241899) | Easymed Instruments Co., Ltd. | 2024-11-27 |
| KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1) (K243409) | Karl Storz SE & CO. KG | 2024-11-27 |
| BioBrace® (K242187) | Conmed Corporation | 2024-11-27 |
| Power wheelchair (K242308) | Zhejiang Zhonglei Medical Technology Co. , Ltd. | 2024-11-27 |
| TACTIX Vector Syndesmosis System (K243408) | Vilex, LLC | 2024-11-27 |
| SmoothSkin Pure Switch (SSC1) (K243362) | Cyden Limited | 2024-11-27 |
| CryoGlow (FW3XXXX) (K242796) | Sharkninja Operating, LLC | 2024-11-27 |
| SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter (K241115) | Spectrum Vascular | 2024-11-27 |
| Nexpowder (K240994) | Nextbiomedical Co., Ltd. | 2024-11-27 |
| Remunity System (K243354) | Deka Research & Development Corp. | 2024-11-27 |
| PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set (K241353) | Bard Access Systems, Inc. | 2024-11-27 |
| R2P Radifocus Glidewire Advantage (K240818) | Terumo Corporation | 2024-11-26 |
| The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Daptomycin in the dilution range of 0.03-64 ug/mL (K242657) | Thermo Fisher Scientific | 2024-11-26 |
| REGENETEN™ Bioinductive Implant (K242631) | Smith & Nephew Inc., Endoscopy Div. | 2024-11-26 |
| da Vinci SP Surgical System (SP1098) (K242318) | Intuitive Surgical, Inc. | 2024-11-26 |
| HyperFlex™ Bunion Correction System (K241995) | Footbridge Medical | 2024-11-26 |
| Intraluminal Applicator Set (K242961) | Varian Medical Systems | 2024-11-26 |
| Arm Blood Pressure Monitor (model: BPM-A7VL) (K243118) | Shenzhen Imdk Medical Technology Co., Ltd. | 2024-11-26 |
| NeuroMatch (K241390) | LVIS Corporation | 2024-11-26 |
| RadUnity (Version 1.0.0) (K242810) | Radunity Corp. | 2024-11-26 |
| 4CIS® Chiron Spinal Fixation System (K231655) | Solco Biomedical Co., Ltd. | 2024-11-26 |
| Cross Wise™ Multi-Use RF Adapter Cable (K243193) | Circa Scientific, Inc. | 2024-11-26 |
| TriMed Posterior Malleolus Fixation System (K243050) | TriMed, Inc. | 2024-11-26 |
| Cellinew (K240897) | VIOL Co., Ltd. | 2024-11-26 |
| Atlas Spine Lateral Expandable Interbody System (K243191) | Atlas Spine, Inc. | 2024-11-26 |
| PrimmaArt (K231859) | Dentscare Ltda | 2024-11-26 |
| Digital Temp (K242559) | Sprintray, Inc. | 2024-11-26 |
| MROpen Evo (03-2000-00); MROpen Evo (03-4000-00) (K242258) | Asg Superconductors S.P.A. | 2024-11-26 |
| OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel Construct (K242494) | Riverpoint Medical, LLC | 2024-11-26 |
| SureCath Set (K242049) | Coloplast Corp. | 2024-11-26 |
| LungProtect (K240650) | Traferox Technologies, Inc. | 2024-11-26 |
| Aptima BV Assay; Aptima CV/TV Assay (K243345) | Hologic, Inc. | 2024-11-25 |
| Electric Wheelchair (KR8803) (K241588) | Zhejiang Kairui Medical Device Co., Ltd. | 2024-11-25 |
| Customized Abutment (K242245) | Arum Dentistry Co., Ltd. | 2024-11-25 |
| JARVIS Glenoid Reverse Shoulder Prosthesis (K242253) | FH Industrie | 2024-11-25 |
| Transpara (2.1.0) (K241831) | Screenpoint Medical B.V. | 2024-11-25 |
| World Liner (K243162) | Signature Orthopaedics Pty, Ltd. | 2024-11-25 |
| Aluna 2 (K232588) | Knox Medical Diagnostics | 2024-11-25 |
| AccurSound Electronic Stethoscope (AS101) (K242971) | Heroic Faith International , Ltd. | 2024-11-25 |
| 3M™ Attest™ Super Rapid Readout Biological Indicator 1493; 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490M (K242538) | 3M Company | 2024-11-25 |
| WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281) (K240575) | Eemagine Medical Imaging Solutions GmbH | 2024-11-25 |
| EMS Sculpt Machine (K232982) | Shandong Huamei Technology Co., Ltd. | 2024-11-25 |
| Versus™ Catheter (VS110-8B) (K241851) | Liquet Medical, Inc. | 2024-11-25 |
| MIS LYNX Conical Connection Implant System (K241692) | Dentsply Sirona, Inc. | 2024-11-25 |
| SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology (K241953) | PAJUNK GmbH Medizintechnologie | 2024-11-22 |
| BriefCase-Quantification (K242203) | Aidoc Medical , Ltd. | 2024-11-22 |
| Entarik NI Feeding Tube System (K241169) | Gravitas Medical, Inc. | 2024-11-22 |
| Suction Irrigation Tubing Set (K242927) | Advamedix, GmbH | 2024-11-22 |
| Powered Wheelchair (NXN20-209) (K241529) | Zhejiang Nysin Medical Co., Ltd. | 2024-11-22 |
| Nova Allegro HbA1c Assay, Nova Allegro Analyzer (K221326) | Nova Biomedical Corporation | 2024-11-22 |
| FemVue MINI Saline-Air Device (K242002) | Femasys, Inc. | 2024-11-22 |
| Jasmate® Toothpaste (K242913) | Jasberry Healthcare Private Limited | 2024-11-22 |
| Manual Wheelchair (MASY23) (K242722) | Sichuan Ast Medical Equipment Co., Ltd. | 2024-11-22 |
| Dreem 3S (K242094) | Beacon Biosignals, Inc. | 2024-11-22 |
| OsteoCoil™ Nitinol Compression System (Multiple Component PNs) (K233567) | Flower Orthopedics Corporation Dba Conventus Flower Ortho | 2024-11-22 |
| Nooro Body & Foot Stimulator (SM9141, SM9142) (K243334) | Xf Agencija Limited | 2024-11-22 |
| Giftlife® Single-Step Medium Plus (K242968) | Gimbo Medical Technology Shenzhen Co., Ltd. | 2024-11-22 |
| Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs) (K242543) | Zimmer, Inc. | 2024-11-22 |
| Neuvotion NeuStim NN-01 (K240632) | Neuvotion, Inc. | 2024-11-22 |
| Additively Manufactured Denture Resin (K242884) | Aidite (Qinhuangdao) Technology Co., Ltd. | 2024-11-22 |
| Cala kIQ (K242259) | Cala Health, Inc. | 2024-11-22 |
| Fingertip Pulse Oximeter, models Alpine20, Alpine20A, Alpine20H, Alpine20HA, Alpine20B, Alpine20BA, Alpine20BH, Alpine20BHA, Alpine30, Alpine30A, Alpine30H, Alpine30HA, Alpine30B, Alpine30BA, Alpine30BH, Alpine30BHA, Alpine20L, Alpine20LB, Alpine20LH, Alpine20LBH, Alpine30L, Alpine30LB, Alpine30LH, Alpine30LBH (K232520) | Shenzhen Smallsignal Technology Co., Ltd. | 2024-11-21 |
| Jazz Classic (K241495) | Jazz Imaging | 2024-11-21 |
| GMReis Ankle Plating System (K242998) | GM Dos Reis Industria e Comercio Ltda. | 2024-11-21 |
| Versalock Mini and Micro Plating System (K242596) | GM Dos Reis Industria e Comercio Ltda. | 2024-11-21 |
| MIRARI® Cold Plasma System ( GV-M2-01) (K242553) | General Vibronics, Inc. | 2024-11-21 |
| Xpert vanA (K243405) | Cepheid® | 2024-11-21 |
| Gating Reflector Block (K242874) | Varian Medical Systems, Inc. | 2024-11-21 |
| PliaFX Flo (K242799) | Lifenet Health | 2024-11-21 |
| Luja Coude (K241210) | Coloplast Corp. | 2024-11-21 |
| FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber (K240569) | Fink Engineering Pty, Ltd. | 2024-11-21 |
| TiLink-P Joint Fusion System (K242414) | SurGenTec, LLC | 2024-11-21 |
| SKR 3000 (K241319) | Konica Minolta, Inc. | 2024-11-21 |
| ATTUNE™ Revision Hinge Knee (K242871) | Depuy Ireland UC | 2024-11-21 |
| Secret MAX Multi-platform RF System (K241157) | Ilooda Co,., Ltd. | 2024-11-21 |
| Powered Wheelchair (NXN20-208, NXN20-211) (K241603) | Zhejiang Nysin Medical Co., Ltd. | 2024-11-20 |
| Leg Massager (Models:RP-ALM070H, RP-ALM071H) (K232965) | Shenzhen Ruiyi Business Technology Co., Ltd. | 2024-11-20 |
| Element Vascular Access System (K242520) | Penumbra, Inc. | 2024-11-20 |
| SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/o needle, SOL-M Luer Lock Syringe (Low Dead Space) w/Exchangeable Needle, SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/Exchangeable Needle (K242291) | Sol-Millennium Medical, Inc. | 2024-11-20 |
| TD-7301 Spirometer (TD-7301) (K241843) | Gostar Co., Ltd. | 2024-11-20 |
| INDIBA COMPACT devices (K243164) | Indiba S. A. U. | 2024-11-20 |
| Neurovascular Access System Family (K240746) | Q'Apel Medical, Inc. | 2024-11-20 |
| Strain AI (SAI001) (K242359) | Exo, Inc. | 2024-11-20 |
| AETOS Shoulder System Stemless Humeral Prosthesis (K240716) | Smith & Nephew, Inc. | 2024-11-20 |
| ProAM ACDF System (K242517) | Pro Surgical, Inc. | 2024-11-20 |
| Estar-ZE (K242521) | Osstem Implant Co., Ltd. | 2024-11-20 |
| Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds (K240856) | Osartis GmbH | 2024-11-20 |
| ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test (K243064) | Eterbio, Inc. | 2024-11-20 |
| HIGHERDOSE Red Light Hat (HG-120K) (K242363) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2024-11-20 |
| CerroZone Mini (K242102) | Cerrozone, LLC | 2024-11-19 |
| Iconix Knotless Anchor (K243323) | Riverpoint Medical | 2024-11-19 |
| Freedom® Medial Congruent Liner (K243277) | Maxx Orthopedics, Inc. | 2024-11-19 |
| “BRAXX” Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002) (K243045) | Braxx Biotech Co., Ltd. | 2024-11-19 |