| FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN) (K241219) | ZuriMED Technologies AG | 2024-12-11 |
| Access25™ Delivery Microcatheter (K242033) | Penumbra, Inc. | 2024-12-11 |
| Radiofrequency Generator System, Cura RF Electrode (K240758) | Zhejiang Curaway Medical Technology Co., Ltd. | 2024-12-11 |
| Eclipse Treatment Planning System (18.1) (K242378) | Varian Medical Systems | 2024-12-11 |
| FAQ™ (302) (K242747) | Foreo, Inc. | 2024-12-11 |
| SternalPlate Expansion (K243491) | Stryker Leibinger GmbH & Co KG | 2024-12-11 |
| BriefCase-Triage (K243548) | Aidoc Medical , Ltd. | 2024-12-11 |
| Disposable Subdermal Needle Electrode, Corkscrew (K241045) | Technomed Europe | 2024-12-11 |
| OsseoFit Stemless Shoulder System (K241873) | Zimmer, Inc. | 2024-12-11 |
| Cervical Plating System (K243369) | Life Spine, Inc. | 2024-12-11 |
| DRX-Revolution Mobile X-ray System (K241505) | Carestream Health, Inc. | 2024-12-10 |
| Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler Ultrasound Imaging System (Readius P8); Digital Color Doppler Ultrasound Imaging System (Readius V6); Digital Color Doppler Ultrasound Imaging System (Readius C6) (K243132) | Shantou Institute of Ultrasonic Instruments Co., Ltd. | 2024-12-10 |
| Prelude Small O.D. Introducer Guide Wire (K241521) | Merit Medical Systems, Inc. | 2024-12-10 |
| Elos Accurate® Hybrid Base™ (K242025) | Elos Medtech Pinol A/S | 2024-12-10 |
| Empulse M90 (K242327) | Concourse Assistive Technology Pty, Ltd. | 2024-12-10 |
| POTENZA (K231216) | Jeisys Medical, Inc. | 2024-12-10 |
| Sensinel Cardiopulmonary Management (CPM) System (ADCP1100) (K243216) | Analog Devices | 2024-12-10 |
| IRISeg (K242461) | Intuitive Surgical, Inc. | 2024-12-10 |
| Aerin Console (K242630) | Aerin Medical, Inc. | 2024-12-10 |
| Straumann® PURE Ceramic Implants (K241391) | Institut Straumann AG | 2024-12-10 |
| V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System, XH5 Diagnostic Ultrasound System, V4 Diagnostic Ultrasound System, H4 Diagnostic Ultrasound System, XV4 Diagnostic Ultrasound System, XH4 Diagnostic Ultrasound System (K242511) | Samsung Medison Co., Ltd. | 2024-12-10 |
| Philips IntelliSite Pathology Solution 5.1 (K242848) | Philips Medical Systems Nederland B.V. | 2024-12-10 |
| AutoContour (Model RADAC V4) (K242729) | Radformation, Inc. | 2024-12-09 |
| Verily Numetric Retinal Camera (K242508) | Verily Life Sciences, LLC | 2024-12-09 |
| HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100) (K242451) | Edwards Lifesciences | 2024-12-09 |
| PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+) (K240706) | Ganshorn Medizin Electronic GmbH | 2024-12-09 |
| Digital Radiography System (ManntiX B, ManntiX K) (K240841) | Shenzhen Browiner Tech Co., Ltd. | 2024-12-09 |
| Atrauman® Ag (K242758) | Hartmann USA, Inc. | 2024-12-09 |
| TRIGEN META-TAN Trochanteric Antegrade Nail (K243364) | Smith & Nephew, Inc. | 2024-12-09 |
| HomeSleepTest (HST, HST REM+) (K240700) | Somnomedics GmbH | 2024-12-08 |
| SmartSiteTM Vented Vial Access Device (K243486) | Yukon Medical, LLC | 2024-12-06 |
| Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086) (K241580) | Abbott Molecular | 2024-12-06 |
| PTFE Guidewire (K242824) | Lake Region Medical | 2024-12-06 |
| MC2 Portable X-ray System (K241567) | Oxos Medical | 2024-12-06 |
| Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem) (K241878) | Stryker Corporation (Tornier, Inc.) | 2024-12-06 |
| AnyPlus Navigated Instruments System (K243073) | GS Medical Co., Ltd. | 2024-12-06 |
| Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert (K241989) | Cercare Medical A/S | 2024-12-06 |
| NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090); NanoKnife Single Electrode Activation Probe, 25 cm (H787204001100); NanoKnife Single Electrode Probe Spacer (H787204003010) (K242687) | AngioDynamics, Inc. | 2024-12-06 |
| RED (K242304) | Neuraxis, Inc. | 2024-12-06 |
| INA Moisturizing Intimate Lubricant Water-Based Personal Lubricant (K242645) | Project Chemistry, Inc. | 2024-12-06 |
| Hair Removal Device (R3C16-P, R3C16-W, R3C16-G, R3C16-P Pro, R3C16-W Pro, R3C16-G Pro, R3505-W, R3505-B, R3505-W Pro, R3505-B Pro) (K242710) | Shenzhen Jianchao Intelligent Technology Co., Ltd. | 2024-12-06 |
| EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100) (K241923) | Ever Fortune.Ai, Co., Ltd. | 2024-12-06 |
| CDM Insights (K240680) | Oxford Brain Diagnostics, Ltd. | 2024-12-06 |
| DZ-Tabone Intervertebral Body Fusion Device (K241073) | Shenzhen Dazhou Medical Technology Co., Ltd. | 2024-12-06 |
| SyMRI (K242524) | Syntheticmr AB (Publ.) | 2024-12-06 |
| Rugged Oxygen Generator (ROG) (RO01-00001) (K240561) | Molecular Products , Ltd. | 2024-12-06 |
| OsteoSinter® EVANS and COTTON wedges and related accessories (K240461) | Ames Medical Prosthetic Solutions, S.A.U. | 2024-12-06 |
| 87 NeuGlide Catheter (K240971) | Piraeus Medical | 2024-12-06 |
| PeritX™ 1L Drainage Kit (90-1010); PeritX™ 2L Drainage Kit (90-2010); PeritX™ Peritoneal Catheter Kit (50-9000C); PeritX™ Peritoneal Catheter and Starter Kit (50-9900C); PeritX™ Peritoneal Catheter Mini Kit (50-9050A); PleurX™ Low Profile Catheter Mini Kit (50-8050); Valve Cap (50-7235A); PeritX™ Valve Kit (50-7272); Catheter Access Kit (50-7280A); Lockable Drainage Line (50-7245A); Lockable Drainage Line Kit (50-7265A); PleurX™ Supplemental Insertion Kit (50-7262); Procedure Pack (50- (K241946) | Bard Peripheral Vascular, Inc. | 2024-12-06 |
| ACTIFY™ Unicondylar Knee System (K241260) | Globus Medical, Inc. | 2024-12-06 |
| Oxygen Concentrator (ZY-10AB/115) (K240840) | Foshan Care Medical Technology Co., Ltd. | 2024-12-06 |
| PeekMed web (K240926) | Peek Health, S.A. | 2024-12-06 |
| WallFlex Biliary PLUS RX Stent System (K242950) | Boston Scientific | 2024-12-06 |
| PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL) (K241213) | Pentax of America, Inc. | 2024-12-06 |
| DrAid™ for Liver Segmentation (K241543) | Vinbrain Joint Stock Company | 2024-12-06 |
| BIOFIRE FILMARRAY Tropical Fever Panel (K243463) | Biofire Diagnostics, LLC (Biomerieux) | 2024-12-05 |
| Dental Lithium Disilicate Glass Ceramic ( HT, ML-HT, LT, ML-LT, MT, MO, HO) (K242740) | Liaoning Rachcera Material Technology Co., Ltd. | 2024-12-05 |
| OSTEOPAL® V (K241674) | Heraeus Medical GmbH | 2024-12-05 |
| Magnetic Localization Patch Kit (AFR-00021) (K243435) | Medtronic, Inc. | 2024-12-05 |
| Rapid Surgical Plan (RSP-SW-001) (K243447) | Navbit Pty, Ltd. | 2024-12-05 |
| VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001) (DEN240025) | Ventana Medical Systems, Inc. | 2024-12-05 |
| iTOF® (K242525) | Nerbio Medical Software Platforms, Inc. | 2024-12-05 |
| TDM Plate and Screw System (K241128) | Tdm Co., Ltd. | 2024-12-05 |
| MONTAGE Settable, Resorbable Bone Putty MONTAGE-QS Settable, Resorbable Bone Putty MONTAGE Flowable Settable, Resorbable Bone Paste MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty (K243526) | Orthocon, Inc. | 2024-12-05 |
| The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.25-32 ug/mL (K242653) | Thermo Fisher Scientific | 2024-12-05 |
| LW Pre-milled Abutment (K242703) | Ossvis Co., Ltd. | 2024-12-05 |
| BIOCERAM AZUL® HEAD (K243444) | Kyocera Corporation | 2024-12-05 |
| Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon Tritanium Tibial Baseplate; Triathlon Low Profile Tibial Tray; Triathlon Metal Backed Patella; Triathlon Partial Knee System; Avon Patello-femoral Joint Prosthesis; Restoris Multi-Compartmental Knee System (K242831) | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2024-12-04 |
| CapsoCam Plus (SV-3) Capsule Endoscopy System (K242643) | CapsoVision, Inc. | 2024-12-04 |
| DeepRhythmAI (K241197) | Medicalgorithmics S.A. | 2024-12-04 |
| RelieVRx (K243417) | Appliedvr | 2024-12-04 |
| Neodent Implant System (K242686) | Jjgc Indústria E Comércia DE Materiais Dentários S.A. | 2024-12-04 |
| Locking Screw,CoCrMo (K242348) | Double Medical Technology, Inc. | 2024-12-04 |
| SSPC NXT Delivery Catheter (K243180) | CenterPoint Systems, LLC | 2024-12-04 |
| XBeam (v2) (K240671) | Xstrahl, Ltd. | 2024-12-04 |
| Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256); (K242184) | Alcon Laboratories, Inc. | 2024-12-04 |
| Rextar Pro (K242185) | Raypia Co., Ltd. | 2024-12-04 |
| Chemical Indicator for enspire CLCSPS (LCC015) (K243475) | STERIS Corporation | 2024-12-04 |
| Atellica® CH Creatinine_3 (Crea3) (K242685) | Siemens Healthcare Diagnostics, Inc. | 2024-12-04 |
| Nanox.ARC (K242395) | Nano-X Imaging , Ltd. | 2024-12-04 |
| Ion 3D (K243265) | SurGenTec, LLC | 2024-12-04 |
| Socrates 38 Catheter (K242301) | Scientia Vascular, Inc. | 2024-12-04 |
| Fix2Lock (PEEK Self Punching) (K243470) | Osteonic Co., Ltd. | 2024-12-03 |
| TrueLok Elevate (K242861) | Orthofix Srl | 2024-12-03 |
| Verruca-Freeze H (K243454) | Cryosurgery, Inc. | 2024-12-03 |
| Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) (K243467) | Osteonic Co., Ltd. | 2024-12-03 |
| ClearRead CT CAC (K242188) | Riverain Technologies, Inc. | 2024-12-03 |
| Sofsilk™ Coated Braided Silk Suture (K241486) | Covidien | 2024-12-03 |
| MIDASVu (K243020) | Intravu, Inc. | 2024-12-02 |
| enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System (K243433) | STERIS Corporation | 2024-12-02 |
| GroWell BT Hair Growth System (GW10042) (K242619) | Apira Science, Inc. | 2024-12-02 |
| Ventoux VC2; Ventoux VC3 (K223120) | Flight Medical Innovations , Ltd. | 2024-12-02 |
| Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate Tubing (K243418) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2024-12-02 |
| Philips IntelliSite Pathology Solution (K241871) | Philips Medical Systems Nederland B.V. | 2024-12-02 |
| GripMate (K243232) | Synthon Hispania S.L. | 2024-12-02 |
| Hintermann Series H2 Total Ankle System (K240475) | Vilex, LLC | 2024-12-02 |
| YO Home Sperm Test (K241628) | Medical Electronic Systems , Ltd. | 2024-11-29 |
| Ruthless Spine RJB (K243375) | Ruthless, LLC Dba Ruthless Spine | 2024-11-29 |
| Evie Med Ring (K241090) | Movano Inc. Dba Movano Health | 2024-11-29 |
| Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter (K242225) | Surgical Instrument Service and Savings, Inc. | 2024-11-29 |