| COPAL knee moulds (K222570) | Heraeus Medical GmbH | 2023-02-04 |
| SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control (K221253) | Maine Molecular Quality Controls, Inc. | 2023-02-03 |
| 14F iSLEEVE™ Introducer Set (K230051) | Boston Scientific Corporation | 2023-02-03 |
| Active Anthrax DetectTM Plus Rapid Test (DEN220044) | InBios International, Inc. | 2023-02-03 |
| GaiaBone Bioabsorbable Bone Graft (K220337) | Corliber (Shenzhen) Medical Device Co., Ltd. | 2023-02-03 |
| IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470) (K221348) | Philips Medizin Systeme Böblingen GmbH | 2023-02-03 |
| Anivia SG1000 Pump Console (K221491) | Apmtd, Inc. | 2023-02-03 |
| BIOFIRE SPOTFIRE Respiratory (R) Panel (K213954) | Biofire Diagnostics | 2023-02-03 |
| Cook® Spectrum® 2 MRC Central Venous Catheter (K223648) | Cook Advanced Technologies | 2023-02-03 |
| NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter (K223026) | Northeast Scientific, Inc. | 2023-02-03 |
| VITEK® 2 Streptococcus Tetracycline (<=0.25 - >=16 µg/mL) (K223481) | bioMerieux, Inc. | 2023-02-03 |
| Manta Ray TDF Spacer (K220296) | SeaSpine Orthopedics Corporation | 2023-02-03 |
| SMR Shoulder System (K223876) | Lima Corporate S.P.A. | 2023-02-03 |
| Pre-Formed Silicone Block (K223051) | International Medical Devices, Inc. | 2023-02-03 |
| MONTAGE Settable, Resorbable Bone Putty (K222063) | Orthocon, Inc. | 2023-02-03 |
| Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR) (K222153) | Microlife Intellectual Property GmbH | 2023-02-03 |
| Duoblade (K220996) | Cnc Technologies | 2023-02-03 |
| Digital Flat Panel Detector (K230059) | Ray Imaging Technology (Haining) Limited | 2023-02-03 |
| Luna Dental Implant System (K223395) | Shinhung Mst Co., Ltd. | 2023-02-03 |
| AcuPebble OX100 (K222950) | Acurable Limited | 2023-02-03 |
| Access AMH (K223679) | Beckman Coulter, Inc. | 2023-02-03 |
| DeltaScan Patch (K222671) | Prolira B.V. | 2023-02-02 |
| Atomica Planner (K230012) | Atomica Technology, Inc. | 2023-02-02 |
| Oncospace (K222803) | Oncospace, Inc. | 2023-02-02 |
| Geonic Nasal Aspirator, Geonic Nasal Cleaner (K220126) | Geon Corporation | 2023-02-02 |
| PreView-III™ Anterior Cervical Plate System (K223627) | Nexus Spine, LLC | 2023-02-02 |
| S.E.A.L. Hemostatic Wound Spray (K210751) | Bc3 Technologies, Inc. | 2023-02-02 |
| Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869 (K213545) | Steelco S.P.A. | 2023-02-02 |
| DeltaScan Monitor (K222680) | Prolira B.V. | 2023-02-02 |
| StoneSmart Connect Console, LithoVue Elite Single Use Digital Flexible Ureteroscope Standard w/Pressure Monitoring, LithoVue Elite Single Use Digital Flexible Ureteroscope Reverse w/Pressure Monitoring (K221515) | Boston Scientific Corporation | 2023-02-02 |
| Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH (K221781) | Guangdong Optomedic Technologies, Inc. | 2023-02-02 |
| Wee Bell (K221356) | Wee Medical | 2023-02-02 |
| Implant Direct Dental Implant Systems Portfolio - MR Conditional (K222211) | Implant Direct Sybron Manufacturing, LLC | 2023-02-02 |
| Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device (K223362) | 4Web Medical, Inc. | 2023-02-02 |
| Polaris Valve Electronic Reading Instrument (K222422) | Sophysa | 2023-02-02 |
| SmartRelease Endoscopic Soft Tissue Release System (K223406) | Microaire Surgical Instruments | 2023-02-02 |
| SutureLoc™ Implant (K223284) | Arthrex, Inc. | 2023-02-02 |
| Rapid RV/LV (K223396) | Ischemaview, Inc. | 2023-02-01 |
| LED Light Therapy Device, KN-7000L (K222751) | Xuzhou Kernel Medical Equipment Co., Ltd. | 2023-02-01 |
| Garment Electrodes (K222863) | Tone-A-Matic International, Inc. | 2023-02-01 |
| EmbedMed (K221943) | 3D Lifeprints UK , Ltd. | 2023-02-01 |
| BriefCase (K230020) | Aidoc Medical , Ltd. | 2023-02-01 |
| LVivo IQS (K222970) | Dia Imaging Analysis, Ltd. | 2023-02-01 |
| Tinnitogram Signal Generator (K221168) | Goldenear Company, Inc. | 2023-02-01 |
| 31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil (K213480) | Rapid Biomedical GmbH | 2023-02-01 |
| Certas Plus Programmable Valves (K223330) | Integra Lifesciences Production Corporation | 2023-02-01 |
| RefleXion Medical Radiotherapy System (RMRS) (DEN220014) | Reflexion Medical, Inc. | 2023-02-01 |
| V-SPERM WASH (K223117) | Vitromed GmbH | 2023-01-31 |
| XBody Go USA, XBody Pro USA (K221200) | Xbody Hungary Kft. | 2023-01-31 |
| Naviswiss Knee (K223351) | Naviswiss AG | 2023-01-31 |
| My3D® Personalized Pelvic Reconstruction (K223348) | Onkos Surgical, Inc. | 2023-01-30 |
| Playground For All Love Sesh (K222567) | Playground For All | 2023-01-30 |
| PHMB Wound Dressing (K221532) | Winner Medical Co., Ltd. | 2023-01-30 |
| XChange Device, XChange System (K210112) | Pneuma Therapeutics, Inc. | 2023-01-30 |
| BrainView QEEG Software (K212684) | Medeia, Inc. | 2023-01-28 |
| VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 µg/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 - =8 µg/mL), VITEK 2 AST-GP Moxifloxacin (K220803) | bioMerieux, Inc. | 2023-01-27 |
| Sim&Size (K222664) | Sim&Cure | 2023-01-27 |
| GEM Premier ChemSTAT (K223090) | Instrumentation Laboratory CO | 2023-01-27 |
| Prophecy Preoperative Navigation Alignment System (K222835) | Wrightmedicaltechnologyinc | 2023-01-27 |
| C2 Xplore (K223254) | Inomed Medizintechnik GmbH | 2023-01-27 |
| SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories (K221306) | Gyrus Acmi, Inc. | 2023-01-27 |
| Tacrolimus Assay Kit (K203833) | Shanghai Genext Medical Technology Co., Ltd. | 2023-01-27 |
| Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl SMALL SIZE (NGPF102); MEDIUM SIZE (NGPF103); LARGE SIZE (NGPF104); X-LARGE SIZE (NGPF105) (K223903) | Semperit Investments Asia Pte , Ltd. | 2023-01-27 |
| EVA15 insufflator (K222901) | Palliare , Ltd. | 2023-01-27 |
| Tibia and Fibula System (K213059) | Auxein Medical Private Limited | 2023-01-27 |
| 360CAS (K223927) | Kico Knee Innovation Company Pty Limited | 2023-01-27 |
| QOCA image Smart CXR Image Processing System (K221868) | Quanta Computer, Inc. | 2023-01-27 |
| BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit (K223016) | Bd | 2023-01-27 |
| F&P Airvo 3 (K221338) | Fisher & Paykel Healthcare | 2023-01-27 |
| EasyStat 300 (K211559) | Medica Corporation | 2023-01-27 |
| 14HQ721G-B (K223546) | Lg Electronics.Inc | 2023-01-27 |
| FUJIFILM Endoscope Model EI-740D/S (K221551) | Fujifilm Corporaton | 2023-01-27 |
| Omnispec ED1000 (K210166) | Medispec, Ltd. | 2023-01-27 |
| Revogene (K222779) | Meridian Bioscience, Inc. | 2023-01-26 |
| Sterile Surgical Powder Free Latex Glove (K221424) | New Era Medicare Sdn. Bhd. | 2023-01-26 |
| Surgical Gown (K222403) | Guangzhou Fuzelong Hygiene Material Co., Ltd. | 2023-01-26 |
| ECHELON Oval V6.2 MRI System (K221619) | Fujifilm Healthcare Corporation | 2023-01-26 |
| RMF-2000 (K220073) | DRTECH Corporation | 2023-01-26 |
| Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K223415) | Mah Sing Healthcare Sdn. Bhd. | 2023-01-26 |
| Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee (K222056) | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2023-01-26 |
| PALLAS Premium (K223588) | Laseroptek Co., Ltd. | 2023-01-26 |
| Ortho Device, ADAPTIX 3D Orthopedic Imaging System (K221949) | Pausch Medical GmbH | 2023-01-26 |
| Aristotle Colossus Guidewire (K222437) | Scientia Vascular, Inc. | 2023-01-26 |
| Flexible Suturing System with Anchors (FSSA) (K222589) | Integrity Orthopaedics, Inc. | 2023-01-26 |
| Safety Lancet (K222801) | Sarstedt AG & CO KG | 2023-01-25 |
| Carevix™ Suction Cervical Stabilizer (K223866) | Aspivix SA | 2023-01-25 |
| Advanced Bone Plate (K221150) | Double Medical Technology, Inc. | 2023-01-25 |
| Medline UNITE® Ankle Fusion Plating System (K222665) | Medline Industries, Inc. | 2023-01-25 |
| PowerPAK Syringe (K220114) | Vault Paragon Group, Inc. | 2023-01-25 |
| SPRINT Peripheral Nerve Stimulation (PNS) System (K223306) | Spr Therapeutics, Inc. | 2023-01-25 |
| CREED™ Cannulated Screws (K223847) | Glw, Inc. | 2023-01-25 |
| OsteoCNX (K223563) | Converg Engineering | 2023-01-25 |
| Disposable Blood Lancets (K223314) | Huaian Hening Medical Instruments Co., Ltd. | 2023-01-25 |
| Xpedition ™ Powered Stair Chair (625700000000) (K222818) | Stryker Medical | 2023-01-24 |
| Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1) (K222879) | Wuxi Jiajian Medical Instrument Co., Ltd. | 2023-01-24 |
| Tidepool Loop (K203689) | Tidepool Project | 2023-01-23 |
| Quality Mix Blender, Oxymixer (K221494) | Dehas Medical Systems GmbH | 2023-01-23 |
| LigaSure™ XP Maryland Jaw Sealer/Divider (K223158) | Covidien, LLC | 2023-01-23 |
| CD Horizon Spinal System (K223494) | Medtronic | 2023-01-23 |
| Clarius AI (K222406) | Clarius Mobile Health Corp. | 2023-01-23 |