| FilmArray Pneumonia Panel plus (K222601) | Biofire Diagnostics, LLC | 2022-10-27 |
| Cirq Arm System (2.0);Alignment System Spine (K222966) | Brainlab AG | 2022-10-27 |
| Arthrex BioSuture (K220880) | Arthrex, Inc. | 2022-10-27 |
| Artemis Proximal Femoral Nail System (K221489) | Glw, Inc. | 2022-10-27 |
| CurvaFix IM System (K222505) | Curvafix, Inc. | 2022-10-27 |
| EsoCheck Cell Collection Device (K222366) | Lucid Diagnostics, Inc. | 2022-10-26 |
| Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL) (K221374) | Hebei Titans Hongsen Medical Technology Co., Ltd. | 2022-10-26 |
| DigiX FDX (K223060) | Allengers Medical Systems Limited | 2022-10-26 |
| Eclipse Blood Collection Set (K213690) | Eclipse Medcorp, LLC | 2022-10-26 |
| FIREFLY® Cervical Navigation Guide (K220132) | Mighty Oak Medical, Inc. | 2022-10-26 |
| Preat Abutments (K220823) | Preat Corporation | 2022-10-26 |
| EzRay Air 2 Wall (Model: VEX-S350W) (K223058) | VATECH Co., Ltd. | 2022-10-26 |
| DESS Dental Smart Solutions (K222269) | Terrats Medical SL | 2022-10-26 |
| Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) (K223235) | Pt. Sintong Unigolden Glove | 2022-10-26 |
| TEMA Elbow system - Line extension (K222807) | Lima Corporate S.P.A. | 2022-10-26 |
| VASSALLO GT EXT (K222631) | Filmecc Co., Ltd. | 2022-10-26 |
| 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports (K221885) | 23AndMe, Inc. | 2022-10-26 |
| Intracept Intraosseous Nerve Ablation System (K222281) | Relievant Medsystems, Inc. | 2022-10-26 |
| NEUROMARK System (K222032) | Neurent Medical | 2022-10-26 |
| Medical Examination Gloves (Nitrile) (XS, S, M, L, XL) (K222498) | Humanwell Healthcare Group Medical Supplies Co., Ltd. | 2022-10-26 |
| Adcura® Sagittae® Lateral Lumbar Interbody Fusion Devices (K223065) | Adcura, Inc. | 2022-10-26 |
| Silverlon Wound Contact, Burn Contact Dressings (K221218) | Argentum Medical, Inc. | 2022-10-26 |
| Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant) (K222047) | Elekta Solutions AB | 2022-10-26 |
| Leltek Ultrasound Imaging System (Model: LU700 Series) (K222365) | Leltek, Inc. | 2022-10-25 |
| Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR (K222968) | Canon Medical Systems Corporation | 2022-10-25 |
| Rexious Spinal Fixation System (K222415) | Dio Medical Corporation | 2022-10-25 |
| Unistik® Pro (K222303) | Owen Mumford, Ltd. | 2022-10-25 |
| 3Dicom MD (K222470) | Singular Health Pty, Ltd. | 2022-10-25 |
| Disposable Surgical Face Mask (K212649) | Lyncmed Medical Technology (Beijing) Co., Ltd. | 2022-10-25 |
| Hudson RCI Triflo II Incentive Deep Breathing Exerciser (K220565) | Medline Industries, Inc. | 2022-10-25 |
| EndoNaut (K222070) | Therenva Sas | 2022-10-25 |
| JR MEDIC Nitrile Examination Gloves Powder Free- Black (K221169) | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | 2022-10-25 |
| SafetiCET Safety Lancet (K221783) | Nsp Tech Pte, Ltd. | 2022-10-24 |
| KODEX – EPD™ System 1.5.0 (K212493) | Philips Medical Systems Nederland, B.V. (Pmsn) | 2022-10-24 |
| Soft Palate Elevator (K222127) | The Tmj Clinic PC | 2022-10-24 |
| Neurosteer EEG Recorder (K221563) | Neurosteer, Inc. | 2022-10-24 |
| MectaLIF Anterior Extension (K221545) | Medacta International S.A. | 2022-10-24 |
| The GIRO Growth Modulation System (K220190) | Pega Medical, Inc. | 2022-10-24 |
| Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant (K222058) | Wrp Asia Pacific Sdn. Bhd. | 2022-10-22 |
| cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems (K213804) | Roche Molecular Systems, Inc. | 2022-10-22 |
| Hair Removal Device (Model: IPL-D26, IPL-D19) (K221643) | Shenzhen Desida Technology Co., Ltd. | 2022-10-21 |
| Onetouch Non-paraben Lubricant Gel (K220273) | Thai Nippon Rubber Industry Public Company Limited. | 2022-10-21 |
| MCI-Neuro Fixation System (K212391) | Mci Medical Concept Innovation, Inc. | 2022-10-21 |
| NextDent Ortho Flex (K221022) | Vertex-Dental B.V. | 2022-10-21 |
| HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS Instruments (K222270) | Globus Medical, Inc. | 2022-10-21 |
| NuVasive Cohere ALIF System Intervertebral Body Fusion Device (K221751) | Nu Vasive, Incorporated | 2022-10-21 |
| CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown (K210414) | Medtecs (Taiwan) Corp. | 2022-10-21 |
| PureLift Pro Plus (K221443) | Xtreem Pulse, LLC | 2022-10-21 |
| UHR Bipolar Implants, Restoration GAP II Implants (K222632) | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2022-10-21 |
| Biological Feedback and Stimulation System (K222201) | Medlander Medical Technology, Inc. | 2022-10-21 |
| Enteral Transition Adaptor (K220165) | GBUK Group, Ltd. | 2022-10-21 |
| Viz LVO ContaCT (K223042) | Viz. Ai, Inc. | 2022-10-21 |
| JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple) (K222349) | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | 2022-10-21 |
| Electronic Pulse Stimulator (K221992) | Beijing Choice Electronic Technology Co., Ltd. | 2022-10-21 |
| DePuy Reclaim Monobloc Revision Femoral Stem (K221462) | Depuy Ireland UC | 2022-10-21 |
| IPD Dental Implant Abutments (K222215) | Implant Protesis Dental 2004, S.L. | 2022-10-21 |
| Flex-MI (K221958) | Emsi, Inc. | 2022-10-21 |
| IntraOp VSP Software Device (K213128) | Xironetic, LLC | 2022-10-21 |
| Collagen P.I.N. (Percutaneous Induction Needling) (K222199) | Induction Therapies, LLC | 2022-10-21 |
| Safety Blood Collection Needle (Without Needle Holder) (K222141) | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2022-10-21 |
| eWave Monitor (K214073) | Wearlinq, Inc. | 2022-10-20 |
| Mercu 1717V (K222886) | Iray Technology Taicang , Ltd. | 2022-10-20 |
| PADnet Xpress (K220527) | Collaborative Care Diagnostics, LLC, D.B.A. Biomedix | 2022-10-20 |
| SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NETWORK ENABLED (72205447), SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NON-NETWORK ENABLED (72205448) (K221740) | Smith and Nephew, Inc. | 2022-10-20 |
| Electric nasal aspirator (K222547) | Shenzhen Xinlianfeng Technology Co.,Ltd | 2022-10-20 |
| AI-Rad Companion (Musculoskeletal) (K222361) | Siemens Medical Solutions USA, Inc. | 2022-10-20 |
| Tyber Medical Staple Fixation System (various) (K221947) | Tyber Medical, LLC | 2022-10-20 |
| AccuSert Needle Inserter (K213429) | Emed Technologies Corporation | 2022-10-20 |
| Disposable Surgical Gown (G4003) (K221977) | Xiantao Topmed Nonwoven Protective Products Co., Ltd. | 2022-10-20 |
| eClinic Stethopod (K220099) | Homediagnostic, LLC | 2022-10-20 |
| da Vinci Firefly Imaging System (K222827) | Intuitive Surgical, Inc. | 2022-10-20 |
| Houdini Cross Support Catheter (K213466) | Cruzar Medsystems, Inc. | 2022-10-20 |
| BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel (K220870) | Biofire Defense, LLC | 2022-10-20 |
| BTI Interna Dental Implant System UnicCa - Prosthetic Components (K213106) | B.T.I. Biotechnology Institute, Sl. | 2022-10-20 |
| Evo® sEEG System (K222404) | Neuroone Medical Technologies Corp. | 2022-10-20 |
| V-Patch Cardiac Monitor (K222842) | Shandong Corecare Technology Limited | 2022-10-20 |
| RADIANCE ULTRA 32 4K ZEROWIRE DUO (K222890) | Nds Surgical Imaging, LLC | 2022-10-19 |
| Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple (K220992) | Ever Global (Vietnam) Enterprise Corporation | 2022-10-19 |
| SOMAVAC 100 Sustained Vacuum System (K222856) | Somavac Medical Solutions, Inc. | 2022-10-19 |
| Infinity Pro, Logic, Quality, Sprint (K213742) | Olsen Indústria E Comércio S.A. | 2022-10-19 |
| Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior Cervical Plating (ACP) System, Reflex™ Hybrid ACP System, UniVise™ Spinous Process Fixation Plate (K221728) | Stryker Corporation | 2022-10-19 |
| Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit (K222643) | Sirius Medical Systems B.V. | 2022-10-19 |
| Proximerge 2 Dental Implant System (K211409) | Quadric Biomed, LLC | 2022-10-19 |
| Vascu-Guard Vascular Repair Patch (K221032) | Synovis Life Technologies, Inc. | 2022-10-19 |
| STERN FIX Sternal Stabilization System (K221795) | Neos Surgery S.L | 2022-10-19 |
| PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch (K221029) | Synovis Life Technologies, Inc. | 2022-10-19 |
| TRUEdraw Lancing Device, Mini Lancing Device (K221072) | Trividia Health | 2022-10-18 |
| Violet Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric Acid (K222298) | Onetexx Sdn Bhd | 2022-10-18 |
| EVOS Wrist Spanning Plate (K213123) | Smith & Nephew, Inc. | 2022-10-18 |
| MEBO Wound Dressing (K222657) | Mebo Life Science, Inc. | 2022-10-18 |
| Nova Primary Glucose Analyzer System (K203549) | Nova Biomedical Corporation | 2022-10-18 |
| Spine CAMP™ (K221632) | Medical Metrics, Inc. | 2022-10-18 |
| FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System (K222572) | Dio Medical Corporation | 2022-10-18 |
| E-Z Chek Chlorine Residual Test Strips (K100-0101B) (K222167) | Reprocessing Products Corporation (Rpc) | 2022-10-18 |
| DualXSLIM(R) T/PLIF (K222203) | Amplify Surgical, Inc. | 2022-10-18 |
| Violet Nitrile Powder Free Patient Examination Glove, Non Sterile (K222721) | Safeskin Retailing (Hk) Limited | 2022-10-18 |
| ScanNav Anatomy Peripheral Nerve Block (DEN220024) | Intelligent Ultrasound Limited | 2022-10-18 |
| MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System (K221321) | Ge Medical Systems Information Technologies, Inc. | 2022-10-18 |
| TELIGEN System (K213978) | Medos International SARL | 2022-10-18 |
| XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter (K221986) | Transit Scientific, LLC | 2022-10-18 |