| Nexpowder (K202929) | Nextbiomedical Co., Ltd. | 2022-09-16 |
| OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device (K221074) | Stryker Corporation | 2022-09-16 |
| ECHELON ENDOPATH Staple Line Reinforcement (K221343) | Ethicon Endo-Surgery, LLC | 2022-09-16 |
| True Tulip, True M.I.S. (K220297) | Innovative Surgical Designs, Inc. | 2022-09-16 |
| GelPOINT V-Path Vaginal Access System (K220969) | Applied Medical Resources Corporation | 2022-09-16 |
| CYGNUS™ MoRe Anterior Cervical Plate System (K220441) | MiRus, LLC | 2022-09-16 |
| LEDEX (K221194) | Dentmate Technology Co. , Ltd. | 2022-09-16 |
| Neuro Omega System, NeuroSmart System (K220553) | Alpha Omega Engineering , Ltd. | 2022-09-16 |
| ClearPoint System (K222519) | ClearPoint Neuro, Inc. | 2022-09-16 |
| L1P-1F (TRIOS 5) (K221249) | 3Shape TRIOS A/S | 2022-09-16 |
| AllureTM Surgical Mask (K212926) | Allure Gift Wraps Private Limited | 2022-09-16 |
| cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH (K220134) | Roche Diagnostics | 2022-09-16 |
| TrueBalance™ Surgical System (K220830) | These Three Medical, LLC | 2022-09-15 |
| StageOne™ Shoulder Cement Spacer Molds (K221968) | Biomet, Inc. | 2022-09-15 |
| Nitrile Patient Examination Gloves, Powder Free (K220697) | Lalan Rubbers (Pvt), Ltd. | 2022-09-15 |
| SafePort(TM) Manifold (or Stopcock) (K211204) | Elcam Medical Acal | 2022-09-15 |
| Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30 (K203336) | Oxoid Limited (Part of Thermo Fisher Scientific) | 2022-09-15 |
| Elecsys AFP (K220176) | Roche Diagnostics | 2022-09-15 |
| Identity Shoulder System (K213856) | Zimmer, Inc. | 2022-09-15 |
| ArcTO Transobturator Sling System (K222468) | Urocure, LLC | 2022-09-15 |
| CO2 Laser System (K221597) | Smedtrum Medical Technology Co., Ltd. | 2022-09-15 |
| P12 Elite Series Digital Color Doppler Ultrasound System (K221089) | Sonoscape Medical Corp. | 2022-09-15 |
| Diamond Air+ (UI04A, UI04B, UI04C) (K221553) | Ulike Co., Ltd. | 2022-09-15 |
| NovoSorb Matrix (K221686) | Polynovo Biomaterials Pty, Ltd. | 2022-09-15 |
| MONDRIAN ALIF Cage with Supplementary Fixation Plate (K213641) | Ctl Medical Corporation | 2022-09-15 |
| Dynamic TiBase (K221966) | Talladium Espana, SL | 2022-09-15 |
| AIR OPTIX COLORS (K222500) | Alcon Laboratories, Inc. | 2022-09-15 |
| iRelieve Microcurrent Pain Relief System (K212618) | Fast Track Technologies, Inc. | 2022-09-14 |
| FINDER G6PD (K201049) | Baebies, Inc. | 2022-09-14 |
| Tornier Perform Humeral System – Stemless (K220418) | Tornier, Inc. | 2022-09-14 |
| GEM Biover Microvascular Clamps (K221843) | Synovis Micro Companies Alliance, Inc. | 2022-09-14 |
| V-HEPES PLUS (K213293) | Vitromed Langenfeld | 2022-09-14 |
| WatchPAT300 (WP300) (K222331) | Itamar Medical , Ltd. | 2022-09-14 |
| SafeSept® Transseptal Guidewire (SS-140) (K221707) | Pressure Products Medical Device Manufacturing, LLC | 2022-09-14 |
| Qorda QD1 (K220990) | Winix, Inc. | 2022-09-14 |
| SavvyWire (K213854) | Opsens, Inc. | 2022-09-14 |
| Solea (K221761) | Convergent Dental, Inc. | 2022-09-14 |
| Grappler Suture Anchor System (K222091) | Paragon 28, Inc. | 2022-09-14 |
| SprintRay Denture Base (K220979) | Sprintray, Inc. | 2022-09-14 |
| LightForce Orthodontic System (K222764) | Lightforce Orthodontics | 2022-09-14 |
| BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes and Length Assessment Device (K221797) | Varian Medical Systems, Inc. | 2022-09-14 |
| TSX Implants (K220978) | Biomet 3i, LLC | 2022-09-14 |
| Arthrex SoftStitch (K222078) | Arthrex, Inc. | 2022-09-14 |
| Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip (K222503) | Boston Scientific Corporation | 2022-09-14 |
| MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola Fit (K221733) | Siemens Medical Solutions USA, Inc. | 2022-09-13 |
| Female IC (Not Finalized) (K213575) | Hollister Incorporated | 2022-09-13 |
| LAITEST Medical Face Mask (K214035) | R&R Medical Corporation, Ltd. | 2022-09-13 |
| MagiCath II (K210929) | Woo Young Medical Co., Ltd. | 2022-09-13 |
| Transcutaneous Electrical Nerve Stimulator Model: ST-304 (K221092) | Shenzhen Future Electronic Co., Ltd. | 2022-09-13 |
| Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves (K221748) | Guilin Hbm Health Protections, Inc. | 2022-09-13 |
| Primary Relief (K221425) | Dyansys, Inc. | 2022-09-13 |
| SP-CL Hip Stem and LCU Hip System (K213770) | Waldemar Link GmbH & Co. KG | 2022-09-13 |
| P20 Elite Series Digital Color Doppler Ultrasound System (K221140) | Sonoscape Medical Corp. | 2022-09-13 |
| Simplexa COVID-19 Direct (K212147) | Diasorin Molecular, LLC | 2022-09-13 |
| ChoiceSpine TigerShark™ M, Modular Interbody System (K220953) | Choice Spine, LLC | 2022-09-13 |
| Solid State X-ray Imager(Model: FXRD-4386WB) (K220239) | Vieworks Co., Ltd. | 2022-09-13 |
| CLAROX plus (Model: VX-100) (K221417) | Vsi Co., Ltd. | 2022-09-13 |
| Aquilion Precision (TSX-304A/4) V10.10 with AiCE (K220986) | Canon Medical Systems Corporation | 2022-09-12 |
| Phosphoric Acid Etching Gel (K221450) | Rizhao Huge Biomaterials Company, Ltd. | 2022-09-12 |
| Infrared Forehead Thermometer (K220084) | Qingdao Yasee Medical Device Co., Ltd. | 2022-09-12 |
| KOLO Evolution XHD Series Ultrasound Diagnostic System (K221568) | Kolo Medical (Suzhou) Co., Ltd. | 2022-09-12 |
| Plasma Shield (K221533) | Plasmatica, Ltd. | 2022-09-12 |
| Integrity-SI Fusion System (K222512) | OsteoCentric Technologies | 2022-09-12 |
| Rapid ICH (K221456) | Ischemaview, Inc. | 2022-09-12 |
| SOFIA 88 Catheter (K214024) | MicroVention, Inc. | 2022-09-12 |
| AMBARINO High-Class (K222723) | Creamed GmbH & Co. Produktions- Und Handels KG | 2022-09-09 |
| Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays (K222440) | Steris | 2022-09-09 |
| NuVasive Reline Cervical System (K221388) | Nu Vasive, Incorporated | 2022-09-09 |
| Dexus Prosthetics System (Model: MSL1, MSR1) (K220002) | Zhejiang Qiangnao Technology Co.,Ltd | 2022-09-09 |
| V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System (K222093) | Steris | 2022-09-09 |
| PointCore Surgical Mask (K220944) | Pointcore, Inc. | 2022-09-09 |
| AUTOBAHN(R) EVO Femoral Nails (K220659) | Globus Medical, Inc. | 2022-09-09 |
| Powder Free Nitrile Examination Gloves, Colored (Green, Orange, Purple, White, & Black) (K220859) | Careglove Global Sdn. Bhd. | 2022-09-09 |
| MICOR Lens Fragmentation System (K214028) | Carl Zeiss Meditec Cataract Technology, Inc. | 2022-09-09 |
| Ellusa Reusable Bipolar Cable (K222429) | Ellusa, LLC | 2022-09-09 |
| Arthrex SutureTape (K221354) | Arthrex, Inc. | 2022-09-09 |
| Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration) (K213244) | Prevest Denpro Limited | 2022-09-09 |
| Osstem Abutment System (K221684) | Osstem Implant Co., Ltd. | 2022-09-08 |
| NeoNavia Biopsy System (K220595) | Neodynamics AB | 2022-09-08 |
| Ellusa Reusable Neutral Plates (K222425) | Ellusa, LLC | 2022-09-08 |
| Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay (K211648) | Diazyme Laboratories, Inc. | 2022-09-08 |
| Soundly Anti Snoring Device (K220330) | Greystone Ip, Ltd. | 2022-09-08 |
| BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens (K220143) | Shenzhen Dashicheng Optical Technology Co., Ltd. | 2022-09-08 |
| Ultrasonic Endo Activation Device (Model:Actor I pro) (K213947) | Changzhou Bomedent Medical Technology Co.,Ltd | 2022-09-08 |
| Cranial EM System (K213989) | Brainlab AG | 2022-09-08 |
| MammaPrint FFPE NGS Kit (K210973) | Agendia, Inc. | 2022-09-08 |
| Dynamis Pro Family (K213267) | Fotona D.O.O. | 2022-09-08 |
| CAPTIVATE® Compression Screws (K222409) | Globus Medical, Inc. | 2022-09-08 |
| Disposable Endoscope Valves System (K221331) | Changzhou Endoclean Medical Device Co., Ltd. | 2022-09-08 |
| HD-550 Video Endoscope System (K222020) | Sonoscape Medical Corp. | 2022-09-08 |
| EFAI ChestSuite XR Pleural Effusion Assessment System (K222076) | Ever Fortune.Ai, Co., Ltd. | 2022-09-08 |
| Mariner RDX System (K222110) | SeaSpine Orthopedics Corporation | 2022-09-07 |
| EyeCTester (K203594) | Neuro-Eye Diagnostic Systems, LLC | 2022-09-07 |
| AXIOS Stent and Electrocautery-Enhanced Delivery System (K220112) | Boston Scientific Corporation | 2022-09-07 |
| Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G (K222111) | Owen Mumford, Ltd. | 2022-09-07 |
| RightLance Blood Lancing System (K222034) | Beijing Ruicheng Medical Supplies Co., Ltd. | 2022-09-07 |
| Matreneu Percutaneous Balloon Compression Kit (K220920) | Shenzhen Shineyard Medical Device Co. , Ltd. | 2022-09-07 |
| Easi-Vue embolic microspheres System (K220567) | Abk Biomedical, Inc. | 2022-09-07 |
| syngo.via RT Image Suite (K220783) | Siemens Medical Solutions USA, Inc. | 2022-09-07 |
| FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire (K221731) | T.A.G. Medical Products Corporation, Ltd. | 2022-09-07 |