| Disposable Safety Lancets (K223313) | Huaian Hening Medical Instruments Co., Ltd. | 2023-01-23 |
| Synthetic Polymer Glove - Polyethylene (Black) (K222531) | Ur Industry Sdn Bhd | 2023-01-22 |
| VX1+ (K223516) | Volta Medical | 2023-01-21 |
| Sentimag System (K222832) | Endomagnetics Ltd., | 2023-01-21 |
| OIC Variable Angle Small Fragment Locking Plate System (K223118) | Orthopaedic Implant Company | 2023-01-21 |
| FlowArt® Needle-Free Split Septum Valve (K222889) | Asset Medikal Tasarim San Tic As. | 2023-01-20 |
| DRX - Compass (K223842) | Carestream Health, Inc. | 2023-01-20 |
| Highlander™ 014 PTA Balloon Dilatation Catheter (K223177) | C.R. Bard, Inc. | 2023-01-20 |
| The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml (K221899) | Thermo Fisher Scientific | 2023-01-20 |
| TD-5010 Lancing Device and TD-5084 Sterile Lancets (K221419) | Gostar Co., Ltd. | 2023-01-20 |
| Advanced MyHip Planner (K221725) | Medacta International S.A. | 2023-01-20 |
| Semi-automatic Biopsy-Needle (BIM 18/20); Semi-automatic Biopsy-Needle (BIM 18.15); Semi-automatic Biopsy-Needle (BIM 18/10);Semi-automatic Biopsy-Needle (BIM 16/20);Semi-automatic Biopsy-Needle (BIM 16/15);Semi-automatic Biopsy-Needle (BIM 16/10);Semi-automatic Biopsy-Needle (BIM 14/20);Semi-automatic Biopsy-Needle (BIM 14/15);Semi-automatic Biopsy-Needle (BIM 14/10) (K222462) | Itp Innovative Tomography Products GmbH | 2023-01-20 |
| GMK Sphere & GMK SpheriKA Cementless (K223548) | Medacta International S.A. | 2023-01-20 |
| Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle (K203792) | Pikdare Spa | 2023-01-20 |
| Capiflo 5001 (K222158) | K&L Distributing, Inc. | 2023-01-20 |
| CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2R), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VH) and CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VHR) (K221683) | Olympus Medical Systems Corporation | 2023-01-20 |
| Blueprint Mixed Reality system (K222510) | Tornier S.A.S. | 2023-01-20 |
| Digital Thermometer, Model: DT007, DT008 (K214077) | Guangzhou Berrcom Medical Device Co., Ltd. | 2023-01-20 |
| ZESPIN SI Joint Fusion System (K223521) | Aegis Spine, Inc. | 2023-01-20 |
| pRESET Thrombectomy Device (K222848) | Phenox Limited | 2023-01-20 |
| Triathlon® Hinge Knee System (K223528) | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2023-01-20 |
| Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4V (K223404) | Quanta System Spa | 2023-01-20 |
| Biosci™ Inactivated Transport Medium, Biosci™ ITM (K220059) | Shenzhen Dakewe Bio-Engineering Co., Ltd. | 2023-01-19 |
| PerfusionGo Plus (K221627) | Yukun (Beijing) Technology Co., Ltd. | 2023-01-19 |
| Medaica M1 Telehealth Stethoscope (K223166) | Medaica, Inc. | 2023-01-19 |
| TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear) (K223108) | Medos International SARL | 2023-01-19 |
| Disposable Nitrile Examination Glove (K223250) | Yangzhou Saraguard Medical Supplies Co., Ltd. | 2023-01-19 |
| EL CAPITAN Anterior Lumbar Interbody Fusion (K222554) | Astura Medical | 2023-01-19 |
| LM-9300 Plus Lithotripter (K213772) | Lite-Med, Inc. | 2023-01-19 |
| HF-cables (resusable) (K221522) | Olympus Winter & Ibe GmbH | 2023-01-19 |
| AvalancheLase Family (K223540) | Fotona D.O.O. | 2023-01-19 |
| Low Profile Companion Sheath (K223872) | Merit Medical Systems, Inc. | 2023-01-19 |
| Disposable Endoscopic Cutter Stapler and Cartridge (K211197) | Changzhou Waston Medical Appliance Co., Ltd. | 2023-01-19 |
| Self-adhesive Electrode (K222252) | Shenzhen Roundwhale Technology Co. , Ltd. | 2023-01-19 |
| Tunnel Crossing Catheter (K221163) | Tractus Vascular, LLC | 2023-01-19 |
| Disposable Non-invasive EEG Sensor (K220448) | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2023-01-19 |
| Access 25(OH) Vitamin D Total (K223503) | Beckman Coulter, Inc. | 2023-01-19 |
| No Stress Impress (K213175) | No Stress Impress, LLC | 2023-01-19 |
| Transit-Pellets (K222000) | Medifactia AB | 2023-01-18 |
| eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) (K223446) | Signifier Medical Technologies, Ltd. | 2023-01-18 |
| SI-Cure Sacroiliac Joint Fusion System (K223819) | Alevio, LLC | 2023-01-18 |
| MOLLI 2 (K223107) | Molli Surgical, Inc. | 2023-01-18 |
| Uni-FuZe-C Bone Strip (K221726) | Zavation Medical Products, LLC | 2023-01-18 |
| Selux AST System; Model AST Gen 1.0 (K211759) | Selux Diagnostics, Inc. | 2023-01-18 |
| PercuNav Image Fusion and Interventional Navigation System (K223804) | Philips Ultrasound, LLC | 2023-01-18 |
| MultiCut Solo (K213597) | Asclepion Laser Technologies GmbH | 2023-01-18 |
| Anatomic Bone Plate (K221088) | Double Medical Technology, Inc. | 2023-01-18 |
| TruPlan Computed Tomography (CT) Imaging Software (K222593) | Circle Cardiovascular Imaging, Inc. | 2023-01-18 |
| Disposable Endoscope Valve Sets (K220884) | Sml Med-Tech Solutions Limited | 2023-01-17 |
| Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone Ag Foam Dressing (OTC); Silicone Ag Foam Dressing with Border (OTC) (K221754) | Winner Medical Co., Ltd. | 2023-01-17 |
| Halcyon, Ethos Radiotherapy System (K222941) | Varian Medical Systems, Inc. | 2023-01-17 |
| Elucis (K220649) | Realize Medical, Inc. | 2023-01-17 |
| Plasma IQ (K223222) | Neauvia North America, Inc. | 2023-01-17 |
| hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS (K223794) | Cefla S.C. | 2023-01-17 |
| Portable X-ray System (K223010) | Iray Technology Taicang , Ltd. | 2023-01-17 |
| FairFix QT Adjustable Button (K223795) | Medacta International S.A. | 2023-01-17 |
| HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch) (K213655) | Hilltek, LLC | 2023-01-17 |
| MIM – Additional Tracers (K223800) | Mim Software, Inc. | 2023-01-17 |
| Wearable Breast Pump (Model:YD-1193,YD-1195,YD-1196,YD-1198,YD-1199;YD-1193S,YD-1195S,YD-1196S,YD-1198S,YD-1199S) (K222782) | Zhejiang Carebao Co., Ltd. | 2023-01-13 |
| Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sponge dressing (K221755) | Winner Medical Co., Ltd. | 2023-01-13 |
| s-Clean Link Abutment (K222913) | Dentis Co., Ltd. | 2023-01-13 |
| Vibrant System (K223031) | Vibrant, Ltd. | 2023-01-13 |
| S-Mono (K221317) | Shinhung Mst Co., Ltd. | 2023-01-13 |
| Access Testosterone (K223405) | Beckman Coulter, Inc. | 2023-01-13 |
| SignaSure Dual Mobility System (K220495) | Signature Orthopaedics Pty, Ltd. | 2023-01-13 |
| MR Diffusion Perfusion Mismatch V1.0 (K223502) | Olea Medical | 2023-01-13 |
| Scivita 4KINSIGHT ICG Imaging System (K221252) | Scivita Medical Technology Co., Ltd. | 2023-01-13 |
| Non-Sterile Powder Free Nitrile Examination Gloves (K223221) | Dynacare Sdn Bhd | 2023-01-13 |
| Ideal Med Pro 3-Ply Disposable Face Mask (K221682) | Jsn Holdings, LLC | 2023-01-13 |
| Medipoint Blood Lancets (K223480) | Medipoint Holdings, LLC | 2023-01-13 |
| Nitrile Exam Gloves (Chemotherapy Drug Tested) (K223748) | Us Medical Glove Company, LLC | 2023-01-13 |
| Contour Knee (K223429) | Quality Electrodynamics, LLC | 2023-01-13 |
| Galileo Vertebral Body Replacement Device (K221542) | Bright Spine | 2023-01-13 |
| Silk’n Toothwave (K214078) | Home Skinovations , Ltd. | 2023-01-13 |
| Power Acute Triple Lumen Hemodialysis Catheter (K222170) | Health Line International Corporation | 2023-01-13 |
| MONTAGE Settable, Resorbable Bone Putty (K221933) | Orthocon, Inc. | 2023-01-13 |
| Light-Guide Cables (K223183) | Olympus Winter & Ibe GmbH | 2023-01-13 |
| Spectricept Skin and Wound Cleanser (K213514) | Spectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc. | 2023-01-13 |
| Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 F (K221020) | Potrero Medical, Inc. | 2023-01-13 |
| Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard XP Console, Thermogard HQ Console (K223746) | Zoll Circulation, Inc. | 2023-01-13 |
| Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+ (K222171) | Magstim Company, Ltd. | 2023-01-13 |
| PathLoc-TA Expandable Lumbar Cage System (K223474) | L&K BIOMED Co., Ltd. | 2023-01-13 |
| Garmin ECG App (K221774) | Garmin International, Inc. | 2023-01-12 |
| MU System (K222976) | Dentis Co., Ltd. | 2023-01-12 |
| PreXion3D Expedition (K222150) | Prexion Corporation | 2023-01-12 |
| HandX Instrument - Monopolar Spatula (K222011) | Human Xtensions , Ltd. | 2023-01-12 |
| Rainbow 360 (K222830) | Kerr Corporation | 2023-01-12 |
| NeoGen PSR System (K221873) | Energist Limited | 2023-01-12 |
| Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD 5.0/2.2 Sampler Set (K223782) | Ambu A/S | 2023-01-12 |
| NuVasive Modulus-C Interbody System (K223731) | Nuvasive, Inc. | 2023-01-12 |
| MAMMOVISTA B.smart (VB70) (K223363) | Siemens Medical Solutions USA, Inc. | 2023-01-12 |
| AIBOLIT 3D+ (K222458) | Aibolit Technologies, LLC | 2023-01-12 |
| Neuronaute with IceCap 2 & IceCap 2 Small (K223644) | Bioserenity | 2023-01-12 |
| INFINITY OCT System (K223764) | Medtronic Sofamor Danek USA, Inc. | 2023-01-11 |
| Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D (K223295) | Fujifilm Corporaton | 2023-01-11 |
| Artix BG (K223000) | Inari Medical | 2023-01-11 |
| Alpha Control Liner System (ACLS) (K223738) | Coapt | 2023-01-11 |
| Transducer Probe Cover (K221278) | Hony Medical Co., Ltd. | 2023-01-11 |
| NuVasive Reline System (K223181) | Nu Vasive, Incorporated | 2023-01-11 |
| RadianceTx Radionuclide Brachytherapy Source (K223465) | Radiance Therapeutics, Inc. | 2023-01-11 |