| AI.ME System (K221011) | Venus Concept USA, Inc. | 2022-12-20 |
| AEON-C™ Stand Alone System (K223140) | Dio Medical, Inc. | 2022-12-20 |
| Kangaroo OMNI™ Enteral Feeding Pump (385400 );Kangaroo OMNI™ Feeding Set 500ml (B5FD );Kangaroo OMNI™ ENtelliSet 500ml (E5FD );Kangaroo OMNI™ Feeding Set 1000ml (B10FD );Kangaroo OMNI™ ENtelliSet 1000ml (E10FD );Kangaroo OMNI™ ENPlus Spike Set (BSPFD );Kangaroo OMNI™ ENtelliSet ENPlus Spike ( ESPFD );Kangaroo OMNI™ Feeding Set 500ml with Flush Bag ( B5FF);Kangaroo OMNI™ ENtelliSet 500ml with Flush Bag (E5FF);Kangaroo OMNI™ Feeding Set 1000ml with Flush Bag ( E10FF );Kangaroo OMNI™ (K221603) | Cardinal Health, LLC | 2022-12-20 |
| IBS System (K220517) | Innobiosurg Co., Ltd. | 2022-12-20 |
| AirRay (K222896) | Poskom Co., Ltd. | 2022-12-20 |
| HOPKINS Telescopes (K221004) | Karl Storz Endoscopy America, Inc. | 2022-12-20 |
| Bonafix 2 Plus (K213677) | Zentek Medical, LLC | 2022-12-20 |
| Mineral Collagen Composite Bioactive Moldable (K221735) | Collagen Matrix, Inc. | 2022-12-20 |
| LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003) (K221775) | Light Tree Ventures Europe B.V. | 2022-12-20 |
| Indigo Aspiration System - Lightning Flash (K222358) | Penumbra, Inc. | 2022-12-20 |
| SpineJack® Expansion Kit (K223294) | Stryker Instruments | 2022-12-20 |
| Infrared Thermometer, models AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F, AOJ-20H, AOJ-20M, AOJ-20T, AOJ-20R and AOJ-20Y (K221039) | Shenzhen AOJ Medical Technology Co., Ltd. | 2022-12-20 |
| Arthrex DualCompression Hindfoot Fusion Nail Implant System (K221031) | Arthrex, Inc. | 2022-12-20 |
| IntelliSep test (K220991) | Cytovale, Inc. | 2022-12-20 |
| Al Smile Aligner (K222308) | Nanjing Jiahe Dental Technology Co., Ltd. | 2022-12-20 |
| EK12 V2 Algorithm (K221904) | Ge Medical Systems Information Technologies, Inc. | 2022-12-20 |
| Penumbra System (Reperfusion Catheter RED 43) (K222808) | Penumbra, Inc. | 2022-12-20 |
| Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103, UC-104) (K222213) | Unimed Medical Supplies, Inc. | 2022-12-19 |
| GORE® ENFORM Biomaterial (K222919) | W. L. Gore and Associates, Inc. | 2022-12-19 |
| EsCem (K214076) | Spident Co., Ltd. | 2022-12-19 |
| 4CIS BLACK MARLIN PLIF CAGE SYSTEM, 4CIS DOLPHIN TLIF CAGE SYSTEM (K213653) | Solco Biomedical Company India Private Limited | 2022-12-19 |
| BreathID Hp System (K221896) | Meridian Bioscience Israel , Ltd. | 2022-12-19 |
| MARVEL™ Growing Rods (K213196) | Globus Medical, Inc. | 2022-12-19 |
| Mechanical Guidewire (K221351) | Baylis Medical Company, Inc. | 2022-12-19 |
| ViewFlex Xtra Reprocessed ICE Catheter (K222217) | ABBOTT MEDICAL | 2022-12-19 |
| INOUE BALLOON A (K220881) | Toray Industries, Inc. | 2022-12-18 |
| Tornier Pyrocarbon Humeral Head (DEN220012) | Tornier S.A.S. | 2022-12-16 |
| Sterile Hypodermic Needles for Single Use (K223334) | Zhejiang Kindly Medical Devices Co., Ltd. | 2022-12-16 |
| AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In Anchor (K213110) | Auxein Medical Private Limited | 2022-12-16 |
| multiFiltratePRO System (K220281) | Fresenius Medical Care Renal Therapies Group, LLC | 2022-12-16 |
| BD Microtainer® Contact-Activated Lancets; BD Microtainer® Quikheel™ Lancets (K223243) | Becton, Dickinson and Company | 2022-12-16 |
| Overjet Calculus Assist (K220928) | Overjet, Inc. | 2022-12-16 |
| Copan FecalSwab Collection, Transport and Preservation System (K220052) | Copan Italia Spa | 2022-12-16 |
| KLICK (VARIANTS: POWER, RACE, MONSTER) (K222502) | Klaxon Mobility GmbH | 2022-12-16 |
| Daylily Single Use Sterile Embryo Transfer Catheter (K220010) | Shanghai Horizon Medical Technology Co., Ltd. | 2022-12-16 |
| Caduceus S (K220554) | Taiwan Main Orthopaedic Biotechnology Co., Ltd. | 2022-12-16 |
| Surgical Mask (K213601) | Wuhan Zonsen Medical Products Co., Ltd. | 2022-12-16 |
| Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface Technology (K223153) | Medtronic Sofamor Danek USA, Inc. | 2022-12-16 |
| Wellead Ureteral Catheter (K220036) | Well Lead Medical Co., Ltd. | 2022-12-16 |
| Phantom Metatarsal Shortening System (K223184) | Paragon 28, Inc. | 2022-12-16 |
| Hexanium PLIF (K223251) | Spinevision, S.A.S. | 2022-12-16 |
| CardioPhase® hsCRP (K212559) | Siemens Healthcare Diagnostics Products GmbH | 2022-12-16 |
| Oximeter (Model: JZK-301,JZK-303,JZK-305,JZK-307) (K213984) | Shenzhen Zhengkang Technology Co., Ltd. | 2022-12-16 |
| Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS (K222608) | Tuttnauer , Ltd. | 2022-12-16 |
| Saige-Density (K222275) | DeepHealth, Inc. | 2022-12-16 |
| BRM TOOL Screws, BIOPLAN Subtalar Implant (K222820) | Brm Extremities | 2022-12-16 |
| BrainInsight (K223268) | Hyperfine, Inc. | 2022-12-16 |
| Rejoni Intrauterine Catheter (K222798) | Rejoni, Inc. | 2022-12-16 |
| SofWave System (K223237) | Sofwave Medical, Ltd. | 2022-12-16 |
| Perceptive electric dental motor and control unit (K220873) | Lares Research | 2022-12-15 |
| PM Excellence SEQUR 100 Surgical Face Mask (K220520) | Pm Excellence, LLC | 2022-12-15 |
| Proxima (K220591) | Dynasthetics, LLC | 2022-12-15 |
| Powder Free Polyurethane Examination Gloves, Blue color, Tested for use with Chemotherapy Drugs (K222892) | Grand Work Plastic Products Co., Ltd. | 2022-12-15 |
| VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor (K221267) | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | 2022-12-15 |
| TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian Motorized Dilator Sheath, 11 French (575-011); TightRail Guardian Motorized Dilator Sheath, 13 French (575-013) (K223472) | Spectranetics, Inc. | 2022-12-15 |
| S.I.N. Dental Implant System (K221453) | S.I.N. – Sistema DE Implante Nacional S.A. | 2022-12-15 |
| Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty (K214086) | Genoss Co., Ltd. | 2022-12-15 |
| LOTUS Series 4 Enhanced Shears, LOTUS Series 5 (K221102) | Sra Developments, Ltd. | 2022-12-15 |
| Dozee VS (K221555) | Turtle Shell Technologies Private Limited | 2022-12-15 |
| Small Field Applicator (K220883) | Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha | 2022-12-15 |
| QRS Dental Implants System (K221910) | Qrs Medical , Ltd. | 2022-12-14 |
| Infrared Thermometer (Model: Y20001, Y20002) (K221800) | Zhangzhou Easepal Medical Science and Technology Co., Ltd. | 2022-12-14 |
| Nitrile Patient Examination Glove (K222527) | Pingan Medical Products Co., Ltd. | 2022-12-14 |
| Magicore Narrow System (K220079) | Innobiosurg Co., Ltd. | 2022-12-14 |
| UNO Negative Pressure Wound Therapy System (K221891) | Genadyne Biotechnologies, Inc. | 2022-12-14 |
| PTA Balloon Dilatation Catheter (K221245) | Kossel Medtech (Suzhou) Co., Ltd. | 2022-12-14 |
| Digital Crown (K222623) | Sprintray, Inc. | 2022-12-14 |
| ICE Ceramics, ICE Stains, Fresco (K213722) | Zirkonzahn Srl | 2022-12-14 |
| QuikClot Control+ Hemostatic Dressing (K220971) | Z-Medica, LLC | 2022-12-14 |
| Target Tetra Detachable Coils (K222533) | Stryker Neurovascular | 2022-12-14 |
| Quantra QPlus System (K223433) | Hemosonics, LLC | 2022-12-13 |
| Surgical Face Mask (K222651) | Xiantao Sanda Industrial Co., Ltd. | 2022-12-13 |
| Conductive Gel (K222770) | Top-Rank Health Care Co., Ltd. | 2022-12-13 |
| HVT 2.0 (K221318) | Vapotherm, Inc. | 2022-12-13 |
| Epilaser Absolute (K213105) | Epilady 2000, LLC | 2022-12-13 |
| REDEMPTION Beaming System (K221342) | Vilex, LLC | 2022-12-13 |
| CCBIO ASCPO Needle (K214004) | Cc Biotechnology Corporation | 2022-12-13 |
| Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx (K212071) | Cefaly Technology | 2022-12-13 |
| Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11 (K220046) | Shenzhen Superbio Technology Co., Ltd. | 2022-12-13 |
| Hive™ Standalone Cervical System (K223190) | NanoHive Medical, LLC | 2022-12-12 |
| SIRIUS Endoscope System (K221642) | Precision Robotics (Hong Kong) Limited | 2022-12-12 |
| VITROS Immuodiagnostic Products CA 125 II Reagent Pack (K221355) | Ortho Clinical Diagnostics | 2022-12-12 |
| Medidenta High Speed Handpieces (K202674) | Pac-Dent, Inc. | 2022-12-12 |
| BioButton System (K212957) | Biolntellisense, Inc. | 2022-12-12 |
| Spectra Wearable (K220926) | Uzinmedicare Co., Ltd. | 2022-12-12 |
| Matrix HA Fusion Porous Cervical IBF System (K223510) | Innovasis, Inc. | 2022-12-12 |
| Metal Bone Screw (K220921) | Double Medical Technology, Inc. | 2022-12-12 |
| Disposable Nitrile Examination Glove (Tested for use with Chemotherapy Drug) (K222733) | Inner Mongolia Boming Medical Supplies Co., Ltd. | 2022-12-11 |
| 120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen Collection Manifold Kit (0750-200-000);V2 Specimen Collection Tray (0750-210-000) (K222552) | Stryker Instruments | 2022-12-09 |
| Vesseal (K221280) | Lydus Medical , Ltd. | 2022-12-09 |
| AIROS 6P Sequential Compression Device (K223195) | Airos Medical, Inc. | 2022-12-09 |
| HemosIL von Willebrand Factor Antigen (K223402) | Instrumentation Laboratory CO | 2022-12-09 |
| Swang-Ganz IQ pulmonary artery catheter (K222117) | Edwards Lifesiences, LLC | 2022-12-09 |
| Inogen Rove 4 Portable Oxygen Concentrator (K222086) | Inogen | 2022-12-09 |
| Wearable breast pump (K221598) | Mayborn (Uk) Limited | 2022-12-09 |
| Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe (K213054) | Medline Industries, Inc. | 2022-12-09 |
| CELLO II Balloon Guide Catheter (K223275) | Fuji Systems Corporation | 2022-12-09 |
| PMT Facet Fixation System (PMT FFS) (K220951) | Providence Medical Technology, Inc. | 2022-12-09 |
| US 450 Diode Laser Equipment (K222916) | Beijing Globalipl Development Co., Ltd. | 2022-12-09 |
| RobPath® Total Hip Application (K220774) | Hangzhou Lancet Robotics Co., Ltd. | 2022-12-09 |