| Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application (K220454) | Avation Medical, Inc. | 2023-04-03 |
| Sclerotherapy & Endoscopic Needles (K222006) | G-Flex Europe Sprl | 2023-04-03 |
| M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic Disposable Biopsy Needle, M Biopsy /SureAim Coaxial Biopsy Needle (K222865) | Canyon Medical, Inc. | 2023-04-03 |
| 1788 4K Camera System with Advanced Imaging Modality (K230605) | Stryker | 2023-03-31 |
| HOPKINS Telescopes (K223923) | KARL STORZ Endoscopy-America, Inc. | 2023-03-30 |
| ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System (K221872) | Nova Eye Inc. (Business Name Nova Eye Medical) | 2023-03-30 |
| EndoDrill® Model X (K212423) | Bibbinstruments AB | 2023-03-29 |
| PUMA-G System (K223916) | Coaptech, Inc. | 2023-03-29 |
| Disposable Endoscopic Hemoclip (K222146) | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | 2023-03-28 |
| Entarik Feeding Tube System; Entarik Feeding Tube (K230206) | Gravitas Medical, Inc. | 2023-03-24 |
| EVA5 Insufflator (K230474) | Palliare , Ltd. | 2023-03-24 |
| Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar (K223593) | Taiwan Surgical Corporation | 2023-03-22 |
| Specimen Bag, model: WEP040306B, WEP010304B, WEP040304B, WEP010759B, WEP010709B, WEP010304A, WEP010759A, WEP010709A (K222828) | Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd | 2023-03-20 |
| KARL STORZ Bipolar Resectoscopes with HF Cable (K221893) | Karl Storz Endoscopy America, Inc. | 2023-03-17 |
| Senhance Surgical System (K223095) | Asensus Surgical, Inc. | 2023-03-16 |
| EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 System (K222839) | Intuitive Surgical, Inc. | 2023-03-16 |
| MultiStage Balloon Dilatation Catheter (K222663) | Dongguan TT Medical, Inc. | 2023-03-09 |
| Single-Use Video Flexible Ureterorenoscope System (K221158) | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2023-03-06 |
| Polypectomy Snare (K221713) | Hangzhou AGS MedTech Co., Ltd. | 2023-03-03 |
| Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie) (K222880) | Endolumik, Inc. | 2023-03-03 |
| NIKKICART (K221652) | Renal Care Dialysis Solutions, S.A. DE C.V. | 2023-03-03 |
| Endo SmartCap (K223040) | Medivators, Inc. | 2023-03-01 |
| 8X-10-6XXX Camera Head (K223116) | Santa Barbara Imaging Systems | 2023-02-28 |
| Saneso Lens Wash Bottle Assembly (SAN-LWB-A) (K222173) | Saneso, Inc. | 2023-02-27 |
| ELITONE Urge Urinary Incontinence Device (K223884) | Elidah, Inc. | 2023-02-24 |
| Arthrex SynergyID Endoscopic Imaging System (K223759) | Arthex, Inc. | 2023-02-24 |
| Veloxion System (K230205) | Corinth Medtech, Inc. | 2023-02-24 |
| Pill Sense System (DEN220065) | Enterasense , Ltd. | 2023-02-24 |
| 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000) (K230216) | Stryker | 2023-02-23 |
| Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source (K221591) | Schoelly Fiberoptic GmbH | 2023-02-23 |
| Delta III Pro (K221903) | Dornier Medtech America, Inc. | 2023-02-22 |
| Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA) (K223612) | Ranfac Corporation | 2023-02-21 |
| FloNavi Endoscopic Fluorescence Imaging System (K221861) | Guangdong Optomedic Technologies, Inc. | 2023-02-18 |
| troCarWash™ System (K222695) | Biotex, Inc. | 2023-02-17 |
| Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101; Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101; Vision1 Imaging Console and Display System, PN VIS101 (K223466) | STERIS Corporation | 2023-02-17 |
| Single-use Video Pancreaticobiliary Scope, PB Digital Controller (K221784) | Micro-Tech (Nanjing) Co., Ltd. | 2023-02-16 |
| ReShape Calibration Tubes (K230131) | Reshape Lifesciences | 2023-02-15 |
| AmeriWater MediQA Reverse Osmosis System (MSP3HF) (K223656) | AmeriWater, LLC | 2023-02-13 |
| DiLumen C1, EZ1 and Tool Mount (K221452) | Lumendi, LLC | 2023-02-10 |
| hygh-tec drainage (K221400) | Creative Balloons GmbH | 2023-02-09 |
| ETHICON LINX® Esophagus Sizing Tool (K230089) | Torax Medical, Inc. | 2023-02-09 |
| 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 |
| FUJIFILM Endoscope Model EI-740D/S (K221551) | Fujifilm Corporaton | 2023-01-27 |
| 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 |
| 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 |
| LM-9300 Plus Lithotripter (K213772) | Lite-Med, Inc. | 2023-01-19 |
| Transit-Pellets (K222000) | Medifactia AB | 2023-01-18 |
| MultiCut Solo (K213597) | Asclepion Laser Technologies GmbH | 2023-01-18 |
| Disposable Endoscope Valve Sets (K220884) | Sml Med-Tech Solutions Limited | 2023-01-17 |
| Vibrant System (K223031) | Vibrant, Ltd. | 2023-01-13 |
| Scivita 4KINSIGHT ICG Imaging System (K221252) | Scivita Medical Technology Co., Ltd. | 2023-01-13 |
| Power Acute Triple Lumen Hemodialysis Catheter (K222170) | Health Line International Corporation | 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 |
| HandX Instrument - Monopolar Spatula (K222011) | Human Xtensions , Ltd. | 2023-01-12 |
| Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D (K223295) | Fujifilm Corporaton | 2023-01-11 |
| Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device (K223616) | Boston Scientific Corporation | 2022-12-30 |
| Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers (K223592) | Boston Scientific Corporation | 2022-12-29 |
| OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5R), LIGHT GUIDE ADAPTER (MAJ-1413) (K221690) | Olympus Medical Systems Corp. | 2022-12-29 |
| Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App (K220935) | Iren-Medical, Ltd. | 2022-12-29 |
| Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence Stimulation/EMG Electrode Probe, Well-Life Probe Electrode (K222528) | Well-Life Healthcare Limited | 2022-12-29 |
| CORE-INJECTOR (K221054) | Incore Co., Ltd. | 2022-12-21 |
| HOPKINS Telescopes (K221004) | Karl Storz Endoscopy America, Inc. | 2022-12-20 |
| multiFiltratePRO System (K220281) | Fresenius Medical Care Renal Therapies Group, LLC | 2022-12-16 |
| Wellead Ureteral Catheter (K220036) | Well Lead Medical Co., Ltd. | 2022-12-16 |
| Sleeved IC (K220667) | Hollister Incorporated | 2022-12-08 |
| PVC Hydrophilic Urethral Catheter (K212567) | Chengdu Daxan Innovative Medical Tech. Co., Ltd. | 2022-12-07 |
| HurriChem Device Kit (K222575) | Thermasolutions, LLC | 2022-12-06 |
| SUREcore Plus Biopsy Instrument (K220611) | Uro-1, Inc. | 2022-12-02 |
| NaviCam Small Bowel Capsule Endoscopy System (K221590) | Ankon Technologies Co., Ltd. | 2022-12-02 |
| Self-Cath and Self-Cath Plus (K221401) | Coloplast | 2022-12-02 |
| 2-Way 100% Silicone Cleartract Catheter (K222118) | Silq Technologies, Corp. | 2022-12-01 |
| SmartSurgN Visualization System (K213943) | Smartsurgn Incorporated | 2022-11-29 |
| NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam Tether, NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule and NaviCam Tether (K221608) | Anx Robotica Corp | 2022-11-22 |
| Canady Flex RoboWrist (K212736) | Us Medical Innovations, LLC | 2022-11-22 |
| da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000) (K223080) | Intuitive Surgical, Inc. | 2022-11-22 |
| CORE-SNARE (K220846) | Incore Co., Ltd. | 2022-11-21 |
| Pentax Medical Valve Set (K222980) | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 2022-11-21 |
| OCS Lung Donor Flush Set (K222535) | TransMedics, Inc. | 2022-11-18 |
| Single-Use Flexible Cystoscope (K221580) | Hunan Vathin Medical Instrument Co., Ltd. | 2022-11-18 |
| Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus (K221593) | Convatec, Inc. | 2022-11-17 |
| Disposable hemoclip (K213217) | Beijing Zksk Technology Co., Ltd. | 2022-11-14 |
| H1 (K222504) | Karl Storz Endoscopy America, Inc. | 2022-11-10 |
| SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set (K222067) | Quanta Dialysis Technologies, Ltd. | 2022-11-10 |
| APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APDL Drainage Catheter System Kit with Dissolving Tip, Flexima APDL Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System, Flexima APD Drainage Catheter System Kit, Flexima APD Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System Kit with Dissolving Tip, Flexima Quickstick Drainage Catheter System, vanSonnenberg Drainage Cateter System, vanSonnenberg (K211934) | Boston Scientific Corporation | 2022-11-10 |
| AquaPulse® Irrigation Tubing (K223171) | Ga Health Company Limited | 2022-11-10 |
| Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) (K222162) | Shanghai AnQing Medical Instrument Co., Ltd. | 2022-11-09 |
| Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing (K222734) | Diversatek Healthcare | 2022-11-08 |
| Fresenius Liberty Select Cycler (K222318) | Fresenius Medical Care Renal Therapies Group, LLC | 2022-10-31 |
| Standard Tapered Bougie, 38 Fr. (K222085) | Standard Bariatrics, Inc. | 2022-10-31 |
| VS3-Iridium System (VS3-IR) (K223020) | Visionsense, Ltd. | 2022-10-28 |
| Mobility+ Enteral Feeding System (K222678) | Rockfield Medical | 2022-10-27 |
| 2008T BlueStar Hemodailysis Machine (K222952) | Fresenius Medical Care Renal Therapies Group, LLC | 2022-10-27 |
| Enteral Transition Adaptor (K220165) | GBUK Group, Ltd. | 2022-10-21 |
| 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 |
| da Vinci Firefly Imaging System (K222827) | Intuitive Surgical, Inc. | 2022-10-20 |
| RADIANCE ULTRA 32 4K ZEROWIRE DUO (K222890) | Nds Surgical Imaging, LLC | 2022-10-19 |
| E-Z Chek Chlorine Residual Test Strips (K100-0101B) (K222167) | Reprocessing Products Corporation (Rpc) | 2022-10-18 |
| allFlex Ureteral Catheters, Krait Ureteral Catheters (K220730) | Allwin Medical Devices, Inc. | 2022-10-13 |
| Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control (K222079) | Stryker Endoscopy | 2022-10-11 |