| Incontinence Probe (K210441) | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2021-09-17 |
| Uramix CuraWay Biopsy Needle (K203141) | Uramix, Inc. | 2021-09-17 |
| RedEx (K211234) | Advanced Surgical Concepts, Ltd. | 2021-09-17 |
| End Cap (K210461) | Medical Components Inc (Medcomp) | 2021-09-14 |
| HandX (K212214) | Human Xtensions , Ltd. | 2021-09-13 |
| JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve (K210625) | Fujifilm Medwork GmbH | 2021-09-10 |
| SANSIN Tubing Sets for Hemodialysis (K202796) | Jiangxi Sanxin Medtec Co., Ltd. | 2021-09-06 |
| KARL STORZ Flexible HD Cysto-Urethroscope System (K212476) | Karl Storz Endoscopy America, Inc. | 2021-09-03 |
| BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor (K210342) | STERIS Corporation | 2021-09-03 |
| Senhance Surgical System (K212054) | Asensus Surgical, Inc. | 2021-08-30 |
| ENFit Reusable Enteral Syringe (K203613) | Shantou Wealy Medical Instrument Co.,Ltd | 2021-08-27 |
| PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E (K211684) | Given Imaging Ltd. (Medtronic) | 2021-08-27 |
| Instinct Plus Endoscopic Clipping Device (K212323) | Wilson-Cook Medical, Inc. | 2021-08-25 |
| Nam illumination probe with chopper (K202670) | Oculight , Ltd. | 2021-08-20 |
| Servator P SALF Solution with THAM (K202652) | S.A.L.F. Spa | 2021-08-19 |
| Enteral Extension Sets (K203633) | GBUK Group, Ltd. | 2021-08-19 |
| Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2 (K212296) | Fujifilm Corporation | 2021-08-19 |
| EnteraLoc Flow (K210971) | Vonco Products | 2021-08-18 |
| Cellvizio I.V.E. system with Confocal Miniprobes (K212322) | Mauna Kea Technologies | 2021-08-18 |
| SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset (K210661) | Quanta Dialysis Technologies, Ltd. | 2021-08-12 |
| Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles (K210946) | Promisemed Hangzhou Meditech Co., Ltd. | 2021-08-12 |
| da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) (K211784) | Intuitive Surgical, Inc. | 2021-08-06 |
| Resection Electrodes with HF cable (K210651) | Olympus Winter & Ibe GmbH | 2021-08-03 |
| Mini PCNL-System (K200770) | Trokamed GmbH | 2021-07-30 |
| Lab Bag with Fabric Pouch (K210248) | Advanced Medical Design Co., Ltd. | 2021-07-30 |
| OCS Lung Solution (K211314) | TransMedics, Inc. | 2021-07-29 |
| Senhance Surgical System (K211325) | Asensus Surgical, Inc. | 2021-07-27 |
| da Vinci SP Surgical System (SP1098) (K211316) | Intuitive Surgical, Inc. | 2021-07-23 |
| GI Genius (K211951) | Cosmo Artificial Intelligence - Ai, Ltd. | 2021-07-23 |
| HMB32 Dialysis Solution (K212052) | Haemopharm Biofluids S.R.L. | 2021-07-23 |
| Arthrex SynergyID Endoscopic Imaging System (K202582) | Arthrex, Inc. | 2021-07-22 |
| WiScope OM Endoscope System, WiScope Single-Use Digital Flexible Ureteroscope.Choledochoscope, WiScope Image System (K210579) | OTU Medical, Inc. | 2021-07-22 |
| EleVation Breast Biopsy System (K211933) | Bard Peripheral Vascular | 2021-07-15 |
| END 200 Endoscopic Tubeset (K202922) | Palliare , Ltd. | 2021-07-08 |
| Cannula for Organ Perfusion (K203262) | Bridge TO Life, Ltd. | 2021-07-01 |
| GlidePath Retro Long-Term Hemodialysis Catheter (K203575) | C.R. Bard, Inc. | 2021-07-01 |
| Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0 (K203717) | Fujifilm Corporaton | 2021-06-30 |
| LUMINELLE DTx System (K210512) | Uvision360, Inc. | 2021-06-30 |
| Oral/Enteral Syringe with ENFit connector (K211025) | Ningbo Tianyi Medical Appliance Co., Ltd. | 2021-06-30 |
| Standard Bougie, 38 Fr. (K210437) | Standard Bariatrics | 2021-06-29 |
| ENFit Disposable Enteral Syringe (K203410) | Shantou Wealy Medical Instrument Co.,Ltd | 2021-06-28 |
| iTind System (K210138) | Medi-Tate , Ltd. | 2021-06-25 |
| Cor-Knot Micro (K202551) | Lsi Solutions, Inc. | 2021-06-24 |
| da Vinci SP Surgical System (SP1098) (K211595) | Intuitive Surgical, Inc. | 2021-06-23 |
| VisionPort System (K211250) | New View Surgical, Inc. | 2021-06-21 |
| Port Access System (K210495) | Surgical Innovations Limited | 2021-06-18 |
| Su2ura Approximation Device (K201744) | Anchora Medical, Ltd. | 2021-06-17 |
| URO-TOUCH 9 French Probe (K202813) | Northgate Technologies, Inc. | 2021-06-14 |
| GlidePath 13F Long-Term Hemodialysis Catheter (K211410) | Bard Peripheral Vascular, Inc. | 2021-06-04 |
| Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS) (K211372) | Mahana Therapeutics, Inc. | 2021-06-02 |
| Single Use Injection Needle (K210917) | Anrei Medical (Hangzhou) Co., Ltd. | 2021-05-28 |
| Pathfinder Endoscope Overtube (K211301) | Neptune Medical, Inc. | 2021-05-28 |
| Aqua Medical RF Vapor System (K211282) | Aqua Medical, Inc. | 2021-05-27 |
| SpyGlass Discover Retrieval Basket (K203322) | Boston Scientific Corporation | 2021-05-26 |
| Pathfinder Endoscope Cap (K210915) | Neptune Medical, Inc. | 2021-05-25 |
| EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle, EchoTip Ultra Endobronchial High Definition Ultrasound Needle, EchoTip ProCore Endobronchial High Definition Ultrasound Biopsy Needle (K210476) | Cook Ireland, Ltd. | 2021-05-20 |
| Electrosurgical accessory (K210394) | Dornier Medtech America, Inc. | 2021-05-19 |
| TELESCOPE 0 O 10MM WL 305MM / TELESCOPE 30 O 10MM WL 305MM / TELESCOPE 50 O 10MM WL 305MM, TELESCOPE 0 O 10MM WL 440MM / TELESCOPE 30 O 10MM WL 440MM / TELESCOPE 50 O 10MM WL 440MM (K203226) | Richard Wolf Medical Instruments Corporation | 2021-05-14 |
| PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC Family) (K210485) | Pentax of America, Inc. | 2021-05-13 |
| Tablet Application (K203566) | Smith & Nephew | 2021-05-13 |
| HANAROSTENT Benefit Biliary (NNN) (K202973) | M.I.Tech Co., Ltd. | 2021-05-11 |
| AutoCap RX (K210353) | Boston Scientific Corporation | 2021-05-06 |
| Uro-G Cystoscope (K202921) | Uroviu Corporation | 2021-05-04 |
| NaviCam Xpress Stomach System (K203192) | Anx Robotica Corp | 2021-05-04 |
| Disposable Ureteral Access Sheath (K203165) | Suzhou Beyo Medical Technology Co., Ltd. | 2021-04-30 |
| Pure Vu System (K210981) | Motus GI Medical Technologies , Ltd. | 2021-04-29 |
| Oral/Enteral Syringe (K210621) | Ningbo Tianyi Medical Appliance Co., Ltd. | 2021-04-28 |
| Stone Retrieval Balloon Catheter (K210660) | Anrei Medical (Hangzhou) Co., Ltd. | 2021-04-27 |
| Safety Trocar Cannula (K211072) | Boston Scientific Corporation | 2021-04-27 |
| da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System (K210918) | Intuitive Surgical, Inc. | 2021-04-26 |
| Percuflex Ureteral Stent System, Percuflex Ureteral Stent System Kit, Percuflex Nephroureteral Stent System, Amplatz Anchor Catheter System (K200260) | Boston Scientific Corporation | 2021-04-26 |
| DiLumen Endolumenal Interventional Platform (DiLumen) (K210851) | Lumendi, LLC | 2021-04-21 |
| Bead Block (100 - 300µm, 1ml), Bead Block (300 - 500µm, 1ml), Bead Block (500 - 700µm, 1ml), Bead Block (700 - 900µm, 1ml), Bead Block (900 - 1200µm, 1ml), Bead Block (100 - 300µm, 2ml), Bead Block (300 - 500µm, 2ml), Bead Block (500 - 700µm, 2ml), Bead Block (700 - 900µm, 2ml), Bead Block (900 - 1200µm, 2ml) (K203276) | Biocompatibles UK Ltd (Part of Boston Scientific Corporation | 2021-04-20 |
| AXIOS Stent and Electrocautery Enhanced Delivery System (K203132) | Boston Scientific Corporation | 2021-04-15 |
| 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, AIM Laparoscopes (K210088) | Stryker | 2021-04-13 |
| PENTAX Medical Video Duedenoscope ED34-i10T2 (K210710) | Pentax of America, Inc. | 2021-04-09 |
| Endoscope Model EI-740D/S (K210162) | Fujifilm Corporation | 2021-04-09 |
| GI Genius (DEN200055) | Cosmo Artificial Intelligence - Ai, Ltd. | 2021-04-09 |
| Enteral Feeding Catheter (K202748) | Medcaptain Life Science Co., Ltd. | 2021-04-09 |
| Well Lead All Silicone Foley Catheter with Temperature Sensor (K202134) | Well Lead Medical Co., Ltd. | 2021-04-08 |
| ActivSight Intraoperative Imaging System (K203550) | Activ Surgical, Inc. | 2021-04-08 |
| Pristine Long-Term Hemodialysis Catheter (K203767) | C B Bard, Inc. | 2021-04-02 |
| Pentax Medical Video Duodenoscope ED32-i10 (K202365) | Pentax of America, Inc. | 2021-04-01 |
| EnCor Breast Biopsy Probe with Rinse Tube (K210654) | Senorx, Inc. | 2021-03-31 |
| Avitus(r) Bone Harvester (K210631) | Avitus Orthopaedics, Inc. | 2021-03-31 |
| Modulith SLX-F2 (K201001) | Karl Storz Endoscopy America | 2021-03-30 |
| ENvizion Medical ENvue ENvizion Medical Enteral Feeding Tube (K203133) | Envizion Medical , Ltd. | 2021-03-24 |
| ZIDA Wearable Neuromodulation System (K192731) | Exodus Innovations | 2021-03-19 |
| SDC3 HD Information Management System with Wireless Device Control Capability (K210584) | Stryker | 2021-03-18 |
| Ensure Single-Use Coagulation Forceps (K202438) | Micro-Tech (Nanjing) Co., Ltd. | 2021-03-15 |
| AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory (K201809) | Baxter Healthcare Corportation | 2021-03-10 |
| NovaLine Tubing Sets for Hemodialysis (K201866) | Bain Medical Equipment (Guangzhou) Co., Ltd. | 2021-03-10 |
| Andorate Universal Endoscope Tip Guard (K202838) | Ga Health Company Limited | 2021-03-05 |
| OverStitch Sx Endoscopic Suturing System (K210266) | Apollo Endosurgery, Inc. | 2021-03-02 |
| Senhance Surgical System (K202166) | Transenterix, Inc. | 2021-03-02 |
| Vortek Single Loop Ureteral Stent (K201436) | Coloplast Corp. | 2021-02-25 |
| 4K UHD Laparoscope (K203255) | Scivita Medical Technology Co., Ltd. | 2021-02-24 |
| ClearCap Distal Attachment (K202616) | Finemedix Co., Ltd. | 2021-02-19 |
| CORE E3 Suction/irrigator (K202303) | Conmed Corporation | 2021-02-19 |
| da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da Vinci Xi/X (IS4000/IS4200) 8mm Reusable Instruments (K203632) | Intuitive Surgical, Inc. | 2021-02-10 |