| Ureterorenoscope System (K201293) | Shanghai AnQing Medical Instrument Co., Ltd. | 2020-07-24 |
| PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound Upper GI Video Scope (Convex Array Type), EG36-J10UR Ultrasound Upper GI Video Scope (Radial Array Type), EG38-J10UT Ultrasound Upper GI Video Scope (Convex Array Type) (K200090) | Pentax of America, Inc. | 2020-07-23 |
| Visera Elite II Video System Center (K201200) | Olympus Medical Systems Corp. | 2020-07-22 |
| Ambu Duodeno System (K201098) | Ambu Innovation GmbH | 2020-07-17 |
| Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video System Center, HD 3CMOS Autoclavable Camera Head, HD 3CMOS Camera Head (K200542) | Olympus Medical Systems Corp. | 2020-07-17 |
| S+N Laparoscopes, 4KO, Autoclavable, S+N Bariactric Laparoscopes, 4KO, Autoclavable (K201198) | Smith & Nephew | 2020-07-17 |
| Evis Exera III Colonovideoscope Olympus PCF-H190TL, Evis Exera III Colonovideoscope Olympus PCF-H190TI, Evis Exera III Colonovideoscope Olympus PCF-HQ190L, Evis Exera III Colonovideoscope Olympus PCF-HQ190I (K192793) | Olympus Medical Systems Corp. | 2020-07-17 |
| Disposable Specimen Retrieval Bag (K201243) | Beijing Biosis Healing Biolog Ical Technology Co., Ltd. | 2020-07-10 |
| Optiflux Enexa F500 Dialyzer (K192928) | Fresenius Medical Care Reanal Therapies Group, LLC | 2020-07-09 |
| GTK Trocars (K193272) | Guangzhou T.K Medical Instrument Co., Ltd. | 2020-07-09 |
| ETHICON Linx Esophagus Sizing Tool (K201035) | Torax Medical, Inc. | 2020-07-09 |
| Looking Glass 4K Integrated Visualization System (K201593) | Conmed Corporation | 2020-07-08 |
| Fujifilm Ultrasonic Processor (K200850) | Fujifilm Corporation | 2020-07-06 |
| SherpaPak Pediatric Liver Transport System (K201048) | Paragonix Technologies | 2020-07-02 |
| EndoGI Biliary Stent System (K193600) | Endogi Medical, Ltd. | 2020-06-26 |
| Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve (K200495) | Ga Health Company Limited | 2020-06-24 |
| Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller, Adapter for Controller 5525 (K200617) | Richard Wolf Medical Instruments Corporation | 2020-06-23 |
| CO2mbiLED (K201096) | Karl Storz Endoscopy America, Inc. | 2020-06-23 |
| GlidePath 10F Long-Term Dialysis Catheter (K200627) | C.R. Bard, Inc. | 2020-06-22 |
| O-Mec 690 Series Laparoscopes (K201151) | Omec Medical, Inc. | 2020-06-22 |
| EverLift Submucosal Lifting Agent (K191923) | Gi Supply | 2020-06-20 |
| Andorate Biopsy Valve, Andorate Biopsy Irrigator (K200481) | Ga Health Company Limited | 2020-06-18 |
| Entuit Nasal Jejunal Feeding Tube (K201322) | Wilson-Cook Medical, Inc. | 2020-06-17 |
| In-Ka Ureteral Balloon Dilatation Catheter (K201007) | Coloplast Corp. | 2020-06-11 |
| UroLift Advanced Tissue Control (ATC) System (K200441) | Neotract, Inc. | 2020-06-05 |
| gastroduodenal FTRD Set (K200684) | Ovesco Endoscopy AG | 2020-06-02 |
| Jimushi Sterile Urethral Catheter for single use (K200134) | Hangzhou Jimushi Meditech Co., Ltd. | 2020-06-01 |
| NaviCam Capsule Endoscope System with NaviCam Stomach Capsule (DEN190037) | Anx Robotica, Inc. | 2020-05-22 |
| Kalera Vacuum Aspiration Catheter (K-VAC) (K200419) | Kalera Medical, Inc. | 2020-05-22 |
| SpyGlass Discover Digital Catheter, SpyGlass Discover Digital Controller (K200483) | Boston Scientific Corporation | 2020-05-21 |
| Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare combination and Single use electrosurgical knife combination accessories) (K192342) | Hangzhou AGS MedTech Co., Ltd. | 2020-05-21 |
| SPY Portable Handheld Imaging (SPY-PHI) System (K200737) | Novadaq Technologies Ulc. (Now A Part of Stryker) | 2020-05-21 |
| LotusCatheter (Lotus No Balloon Catheter) (K191512) | Hakki Medical Technologies, Inc. | 2020-05-21 |
| IntraMarX 3D Radiopaque Marker (K201106) | Anx Robotica Corp | 2020-05-21 |
| AquaPulse Auxiliary Water Connector (K200479) | Ga Health Company Limited | 2020-05-15 |
| Reliance Endoscope Processing System (K200989) | STERIS Corporation | 2020-05-14 |
| Single Use Endoscope Valves Set (K192048) | Anrei Medical (Hangzhou) Co., Ltd. | 2020-05-14 |
| Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate (K192209) | Fresenius Medical Care Renal Therapies Group, LLC | 2020-05-08 |
| Actreen Hi-Lite Intermittent Urinary Catheters (K192577) | B.Braun Medical, Inc. | 2020-05-07 |
| InMode System with vTone Applicator (K200293) | InMode , Ltd. | 2020-05-05 |
| FUJIFILM EP-6000 Video Processor (K192286) | Fujifilm Corporation | 2020-05-01 |
| Stone Retrieval Balloon (K200173) | Hangzhou AGS MedTech Co., Ltd. | 2020-05-01 |
| ClickClean (K200902) | Medeon Biodesign, Inc. | 2020-04-30 |
| CARPEDIEM System (DEN180055) | Bellco Srl (Now Part of Medtronic, Inc) | 2020-04-29 |
| da Vinci Xi Surgical System, da Vinci X Surgical System (K192803) | Intuitive Surgical | 2020-04-29 |
| GelPOINT Mini Advanced Access Platform (K191866) | Applied Medical | 2020-04-29 |
| Single Use Injector (K192498) | Olympus Medical Systems Corp. | 2020-04-28 |
| Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate (K192017) | Fresenius Medical Care Renal Therapies Group, LLC | 2020-04-24 |
| Custodiol HTK Solution (K192408) | Dr. Franz Kohler Chemie GmbH | 2020-04-24 |
| RocaTub Ureteral Catheter (K192183) | Promepal Sam | 2020-04-23 |
| Duo-Flow Side x Side Double Lumen Catheter (K192807) | Medical Components, Inc. (dba MedComp) | 2020-04-23 |
| Lariat, Hot/Cold Snare (K200745) | United States Endoscopy Group, Inc. | 2020-04-21 |
| Pristine Scope (K193161) | Pristine Surgical | 2020-04-21 |
| HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way Foley Catheter, 16Fr/5cc, HDX 100% Silicone 2-way Foley Catheter, 18Fr/10cc (K192034) | Pathway, LLC | 2020-04-21 |
| DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only) (K200053) | Dannik | 2020-04-21 |
| EON Portable RO Water Purification System (K200670) | Mar Cor Purification, Inc. | 2020-04-16 |
| 7 mm Extended Length Endoscope (K191930) | Maquet Cardiovascular, LLC | 2020-04-15 |
| G-EYE System (K192588) | Smart Medical Systems , Ltd. | 2020-04-15 |
| Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector (K200388) | Ga Health Company Limited | 2020-04-14 |
| Standard Trocar (K200517) | Standard Bariatrics | 2020-04-09 |
| Standard Bougie (K191885) | Standard Bariatrics | 2020-04-08 |
| Irrigation Tubing with CO2 or Air (K193250) | Keymed (Medical and Industrial Equipment) , Ltd. | 2020-04-06 |
| RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector (K200577) | STERIS Corporation | 2020-04-03 |
| Visera Elite II Video System Center, Visera Elite II Endoeye 3D (K193026) | Olympus Medical Systems Corp. | 2020-04-03 |
| Medone Ultra, Medextra (K192101) | Medax Srl Unipersonale | 2020-04-02 |
| MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone Marrow Biopsy and Aspiration System, MED-B Bone Marrow Biopsy System, MED-J Bone Marrow Biopsy and Aspiration System (K192099) | Medax Srl Unipersonale | 2020-04-02 |
| Ambu aScope 4 Cysto (K193095) | Ambu A/S | 2020-04-02 |
| Tablo Hemodialysis System (K200741) | Outset Medical, Inc. | 2020-03-31 |
| CytoCore (K200278) | Praxis Medical, LLC | 2020-03-31 |
| AquaFlate Pre-Filled Sterile Water Syringe 10mL (K200556) | H R Pharmaceuticals, Inc. | 2020-03-31 |
| da Vinci X and Xi Surgical System (K183086) | Intuitive Surgical, Inc. | 2020-03-31 |
| System 83 Plus Washer/Disinfector (K173590) | Custom Ultrasonics, Inc. | 2020-03-30 |
| Single Use Grasping Forceps (K191900) | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2020-03-27 |
| AbClose - Port Site Closure Device (K193652) | Medeon Biodesign, Inc. | 2020-03-26 |
| EnlightenVue Microendoscopy System (K192300) | Enlightenvue, Inc. | 2020-03-20 |
| Creo Electrosurgical System with HS1 Hemostasis Accessory (K192905) | Creo Medical, Ltd. | 2020-03-19 |
| Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches (K193325) | Prosys International, Ltd. | 2020-03-13 |
| PrisMax System Version 3 (K193482) | Baxter Healthcare Corporation | 2020-03-13 |
| AMT Suture Delivery System (K193612) | Applied Medical Technology, Inc. | 2020-03-12 |
| Senhance Surgical System (K200049) | Transenterix, Inc. | 2020-03-09 |
| 1688 Pendulum 4K Camera Head with Integrated Coupler, 1688 4K Camera Control Unit with Advanced Imaging Modality (K200310) | Stryker | 2020-03-06 |
| Instinct Plus Endoscopic Clipping Device (K192697) | Cook Endoscopy | 2020-03-05 |
| GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters (K190527) | C. R. Bard | 2020-03-05 |
| Cellvizio I.V.E. with Confocal Miniprobes (K193416) | Mauna Kea Technologies | 2020-02-28 |
| Fusion Quattro Extraction Balloon (K200247) | Wilson-Cook Medical, Inc. | 2020-02-27 |
| INTELLIO Tablet Application (K192876) | Smith & Nephew | 2020-02-27 |
| APrioCore Plus (K193268) | Apriomed AB | 2020-02-27 |
| Disposable Sclerotherapy Needle (K190032) | Hangzhou AGS MedTech Co., Ltd. | 2020-02-27 |
| iTind System (DEN190020) | Medi-Tate , Ltd. | 2020-02-25 |
| Aquadex FlexFlow System 2.0 (K192756) | Chf Solutions, Inc. | 2020-02-24 |
| NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry Bicarbonate Concentrate (Rx-12 Bag), NaturaLyte Dry Bicarbonate Concentrate (Carton) (K191474) | Fresenius Medical Care Renal Therapies Group, LLC | 2020-02-24 |
| PatCom Single-Use Introducer (K192691) | H&A Mui Enterprises, Inc. | 2020-02-21 |
| Video Laparoscope, Video Processor, Light Source (K192918) | Fujifilm Corporation | 2020-02-20 |
| ClearCam System (K200228) | Clearcam, LLC | 2020-02-19 |
| CapsoCam Plus (SV-3) Capsule Endoscopy System (K192662) | CapsoVision, Inc. | 2020-02-14 |
| da Vinci Xi Surgical System, da Vinci X Surgical System (K191529) | Intuitive Surgical | 2020-02-06 |
| Arc Enterocuff (K191330) | Boddingtons Plastics, Ltd. | 2020-01-31 |
| EndoClot (K191254) | Endoclot Plus Co., Ltd. | 2020-01-30 |
| TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord (K192339) | Wilson-Cook Medical, Inc. | 2020-01-30 |
| Biopsy Needle (K191472) | Ushare Medical, Inc. | 2020-01-29 |