| Xenocor Articulating Xenoscope Laparoscope (K193315) | Xenocor, Inc. | 2020-01-27 |
| Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile (K191715) | STERIS Corporation | 2020-01-27 |
| Cellvizio 100 Series System with Confocal Miniprobes (K191144) | Mauna Kea Technologies | 2020-01-24 |
| Isopure Dry Acid Dissolution System (K191093) | Isopure, Corp. | 2020-01-22 |
| HydroPearl Microspheres (K192684) | MicroVention, Inc. | 2020-01-22 |
| Evis Exera III Duodenovideoscope Olympus TJF-Q190V (K193182) | Olympus Medical Systems Corp. | 2020-01-17 |
| Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter (K192302) | Covidien, LLC | 2020-01-17 |
| SherpaPak Lung Preservation System , SherpaPak Liver Transport System (K192869) | Pragonix Technologies | 2020-01-16 |
| INNOVO (K192357) | Atlantic Therapeutics, Ltd. | 2020-01-16 |
| IP Converter (K191678) | Sony Electronics, Inc. | 2020-01-10 |
| EASYGRIP FLO-41 Precision MIS Delivery System (K193137) | Baxter Healthcare Corportation | 2020-01-08 |
| Endotics (K190669) | Era Endoscopy S.R.L. | 2020-01-03 |
| Optilume Basic Urological Balloon Dilation Catheter (K191061) | Urotronic, Inc. | 2020-01-02 |
| Ureteral Stent Systems, Biliary Drainage Catheters (K191446) | Boston Scientific Corporation | 2020-01-02 |
| Disposable Valve Sets (K192258) | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2019-12-30 |
| Mucosal Integrity Conductivity (MI) Test System (DEN180067) | Diversatek Healthcare, Inc. | 2019-12-23 |
| Paragonix SherpaPak Pancreas Transport System (K191440) | Paragonix Technologies | 2019-12-20 |
| PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonoscope EC34-i10cL, PENTAX Medical Video Colonoscope EC38-i10cL (K190805) | Pentax of America, Inc. | 2019-12-20 |
| Telepack + (K193235) | Karl Storz Endoscopy America, Inc. | 2019-12-20 |
| UroLift System (UL400) (K193269) | Neotract, Inc. | 2019-12-20 |
| Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI) (K190829) | Wilson-Cook Medical Inc./Cook Endoscopy | 2019-12-19 |
| IntraMarX Radiopaque Markers (K191087) | Anx Robotica Corp | 2019-12-18 |
| Single Use Balloon Dilator V (with knife) (K193039) | Olympus Medical Systems Corp. | 2019-12-17 |
| EXALT Model D Single-Use Duodenoscope, EXALT Controller (K193202) | Boston Scientific Corporation | 2019-12-13 |
| VaPro Plus Pocket, VaPro Plus (K193148) | Hollister Incorporated | 2019-12-13 |
| Tri-Ex Extraction Balloon with Multiple Sizing (K193344) | Wilson-Cook Medical, Inc. | 2019-12-13 |
| Tablo Hemodialysis System, Tablo Cartridge (K190793) | Outset Medical, Inc. | 2019-12-12 |
| FUJIFILM Distal Cap Models 33-40 (K193123) | Fujifilm Corporation | 2019-12-11 |
| EQUINOX Balloon Dilatation Catheter (K190612) | Dornier Medtech America, Inc. | 2019-12-06 |
| Medline Quick Switch Valve with ENFit Connector (K191759) | Medline Industries, Inc. | 2019-12-04 |
| RELiZORB (K191379) | Alcresta Therapeutics, Inc. | 2019-12-04 |
| Ureteral Stent Open Tip/Closed Tip/Intraoperative Tip, Ureteral Stent via Ureterorenoscope Open Tip/Closed Tip, Pediatric Ureteral Stent Open Tip/Closed Tip, Mono J Urinary Diversion Ureteral Stent Open Tip/Closed Tip, Multiloop Ureteral Stent Open Tip/Closed Tip (K190659) | Allwin Medical Devices, Inc. | 2019-12-02 |
| Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Femal, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Pediatric, Nelaton-tip Ready-to-Use Hydrophilic Catheter Intermittent Catheter; Male, Tapered-Tip Tiemann Ready-to-Use Hydrophilic Catheter; Male, Olive-Tip Tiemann Ready-to-Use Hydrophilic Catheter (K192468) | Hangzhou Bever Medical Devices Co., Ltd. | 2019-11-27 |
| VS3-IR (K191851) | Medtronic | 2019-11-25 |
| C2 CryoBalloon EndoGrip (K193036) | Pentax Medical, A Division of Pentax of America, Inc. | 2019-11-22 |
| Senhance Surgical System (K192877) | Transenterix, Inc. | 2019-11-22 |
| Navina Smart System, Navina Classic System (K190977) | Dentsply Sirona | 2019-11-22 |
| SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare (K190512) | Intelligent Endoscopy | 2019-11-22 |
| FUJIFILM Endoscope Model EC-760Z-V/L (K192664) | Fujifilm Corporation | 2019-11-20 |
| EchoTip Insight Portosystemic Pressure Gradient Measuring System (DEN180062) | Cook Ireland, Ltd. | 2019-11-20 |
| Dannik Laparoscopic Suction Irrigation System (K192643) | Dannik | 2019-11-19 |
| L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight Cable (K192292) | Stryker | 2019-11-19 |
| Gabriel Feeding Tube with Balloon, and EnFit Connector (K191784) | Syncro Medical Innovations, Inc. | 2019-11-15 |
| SPY Portable Handheld Imaging (SPY-PHI) System (K192174) | Novadaq Technologies Ulc. (Now A Part of Stryker) | 2019-11-15 |
| Dornier Ureteral Stent (K190312) | Dornier Medtech America, Inc. | 2019-11-15 |
| Pentax Medical Video Duodenoscope ED34-i10T2 (K192245) | Pentax of America, Inc. | 2019-11-15 |
| E-100 Electrosurgical Generator, SynchroSeal (K191280) | Intuitive Surgical, Inc. | 2019-11-14 |
| Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes (K192908) | Wilson-Cook Medical, Inc. | 2019-11-14 |
| PENTAX Medical Video Upper GI Scopes (EG Family) (K190799) | Pentax of America, Inc. | 2019-11-12 |
| PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family (K191282) | Pentax of America, Inc. | 2019-11-08 |
| Salem Sump Dual Lumen Stomach Tube with ENFit Connection (K190923) | Cardinalhealth | 2019-11-07 |
| EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast Biopsy Probe - 14G (K192948) | Bard Peripheral Vascular, Inc. | 2019-11-07 |
| Laparoscope Lens Shield Device (LENS) (K192891) | Medeon Biodesign, Inc. | 2019-11-07 |
| Silicone Foley Catheter (K182463) | Biosensors International Pte, Ltd. | 2019-11-06 |
| Perfect PFE (K191312) | Tenscare, Ltd. | 2019-11-01 |
| MiniCap Extended Life PD Transfer Sets (K192705) | Baxter Healthcare | 2019-10-25 |
| FILTRAY 2G Disposable Water Filters (K191563) | Aqua-Tools | 2019-10-25 |
| Padlock Clip defect closure system, Padlock Pro-Select defect closure device (K192722) | STERIS Corporation | 2019-10-24 |
| stentfix OTSC System Set (K183309) | Ovesco Endoscopy AG | 2019-10-22 |
| PENTAX Medical ED-3490TK Video Duodenoscope (K192280) | Pentax Medical | 2019-10-21 |
| McLean-Ring Enteral Feeding Tube Set (K190084) | Cook Incorporated | 2019-10-11 |
| ScopeSeal Duodenoscope Protective Device (K183171) | Gi Scientific, LLC | 2019-10-08 |
| Urethrotech UCD (K190060) | Urethrotech | 2019-10-04 |
| Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe (K190208) | Diversatek Healthcare | 2019-10-03 |
| Millenium HX (K192398) | Mar Cor Purification, Inc. | 2019-10-03 |
| Fidmi Low Profile Enteral Feeding Device (K191844) | Fidmi Medical, Ltd. | 2019-09-30 |
| FUJIFILM Duodenoscope Model ED-580XT (K191747) | Fujifilm Corporation | 2019-09-27 |
| Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar, Disposable Spiral Trocar, Disposable Bladed Trocar (K190029) | Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd | 2019-09-26 |
| 3D Visualization System (K183675) | Scivita Medical Technology Co., Ltd. | 2019-09-25 |
| EasiSlush (K191006) | Bridge TO Life, Ltd. | 2019-09-24 |
| Dornier MINNOW Ureteral Catheter (K191187) | Dornier Medtech America, Inc. | 2019-09-18 |
| Flexible HD Cysto-Urethroscope System (K191357) | KARL STORZ Endoscopy-America, Inc. | 2019-09-18 |
| Bio Guard Air/Water & Suction Valves (K192059) | United States Endoscopy Group, Inc. | 2019-09-17 |
| Connected OR Hub with Device and Voice Control (K192172) | Stryker | 2019-09-09 |
| Vacutore Air/Water Bottle Tubing (K191366) | Smartdata Suzhou Co., Ltd. | 2019-09-06 |
| FUJIFILM Ultrasonic Endoscope (K183433) | Fujifilm Corporation | 2019-09-05 |
| Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Head (K190449) | Olympus Medical Systems Corp. | 2019-08-30 |
| Pathfinder Endoscope Overtube (K191415) | Neptune Medical, Inc. | 2019-08-30 |
| OverStitch 2-0 Polypropylene Suture (K191439) | Apollo Endosurgery | 2019-08-29 |
| AXIOS Stent and Electrocautery Enhanced Delivery System (K192043) | Boston Scientific Corporation | 2019-08-26 |
| LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K Camera Head (K191177) | Smith and Nephew, Inc. | 2019-08-23 |
| Hemoflow F3 and F4 Dialyzers (K190459) | Fresenius Medical Care Renal Therapies Group, LLC | 2019-08-23 |
| RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector (K190081) | STERIS Corporation | 2019-08-21 |
| Tria Soft Ureteral Stent (K191609) | Boston Scientific Corporation | 2019-08-16 |
| TULSA-PRO System (K191200) | Profound Medical, Inc. | 2019-08-15 |
| Servator C SALF Solution (K190063) | S.A.L.F. Spa | 2019-08-14 |
| NxStage Cartridge Express with Speedswap (K183158) | Nxstage Medical, Inc. | 2019-08-09 |
| Transit-Pellets (K181760) | Medifactia AB | 2019-08-08 |
| Percutaneous Introducer Needle (K191295) | Progressive Medical, Inc. | 2019-08-06 |
| ENFit Oral / Enteral Syringe (K190502) | Jiangsu Caina Medical Co.,Ltd | 2019-08-06 |
| TDS Standard Solution (K191496) | Mesa Laboratories, Inc. | 2019-08-05 |
| UPJ Occlusion Balloon Catheter (K183323) | Cook Incorporated | 2019-08-05 |
| Rezum System (K191505) | Nxthera (A Boston Scientific Company) | 2019-08-02 |
| AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM (K191559) | United States Endoscopy Group, Inc. | 2019-08-01 |
| Single Use Reloadable Clip Applicator, Clip, Long Clip, Short Clip, Super Short Clip (K183590) | Olympus Medical Systems Corp. | 2019-08-01 |
| da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30 (K191736) | Intuitive Surgical | 2019-07-26 |
| PrisMax System Version 2 (K190910) | Baxter Healthcare Corp | 2019-07-25 |
| Stonetome Stone Removal Device (K191789) | Boston Scientific Corporation | 2019-07-25 |
| BAROnova Access Sheath Kit (K191078) | Baronova, Inc. | 2019-07-22 |
| Surdial DX Hemodialysis System (K182940) | Nipro Medical Corporation | 2019-07-19 |