| ENvizion Medical ENvue; ENvizion Medical Enteral Feeding Tube (K182915) | Envizion Medical , Ltd. | 2019-02-13 |
| Elitone Device (K183585) | Elidah, Inc. | 2019-02-11 |
| HANAROSTENT FASTTM Biliary (NNN) (K183396) | M.I.Tech Co., Ltd. | 2019-02-11 |
| Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush (K181317) | Wilson-Cook Medical, Inc. | 2019-02-08 |
| Glo-Tip Spray Catheter (K182319) | Wilson-Cook Medical, Inc. | 2019-02-01 |
| Wilson-Cook Achalasia Balloon (K182895) | Wilson-Cook Medical, Inc. | 2019-01-25 |
| AMD Anti-Fog Solution (K181887) | Advanced Medical Design Co., Ltd. | 2019-01-22 |
| SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller (K183636) | Boston Scientific Corporation | 2019-01-22 |
| SureForm 45, SureForm 45 Reloads (K183224) | Intuitive Surgical | 2019-01-18 |
| Flex-THOR scope (K183264) | KARL STORZ Endoscopy-America, Inc. | 2019-01-18 |
| PENTAX Video Colonoscopes (EC Family) (K181084) | Pentax of America, Inc. | 2019-01-18 |
| Cook Cystostomy Catheter Set (K181097) | Cook Incorporated | 2019-01-18 |
| VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES) (K180236) | Vr Medical Technology Co., Ltd. | 2019-01-18 |
| URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R, URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R (K181451) | Olympus Medical Systems Corp. | 2019-01-16 |
| Dosis SAM (K180410) | Dosis, Inc. | 2019-01-16 |
| Senhance Ultrasonic System (K182421) | Transenterix, Inc. | 2019-01-11 |
| DIASAFEplusUS (K182367) | Fresenius Medical Care Renal Therapies Group, LLC | 2019-01-10 |
| Signal Catheter (K182635) | Safe Medical Design | 2019-01-10 |
| One-Step Suprapubic Introducer (K182709) | Cook Incorporated | 2018-12-26 |
| Clear-Jet Injection Catheter (K181690) | Finemedix Co., Ltd. | 2018-12-21 |
| SEM Scanner (Model 200) (DEN170021) | Bruin Biometrics, LLC | 2018-12-20 |
| Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle (K181756) | Apriomed AB | 2018-12-18 |
| ValPro 2 Plus, VaPro 2 Plus Pocket (K183253) | Hollister Incorporated | 2018-12-18 |
| SureClip Repositionable Hemostasis Clip (K182556) | Micro-Tech (Nanjing) Co., Ltd. | 2018-12-14 |
| Acu-sInQ Complete Endoscope Cleaning Aid System (K181865) | STERIS Corporation | 2018-12-14 |
| LaparoGuard (K182434) | Mariner Endosurgery, Inc. | 2018-12-13 |
| Intuitive Surgical Vessel Sealer Extend (K183107) | Intuitive Surgical, Inc. | 2018-12-11 |
| CitriCon Liquid and Powder (Acid Concentrate acidified with Citric Acid), AcetiCon Liquid and Powder (Acid Concentrate acidified with Acetic Acid or Na Di Acetate), BicarboCon Liquid and Powder (Bicarb Concentrate), RenaCon Liquid and Powder (Acetate Concentrate with Na Acetate) (K180679) | Global Scientific Technologies, LLC | 2018-12-07 |
| FiXcision (K182664) | Agency For Medical Innovations GmbH | 2018-12-07 |
| Senhance Surgical System (K183098) | Transenterix, Inc. | 2018-12-06 |
| Single Use Hot Biopsy Forceps FD-231 (K173495) | Olympus Medical Systems Corp. | 2018-11-30 |
| Greene Renal Transplant Stent Set (K180557) | Cook Incorporated | 2018-11-23 |
| PINPOINT Endoscopic Fluorescence Imaging System (K182606) | Novadaq Technologies Ulc. (Now A Part of Stryker) | 2018-11-21 |
| Roth Net Retriever Product Line (K182909) | United States Endoscopy Group, Inc. | 2018-11-21 |
| Telepack X LED (K182696) | KARL STORZ Endoscopy-America, Inc. | 2018-11-20 |
| Zilver 518 Biliary Stent, Zilver 635 Biliary Stent (K182980) | Cook Ireland, Ltd. | 2018-11-16 |
| SmartBag (SmartPouch) (K181643) | 11 Health Technologies Limited | 2018-11-16 |
| SITZMARKS (K181750) | Konsyl Pharmaceuticals | 2018-11-15 |
| Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N (K180668) | Olympus Medical Systems Corp. | 2018-11-15 |
| HPM-6000UF (K181497) | BTL Industries, Inc. | 2018-11-14 |
| Aspire Venting Tube (K182248) | Aspire Bariatrics, Inc. | 2018-11-13 |
| Enteral Feeding Syringes with Enfit Connectors (K182649) | Jiangsu Kangbao Medical Equipment Co., Ltd. | 2018-11-09 |
| MiroCam Capsule Endoscope System (K180732) | Intromedic Co., Ltd. | 2018-11-08 |
| neoClose PDS (K173917) | Neosurgical, Ltd. | 2018-11-08 |
| ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent (K180469) | Coloplast Corp. | 2018-11-06 |
| Innovo (DEN170049) | Bio-Medical Research, Ltd. | 2018-11-06 |
| ERBEFLO Olympus Scope Port Connector (K182444) | Erbe USA, Inc. | 2018-11-06 |
| ConnectedOR Hub with Device and Voice Control (K181258) | Stryker | 2018-11-05 |
| Actreen Hi-Lite Cath, Actreen Hi-Lite Set (K180801) | B.Braun Medical, Inc. | 2018-11-05 |
| 1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head with Integrated Coupler ; AIM 4K Coupler, 20mm, C-Mount ; L11 LED Light Source with AIM (K182160) | Stryker | 2018-11-05 |
| Clear-Tip EUS-FNA (K180363) | Finemedix Co., Ltd. | 2018-11-01 |
| Single Use Aspiration Needle NA-U201H (K181994) | Olympus Medical Systems Corp. | 2018-10-31 |
| DiLumen Endolumenal Interventional Platform (K182540) | Lumendi, LLC | 2018-10-30 |
| Wilson-Cook Mini Basket (K182381) | Wilson-Cook Medical, Inc. | 2018-10-30 |
| UroGen Ureteral Catheter (K180354) | Urogen Pharma, Ltd. | 2018-10-30 |
| O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set (K182066) | Cook Incorporated | 2018-10-30 |
| PENTAX Medical Video Colonoscope EC34-i10T Series (K180285) | Pentax Medical of America, Inc. | 2018-10-26 |
| SpeediCath Standard (K180258) | Coloplast | 2018-10-25 |
| da Vinci Xi Surgical System, da Vinci X Surgical System (K182140) | Intuitive Surgical, Inc. | 2018-10-24 |
| GastroFlush (K180605) | Bionix Development Corporation | 2018-10-24 |
| Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port (K180622) | Covidien | 2018-10-23 |
| Paragonix SherpaPak Cardiac Transport System (K182735) | Paragonix Technologies | 2018-10-19 |
| Medax Biopsy Systems III (K181803) | Medax Srl Unipersonale | 2018-10-18 |
| Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube with ENFit Connection, Entuit LP Patient Care Kit, Entuit LP Patient Care Kit with ENFit Connection, PromaX Low Profile Gastrostomy Feeding Tube, PromaX LP Patient Care Kit with ENFit (K180708) | Xeridiem Medical Devices, A Spectrum Plastics Group Company | 2018-10-18 |
| Reliant(TM) Multistage Dilatation Balloon Catheter (K180418) | Micro-Tech (Nanjing) Co., Ltd. | 2018-10-15 |
| PENTAX Video Upper G.I. Scope EG34-i10 (K180292) | Pentax Medical of America, Inc. | 2018-10-12 |
| Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL) (K181426) | Jiangsu Micsafe Medical Technology Co., Ltd. | 2018-10-11 |
| Senhance Surgical System (K181517) | Transenterix, Inc. | 2018-10-09 |
| Swiss LithoClast Trilogy (K182490) | E.M.S Electro Medical Systems S.A | 2018-10-09 |
| Ureteric Catheters (K182122) | Coloplast Corp. | 2018-10-04 |
| FUJIFILM Duodenoscope Model (K182051) | Fujifilm Corporation | 2018-10-02 |
| AMSure Hydrophilic Intermittent Catheter (K181445) | Amsino International, Inc. | 2018-10-01 |
| Seidmon Antegrade AQ Stent Set (K180216) | Cook Incorporated | 2018-09-28 |
| ORISE Gel (K180068) | Boston Scientific | 2018-09-28 |
| Disposable Standard Clamp (K181608) | Standard Bariatrics | 2018-09-27 |
| NxStage Connected Health System (K181991) | Nxstage Medical, Inc. | 2018-09-26 |
| PSM 3-Way Silicone Foley Catheter (K181616) | Pathway, LLC | 2018-09-21 |
| SOLOASSIST II (K171947) | Aktormed GmbH | 2018-09-21 |
| AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - Fujifilm (K182258) | United States Endoscopy Group, Inc. | 2018-09-21 |
| Malecot Nephrostomy Catheter/Stent Set (K180029) | Cook Incorporated | 2018-09-21 |
| Scope Antifogging System (K182080) | Xodus Medical, Inc. | 2018-09-19 |
| Bard Vertus Foley Catheter (K180781) | C.R. Bard, Inc. | 2018-09-19 |
| Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter (K180182) | Cook Incorporated | 2018-09-14 |
| Seal Single Use Biopsy Valve (K182275) | Boston Scientific Corporation | 2018-09-13 |
| Sof-Flex Ureteral Stent Set (K180053) | Cook Incorporated | 2018-09-13 |
| Anchor Tissue Retrieval System by CONMED (K173822) | Conmed Corporation | 2018-09-11 |
| ReTrace Ureteral Access Sheath (K181811) | Coloplast A/S | 2018-09-07 |
| Bi-Flex Evo (K182144) | Promepla Sam | 2018-09-07 |
| HD-500 Video Endoscope System (K173921) | Sonoscape Medical Corp. | 2018-09-05 |
| AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water (K181814) | Amsino International, Inc. | 2018-09-04 |
| Dissecting Balloon System (K182024) | Applied Medical Resources Corp. | 2018-08-30 |
| Swiss LithoClast Trilogy (K181997) | E.M.S Electro Medical Systems S.A | 2018-08-30 |
| AcuSnare Polypectomy Snare (K173673) | Wilson-Cook Medical, Inc. | 2018-08-24 |
| Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter (K173657) | Cook Incorporated | 2018-08-23 |
| SpyGlass DS and DS II Direct Visualization System (K181439) | Boston Scientific Corporation | 2018-08-23 |
| PENTAX Medical Endoscopic Ultrasound System (K182004) | Pentax of America, Inc. | 2018-08-21 |
| SIMPLYSTRONG, SIMPLYEZEE (K181791) | Genicon, Inc. | 2018-08-21 |
| BEXCORE Breast Biopsy System, Biopsy Needle (K171890) | Medical Park Co., Ltd. | 2018-08-20 |
| GentleCath Glide Intermittent Urinary Catheter (K181206) | Convatec Limited | 2018-08-16 |
| Luminelle DTx Hysteroscopy System (K181909) | Uvision360, Inc. | 2018-08-16 |