| Infyna Chic (K191633) | Hollister Incorporated | 2019-07-19 |
| Peralta Stone Removal Catheter (K190492) | Calcula Technologies, Inc. | 2019-07-18 |
| AcuSnare Polypectomy Snare - Duckbill (K191048) | Wilson-Cook Medical, Inc. | 2019-07-18 |
| FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/L (K183572) | Fujifilm Corporation | 2019-07-16 |
| SureForm 45 Curved Tip, SureForm 45 Gray Reload (K190999) | Intuitive Surgical, Inc. | 2019-07-12 |
| Remington Medical, Inc. Automatic Cutting Needle (NAC) (K191315) | Remington Medical, Inc. | 2019-07-12 |
| ScopeFlow Pure(TM) (K181418) | Partnership Medical Limited | 2019-07-11 |
| EndoStream(TM) (K181457) | Partnership Medical Limited | 2019-07-11 |
| Senhance Surgical System (K191482) | Transenterix, Inc. | 2019-07-11 |
| SpeediCath Flex Coude Pro (K190620) | Coloplast | 2019-07-10 |
| ENDOSCOPE REPROCESSOR OER-Elite (K190969) | Olympus Medical Systems Corp. | 2019-07-09 |
| Arthrex NanoScope System (K190645) | Arthrex, Inc. | 2019-07-05 |
| Uro-N Cystoscope (K182876) | Uroviu Corporation | 2019-07-02 |
| ClearEndoclip (K183021) | Finemedix Co., Ltd. | 2019-06-28 |
| ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector (K191438) | Erbe USA, Inc. | 2019-06-27 |
| Deflectable Brush Biopsy Set (K191485) | Cook Incorporated | 2019-06-26 |
| Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set (K182832) | Cook Incorporated | 2019-06-26 |
| FUJIFILM Double Balloon Endoscope EI580BT (K183032) | Fujifilm Corporation | 2019-06-24 |
| Aqua Medical RF Vapor System (K183595) | Aqua Medical, Inc. | 2019-06-21 |
| Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter (K182695) | Cook Incorporated | 2019-06-17 |
| ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube (K191387) | Envizion Medical , Ltd. | 2019-06-14 |
| Moss Gastrostomy Tube, Moss Nasal Tube – Mark IV (K190414) | Moss Tubes, Inc. | 2019-06-14 |
| Trio-CT Triple Lumen Catheter (K183219) | Medical Components, Inc. (dba MedComp) | 2019-06-14 |
| Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags (K191341) | Corinth Medtech, Inc. | 2019-06-13 |
| J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle, (K190177) | Ranfac Corporation | 2019-06-12 |
| Medline Poly-Cath Red Polymer Urethral Catheter (K183335) | Medline Industries, Inc. | 2019-06-12 |
| Andorate Auxiliary Water Connector, Andorate Valves Set (K191231) | Smartdata Suzhou Co., Ltd. | 2019-06-07 |
| IB-Stim (DEN180057) | Innovative Health Solutions (Ihs), Inc. | 2019-06-07 |
| da Vinci Handheld Camera (K191043) | Intuitive Surgical, Inc. | 2019-06-06 |
| Pure Vu System (K191220) | Motus GI Medical Technologies , Ltd. | 2019-06-06 |
| WalterLorenz Surgical Assist Arm Scope Holder (K190576) | Biomet Microfixation | 2019-06-05 |
| CORTRAK* 2 Equilateral Enteral Access System (K191340) | Avanos Medical, Inc. | 2019-06-04 |
| U Deliver Bolink ENFit Enteral Feeding Sets (K190310) | U Deliver Medical, LLC | 2019-05-31 |
| E240AG LCD Monitor, E240A LCD Monitor, JUSHA-E240AG LCD Monitor, JUJSHA-E240A LCD Monitor, C230A LCD Monitor, JUSHA-C230A LCD Monitor, C230M LCD Monitor, JUSHA-C230M LCD Monitor (K190831) | Nanjing Jusha Display Technology Co., Ltd. | 2019-05-31 |
| Pristine Hemodialysis Catheter (K182443) | Pristine Access Technologies , Ltd. | 2019-05-31 |
| Arc Endocuff Glide AEG110 & AEG120 (K191067) | Boddingtons Plastics, Ltd. | 2019-05-30 |
| Swiss LithoClast Trilogy (K191124) | E.M.S Electro Medical Systems S.A | 2019-05-29 |
| Peel-Away Introducer (K182403) | Cook Incorporated | 2019-05-29 |
| Entuit PEG, Entuit PEGJ (K183336) | Wilson-Cook Medical, Inc. | 2019-05-29 |
| Tria Firm Ureteral Stent (K190603) | Boston Scientific Corporation | 2019-05-24 |
| Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter (K181979) | Teleflexmedical, Inc. | 2019-05-24 |
| Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14 Gauge, Spirotome Endo 14 Gauge with 10 mm Helix (K190378) | Bioncise NV | 2019-05-24 |
| ERBEFLO 2 Disposable Tubing System (K190469) | Erbe USA, Inc. | 2019-05-23 |
| Smith & Nephew Tablet Application (K190367) | Smith & Nephew | 2019-05-21 |
| Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645 (K182408) | Olympus Medical Systems Corp. | 2019-05-15 |
| Flexible Overtube (K182520) | Sumitomo Bakelite Co., Ltd. | 2019-05-15 |
| BAROnova Insufflation System, BAROnova Accessory Kit (K190985) | Baronova, Inc. | 2019-05-14 |
| L10 LED Light Source with AIM, L11 LED Light Source with AIM (K191046) | Stryker | 2019-05-10 |
| Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter (K183461) | Teleflexmedical, Inc. | 2019-05-08 |
| FUJIFILM Endoscope Model EC-760S-V/L (K190649) | Fujifilm Corporation | 2019-05-07 |
| Scope ProTech (K191011) | Meditech Endoscopy, Ltd. | 2019-05-07 |
| Medline Quick-Clear Wand (K183577) | Medline Industries, Inc. | 2019-05-04 |
| Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF (K183188) | Richard Wolf Medical Instruments Corporation | 2019-05-03 |
| Brush Biopsy Set ; Deflectable Brush Biopsy Set (K182231) | Cook Incorporated | 2019-05-01 |
| Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector) (K190114) | Convatec Limited | 2019-04-30 |
| Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral Syringes with ENFit connector (1 mL to 6 mL) (K183540) | Neomed, Inc. | 2019-04-30 |
| YelloPort Elite Port Access System (K190592) | Surgical Innovations Limited | 2019-04-29 |
| Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding Tubes (K181787) | Cedic S.R.L. | 2019-04-25 |
| Ranfac Cartilage Biopsy Needle (K183146) | Ranfac Corporation | 2019-04-25 |
| AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor (K181472) | Advanced Sterilization Products (Asp) | 2019-04-23 |
| Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy Stent Set (K181971) | Cook Incorporated | 2019-04-23 |
| Flexible HD Cysto-Urethroscope System (K182723) | KARL STORZ Endoscopy-America, Inc. | 2019-04-23 |
| SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long (K190621) | Sumitomo Bakelite Co., Ltd. | 2019-04-23 |
| CapsoCam Plus (SV-3) (K183192) | CapsoVision, Inc. | 2019-04-19 |
| SPY Portable Handheld Imaging (SPY-PHI) System (K190729) | Novadaq Technologies Ulc. (Now A Part of Stryker) | 2019-04-19 |
| Disposable Standard Clamp (K190788) | Standard Bariatrics | 2019-04-18 |
| Andorate Auxiliary Water Connector (K182998) | Smartdata Suzhou Co., Ltd. | 2019-04-17 |
| Avulsion Forceps (K183428) | STERIS Corporation | 2019-04-16 |
| Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm Device (K183619) | Boston Scientific Corporation | 2019-04-16 |
| Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer (K182828) | Surgical Instrument Service and Savings, Inc. | 2019-04-15 |
| Rigi10 Malleable Penile Prosthesis (K181673) | Rigicon, Inc. | 2019-04-15 |
| Plenity (DEN180060) | Gelesis, Inc. | 2019-04-12 |
| ELRA Electrode (K181758) | Starmed Co., Ltd. | 2019-04-11 |
| PUMA-G System (K183057) | Coaptech, LLC | 2019-04-10 |
| ENConnect 40 mm Screw Cap to ENPlus Adapter (K190327) | Cedic S.R.L. | 2019-04-09 |
| CleverLock Guidewire Locking Device and Biopsy Cap (K190164) | Olympus Surgical Technologies America | 2019-04-04 |
| FUJIFILM Endoscope Model EG-740N (K182836) | Fujifilm Corporation | 2019-04-02 |
| Micro Transgastric-Jejunal Feeding Device (K183508) | Applied Medical Technology, Inc. | 2019-03-29 |
| Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet, Ecolab POU Water Filter Shower Wand (K182164) | Ecolab, Inc. | 2019-03-29 |
| Pusen Eview Medical Video Endoscope Image Processor (K190648) | Zhuhai Pusen Medical Technology Co., Ltd. | 2019-03-29 |
| FUJIFILM Duodenoscope Model (K181745) | Fujifilm Corporation | 2019-03-28 |
| Rezum Delivery Device, Rezum Generator (K190093) | Nxthera (A Boston Scientific Company) | 2019-03-25 |
| AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System (K181905) | Boston Scientific Corporation | 2019-03-25 |
| ELMED Laparoscopic Instruments and Accessories (K181173) | Elmed Incorporated | 2019-03-22 |
| UroLift System UL400 (K190377) | Neotract, Inc. | 2019-03-21 |
| SimplCath (K182511) | F&S Medical Solutions, LLC | 2019-03-20 |
| ApexMV (K182022) | Incontrol Medical, LLC | 2019-03-15 |
| Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch (K190099) | Corinth Medtech, Inc. | 2019-03-15 |
| ConvertX Biliary Stent System (K181669) | Brightwater Medical | 2019-03-14 |
| da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories (K182371) | Intuitive Surgical, Inc. | 2019-03-14 |
| Anchor Bag-Alone Tissue Retrieval System by ConMed (K183600) | Conmed Corporation | 2019-03-13 |
| ClearGrasp Snare (K183289) | Finemedix Co., Ltd. | 2019-03-06 |
| Embrella Endoscopic Distal Attachment (K190030) | Micro-Tech (Nanjing) Co., Ltd. | 2019-03-05 |
| Olympus Small Intestinal Capsule Endoscope System (K183053) | Olympus Medical Systems Corp. | 2019-03-05 |
| VS3-IR (K183453) | Medtronic | 2019-03-04 |
| Traditional Length GJ Feeding Device (K182804) | Applied Medical Technology, Inc. | 2019-03-01 |
| FUJIFILM Endoscope Model EG-530N (K183686) | Fujifilm Corporation | 2019-02-28 |
| FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5 (K183683) | Fujifilm Corporation | 2019-02-27 |
| Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes (K183640) | Mauna Kea Technologies | 2019-02-22 |
| EndoFLIP System (K183072) | Crospon, Ltd. | 2019-02-15 |