| WiScope Digital Endoscope System (K181977) | OTU Medical, Inc. | 2018-08-14 |
| EndoWrist Mercury Bipolar Grasper (K180351) | Intuitive Surgical, Inc. | 2018-08-07 |
| CystoSure Plus Catheter (K181346) | Emmy Medical, LLC | 2018-08-06 |
| FUJIFILM 600 Series Endoscope EG-600WR v2 (K180341) | Fujifilm Corporation | 2018-08-03 |
| Universal Cannula Seal (5-12 mm) (K181395) | Intuitive Surgical, Inc. | 2018-07-27 |
| Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis Catheter and Kits, Argyle Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter, Argyle Adult Peritoneal Dialysis Accessory Titanium Catheter Extender (K180485) | Covidien, LLC | 2018-07-27 |
| FUJIFILM Ultrasonic Endoscope (K181763) | Fujifilm Corporation | 2018-07-27 |
| San Antonio Stopcock (K181712) | Cook Incorporated | 2018-07-26 |
| da Vinci Xi Surgical System, da Vinci X Surgical System (K173585) | Intuitive Surgical, Inc. | 2018-07-19 |
| KARL STORZ New Generation Trocars (K180977) | KARL STORZ Endoscopy-America, Inc. | 2018-07-18 |
| Ureteral Dilator Sets, Ureteral Dilators (K173654) | Cook Incorporated | 2018-07-17 |
| Yikang Latex Foley Catheter (K173340) | Jiangxi Yikang Medical Instrument Group Co., Ltd. | 2018-07-13 |
| CONOD Enteral Feeding Sets (K181276) | Conod Medical Co., Limited | 2018-07-12 |
| Aspire Introducer Needle (K180725) | Aspire Bariatrics, Inc. | 2018-07-11 |
| PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video Duodenoscope (K181522) | Pentax of America, Inc. | 2018-07-09 |
| Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal Biliary Drainage Set, Leung Nasal Biliary Drainage Set (K180868) | Cook Ireland | 2018-07-06 |
| Howell D.A.S.H Extraction Balloon with Multiple Sizing (K173659) | Wilson-Cook Medical, Inc. | 2018-07-06 |
| Endorate Valve Sets (K181509) | Smartdata Suzhou Co., Ltd. | 2018-07-06 |
| SureForm 60 and SureForm 60 Reloads (K173721) | Intuitive Surgical | 2018-07-05 |
| 12F Tri-Flow Triple Lumen Catheter (K181175) | Medical Components, Inc. (dba MedComp) | 2018-07-05 |
| Disposable Hot Biopsy Forceps (K180018) | Micro-Tech (Nanjing) Co., Ltd. | 2018-07-05 |
| PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes (K173679) | Pentax of America, Inc. | 2018-07-03 |
| Ureterorenoscope System (K180367) | Shanghai AnQing Medical Instrument Co., Ltd. | 2018-07-03 |
| TubeClear System (K172556) | Actuated Medical, Inc. | 2018-06-29 |
| Ensizor Monopolar Endoscopic Scissors (K180134) | Slater Endoscopy, LLC | 2018-06-29 |
| Servator B SALF Solution (K180481) | S.A.L.F. Spa | 2018-06-29 |
| Ecolab POU Water Filter (K173164) | Ecolab, Inc. | 2018-06-29 |
| LOGIC 4K CAMERA CONTROLLER, LOGIC 4K CAMERA HEAD (K180583) | Richard Wolf Medical Instruments Corporation | 2018-06-28 |
| Angled Tip Ureteral Catheter (K181144) | Cook Incorporated | 2018-06-28 |
| OverStitch Endoscopic Suturing System and Accessories (K181141) | Apollo Endosurgery | 2018-06-27 |
| Advance Biliary Balloon Catheter (K173414) | Cook Incorporated | 2018-06-22 |
| Perfadex Plus (K170826) | Xvivo Perfusion AB | 2018-06-22 |
| VaPro 2 Intermittent Catheter (K180824) | Hollister Incorporated | 2018-06-22 |
| Pure Vu System (K181437) | Motus GI Medical Technologies , Ltd. | 2018-06-21 |
| Visura Technologies TEECAD System (K180911) | Visura Technologies, LLC | 2018-06-20 |
| Swiss LithoClast Trilogy (K181364) | E.M.S Electro Medical Systems S.A | 2018-06-20 |
| SpeedBird Model SB38 Soft Tissue Biopsy Device; SpeedBird Model SBU Soft Tissue Biopsy Device; SpeedBird Model SBU99 Soft Tissue Biopsy Device (K173316) | Transmed7, LLC | 2018-06-19 |
| Ligation Device (K172985) | Leo Medical Co., Ltd. | 2018-06-14 |
| COMPACTCATH Lubricated Intermittent UrinaryCatheter and OneCath Intermittent Urinary Catheter (K180738) | Compactcath, Inc. | 2018-06-14 |
| Single Use Aspiration Needle NA-U200H (K180449) | Olympus Medical Systems Corp. | 2018-06-08 |
| FOCAL ONE (K172721) | Edap Technomed, Inc. | 2018-06-07 |
| Silicone Foley Catheter for single use (K172807) | Changzhou Rongxin Medicine Minimal Invasion Technology | 2018-06-04 |
| Bowel Management Device, Bowel Management Irrigation Set (K180026) | Applied Medical Technology, Inc. | 2018-06-01 |
| Colonic Plus Regular, Small, and Straight Shape Hydrokit (K180800) | Colonic Plus | 2018-06-01 |
| Single Use MultiClip Device (K180325) | Micro-Tech (Nanjing) Co., Ltd. | 2018-06-01 |
| da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories (K173906) | Intuitive Surgical, Inc. | 2018-05-31 |
| EndoWrist 5mm Thoracic Grasper (K173415) | Intuitive Surgical, Inc. | 2018-05-31 |
| FUJIFILM Endoscopic CO2 Regulator GW-100 (K180711) | Fujifilm Corporation | 2018-05-25 |
| ClearGuard HD Antimicrobial Barrier Cap (K180111) | Pursuit Vascular, Inc. | 2018-05-25 |
| TransEnterix Senhance Surgical System (K180163) | Transenterix, Inc. | 2018-05-25 |
| Fresenius Liberty Select Cycler (K181108) | Fresenius Medical Care Renal Therapies Group, LLC | 2018-05-24 |
| Celling Aspiration Needle (K180807) | Spine Smith Holdings, LLC | 2018-05-24 |
| EPX-4440FN Digital Video Processor with Light Source (K180414) | Fujifilm New Development U.S.A., Inc. | 2018-05-24 |
| Safety Wire Guide Introducer (K180756) | Cook Incorporated | 2018-05-24 |
| Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton CannulaTome II® PC, UTS® Ultra Taper Sphincterotome, Tri-Tome pc® Triple Lumen Sphincterotome, Howell D.A.S.H.® Sphincterotome with DomeTip®, Billroth II Sphincterotome, Soehendra® BII Sphincterotome, Models ACU-1 and ACU-1-VL active cords (K172665) | Wilson-Cook Medical Inc./Cook Endoscopy | 2018-05-24 |
| stay•safe catheter extension set with Safe-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 6 inch, stay•safe catheter extension set with Luer-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 18 inch, stay•safe to Luer-Lock adapter, 4 inch (K173593) | Fresenius Medical Care Renal Therapies Group, LLC | 2018-05-21 |
| Polypectomy Snare (K172729) | Hangzhou AGS MedTech Co., Ltd. | 2018-05-21 |
| Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series) (K171505) | Dimesol, Inc. | 2018-05-17 |
| 15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 28 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 33 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 37 cm Symetrex Long Term Hemodialysis Catheter with Sideholes (K173667) | Medical Components, Inc. (dba MedComp) | 2018-05-17 |
| Disposable Biopsy Valve (K173758) | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2018-05-14 |
| 2008T BlueStar Hemodialysis Machine (K173972) | Fresenius Medical Care Renal Therapies Group, LLC | 2018-05-10 |
| SB Soft Hood - Straight type, SB Soft Hood - Undercut type (K173004) | Sumitomo Bakelite Co., Ltd. | 2018-05-08 |
| Repris Bladder Injection System (K180214) | Uro-1, Inc. | 2018-05-03 |
| Cook 810 Set, Desilets-Hoffman Introducer Set (K180028) | Cook Incorporated | 2018-05-02 |
| Liberty Cycler Set (K173718) | Fresenius Medical Care Renal Therapies Group, LLC | 2018-05-01 |
| Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter, Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set, Multipurpose Drainage Catheters and Sets (K173035) | Cook Incorporated | 2018-05-01 |
| Intuitive Surgical EndoWrist Vessel Sealer Extend (K173337) | Intuitive Surgical, Inc. | 2018-04-26 |
| Beacon EUS Access System (K180037) | Covidien, LLC | 2018-04-26 |
| da Vinci Xi Surgical System, da Vinci X Surgical System (K173842) | Intuitive Surgical, Inc. | 2018-04-23 |
| Embozene Color-Advanced Microspheres (K180102) | Boston Scientific | 2018-04-19 |
| Balloon Catheter and Balloon Ureteral Dilator Set (K172588) | Cook Incorporated | 2018-04-19 |
| Ultramatrix EUS Balloon (K180731) | United States Endoscopy Group, Inc. (Us Endoscopy) | 2018-04-19 |
| Genistrong (K180836) | Genicon, Inc. | 2018-04-18 |
| DiLumen C2; DiLumen Tool Mount (K173317) | Lumendi, LLC | 2018-04-17 |
| Fusion OMNI Sphincterotome (K172288) | Wilson-Cook Medical Inc./Cook Endoscopy | 2018-04-17 |
| Hemoclip (K172727) | Hangzhou AGS MedTech Co., Ltd. | 2018-04-16 |
| Cope Nephroureterostomy Stent and Amplatz Ureteral Stent Set (K171603) | Cook Incorporated | 2018-04-16 |
| Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure device (K180689) | STERIS Corporation | 2018-04-12 |
| Imager II Urology Torque Catheter (K180530) | Boston Scientific Corporation | 2018-04-10 |
| Eviva Stereotactic Guided Breast Biopsy System (K180233) | Hologic, Inc. | 2018-04-10 |
| Disposable Endoscopic Trocar (K180208) | Fengh Medical Co., Ltd. | 2018-04-09 |
| 8mm Monopolar Curved Scissors (K180033) | Intuitive Surgical, Inc. | 2018-04-06 |
| SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System (K180194) | Paragonix Technologies, Inc. | 2018-03-30 |
| OLYMPUS URF-V2/V2R (K172246) | Olympus Medical Systems Corp. | 2018-03-30 |
| AMSure® Enteral Feeding Syringe with ENFit Tip (K171857) | Amsino International, Inc. | 2018-03-30 |
| Dimesol Tubing Sets for Hemodialysis (K171952) | Dimesol, Inc. | 2018-03-30 |
| OLYMPUS URF-P6/P6R (K172298) | Olympus Medical Systems Corp. | 2018-03-29 |
| Duette 100% Silicone Dual-Balloon, Temperature-Sensing Catheter (K173533) | Poiesis Medical, LLC | 2018-03-29 |
| Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket, Memory 5 Fr. Soft Wire Baskets or Memory Helical Stone Extractor, Memory Eight Wire Baskets or Memory Hard Wire Baskets, Fusion Wire Guided Extraction Basket, Non-Lithotripsy Extraction Basket (K171969) | Wilson-Cook Medical, Inc. | 2018-03-28 |
| AEON Retrieval Bag (K180114) | Lexington Medical, Inc. | 2018-03-27 |
| Black Silicone Filiform Double Pigtail Stent Set (K172017) | Cook Incorporated | 2018-03-26 |
| Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst Adapter (K173105) | Cook Incorporated | 2018-03-22 |
| Captura® Disposable Hot Biopsy Forceps (K171973) | Wilson-Cook Medical, Inc. | 2018-03-21 |
| Single Use Hemoclip (K172762) | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2018-03-20 |
| Habib EndoHPB (K180165) | Emcision , Ltd. | 2018-03-20 |
| HX Device (K173919) | Human Extension , Ltd. | 2018-03-20 |
| Classic ERCP Catheter and Huibregtse-Katon ERCP Catheter and Huibregtse-Katon Angled, Glo-Tip ERCP Catheter, Glo-Tip II Double Lumen ERCP Catheter & w/ Radiopaque Bands, Fusion ERCP Catheter with DomeTip and Fusion OMNI ERCP Catheter with DomeTip, Haber RAMP Catheter, Soehendra Universal Catheter (K171989) | Wilson-Cook Medical, Inc. | 2018-03-20 |
| Ezee Retrieval (K180579) | Genicon, Inc. | 2018-03-19 |
| FUJIFILM Endoscope Models EC-600HL and EC-600LS (K180405) | Fujifilm Corporation | 2018-03-15 |
| Incontinence Treatment Device, Model LT2061 (K171430) | Shenzhen Dongdixin Technology Co., Ltd. | 2018-03-15 |