| Olympus Small Intestinal Capsule Endoscope System (K173459) | Olympus Medical Systems Corp. | 2018-03-13 |
| RocaJJ Soft Stents (K173734) | Promepla Sam | 2018-03-12 |
| Corvocet Biopsy System (K180450) | Merit Medical Systems, Inc. | 2018-03-12 |
| VORTEK URETERAL DOUBLE LOOP STENT (K180057) | Coloplast Corp. | 2018-03-09 |
| Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing Catheter and Guiding Catheter, Johlin Pancreatic Wedge Stent and Introducer Set (K172057) | Cook Ireland, Ltd. | 2018-03-09 |
| PillCam Patency System (K180171) | Given Imaging , Ltd. | 2018-03-08 |
| Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter (K180086) | Gyrus Acmi, Inc. | 2018-03-08 |
| THD Anopress with THD SensyProbe (K180135) | Thd Spa | 2018-03-08 |
| Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter (K171810) | Cook Incorporated | 2018-03-07 |
| ALVUE Balloon Dilation System (K171939) | Globus Medical, Inc. | 2018-03-07 |
| Rotatable Snares, Non-Rotatable Snares (K172758) | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2018-03-07 |
| Citric Complete Dry Citric Acid (45X) (K171750) | Dimesol USA, LLC | 2018-03-06 |
| Cytology Brush (K172663) | Micro-Tech (Nanjing) Co., Ltd. | 2018-03-05 |
| FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM Water Tank Model WT-603 (K172916) | Fujifilm Corporation | 2018-03-01 |
| Nathanson Transcystic Bile Duct Stone Exploration Pack (K171915) | Cook Incorporated | 2018-03-01 |
| Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex Biliary Stent, Soehendra Tannenbaum Biliary Stent, Zimmon Biliary Stent, Guiding Catheter, Pushing catheter, Fusion pushing catheter, Stent Introducer Set, Fusion Oasis One Action Sent Introduction System, Zimmon Biliary Stent Set, Oasis One Action Stent Introduction System, Solus Double Pigtail Stent and Introduction System, Cotton-Huibregtse Biliary Stent Set, Cotton-Leung Biliary Stent Set, Oasis One Action S (K172044) | Cook Ireland, Ltd. | 2018-02-27 |
| Rezum System (K180237) | Nxthera, Inc. | 2018-02-27 |
| Stryker iVAS 13g Bone Biopsy Kit (K180327) | Stryker Corporation | 2018-02-26 |
| OpClear System (K171637) | Cipher Surgical, Ltd. | 2018-02-26 |
| Prismaflex System 8.10 (K171671) | Baxter Healthcare Corporation | 2018-02-23 |
| Medline Catheter Specimen Collector (K172541) | Medline Industries, Inc. | 2018-02-22 |
| Aesculap Video Assisted Thoracic Surgery (VATS) INstruments (K170683) | Aesculap, Inc. | 2018-02-20 |
| Renal Access Cobra Catheter, Kumpe Access Catheter (K171600) | Cook Incorporated | 2018-02-16 |
| Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set (K173651) | Fresenius Medical Care Renal Therapies Group, LLC | 2018-02-14 |
| MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle (K172775) | Teleflexmedical, Inc. | 2018-02-12 |
| ORISE Tissue Retractor System (K173400) | Boston Scientific | 2018-02-09 |
| Kohli Urinary Drainage Catheter (K172422) | Nellie Medical, LLC | 2018-02-09 |
| Ergonomic Handle (K173272) | Symmetry Surgical, Inc. | 2018-02-09 |
| NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (23cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (27cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (31cm),NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (35cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (55cm) (K173805) | Marvao Medical Devices, Ltd. | 2018-02-08 |
| PENTAX MEDICAL ED-3490TK, Video Duodenoscope (K161222) | Pentax Medical | 2018-02-07 |
| Trans-anal Introducer (K171208) | Visionsense, Ltd. | 2018-02-05 |
| SpeediCath Flex Coude Pro (K180070) | Coloplast | 2018-02-02 |
| Specimen Retrieval Bag (K172789) | Beijing Hangtian Kadi Technology R&D Institute | 2018-02-01 |
| Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-End Ureteral Catheter, Open-End Flexi-Tip Ureteral Catheter, Flexi-Tip Ureteral Catheter (Closed End), Whistle Tip Ureteral Catheter, Round Tip Ureteral Catheter, Spiral Tip Ureteral Access Catheter, Pediatric Ureteral Catheter (K171662) | Cook Incorporated | 2018-02-01 |
| da Vinci Xi Surgical System; da Vinci X Surgical System (K172643) | Intuitive Surgical, Inc. | 2018-01-31 |
| MiroCam Capsule Endoscope System (K170438) | Intromedic Co., Ltd. | 2018-01-30 |
| Uro-V Cystoscope (K171500) | Uroviu Corporation | 2018-01-30 |
| Rusch Intermittent Urethral Catheters (K173596) | Teleflex Medical | 2018-01-29 |
| Mic-Key* SF Over-the-Wire Stoma Measuring Device (K173955) | Halyard Health, Inc. | 2018-01-26 |
| Cycler Drain Bag Set (K173363) | Fresenius Medical Care Renal Therapies Group, LLC | 2018-01-24 |
| Focus Cap (K171673) | Gce Medical Corporation | 2018-01-19 |
| Stryker AIM Light Source and SafeLight cable (K173866) | Stryker | 2018-01-18 |
| BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap (K172575) | Baronova, Inc. | 2018-01-18 |
| Pelvifine Pelvic Muscle Trainer (K163288) | Shenzhen Konmed Technology Co., Ltd. | 2018-01-18 |
| Barrx SB RFA Endoscopic Catheter (K173559) | Covidien, LLC | 2018-01-18 |
| FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M (K171207) | Fujifilm Medical Systems U.S.A, Inc. | 2018-01-11 |
| Swiss LithoClast Trilogy (K173234) | E.M.S Electro Medical Systems S.A | 2018-01-10 |
| invendoscopy E210 System (K173085) | Invendo Medical GmbH | 2018-01-08 |
| AquaShield System CO2- Fujifilm (K173650) | United States Endoscopy Group, Inc. | 2018-01-05 |
| EON Portable Reverse Osmosis Water Purification System (K171099) | Cantel | 2018-01-05 |
| Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush (K171573) | Wilson-Cook Medical, Inc. | 2017-12-29 |
| UroLift System (UL400 and UL500) (K173087) | Neotract, Inc. | 2017-12-28 |
| Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters (K171043) | Coloplast Corp. | 2017-12-21 |
| Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree Long Cystoscope,Vesair 30 degree Cystoscope,Vesair 70 degree Cystoscope (K170862) | Solace Therapeutics, Inc. | 2017-12-19 |
| Advantage Plus Pass-Thru (K172677) | Medivators, Inc. | 2017-12-19 |
| Cellvizio 100 Series System with Confocal Miniprobes (K172844) | Mauna Kea Technologies | 2017-12-15 |
| Strange Bile Duct Stone Exploration Set (K173687) | Cook Incorporated | 2017-12-15 |
| CAREline Airless Hemodialysis Blood Tubing Sets (K172238) | Fresenius Medical Care Renal Therapies Group, LLC | 2017-12-14 |
| SAM CRRT Unit, SAM Cassette CRRT (K170790) | Spectral Medical, Inc. | 2017-12-13 |
| Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access Sheath (K172217) | Cook Incorporated | 2017-12-13 |
| Wittich Nitinol Stone Basket (K170898) | Cook Incorporated | 2017-12-12 |
| Sterile Endoscope Biopsy Sampling Needle (K171956) | Changzhou Detain Medical Devices Co., Ltd. | 2017-12-12 |
| Pure-Vu System (K173392) | Motus GI Medical Technologies , Ltd. | 2017-12-12 |
| Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0° WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto-Urethroscope Sheath (K171336) | Henke-Sass, Wolf GmbH | 2017-12-07 |
| Single Use Electrosurgical Snare SD-400 (K172734) | Olympus Medical Systems Corp. | 2017-12-07 |
| Equipment Pouch (K172578) | Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd | 2017-12-07 |
| SYSTEMS INTEGRATION ENDOALPHA MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-4 Software Version 1 (K172618) | Olympus Medical Systems Corp. | 2017-12-05 |
| CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor (K172666) | Sutureease, Inc. | 2017-12-01 |
| NexSite HD, Hemodialysis Step Tip Catheter (60cm) (K171571) | Marvao Medical Devices, Ltd. | 2017-11-30 |
| Suction Irrigation Set (K172794) | Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd | 2017-11-29 |
| Single Use Retrieval Nitinol Basket V (K170811) | Olympus Medical Systems Corp. | 2017-11-27 |
| EsoFLIP® ES-310 Balloon Catheter (K172128) | Crospon, Ltd. | 2017-11-22 |
| Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent (K172278) | Cook Incorporated | 2017-11-22 |
| GentleCath Intermittent Urinary Catheter (K172924) | Convatec Limited | 2017-11-21 |
| Single Use Electrosurgical knife (K171158) | Olympus Medical Systems Corp. | 2017-11-17 |
| Gastric Sizing Balloon Catheter (K173355) | Cook Incorporated | 2017-11-17 |
| Symetrex Long Term Hemodialysis Catheter (K171618) | Medcomp (Dba Medical Components, Inc.) | 2017-11-16 |
| VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTS (K170362) | Coloplast Corp. | 2017-11-15 |
| OverStitch SX Endoscopic Suturing System (ESS) (K171886) | Apollo Endosurgery, Inc. | 2017-11-15 |
| Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK) (K172344) | Medax Srl Unipersonale | 2017-11-13 |
| NCompass Nitinol Stone Extractors (K173009) | Cook Incorporated | 2017-11-07 |
| BIOSOFT DUO DOUBLE LOOP URETERAL STENTS (K170422) | Coloplast Corp. | 2017-11-02 |
| BD Curve Ascites Shunt (K170405) | Care Fusion | 2017-11-02 |
| Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle (K173184) | Boston Scientific | 2017-10-27 |
| Trocar (K172038) | Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd | 2017-10-27 |
| Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC free bags (K170150) | S.A.L.F. Spa | 2017-10-20 |
| DASH 3 ENFit Syringe, DASH 3 Eccentric ENFit Syringe, DASH 3 Plus ENFit Syringe, DASH 3 Plus Eccentric ENFit Syringe, DASH 3 ENFit Low Dose Tip Syringe (K170371) | Intervene Group Limited | 2017-10-20 |
| EsophyX Z, EsophyX2 HD (K172811) | Endogastric Solutions, Inc. | 2017-10-19 |
| ANCHOR Tissue Retrieval System (K172940) | Conmed Corporation | 2017-10-18 |
| 4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB, 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EA (K172817) | Olympus Medical Systems Corp. | 2017-10-17 |
| Single Use Hot Biopsy Forceps FD-231 (K171916) | Olympus Medical Systems Corp. | 2017-10-13 |
| Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation Catheter (K171548) | Wilson-Cook Medical, Inc. | 2017-10-13 |
| Citryte (K171015) | Di-Chem, Inc. | 2017-10-13 |
| Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter) (K170233) | Zhanjiang Star Enterprise Co., Ltd. | 2017-10-13 |
| Senhance Surgical Robotic System (K171120) | Transenterix, Inc. | 2017-10-13 |
| Stomach Tube (K162340) | Well Lead Medical Co., Ltd. | 2017-10-11 |
| Low Profile Non-Balloon Feeding Device (K170319) | Applied Medical Technology, Inc. | 2017-10-06 |
| Tamper Evident Cap For use with ENFit Syringes (K170672) | International Medical Industries, Inc. | 2017-10-06 |
| Endoscopic Applicator, 41 cm (K172672) | Micromedics, Inc. (D/B/A Nordson Medical) | 2017-10-06 |
| Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar Sleeves (K172097) | Renovo, Inc. | 2017-10-06 |