| PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope (Convex Array Type) with EPK-i5010 Video Processor and HI VISION Preirus Ultrasound Scanner (K162447) | Pentax of America, Inc. | 2017-04-13 |
| ZeroWire Mobile (K170598) | Nds Surgical Imaging, LLC | 2017-04-07 |
| Optiflux dialyzer (K162488) | Fresenius Medical Care North America | 2017-04-06 |
| Howell Biliary Aspiration Needle (K153763) | Wilson-Cook Medical, Inc. | 2017-04-06 |
| Zenysis Short-Term Dialysis Catheter (K163458) | C.R. Bard, Inc. | 2017-04-04 |
| Hach CM130 Chlorine Monitoring System (K162471) | Hach Company | 2017-03-30 |
| AngioDynamics Total Abscession Biliary Drainage Catheter (K170743) | AngioDynamics, Inc. | 2017-03-30 |
| Brevera Biopsy System with Corlumina Imaging Technology (K163052) | Hologic, Inc. | 2017-03-29 |
| Veloxion System (K162979) | Corinth Medtech, Inc. | 2017-03-24 |
| ENFit enteral syringe (K161979) | Jiangyin Caina Technology Co., Ltd. | 2017-03-22 |
| ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT (K161141) | Pentaferte Italia S.R.L. | 2017-03-22 |
| Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone Harvester - 5mm, Avitus Bone Harvester with Filter Insert - 8mm, Avitus Filter Insert - 8mm, Avitus Filter Insert - 5mm (K170539) | Avitus Orthopaedics, Inc. | 2017-03-20 |
| Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit Connector (K163586) | Trovrx, Inc. Dba Trovita Health Science | 2017-03-17 |
| Rapid Barostat Bag (RBB) Pump and Catheter (K160287) | Mui Scientific | 2017-03-14 |
| THD ANOPRESS (K161785) | Thd Spa | 2017-03-14 |
| FUJIFILM Surgical System (K162836) | Fujifilm New Development U.S.A., Inc. | 2017-03-13 |
| NOVATECH TALCAIR (K170030) | Novatech SA | 2017-03-13 |
| AdvanCE capsule endoscope delivery device (K163495) | United States Endoscopy Group, Inc. | 2017-03-10 |
| InterLock Trocar (K170084) | Fujifilm New Development U.S.A., Inc. | 2017-03-10 |
| EndoWrist Stapler 45 Instrument, EndoWrist Stapler 45 Reloads, EndoWrist Stapler 30 Instrument, EndoWrist Stapler 30 Reloads (K170508) | Intuitive Surgical, Inc. | 2017-03-10 |
| VersaOne fascial closure system bladed trocar, VersaOne fascial closure system bladeless trocar, VersaOne fascial closure system optical trocar (K163654) | Covidien, LLC | 2017-03-08 |
| Flexi-Seal PROTECT Fecal Management System (K162906) | Convatec | 2017-03-07 |
| Edi Catheter ENFit (K153688) | Maquet Critical Care AB | 2017-03-02 |
| Vesair Cystoscopic Sheath (K162356) | Solace Therapeutics | 2017-03-02 |
| EndoPur Filter (K161304) | Nephros, Inc. | 2017-03-02 |
| Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle Set (K170008) | Cook Incorporated | 2017-02-28 |
| Rusch Simplastic Foley Catheters (K162989) | Teleflexmedical, Inc. | 2017-02-24 |
| AXIOS Stent and Electrocautery Enhanced Delivery System (K163272) | Boston Scientific Corporation | 2017-02-18 |
| Laparoscope Lens Shield Device (LENS) (K170103) | Medeon Biodesign, Inc. | 2017-02-16 |
| Medela Low Dose Enteral Syringe (K161811) | Medela, Inc. | 2017-02-15 |
| Low Profile Balloon Feeding Device (K161413) | Applied Medical Technology, Inc. | 2017-02-09 |
| FB-U Hemodialyzer (K160444) | Nipro Medical Corporation | 2017-02-08 |
| Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent (K163169) | Cook Ireland, Ltd. | 2017-02-07 |
| EndoWrist Suction Irrigator (K162973) | Intuitive Surgical, Inc. | 2017-02-06 |
| Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle (K163058) | Boston Scientific | 2017-01-30 |
| Universa Firm Ureteral Stents and Stent Sets (K161236) | Cook Incorporated | 2017-01-27 |
| KARL STORZ ICG Imaging System (K162882) | KARL STORZ Endoscopy-America, Inc. | 2017-01-26 |
| Onli Intermittent Catheter (K163179) | Hollister Incorporated | 2017-01-26 |
| Reliant Multistage Dilatation Balloon Catheter (K162226) | Micro-Tech (Nanjing) Co., Ltd. | 2017-01-25 |
| OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM (K163069) | Olympus Medical Systems Corp. | 2017-01-19 |
| da Vinci Xi Surgical System (K161178) | Intuitive Surgical, Inc. | 2017-01-19 |
| EndoClot (K162197) | Endoclot Plus Co., Ltd. | 2017-01-18 |
| ENDOCAM Flex HD Camera System 5521 (K161204) | Richard Wolf Medical Instruments Corporation | 2017-01-11 |
| SPY Phi Open Field Handheld Fluorescence Imaging System (K162885) | Novadaq Technologies, Inc. | 2017-01-11 |
| U-IGNITE Bladeless Trocar (K162387) | Tianjin Uwell Medical Device Manufacturing Co., Ltd. | 2017-01-11 |
| Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex balloon - Olympus Linear; Oracle EUS latex balloon - Fujinon Radial; Oracle EUS latex balloon - Fujinon Linear (K163492) | United States Endoscopy Group, Inc. | 2017-01-06 |
| Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray (K161504) | Cook Incorporated | 2017-01-06 |
| PrismaSATE (K162887) | Baxter Healthcare Corporation | 2017-01-06 |
| SureClip(TM) Repositionable Hemostasis Clip (K161463) | Micro-Tech (Nanjing) Co., Ltd. | 2017-01-06 |
| AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON (K163424) | United State Endoscopy Group, Inc. | 2017-01-04 |
| Zilver 635 Biliary Stent (K163018) | Cook Ireland, Ltd. | 2016-12-23 |
| HydraGuard 10 UltraFilter (K161467) | Nephros, Inc. | 2016-12-22 |
| pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent (K163068) | Q Urological Corporation | 2016-12-22 |
| Scope Buddy Plus Endoscope Flushing Aid (K162128) | Medivators, Inc. | 2016-12-21 |
| Sonablate (K160942) | Sonacare Medical, LLC | 2016-12-21 |
| HPM-6000U (K162010) | BTL Industries, Inc. | 2016-12-13 |
| Matrix Pre-Treatment Controller (K161844) | Better Water, LLC | 2016-12-13 |
| Arc EndoCuff and Arc EndoCuff Vision (K162205) | Boddingtons Plastics, Ltd. | 2016-12-09 |
| DiLumen Endolumenal Interventional Platform (K162428) | Lumendi, LLC | 2016-12-06 |
| ReliaCatch Specimen Retrieval Bag 10mm; ReliaCatch Specimen Retrieval Bag 12mm (K163102) | Covidien | 2016-11-30 |
| TubeClear Control Box and Clearing Stem (K163092) | Actuated Medical, Inc. | 2016-11-30 |
| Medline ENFit Syringe (K160642) | Medline Industries, Inc. | 2016-11-29 |
| Well Lead Extraction Bag (K160801) | Well Lead Medical Co., Ltd. | 2016-11-29 |
| U&U Enteral Syringe (K160855) | U&U Medical Technology Co, Ltd. | 2016-11-22 |
| ConvertX Nephroureteral Stent System (K161277) | Brightwater Medical | 2016-11-22 |
| Disposal Lens Cleaning Sheath (K153773) | Olympus Medical Systems Corp. | 2016-11-22 |
| RAPIDO HOLLOW-FIBRE DIALYZERS (K160558) | Bellco Srl | 2016-11-18 |
| Tablo Console (K160881) | Outset Medical, Inc. | 2016-11-15 |
| Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit (K162457) | Rocket Medical Plc | 2016-11-14 |
| PleurX Peritoneal Catheter System (K160437) | Care Fusion | 2016-11-03 |
| SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer Needles (K160316) | M.D.L. S.R.L. | 2016-10-27 |
| Standard Clamp (K161720) | Standard Bariatrics | 2016-10-24 |
| CapsoCam Plus (SV-3) Capsule Endoscope System (K161773) | CapsoVision, Inc. | 2016-10-21 |
| NOSOGARD FILTERS (K153784) | Evoqua Water Technologies, LLC | 2016-10-21 |
| Rockwell Medical CitraPure Acid Concetrate (K160847) | Rockwell Medical | 2016-10-20 |
| LiVac Retractor System (K162445) | Livac Pty, Ltd. | 2016-10-20 |
| Fujifilm Endoscope Models EC-600HL and EC-600LS (K162622) | Fujifilm Medical Systems U.S.A, Inc. | 2016-10-18 |
| VersaOne Bladeless Trocar (K162584) | Covidien | 2016-10-18 |
| ClearPetra Suction-Evacuation Sheath (K161110) | Well Lead Medical Co., Ltd. | 2016-10-12 |
| FTRD System Set (K153550) | Ovesco Endoscopy AG | 2016-10-12 |
| Express SD Biliary Monorail Premounted Stent System (K162404) | Boston Scientific Corporation | 2016-10-12 |
| SpeediCath Flex Coude (K161672) | Coloplast Corp. | 2016-09-29 |
| Nexcore GI Insufflator (K162332) | Nexcore Technology, LLC | 2016-09-29 |
| EZEE RETRIEVAL (K162059) | Genicon, Inc. | 2016-09-29 |
| Sensor Monitored Alimentary Restriction Therapy (SMART) Device (DEN150033) | Scientific Intake | 2016-09-26 |
| Xenocor Xenoscope Laparoscopic System (K161838) | Xenocor, Inc. | 2016-09-26 |
| Pure Vu (K160015) | Motus GI Medical Technologies , Ltd. | 2016-09-22 |
| Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml) (K162188) | Vr Medical Technology | 2016-09-22 |
| UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge (K162345) | Neotract, Inc. | 2016-09-21 |
| da Vinci Xi 12 – 8 mm Reducer (K162411) | Intuitive Surgical, Inc. | 2016-09-21 |
| PINPOINT Endoscopic Fluorescence Imaging System (K161792) | Novadaq Technologies, Inc. | 2016-09-20 |
| GentleCath Glide Intermittent Catheter (K161344) | Convatec Limited | 2016-09-20 |
| CORGRIP NG/NI Tube Retention System (K162110) | Corpak Medsystems, Inc. A Division of Haylard Health | 2016-09-15 |
| AbClose - Port Site Closure Device (K160117) | Medeon Biodesign, Inc. | 2016-09-09 |
| Pelican Sling Retractor (K153542) | Beacon Surgical, Inc. | 2016-09-07 |
| Perineologic Access Needle (K160423) | Corbin Clinical Resources, LLC | 2016-09-02 |
| Monoject Enteral Syringe with ENFit Connector (K161963) | Covidien | 2016-09-01 |
| Erbe’s CO2 Tubing/Cap Sets (K162152) | Erbe USA, Inc. | 2016-08-31 |
| Miret Grasper, Alligator, Miret Grasper, Maryland (K160149) | Miret Surgical, Inc. | 2016-08-30 |
| UreTron PF Series Probe (K162119) | Med-Sonics Corp. | 2016-08-29 |