| Intact® Gen2 System (K152596) | Intact Medical Corporation | 2016-02-15 |
| Arthrex Synergy UHD4 System (K153218) | Arthrex, Inc. | 2016-02-12 |
| Single Use Injector NM600/610 (K153625) | Olympus Medical Systems Corp. | 2016-02-12 |
| X-Suit NIR Biliary Metallic Stent (K150487) | Medinol, Ltd. | 2016-02-12 |
| CapsoCam (SV-1) (K151635) | CapsoVision, Inc. | 2016-02-09 |
| ENDOFLOW II - Irrigation, Warming and Suction System (K152278) | Promepla Sam | 2016-02-09 |
| Nutrisafe 2- ENFit Adaptor (K151237) | Vygon | 2016-02-09 |
| Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set (K151308) | Schoelly Fiberoptic GmbH | 2016-02-09 |
| Actreen Mini Intermittent Urinary Catheters (K151772) | B.Braun Medical, Inc. | 2016-02-09 |
| EndoChoice Select Injection Needle (K151475) | Endochoice, Inc. | 2016-02-08 |
| Medline Anti-Fog Solution (K152948) | Medline Industries, Inc. | 2016-02-04 |
| Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic Instruments (K151036) | Carefusion 2200, Inc. | 2016-02-01 |
| Image1 SPIES System (K160044) | Karl Storz Endoscopy America, Inc. | 2016-02-01 |
| VersaOne Bladed Trocar 5mm (K152149) | Covidien | 2016-01-22 |
| General & Plastic Surgery Instruments (K152400) | Sontec Instruments, Inc. | 2016-01-22 |
| Grasping Forceps (K152802) | Micro-Tech (Nanjing) Co., Ltd. | 2016-01-21 |
| Firefly Peritoneal Dialysis Connector Disinfection System (K151620) | Puracath Medical, Inc. | 2016-01-20 |
| da Vinci Xi Surgical System (K151794) | Intuitive Surgical, Inc. | 2016-01-15 |
| EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V (K143153) | Olympus Medical Systems Corp. | 2016-01-15 |
| PillCam COLON 2 Capsule Endoscopy System (K153466) | Given Imaging , Ltd. | 2016-01-14 |
| core nova Complete Operating Room Endoscopy (K151282) | Richard Wolf Medical Instruments Corp. | 2016-01-12 |
| Universa Soft Ureteral Stents and Stent Sets (K151051) | Cook Incorporated | 2016-01-11 |
| Well Lead Ureteral Access Sheath (K151084) | Well Lead Medical Co., Ltd. | 2016-01-07 |
| K2M Fenestrated Tap System (K152872) | K2m | 2016-01-05 |
| Zenysis Short-Term Dialysis Catheter (K153190) | C.R. Bard, Inc. | 2016-01-05 |
| Cellvizio 100 Series System with Confocal Miniprobes (K150831) | Mauna Kea Technologies | 2015-12-22 |
| New Medax Biopsy Systems (K142125) | Medax Srl Unipersonale | 2015-12-22 |
| Imbibe Needle (K153306) | Orthovita, Inc. | 2015-12-18 |
| Asahi REXEED-S Series Dialyzer (K153344) | Asahi Kasei Medical Co., Ltd. | 2015-12-17 |
| NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip Caps (K152857) | Neomed, Inc. | 2015-12-17 |
| AquaShield system CO2, AquaShield system-PENTAX (K153362) | United States Endoscopy Group, Inc. | 2015-12-16 |
| 8X-10-XXXX Camera System (K152513) | Santa Barbara Imaging Systems | 2015-12-15 |
| Balloon controller PB-30 (K153483) | Fujifilm Medical Systems U.S.A, Inc. | 2015-12-15 |
| AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery System (K153088) | Boston Scientific Corporation | 2015-12-11 |
| Guide wire for Edi Catheter 6 Fr, Guide wire for Edi Catheter 8 Fr, 100 cm, Guide wire for Edi Catheter 8 Fr, 125 cm (K153461) | Maquet Critical Care AB | 2015-12-11 |
| Fuse Gastroscopy System (K152182) | Endochoice, Inc. | 2015-12-10 |
| 2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis Machine (K150708) | Fresenius Medical Care Renal Therapies Group, LLC | 2015-12-10 |
| Sterile Repositionable Hemostasis Clipping Device (K152001) | Micro-Tech (Nanjing) Co., Ltd. | 2015-12-10 |
| da Vinci Xi Hasson Cone (K153126) | Intuitive Surgical, Inc. | 2015-12-09 |
| HMB32 (K150966) | Haemopharm Biofluids S.R.L. | 2015-12-04 |
| Disposable Endoscope Valves Set A (K151714) | Wilson Instruments (Shanghai) Company Limited | 2015-12-03 |
| OES ELITE Telescopes, Protective Tube (K151191) | Olympus Winter & Ibe GmbH | 2015-11-24 |
| PENTAX Medical EPK-i7010 Video Processor with GI Family (K150618) | Pentax of America, Inc. | 2015-11-24 |
| SilverCoat Silicone Foley Catheter (K150550) | Covalontechnologies, Inc. | 2015-11-24 |
| Single Use Aspiration Needle NA-U200H (K151738) | Olympus Medical Systems Corp. | 2015-11-20 |
| RELIZORB (DEN150001) | Alcresta, Inc. | 2015-11-20 |
| WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary (K152853) | Boston Scientific Corp | 2015-11-20 |
| AUTOLAP SYSTEM (K152848) | M.S.T Medical Surgery Technologies, Ltd. | 2015-11-17 |
| LithoVue System (K153049) | Boston Scientific Corporation | 2015-11-13 |
| Eclipse System (K150558) | Pelvalon, Inc. | 2015-11-12 |
| Ablatherm Integrated Imaging (K153023) | Edap Technomed, Inc. | 2015-11-06 |
| ZeroWire Duo Wireless HD Video Transfer System G2 or ZeroWire G2 (K151609) | Nds Surgical Imaging, LLC | 2015-11-06 |
| Elation Wireguided Balloon Dilation Catheter (K151925) | Merit Medical Systems, Inc. | 2015-11-06 |
| CRIT-LINE CLIP (CLIC) BLOOD CHAMBER (K152953) | Fresenius Medical Care North America | 2015-11-05 |
| rescuenet (K152580) | Endochoice, Inc. | 2015-11-03 |
| FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine Solution (K152129) | Baxter Healthcare Corporation | 2015-10-29 |
| Optiflux dialyzer (K152367) | Fresenius Medical Care North America | 2015-10-29 |
| EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER ADAPTER AND LOCKING CAP FOR TITANIUM CATHETER ADAPTER (K152675) | Baxter Healthcare | 2015-10-29 |
| VS3-IR system (K152204) | Visionsense, Ltd. | 2015-10-28 |
| Express SD Biliary Monorail Premounted Stent System (K152607) | Boston Scientific | 2015-10-27 |
| Resection Electrodes (K152092) | Olympus Winter & Ibe GmbH | 2015-10-26 |
| Retrieval bag system (K151489) | Beacon Surgical, Inc. | 2015-10-26 |
| Cellvizio 100 Series System with Confocal Miniprobes (K151593) | Mauna Kea Technologies | 2015-10-23 |
| Avitus Bone Harvester (K152474) | Avitus Orthopaedics, Inc. | 2015-10-23 |
| Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle (K151895) | Boston Scientific Corporation | 2015-10-22 |
| AquaC UNO H (K143617) | Vivonic GmbH | 2015-10-19 |
| Disposable Multistage Dilation Balloon Catheter (K151671) | Micro-Tech (Nanjing) Co., Ltd. | 2015-10-16 |
| Bladeless Optical Obturators (K152663) | Intuitive Surgical, Inc. | 2015-10-16 |
| iSnare system-Lariat (K152035) | United States Endoscopy Group, Inc. | 2015-10-15 |
| HD-Camera HDC1000 (K152109) | W.O.M. World of Medicine GmbH | 2015-10-13 |
| Boa Endoscopic Valve (K152140) | C2 Therapeutics, Inc. | 2015-10-13 |
| Amia Automated PD System with Sharesource (K151525) | Deka Research and Development | 2015-10-09 |
| Auto Suture Locking Trocar (K152565) | Covidien | 2015-10-09 |
| Sonablate 450 (DEN150011) | Sonacare Medical, LLC | 2015-10-09 |
| Single Use Balloon Dilator V (with Knife) (K150142) | Olympus Medical Systems Corp. | 2015-10-08 |
| Salem Sump Dual Lumen Stomach Tube with Multi-functional Port (K150711) | Covidien | 2015-10-08 |
| AXIOS Stent and Delivery System (K152572) | Boston Scientific Corporation | 2015-10-06 |
| EPX-4440HD and EPX-4400HD with FICE (K150221) | Fujifilm Medical System U.S.A., Inc. | 2015-10-01 |
| Entuit Secure Gastrointestinal Suture Anchor Set, Entuit Secure Adjustable Gastrointestinal Suture Anchor Set (K152524) | Cook Incorporated | 2015-09-30 |
| Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, Exodus Believe Biliary Drainage Catheter (K152069) | Navilyst Medical, Inc. | 2015-09-24 |
| UPT Series Medical RO Water System (K151637) | Specialty Water Technologies | 2015-09-23 |
| Phoenix XL Dialysate Meter (K150657) | Mesa Laboratories, Inc. | 2015-09-21 |
| CoStorSol plus G (K151728) | Preservation Solutions, Inc. | 2015-09-18 |
| Radifocus Glidewire Endoscopic Wire (K151471) | Terumo Medical Corporation | 2015-09-17 |
| KSEA CMOS Camera System (C-cam) (K143640) | KARL STORZ Endoscopy-America, Inc. | 2015-09-17 |
| OTSC Proctology (K150067) | Ovesco Endoscopy AG | 2015-09-16 |
| AQUA CLEANSE (K150381) | Quality Medical Supply, Inc. | 2015-09-11 |
| Tissue Removal System (K151990) | Boehringer Laboratories, LLC | 2015-09-11 |
| 23ga Chandelier Illuminator, 25ga Chandelier Illuminator (K151604) | Peregrine Surgical , Ltd. | 2015-09-11 |
| VAPRO PLUS POCKET Intermittent Catheter (K152268) | Hollister Incorporated | 2015-09-09 |
| ab medica irrigation/suction gravity system (K151822) | Ab Medica Sas | 2015-09-04 |
| SIC 8000 (K150852) | Cosmo Technologies, Ltd. | 2015-09-03 |
| Peristeen Anal Irrigation System (K140310) | Coloplast A/S | 2015-09-03 |
| Rezum System (K150786) | Nxthera, Inc. | 2015-08-27 |
| BioGuard Air/Water Valve, BioGuard Suction Valve (K151345) | United States Endoscopy Group, Inc. | 2015-08-25 |
| STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit] (K151243) | Stryker Endoscopy | 2015-08-20 |
| Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T (K143556) | Fujifilm Medical Systems U.S.A, Inc. | 2015-08-20 |
| Laparoscope Lens Shield Device (K151117) | Medeon Biodesign, Inc. | 2015-08-20 |
| Sertera Biopsy Device (K150169) | Hologic, Inc. | 2015-08-14 |
| Arc Endocuff Vision (K151801) | Boddingtons Plastics, Ltd. | 2015-08-13 |