| FMX314 Surgical Platform (K160797) | Fortimedix Surgical B.V. | 2016-08-26 |
| invendoscopy E200 System (K161355) | Invendo Medical GmbH | 2016-08-25 |
| Ambu USR, Ambu M (K160766) | Ambu A/S | 2016-08-17 |
| PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro C (K161445) | Adapta Medical, Inc. | 2016-08-16 |
| Aer-O-Scope Colonoscope System (K161791) | Gi View , Ltd. | 2016-08-11 |
| Laparoscopic Spray Applicator with Spinning Luers (K162077) | Micromedics, Inc. (D/B/A Nordson Medical) | 2016-08-11 |
| Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10 (K152834) | Colonplus Equipments & Speculums, S.L. | 2016-08-10 |
| Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preassembled with Stylet (K160787) | Syncro Medical Innovations, Inc. | 2016-08-09 |
| NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 cm, 36 cm, 40 cm, 55 cm) (K161026) | Marvao Medical Devices, Ltd. | 2016-08-09 |
| Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe, Mammotome elite Biopsy System-Holster, Mammotome elite Biopsy System-13G Introducer Stylet, Mammotome elite Biopsy System-10G Introducer Stylet (K153709) | Devicor Medical Products, Inc. | 2016-08-08 |
| da Vinci Xi Surgical System (K153276) | Intuitive Surgical, Inc. | 2016-08-07 |
| MED-TECH Water Systems Inc Exchangeable Carbon Tanks for Dialysis (K153329) | Med-Tech Water Systems, Inc. | 2016-08-04 |
| CASSI II Rotational Core Biopsy System (K161234) | Scion Medical Technologies, LLC | 2016-08-03 |
| M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem (K161409) | Mermaid Medical A/S | 2016-08-02 |
| Fuse Endoscopic System with FuseBox Processor (K160275) | Endochoice, Inc. | 2016-08-01 |
| IDSS ForceTriad Control Module (K153205) | Black Diamond Video, Inc. | 2016-08-01 |
| EVOTECH ECR (K152189) | Advanced Sterilization Products (Asp) | 2016-07-20 |
| EnCor MRI Introducer Set, EnCor Probe Introducer (K161805) | Senorx, Inc. | 2016-07-19 |
| AmplifEYE (K160846) | Medivators, Inc. | 2016-07-14 |
| Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji – 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15 (K161055) | Fuji Dynamics , Ltd. | 2016-07-12 |
| da Vinci Xi Surgical System (K161271) | Intuitive Surgical, Inc. | 2016-07-11 |
| Relizorb (K161247) | Alcresta Therapeutics, Inc. | 2016-06-30 |
| Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter) (K161186) | Fujifilm Medical Systems U.S.A, Inc. | 2016-06-29 |
| Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode (K151976) | Omnitech Systems, Inc. | 2016-06-27 |
| EndoChoice Water Bottle Cap Irrigation System (K161482) | Endochoice, Inc. | 2016-06-27 |
| Single Use Surgical Suction Irrigator (K161421) | Jiangsu Haize Medical Scientific Development Co., Ltd. | 2016-06-24 |
| Ultrathane Endoureterotomy Stent Set (K160891) | Cook Incorporated | 2016-06-24 |
| Aquarius Stoma Measuring Device (K152246) | Degania Silicone , Ltd. | 2016-06-21 |
| Lehman Manometry Catheter (K160170) | Wilson-Cook Medical, Inc. | 2016-06-20 |
| Monoject (K161045) | Covidien | 2016-06-17 |
| EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, EndoVive Button Right Angle Feeding Set with ENFit Connector, EndoVive Button Bolus Feeding Set with ENFit Connector, EndoVive Button Decompression Tube with ENFit Connector (K161003) | Boston Scientific Corporation | 2016-06-17 |
| NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL) (K161039) | Neomed, Inc. | 2016-06-17 |
| SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long (K152771) | Sumitomo Bakelite Co., Ltd. | 2016-06-17 |
| United Urologics Intermittent Catheter (K160795) | Robling Medical | 2016-06-16 |
| Disposable Hot Biopsy Forceps (K160625) | Micro-Tech (Nanjing) Co., Ltd. | 2016-06-14 |
| Pall-Aquasafe Water Filter (K153434) | Pall International Sarl | 2016-06-10 |
| Sony IP Converter NU-IP40S (K161122) | Sony Electronics, Inc. | 2016-06-08 |
| EndoCure Model EUR078A (K161147) | Endocure Technologies, Inc. | 2016-06-07 |
| WallFlex Biliary RX Fully Covered Stent System RMV (DEN150040) | Boston Scientific | 2016-06-03 |
| LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head, Camera Coupler, Tablet Application (K153606) | Smith & Nephew | 2016-06-02 |
| KARL STORZ Endoscopic ICG Imaging System (K152583) | KARL STORZ Endoscopy-America, Inc. | 2016-05-31 |
| Radiance Ultra Series ZeroWire Embedded (K161228) | Nds Surgical Imaging, LLC | 2016-05-26 |
| AdTec (K160393) | Aesculap, Inc. | 2016-05-26 |
| Seal Single-Use Biopsy Valve (K161167) | Endochoice, Inc. | 2016-05-26 |
| PINPOINT Endoscopic Fluorescence Imaging System (K150956) | Novadaq Technologies, Inc. | 2016-05-23 |
| CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes (K160416) | Mauna Kea Technologies | 2016-05-20 |
| United Urologics Closed System Catheter (K160877) | Robling Medical, Inc. | 2016-05-20 |
| SmartStart Air/Water and Suction Valves (K160403) | Endochoice, Inc. | 2016-05-19 |
| EasyPass Guidewire (K153264) | Medi-Globe Corporation | 2016-05-19 |
| Stryker SDC3 HD Information Management System with Wireless Device Control Capability (K160332) | Stryker Endoscopy | 2016-05-18 |
| Third Eye Panoramic Auxiliary Endoscopy System - Resposable (K160356) | Avantis Medical Systems, Inc. | 2016-05-17 |
| Monoject Enteral Feeding Syringe with ENFit Connector (K160419) | Covidien | 2016-05-12 |
| True HD 3MOS Camera System (K161017) | Conmed Corporation | 2016-05-09 |
| Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management Kit (K153506) | Consure Medical Pvt , Ltd. | 2016-05-06 |
| Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology (K160740) | Surgical Instrument Service and Savings, Inc. | 2016-05-06 |
| Soehendra Stent Retriever (K161203) | Wilson-Cook Medical, Inc. | 2016-05-04 |
| Yarlap II (K160773) | International Trade Group, Inc. | 2016-05-04 |
| GastriSail Gastric Positioning System 40 Fr/CH (13.3mm) (K160654) | Covidien, LLC | 2016-05-04 |
| Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device (K160845) | Boston Scientific Corporation | 2016-05-03 |
| EndoFLIP (K160725) | Crospon, Ltd. | 2016-05-01 |
| EsophyX® Z Device with SerosaFuse Fasteners and Accessories (K160960) | Endogastric Solutions, Inc. | 2016-05-01 |
| da Vinci Xi Surgical System (K152892) | Intuitive Surgical | 2016-04-29 |
| Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible) (K152619) | Prosurg, Inc. | 2016-04-29 |
| ManoScan System (K151086) | Given Imaging , Ltd. | 2016-04-28 |
| 2008K2 Hemodialysis Machine (K153449) | Fresenius Medical Care Renal Therapies Group, LLC | 2016-04-26 |
| CompactCath Intermittent Urinary Catheter (K160858) | Compactcath, Inc. | 2016-04-26 |
| Laparoscope Lens Shield Device (K160172) | Medeon Biodesign, Inc. | 2016-04-21 |
| LumenR Tissue Retractor System (K153698) | Lumenr, LLC | 2016-04-19 |
| Accuryn Monitoring System (K153655) | Potrero Medical, Inc. | 2016-04-15 |
| CRIT-LINE III Blood Chamber II (K160749) | Fresenius Medical Care Renal Therapies Group, LLC | 2016-04-15 |
| Nephros S100 (K153084) | Nephros, Inc. | 2016-04-08 |
| NUTRICARE-ISOSAF NASO-GASTRIC FEEDING TUBE (K151503) | Gbuk Enteral Limited | 2016-04-05 |
| Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars (K153258) | Surgical Instrument Service and Savings (Dba Medline Renewal | 2016-04-05 |
| Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis Catheter (K151967) | Merit Medical Systems, Inc. | 2016-04-04 |
| NOVATECH TALCAIR (K151832) | Novatech SA | 2016-03-31 |
| Proxis Ureteral Access Sheath (K160861) | C.R. Bard, Inc. | 2016-03-31 |
| da Vinci Surgical System, Model IS4000 (K152578) | Intuitive Surgical, Inc. | 2016-03-30 |
| Rotatable Snares (K160637) | Boston Scientific Corporation | 2016-03-30 |
| Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set (K152105) | Rocket Medical Plc | 2016-03-29 |
| Corvocet Biopsy System (K153337) | Merit Medical Systems, Inc. | 2016-03-25 |
| Single Use Aspiration Needle NA-U401SX (K160098) | Olympus Medical Systems Corp. | 2016-03-22 |
| Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle (K160229) | Cook Ireland, Ltd. | 2016-03-21 |
| DBB-06 Hemodialysis Delivery System (K152938) | NIKKISO CO., LTD. | 2016-03-18 |
| Rezum System (K160417) | Nxthera, Inc. | 2016-03-17 |
| Endo Keeper (K152598) | Nelis | 2016-03-17 |
| NeoTract UroLift System UL500 (K153584) | Neotract, Inc. | 2016-03-15 |
| da Vinci Single-Site Instrument and Accessories (K152448) | Intuitive Surgical, Inc. | 2016-03-09 |
| IS4000 Stapler 30 Instrument and Stapler 30 Reloads (K152421) | Intuitive Surgical, Inc. | 2016-03-04 |
| Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1 (K153206) | Fujifilm Medical System U.S.A., Inc. | 2016-03-03 |
| FULL CARE Disposable PVC Nelaton Catheter (K151745) | Shaoxing Fuqing Health Products Co., Ltd. | 2016-03-03 |
| Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215 (K160241) | Olympus Medical Systems Corp. | 2016-03-02 |
| VersaOne Optical Trocar 15mm, VersaOne Bladeless Trocar 15mm (K160230) | Covidien | 2016-03-01 |
| xevonta dialyzer (K143482) | B. Braun Avitum AG | 2016-03-01 |
| Mammotome revolve Dual Vacuum Assist Biopsy System (K152989) | Devicor Medical Products, Inc. | 2016-02-25 |
| EndoChoice Water Bottle Cap System (K153588) | Endochoice, Inc. | 2016-02-24 |
| Oxyless Blood Tubing Set (K150304) | Oxyless, Ltd. | 2016-02-24 |
| Fujifilm Video Colonoscope Model EC-600WL V2 (K160196) | Fujifilm Medical Systems U.S.A, Inc. | 2016-02-23 |
| UreTron MultiProbe Lithotripter System (K160198) | Med-Sonics Corp. | 2016-02-23 |
| Low Potassium Dextran Solution with Tris Diluent (K153384) | United Therapeutics Corporation | 2016-02-19 |
| Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter) (K151474) | Fujifilm Medical System U.S.A., Inc. | 2016-02-18 |