| VaPro Pocket (K143594) | Hollister Incorporated | 2015-01-09 |
| EnteraLite Infinity Enteral Pump Delivery Set, 1200 mL Enteral Feeding Delivery Set (K142539) | Zevex, Inc. | 2015-01-08 |
| BI-FUNNEL GASTROSTOMY FEEDING TUBE, TRI-FUNNEL GASTROSTOMY FEEDING TUBE (K142075) | Xeridiem (Formerly Mri) | 2015-01-08 |
| Endo Vive 3S Low Profile Balloon Kit, Endo Vive 3S Bolus Extension Sets, Endo Vive 3S Continuous Extension Sets, Endo Vive 3S Medication Extension Set (K142297) | Xeridiem (Formerly Mri) | 2015-01-08 |
| AQUARIUS Gastrostomy Replacement Tube (K143378) | Degania Silicone , Ltd. | 2014-12-29 |
| JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4) (K142564) | JMS North America Corporation | 2014-12-23 |
| TISSUE CONTAINMENT SYSTEM; 10, 14, 17, 25 (K142427) | Applied Medical Resources | 2014-12-23 |
| EVOTECH ECR (K140977) | Advanced Sterilization Products | 2014-12-22 |
| TurboSEAL Nasogastric Aspiration Tube (K142483) | Turboseal, L.P. | 2014-12-19 |
| Echotip Procore HD Ultrasound Biopsy Needle (K142688) | Cook Ireland, Ltd. | 2014-12-19 |
| CytoSure Urinary Access System (K142194) | Emmy Medical | 2014-12-19 |
| NXSTAGE SYSTEM ONE (K141752) | Nxstage Medical, Inc. | 2014-12-19 |
| Endo Quickconnect Olympus Scope Port Connector, Endo Quickconnect Pentax Scope Port Connector (K143186) | Erbe USA, Inc. | 2014-12-18 |
| GIVEN PILLCAM UGI CAPSULE ENDOSCOPY SYSTEM (K140284) | Given Imaging , Ltd. | 2014-12-17 |
| The OnControl Bone Marrow Biopsy System by Vidacare (K142377) | Vidacare, LLC | 2014-12-17 |
| WELL LEAD HYDROPHILIC SILICONE FOLEY CATHETER (K140667) | Well Lead Medical Co., Ltd. | 2014-12-15 |
| ADVANCE SALIVARY BALLOON CATHETER WITH WIRE GUIDE (K140593) | Cook, Inc. | 2014-12-15 |
| Intact Advance and Intact Excision XL, Intact BLES (K142477) | Intact Medical Corporation | 2014-12-15 |
| AMERIWATER OZONE DISINFECTION SYSTEM (K141213) | Ameriwater | 2014-12-10 |
| 12 mm Endoscopes and Accessories (K142683) | Intuitive Surgical, Inc. | 2014-12-10 |
| Bluntport Blunt Trocar with Threaded Anchor 5mm-12mm (K142547) | Covidien | 2014-12-09 |
| Schoelly Laparoscope (K143221) | Schoelly Fiberoptic GmbH | 2014-12-05 |
| 12 mm & Stapler Bladeless Obturators (K143217) | Intuitive Surgical, Inc. | 2014-12-03 |
| Stryker Infrared Fluorescence (IRF) Imaging System (K142310) | Stryker Endoscopy | 2014-12-02 |
| AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V, 60hz, Ameriwater Heatsan, 3-phase, 575v, 60hz (K142285) | Ameriwater | 2014-12-01 |
| Resolution Clip (K142973) | Boston Scientific Corporation | 2014-12-01 |
| APEX (K141158) | Incontrol Medical, LLC | 2014-11-26 |
| RESOLVE BILIARY LOCKING DRAINAGE CATHETER (K141408) | Merit Medical Systems, Inc. | 2014-11-26 |
| Surgisleeve Wound Protector (K143091) | Covidien, LLC | 2014-11-26 |
| SYMETREX LONG TERM HEMODIALYSIS CATHETER (K140884) | Phase One Medical | 2014-11-26 |
| Sherpa Pak Cardiac Transport System (K143074) | Paragonix Technologies, Inc. | 2014-11-25 |
| Sherpa Pak Kidney Transport System (K143054) | Paragonix Technologies, Inc. | 2014-11-25 |
| FARRELL VALVE SYSTEM WITH EQUILIBRIUM TECHNOLOGY AND ENFIT ENTERAL CONNECTORS (K142012) | Corpak Medsystems | 2014-11-20 |
| ENDO-MARYLAND DISSECTOR (K141794) | Ovesco Endoscopy AG | 2014-11-19 |
| UNIVERSA PERCULTANEOUS DRAINAGE CATHETER (K140085) | Cook Incorporated | 2014-11-18 |
| TRACTION POLYPECTOMY SNARE (K140923) | Ovesco Endoscopy AG | 2014-11-18 |
| THIRD EYE PANORAMIC AUXILIARY ENDOSCOPY SYSTEM (K140595) | Avantis Medical Systems, Inc. | 2014-11-17 |
| UNIMICRO DISPOSABLE RETRIEVAL ENDO-POUCH (K141593) | Unimicro Medical Systems (Shenzhen) Co., Ltd. | 2014-11-13 |
| NEXSITE HD (55CM), HEMODIALYSIS CATHETER FOR LONG TERM USE (K140492) | Marvao Medical Devices, Ltd. | 2014-11-13 |
| Shock Pulse-SE Lithotripsy System CYBERWAND II (K142428) | Cybersonics, Inc. | 2014-11-13 |
| neoClose 2 AutoAnchor Pack US, neoClose 4 AutoAnchor Pack US (K142903) | Neosurgical, Ltd. | 2014-11-12 |
| Acrobat Calibrated Tip Wire Guide (K142950) | Wilson-Cook Medical, Inc. | 2014-11-05 |
| Bard RiteCath Intermittent Urinary Catheter (K142575) | C.R. Bard, Inc. | 2014-10-31 |
| Well Lead PVC Urethral Catheter (K142563) | Well Lead Medical Co., Ltd. | 2014-10-28 |
| Uroflowmeter (K142425) | Be Technologies, Inc. | 2014-10-27 |
| NEPHROS DSU-H, NEPHROS SSU-H (K141731) | Nephros, Inc. | 2014-10-24 |
| Flexible Video-Uretero-Choledochoscope System (K142556) | KARL STORZ Endoscopy-America, Inc. | 2014-10-23 |
| Stryker Precision HD Camera System (K142603) | Stryker Endoscopy | 2014-10-23 |
| JAGWIRE HIGH PERFORMANCE GUIDWIRE (K141820) | Boston Scientific Corp | 2014-10-21 |
| EXPEL APD DRAINAGE CATHETER SYSTEM (K141335) | Boston Scientific Corp | 2014-10-17 |
| CEDIC ENTERAL DISTAL END ENFIT TRANSITION CONNECTOR, CEDIC ENTERAL ENFIT TRANSITION CONNECTOR FOR MEDICATION PORT (K140581) | Cedic S.R.L. | 2014-10-17 |
| EXPEL NEPHROURETERAL DRAINAGE STENT WITH TWIST-LOC HUB SYSTEM, EXPEL URETERAL DRAINAGE STENT SYSTEM (K141344) | Boston Scientific Corp | 2014-10-17 |
| AQUARIUS NASAL FEEDING TUBE (K141753) | Degania Silicone , Ltd. | 2014-10-16 |
| INFLOW INTRAURETHRAL VALVE-PUMP (DEN130044) | Vesiflo, Inc. | 2014-10-14 |
| HS NOTA (K131925) | H.S. Hospital Services S.P.A. | 2014-10-10 |
| OSTOM-I ALERT (K140938) | 11 Health and Technologies, LLC | 2014-10-10 |
| SHARKCORE FINE NEEDLE BIOPSY SYSTEM (K141894) | Covidien, LLC( Formerly Beacon Endoscopic Corp.) | 2014-10-06 |
| AER-O-SCOPE COLONOSCOPE SYSTEM (K141286) | Gi View , Ltd. | 2014-09-30 |
| PolyCatch Retrieval Device (K142258) | Medi-Globe Corporation | 2014-09-30 |
| FUSE COLONOSCOPY SYSTEM (K141598) | Endochoice, Inc. | 2014-09-30 |
| ESOPHYX2 HD (K142113) | Endogastric Solutions, Inc. | 2014-09-30 |
| SINGLE-SITE WRISTED NEEDLE DRIVER (K141075) | Intuitive Surgical | 2014-09-26 |
| EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER (K131817) | Osmunda Medical Device Consulting Co., Ltd. | 2014-09-26 |
| ESOFLIP ES (K142000) | Crospon, Ltd. | 2014-09-25 |
| CELLVIZIO 100 SERIES WITH SYSTEM CONFOCAL MINIPROBES (K141358) | Mauna Kea Technologies | 2014-09-25 |
| POWER-TRIALYSIS SHORT-TERM DIALYSIS CATHETER (K133456) | C.R. Bard, Inc. | 2014-09-24 |
| Predicate III Guidewire (K142397) | Lake Region Medical | 2014-09-19 |
| DA VINVI SURGICAL SYSTEM (K123329) | Intuitive Surgical, Inc. | 2014-09-17 |
| RANFAC ASPIRATION NEEDLE WITH ADJUSTABLE GUIDE (K140991) | Ranfac, Corp. | 2014-09-11 |
| TABLO CARTRIDGE (K140841) | Home Dialysis Plus | 2014-09-11 |
| MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECTOR, MEDISYSTEMS ONESITE DUAL LUMEN BUTTO (K134019) | Nxstage Medical, Inc. | 2014-09-11 |
| TABLO CONSOLE (K140866) | Home Dialysis Plus | 2014-09-10 |
| FUJIFILM ENDOSCOPIC CO2 REGULATOR (K133976) | Fujifilm Medical System U.S.A., Inc. | 2014-09-09 |
| ACHIEVE PROGRAMMABLE AUOMATED BIOPSY SYSTEMS (K141552) | Care Fusion | 2014-09-05 |
| COMPAT ENTERAL DELIVERY PUMP SETS (K140947) | Nestle Healthcare Nutrition, Inc. | 2014-09-04 |
| FLOSHIELD 10MM ENDOSCOPIC CANNULA AND BLUNT OBTURATOR, FLOSHIELD 10MM ENDOSCOPIC CANNULA, FLOSHIELD 10MM BLUNT OBTURATOR (K141272) | Minimmally Invasive Devices | 2014-09-04 |
| IVAS 8 GAUGE BONE BIOPSY KIT (K141673) | Stryker Corporation | 2014-09-04 |
| MINNCARE HD (K133724) | Medivators, Inc. | 2014-08-27 |
| VERITRACT ENTERAL FEEDING TUBE SYSTEM (K133334) | Veritract, Inc. | 2014-08-26 |
| COMPACTCATH INTERMITTENT URINARY CATHETER (K140945) | Compactcath, Inc. | 2014-08-22 |
| EPX-4440HD DIGITAL VIDEO PROCESSOR (K140149) | Fujifilm Medical Systems U.S.A, Inc. | 2014-08-22 |
| VAPRO INTERMITTENT CATHETER (K141642) | Hollister Incorporated | 2014-08-22 |
| MUSTANG BALLOON DIALATION CATHETER (K141597) | Boston Scientific Corporation | 2014-08-22 |
| CRIT-LINE CLIP (CLIC) BLOOD CHAMBER (K141281) | Fresenius Medical Care Renal Therapies Group, LLC | 2014-08-14 |
| DA VINCI FIREFLY IMAGING SYSTEM (K141077) | Intuitive Surgical, Inc. | 2014-08-12 |
| VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE VA2, VISERA CYSTO-NE (K133538) | Olympus Corporation of the Americas | 2014-08-07 |
| UNIMICRO SUCTION IRRIATION TUBING SET (K141592) | Unimicro Medical Systems (Shenzhen) Co., Ltd. | 2014-08-04 |
| ENSIZOR ENDOSCOPIC SCISSORS (K141058) | Slater Endoscopy, LLC | 2014-08-01 |
| GENTLECATH MALE COUDE OLIVE TIP INTERMITTENT URINARY CATHETER (K140953) | Convatec, Ltd. | 2014-08-01 |
| LIBERTY PDX CYCLER (K141145) | Fresenius Medical Care Renal Therapies Group, LLC | 2014-07-30 |
| ENDOLED (K133311) | Olympus Winter & Ibe GmbH | 2014-07-30 |
| GENERICA MEDICAL ENTERNAL DELIVERY; PUMP BAG SET, PUMP SPIKE SET, GRAVITY BAG SET (K133077) | Generica Medical International, Inc. | 2014-07-28 |
| AQUARIUS EXTENSION FEEDING SET (K141631) | Degania Silicone , Ltd. | 2014-07-28 |
| CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES (TM) (K133466) | Mauna Kea Technologies | 2014-07-25 |
| ENDOWRIST STAPLER 45 AND STAPLER 45 RELOADS (K140553) | Intuitive Surgical, Inc. | 2014-07-25 |
| NOVAPROBE LED LIGHT SOURCE (K131226) | Novaprobe Incorporated | 2014-07-24 |
| RE-TRACE URETERAL ACCESS SHEATH, 12/14 CH/FR, LENGTH 35 CM, LENGTH 45 CM (K140523) | Coloplast A/S | 2014-07-24 |
| GIS ENDOSCOPIC OPTICAL LENS (K140295) | Gi Scientific, LLC | 2014-07-24 |
| EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER, COMED ASADAL-M1 (K131721) | Comed Medical Systems Co., Ltd. | 2014-07-22 |
| CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES - BOX 1, CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES - BOX 5, CAPTIV (K140726) | Boston Scientific Corp | 2014-07-21 |