| OPTIFLUX ULTRA DIALYZER (K123262) | Fresenius Medical Care North America | 2014-01-06 |
| EXPECT SLIMLINE ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE (K133312) | Boston Scientific Corporation | 2014-01-03 |
| PRISMAFLEX SYSTEM 7.10 (K131516) | Gambro Renal Products, Inc. | 2014-01-03 |
| FLEXIBLE CMOS-VIDEO-CYSTO-URETHROSCOPE (K131364) | KARL STORZ Endoscopy-America, Inc. | 2014-01-02 |
| GELPOINT PATH TRANSANAL ACCESS PLATFORM (K133393) | Applied Medical Resources Corp. | 2014-01-02 |
| REPROCESSED DILATING TIP TROCARS (K132629) | Stryker Sustainability Solutions | 2013-12-31 |
| NXSTAGE 1.6M2 DIALYZER (K131050) | Nxstage Medical, Inc. | 2013-12-27 |
| CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATED (K132500) | Cure Medical, LLC | 2013-12-23 |
| SEAL BIOPSY VALVE - REUSABLE (K132776) | Endochoice, Inc. | 2013-12-20 |
| NEOTRACT UROLIFT SYSTEM (K133281) | Neotract, Inc. | 2013-12-20 |
| IMAGE1 SPIES (K131953) | KARL STORZ Endoscopy-America, Inc. | 2013-12-20 |
| ELISIO-H HEMODIALYZER, ELISIO-M HEMODIALYZER (K131935) | Nipro Medical Corporation | 2013-12-20 |
| MULTI-STAGE SNARE (K133513) | United States Endoscopy Group, Inc. | 2013-12-20 |
| PHYSOFT AMS (K130579) | Physicians Software Systems, LLC | 2013-12-19 |
| ELISIO-H HEMODIALYZER (K131381) | Nipro Medical Corporation | 2013-12-19 |
| ENTUIT THRIVE BALLOON RETENTION GASTROSTOMY FEEDING TUBE (K130611) | Xeridiem Medical Devices | 2013-12-19 |
| AXIOS STENT AND DELIVERY SYSTEM (DEN130007) | Xlumena, Inc. | 2013-12-18 |
| ERBEFLO CLEVERCAP HYBRID TUBING/CAP SET FOR PENTAX SCOPES, ERBEFLO CLEVERCAP HYBRID CO2 TUBING/CAP SET FOR OLYMPUS 160/1 (K132340) | Erbe USA, Inc. | 2013-12-17 |
| STRYKER 1488 HD VIDEO CAMERA WITH INFRARED COMPATIBILITY (K132785) | Stryker Endoscopy | 2013-12-16 |
| CLEARGUARD HD END CAP (K131060) | Pursuit Vascular, Inc. | 2013-12-16 |
| THD N-ANO ANOSCOPE (K133687) | Thd Spa | 2013-12-11 |
| RETRIEVAL BAG (K123728) | Flexbar Machine Corp. | 2013-12-11 |
| MINS NEEDLESCOPIC RESPOSABLE DEVICE SYSTEM (K132232) | Minilap Technologies | 2013-12-04 |
| NIPRO PUREFLUX-L HEMODIALYZER (K122952) | Nipro Medical Corporation | 2013-12-04 |
| FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM (K131369) | KARL STORZ Endoscopy-America, Inc. | 2013-11-26 |
| CYBERWAND STERILE PROBE SET (K132795) | Cybersonics, Inc. | 2013-11-26 |
| REDSENSE ALARM SYSTEM (K130554) | Redsense Medical AB | 2013-11-22 |
| BNX DELIVERY SYSTEM PRE-LOADED WITH 19, 22 AND 25 GAUGE NEEDLE, 19, 22 OR 25 GAUGE NEEDLES (INDIVIDUALLY STERILE-PACKED, (K133008) | Beacon Endoscopic | 2013-11-20 |
| AUTOLITH TOUCH; URO TOUCH (K130368) | Northgate Technologies, Inc. | 2013-11-15 |
| MEDIQA SINGLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION, MEDIQA DOUBLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SA (K131904) | Ameriwater | 2013-11-13 |
| NURO NEUROMODULATION SYSTEM (K132561) | Advanced Uro-Solutions, Inc. | 2013-11-05 |
| LIGHTHOUSE(TM) URINARY CATHETER (K131655) | Seedings Life Science Ventures, LLC | 2013-11-04 |
| SENSATION SHORT THROW, CAPTIFLEX, CAPTIVATOR, CAPTIVATOR II, PROFILE, SINGLE-USE POLYPECTOMY SNARES (K131700) | Boston Scientific Corp | 2013-11-04 |
| INSTINCT ENDOSCOPIC HEMOCLIP (K132809) | Wilson-Cook Medical, Inc. | 2013-10-25 |
| INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE (K131590) | Philips Medical Systems | 2013-10-23 |
| RANFAC BONE MARROW ASPIRATION NEEDLE (K131157) | Ranfac, Corp. | 2013-10-22 |
| GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER (K132181) | Olympus Surgical Technologies America | 2013-10-21 |
| ENDOCHOICE HOT BIOPSY FORCEPS (K131991) | Endochoice, Inc. | 2013-10-15 |
| 2008T HEMODIALYSIS MACHINE WITH OPTIONAL CRIT-LINE MONITOR (CLIC) (K131908) | Fresenius Medical Care Renal Therapies Group, LLC | 2013-10-11 |
| CLASSIC INTERMITTENT CATHETER (K132619) | Flexicare Medical, Ltd. | 2013-10-11 |
| PEERSCOPE SYSTEM (K131422) | Endochoice, Inc. | 2013-10-10 |
| NXSTAGE CONNECTED HEALTH SYSTEM (K131739) | Nxstage Medical, Inc. | 2013-10-10 |
| WECK EFX ENDO FASCIAL CLOSURE SYSTEM (K132362) | Teleflexmedical, Inc. | 2013-10-08 |
| ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE GASTROINTESTINAL SUTURE ANCHOR SET (K131201) | Cook, Inc. | 2013-10-07 |
| ESOFLIP BALLOON DILATION CATHETER (K132337) | Crospon, Ltd. | 2013-10-07 |
| THERMOCHEM HT-2000 (K131583) | Thermasolutions, Inc. | 2013-10-03 |
| DISPOSABLE SILICONE FOLEY CATHETER (K130908) | Guangdong Baihe Medical Technology Co., Ltd. | 2013-10-03 |
| EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER (K132672) | Dornier Medtech America | 2013-09-23 |
| MROZ REVERSE OSMOSIS SYSTEM (K131622) | Ameriwater | 2013-09-20 |
| AUTOLAP SYSTEM (K131375) | Mst - Medical Surgery Technologies , Ltd. | 2013-09-19 |
| APD LUER-LOCK ADAPTER (K124024) | Fresensius Medical Care North America | 2013-09-19 |
| MEDLINE ANTI-REFLUX VALVE (K132314) | Medline Industries, Inc. | 2013-09-18 |
| DA VINCI FLUORESCENCE IMAGING VISION SYSTEM (K124031) | Intuitive Surgical, Inc. | 2013-09-13 |
| VWING VASCULAR NEEDLE GUIDE, 4MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 6MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 8MM X 07M (K130873) | Vital Access | 2013-09-13 |
| UROLIFT SYSTEM (DEN130023) | Neotract, Inc. | 2013-09-13 |
| FRESENIUS LIBERTY CYCLER (K123630) | Fresenius Medical Care North America, Design Cente | 2013-09-09 |
| LIFESTENT BILIARY STENT SYSTEM, LIFESTENT XL BILIARY STENT SYSTEM (K130792) | C.R. Bard, Inc. | 2013-08-30 |
| FRESENIUS DRY ACID DISSOLUTION UNITS (K131611) | Fresenius Medical Care North America | 2013-08-29 |
| ENDOWRIST ONE VESSEL SEALER (K130266) | Intuitive Surgical, Inc. | 2013-08-29 |
| EVIS EXERA III VIDEO SYSTEM (K131780) | Olympus Medical Systems Corp. | 2013-08-29 |
| AUTOBAND LIGATOR (K132535) | Endochoice, Inc. | 2013-08-23 |
| SIM (K130951) | Simavita Pty Limited | 2013-08-22 |
| SURGIQUEST AIRSEAL IFS (K132169) | Surgiquest, Inc. | 2013-08-22 |
| GUARDIAN URETHRAL SHEATH (K131803) | Solace Therapeutics | 2013-08-20 |
| PERF-GEN PULSATILE PERFUSION SOLUTION (K121736) | Waters Medical Systems, LLC | 2013-08-16 |
| TUBECLEAR MODEL 101 (WITH NEW CLEARING STEM NE AND G MODELS) (K131052) | Actuated Medical, Inc. | 2013-08-16 |
| ELECTROMAGNETIC TRANSMITTING STYLET (K131532) | Corpak Medsystems | 2013-08-12 |
| GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEM (K123864) | Given Imaging , Ltd. | 2013-08-12 |
| MAXFORCE BILIARY DILATATION CATHETER AND HURRICANE RX BILIARY CATHETER (K130484) | Boston Scientific Corp | 2013-08-09 |
| FOREIGN BODY HOOD (K130148) | United States Endoscopy Group, Inc. | 2013-08-07 |
| RSH BILIARY STONE REMOVAL DEVICE (K131642) | Rsh, LLC | 2013-08-07 |
| BRACCO DIAGNOSTICS INC. CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SET (K123047) | Bracco Diagnostic, Inc. | 2013-08-06 |
| VECTEC DISPOSABLE PNEUMOPERITONEUM NEEDLE (K121370) | Vectec | 2013-08-02 |
| PASSPORT ROBOTIC REDUCER CAP; PASSPORT STOPCOCK WITH ROTATING MALE LUER (K130826) | Stryker Endoscopy | 2013-08-01 |
| DA VINCI SINGLE-SITE INSTRUMENTS AND ACCESSORIES (K122532) | Intuitive Surgical, Inc. | 2013-07-30 |
| COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY (K122091) | Cook, Inc. | 2013-07-29 |
| RELIANCE ADVANCE ENDOSCOPE PROCESSING SYSTEM (K123768) | STERIS Corporation | 2013-07-26 |
| AMECATH DUAL LUMEN IMPLANTED HEMODIALYSIS CATHETER (K131814) | Ameco Medical Industries | 2013-07-26 |
| BARRX CHANNEL RFA ENDOSCOPIC CATHETER (K130623) | Covidien, LLC | 2013-07-26 |
| NEOCLOSE HASSON, NEOCLOSE UNIVERSAL (K131688) | Neosurgical, Ltd. | 2013-07-18 |
| ENDOFLIP CATHETER (K130906) | Crospon, Ltd. | 2013-07-17 |
| NEXUS HEMORRHOID LIGATOR (K131282) | Inx Medical | 2013-07-11 |
| NXSTAGE DOSING CALCULATOR (K130460) | Nxstage Medical, Inc. | 2013-07-11 |
| ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC GUIDEWIRE STRAIGHT STIFF, ORCHESTRA HYDROPHILIC (K131072) | Coloplast A/S | 2013-07-09 |
| 2008K@HOME HEMODIALYSIS MACHINE (K124035) | Fresenius Medical Care North America | 2013-07-03 |
| HEMOCONCENTRATOR (K123288) | Maquet Cardiopulmonary, AG | 2013-06-26 |
| MIC-KEY SF LOW PROFILE GASTROSTOMY TUBE AND ACCESSORIES (K122653) | Kimberly-Clark Corporation | 2013-06-26 |
| CLL- V1 LIGHT SOURCE (K130819) | Olympus Winter & Ibe GmbH | 2013-06-19 |
| AMIA AUTOMATED PD SYSTEM (K124018) | Deka Research & Development Corp. | 2013-06-14 |
| BEL-GEN COLD STORAGE SOLUTION (K121618) | Waters Medical Systems, LLC | 2013-06-14 |
| T3 (K123292) | Medcomp | 2013-06-11 |
| ZEROWIRE DUO WIRELESS HD VIDEO TRANSFER SYSTEM, OR ZERO WIRE (K131115) | Nds Surgical Imaging | 2013-06-07 |
| DA VINCI SINGLE-SITE PERMANENT CAUTERY HOOK (K130726) | Intuitive Surgical, Inc. | 2013-06-07 |
| UROMAX ULTRA BALLOON DILATATION CATHETER (K130804) | Boston Scientific Corporation | 2013-05-22 |
| MIROCAM CAPSULE ENDOSCOPE SYSTEM (K123428) | Intromedic Co., Ltd. | 2013-05-20 |
| SCOPEVALET DISPOSABLE BIOPSY VALVE (K122417) | The Ruhof Corp. | 2013-05-17 |
| GATEWAY ADVANAGE Y-ADAPTER (K130909) | Boston Scientific Corp | 2013-05-16 |
| EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER (K130729) | Dornier Medtech Systems | 2013-05-14 |
| HYDROSIL; MAGIC; PERSONAL CATHETER (K122785) | Rochester Medical Corp. | 2013-05-14 |
| REMINGTON MEDICAL CENTREFIRE 22 BIOPSY INSTRUMENT (K130282) | Remington Medical, Inc. | 2013-05-13 |