| NEXTSTEP RETROGRADE (K130192) | Arrow International, Inc. | 2013-05-10 |
| TEMPERATURE SENSOR CATHETER (K131020) | Degania Silicone , Ltd. | 2013-05-09 |
| PUREFLUX-H HEMODIALYZER (K122343) | Nipro Medical Corporation | 2013-05-07 |
| SUPERA VERITAS (K130591) | Idev Technologies, Inc. | 2013-05-02 |
| REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER (K130039) | Gambro Renal Products, Inc. | 2013-05-02 |
| ELISIO-H AND ELISIO-M HEMODIALYZERS (K122347) | Nipro Medical Corporation | 2013-05-01 |
| OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM (K123421) | Olympus Medical Systems Corp. | 2013-04-29 |
| SINGLE USE REPOSITIONABLE CLIP (K123601) | Olympus Medical Systems Corp. | 2013-04-29 |
| DEONIZATION EXCHANGE TANKS, CARBON EXCHANGE TANKS (K123282) | Ultrapure & Industrial Services, LLC | 2013-04-25 |
| NXSTAGE SYSTEM ONE (K122051) | Nxstage Medical, Inc. | 2013-04-23 |
| AMT LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE KIT (K123716) | Applied Medical Technology, Inc. | 2013-04-19 |
| FALLER STYLET (K130441) | Medionics International, Inc. | 2013-04-19 |
| ELECTRODE, FLEXIBLE SUCTION COAGULATOR (K130489) | Optim, LLC | 2013-04-19 |
| COMINED STANDARD SOLUTION (K130100) | Mesa Laboratories, Inc. | 2013-04-18 |
| CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES (K123676) | Mauna Kea Technologies | 2013-04-18 |
| NEOCLOSE HASSON, NEOCLOSE UNIVERSAL (K123280) | Neosurgical, Ltd. | 2013-04-18 |
| INSTAFLO BOWEL CATHETER SYSTEM KIT (K123804) | Hollister, Inc. | 2013-04-17 |
| VS3 (K123467) | Visionsense, Ltd. | 2013-04-17 |
| PEERSCOPE SYSTEM (K130718) | Peermedical , Ltd. | 2013-04-16 |
| SHORT PORT BLUNT TIP TROCAR (K130121) | Boston Scientific Corporation | 2013-04-11 |
| SINGLE USE PRELOADED SPHINCTEROTOME V (K122505) | Olympus Medical Systems Corp. | 2013-04-11 |
| PENTAX EPK-I5010 VIDEO PROCESSOR (K122470) | Pentax Medical | 2013-04-10 |
| LIFE-CARE VAGINAL PROBE LIFE-CARE ANAL PROBE (K122194) | Everyway Medical Instruments Co.,Ltd | 2013-04-04 |
| THE RICHARD WOLF ENDOCAM LOGIC HD CAMERA SYSTEM 5525 (K130423) | Richard Wolf Medical Instruments Corp. | 2013-04-03 |
| AMECATH DUAL LUMEN HEMODIALYSIS CATHETER (K123943) | Ameco Medical Industries | 2013-04-02 |
| BOEHRINGER GASTRIC SIZING TUBE (K130483) | Boehringer Laboratories, LLC | 2013-03-28 |
| AQUABOSS ECORO DIA I (HT); AQUABOSS ECORO DIA II (HT) (K124059) | Lauer Membran Wassertechnik GmbH | 2013-03-25 |
| ENDOSCOPIC INTRODUCER (K123013) | Novadaq Technologies, Inc. | 2013-03-22 |
| PENTAX EG-3670URK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS (K130206) | Pentax of America, Inc. | 2013-03-20 |
| E-Z CHEK BLOOD LEAK TEST STRIPS (K123805) | Reprocessing Products Corp | 2013-03-20 |
| PENTAX EG-3870UTK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS (K130247) | Pentax of America, Inc. | 2013-03-20 |
| VERSAPORT V2 BLADELESS OPTICAL TROCAR (K130435) | Covidien, Formerly US Surgical A Divison of Tyco H | 2013-03-14 |
| NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (28CM) NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (24CM) (K121933) | Marvao Medical Devices, Ltd. | 2013-03-14 |
| NXSTAGE SYSTEM ONE LOW VOLUME CARTRIDGE EXPRESS (K123395) | Nxstage Medical, Inc. | 2013-03-07 |
| INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBE (K120815) | Philips Medical Systems | 2013-03-06 |
| RE-TRACE URETERAL ACCESS SHEATH, 10/12 FRENCH, LENGTH 35 AND 45 CM, URETERAL ACCESS SHEATH, 12/14 CH-FR, LENGTH 35CM, UR (K123675) | Coloplast A/S | 2013-03-01 |
| CASSI II ROTATIONAL CORE BIOPSY SYSTEM; CASSI QUADPOINT DISPOSABLE (K123606) | Scion Medical Technologies, LLC | 2013-03-01 |
| EVOLUTION BILIARY STENT SYSTEM (K121430) | Cook Ireland, Ltd. | 2013-03-01 |
| LOFRIC SENSE (K123751) | Wellspect Healthcare | 2013-02-28 |
| OSTAVI HYDROPHILIC GUIDEWIRE (K124052) | Lake Region Medical | 2013-02-26 |
| 2008 HEMODIALYSIS SORBENT SYSTEM (K123835) | Renal Solutions, Inc. | 2013-02-15 |
| CONNECT FOR DA VINCI SURGICAL SYSTEM(S) (K123840) | Intuitive Surgical, Inc. | 2013-02-14 |
| SHERPA PAK CARDIAC TRANSPORT SYSTEM (K123326) | Paragonix Technologies, Inc. | 2013-02-06 |
| ASAHI REXEED-SX/LX SERIES DIALYZER (K121409) | Asahi Kasei Medical Co., Ltd. | 2013-02-06 |
| AUTOMATED ENDOSCOPE LEAK TESTER (K123704) | Olympus Medical Systems Corp. | 2013-02-04 |
| VARI-PASS VARIABLE LENGTH ACCESS SHEATH (K123170) | Olympus Surgical Technologies America | 2013-02-04 |
| PALINDROME PRECISION H CHRONIC CATHETER, PALINDROME PRECISION SI CHRONIC CATHETER, PALINDROME PRECISION HSI CHRONIC CATH (K123196) | Covidien | 2013-01-31 |
| SYSTEM 83 PLUS (K122172) | Custom Ultrasonics | 2013-01-25 |
| POWER LED 175 (K123956) | KARL STORZ Endoscopy-America, Inc. | 2013-01-25 |
| Medafor Direct Gas-Assisted Application System (K123325) | Medafor, Inc. | 2013-01-24 |
| PRETZELFLEX SURGICAL RETRACTOR MODEL SHR7301 (K123110) | Surgical Innovations Plc | 2013-01-17 |
| FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT) (K121421) | Fresenius Medical Care North America, Design Cente | 2013-01-17 |
| SWISS LITHOBREAKER (K123038) | E.M.S Electro Medical Systems S.A | 2013-01-16 |
| EC SINGLE USE, POLYPECTOMY SNARE (K123223) | Endochoice, Inc. | 2013-01-10 |
| XENX STONE MANAGEMENT DEVICE (K123438) | Xenolith Medical | 2013-01-10 |
| MALLEABLE TIP ENDOSCOPIC APPLICATOR (K123847) | Micromedics, Inc. | 2013-01-08 |
| NEO ERCP GUIDEWIRE (K123439) | Neometrics, Inc. | 2013-01-03 |
| SOVEREIGN MINI (K123102) | Aesculap, Inc. | 2013-01-03 |
| STREAMLINE AIRLESS SYSTEM SET WITH PRE-ATTACHED DIALYZER (K113023) | Nxstage Medical, Inc. | 2012-12-21 |
| INVENDO C25 COLONOSCOPY SYSTEM (K121582) | Invendo Medical Gbmh | 2012-12-20 |
| TUBE-CLEAR, CONTROL BOX (COMPONENT OF TUBECLEAR), CLEARING STEM (COMPONENT OF TUBECLEAR) (K123659) | Actuated Medical, Inc. | 2012-12-20 |
| ENDOSCOPE REPROCESSOR OER-MINI (K120357) | Olympus Medical Systems Corp. | 2012-12-20 |
| OVS1 VIDEO SYSTEM (K123359) | Olive Medical Corp. | 2012-12-19 |
| NUTRISAFE 2 FEEDING TUBE (K121105) | Vygon Corp. | 2012-12-18 |
| MOLECULAR ADSORBENT RECIRCULATING(MARS) (K113313) | Gambro Renal Products, Inc. | 2012-12-14 |
| VIDEO SYSTEM CENTER (K122831) | Olympus Medical Systems Corp. | 2012-12-14 |
| GYRUS ACMI BICOAG HEMOSTASIS PROBE (K123319) | Olympus Surgical Technologies America | 2012-12-14 |
| SIGNAL GEAR URETHRAL CATHETER ELECTRODE (K113771) | Neurovision Medical Products, Inc. | 2012-12-13 |
| NAVIGATOR HD URETERAL ACCESS SHEATH SET (K122649) | Boston Scientific Corp | 2012-12-12 |
| EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIXP190N (K123317) | Olympus Medical Systems Corporation | 2012-12-11 |
| JETPREP FLUSHING DEVICE OL-103037, JETPREP FLUSHING DEVICE OL-133037, JETPREP FLUSHING DEVICE OL-168037, JETPREP FLUSHIN (K122740) | Jetprep, Ltd. | 2012-12-10 |
| SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM (K122546) | Idev Technologies, Inc. | 2012-12-07 |
| FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM (K121341) | Fresenius Medical Care North America | 2012-12-06 |
| RESOLUTION CLIP MODEL M00522600, M00522601, M00522602, M00522610, M00522611, M00522612 (K122660) | Boston Scientific Corporation | 2012-12-03 |
| INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM SMARTPEDALS (K123463) | Intuitive Surgical, Inc. | 2012-12-03 |
| WATER BOTTLE CAP IRRIGATON SYSTEM (K120862) | Endochoice, Inc. | 2012-11-27 |
| 360 GAS ASSISTED ENDOSCOPIC APPLICATOR (K122526) | Micromedics, Inc. | 2012-11-16 |
| MAMMOTOME REOLVE DUAL VACUUM ASSISTED BIOPSY (VAB) SYSTEM (K123259) | Devicor Medical Products, Inc. | 2012-11-15 |
| CRIT-LINE CLIP (CLIC) (K121599) | Fresenius Medical Care-North America | 2012-11-09 |
| PRESSURIZED INFUSION PUMP (K122294) | Mui Scientific | 2012-11-01 |
| LOFRIC PRIMO, LOFRIC HYDRO-KIT (K122078) | Astra Tech, Inc. | 2012-10-31 |
| SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SYSTEM (K120127) | Swan Valley Medical, Incorporated | 2012-10-26 |
| RENEW INSERT (K122003) | Renew Medical, Inc. | 2012-10-26 |
| SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR GRASPER WAVY RATCHETED, SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR (K122299) | Transenterix, Inc. | 2012-10-25 |
| INTUITIVE SURGICAL ONSITE FOR DA VINCI SURGICAL SYSTEMS (K121921) | Intuitive Surgical, Inc. | 2012-10-25 |
| PLEURX PLEURAL CATHETER SYSTEM PLEURX CATHETER ACCESS KIT PLEURX SLIDE VALVED PEELABLE INTRODUCER (K122422) | Care Fusion | 2012-10-24 |
| CRE FIXED WIRE BALLON DILATION CATHETER (K122924) | Boston Scientific Corp | 2012-10-24 |
| ENDOWRIST STAPLER SYSTEM (K113706) | Intuitive Surgical, Inc. | 2012-10-17 |
| WECK REUSABLE OBTURATOR (K121796) | Teleflexmedical, Inc. | 2012-10-11 |
| AXCESS SOFT TIP WIRE GUIDE (K122816) | Wilson-Cook Medical, Inc. | 2012-10-09 |
| SPEEDICATH COMPACT SET (12 FR) (K121457) | Coloplast Corp. | 2012-10-02 |
| SPEEDICATH COMPACT SET (12/18 FR) (K121458) | Coloplast A/S | 2012-10-01 |
| ENDOPATH XCEL BLADELESS TROCAR WITH OPTIVIEW TECHNOLOGY ENDOPATH XCEL BLUNT TIP TROCAR WITH OPTIVIEW TECHNOLOGY ENDOPATH (K122511) | Ethicon Endo-Surgery, LLC | 2012-10-01 |
| PEERSCOPE SYSTEM (K120289) | Peermedical | 2012-09-28 |
| NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET (K112628) | Nipro Medical Corporation | 2012-09-28 |
| WALLFLEXTM BILIARY RX STENT SYSTEM (UNCOVERED, PARTIALLY COVERED, AND FULLY COVERED) WALLFLEXTM BILIARY TRANSHEPATIC STE (K122072) | Boston Scientific Corporation | 2012-09-28 |
| OVERTUBE ENDOSCOPIC ACCESS SYSTEM (K122270) | Apollo Endosurgery, Inc. | 2012-09-28 |
| CHF-Y0005 (K113120) | Olympus Medical Systems Corp. | 2012-09-25 |
| GEMINI LITHOTRIPTER (K121656) | Dornier Medtech America, Inc. | 2012-09-24 |
| SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT CATH III 40CM AND 55CM (K121848) | Medical Components, Inc. | 2012-09-21 |