| FRESENIUS 2008T HEMODIALYSIS MACHINE (K120505) | Fresenius Medical Care North America, Design Cente | 2012-03-06 |
| DUET MAGNA (K111947) | Direx Systems Corp. | 2012-03-01 |
| SONY LMD-2451MT LCD MONITOR (K113203) | Sony Electronics, Inc. | 2012-02-24 |
| INVENDO C20 COLONOSCOPY SYSTEM (K100624) | Invendo Medical Gbmh | 2012-02-23 |
| BONETRAP (K120189) | Berni Farns Incorporated | 2012-02-22 |
| INCONTROL (K110179) | Incontrol Medical, LLC | 2012-02-22 |
| ACE STAPLER AND CARTRIDGE (K120147) | Barosense, Inc. | 2012-02-17 |
| AMERITUS MEDICAL ENTERAL FEEDING EXTENSION SET (K120272) | Kentec Medical, Inc. | 2012-02-17 |
| EVIS EXERA III VIDEO SYSTEM (K112680) | Olympus Medical Systems Corporation | 2012-02-16 |
| WAVES (K111521) | Waters Medical Systems, LLC | 2012-02-16 |
| INJEKT CYSTO FLEXIBLE INJECTION NEEDLE (K113634) | Cook Ireland, Ltd. | 2012-02-14 |
| BEVER UNOCATED / COATED, PAEDIATRIC / MALE / FEMALE NELATON-TIP / TIEMANN-TIP INTERMITTENT CATHETER, (K111405) | Hangzhou Bever Medical Devices Co., Ltd. | 2012-02-13 |
| CRE DITATATION BALLON (K112994) | Boston Scientific Corporation | 2012-02-10 |
| NAVIAID ICVI-F,S,B,R DEVICE (K112106) | Smart Medical Systems , Ltd. | 2012-02-06 |
| FRESENIUS 2008 HEMODIAYSIS MACHINE WITH BIBAG SYSTEM (K120017) | Fresenius Medical Care North America | 2012-02-02 |
| BICARB MIXING AND DISTRIBUTION SYSTEM (K112427) | Isopure, Corp. | 2012-01-26 |
| ENDOCHOICE WATER BOTTLE CAP SYSTEM (K112576) | Endochoice, Inc. | 2012-01-25 |
| TRIPORT, TRIPORT+, TRIPORT15, QUADPORT (K111407) | Advanced Surgical Concepts | 2012-01-18 |
| PDE PHOTODYNAMIC EYE (K110480) | Hamamatsu Photonics K.K. | 2012-01-13 |
| LUCEA LED SURGICAL LIGHT SYSTEM (K113679) | Maquet S.A.S. | 2012-01-12 |
| CORTRAK ENTERAL ACCESS DEVICE (K113351) | Corpak Medsystems | 2012-01-10 |
| KARL STORZ SCB / COVIDIEN FORCETRIAD INTERFACE MODULE (K111165) | KARL STORZ Endoscopy-America, Inc. | 2012-01-06 |
| HANAROSTENT BILIARY (NNN) (K111149) | M.I.Tech Co., Ltd. | 2011-12-30 |
| FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM (K112522) | Flexible Stenting Solutions, Inc. | 2011-12-30 |
| WALLFLEX BILIARY TRANSHEPATIC UNCOVERED STENT SYSTEM, WALLFLEX BILIARY TRANSHEPATIC COVERED STENT SYSTEM (K112543) | Boston Scientific Corporation | 2011-12-29 |
| ENDOWRIST ONE VESSEL SEALER (K110639) | Intuitive Surgical, Inc. | 2011-12-28 |
| FRESENIUS 2008T HEMODIALYSIS MACHINE (K113427) | Fresenius Medical Care North America | 2011-12-21 |
| ACEM (K111013) | Sandhill Scientific, Inc. | 2011-12-19 |
| MED GRAVITY SET, IMED PUMP SET (K102712) | Imed Technology, Inc. | 2011-12-16 |
| AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KITS (K110793) | Ameco Medical Industries | 2011-12-16 |
| SPLIT CATH III (K111651) | Medical Components, Inc. | 2011-12-08 |
| INTUTIVE SURGICAL DA VINCI SINGLE SITE INSTRUMENTS AND ACCESSORIES (K112208) | Intuitive Surgical, Inc. | 2011-12-08 |
| SURECORE BIOPSY DEVICE (K102756) | Chest Innovations, Inc. | 2011-11-29 |
| CHIBA SONO (K113209) | Pajunk GmbH | 2011-11-21 |
| DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS (K102833) | Foshan Nanhai Bai HE Medical Technology Co., Ltd. | 2011-11-18 |
| ENTERAL FEEDING BAG AND SETS (K102741) | Shandong Weigao Group Medical Polymer Co., Ltd. | 2011-11-08 |
| BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATOR (K111648) | Bracco Diagnostic, Inc. | 2011-11-03 |
| ELITECORE FULL CORE BIOPSY DEVICE 18GAX10CM, 18GAX15CM, 18GAX20, WITH/HILITIER 18GAX10CM , W/HILITER 18GAX15CM (K112945) | Inrad, Inc. | 2011-11-03 |
| EUS BALLOON (K111028) | United States Endoscopy Group, Inc. | 2011-11-01 |
| SUMO ACCESS AND TISSUE RESECTION SYSTEM (K103155) | Apollo Endosurgery, Inc. | 2011-10-28 |
| JMS APHERESIS NEEDLE SET WINGEATER(R) V2 (K112178) | JMS North America Corporation | 2011-10-27 |
| CHARGER BALLOON DILATATION CATHETER (K112701) | Boston Scientific | 2011-10-25 |
| WINGEATER V2 (K111948) | JMS North America Corporation | 2011-10-24 |
| FRESENIUS 2008T HEMODIALYSIS MACHINE (K111639) | Fresenius Medical Care | 2011-10-21 |
| THE ONCONTROL BONE ACCESS SYSTEM BY VIDACARE (K112468) | Regulatory Specialists, Inc. | 2011-10-20 |
| SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPTIC BILIARY SYSTEMS (K111766) | Idev Technologies, Inc. | 2011-10-19 |
| AMT G-J TUBE (K110804) | Applied Medical Technology, Inc. | 2011-10-19 |
| UNIMAX TROCAR SYSTEM (K112358) | Unimax Medical Systems, Inc. | 2011-10-17 |
| NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX (K100163) | Vygon Corp. | 2011-10-13 |
| MONOPOLAR CURVED SCISSORS TIP COVER ACCESSORY (K112263) | Intuitive Surgical, Inc. | 2011-10-07 |
| ENDOFLIP ECD (K110531) | Crospon, Ltd. | 2011-10-06 |
| AMERIWATER MRO PORTABLE REVERSE OSMOSIS SYSTEM - SINGLE PATIENT, 1 TO 3 STATION (K111740) | Ameriwater | 2011-10-05 |
| ADAPT(TM) UNIVERSAL BALLOON OPEN ACCESS PORT (K112456) | Teleflexmedical, Inc. | 2011-10-04 |
| BD ORAL/ENTERAL SYRINGE WITH BD UNIVIA CONNECTION (K112434) | Bd Medical Surgical | 2011-09-29 |
| 5MM/8MM HARMONIC ACE(TM) CURVED SHEARS, DISPOSABLE HARMONIC ACE(TM) INSERT, DISPOSABLE HARMONIC(TM) CURVED SHEARS INSERT (K112584) | Intuitive Surgical, Inc. | 2011-09-29 |
| LITE-MED LM-9200 ELMA (K103217) | Lite-Med, Inc. | 2011-09-28 |
| PALINDROME H, SI, HSI CHRONIC CATHETER (K112477) | Covidien | 2011-09-28 |
| THE ESPINER SAC OR E SAC (K111845) | Espiner Medical Limited | 2011-09-26 |
| NXSTAGE PUREFLOW SL (K111174) | Nxstage Medical, Inc. | 2011-09-19 |
| EXPECT ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE (K112198) | Boston Scientific Corporation | 2011-09-14 |
| OCTOTMPORT (K112196) | Dalim Surgnet Corporation | 2011-09-14 |
| UNIMAX ANTI-FOG SOLUTION (K111622) | Unimax Medical Systems, Inc. | 2011-09-09 |
| PREFILLED CATHETER INFLATION SYRINGE (K112209) | Avail Medical Products, Inc. | 2011-09-08 |
| FULL CORE BIOPSY SYSTEM (K111765) | Promex Technologies, LLC | 2011-09-06 |
| VERSAPORT V2 BLADELESS OPTIICAL TROCAR AND/OR VERSAPORT BLADELESS OPTICAL TROCAR (K112349) | Covidien, Formerly US Surgical A Divison of Tyco H | 2011-09-01 |
| PALINDROME RT CHRONIC CATHETER (K111817) | Covidien | 2011-08-30 |
| ENDOWRIST ONE SUCTION/IRRIGATOR (K110451) | Intuitive Surgical, Inc. | 2011-08-26 |
| COMFORTGLIDE INTERMITENT CATHETER (K112137) | C.R. Bard, Inc. | 2011-08-26 |
| DEKA TAC DEVICE (K093915) | Deka Research & Development Corp. | 2011-08-23 |
| VITALA CONTINENCE CONTROL DEVICE (K111365) | Convatec, Inc. | 2011-08-19 |
| NEXTSTEP ANTEGRADE CHRONIC HEMODIALYSIS CATHETER (K111900) | Teleflexmedical, Inc. | 2011-08-17 |
| NAVIAID(TM) BGC DEVICE (K111760) | Smart Medical Systems , Ltd. | 2011-08-09 |
| CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES (K111047) | Mauna Kea Technologies, Inc. | 2011-08-08 |
| TAL PALLINDROME (TM) SYMMETRIC TIP DUAL LUMEN CATHETER, MAHURKAR (R) MAXID (TM) DUAL LUMEN CATHETER, PALINDROME (TM)... (K111372) | Covidien | 2011-08-04 |
| SYNCRO - BLUE TUBE, THE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE- 8FR TUBE (K110005) | Syncro Medical Innovations, Inc. | 2011-08-04 |
| SONOLITH I-MOVE (K111808) | Edap Tms France | 2011-08-01 |
| CURE CATHETER (K110653) | Cure Medical, LLC | 2011-08-01 |
| MAGNUM CORE TISSUE BIOPSY NEEDLE MODEL MN1820, RP CUTTING NEEDLE MODEL RP-1820, MCN CORE TISSUE BIOPSY NEEDLE MODEL MCN- (K111529) | Insert Molding Solutions, Inc. | 2011-07-29 |
| VOYAGER PERITONEAL DIALYSIS SYSTEM (K103220) | Deka Research & Development Corp. | 2011-07-29 |
| BIOPSY VALVE (K111821) | Endochoice, Inc. | 2011-07-28 |
| TISSUE SAMPLING NEEDLE (K103694) | United States Endoscopy Group, Inc. | 2011-07-27 |
| ENDOFLIP GASTRIC TUBE (K110529) | Crospon, Ltd. | 2011-07-22 |
| COOK GI ENDOSCOPIC INJECTION GEL KIT, GEL-S, GEL-N, GEL-H, GEL-K (K111495) | Wilson-Cook Medical, Inc. | 2011-07-19 |
| REPROCESSED ENDOSCOPIC TROCARS (K111002) | Sterilmed, Inc. | 2011-07-18 |
| NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER (K110285) | Nephros, Inc. | 2011-07-14 |
| CANNON II PLUS CHRONIC HEMODIALYSIS CATHETER, EDGE CHRONIC HEMODIALYSIS CATHETER, NEXTSTEP(R) RETROGRADE CHRONIC... (K111117) | Teleflexmedical, Inc. | 2011-06-30 |
| IBAG (K110518) | Future Path Medical, LLC | 2011-06-24 |
| BIOPSY HANDY, MRI BIOPSY HANDY (K102771) | Somatex Medical Technologies GmbH | 2011-06-24 |
| TENSCARE ITOUCH SURE MODEL ITS (K103698) | Tenscare, Ltd. | 2011-06-21 |
| PRISMAFLEX (K110823) | Gambro Renal Products, Inc. | 2011-06-17 |
| NAVIAID ICVI-F DEVICE, NAVIAID ICVI-S DEVICE, NAVIAID ICVI-B DEVICE (K110291) | Smart Medical Systems , Ltd. | 2011-06-17 |
| ENCOR ENSPIRE BREAST BIOPSY SYSTEM (K111100) | C.R. Bard, Inc. | 2011-06-16 |
| COLONOSCOPY ASSISTANT (K102949) | Sti Medical Systems, LLC | 2011-06-15 |
| DEFENDO Y-OPSY IRRIGATOR (K110088) | Byrne Medical Incorporated | 2011-06-10 |
| DURAFLOW 2 CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT (K110936) | AngioDynamics, Inc. | 2011-06-10 |
| MULTIPURPOSE DRAINAGE CATHETER (K111315) | Navilyst Medical, Inc. | 2011-06-08 |
| J-STYLE BONE MARROW BIOPSY / ASPIRATION NEEDLE WITH SNARE-IT MARROW ACQUISITION CANNULA (K110883) | Busse Hospital Disposables | 2011-06-08 |
| DYNAREX INTERMITTENT CATHETERS, MALE, FEMALE, PEDIATRIC (K103086) | Dynarex Corporation | 2011-06-07 |
| REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIES (K101733) | Sac, LLC Dba Pinnacle Medical Surgical | 2011-06-06 |
| ACE STAPLER AND CARTRIDGE (K110829) | Barosense, Inc. | 2011-06-03 |