| NXSTAGE SYSTEM ONE WITH THERAPEUTIC PLASMA EXCHANGE CARTRIDGE (K093069) | Nxstage Medical, Inc. | 2010-10-23 |
| URGENT PC STIMULATOR; URGENT PC LEAD SET (K101847) | Uroplasty, Inc. | 2010-10-21 |
| GYRUS ACMI BIOCOAG PROBE (K092571) | Gyrus Acmi, Inc. | 2010-10-20 |
| DURAMAX CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT (K101843) | AngioDynamics, Inc. | 2010-10-20 |
| PMC LAPAROSCOPIC INSTRUMENTS (K101193) | Pmc Medical GmbH | 2010-10-18 |
| RE-TRACE URETERAL ACCESS SHEATH (K102485) | Coloplast A/S | 2010-10-18 |
| AUTOCLAVABLE CAMER HEAD MODEL OTV-Y0017 (K102059) | Olympus Medical Systems Corporation | 2010-10-08 |
| SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM (K093893) | Idev Technologies, Inc. | 2010-10-05 |
| RADIAL 4 HOT BIOPSY FORCEPS BOX 5; RADIAL JAW 4 HOT BIOPSY FORCEPS BOX 20; RADIAL JAW 4 HOT BIOPSY FORCEPS BOX 40 (K101657) | Boston Scientific Corp | 2010-10-05 |
| PERFADEX AND PERFADEX WITH THAM (K091989) | Xvivo Perfusion AB | 2010-10-01 |
| PILLCAM EXPRESS VIDEO CAPSULES DELIVERY DEVICE (K101200) | Given Imaging , Ltd. | 2010-09-30 |
| SOCORRO SMI TUNNEL RELEASE DEVICE (K102219) | Socorro Medical, Inc. | 2010-09-24 |
| AMSURE 3-WAY HYDROPHILIC LATEX FOLEY CATHETER (K101824) | Amsino International, Inc. | 2010-09-13 |
| OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2 (K100899) | Keymed (Medical & Industrial Equipment), Ltd. | 2010-09-13 |
| FASTCLAMP ENDOSCOPIC CLAMPING SYSTEM (K100442) | Surgical Innovations Group Plc | 2010-09-07 |
| MERIT BIPOLAR COAGULATION PROBE (K102273) | Merit Medical Systems, Inc. | 2010-09-07 |
| 3DHJD CAMERA SYSTEM MODEL (K101810) | Vision Systems Group, A Division of Viking Systems | 2010-08-30 |
| CYBERWAND LITHOTRIPTER (K102169) | Cybersonics, Inc. | 2010-08-30 |
| CYSTOSCOPE, MODELS CE0004-C, CE006-C, CE3004-C, CE3027-C, CE7004-C, CE1204-C, CE1227-C (K093725) | Canada Endoscope Corporation | 2010-08-30 |
| GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER, (K101199) | Maquet Critical Care AB | 2010-08-27 |
| BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT (K101832) | Medical Device Technologies, Inc. | 2010-08-27 |
| INNOVIA INNOPORT LAPAROSCOPIC ACCESS PORT (K093783) | Innovia, LLC | 2010-08-23 |
| EXTRACTOR PRO RX RETRIEVAL BALLONS, EXTRACTOR PRO XL RETRIEVAL BALLONS, EXTRACTOR PRO DL RETRIEVAL BALLONS MODEL M005470 (K102082) | Boston Scientific Corp | 2010-08-23 |
| MODULAR ENDOSCOPE (K093785) | Sialo Technology, Ltd. | 2010-08-18 |
| LO-50 LED LIGHT SOURCE (K102167) | Fiberoptics Technology, Inc. | 2010-08-17 |
| 2008 HEMODIALYSIS SORBENT SYSTEM (K093362) | Renal Solutions, Inc. | 2010-08-13 |
| HYBRID TROCAR SYSTEM (K101937) | Aesculap, Inc. | 2010-08-11 |
| ENDOCHOICE GRASPING INSULATED AND ALIGATOR JAW FORCEPS MODEL AMHGFA, ENDOCHOICE GRASPING INSULATED AND RAT TOOTH FORCEPS (K101298) | Endochoice, Inc. | 2010-08-05 |
| COLONOSCOPE/SIGMOIDOSCOPE SHEATHES (K100966) | Sheathing Technologies, Inc. | 2010-08-03 |
| NEOMED ENTERAL ONLY EXTENSION SET (K100288) | Neomed, Inc. | 2010-08-03 |
| TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-U (K093079) | Hobbs Medical, Inc. | 2010-08-02 |
| CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 (K101261) | C.R. Bard, Inc. | 2010-07-29 |
| GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H (K093608) | Gambro Renal Products, Inc. | 2010-07-29 |
| NAVIAID ICVI DEVICE (K101191) | Smart Medical Systems , Ltd. | 2010-07-27 |
| ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM (K101314) | Boston Scientific Corp | 2010-07-23 |
| MINI-TONG (K101101) | Mini Lap Technologies, Inc. | 2010-07-23 |
| ADVANIX DOUBLE PIGTAIL BILIARY STENT (K101786) | Boston Scientific Corp | 2010-07-23 |
| GUARDIAN CONNECTION (K101214) | Maulin Medical, LLC | 2010-07-23 |
| DIRECT PERORAL CHOLANGIOSCOPY BALLOON (K101095) | Wilson-Cook Medical, Inc. | 2010-07-19 |
| WATER BOTTLE CAP SYSTEM (K101146) | United States Endoscopy Group, Inc. | 2010-07-16 |
| LOGIFLEX LAPAROSCOPIC BAND POSITIONING DEVICE (K100109) | Surgical Innovations Plc | 2010-07-15 |
| THD BANDY (K093497) | Thd Spa | 2010-07-15 |
| OLYMPUS CF TYPE Y0023-L, Y0023I (K101053) | Olympus Medical Systems Corporation | 2010-07-14 |
| VENOFER PUMP (K093964) | Renal Solutions, Inc. | 2010-07-09 |
| EVIS EXERAII 180 SYSTEM (K100584) | Olympus Medical Systems Corporation | 2010-07-02 |
| MEDLINE PVC URETHRAL CATHETER (K100302) | Medline Industries, Inc. | 2010-07-02 |
| WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATON, HF-RESECTION ELECTRODE LOOPS AND BANDS (K100275) | Olympus Winter & Ibe GmbH | 2010-07-01 |
| SINGLE SITE FLEXIBLE BLADELESS OBTURATOR (K101671) | Teleflexmedical, Inc. | 2010-06-25 |
| OCTO (K100045) | Dalim Surgnet Corporation | 2010-06-25 |
| MEDICINA ENTERAL FEEDING TUBES AND ACCESSORIES MODEL MGX/YY (K100366) | Maxter Catheters | 2010-06-14 |
| GASTRIC PORT, MODELS: GAP-0016-00, GAP-0018-00, GAP-0020-00 (K082102) | Apollo Endosurgery, Inc. | 2010-06-14 |
| ORAL/ENTERAL SYRINGES (K100099) | Philips Children'S Medical Ventures | 2010-06-14 |
| THE WATER LILY (K094022) | Clearwater Products, LLC | 2010-06-11 |
| MODIFICATION TO:FRESENIUS 2008T HEMODIALYSIS MACHINE, MODEL 190573 (K093902) | Fresenius Medical Care North America | 2010-05-27 |
| SELF CATH CATHETER (K100878) | Coloplast Manufacturing Us, LLC | 2010-05-26 |
| PROSTIVA RF THERAPY MODEL 8929 HAND PIECE (K101139) | Medtronic, Inc. | 2010-05-21 |
| FARRELL VALVE WITH CORFLO ANTI-IV CONNECTORS MODEL 20-4300AIV (K100365) | Corpak Medsystems | 2010-05-20 |
| ENTERAL FEEDING TUBE AND ACCESSORIES, FEEDING TUBE EXTENSION SET (K092628) | Alan Reid | 2010-05-20 |
| KNOCKOUT SR MEDIUM, KNOCKOUT SR XENOFREE MEDIUM MODEL 10828, 12618 (K100616) | Life Technologies Corporation | 2010-05-20 |
| DISPOSABLE SUCTION AND IRRIGATION SYSTEM (K093479) | Modern Medical Equipment Mfg., Ltd. | 2010-05-19 |
| CLEARJET (K101094) | Easyglide , Ltd. | 2010-05-17 |
| VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM (K092789) | Terumo Cardiovascular Systems Corp. | 2010-05-12 |
| ACE STAPLER, MODEL F0031 (K082044) | Barosense, Inc. | 2010-05-11 |
| REDSENSE-HOME USE (K092955) | Redsense Medical AB | 2010-05-10 |
| STRYKER SWITCHPOINT INFINITY 3 CONTROL SYSTEM, MODEL: 067-8001-000 (K100852) | Stryker Communications | 2010-05-06 |
| SURGIQUEST ANCHORPORT SIL KIT (K100180) | Surgiquest, Inc. | 2010-05-05 |
| VIBROLITH AND VIBROLITH PLUS INTRACORPOREAL LITHOTRIPTOR (K092033) | Elmed USA | 2010-04-30 |
| MAMMOTOME BIOPSY SYSTEM FOR MOLECULAR IMAGING (K093899) | Ethicon Endo-Surgery, LLC | 2010-04-29 |
| VERSAPORT BLADELESS LOW PROFILE TROCAR MODEL NB3SHFLP, NB5SHFLP, NB5STFLP (K100548) | Covidien Lp, Formerly Registered AS Tyco Healthcar | 2010-04-26 |
| DIALYSATE METER, MODEL D-6 (K100237) | Myron L Company | 2010-04-23 |
| OLYMPUS FLUSHING PUMP OFP MODEL: OFP-1 (K100803) | Keymed, Inc. | 2010-04-22 |
| SPECIMEN RETRIEVAL SYSTEM (K100959) | Applied Medical Resources | 2010-04-22 |
| INSTAFLO BOWEL CATHETER SYSTEM KIT (K100273) | Hollister, Inc. | 2010-04-22 |
| DIACAP POLYSULFONE HIFLO 23 HEMODILAYZER , MODEL 72036811 (K100334) | B. Braun Avitum AG | 2010-04-22 |
| AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE (K100526) | Kentec Medical, Inc. | 2010-04-22 |
| NDS SURGICAL IMAGING, LLC FOR THE ZEROWIRE DUO WIRELESS HD VIDEO TRANSFER SYSTEM, MODEL WU-WX-WY (WHERE U=R OR T, W=P, X (K100195) | Nds Surgical Imaging | 2010-04-21 |
| IYUNNI 3ID TRI-FUNNEL FEEDING TUBE KIT (K100173) | Sainath Intellectual Properties, LLC | 2010-04-16 |
| ENTEROSCOPY OVERTUBE, MODEL 00712140 (K100081) | United States Endoscopy Group, Inc. | 2010-04-12 |
| NAVIX ACCESS DEVICE (K093279) | Xlumena | 2010-04-07 |
| MEDIVATORS DSD EDGE ENDOSCOPE REPROCESSING SYSTEM (K092387) | Minntech Corp. | 2010-04-05 |
| HEMODIALYSIS CARBON EXCHANGE, DUAL BED DEIONIZER EXCHANGE, MIXED BED DEIONIZER EXCHANGE, MODEL .60MAW,1.2MAW,3.6MAW, 1.2 (K092481) | New Aqua, LLC (Dba Aqua Systems) | 2010-04-02 |
| VITALA CONTINENCE CONTROL DEVICE (K083785) | Convatec | 2010-04-02 |
| RESOUND ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE (K100712) | Boston Scientific Corporation | 2010-03-30 |
| ETHICON ENDO SURGERY SLOTTED ANOSCOPE (K093896) | Ethicon Endo-Surgery, Inc. | 2010-03-25 |
| DBB-06 HEMODIALYSIS DELIVERY SYSTEM (K091978) | NIKKISO CO., LTD. | 2010-03-25 |
| BONASTENT BILIARY (K093003) | Endochoice, Inc. | 2010-03-24 |
| SYSTEMS INTEGRATION MODEL: ENDOALPHA (K100345) | Olympus Medical Systems Corporation | 2010-03-22 |
| LAPORT (K092584) | Mgb Endoskopische Gerate GmbH (Berlin) | 2010-03-22 |
| REPROCESSED TROCARS, MODEL B5LT AND CB5LT (K100080) | Ascent Healthcare Solutions | 2010-03-19 |
| LED LIGHT SOURCE (K093792) | Sunoptic Technologies, LLC | 2010-03-18 |
| NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER (K100520) | Nipro Medical Corporation | 2010-03-17 |
| SCUBA BILIARY STENT SYSTEM (K092352) | Invatec S.P.A. | 2010-03-16 |
| SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L (K091656) | Organ Recovery Systems, Inc. | 2010-03-11 |
| OLYMPUS CHF TYPE Y0003 (K093507) | Olympus Medical Systems Corporation | 2010-03-10 |
| ENDOCLEAR SYSTEM (K100346) | Virtual Ports, Ltd. | 2010-03-10 |
| CLEARPATH UGI (K093779) | Easyglide , Ltd. | 2010-03-09 |
| OPTISCAN MODEL OPTISCAN CEIS (K093624) | Optiscan Pty. , Ltd. | 2010-03-05 |
| MGB DISPOSABLE RETRIEVAL BAG LAPBAG (K093194) | Mgb Endoskopische Gerate GmbH (Berlin) | 2010-03-03 |
| ASEPT PERITONEAL DRAINAGE SYSTEM (K093796) | Pfm Medical, Inc. | 2010-02-26 |
| GYRUS ACMI PK BUTTON ELECTRODE (K093181) | Gyrus Acmi, Inc. | 2010-02-24 |