| VIVANT BREAST LESION LOCALIZATION DEVICE (K003439) | Vivant Medical, Inc. | 2000-12-15 |
| MERIT DRAINAGE DEPOT (K003078) | Merit Medical Systems, Inc. | 2000-12-11 |
| SCHAEFER WATER CENTER HEMODIALYSIS WATER PURIFICATION SYSTEM, MODEL HWPS-100 (K000249) | Schaefer Water Centers | 2000-12-11 |
| SNARE,FLEXIBLE (K002927) | Odon Lifetechnology | 2000-12-10 |
| BARD ALL-SILICONE 3-WAY FOLEY CATHETER; BARD LUBRI-SIL 3-WAY FOLEY CATHETER; BARD LUBRI-SIL I.C. 3-WAY FOLEY CATHETER (K002868) | C.R. Bard, Inc. | 2000-12-08 |
| INTRASTENT DOUBLESTRUT PARAMOUNT BILIARY ENDOPROSTHESIS (K003450) | Intratherapeutics, Inc. | 2000-12-07 |
| NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET (K001465) | Nipro Medical Corp. | 2000-12-05 |
| ENDOSCOPE CONTOUR DETECTION DEVICE, MODEL 3DX45 AND COLONOSCOPE, MODEL XCF-Q140L/13D (K002749) | The Olympus Optical Co. | 2000-12-04 |
| FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS (K002761) | Fresenius Medical Care North America | 2000-12-04 |
| FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2 (K003445) | Fresenius Medical Care North America | 2000-12-01 |
| MODIFICATION TO S.M.A.R.T NITINOL STENT TRANSHEPATIC BILIARY SYSTEM (K003336) | Cordis Corp. | 2000-11-22 |
| SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET (K001563) | Scion Cardiovascular, Inc. | 2000-11-22 |
| TRANSONIC HEMODIALYSIS FLOW REVERSER, MODEL B FLOWREV (K002816) | Transonic Systems, Inc. | 2000-11-22 |
| S.M.A.R.T NITINOL STENT ENDOSOPIC BILLARY SYSTEM (VARIOUS) (K003365) | Cordis Corp. | 2000-11-22 |
| ENTERIC INJECTION CATHETER WITH IRRIGATION (K002778) | Enteric Medical Technologies, Inc. | 2000-11-22 |
| JAMSHIDI MARROW ACQUISITION CRADLE (K003370) | Allegiance Healthcare Corp. | 2000-11-22 |
| NIPRO SAFETOUCH SAFETY FISTULA NEEDLE (K002813) | Nipro Medical Corp. | 2000-11-21 |
| ADVANCED UROSCIENCE INNERSHEATH (K002573) | Advanced Uroscience, Inc. | 2000-11-16 |
| PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210 (K001685) | Baxter Healthcare Corp | 2000-11-15 |
| MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER (K003222) | Computer Motion, Inc. | 2000-11-03 |
| HERMES PORT EXPANDER (K003217) | Computer Motion, Inc. | 2000-11-03 |
| 3D ENDOSCOPE (K002924) | KARL STORZ Endoscopy-America, Inc. | 2000-11-03 |
| ENDOPATH ETS45, ETS FLEX45, ETS COMPACT-FLEX45 LINEAR CUTTERS, ETS FLEX45 AND ETS COMPACT-FLEX45 NO-KNIFE ARTICULATING (K002398) | Ethicon Endo-Surgery, Inc. | 2000-11-03 |
| MEDOVATIONS ESOPHAGEAL DILATOR (K002363) | Medovations, Inc. | 2000-11-01 |
| CIV-FLEX HOLSTER COVER, MODEL STERILE, LATEX-FREE (K002546) | CIVCO Medical Instruments Co., Inc. | 2000-10-31 |
| NIR BILIARY STENT (K002130) | Medinol, Ltd. | 2000-10-30 |
| KSEA VASCULAR FIBERSCOPES (K001408) | KARL STORZ Endoscopy-America, Inc. | 2000-10-30 |
| GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER (K994390) | Gambro Healthcare | 2000-10-26 |
| ACCESS ALERT GAUGE (K002372) | Medisystems Corp. | 2000-10-25 |
| NEU-ION HEMODIALYIS WATER TREATMENT SYSTEM (K001811) | Neu-Ion, Inc. | 2000-10-25 |
| ELRAN 01 SYSTEM (K002431) | Envision Advanced Medical System, Ltd. | 2000-10-24 |
| REUSABLE CANNULA (K002542) | Genicon, LC | 2000-10-23 |
| IMPOAID (K000730) | Impoaid, Inc. | 2000-10-19 |
| INSIGHT 4000 ENDOSCOPE (K000252) | Insight Instruments Mfg., Inc. | 2000-10-17 |
| ENDOCARE PERCUTANEOUS ACCESS SET (K002396) | Endocare, Inc. | 2000-10-13 |
| NIR BILLIARY STENT SYSTEM; MARSHAL BALLOON DILATATION CATHETER (K002133) | Boston Scientific Corp | 2000-10-12 |
| DYNALINK BILIARY SELF-EXPANDING STENT SYSTEM (K002143) | Guidant Corp. | 2000-10-12 |
| RAPID EXCHANGE TAPERTOME (K002802) | Boston Scientific Corp | 2000-10-05 |
| BRAVO PH MONITORING SYSTEM (K002028) | Endonetics, Inc. | 2000-09-29 |
| OMNIPORT (K002013) | Advanced Surgical Concepts (Asc) | 2000-09-29 |
| KEYSTONE MEDICAL SCHON XL SOFT-LINE DOUBLE LUMENT CATHETER. KEYSTONE MEDICAL 12 F DUO-FLOW AND 14F DUO-FLOW 400 XL CATH (K001958) | Keystone Medical | 2000-09-25 |
| 14 FR TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT WITH BLUE FLEXTIP ARROWG+ARD BLUE CATHETER FOR HIGH VOLUME INFUSIONS, PRO (K993933) | Arrow Intl., Inc. | 2000-09-14 |
| OLYMPUS XGIF-N200H GASTROINTESTINAL VIDEOSCOPE (K001766) | Olympus Optical Co., Ltd. | 2000-09-08 |
| SPECTRUM SILICONE FOLEY CATHETER (K000251) | Cook Urological, Inc. | 2000-08-30 |
| MICROVASIVE RAPID EXCHANGE BILIARY BALLOON DILATATION CATHETER (K001338) | Boston Scientific Corp | 2000-08-30 |
| NEOCONTROL PELVIC FLOOR THERAPY SYSTEM (K001903) | Neotonus, Inc. | 2000-08-29 |
| FLUID PROCESS SYSTEMS EXCHANGE CARBON AND DEIONIZATION TANKS FOR USE IN HEMODIALYSIS (K991495) | Fluid Process Systems, Inc. | 2000-08-28 |
| INTRASTENT DOUBLESTRUT PARAMOUNT (K001648) | Intratherapeutics, Inc. | 2000-08-28 |
| HEMOFEEL-CH, MODELS CH-0.35L, CH-0.6L, CH-1.0L (K994198) | Toray Industries (America), Inc. | 2000-08-25 |
| FRESENIUS OPTIFLUX 200NR (K002277) | Fresenius Medical Care North America | 2000-08-25 |
| MODIFICATION TO INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM (K001666) | Intuitive Surgical, Inc. | 2000-08-24 |
| LIFESITE HEMODIALYSIS ACCESS SYSTEM/CANNULA EXCHANGE, MODEL LHAS14120 & LHCEK0000 (K001633) | Vasca, Inc. | 2000-08-24 |
| FLO ASSISTANT, MODEL 4-250-00 (K001325) | Northgate Technologies, Inc. | 2000-08-18 |
| NDO SURGICAL SURGICAL OVERTUBE (K002018) | Surgical, Inc. | 2000-08-17 |
| APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS) (K001250) | Asahi Medical Co., Ltd. | 2000-08-16 |
| DIALGUARD ENDOTOXIN REMOVAL DEVICE (K993806) | Clarigen, Inc. | 2000-08-14 |
| SIEMENS INTEGRATED OPERATING SYSTEM (SIOS) (K994231) | Siemens Medical Corp. | 2000-08-10 |
| CLEARWATER COLON HYDROTHERAPY (DISPOSABLE SPECULUM SPO1 LARGE & SP02 SMALL) (K000388) | Clearwater Colon Hydrotherapy, Inc. | 2000-08-08 |
| DETRUSAN 500 (K994109) | Innovamed USA, Inc. | 2000-08-03 |
| A.V. FISTULA NEEDLE (K001496) | Exelint International, Co. | 2000-08-01 |
| PATHWAY CTS 2000 PELVIC FLOOR TRAINING SYSTEM, MODEL PATHWAY CTS 2000 (K001515) | The Prometheus Group | 2000-07-31 |
| ADVANCED UROSCIENCE INJECTION NEEDLE (K002323) | Advanced Uroscience, Inc. | 2000-07-31 |
| ANGIODYNAMICS ABSCESSION BILIARY DRAINAGE CATHETER (K002101) | AngioDynamics, Inc. | 2000-07-31 |
| HEMOSAFE PATIENT CONNECTOR FOR FRESENIUS BLOODLINES, MODEL 04-9100-0 (K001873) | Fresenius Medical Care North America | 2000-07-28 |
| GASTRIC LAVAGE VALVE (K990365) | T-Med Vac Corporation | 2000-07-26 |
| MICROVASIVE LITHOTRIPTOR FLEXPROBE II (K002084) | Boston Scientific Corp | 2000-07-19 |
| NANMA VACUUM PUMP (K993909) | Nanma Mfg Co., Ltd. | 2000-07-19 |
| CA GUARD, LTD. PSP (PORT SITE PROTECTOR) (K992182) | Ca Guard, Ltd. | 2000-07-18 |
| S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM (K001843) | Cordis Corp. | 2000-07-18 |
| MICRO LINK ENDOSCOPIC FIBER CABLE, MODEL B1-90159 (K001698) | Cogent Light Technologies, Inc. | 2000-07-17 |
| INTRODUCER SHEATH (K001328) | Novasys Medical, Inc. | 2000-07-17 |
| RIZA BAND STRETCHER (RBS)-60000 (K001236) | R-Med, Inc. | 2000-07-17 |
| KARL STORZ 3D VIDEO SYSTEM (K001362) | Karl Storz Imaging, Inc. | 2000-07-17 |
| ACCUSET SENSOR, MODEL 2000 (K001386) | Pelvicare, Inc. | 2000-07-17 |
| ISLAND BIOSURGICAL BNS KIT #3 (K001583) | Island Biosurgical, LLC | 2000-07-13 |
| STERICHEK TOTAL CHLORINE REAGENT STRIPS (K001194) | Environmental Test Systems, Inc. | 2000-07-11 |
| INSIDE VIEW (K001217) | Monadnock Optics, Inc. | 2000-07-11 |
| INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENTS, INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEM (K990144) | Intuitive Surgical, Inc. | 2000-07-11 |
| SENSATION -VACUUM ASSIST DEVICES (K000124) | Prosurg, Inc. | 2000-07-10 |
| PHOENIX HEMODIALYSIS DELIVERY SYSTEM, GAMBRO CARTRIDGE FOR HEMODIALYSIS BLOOD TUBING SET (K001156) | Gambro Renal Products | 2000-07-07 |
| RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER (K001143) | Rochester Medical Corp. | 2000-07-07 |
| NORMOCARB STERILE BICARBONATE RENAL DIALYSIS (K001059) | Novex Pharma | 2000-06-30 |
| GENYX FLEXIBLE INJECTION NEEEDLE (K001146) | Geny Medical, Inc. | 2000-06-30 |
| RECTOSIGHT RS 300-04 (K994130) | Sightline Technologies , Ltd. | 2000-06-30 |
| BX TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM (K001258) | Cordis Corp. | 2000-06-27 |
| FRESENIUS COMBILINES LOW VOLUME BLOOD TUBING SET, MODELS 03-2291 (POST PUMP) AND 03-2292 (PRE-PUMP) (K001107) | Fresenius Medical Care North America | 2000-06-23 |
| 3.5 MM LAPAROSCOPE (LG100, LG103) (K001594) | Surgical Image Laboratories, Inc. | 2000-06-12 |
| CITRASATE DIALYSATE ACID CONCENTRATE LIQUID, MODELS CS-1XXX-XX, CS-XXX-XX, CS-3XXX-XX (K000792) | Advanced Renal Technologies, Inc. | 2000-06-08 |
| BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR (K000702) | Fresenius Medical Care North America | 2000-06-07 |
| MEMCATH UROLOGY INTRODUCER SHEATH, MODEL 201 (K000767) | Memcath Technologies, LLC | 2000-06-05 |
| CONMED TROGARD FINESSE TROCAR SYSTEM, MODEL 60-6050-XXX (K001597) | Conmedcorp | 2000-06-05 |
| NEPHROSCOPE, 12 DEGREES; DIAPHRAGM VALVE; IRRIGATION ATTACHMENT; NEPHROSCOPE, 20 DEGREE, STRAIGHT VIEW; NEPHROSCOPE, 20 (K994223) | Richard Wolf Medical Instruments Corp. | 2000-06-05 |
| MEDTRONIC AVE BRIDGE X3 STENT (K000744) | Medtronic Ave, Inc. | 2000-06-05 |
| PSN HEMODIALYZER, MODELS PSN 170, PSN 210 (K001422) | Baxter Healthcare Corp | 2000-06-02 |
| KSEA MANHES PNEUMOTROCAR (K000769) | KARL STORZ Endoscopy-America, Inc. | 2000-06-01 |
| EAGLE ENDO SPECIMEN RETRIEVAL BAG (K001264) | Eagle Endoscopic, Inc. | 2000-05-30 |
| MEDIVISION I-VIEW PERSONAL VIDEO DISPLAY (K000669) | Medivision Endoscopy | 2000-05-26 |
| NELSON WATER SYSTEMS FOR HEMODIALYSIS (K993877) | Nelson Environmental Technologies, Inc. | 2000-05-25 |
| WALLSTENT BILIARY ENDOPROSTHESIS (K000308) | Boston Scientific Corp | 2000-05-19 |
| HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC) (K000723) | Rochester Medical Corp. | 2000-05-19 |