| RX HERCULINK 14 BILIARY STENT SYSTEM, MODELS 1005127-13, 1005129-13, 1005131-13, 1005133-13, 1005135-13, 1005137-13, 100 (K001224) | Guidant Corp. | 2000-05-17 |
| OTW MEGALINK SDS BILLIARY STENT SYSTEM, MODELS 1005509-18, 1005510-18, 1005511-18, 1005512-18, 1005509-28, 1005510-28, 1 (K001222) | Guidant Corp. | 2000-05-17 |
| OPTIVU HDVD SYSTEM (K001169) | Optimize, Inc. | 2000-05-16 |
| STRYKER IRRIGATION TUBE SET (K000493) | Stryker Endoscopy | 2000-05-15 |
| URETHROTOME 8667.XXX AND 8670.XXX (K000905) | Richard Wolf Medical Instruments Corp. | 2000-05-12 |
| OLYMPUS ENDOSCOPIC FLUSHING PUMP MODEL OFP-1 (K000948) | Keymed (Medical & Industrial Equipment), Ltd. | 2000-05-12 |
| FRESENIUS COMBILLINES SINGLE NEEDLE BLOOD TUBING SET, CATALOG #03-2290 (K000451) | Fresenius Medical Care North America | 2000-05-09 |
| PSK ENDOSCOPE CLEANING SYSTEM (K000216) | Psk Connectors Pty, Ltd. | 2000-05-09 |
| EVIS EXERA COLONOVIDEOSCOPE CF-Q160 AL/I AND PCF-160 AL/I (K001241) | The Olympus Optical Co. | 2000-05-09 |
| TRANSPAK (VITREORETINAL INFUSION PAK), MODELS 90000, 90001 (K000416) | Retinalabs.Com | 2000-05-08 |
| POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, MODEL 9043S0111 (K000386) | Medtronic Functional Diagnostics A/S | 2000-05-05 |
| H20NLY COMPLETE WATER PURIFICATION SYSTEM FOR HEMODIALYSIS (K993520) | Serv-A-Pure Co. | 2000-05-03 |
| KRONNER LOW PROFILE SCOPE HOLDER (K000663) | Kronner Prototypes, Inc. | 2000-05-02 |
| SENTRY EXPANDING INTRODUCER SHEATH (EIS) (K000545) | Applied Medical Resources | 2000-05-02 |
| BONE BIOPSY NEEDLE (K001132) | Promex, Inc. | 2000-05-01 |
| PERITONEAL DIALYSIS CATHETERS AND ADAPTERS (K993149) | Medionics International, Inc. | 2000-04-28 |
| GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODE (K001270) | Gyrus Medical , Ltd. | 2000-04-28 |
| ERCHINGER HEMORRHOIDAL LIGATORS: SUCTION LIGATORS, MOD. ERCHINGER, RUDD, MCGIVNEY MOD. ERCHINGER (K000297) | Erchinger Medizintecnik | 2000-04-24 |
| ACCUCORE SINGLE ACTION CORE BIOPSY DEVICE (K000612) | Inrad | 2000-04-24 |
| THERMOFLEX SYSTEM (K000508) | Argomed, Inc. | 2000-04-18 |
| IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS (K991908) | Idemsa | 2000-04-17 |
| AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS (K991519) | Ameriwater | 2000-04-14 |
| INTRASTENT DOUBLESTRUT XS STENT (K000864) | Intratherapeutics, Inc. | 2000-04-14 |
| DISPOSABLE INJECTOR OR DISPOSABLE SCLEROTHERAPY NEEDLE (K000646) | Enteric Medical Technologies | 2000-04-13 |
| 1 OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER (K000793) | Guidant Corp. | 2000-04-12 |
| MTP DISPOSABLE TROCAR VALVES (K000337) | Mtp Medical Technical Promotion GmbH | 2000-04-12 |
| MODIFICATION TO JMS APHERESIS NEEDLE (K000843) | Jms Co., Ltd. | 2000-04-10 |
| PRO.DUCT CATHETER, MODEL CTH03 (K000135) | Pro. Duct Health, Inc. | 2000-04-10 |
| PURE WATER, INC.'S BICARB MIX, STORAGE AND DISTRIBUTION SYSTEM (K993272) | Pure Water, Inc. | 2000-04-10 |
| MODIFICATION TO JMS A.V. FISTULA NEEDLE SET (K000845) | Jms Co., Ltd. | 2000-04-10 |
| RENAFLO II HF 2000 HEMOFILTER (K000028) | Minntech Corp. | 2000-04-04 |
| S57D DIGITAL OPERATING ROOM CAMERA (K000422) | Sopro | 2000-03-31 |
| CORTEK LAPAROSCOPES (K000202) | Cortek Endoscopy, Inc. | 2000-03-31 |
| S52D DIGITAL VIDEO LAPAROSCOPE (K000423) | Sopro | 2000-03-31 |
| S51D DIGITAL ENDOSCOPY CAMERA (K000424) | Sopro | 2000-03-31 |
| SMITH & NEPHEW SUTURELOK, MODEL 7207321 (K000717) | Smith & Nephew, Inc. | 2000-03-30 |
| OLYMPUS XCYF-1T3 OES CYSTOFIBERSCOPE/NEPHROFIBERSCOPE ACCESSORIES AND ANCILLARY EQUIPMENT (K993041) | The Olympus Optical Co. | 2000-03-30 |
| CORDIS MEDIUM PALMAZ TRANSHEPATIC BILIARY STENT & DELIVERY (K000564) | Cordis Corp. | 2000-03-23 |
| SEMI COMPLIANT (SC) 35 BALLOON DILATATION CATHETER (K993303) | Boston Scientific Corp | 2000-03-23 |
| STERICHEK TOTAL CHLORINE REAGENT STRIPS (K994226) | Environmental Test Systems, Inc. | 2000-03-22 |
| VIDEOLABS MEDCAM PROPLUS VIDEO CAMERA AND INTEGRAL LIGHT SOURCE (K000229) | Videolabs, Inc. | 2000-03-21 |
| BARD ENDOSCOPIC SUTURING SYSTEM (K994290) | C.R. Bard, Inc. | 2000-03-20 |
| ERECXEL ADJUSTABLE PENILE BANDS, CONTREX ADJUSTABLE PENILE BANDS (K993343) | Erecxel Enterprises | 2000-03-20 |
| REVERSO (K994306) | Medisystems Corp. | 2000-03-20 |
| OTW MEGALINK SDS BILIARY STENT SYSTEM (K000550) | Advanced Cardiovascular Systems, Inc. | 2000-03-17 |
| FRESENIUS 2008K (K994267) | Fresenius Medical Care | 2000-03-16 |
| WILSON-COOK REUSABLE HOT BIOPSY FORCEPS (K000086) | Wilson-Cook Medical, Inc. | 2000-03-15 |
| SIGHTSURE OPERATION INDICATOR, MODEL SS301 (K993358) | Medevices, Inc. | 2000-03-15 |
| SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228; INJECTION SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODEL (K000397) | Boston Scientific Corp | 2000-03-07 |
| CORTEK CYSTOSCOPE (K000197) | Cortek Endoscopy, Inc. | 2000-03-03 |
| ENDOSCOPIC ANTI FOG DEVICE (K993604) | Mectra Labs, Inc. | 2000-03-03 |
| KSEA SCB-RUI (K994348) | KARL STORZ Endoscopy-America, Inc. | 2000-03-03 |
| CORTEK URETHEROSCOPE (K000200) | Cortek Endoscopy, Inc. | 2000-03-03 |
| SUPERSTITCH (K994087) | Sutura, Inc. | 2000-03-01 |
| NEURO URODYNAMIC SUITE, MODEL 9032E0101 (K992715) | Medtronic Functional Diagnostics A/S | 2000-02-28 |
| PATHWAY VAGINAL EMG/STIM PERINEOMETER SENSOR, PATHWAY ANAL EMG/STIM PERINEOMETER SENSOR (K993976) | The Prometheus Group | 2000-02-22 |
| FLOCATH (K000070) | Rusch Intl. | 2000-02-18 |
| SPOT ENDOSCOPIC MARKER (K993951) | Chek-Med Systems | 2000-02-18 |
| CAVERMAP SURGICAL AID (K993436) | Uromed Corp. | 2000-02-11 |
| GASTRO-INTESTINAL SYSTEM EN-410WM (K993704) | Fujinon, Inc. | 2000-02-11 |
| EASY CARE AND TUBING SETS (K994218) | Medionics International, Inc. | 2000-02-10 |
| EXEL I.V. BLOOD LINE SET (K992039) | Exelint Intl. Co. | 2000-02-10 |
| NASOGASTRIC TUBE HOLDER, MODEL 160 (K994300) | Dale Medical Products, Inc. | 2000-02-10 |
| UROSURGE PERCUTANEOUS SANS (STOLLER AFFERENT NERVE STIMULATOR) DEVICE (DEN000002) | Urosurge, Inc. | 2000-02-09 |
| BIOTEQUE HEMODIALYSIS BLOOD TUBING SET (K992930) | Bioteque Corp. | 2000-02-09 |
| KARL STORZ AUTOCLAVABLE CAMERA HEAD (K994090) | Karl Storz Imaging, Inc. | 2000-02-04 |
| SUCTION IRRIGATION TRUMPET VALVE SET, MODEL Q65-823 (K994256) | A & A Medical, Inc. | 2000-02-03 |
| INTRASTENT DOUBLESTRUT LD (K993904) | Intratherapeutics, Inc. | 2000-02-01 |
| BARD UROFORCE BALLOON DILATION CATHETER (K993840) | C.R. Bard, Inc. | 2000-01-31 |
| NANMA NON-ADJUSTABLE CONSTRICTION RING (K993906) | Nanma Mfg Co., Ltd. | 2000-01-31 |
| NANMA AJUSTABLE CONSTRICTION RING (K993908) | Nanma Mfg Co., Ltd. | 2000-01-31 |
| MD 420/440/460/470/480/490 (K993200) | Isopure, Corp. | 2000-01-24 |
| PURE WATER, INC.'S WATER PURIFICATION SYSTEMS (K992786) | Pure Water, Inc. | 2000-01-24 |
| PURE WATER INC'S ACIDIFIED STORAGE AND DISTRIBUTION SYSTEM WITH OPTIONAL REMOTE FILL (K993058) | Pure Water, Inc. | 2000-01-24 |
| SMITH & NEPHEW XENON LIGHT SOURCES AND ACCESSORIES (K994084) | Smith & Nephew, Inc. | 2000-01-20 |
| HP M2376A DEVICE LINK SYSTEM (K993587) | Hewlett-Packard Co. | 2000-01-20 |
| MTP DISPOSABLE TROCARS (K994066) | Mtp Medical Technical Promotion GmbH | 2000-01-20 |
| AF-180 HEMODIALYZER (K992564) | Althin Medical AB | 2000-01-18 |
| AF-150 HEMODIALYZER (K992566) | Althin Medical AB | 2000-01-18 |
| AF-220 HEMODIALYZER (K992573) | Althin Medical AB | 2000-01-18 |
| A-22 HEMODIALYZER (K992563) | Althin Medical AB | 2000-01-18 |
| CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER (K993720) | Cordis Corp. | 2000-01-18 |
| VIRGINIA WATER SYSTEMS' WATER PURIFICATION SYSTEM FOR HEMODIALYSIS (K991916) | Virginia Water Systems, Inc. | 2000-01-14 |
| LEMAITRE BILIARY CATHETER (K992941) | Vascutech, Inc. | 2000-01-12 |
| AMSURE ENTERAL DELIVERY PUMP SET WITH SPIKE (K992719) | Amsino Intl., Inc. | 2000-01-12 |
| AMUKIN D (K992016) | Amuchina Intl., Inc. | 2000-01-10 |
| AUTOMATED CORE BIOPSY DEVICE (K994272) | Promex, Inc. | 2000-01-07 |
| MODIFICATION TO CORDIS PALMAZ CORINTHIAN IQ TRANSHEPATIC BILIARY STENT, MODELS PQ294B, PQ394B (K994156) | Cordis Corp. | 2000-01-07 |
| BARD MEMOTHERM FLEXX BILIARY STENT (K993392) | C.R. Bard, Inc. | 2000-01-06 |
| DURAGLIDE STONE REMOVAL BALLOON, MODEL 000635-38, 000646-47, DURAGLIDE STONE BALLOON, MODEL 007124-25,007144-45 (K993892) | C.R. Bard, Inc. | 2000-01-06 |
| HYDROTOWER MANAGEMENT SYSTEM, MODEL 4-750-00 (K993778) | Northgate Technologies, Inc. | 2000-01-06 |
| DISPOS-A-SCOPE (K993738) | Dispos-A-Scope | 2000-01-06 |
| MEDISYSTEMS BUTTONHOLE NEEDLE SETS (K990803) | Medisystems Corp. | 2000-01-06 |
| THERMOCHEM-HT SYSTEM (K993330) | Hemocleanse, Inc. | 1999-12-30 |
| WALLSTENT BILIARY ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM (K993232) | Boston Scientific Scimed, Inc. | 1999-12-30 |
| URETERAL ACCESS SHEATH SET - NEW MODELS (K993650) | Applied Medical Resources | 1999-12-28 |
| ELITE CUSTOM (K993142) | Soma Blue, Inc. | 1999-12-27 |
| GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE ELECTRODE (K994166) | Gyrus Medical , Ltd. | 1999-12-27 |
| 15MM SITESELECT BREAST BIOPSY DEVICE, 10 MM SITESELECT BREAST BIOPSY DEVICE, 5MM SITESELECT BREAST BIOPSY DEVICE (K993936) | Imagyn Surgical | 1999-12-27 |
| VITALITY SYSTEM (K993143) | Soma Blue, Inc. | 1999-12-27 |