| MODIFICATION TO VAXCEL DIALYSIS CATHETER (K012948) | Boston Scientific/Medi-Tech | 2001-10-03 |
| AQUA WATER TREATMENT FOR HEMODIALYSIS (K010592) | Aqua Water Treatment, Inc. | 2001-09-28 |
| VANGUARD REPROCESSED ELECTRIC BIOPSY FORCEPS (K011800) | Vanguard Medical Concepts, Inc. | 2001-09-27 |
| DIALYSATE LINE WITH CONNECTORS/RE-USE WASH-OUT LINES (K010712) | Molded Products, Inc. | 2001-09-27 |
| XBO1-824-18/19/20 BIOPSY FORCEPS (K012074) | The Olympus Optical Co. | 2001-09-25 |
| LH400 YES-SET Y-PORT ENTERAL SPIKE PUMP SET (K011341) | Lh Medical Products, Inc. | 2001-09-21 |
| LH 500 ENTERAL FEEDING GRAVITY BAG SET (K011343) | Lh Medical Products, Inc. | 2001-09-21 |
| LH 450 ENTERAL FEEDING BAG PUMP SET W/INTEGRATED Y-PORT (K011340) | Lh Medical Products, Inc. | 2001-09-21 |
| PATTON ENDO-BAG (K012150) | Patton Medical Corp. | 2001-09-20 |
| DYONICS VISION 635 DIGITAL CAPTURE SYSTEM, MODEL 7209088 (K011944) | Smith & Nephew, Inc. | 2001-09-19 |
| LOWSLEY SUPRAPUBIC TRACTOR (K012153) | Circon Video | 2001-09-19 |
| SUCTION PUMP FOR INTRACORPOREAL ULTRASOUND LITHOTRIPTER AND ACCESSORIES, MODEL 2207.XXX (K011911) | Richard Wolf Medical Instruments Corp. | 2001-09-17 |
| ANCHOR GUIDE LESION LOCALIZATION DEVICE; ANCOR GUIDE HOLDER; RF GENERATOR CABLE (K012023) | Senorx, Inc. | 2001-09-12 |
| CIRCON AEH-4 ELECTROHYDRAULIC LITHOTRIPSY PROBE (K011848) | Circon Video | 2001-09-11 |
| KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR (K011841) | Karl Storz Endoscopy | 2001-09-10 |
| AQUANET, MODEL EC 2000 (K000031) | Prime Pacific Health Innovations Corporation | 2001-09-10 |
| PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY (K011806) | Sulzer Intratherapeutics, Inc. | 2001-09-07 |
| CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON OPTA PRO .035 DELIVERY SYSTEM (K012590) | Cordis Corp. | 2001-09-07 |
| JMS A.V. FISTULA NEEDLE SET ACCORDION TYPE (K002352) | Jms Co., Ltd. | 2001-09-06 |
| LIVER TAMPONADE BALLOON (K010450) | Cook, Inc. | 2001-09-06 |
| UROSCOPE, ARTES MEDICAL, USA (K003988) | Artes Medical USA, Inc. | 2001-09-06 |
| VERASTEP (K012539) | United States Surgical, A Division of Tyco Healthc | 2001-09-06 |
| DORNIER LITHOTRIPTER S(DOLI S) & DORNIER LITHOTRIPTER S-XP (DOLI S-XP) (K011873) | Dornier | 2001-08-31 |
| MONARCH, TRANSSHAPING GASTROSTOMY TUBE MODEL 9-2010 (K012476) | Applied Medical Technology, Inc. | 2001-08-31 |
| PALMAZ GENESIS TRANSHEPATIC BILLARY STENT AND DELIVERY SYSTEM (K010411) | Cordis Corp. | 2001-08-27 |
| OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CTR, EUS EXERA ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UM 160, (K011886) | Olympus America, Inc. | 2001-08-27 |
| VAXCEL DIALYSIS CATHETER (K012365) | Boston Scientific Corp | 2001-08-24 |
| EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA) (K012445) | Electro Medical Systems SA | 2001-08-24 |
| PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY (K012347) | Sulzer Intratherapeutics, Inc. | 2001-08-23 |
| MODIFICATION TO: LOFRIC PLUS SINGLE USE URINARY CATHETER (K012374) | Astra Tech, Inc. | 2001-08-23 |
| RADIUS NEXT GENERATION GUIDEWIRE (K011759) | Radius Medical Technologies, Inc. | 2001-08-23 |
| BRIDGE FX (K011817) | Medtronic Ave, Inc. | 2001-08-22 |
| SINGLE ACTION BIOPSY NEEDLE, MODEL RCBS: XX GAUGE, XX LENGTH, XX THROW (K012224) | Ranfac, Corp. | 2001-08-22 |
| NIROYAL BILIARY PREMOUNTED STENT SYSTEM (K012216) | Boston Scientific Scimed, Inc. | 2001-08-17 |
| SPEEDYBELL (K010735) | Biopsybell S.A.S. | 2001-08-17 |
| 22MM SITESELECT BREAST BIOPSY DEVICE MODEL SSD022 (K011575) | Imagyn Surgical | 2001-08-17 |
| HORIZONS INTERNATIONAL POLYPECTOMY SNARES (K011667) | Horizons Intl. Corp. | 2001-08-16 |
| FRESENIUS ARTERIAL BLOODLINE SETS FOR HEMODIALYSIS, FRESENIUS COMBI SETS HEMODIALYSIS BLOOD TUBING SETS (K012242) | Fresenius Medical Care North America | 2001-08-16 |
| NURSE'S ASSISTANT O.R. CONTROL SYSTEM (K010754) | Valmed Corp. | 2001-08-15 |
| DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC(32 CM), CC3200PC(36 CM) (K010399) | Diatek, Inc. | 2001-08-14 |
| INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESIS (K011184) | Intratherapeutics, Inc. | 2001-08-13 |
| COOK ZILVER BILIARY STENT (K010242) | Cook, Inc. | 2001-08-13 |
| OLYMPUS INJECTOR NM-4-1, NM-5-1, NM-6-1, NM-7-1, NM-8-1, NM-9-1 (K011484) | Olympus Optical Co., Ltd. | 2001-08-10 |
| CYSTO-URETHROSCOPES E-LINE EXISTING OF: SHEATHS, OBTURATORS, INSERTS, ATTCHEMENTS, AND FORCEPS MODEL 8650, 8652, 8660 (K011496) | Richard Wolf Medical Instruments Corp. | 2001-08-10 |
| ROSS EMBRACE PUMP SET (K011467) | Ross Products | 2001-08-10 |
| POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, POLYGRAM 98 ESOPHAGEAL MANOMETRY APPLICATION, POLYGRAF ID (K011472) | Medtronic Functional Diagnostics A/S | 2001-08-10 |
| GIBBONS STERILE TROCAR KITS (K012198) | Gibbons Surgical Corp. | 2001-08-09 |
| ENDOPATH NON-BLADED SOLID OBTURATOR TROCAR SYSTEM (K011538) | Ethicon Endo-Surgery, Inc. | 2001-08-09 |
| DRY AC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS (K011368) | Gambro Renal Products | 2001-08-02 |
| CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT (K012090) | Cordis, A Johnson & Johnson Co. | 2001-08-01 |
| CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT (K012087) | Cordis Corp. | 2001-08-01 |
| PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY (K012066) | Sulzer Intratherapeutics, Inc. | 2001-08-01 |
| CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM (K012056) | Cordis Europa, N.V. | 2001-08-01 |
| GIVEN DIAGNOSTIC IMAGING SYSTEM (DEN010002) | Given Imaging , Ltd. | 2001-08-01 |
| UNITIP GASTROINTESTINAL PRESSURE SENSOR CATHETER (K003580) | Unisensor AG | 2001-07-31 |
| R STENT BILIARY ENDOPROSTHESIS (K010107) | Orbus Medical Technologies | 2001-07-31 |
| MEDIFIX URETEROSCOPE (K011325) | Medifix, Inc. | 2001-07-25 |
| TACKER, MODEL R65-933 (K003949) | A & A Medical, Inc. | 2001-07-25 |
| DRAINAGE CATHETER OR FOLEY CATHETER (K010006) | Applied Medical Resources Corp. | 2001-07-25 |
| INTUITIVE SURGICAL ULTRASONIC SHEARS (K011281) | Intuitive Surgical, Inc. | 2001-07-24 |
| VACUUM ASSISTED CORE BIOPSY DEVICE (K010400) | Promex, Inc. | 2001-07-24 |
| MTP LAPAROMAT DISPOSABLE TUBING SET (K011360) | Mtp Medical Technical Promotion GmbH | 2001-07-19 |
| ENDOPOUCH RETRIEVER (K011501) | Ethicon Endo-Surgery, Inc. | 2001-07-19 |
| UROLOGICAL CATHETER (K011552) | Apogee Medical, Inc. | 2001-07-18 |
| PARALLAX BONE AND VERTEBRAL BODY BIOPSY AND INFUSION NEEDLES (K011206) | Parallax Medical, Inc. | 2001-07-18 |
| DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM (K011881) | Guidant Corp. | 2001-07-18 |
| MESH URETERAL STENT (K011264) | Applied Medical Resources Corp. | 2001-07-17 |
| VIADUCT MICROENDOSCOPE AND ACCESSORIES (K011189) | Acueity, Inc. | 2001-07-16 |
| IMAGER II UROLOGY TORQUE CATHETER, MODEL 40030X1, 40040X1, AND 40050X1 (K011965) | Boston Scientific Corp | 2001-07-13 |
| ENDOPATH NON-BLADED OBTURATOR TROCAR SYSTEM (5 MM) (K011257) | Ethicon Endo-Surgery, Inc. | 2001-07-13 |
| DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNT (K011862) | Denver Biomedical, Inc. | 2001-07-12 |
| RECTOSIGHT RS300-04;AND PROTOSIGHT PS300-04 DEVICE (K011825) | Sightline Technologies , Ltd. | 2001-07-11 |
| MODULAR VALVE HANDLES FOR ADAPTABLE TUBES, MODEL 1298-XX-XX, 1295-XX-XX (K011997) | Pajunk GmbH | 2001-07-10 |
| GASTRIC SUCTION AND DRAINAGE CATHETER (K002838) | Bioenterics Corp. | 2001-07-09 |
| PRECISION TUNA OFFICE SYSTEM WITH NO RECTAL TEMPERATURE MONITORING TAPE (K011787) | Vidamed, Inc. | 2001-07-06 |
| MODIFICATION TO KSEA ENDOTIP SYSTEM (K011359) | KARL STORZ Endoscopy-America, Inc. | 2001-06-28 |
| EASYBELL (K011075) | Biopsybell S.A.S. | 2001-06-27 |
| DORNIER LITHOTRIPTER 140(DOLI 140) (K011773) | Dornier | 2001-06-22 |
| TAUT BALLOON CATHETER, MODEL 50640 (K011018) | Taut, Inc. | 2001-06-22 |
| CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 (K011015) | C.R. Bard, Inc. | 2001-06-22 |
| SANDHILL UNITIP CATHETER PRESSURE SENSOR, MODEL K 5251-L3-0026 (K002427) | Sandhill Scientific, Inc. | 2001-06-22 |
| HMT 21, HMT 2000 URINARY INCONTINENCE SYSTEM (K011435) | Hmt, Inc. | 2001-06-22 |
| MAR COR SERVICES SEMPER PURE RO MACHINE (K003877) | Mar Cor Services, Inc. | 2001-06-22 |
| AUTOMATED CORE BIOPSY DEVICE (K011270) | Promex, Inc. | 2001-06-22 |
| MEDCOMP ASH SPLIT (K011576) | Medical Components, Inc. | 2001-06-21 |
| LAP DISC 120 X 120, MODEL LD111, LAP DISC 120 X 100, MODEL LD112, LAP DISC 70 X 70, MODEL LD113 (K010870) | Ethicon Endo-Surgery, Inc. | 2001-06-18 |
| OMNILINK .035 BILIARY STENT SYSTEM (K011506) | Guidant Corp. | 2001-06-15 |
| OMNIPORT HAND AND INSTRUMENT ACCESS DEVICE (K011183) | Advanced Surgical Concepts (Asc) | 2001-06-15 |
| ULTRACONCENTRATOR SYSTEM (K011148) | Interpore Cross Intl. | 2001-06-13 |
| MEDCOMP ULTRA-FLOW CATHETER (K003207) | Medical Components, Inc. | 2001-06-12 |
| ART BICARBONATE FOR HEMODIALYSIS, ART BICARBONATE LIQUID FOR HEMODIALYSIS (K010760) | Advanced Renal Technologies, Inc. | 2001-06-11 |
| MAR COR SERVICES BICARB SYSTEM (K003560) | Mar Cor Services, Inc. | 2001-06-08 |
| THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS (K011055) | Go Medical Industries Pty. , Ltd. | 2001-06-06 |
| GAMBRO POLYFLUX 24S, GAMBRO POLYFLUX 24R (K010667) | Gambro Renal Products | 2001-06-04 |
| CONTINUOUS FLOW Y-TUBING (K010122) | G.U.-Tek | 2001-06-04 |
| DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER (K011020) | Denver Biomedicals, Inc. | 2001-06-01 |
| OSTEOBELL (K011104) | Biopsybell S.A.S. | 2001-05-31 |
| LAPAROSCOPIC HAND PORT (K003871) | Applied Medical Resources Corp. | 2001-05-31 |
| INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL ISI 1000 (K011002) | Intuitive Surgical, Inc. | 2001-05-30 |
| HEMODIALYSIS TUBING SETS (K001971) | Ofi Biomedica S.P.A. | 2001-05-24 |