| MEDCOMP 14.5F DOUBLE LUMEN HEMODIALYSIS CATHETER (K012562) | Medical Components, Inc. | 2002-02-08 |
| ENDOSCOPIC MULTI-FIRE CLIP APPLIER (K013889) | Inscope, LLC | 2002-02-07 |
| GENTLE COLONICS IRRIGATION SYSTEM (K002102) | Gentle Colonics, Inc. | 2002-02-06 |
| WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS (K014169) | Bob J. Johnson & Assoc., Inc. | 2002-02-06 |
| TRAPSYSTEM SET (K013692) | H.S. Hospital Service S.R.L. | 2002-02-05 |
| ERECAID CLASSIC SYSTEM; ERECAID ESTEEM MANUAL SYSTEM; ERECAID ESTEEM BATTERY SYSTEM (K020082) | Endocare, Inc. | 2002-02-05 |
| EG-3630UR, ULTRASUND VIDEO GASTROSCOPE (K013640) | Pentax Precision Instrument Corp. | 2002-02-04 |
| MEDIGROUP CATHETER EXTENDER/REPAIR KIT (K012502) | Janin Group, Inc. | 2002-02-04 |
| NXSTAGE DIALYSATE CONCENTRATE, MODEL RFC-100 (K013655) | Nxstage Medical, Inc. | 2002-02-04 |
| ENDO-GLIDE (K013701) | Sonotech, Inc. | 2002-02-04 |
| HENKE SASS WOLF SAPHENOUS VEIN LAPAROSCOPE (K013611) | Henke Sass Wolf of America, Inc. | 2002-02-01 |
| LTF-240 PLEURAVIDEOSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENTS (K013617) | Olympus Optical Co., Ltd. | 2002-01-30 |
| PERICSCOPE, MODEL # PERISC1 (K013576) | Ethicon Endo-Surgery, Inc. | 2002-01-25 |
| KPS-I, THE KIDNEY PERFUSION SOLUTION (K013575) | Organ Recovery Systems, Inc. | 2002-01-25 |
| USA SERIES LAPAROSCOPES (K013165) | Circon Acmi | 2002-01-18 |
| BILIARY AND PANCREATIC ENDOPROSTHESES (STENTS) (K010549) | Medi-Globe Corp. | 2002-01-18 |
| HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE POWDER (K012328) | Di-Chem, Inc. | 2002-01-18 |
| HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTION (K012547) | Di-Chem, Inc. | 2002-01-18 |
| MODIFICATION TO DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM (K014184) | Guidant Corp. | 2002-01-18 |
| MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY (K014136) | Sulzer Intratherapeutics, Inc. | 2002-01-17 |
| DILATING TIP OBTURATOR (K012884) | Applied Medical Resources Corp. | 2002-01-17 |
| PRISMASATE (K013448) | Gambro Renal Products | 2002-01-15 |
| MODIFICATION TO BRIDGE SELF-EXPANDING BILIARY STENT DELIVERY SYSTEM (BRIDGE SE) (K014205) | Medtronic Ave, Inc. | 2002-01-14 |
| INCARE ADVANCE; INTERMITTENT CATHETER, PLUS INTERMITTENT CATHETER, PLUS KIT (K013483) | Hollister, Inc. | 2002-01-14 |
| NUTRISAFE PUR ENTERAL FEEDING TUBE (K003311) | Vygon Corp. | 2002-01-11 |
| 7MM EXTENDED LENGTH ENDOSCOPE,DISSECTION TIPS, MODELS VH-1111, VH-1114 (K014250) | Guidant Corp. | 2002-01-10 |
| LIGHT PROJECTOR WITH ENDOSCOPIC CAMERA, 1 CCD CAMERA HEAD NTSC, 1 CCD CAMERA HEAD PAL, LIGHT PROJECTOR, MODEL 5551.107 (K010033) | Richard Wolf Medical Instruments Corp. | 2002-01-10 |
| MICROLINE INC. REUSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS, MODEL M/L-10 (K013695) | Microline Pentax, Inc. | 2002-01-08 |
| BICART (K013724) | Gambro Renal Products | 2002-01-08 |
| DYNALINK .018 BILLARY SELF-EXPANDING STENT SYSTEM (K014007) | Guidant Corp. | 2002-01-07 |
| INCARE INTERMITTENT CATHETER (K013345) | Hollister, Inc. | 2002-01-07 |
| DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES, MODEL: POLYSULFONE 100 HFS, POLYSULFONE 130 HFS (K011537) | Dynamic Technology Corp. | 2002-01-07 |
| SHARGHP A.V. FISTULA NEEDLE SET (K013384) | Shargh Pharmaceutical Co., Inc. | 2002-01-07 |
| PROGES FOLYSIL SILICONE FOLEY CATHETER, STRAIGHT CYLINDRICAL TIP, SILICONE FEMALE FOLEY CATHETER, STRAIGHT CYLINDRICAL, (K013174) | Porges S.A. | 2002-01-04 |
| PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE TIP, DUFOUR TIP, OVER THE GUIDE TIP, MODEL (K013172) | Porges S.A. | 2001-12-20 |
| GIMMI'ALPHA' ENDOSCOPES & ACCESSORIES (K012660) | Gimmi GmbH | 2001-12-20 |
| MICROGYN PLUS STIMULATION DEVICE (K013141) | Hollister, Inc. | 2001-12-19 |
| NASTECH MAMMARY ASPIRATION SPECIMAN CYTOLOGY TEST MASCT (K012088) | Nastech Pharmaceutical Company, Inc. | 2001-12-18 |
| SOPRO 67D OPERATING ROOM CAMERA (K013090) | Sopro | 2001-12-13 |
| BIOSPEED (K013069) | H.S. Hospital Services S.P.A. | 2001-12-12 |
| JAMSHIDI BIOPSY NEEDLE (K013070) | H.S. Hospital Services S.P.A. | 2001-12-12 |
| SECURCUT ASPIRATION BIOPSY NEEDLE (K013071) | H.S. Hospital Services S.P.A. | 2001-12-12 |
| HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE (K013066) | Olympus America, Inc. | 2001-12-11 |
| RF GENERATORS, DISPOSABLE CARTRIDGE KIT, DISPOSABLE CARTRIDGE, REUSABLE HANDLE, DISOISABLE HANDPIECE REUSABLE TELESCOPE (K012587) | Vidamed, Inc. | 2001-12-11 |
| SOCRATES ROBOTIC TELEMONITORING SYSTEM (K013804) | Computer Motion, Inc. | 2001-12-10 |
| MICRO-6-SERIES (MR-6, MR-6L) URETEROSCOPES, MRO-6 SERIES (MR-633, MR-642) URETEROSCOPES, MRO-7 SERIES (MRO-733) URETEROS (K011849) | Circon Video | 2001-12-10 |
| EXCEL A.V FISUTAL NEEDLE SET (K013037) | Exelint Intl. Co. | 2001-12-07 |
| DAYLITE XENON LIGHT SOURCES (K013880) | Designs For Vision, Inc. | 2001-12-07 |
| MEDIGROUP KEY TUBE (K013017) | Janin Group, Inc. | 2001-12-06 |
| HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302, 5C4471, 5C4469 (K012988) | Baxter Healthcare Corp | 2001-12-05 |
| APPLIED ACCESS SEAL (K012968) | Applied Medical Resources Corp. | 2001-12-03 |
| SERIM BLOOD LEAK TEST STRIP-2 (K012115) | Serim Research Corp. | 2001-11-30 |
| MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4001 (K010607) | Benlan, Inc. | 2001-11-28 |
| DISPOSABLE STORAGE CAP (K010366) | Molded Products, Inc. | 2001-11-28 |
| ULTRA-THIN SDS BALLOON DILATATION CATHETER (K011909) | Boston Scientific Corp | 2001-11-28 |
| CLIRANS E-SERIES DIALYZER (K013550) | Terumo Medical Corp. | 2001-11-20 |
| FLEXIBLE PEDIATRIC CYSTOURETEROSCOPE, MODEL AUR- 735 (K012929) | Circon Video | 2001-11-19 |
| HILL-ROM PRIMAVIEW MONITOR SYSTEM (K013709) | Hill-Rom, Inc. | 2001-11-16 |
| INTUITIVE SURGICAL BIPOLAR FORCEPS (K012833) | Intuitive Surgical, Inc. | 2001-11-16 |
| FANELLI BILIARY STENT (K010601) | Cook, Inc. | 2001-11-16 |
| TWINTRODE ELC 134 ELECTRODE (K012785) | Healthtronics Surgical Services, Inc. | 2001-11-16 |
| WALLSTENT RX BILIARY ENDOPROSTHESES, MODELS 6961-6972 INCLUSIVE (K012752) | Boston Scientific Corp | 2001-11-15 |
| TROCAR SLEEVE AND ACCESSORIES, MODELS 1287-XX-XX (K012771) | Pajunk GmbH | 2001-11-14 |
| APN-2 USA SERIES FLEXIBLE CHOLEDOCHOSCOPE (K012951) | Circon Video | 2001-11-09 |
| SE-100 VACUUM ERECTION DEVICE (K012662) | Vts, Inc. | 2001-11-09 |
| BOSS 2000-3 VACUUM ERECTION DEVICE (K012670) | Pos-T-Vac, Inc. | 2001-11-09 |
| VT-1 (K012619) | Vts, Inc. | 2001-11-09 |
| BOSS-2000-2 VACUUM ERECTION DEVICE (K012672) | Pos-T-Vac, Inc. | 2001-11-09 |
| SE-300 VACUUM THERAPY SYSTEM (K012639) | Vts, Inc. | 2001-11-09 |
| SE-200 (K012620) | Vts, Inc. | 2001-11-09 |
| SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273 (K012724) | Smith & Nephew, Inc. | 2001-11-08 |
| REPROCESSED ENDOSCOPIC TROCAR (K012578) | Sterilmed, Inc. | 2001-11-07 |
| DUR-8, MODELS DUR-8 (K012925) | Circon Video | 2001-11-07 |
| DEVICE MODIFICATION OF ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE (K012147) | Zevex, Inc. | 2001-11-02 |
| VARICES INJECTION NEEDLE (K012977) | Endo-Therapeutics, Inc. | 2001-11-02 |
| DIACLEAR ULTRAFILTER (K003957) | Gambro Renal Products | 2001-11-01 |
| KSEA SIALOENDOSCOPES AND ACCESSORIES (K012527) | KARL STORZ Endoscopy-America, Inc. | 2001-11-01 |
| SUPER C HEMODIALYSIS/APHERESIS CHRONIC CATHETER, MODEL DC-36 SERIES, DC-40 SERIES, DC-45 SERIES (K011916) | Horizon Medical Products, Inc. | 2001-10-31 |
| PRISMA HF 1000 SET, PRISMA HF 1000 PRE-SET (K011221) | Gambro Renal Products | 2001-10-31 |
| MODIFICIATION TO: BILIARY WALLSTENT ENDOPROSTHEIS WITH MONORAIL DELIVERY SYSTEM, MODEL 71-XXX (K012822) | Boston Scientific Scimed, Inc. | 2001-10-24 |
| INTERJECT INJECTION THERAPY NEEDLE, MODELS 1810, 1811, 1815, 1816, 1820, 1821, 1825, 1826, 1830, 1831, 1835, 1836 (K012864) | Boston Scientific Corp | 2001-10-24 |
| MARK II/MARK III MANOMETRIC PERFUSION PUMP (K013154) | Dentsleeve Pty., Ltd. | 2001-10-19 |
| MODIFICATION TO: LIFEMATE HEMOFILTRATION SYSTEM (K012510) | Nxstage Medical, Inc. | 2001-10-19 |
| WILSON-COOK ULTRASOUND BIOPSY NEEDLE (K013356) | Wilson-Cook Medical, Inc. | 2001-10-19 |
| 14F X 24CM ASH SPLIT-CATH,14F X 28CM ASH SPLIT-CATH, 14F X 32CM ASH SPLIT-CATH, 14FX36CM ASH SPLIT-CATH, 14F X 40CM ASH (K013162) | Medcomp | 2001-10-19 |
| DUAL PORT WIZARD LOW PROFILE REPLACEMENT GASTROSTOMY DEVICE; DUAL PORT WIZARD FEEDING/DECOMPRESSION TUBE, MODEL 00220W (K013144) | C.R. Bard, Inc. | 2001-10-19 |
| AUTOTOME RX MODEL # 4515, 4516 (K013153) | Boston Scientific Corp | 2001-10-19 |
| RIWO SYSTEM TRAYS (K012309) | Richard Wolf Medical Instruments Corp. | 2001-10-19 |
| METAL HALIDE LIGHT SOURCE, MODELS MV-9088-T, MV-9088 (K012265) | Circon Video | 2001-10-17 |
| STORZ MODULITH SLK LITHOTRIPTER WITH MULTIVIEW OPTION (K012482) | KARL STORZ Endoscopy-America, Inc. | 2001-10-16 |
| CHIBA NEEDLE (K012358) | Ispg, Inc. | 2001-10-15 |
| TORAYSULFONE DIALYZER (K002512) | Toray Industries (America), Inc. | 2001-10-15 |
| BRIDGE SE SELF-EXPANDING STENT DELIVERY SYSTEM (K011080) | Medtronic Ave, Inc. | 2001-10-11 |
| GAMBRO POLYFLUX 6L, GAMBRO POLYFLUX 8L, GAMBRO POLYFLUX 10L, MODEL 6L, 8L, 10L (K010985) | Gambro Renal Products | 2001-10-10 |
| ZEUS ROBOTIC SURGICAL SYSTEM (K003431) | Computer Motion, Inc. | 2001-10-05 |
| SOCRATES ROBOTIC TELEMONITORING SYSTEM (K003661) | Computer Motion, Inc. | 2001-10-05 |
| MODIFICATION TO PRECISE NITINOL STENT TRANSHEPATIC BILIARY SYSTEM (K012993) | Cordis Corp. | 2001-10-05 |
| DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER (K012235) | Denver Biomedical, Inc. | 2001-10-04 |
| MEDCOMP EXCELL SPLIT TIP CATHETER (K010306) | Medcomp | 2001-10-03 |
| HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-24, HFS-28, HFS-32, HFS-36, HFS-40 (K994105) | Medical Components, Inc. | 2001-10-03 |