| COMPASS ESOPHAGEAL PRESSURE CATHETER, MODEL GIE-8500, COMPASS ANO-RECTAL PRESSURE CATHETER, MODEL GIA-8500 (K022023) | Clinical Innovations, Inc. | 2003-01-07 |
| CUSTODIOL HTK SOLUTION (K020924) | Dr. Franz Kohler Chemie GmbH | 2003-01-06 |
| MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM (K024048) | Boston Scientific Scimed, Inc. | 2003-01-06 |
| USA SERIES DUR 8 ELITE, USA SERIES DUR 8, MODELS DUR 8E, DUR 8 (K023358) | Acmi Corporation | 2003-01-03 |
| BICARBONATE DIALYSATE CONCENTRATE MIXER, MODEL 50 GALLON & 100 GALLON (K022521) | Rockwell Medical Technologies, Inc. | 2003-01-03 |
| BARD CONFORMEXX BILIARY STENT AND DELIVERY SYSTEM (K021994) | C.R. Bard, Inc. | 2003-01-02 |
| SOVIS OPTIQUE'S ENDOSCOPIC CABLE (K023633) | Sovis Optique | 2002-12-31 |
| INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200 (K023259) | Helix Medical, Inc. | 2002-12-26 |
| AIM-V (R) MEDIUM, MODEL 087-0112 (K022086) | Invitrogen Corporation | 2002-12-23 |
| LTFS230 (K021775) | Healthtronics, Inc. | 2002-12-23 |
| DISPOSABLE ASPIRATION NEEDLE NA-200H (K023272) | The Olympus Optical Co. | 2002-12-23 |
| DRI-SATE DRY ACID CONCENTRATE FOR BICARBONATE DIALYSATE (K022500) | Rockwell Medical Technologies, Inc. | 2002-12-23 |
| XTJF-160AF DUODENOVIDEOSCOPE (K024033) | Olympus Optical Co., Ltd. | 2002-12-20 |
| FLEXIMA BILIARY CATHETER (K023870) | Boston Scientific/Medi-Tech | 2002-12-20 |
| MODIFICATION TO NANMA VACUUM PUMP (K013113) | Nanma Mfg Co., Ltd. | 2002-12-20 |
| SISS REPROCESSED HOT BIOPSY FORCEPS, LAPAROSCOPIC, ENDOSCOPIC AND ELECTROSURGICAL SURGICAL INSTRUMENTS AND ACCESSORIES (K024011) | Surgical Instruments Service and Savings, Inc. | 2002-12-19 |
| VIABIL BILIARY ENDOPROSTHESIS (K014215) | W. L. Gore & Associates, Inc. | 2002-12-19 |
| CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER, CORDIS MAXI LD PTA BALLOON DILATION CATHETER (K023907) | Cordis Corp. | 2002-12-18 |
| ADAPT BALLOON OPEN ACCESS PORT, MODEL 41244 (K023261) | Taut, Inc. | 2002-12-13 |
| LIFEJET F16 HEMODIALYSIS/APHERESIS CHRONIC CATHETER (K022905) | Horizon Medical Products, Inc. | 2002-12-13 |
| MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY (K023243) | Sulzer Intratherapeutics, Inc. | 2002-12-13 |
| AURORA SYSTEM 1000 SERIES HOME SELF-CARE SINGLE PATIENT DELIVERY SYSTEM; MODELS- SYS 1000, L3 WITH N100 ARM, 4B SOFTWARE (K013562) | Baxter Healthcare Corp | 2002-12-12 |
| SENOCOR 360 CIRCUMFERENTIAL VACUUM ASSISTED BIOPSY DEVICE, 8 GAUGE (K023923) | Senorx, Inc. | 2002-12-11 |
| NXSTAGE CARTRIDGE EXPRESS (K014152) | Nxstage Medical, Inc. | 2002-12-11 |
| VOMED URETHRA OLIVE, MODELS 1420 000, 1425 000, 1430 000 (K023019) | Vomed Volzer Medizintechnik GmbH & Co. | 2002-12-10 |
| TRANSONIC SYRINGE WARMER, MODEL SYR-1000 (K022963) | Transonic Systems, Inc. | 2002-12-04 |
| LAP SURGICAL SYSTEMS MULTIPLE INSTRUMENT GUIDE (K022686) | Lap Surgical Systems, LLC | 2002-11-25 |
| POLYGRAM NET ELECTROGASTROGRAPHY APPLICATION SOFTWARE, MODEL 9043S0151; POLYGRAF ID, MODEL 9043G0102 (K014269) | Medtronic Functional Diagnostics A/S | 2002-11-21 |
| BAXTER ACCURA SYSTEM, MODEL 5M5660 (K021615) | Baxter Healthcare Corp | 2002-11-18 |
| RENAX HEMODIALYSIS BLOOD TUBING SET; SUNDER HEMODIALYSIS BLOOD TUBING SET (K014140) | Sunder Biomedical Tech. Co., Ltd. | 2002-11-18 |
| HERMES OPERATING ROOM CONTROL CENTER (K023095) | Computer Motion, Inc. | 2002-11-15 |
| FRESENIUS ICARE MONITORING SYSTEM (K021060) | Fresenius Medical Care North America | 2002-11-13 |
| INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEM & ENDOSCOPIC INSTRUMENTS, MODEL DA VINCI ISI 1000/1200 (K022574) | Intuitive Surgical, Inc. | 2002-11-12 |
| ESSEX ENDOSCOPE, MODEL SXD-1000 (K023627) | Guidant Corp. | 2002-11-12 |
| ESSEX DISSECTION CANNULA, MODEL SXD-1100, ESSEX DISSECTION TIP, MODEL SXD-1200 (K023629) | Guidant Corporation, Cardiac Surgery | 2002-11-12 |
| BILITEC 2000, POLYGRAM '98 PH TESTING APPLICATION (INCL.BILE), OPTICAL FIBER PROBER (K011471) | Medtronic Functional Diagnostics A/S | 2002-11-08 |
| INDWELLING FECAL MANAGEMENT SYSTEM-NON-STERILE (K023344) | Bowel Management Systems, LLC | 2002-11-06 |
| RETRO REPAIR KIT, MODEL PRRK5 (K022644) | Spire Biomedical, Inc. | 2002-11-06 |
| REPROCESSED USED DISPOSABLE HOT AND COLD BIOPSY FORCEPS (K022751) | Medical Device Services | 2002-11-04 |
| DHF 0.2 HEMOCONCENTRATOR: DIDECO NEWBORN-INFANT HEMONCENTRATION; DHR 0.6 HEMOCONCENTRATOR: DIDECO PEDIATRIC/SMALL ADULT (K021732) | Dideco S.P.A. | 2002-11-04 |
| PURE WATER SOLUTIONS CENTRAL WATER SYSTEM FOR HEMODIALYSIS (K011005) | Pure Water Solutions, Inc. | 2002-11-01 |
| MEDCOMP REPAIR KIT, MODEL ASPCRPK (K022570) | Medcomp | 2002-10-31 |
| \RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE ACCCES FLOW RESERVING CONNECTOR (K022536) | Fresenius Medical Care | 2002-10-30 |
| BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM (K021630) | Boston Scientific Corp | 2002-10-25 |
| COOK INJECTION NEEDLE (K022484) | Cook Urological, Inc. | 2002-10-25 |
| HORIZONS REUSABLE POLYPECTOMY SNARES (K022268) | Horizons Intl. Corp. | 2002-10-25 |
| INFUSION CATHETER EXTENSION SET (K023224) | Chf Solutions, Inc. | 2002-10-25 |
| MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM (K023217) | Cordis Corp. | 2002-10-25 |
| HORIZONS REUSABLE HOT BIOPSY FORCEPS (K022243) | Horizons Intl. Corp. | 2002-10-25 |
| DIASOL-ADDITIVES (K020231) | Diasol, Inc. | 2002-10-21 |
| NXSTAGE PREMIXED DIALYSATE (K022913) | Nxstage Medical, Inc. | 2002-10-21 |
| MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIION (K022391) | Organ Recovery Systems, Inc. | 2002-10-21 |
| PORGES SILICONE DOUBLE LOOP URETERAL STENT, MODEL # AJ4X / BJ1X / BJ2X (K013921) | Porges S.A. | 2002-10-17 |
| WILSON-COOK CYSTOTOME (K022595) | Wilson-Cook Medical, Inc. | 2002-10-17 |
| PORGES URETERAL CATHETERS, MODELS ACN6XX, ACN5XX, AC5B, AC5C07, ACP5XX, ACP2XX, ACP3XX, ACP4XX, ACP6XX (K021856) | Porges S.A. | 2002-10-17 |
| ENCIRCLE LOCALIZATION DEVICE (K022286) | Vivant Medical, Inc. | 2002-10-11 |
| SHEATHLESS ACCESSORY KIT, MODELS XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 AND XRIKRT (K022620) | Spire Biomedical, Inc. | 2002-10-11 |
| MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER (K022897) | Computer Motion, Inc. | 2002-10-11 |
| 10F X 18CM PEDIATRIC ASH SPLIT CATH XL, MODEL ASPC18P-XL; 10F X 24CM PEDIATRIC ASH SPLIT-CATH XL, MODEL ASPC24P-XL (K020936) | Medcomp | 2002-10-11 |
| CLEAR-IT ANTI-FOG, MODEL PS003 (K022826) | Preservation Solutions, Inc. | 2002-10-09 |
| DYONICS VISION 635 IMAGE MANAGEMENT SYSTEM (K023053) | Smith & Nephew, Inc. | 2002-10-03 |
| ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865 (K021142) | Fortune Medical Instrument Corp. | 2002-10-01 |
| ENDO WINDOW HIGH FREQUENCY ELECTROCAUTERY DEVICE, MODEL EW018 (K021266) | Ethicon Endo-Surgery, Inc. | 2002-09-27 |
| DAYTRIPPER DIALYSATE WARMER (K020542) | Stickman Industries, Inc. | 2002-09-27 |
| ZEUS MICROWRIST ROBOTIC SURGICAL SYSTEM AND ACCESSORIES (K021152) | Computer Motion, Inc. | 2002-09-24 |
| TUBING, DIALYSATE (AND CONNECTOR) (K022068) | Molded Products, Inc. | 2002-09-23 |
| 3T/SEWOON TEMPERATURE SENSING FOLEY CATHETERS (K022287) | 3t Medical Systems, LLC | 2002-09-23 |
| NAFD 100 (K020848) | Neomatrix, LLC | 2002-09-23 |
| MODIFICATION TO SANARUS CENTRICA CORE TISSUE BIOPSY (K022879) | Sanarus Medical, Inc. | 2002-09-23 |
| RIWO NET OPERATING OPERATING CONTROL SYSTEM, MODEL #5590 (K020255) | Richard Wolf Medical Instruments Corp. | 2002-09-18 |
| URETERAL ACCESS SHEATH SET (UASS) (K022135) | Boston Scientific Corp | 2002-09-13 |
| FG-36UX FIBER ULTRASOUND GASTROSCOPE (K021276) | Pentax Precision Instrument Corp. | 2002-09-12 |
| EG-3630UR, ULTRASOUND VIDEO GASTROSCOPE (K021278) | Pentax Precision Instrument Corp. | 2002-09-06 |
| SMARTSTITCH SUTURE DEVICE, MODEL OM-8500 (K022229) | Opus Medical, Inc. | 2002-09-06 |
| ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, MODELS 6520 & 6521 (K022648) | Boston Scientific Corp | 2002-09-05 |
| BARDEX I.C.PLUS FOLEY CATHETER WITH SILVER SALTS IN HYDROGEL COATING, MODEL 3CC BALLOON: 17008,170010,5CC BALLOON (K002612) | C.R. Bard, Inc. | 2002-09-03 |
| BIOPSY SCIENCES, LLC. MAXI-CELL BIOPSY NEEDLES (K021847) | Biopsy Sciences, LLC | 2002-09-03 |
| ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM (K022543) | Arthrocare Corp. | 2002-08-30 |
| ANDERSEN NASOGASTRIC TUBE WITH STYLET, MODELS AN 11S, 13S, 14S & 18S (K021493) | Andersen Products, Inc. | 2002-08-30 |
| 14F X 55CM ULTRA-FLOW CATHETER, MODELS UFS55, UFT55 (K021759) | Medcomp | 2002-08-27 |
| CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 (K022561) | C.R. Bard, Inc. | 2002-08-23 |
| NANMA ADJUSTABLE CONSTRICTION RING (K013051) | Nanma Mfg Co., Ltd. | 2002-08-22 |
| ENDOSCOPIC LIGHT SOURCE, MODEL XL300/L5 (K021717) | World of Medicine Lemke GmbH | 2002-08-20 |
| MODULITH SLK LITHOTRIPTER (K011700) | Karl Storz Endoscopy | 2002-08-16 |
| DEGALL LAPAROSCOPIC GALLBLADDER EXTRACTOR (K021747) | Surgicon, Inc. | 2002-08-15 |
| KSEA QUADRO SWITCH (K021776) | Karl Storz Endoscopy | 2002-08-15 |
| MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (K022270) | Olympus Optical Co., Ltd. | 2002-08-14 |
| SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM (K021898) | Cordis Corp. | 2002-08-14 |
| SINGLE STEP BIOPSY DEVICE, SINGLE STEP SURGICAL HANDLE, SINGLE STEP DRIVER, SINGLE STEP HOLDERS (K021707) | Senorx, Inc. | 2002-08-14 |
| TRANSONIC FLOW-QC SET MODEL ADT1010 (K021571) | Transonic Systems, Inc. | 2002-08-12 |
| GIVEN DIAGNOSTICS SYSTEM (K022362) | Given Imaging , Ltd. | 2002-08-09 |
| ADAPT OPEN ACCESS PORT, MODEL 41233 (K021731) | Taut, Inc. | 2002-08-08 |
| URETERAL STENT (K013784) | Boston Scientific Corp | 2002-08-08 |
| PRISMA SYSTEM (K010805) | Gambro Renal Products | 2002-08-06 |
| BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U (K022434) | C.R. Bard, Inc. | 2002-08-05 |
| MEDIPLUS SINGLE USE GI MANOMETRY CATHETER (K013704) | Mediplus , Ltd. | 2002-08-05 |
| MPW HEMODIALYSIS WATER PURIFICATION SYSTEM (K001755) | Mpw Industrial Water Services, Inc. | 2002-08-05 |
| ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, ENDOVIVE STANDARD PROFILE BALLOON REPLACEMENT, MODELS 6520, 6521, 6220 (K020120) | Boston Scientific Corp | 2002-08-02 |
| DAYTON WATER SYSTEMS ULTRAPURE WATER TREATMENT SYSTEMS FOR HEMODIALYSIS (K021352) | Dayton Water Systems | 2002-08-01 |
| ER150/M2 (K021456) | World of Medicine Lemke GmbH | 2002-08-01 |