| ENDOSCOPIC STAPLE REMOVAL INSTRUMENT (K010620) | Onux Medical, Inc. | 2001-05-17 |
| HORIZONS INTERNATIONAL VARICES INJECTION NEEDLES (K010448) | Horizons Intl. Corp. | 2001-05-16 |
| MODIFICATION TO MALE TO MALE LUER ADAPTER (K003712) | Molded Products, Inc. | 2001-05-16 |
| EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GIF-Q160Z (K011151) | The Olympus Optical Co. | 2001-05-15 |
| DISPOSABLE BENDING CANNULA PR-233Q (K011149) | The Olympus Optical Co. | 2001-05-15 |
| MAGNUM FLOW IRRIGATION SYSTEM (K010519) | Scion Valley, Inc. | 2001-05-14 |
| INTRACORPOREAL ULTRASOUND LITHOTRIPTER, MODEL 2271.004, ULTRASOUND TRANSDUCER, MODEL 2271.501, ULTRASOUND PROBES (SONO) (K011065) | Richard Wolf Medical Instruments Corp. | 2001-05-09 |
| RUSCH MMG/O'NEIL CATHETER (K010420) | Rusch, Inc. | 2001-05-09 |
| ANDERSEN INTESTINAL TUBE, MILLER-ABBOTT TYPE (AN 22) (K011077) | Andersen Products, Inc. | 2001-05-09 |
| OMNILINK .018 BILIARY STENT SYSTEM (K011039) | Guidant Corp. | 2001-05-08 |
| MPS M ELECTRODE (K002801) | Medical Physics and Services, Inc. | 2001-05-04 |
| RENAX A.V. FISTULA NEEDLE SETS (K003123) | Sunder Biomedical Tech. Co., Ltd. | 2001-05-04 |
| WILSON-COOK THRU-THE-SCOPE MECHANICAL LITHOTRIPTOR (K011178) | Wilson-Cook Medical, Inc. | 2001-05-04 |
| SANARUS CORE TISSUE BIOPSY SYSTEM (K003528) | Endocare, Inc. | 2001-05-03 |
| KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR (K010346) | KARL STORZ Endoscopy-America, Inc. | 2001-05-02 |
| COBE HC 700 MIDI HEMOCONCENTRATOR (K003023) | Hospal Industrie | 2001-04-30 |
| ORTHO CONTROL FEMALE URINARY CONTROL DEVICE (K010365) | Personal Products Co. | 2001-04-30 |
| ALIEN RX MICRO CANNULA, MODEL 4530 (K010993) | Boston Scientific Corp | 2001-04-30 |
| LSI SOLUTIONS FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES PRODUCT (K011016) | Lsi Solutions | 2001-04-27 |
| CANNULA, SURGICAL GENERAL & PLASTIC SURGERY, MODELR65-995, R65-995-1, R65-995-2, R65-997, R65-997-1 (K010789) | A & A Medical, Inc. | 2001-04-27 |
| KSI'S NEW CAMERA ARCHITECTURE (NCA) VIDEO IMAGING SYSTEM (K003325) | Karl Storz Imaging, Inc. | 2001-04-27 |
| FRESENIUS PRIMING SET WITH NEEDLES ACCESS PORT, MODEL 04-9002-9 (K010268) | Fresenius Medical Care North America | 2001-04-27 |
| NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET (K010264) | Nipro Medical Corp. | 2001-04-27 |
| FG-36UX, FIBER ULTRASOUND GASTROSCOPE (K010740) | Pentax Precision Instrument Corp. | 2001-04-17 |
| DORNIER COMPACT ALPHA LITHOTRIPTER (K002929) | Dornier Medtech America, Inc. | 2001-04-17 |
| NIAGARA SLIM-CATH (K010778) | C.R. Bard, Inc. | 2001-04-13 |
| RX HERCULINK PLUS BILIARY STENT SYSTEM (K010684) | Guidant Corp. | 2001-04-12 |
| DYONICS VISION 111 MOBILE VIDEO UNIT (K010489) | Smith & Nephew, Inc. | 2001-04-10 |
| MODIFICATION TO:LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT (K010779) | Gibbons Surgical Corp. | 2001-04-10 |
| XTRACTOR, MODEL M143 (K010220) | Instruments Medicaux G.B., Inc. | 2001-04-09 |
| TANDEM-CATH 10 FR. CATHETER SYSTEM, MODEL MULTIPLE CODE NUMBERS (K002902) | The Kendall Company | 2001-04-09 |
| KSEA UNIVERSAL LAPAROMAT LAPAROSCOPIC SUCTION AND IRRIGATION PUMP (K010569) | Karl Storz Endoscopy | 2001-04-09 |
| STS-T LITHOTRIPTER, MODEL STS-T (K010900) | Medstone Intl., Inc. | 2001-04-05 |
| FRSENIUS PD IQCARD CYCLER (K002892) | Fresenius Medical Care North America | 2001-04-05 |
| FLEXIBLE ENDOSCOPIC SCISSORS (K010412) | Telemed Systems, Inc. | 2001-04-02 |
| REDTECH GIPC 2000 (K004040) | Red-Tech, Inc. | 2001-03-29 |
| MENTOR SELF-CATH CLOSED SYSTEM (K003873) | Mentor Corp. | 2001-03-29 |
| OPTIFLOW CATHETER #5641190 CATHETER ONLY #5643150 CATHETER KIT #5631000 CATHETERLESS TRAY-GENERIC (COMBINED WITH CATHETR (K010567) | C.R. Bard, Inc. | 2001-03-28 |
| KENDALL 14.5 FR MAXID CUFFED DUAL LUMEN CATHETER (K002901) | The Kendall Company | 2001-03-28 |
| ARTHROCARE UROLOGY ELECTROSURGERY SYSTEM (K010568) | Arthrocare Corp. | 2001-03-27 |
| KSEA SCB-RUI SCO (K003113) | KARL STORZ Endoscopy-America, Inc. | 2001-03-27 |
| RAPID EXCHANGE BIOPSY CAP AND LOCKING DEVICE #4526 & 4527 (K010610) | Boston Scientific Corp | 2001-03-27 |
| MEDICA HP 300 HEMOFILTRATION PUMP, MODEL 300 (K000724) | Medica S.R.L. | 2001-03-22 |
| DAUM DOUBLE-SHOOT BISOPSY GUN (K010037) | Daum GmbH | 2001-03-22 |
| K.E.A.T. (K002154) | Emd Electronic Medical Devices, Corp. | 2001-03-22 |
| NIROYAL BILIARY PREMOUNTED STENT SYSTEM (K003929) | Boston Scientific Corp | 2001-03-22 |
| PRECISE NITINOL STENT TRANSHEPATIC BILLARY SYSTEM (K010445) | Cordis Corp. | 2001-03-16 |
| OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER (K010591) | Olympus Optical Co., Ltd. | 2001-03-15 |
| PERFADEX SOLUTION FOR ORGAN PRESERVATION (K000881) | Vitrolife Sweden AB | 2001-03-08 |
| ENDOCARE PERCUTANEOUS ACCESS SET (K010339) | Endocare, Inc. | 2001-03-07 |
| GENERAL SURGICAL LAPAROSCOPES (K003803) | Global Endoscopy, Inc. | 2001-03-07 |
| MENTOR SELF-CATH PLUS (K003784) | Mentor Corp. | 2001-03-05 |
| INTUITIVE SURGICAL DA VINCI ENDOSCOPIC CONTROL SYSTEM (K002489) | Intuitive Surgical, Inc. | 2001-03-02 |
| OLYMPUS ENDOSCOPIC LIGATION DEVICE (K001744) | Olympus America, Inc. | 2001-02-27 |
| PARE ENDOSCOPIC SUTURING SYSTEM (K003102) | Pare Surgical, Inc. | 2001-02-27 |
| URETEROSCOPES (K003806) | Global Endoscopy, Inc. | 2001-02-22 |
| ADAPT LAPAROSCOPIC PORT & ADAPT REDUCER CAP (K010007) | Taut, Inc. | 2001-02-22 |
| CYSTOSCOPES (K003807) | Global Endoscopy, Inc. | 2001-02-22 |
| VAN ANDLE DILATION, EMERALD GUIDEWIRE, MODEL VAD6, 502-726 (K002650) | Bentec Medical, Inc. | 2001-02-16 |
| DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM) (DEN000008) | Life Technologies, Inc. | 2001-02-16 |
| WATER PURIFICATION SYSTEM FOR HEMODIALYSIS (K002045) | Total Water Treatment Systems, Inc. | 2001-02-16 |
| COMPAT REPLACEMENT GASTROSTOMY TUBE KIT, MODEL 0974XX (K001916) | Novartis Nutrition Corp. | 2001-02-16 |
| SYNTRA DIALYZER, MODEL SYNTRA 120, 160 (K002210) | Baxter Healthcare Corp | 2001-02-14 |
| TUNA (TRANS URETHRA NEEDLE) OFFICE SYSTEM (K002583) | Vidamed, Inc. | 2001-02-13 |
| MODULITH LITHOTRIPSY, MODEL SLK FOR THE FRAGMENTATION OF URINARY AND UPPER URETERAL CALCULI (K010340) | Karl Storz Lithotripsy-America, Inc. | 2001-02-13 |
| SONOLITH PRAKTIS, ENDOUROLOGY TABLE PRAKTIS (K003529) | Edap Technomed, Inc. | 2001-02-12 |
| POLYGRAM 98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODEL 9043S0103 (K010130) | Medtronic Functional Diagnostics A/S | 2001-02-07 |
| DYONICS VISION 337 AUTOCLAVABLE CAMERA HEAD MODEL 7209048; DYONICS AUTOCLAVABLE CAMERA COUPLER MODEL 7207905 (K003710) | Smith & Nephew, Inc. | 2001-02-02 |
| SUCTION IRRIGATOR (K003443) | Applied Medical | 2001-02-01 |
| MODIFICATION TO CAVERMAP SURGICAL AID (K010098) | Uromed Corp. | 2001-02-01 |
| CLIRANS E-SERIES HOLLOW FIBER DIALYZERS (K003425) | Terumo Medical Corp. | 2001-02-01 |
| STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS (K003615) | Environmental Test Systems, Inc. | 2001-02-01 |
| LF-DP GASTROINTESTINAL AND SIGMOID FIBERSCOPE, ACCESSORIES AND ANCILLARY EQUIPMENT (K002231) | Olympus Optical Co., Ltd. | 2001-01-30 |
| INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESIS (K003997) | Intratherapeutics, Inc. | 2001-01-24 |
| HORIZONS PAPILLOTOME (K002236) | Horizons Intl. Corp. | 2001-01-23 |
| HORIZONS ERCP CANNULA (K002235) | Horizons Intl. Corp. | 2001-01-23 |
| CONTOUR POLARIS URETERAL STENT (K010002) | Boston Scientific Corp | 2001-01-22 |
| GLUTARTEST 1 REAGENT STRIP (K002011) | Integrated Biomedical Technology, Inc. | 2001-01-22 |
| MAMMOTOME HAND HELD PROBE, MODEL MHH8 (K003297) | Ethicon Endo-Surgery, Inc. | 2001-01-18 |
| LIFEMATE HEMOFILTRATION SYSTEM (K001283) | Nxstage Medical, Inc. | 2001-01-17 |
| PENILE CONSTRICTOR RING (K001859) | Basic Solutions, LLC | 2001-01-11 |
| BARD MEMOTHERM ENDOSCOPIC BILIARY STENT (K003186) | C.R. Bard, Inc. | 2001-01-09 |
| BARD LUMINEXX BILIARY STENT (K003793) | C.R. Bard, Inc. | 2001-01-05 |
| BARDEX LATEX-FREE TEMPERATURE-SENSING FOLEY CATHETER (UNCOATED); BARDEX LUBRI-SIL TEMPERATURE-SENSING FOLEY CATHETER (LU (K003289) | C.R. Bard, Inc. | 2001-01-05 |
| BARD ENDOCINCH SUTURING SYSTEM # 000452; 000454; 000595 (K003956) | C.R. Bard, Inc. | 2001-01-05 |
| GP GENERAL PURPOSE DRAINAGE SET, MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL, GP GENERAL PURPOSE DRAINAGE CATHE (K003753) | Uresil Corp. | 2001-01-04 |
| FRESENIUS OPTIFLUX 200A (K003498) | Fresenius Medical Care North America | 2001-01-04 |
| WATER PURIFICATION SYSTEM (K994292) | Water & Power Technologies, Inc. | 2001-01-02 |
| DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES SHUNT, DENVER PAK, DOUBLED-VALVED ASCITES T (K003451) | Denver Biomedicals, Inc. | 2001-01-02 |
| INTRASTENT PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY (K003040) | Intratherapeutics, Inc. | 2000-12-28 |
| THE O'NEIL STERILE FIELD URINARY CATHETER KIT (K002803) | Go Medical Industries Pty. , Ltd. | 2000-12-27 |
| PURE WATER-CDS (CENTRAL DIALYSIS SOLUTION) (K994279) | Pure Water Solutions, Inc. | 2000-12-22 |
| DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 5551000, 5552000, 5552001, 552002, 5552003, 5552004, 5552005 (K003790) | Davol, Inc. | 2000-12-22 |
| CRIT-LINE MONITOR III (CLM III) (K001763) | In-Line Diagnostics Corp. | 2000-12-20 |
| BIOMOL ASPIRATION BIOPSY NEEDLE (K002947) | H.S. Hospital Service S.R.L. | 2000-12-19 |
| SILENT BIOPSY NEEDLE (K002946) | H.S. Hospital Service S.R.L. | 2000-12-19 |
| PRECISA BIOPSY NEEDLE (K002944) | H.S. Hospital Service S.R.L. | 2000-12-19 |
| ACTIS ADJUSTABLE CONSTRICTION LOOP (K003115) | Vivus, Inc. | 2000-12-19 |
| PLASMAKINETIC ENDOUROLOGY SYSTEM (K003569) | Gyrus Medical , Ltd. | 2000-12-19 |
| AIW WATER SYSTEM FOR HEMODIALYSIS (K001282) | American Industrial Water | 2000-12-15 |