| ULNAR HEAD IMPLANT (K010786) | Avanta Orthopaedics, Inc. | 2001-04-11 |
| AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES) (K010462) | Avita Corporation | 2001-04-11 |
| FUNET AMY MAMA BODY THERMOMETER (K003326) | Funai Radio & Communications Corp. | 2001-04-11 |
| ECHOSEED/IODINE-125 SEEDS, MODEL 6733 (K010821) | Medi-Physics Inc. Dba Nycomed Amersham Imaging | 2001-04-11 |
| ACUVUE 2 BRAND (ETAFILCON A) CONTACT LENS, WITH UV BLOCKER TINTED (TO MASK OR ENHANCE THE NATURAL IRIS COLOR) (K010114) | Johnson & Johnson Vision Care, Inc. | 2001-04-11 |
| SOCON SPINAL SYSTEM (K003463) | Aesculap, Inc. | 2001-04-11 |
| LIFEPORT VTX ACCESS SYSTEM,MODEL VTX 7000 SERIES (K010767) | Horizon Medical Products, Inc. | 2001-04-10 |
| POLYMER COATED POWDER-FREE GREY COLOR POLYCHLOROPRENE PATIENT EXAMINATION GLOVES (K010486) | Pt. Medisafe Technologies | 2001-04-10 |
| PLATO SRS STEREOTACTIC RADIOSURGERY PLANNING SYSTEM,MODEL 2.0, PLATO IFS IMAGE FUSION SOFTWARE, MODEL 2.1 (K010784) | Nucletron Corp. | 2001-04-10 |
| MULTIFUCTION SUCTION IRRIGATION SYSTEM, EXISTING OF SUCTION IRRIGATION HANDLES, SUCTION IRRIGATION TUBES, AND TUBE SETS; (K002000) | Richard Wolf Medical Instruments Corp. | 2001-04-10 |
| SAFESHEATH MSP INTRODUCER SHEATH KIT WITH INTEGRAL HEMOSTASIS VALVE (K003731) | Thomas Medical Products, Inc. | 2001-04-10 |
| 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 |
| POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, PURPLE COLOR (K010719) | Perusahaan Getah Asas Sdn. Bhd. | 2001-04-10 |
| AMS SACRAL COLPOPEXY SLING, MODEL 72403501 (K010931) | American Medical Systems, Inc. | 2001-04-09 |
| ULTRACISION HARMONIC SCALPEL COAGULATING SHEARS, MODEL LCSC5,LCSC1,CS23C,CS231,CS14C,CS141,LCSB5,LCSK5,LCS15,LCS16,CS150 (K002981) | Ethicon Endo-Surgery, Inc. | 2001-04-09 |
| ICG MODULE (K010164) | General Electric Medical Systems Information Techn | 2001-04-09 |
| STA -CALIBRATOR HBPM/LMWH KIT (K010350) | Diagnostica Stago, Inc. | 2001-04-09 |
| BREAST IMMOBIIZATION AND BIOPSY DEVICE MR-BIOPSY 160 (K010570) | Mri Devices Corp. | 2001-04-09 |
| XTRACTOR, MODEL M143 (K010220) | Instruments Medicaux G.B., Inc. | 2001-04-09 |
| NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE (K010909) | Tyco Healthcare Group LP | 2001-04-09 |
| MIMIX BONE REPLACEMENT SYSTEM (K003494) | Biomet, Inc. | 2001-04-09 |
| MODIFICATION TO SYNTHES (USA) POLYPIN (K003527) | Synthes (Usa) | 2001-04-09 |
| RITA MODEL 2500 ELECTROSURGICAL RF GENERATOR (K003676) | Rita Medical Systems | 2001-04-09 |
| ETEST MEROPENEM (K010363) | Ab Biodisk | 2001-04-09 |
| BAYLIS MEDICAL RF PERFORATION PROBE, MODEL RFP-265 (K010265) | Baylis Medical Co., Inc. | 2001-04-09 |
| TANDEM-CATH 10 FR. CATHETER SYSTEM, MODEL MULTIPLE CODE NUMBERS (K002902) | The Kendall Company | 2001-04-09 |
| ATAC PAK AST REAGENT KIT (K010488) | Elan Holdings, Inc. | 2001-04-09 |
| REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT (K001352) | Corgenix, Inc. | 2001-04-09 |
| STA-QUALITY HBPM/LMWH KIT (K010324) | Diagnostica Stago, Inc. | 2001-04-09 |
| REAL PATIENT EXCEL NEUROWORK, MODEL EX-RP-EEG (PROPOSED) (K010086) | Excel Tech. , Ltd. | 2001-04-09 |
| ENT ENDOSCOPES (K003830) | Global Endoscopy, Inc. | 2001-04-09 |
| POWDER FREE SYNTHETIC VINYL PATIENT EXAM GLOVE (K010671) | Tong Ruhn Medical Products Co., Ltd. | 2001-04-09 |
| MULTIPLE (IZON DNA BLOOD COLLECTION KIT) (K010328) | Izon Business Products, Inc. | 2001-04-09 |
| KSEA UNIVERSAL LAPAROMAT LAPAROSCOPIC SUCTION AND IRRIGATION PUMP (K010569) | Karl Storz Endoscopy | 2001-04-09 |
| POWDER FREE TEXTURED VINYL EXAMINATION GLOVES (K010830) | General Gloves Corp. | 2001-04-09 |
| TERATECH MODEL 8EC4 ENDOCAVITY SMART PROBE (K010883) | Teratech Corp. | 2001-04-06 |
| MODIFICATION TO PLUM XL INFUSION PUMP (K010924) | Abbott Laboratories | 2001-04-06 |
| LPC-PLUS ACETABULAR CUP (K003274) | Plus Orthopedics | 2001-04-06 |
| PREAMP CABLE, MODEL B400-1011PA (K003542) | Beta Biomed Services, Inc. | 2001-04-06 |
| TRINITY POLYAXIAL SCREW, MEHDIAN SPINAL ROD (6MM), MODEL 159.XXX SERIES CATALOGUE NUMBERS (K010776) | Corin USA | 2001-04-06 |
| TCOYF FERTILITY SOFTWARE VERSION 1.0 (K002726) | Ovusoft, LLC | 2001-04-06 |
| PNS MAGNETIC STIMULATOR SYSTEM (K002889) | Neotonus, Inc. | 2001-04-06 |
| AVON PATELLO-FEMORAL JOINT PROSTHESIS (K010100) | Howmedica Osteonics Corp. | 2001-04-06 |
| ARTHREX UNIVERS 30 SHOULDER PROSTHESIS (K010124) | Arthrex, Inc. | 2001-04-06 |
| DURALOC ACETABULAR CUP SYSTEM, 36MM MARATHON +4 POLYETHYLENE LINER (K010171) | DePuy Orthopaedics, Inc. | 2001-04-06 |
| T2 FEMORAL NAIL (K010801) | Howmedica Osteonics Corp. | 2001-04-06 |
| NUVOLASE 532 MEDICAL LASER SYSTEM (K010046) | American Laser Corp. | 2001-04-05 |
| COPELAND RESURFACING HUMERAL HEADS (K010664) | Biomet Manufacturing, Inc. | 2001-04-05 |
| POWDER FREE ELASTIC VINYL EXAMINATION GLOVES (K010829) | General Gloves Corp. | 2001-04-05 |
| VERDICT -II THC/COC/OPI/AMP/PCP/BAR/BZO & THC/COC/BAR/BZO; PROFILE -II 7 THC/COC/OPI/AMP/PCP/BAR/BZO (K010564) | Medtox Diagnostics, Inc. | 2001-04-05 |
| THE LIBERATOR WHEELCHAIR (K010859) | Liberator Wheelchairs, Inc. | 2001-04-05 |
| SUREVUE SERUM/URINE HCG, MODEL 1,30,50,100 TEST KIT (K010593) | Sa Scientific, Inc. | 2001-04-05 |
| STS-T LITHOTRIPTER, MODEL STS-T (K010900) | Medstone Intl., Inc. | 2001-04-05 |
| VERDICT -II BAR/BZO (K010561) | Medtox Diagnostics, Inc. | 2001-04-05 |
| AT HOME DRUG TESTT, MODEL 9150 T (K010655) | Phamatech | 2001-04-05 |
| VERSALUX (K010133) | Centrix, Inc. | 2001-04-05 |
| AT HOME DRUG TEST, MODEL 9078 T (K010654) | Phamatech | 2001-04-05 |
| PERIFORM PERINEOMETRIC PROBE, MODEL 8300 (K002617) | Neen Design , Ltd. | 2001-04-05 |
| HEALTH-PLUS, SANITEX, RELIANCE MULTIPLY POWDER FREE POLYMER AND NITRILE COATED (BLUE) (K003350) | Pamitex Industries Sdn Bhd | 2001-04-05 |
| EXCELART WITH PIANISSIMO, MODEL MRT-1500/P3 (K010129) | Toshiba America Medical Systems, In.C | 2001-04-05 |
| FRSENIUS PD IQCARD CYCLER (K002892) | Fresenius Medical Care North America | 2001-04-05 |
| TOTAL CURE (K010196) | Bisco, Inc. | 2001-04-05 |
| MEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 6254 (K010906) | Medtronic Vascular | 2001-04-05 |
| RECONSTITUTION KIT & VIAL CONNECTOR (K010623) | Bioject, Inc. | 2001-04-05 |
| SENTECH MEDICAL EXPRESS COMPRESSION SYSTEM (P/N SM800) (K003701) | Sentech Medical Systems, Inc. | 2001-04-05 |
| IMMAGE IMMUNOCHEMISTRY SYSTEM HIGH SENSITIVITY C-REACTIVE PROTEIN (CRPH) REAGENT (K010236) | Beckman Coulter, Inc. | 2001-04-05 |
| ALARMVIEW WIRELESS DATA NETWORK SYSTEM (K010912) | Data Critical Corp. | 2001-04-05 |
| MIMIMED SIL-SERTER INFUSION SET INSERTION SYSTEM, MODEL 385 (K010377) | Minimed, Inc. | 2001-04-05 |
| AT HOME DRUG TEST, MODEL 9068 T (K010653) | Phamatech | 2001-04-05 |
| PJUR EROS WATER FORMULATION (K010199) | L.C.C. Pjur Group Germany | 2001-04-05 |
| SELECT CAP ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODEL 78818,78820,78822,78824,78918,78920,78922,78924 (K010737) | Medtronic Cardiac Surgical Products | 2001-04-04 |
| MINI FIBER ENDOSCOPES; OUTER SHEATHS; VERESS CANNULAS; VERESS CANNULAS WITH OUTER SHEATHS, SET (K003417) | Richard Wolf Medical Instruments Corp. | 2001-04-04 |
| IVS TUNNELLER (K010035) | United States Surgical, A Division of Tyco Healthc | 2001-04-04 |
| STANNAH POWER CHAIR, MODEL 201 (K994083) | Stannah Power Chairs , Ltd. | 2001-04-04 |
| GUIDANT AXIUS CORONARY SHUNT (K010117) | Cardiothoracic Systems, Inc. | 2001-04-04 |
| FLO-BOOT (K003272) | Discovery Group, LLC | 2001-04-04 |
| ADVIA RETIC PLUS (K010461) | R&D Systems, Inc. | 2001-04-03 |
| MODEL 455GE PHASED ARRAY WRIST COIL (K010074) | Medical Advances, Inc. | 2001-04-03 |
| POWDER-FREE NITRILE EXAMINATION GLOVES, WHITE (K010110) | Shen Wei (Usa), Inc. | 2001-04-03 |
| THINKINGNET (K010271) | Thinking Systems Corp. | 2001-04-03 |
| LAGLOVE BRAND COLORED POWDERED NITRILE EXAMINATION GLOVES(GREEN/PURPLE) (K010861) | La Glove (M) Sdn. Bhd. | 2001-04-03 |
| QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISA (K010558) | Inova Diagnostics, Inc. | 2001-04-03 |
| MAMMOGRAPH (K010792) | Digitec Medical Service Corp. | 2001-04-03 |
| LAGLOVE BRAND COLORED POWDER FREE NITRILE EXAMINATION GLOVES (GREEN/PURPLE) (K010860) | La Glove (M) Sdn. Bhd. | 2001-04-03 |
| WHITE KNIGHT MASKS (21 MODELS, VARIOUS COLORS WITH AND WITHOUT FACE SHIELDS) (K001892) | White Knight Healthcare, Inc. | 2001-04-03 |
| ULTRASOUND SCANNER TYPE 2102 (K003986) | B-K Medical A/S | 2001-04-03 |
| 3.0.T SIGNA VH/I (T/R) BODY IMAGING COIL (K003613) | GE Medical Systems | 2001-04-03 |
| WHITE KNIGHT MASKS, BLUE, PINK, YELLOW, WHITE MASKS (13 MODELS) (K001893) | White Knight Healthcare, Inc. | 2001-04-02 |
| WHITE KNIGHT BLUE, GREEN FACE MASK, (4 MODELS) (K001997) | White Knight Healthcare, Inc. | 2001-04-02 |
| CYNOSURE PHOTOGENICA DL (K010005) | Cynosure, Inc. | 2001-04-02 |
| BIPOLAR COAGULATION SYSTEM (K010112) | Enable Medical Corp. | 2001-04-02 |
| PHILIPS BV LIBRA (K010762) | Philips Medical Systems, Inc. | 2001-04-02 |
| AT3C70 TRANSDUCER (K002856) | Sonora Medical Systems | 2001-04-02 |
| FLEXIBLE ENDOSCOPIC SCISSORS (K010412) | Telemed Systems, Inc. | 2001-04-02 |
| MODIFICATION TO MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE SYSTEM (8 MM ARTICULAR SURFACE) (K010685) | Zimmer, Inc. | 2001-04-02 |
| XLTEK EVOKED POTENTIAL HEADBOX, MODEL REAL PATIENT EP-8-RP (PROPOSED) (K010092) | Excel Tech. , Ltd. | 2001-04-02 |
| COUCH FOR TOTAL BODY RADIATION (K010063) | Arplay Medical S.A. | 2001-04-02 |
| VALLEYLAB LIGASURE PRECISE INSTRUMENT VESSEL SEALING SYSTEM-MODEL # LS1200 & SLIGAURE GENERATOR (K010010) | Valleylab, Inc. | 2001-04-02 |
| ENDOSCOPIC TUBE SHAFT INSTRUMENTS FOR MONOPLAR COAGULATION (K010192) | Antyllos Medizintechnik GmbH | 2001-04-02 |