| FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEM (K984143) | Fibra Sonics, Inc. | 1999-02-16 |
| ZYMED TELEMETRY SYSTEM, MODEL EASI VIEW (K984089) | Zymed Medical Instrumentation | 1999-02-16 |
| INSTANT-VIEW PREGNANCY URINE MID-STREAM TEST (K984075) | Alfa Scientific Designs, Inc. | 1999-02-16 |
| BARDEX LUBRI-SIL I.C. FOLEY CATHETER (K984136) | Bard Medical Div. | 1999-02-16 |
| MAGNETIC TIBC KIT (K990216) | Reference Diagnostics, Inc. | 1999-02-16 |
| CK (K983070) | Abbott Laboratories | 1999-02-16 |
| IS EBV-EA-D IGG ELISA TEST SYSTEM (K981831) | Diamedix Corp. | 1999-02-16 |
| QUANTASE PHE/GAL SCREENING ASSAY (K984463) | Quantase , Ltd. | 1999-02-16 |
| IS EBV-EBNA-1 IGG ELISA TEST SYSTEM (K981829) | Diamedix Corp. | 1999-02-16 |
| IGEL 56 UV (HEFILCON C) SOFT (HYDROPHILIC) CONTACT LENS (K984523) | Igel Vision Care Pte , Ltd. | 1999-02-16 |
| MICROTAC-BONE ANCHOR SYSTEM (K990160) | Influence, Inc. | 1999-02-16 |
| MEDCO ASPIRATOR IV (K982371) | Medco Mfg. | 1999-02-12 |
| ELK LASER FILM DIGITIZER (K984409) | Nishimoto Sangyo Co., Ltd. | 1999-02-12 |
| SCI-PHARM DFV VARNISH (K982915) | Scientific Pharmaceuticals, Inc. | 1999-02-12 |
| AESCULAP AXIAL CLIP APPLIER (K984109) | Aesculap, Inc. | 1999-02-12 |
| NATURA DENTURE TEETH (K984134) | Davis Schottlander & Davis, Ltd. | 1999-02-12 |
| 130 MODIFIED INTEGRAL FEMORAL COMPONENT (K984408) | Biomet, Inc. | 1999-02-12 |
| D-SIGN III (R&D PROJECT DW264#7) (K990077) | Ivoclar North America, Inc. | 1999-02-12 |
| NORIAN PERIODONTAL/DENTAL CEMENT (PDC) (K983104) | Norian Corp. | 1999-02-12 |
| MAMMARY SIZER, MAMMARY PROTHESIS SIZER (K984106) | Specialty Surgical Products, Inc. | 1999-02-12 |
| GAUZE, SPONGES, CAT # 11-003 (K983016) | Vitalcare Group, Inc. | 1999-02-12 |
| NBR 4 MILS, NITRILE EXAMINATION GLOVE NON-STERILE POWDERED (K984309) | Sumirubber Industries (Kedah) Sdn. Bhd. | 1999-02-12 |
| D-SIGN IV (R&D PROJECT DW265#37) (K990078) | Ivoclar North America, Inc. | 1999-02-12 |
| SCAREASE & SCAREASE ADHESIVE GEL (K984115) | Scarease, Inc. | 1999-02-12 |
| UP-GRADE AND UP-GRADE PRO (K983887) | Medisim, Ltd. | 1999-02-12 |
| DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM (K990259) | Disetronic Medical Systems | 1999-02-12 |
| MODIFICATION TO ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET AND TRAY (K982333) | Cook, Inc. | 1999-02-12 |
| WILSON-COOK PANCREATIC WEDGE STENT (K990130) | Wilson-Cook Medical, Inc. | 1999-02-12 |
| SELF CATH SET/SAFETY CATH (K983010) | Rusch Intl. | 1999-02-12 |
| TRAJECTORY GUIDE, MODEL # TGX-XXX (K983539) | Image-Guided Neurologics, Inc. | 1999-02-12 |
| PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAY (K981913) | Chembio Diagnostic Systems, Inc. | 1999-02-12 |
| CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED SECURIT SHELL, SECURITY SHELL ADAPTER (K990083) | Sims Deltec, Inc. | 1999-02-12 |
| SPINAL CONCEPTS, INC. (SCI) ANTERIOR CERVICAL PLATE SYSTEM (K990005) | Spinal Concepts, Inc. | 1999-02-12 |
| 2.0MM EXPANDABLE LEMAITRE VALVULOTOME (ELV 2.0- GNT) (K980723) | Vascutech, Inc. | 1999-02-12 |
| FUNCTIONAL MRI PACKAGE FOR MAGETETOM VISION MR (K984221) | Siemens Corp. | 1999-02-12 |
| AGEE-WRISTJACK FRACTURE REACTION SYSTEM (STERILE VERSION), MODEL CFD-147 (K984442) | Hand Biomechanics Lab, Inc. | 1999-02-12 |
| APF POROUS COATED LINE EXTENSION (K984154) | Biomet, Inc. | 1999-02-11 |
| DS30 HCY HOMOCYSTEINE ASSAY KIT (K982003) | Drew Scientific , Ltd. | 1999-02-11 |
| NEUROVASX SUB-MICROINFUSION CATHETER (K984258) | Neuro Vasx, Inc. | 1999-02-11 |
| SMOOTHLASE ALEXANDRITE LASER SYSTEM (K990043) | Leisegang Medical, Inc. | 1999-02-11 |
| WELCH ALLYN FRONT-LINE DOC (K984215) | Welch Allyn, Inc. | 1999-02-11 |
| LOBOB UNIVERSAL CONTACT LENS CLEANER (K990044) | Lobob Laboratories, Inc. | 1999-02-11 |
| INFINITY GLUCOSE REAGENT (K984574) | Sigma Diagnostics, Inc. | 1999-02-11 |
| RIGID GAS PERMEABLE CONTACT LENS SOLUTION (K983836) | Polymer Technology Div. Wilmington Partners, L.P. | 1999-02-11 |
| ACIST INJECTOR SYSTEM, MODEL CL100 H (K984058) | Acist Medical Systems | 1999-02-11 |
| UNI-GOLD STREP A TEST KIT (K982373) | Trinity Biotech, Plc | 1999-02-11 |
| MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES (K983702) | Roche Diagnostic Systems, Inc. | 1999-02-11 |
| VENTLAB VERIFY II (K990098) | Ventlab Corp. | 1999-02-11 |
| SLICKTIP SOLID LAPAROSCOPIC ELECTRODE, MODELS LH01Z, LB02Z, LN03Z, LC04Z, LS05Z, LL06Z, LJ07Z (K984239) | Aaron Medical Industries | 1999-02-10 |
| AUTO SUTURE SITE MARKER CLIP (K983400) | United States Surgical, A Division of Tyco Healthc | 1999-02-10 |
| MODIFICATION OF BIONECT HYDROGEL FOAM (K984267) | Fidia Pharmaceutical Corp. | 1999-02-10 |
| BIONECT HYDROGEL (K984413) | Fidia Pharmaceutical Corp. | 1999-02-10 |
| CORFLO CUBBY LOW PROFILE GASTROSTOMY DEVICE (LPGD) (K990127) | Corpak Medsystems | 1999-02-10 |
| MODIFICATION OF BIONECT HYDROGEL GAUZE PADS (K984262) | Fidia Pharmaceutical Corp. | 1999-02-10 |
| SYNTHOFIL NONABSORBABLE PET SURGICAL SUTURE (K990088) | Aesculap, Inc. | 1999-02-10 |
| VIPERSOFT (K984030) | Integra Medical | 1999-02-10 |
| MODIFICATION OF BIONECT HYDROGEL SPRAY (K984266) | Fidia Pharmaceutical Corp. | 1999-02-10 |
| AARON ESU FOOT-CONTROL ADAPTER #A1205A (K984236) | Aaron Medical Industries | 1999-02-10 |
| INNOVA TELESCOPIC DISTRACTOR (K984117) | Innova Corp. | 1999-02-10 |
| MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE (K983704) | Roche Diagnostic Systems, Inc. | 1999-02-10 |
| DISPOSABLE ELECTROSURGERY GROUNDING PAD (K984276) | E & M Engineering, Inc. | 1999-02-10 |
| POTENCY TEST STRIPS, INDICATOR TEST STRIPS (K974426) | Reprocessing Products Corp | 1999-02-10 |
| MEDLITE Q-SWITCHED ND:YAG LASER, MEDLITE IV Q-SWITCHED ND: YAG LASER (K983054) | Continuum Biomedical, Inc. | 1999-02-10 |
| SUPRASHIELD EXPRESS STERILIZATION WRAP (K990300) | Allegiance Healthcare Corp. | 1999-02-10 |
| MODIFICATION OF BIONECT CLEAR HYDROGEL (K984264) | Fidia Pharmaceutical Corp. | 1999-02-10 |
| CARE TENS (K984025) | Care Rehab, Inc. | 1999-02-10 |
| DC-CORE (K984097) | S & C Polymer GmbH | 1999-02-09 |
| NBR4 MILS NITRILE POWDER FREE EXAMINATION GLOVES NON-STERILE (K984311) | Sumirubber Industries (Kedah) Sdn. Bhd. | 1999-02-09 |
| RESIN 4 (K981862) | Harry J. Bosworth Co. | 1999-02-09 |
| PARAGON BASAL/BOLUS ADMINISTRATION SET (K984063) | I-Flow Corp. | 1999-02-09 |
| LITE-TOUCH SYRINGE (K983430) | Medicore, Inc. | 1999-02-09 |
| POWDERED LATEX EXAMINATION GLOVES, NON-STERILE (K984125) | Kilang Barangan Getah Dioh | 1999-02-09 |
| ENIGMA DENTURE TEETH (K984128) | Davis Schottlander & Davis, Ltd. | 1999-02-09 |
| PARAGON INFUSION (K984146) | I-Flow Corp. | 1999-02-09 |
| MEDTRONIC MODEL 7495 EXTENSION KIT (K990104) | Medtronic Vascular | 1999-02-09 |
| PARAGON BOLUS ACCESSORY SET (K984638) | I-Flow Corp. | 1999-02-09 |
| STERITITE PROCESS INDICATOR ACCESSORIES (K982151) | Case Medical, Inc. | 1999-02-09 |
| ADEC DENTAL UNIT, MODELS CENTURY PLUS & CASCADE, DCI DENTAL UNIT, MODEL SERIES III (K984609) | Lite Specialty Metal Works, Inc. | 1999-02-09 |
| PRE-POWDER VINYL PATIENT EXAMINATION GLOVES (K984461) | Shanghai Huamao Gloves Co., Ltd. | 1999-02-09 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K984460) | Shanghai Huamao Gloves Co., Ltd. | 1999-02-09 |
| 1ST IMPRESSION (K983106) | Den-Mat Corp. | 1999-02-09 |
| RE NU (K973289) | Pacific Rim Dental, Inc. | 1999-02-09 |
| SCICAN CLASSIC (K984556) | Scholly Fiberoptic GmbH | 1999-02-09 |
| COLORVEES IV SET 20 DROPS/ML 105, 60 DROPS/ML 105, VENTED 20 DROPS 105, VENTED 60 DROPS 105 (K983411) | Valnet Medical Corp. | 1999-02-09 |
| SYSTEM U3 FOR AMOXICILLIN/CLAVULANIC ACID (K984144) | Ab Biodisk | 1999-02-09 |
| OMNICORDER, MODEL 464 (K990027) | Del Mar Avionics | 1999-02-09 |
| POWDER FREE NITRILE EXAMINATION GLOVES (K984610) | Shiva Medicare , Ltd. | 1999-02-09 |
| TCM 3000 AND TCM ENDO (K981679) | NOUVAG AG | 1999-02-09 |
| SONICATOR PLUS 992, MODEL NUMBER ME 992 AND SONICATOR PLUS 994, MODEL NUMBER ME 994 (K984142) | Mettler Electronics Corp. | 1999-02-09 |
| SYS STIM 294, MODEL ME 294 (K984114) | Mettler Electronics Corp. | 1999-02-09 |
| GE LOGIQ700 DIAGNOSTIC ULTRASOUND SYSTEM WITH B-FLOW (K990226) | Ge Medical Systems, Inc. | 1999-02-09 |
| IMAGEFUSION 2.0 (K990071) | Radionics, Inc. | 1999-02-08 |
| QUANTA LITE GBM ELISA (K984336) | Inova Diagnostics, Inc. | 1999-02-08 |
| ELECYS IGE ASSAY (K984326) | Boehringer Mannheim Corp. | 1999-02-08 |
| TRANSMYOMETRIAL EMBRYO TRANSFER SET (K983595) | Cook Ob/Gyn | 1999-02-08 |
| HUMAN SERUM ALBUMIN (HSA) (K983584) | Irvine Scientific Sales Co., Inc. | 1999-02-08 |
| CARESIDE AMYLASE (K990025) | Careside, Inc. | 1999-02-08 |
| MAX IT (K983438) | Dorea, Inc. | 1999-02-08 |
| MILLENNIUM MLC -120 (K990085) | Varian Assoc., Inc. | 1999-02-08 |
| IQ SYSTEM (K981720) | Renaissance Technology, Inc. | 1999-02-08 |