| NUVO BARRIER FILM (K980117) | Biomedical Development Co. | 1998-12-18 |
| MODIFICATION TO VENTURE IHO 100 COMPLETE HOME OXYGEN SYSTEM (K983777) | Invacare Corp. | 1998-12-18 |
| MEDTRONIC INSTENT ESOPHACOIL ESOPHAGEAL STENT SYSTEM WITH SLOW RELEASE (K983297) | Medtronic Instent, Inc. | 1998-12-18 |
| HEP-2000 COLORZYME ANA-RO TEST SYSTEM, MODEL 4200-RO (K983924) | Immuno Concepts, Inc. | 1998-12-18 |
| MODULAP (K983623) | Atc Technologies, Inc. | 1998-12-18 |
| OPTI-ONE MULTI-PURPOSE SOLUTION (K983973) | Alcon Laboratories | 1998-12-18 |
| PROXIMATE CURVED AND STRAIGHT INTRALUMINAL STAPLERS (K983536) | Ethicon Endo-Surgery, Inc. | 1998-12-18 |
| SUNDT SLIM-LINE ANEURYSM CLIP APPLIER (K982379) | Johnson & Johnson Professionals, Inc. | 1998-12-18 |
| LIQUICHEK ANA CONTROL, SPECKLED PATTERN, MODEL 202 (K984400) | Bio-Rad | 1998-12-18 |
| RAPID TRANSFER BLOOD BAG MODEL A-1650, RAPID TRANSFER BLOOD BAG MODEL S-250 (K982712) | Genzyme Surgical Product (Genzyme Biosurgery) | 1998-12-18 |
| SYNTHES SYNMESH (K983766) | Synthes (Usa) | 1998-12-18 |
| LIQUICHEK ANA CONTROL, HOMOGENEOUS PATTERN, MODEL 201 (K984398) | Bio-Rad | 1998-12-18 |
| LIQUICHEK ANA CONTROL, CENTROMERE PATTERN, MODEL 203 (K984397) | Bio-Rad | 1998-12-18 |
| ML UNIVERSAL TUBING (K983448) | Med-Logics, Inc. | 1998-12-18 |
| ACCUSIGN DOA 10,ACCUSIGN DOA PANEL,ACCUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP,BIOSIGN DOA 10, BIOSIGN MET/OPI/COC/ (K983501) | Princeton BioMeditech Corp. | 1998-12-18 |
| DEPUY ORTHOTECH SPIKED WASHER (K983906) | DePuy Orthopaedics, Inc. | 1998-12-18 |
| SCS SPINAL SYSTEM (K983353) | Orthotec, Inc. | 1998-12-18 |
| ULTRACARE NEUTRALIZING TABLETS (K984383) | Allergan, Inc. | 1998-12-18 |
| SULZER ORTHOPEDICS APOLLO REVISION/CONSTRAINED KNEE TIBIAL BASEPLATE STEM PLUGS (K983733) | Sulzer Orthopedics, Inc. | 1998-12-18 |
| CORDIS NITINOL STENT AND DELIVERY SYSTEM (K980823) | Cordis Corp. | 1998-12-18 |
| AESCULAP MINOP SYSTEM (K983365) | Aesculap, Inc. | 1998-12-18 |
| EVERLAST NEUROSTIMULATION ELECTRODES 2X 2,MODEL # EL2020 (K983741) | Axelgaard Mfg. Co., Ltd. | 1998-12-18 |
| CD SPINAL SYSTEM (K980184) | Sofamor Danek USA,Inc. | 1998-12-18 |
| OSTEONICS SPINAL SYSTEM CYLINDRICAL BONE SCREWS (K984302) | Osteonics Corp. | 1998-12-18 |
| LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, MODEL 204 (K984399) | Bio-Rad | 1998-12-18 |
| YASARGIL TITANIUM ANEURYSM CLIPS (K983758) | Aesculap, Inc. | 1998-12-18 |
| NON-INVASIVE DYNAMIC REFERENCE FRAME (DRF) FOR OPTICAL TRACKING SYSTEM, MODEL OTS (K984245) | Radionics, Inc. | 1998-12-18 |
| DCI ENDOSCOPE (K983363) | KARL STORZ Endoscopy-America, Inc. | 1998-12-18 |
| C.T.M. MOBILITY SCOOTER, MODEL # HS-686 (K983662) | Warepalmy Enterprise, LLC (Usa) | 1998-12-18 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS AFP ASSAY (K983031) | Ortho-Clinical Diagnostics, Inc. | 1998-12-18 |
| SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH GREPAFLOXACIN (K983306) | Accumed Intl., Inc. | 1998-12-18 |
| MULTI-PURPOSE DISINFECTING SOLUTION ID 90746 (K983780) | Alcon Laboratories | 1998-12-18 |
| MODIFICATION TO SKVEKPATCH (K984177) | Marine Polymer Technologies, Inc. | 1998-12-18 |
| LASERSCOPE COOLSPOT (K984110) | Laserscope | 1998-12-18 |
| TRANSFERRIN SPQ III ANTIBODY REAGENT SET (K983880) | DiaSorin, Inc. | 1998-12-18 |
| C.T.M. MOBILITY SCOOTER, MODEL # HS-666 (K983663) | Warepalmy Enterprise, LLC (Usa) | 1998-12-18 |
| LIQUICHEK ANTI-DSDNA CONTROL, MODEL 213 (K984396) | Bio-Rad | 1998-12-18 |
| SUPREME II CONTROL SOLUTIONS (K983432) | Chronimed, Inc. | 1998-12-17 |
| FERTILMARQ TEST KIT (K983473) | Embryotech Laboratories, Inc. | 1998-12-17 |
| FASTTAKE ADAPTER, MODEL # P/N 020-072-01 (K983468) | Selfcare, Inc. | 1998-12-17 |
| SCI-PHARM DESENSITIZING VARNISH (K983305) | Scientific Pharmaceuticals, Inc. | 1998-12-17 |
| MODIFICATION TO: PREMIER PLATINUM HPSA (K983255) | Meridian Diagnostics, Inc. | 1998-12-17 |
| OASIS (K984218) | Glimex Corp. | 1998-12-17 |
| VARIANT II HEMOGLOBIN A1C PROGRAM (K984268) | Bio-Rad | 1998-12-17 |
| HEARTSTREAM ELECTRODE ADAPTER (K984286) | Hewlett-Packard Co. | 1998-12-17 |
| SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH SPARFLOXACIN (K983310) | Accumed Intl., Inc. | 1998-12-17 |
| NEW ZIMMER SHOULDER SYSTEM (K982981) | Zimmer, Inc. | 1998-12-17 |
| CARESIDE CALCIUM, ORIGINAL (K983789) | Careside, Inc. | 1998-12-17 |
| THE APTUS (AUTOMATED) APPLICATION OF THE PR-3 ELISA TEST SYSTEM. AN ANEYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DE (K984315) | Zeus Scientific, Inc. | 1998-12-17 |
| SPIFE ALKALINE HEMOGLOBIN (K982426) | Helena Laboratories | 1998-12-17 |
| ALASTAT MICROPLATE MIXED ALLERGEN PANELS (K983954) | Diagnostic Products Corp. | 1998-12-17 |
| THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (F (K984347) | Zeus Scientific, Inc. | 1998-12-17 |
| ARCHITECT FERRITIN MASTERCHECK, MODEL NUMBER 6C11-05 (K984325) | Bio-Rad | 1998-12-17 |
| SALTER LABS NEBULIZER EXHALATION AEROSOL FILTER (K983403) | Salter Labs | 1998-12-17 |
| THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGM ELISA TEST SYSTEM (K984175) | Zeus Scientific, Inc. | 1998-12-17 |
| UNIPULSE CO2 SURGICAL LASER SYSTEM (K980475) | Nidek, Inc. | 1998-12-16 |
| DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION (K980926) | Howmedica Corp. | 1998-12-16 |
| MODIFICATION TO TAC-S MONOPOLAR CAUTERY PROBE FAMILY (K984185) | Oratec Interventions, Inc. | 1998-12-16 |
| EVERBOND (K983414) | Espe Dental AG | 1998-12-16 |
| PEDIATRIC CANNULATED OSTEOTOMY PLATES (K983967) | Biomet, Inc. | 1998-12-16 |
| AUTOLOGOUS BLOOD MANAGEMENT SYSTEM (ABMS) (K982650) | Dideco S.P.A. | 1998-12-16 |
| SYNTEC-TAICHUNG NON-STERILE BONE PLATE AND SCREW IMPLANTS, MODEL#'S 222020-248120, 240050-240980, 241130-246620, 4240420 (K983495) | Syntec Scientific Corp. | 1998-12-16 |
| BIATAIN FOAM DRESSING (K983163) | Coloplast Corp. | 1998-12-16 |
| PAIN CARE 2000 (K983454) | Breg, Inc. | 1998-12-16 |
| FUJINON EVL-F VIDEO LAPROSCOPE (K983561) | Fujinon, Inc. | 1998-12-16 |
| SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM (K983530) | Synthes (Usa) | 1998-12-16 |
| OSTEO 9MM IC TIBIAL NAIL (K984353) | Osteonics Corp. | 1998-12-16 |
| DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION (K980925) | Howmedica Corp. | 1998-12-16 |
| POLYMER THREADED ANCHOR (K983169) | Orthopaedic Biosystems, Ltd. | 1998-12-16 |
| COOK TEST TUBE HEATER (K983609) | Cook Ob/Gyn | 1998-12-16 |
| QUADRANT POSTERIOR DENSE (K984044) | Cavex Holland BV | 1998-12-16 |
| I.V. EXTENSION SET OR I.V. ADMINISTRATION SET (K983073) | Integra Biotechnical, LLC | 1998-12-16 |
| HYSTEROSCOPIC GIFT CATHETER SETS (K983587) | Cook Ob/Gyn | 1998-12-16 |
| NU-GEL * WOUND DRESSING (K983362) | Johnson & Johnson Medical, Inc. | 1998-12-16 |
| AUTO SUTURE LAPAROSCOPES DEVICE (K983293) | United States Surgical, A Division of Tyco Healthc | 1998-12-16 |
| IS BORRELIA BURGDORFERI IGM TEST SYSTEM (K983606) | Columbia Bioscience, Inc. | 1998-12-16 |
| IMPLEX CONTINUUM KNEE UNITY TIBIAL COMPONENT (K980637) | Implex Corp. | 1998-12-16 |
| MILLENIUM SLEDGEHAMMER, FORMULA 99 AND NATURALYKE H.C., HIGH IMPACT DENTURE ACRYLIC (K983876) | Mycone Dental Supply Co., Inc. (A/K/A Keystone Ind | 1998-12-16 |
| BIATAIN FOAM ADHESIVE DRESSING (K983173) | Coloplast Corp. | 1998-12-16 |
| LIGHTSOURCE OR ILLUMINATOR MODEL I-100 (K983277) | Cuda Products Co. | 1998-12-16 |
| LASEAWAY ALEXANDRITE LASER SYSTEM (K982316) | Silver Creek, Inc. | 1998-12-16 |
| MEDTRONIC PS MEDICAL INNERVISION VENTRICULAR CATHETER, 15CM MODEL 99102 (K983331) | Medtronic PS Medical | 1998-12-16 |
| OSTEONICS SECUR-FIT AD GENERATION II ACETABULAR COMPONENT SYSTEM (K983502) | Osteonics Corp. | 1998-12-16 |
| DYNA-LOK SPINAL SYSTEM (K983672) | Sofamor Danek USA,Inc. | 1998-12-16 |
| ACCU-PULSE 1000 CO2 SURGICAL LASER SYSTEM (K983543) | Argus Photonics Group | 1998-12-16 |
| IS BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM (K983605) | Columbia Bioscience, Inc. | 1998-12-16 |
| BRAUN PREFILLED SYRINGE (K970736) | B.Braun Medical, Inc. | 1998-12-16 |
| SPYROGEL HYDROGEL WOUND AND BURN DRESSING (K982804) | Innovative Technologies (Us), Inc. | 1998-12-16 |
| LYPHOCHEK TUMOR MARKER CONTROL, MODEL #580 (K983807) | Bio-Rad | 1998-12-16 |
| ROCHE COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS (K973718) | Roche Molecular Systems, Inc. | 1998-12-15 |
| ABUSCREEN ONLINE BENZ 300 CALIBRATORS (K983556) | Roche Diagnostic Systems, Inc. | 1998-12-15 |
| DEMAND OXYGEN CONSERVING DEVICE, DOCD, THE DOC (K983601) | Medical Electronic Devices, Inc. | 1998-12-15 |
| ARCHITECT FSH MASTERCHECK, MODEL NUMBER 6C24-05 (K984318) | Bio-Rad | 1998-12-15 |
| BARD INLAY LUBRICIOUS DOUBLE PIGTAIL URETERAL STENT WITH SUTURE (HEREINAFTER REFERRED TO AS BARD LUBRICIOUS URETERAL STE (K983498) | C.R. Bard, Inc. | 1998-12-15 |
| DATA RAY CORPORATION DR11021 MEDICAL IMAGING MONITOR (K983392) | Data Ray | 1998-12-15 |
| ADVANTAGE WINDOWS (AW) FUSION (K983256) | GE Medical Systems | 1998-12-15 |
| ARCHITECT PROLACTIN MASTERCHECK, MODEL NUMBER 6C27-05 (K984324) | Bio-Rad | 1998-12-15 |
| ABUSCREEN ONLINE BENZ 200 CALIBRATORS (K983555) | Roche Diagnostic Systems, Inc. | 1998-12-15 |
| ARCHITECT LH MASTERCHECK, MODEL NUMBER 6C25-05 (K984323) | Bio-Rad | 1998-12-15 |
| DISTAFLO BYPASS GRAFT (K983769) | Impra, Inc. | 1998-12-15 |