| LORENZ MAXILLA (LE FORT) DISTRACTION SYSTEM (K982604) | Walter Lorenz Surgical, Inc. | 1998-10-23 |
| SHIKANI-FRENCH SPEAKING VALVE (K982128) | Pilling Weck Surgical | 1998-10-23 |
| BIO PONTOSTAR (K983077) | Bego U.S.A. | 1998-10-23 |
| PLATINLLOYD 100 (K983079) | Bego U.S.A. | 1998-10-23 |
| WINSTATION RETINAL IMAGER (K982689) | Ophthalmic Imaging Systems | 1998-10-23 |
| OLYMPUS ENDOSCOPIC SYSTEM LUMBAR HERNIA DISCECTOMY AND ITS ANCILLARY EQUIPMENT (K982133) | The Olympus Optical Co. | 1998-10-22 |
| JOINT MOTION DEVICE PACKAGE PN 1032,KNEEL CERVICAL PN 1026, LUMBAR 1027, WRIST 1028, ANKLE 1029, SHOULDER 1030, HIP 1031 (K982761) | Chamco, Inc. | 1998-10-22 |
| FRIALIT-2 AUROBASE MODEL NUMBERS 45-2446, 45-2456, 45-2466, 45-2476 (K982576) | Friatec AG | 1998-10-22 |
| BAYER IMMUNO 1 SYSTEM FERRITIN ASSAY (K982714) | Bayer Corp. | 1998-10-22 |
| ORTHOPHOS 5/PLUS/CD (K983057) | Sirona Dental Systems GmbH | 1998-10-22 |
| WILLI GELLER CREATION PORCELAIN (K981490) | Jensen Industries, Inc. | 1998-10-22 |
| MODEL 2000 PULSE OXIMETER (K982255) | Ivy Biomedical Systems, Inc. | 1998-10-22 |
| ATLANT'S (K974395) | Grad-Line Corp. | 1998-10-22 |
| BIRD MONITOR INTERFACE (K982580) | Bird Products Corp. | 1998-10-22 |
| SLE ELECTRODES AND ACCESSORIES (K980410) | Specialized Laboratory Equipment, Ltd. | 1998-10-22 |
| UNICAP GLIADIN IGA ASSAY (K982533) | Pharmacia & Upjohn Co. | 1998-10-22 |
| LUBE FREE AUTOCHUCK TURBINE WITH VORTEX AIR SEAL FOR USE WITH STAR DENTAL 430 SERIES LUBE FREE HIGH SPEED DENTAL HANDPIE (K982593) | Dentalez Group | 1998-10-22 |
| STERNOMEGA BONDING AGENT, STERNOMEGA COMPOSITE LC, STERNOMEGA COMPOMER LC (K982692) | Sterngold/Implamed | 1998-10-22 |
| MONKEY OESOPHAGUS IFA DIAGNOSTIC TEST KITS (K981209) | The Binding Site, Ltd. | 1998-10-22 |
| VFE (K983107) | Ramco Laboratories, Inc. | 1998-10-22 |
| EXMOOR MYRINGOTOMY KIT (K980828) | Exmoor Plastics , Ltd. | 1998-10-22 |
| VARISOURCE HENSCHKE TYPE GYN APPLICATOR FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER (K980590) | Varian Medical Systems, Inc. | 1998-10-22 |
| UNICAP GLIADIN IGG ASSAY (K982701) | Pharmacia & Upjohn Co. | 1998-10-22 |
| ZINC PHOSPHATE CEMENT (K983018) | Medental Intl. | 1998-10-22 |
| TITANIUM INTRAMEDULLARY NAILS-VARIOUS STYLES (K982953) | Biomet, Inc. | 1998-10-21 |
| TFR (K981208) | Ramco Laboratories, Inc. | 1998-10-21 |
| XPS DRILL SYSTEM (K983224) | Xomed, Inc. | 1998-10-21 |
| THREADED FIXATION PIN (K982931) | Sgarlato Laboratories, Inc. | 1998-10-21 |
| DOCKING-EXTENSION WIRE (K982592) | Schneider (Europe) GmbH | 1998-10-21 |
| SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM (K982987) | Synthes Spine | 1998-10-21 |
| BIODERM FOAM WOUND DRESSING (K982778) | Bioderm, Inc. | 1998-10-21 |
| VARISOURCE WRIGHT VAGINAL CUFF APPLICATOR FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERIOADER (K980601) | Varian Assoc., Inc. | 1998-10-21 |
| HOSPAL TIPSTOP (K982818) | Gambro Healthcare | 1998-10-21 |
| ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP9 (K982896) | Alexander Mfg. Co. | 1998-10-21 |
| TSRH SPINAL SYSTEM (K982990) | Sofamor Danek USA,Inc. | 1998-10-21 |
| ALDEN CLASSIC PROSTHETIC (POLYMACON) TINTED, SOFT DAILY WEAR CONTACT LENS (SIGHTED AND NON-SIGHTED EYES) (K983053) | Alden Optical Labs., Inc. | 1998-10-21 |
| GREINER MINICOLLECT SERUM GEL BLOOD COLLECTION TUBE (K982998) | Greiner Meditech, Inc. | 1998-10-21 |
| ZETA MULTIZONE SCN LOCKING NAIL (K982873) | Howmedica Corp. | 1998-10-21 |
| ASTEION CT SCANNER, TSX-021A (K982787) | Toshiba America Medical Systems, In.C | 1998-10-21 |
| MGB LAPALUX TELESCOPE (K982013) | Mgb Endoskopische Gerate GmbH | 1998-10-21 |
| ULTRACISION 5MM INSTRUMENTS (K983316) | Ethicon Endo-Surgery, Inc. | 1998-10-21 |
| ANSPACH ACCESS CRANIAL PERFORATOR (K982991) | The Anspach Effort, Inc. | 1998-10-21 |
| RADWORKS MEDICAL IMAGING SOFTWARE WITH QUALITY CONTROL MODULE (K982862) | Applicare Medical Imaging, B.V. | 1998-10-21 |
| ROCHE DIAGNOSTICS MAGNESIUM REAGENT, CAT# 1551353 (K983416) | Boehringer Mannheim Corp. | 1998-10-21 |
| AUTOMATIC SELF-OPERATED SCREENING AUDIOMETER DEVICE (ASAM) (K982566) | Bar - Advanced Control Systems , Ltd. | 1998-10-21 |
| ECHO-SCREEN (K982642) | Fischer-Zoth Audiologic Systems, Inc. | 1998-10-21 |
| OSTEONICS EXTENDED FEMORAL BEARING HEAD (K982936) | Osteonics Corp. | 1998-10-21 |
| MODIFICATION TO SPINAL CONCEPTS BACFIX TI SPINAL FIXATION SYSTEM (K983260) | Spinal Concepts, Inc. | 1998-10-21 |
| MODIFICATION TO SPINAL CONCEPTS BACFIX SPINAL FIXATION SYSTEM (K983258) | Spinal Concepts, Inc. | 1998-10-21 |
| ISOLA SPINAL SYSTEM (K980485) | Acromed Corp. | 1998-10-21 |
| ACCUSHEAR LAPAROSCOPIC SURGICAL INSTRUMENTS (K982984) | Microline Pentax, Inc. | 1998-10-21 |
| SULZER ORTHOPEDICS FLUTED STEMS (K982903) | Sulzer Orthopedics, Inc. | 1998-10-21 |
| BIO-ANCHOR, PRE-LOADED BIOABSORBABLE SUTURE ANCHOR (K983186) | Linvatec Corp. | 1998-10-21 |
| ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197013 (K974891) | Acutek Adhesive Specialties, Inc. | 1998-10-21 |
| SLE EMG ELECTRODES AND ACCESSORIES (K981004) | Specialized Laboratory Equipment, Ltd. | 1998-10-21 |
| NEUFINISH RESURFACING CREAM (K982577) | Neutrogena Corp. | 1998-10-21 |
| CERALAS D LASER SYSTEM, MODEL # CERALAS D15 (K983058) | Ceram Optec, Inc. | 1998-10-21 |
| ROEKO SEAL (K983037) | Roeko Ulm, Roescheisen GmbH & Co. | 1998-10-20 |
| VAXCEL IMPANTABLE VASCULAR ACCESS SYSTEM (K982888) | Boston Scientific Corp | 1998-10-20 |
| DX-480, ADD ON DIGITAL IMAGER (K981880) | Wuestec Medical, Inc. | 1998-10-20 |
| UNIGRAFE (K982699) | Unicare Biomedical | 1998-10-20 |
| MLT 30 LASER (K982548) | Medical Laser Technologies , Ltd. | 1998-10-19 |
| SANITHERM ORAL DISPOSABLE THERMOMETER SHEATHS FOR MERCURY THERMOMETER, SENITHERM ORAL DISPOSABLE THERMOMETER SHEATHS FOR (K983406) | Banta Healthcare Group, Ltd. | 1998-10-19 |
| ZINFOS ZINC PHOSPHATE CEMENT (K982913) | Scientific Pharmaceuticals, Inc. | 1998-10-19 |
| VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS (K983381) | Paragon Trade Brands, Inc. | 1998-10-19 |
| LEISEGANG VIDEO COLPOSCOPE (K981958) | Netoptix Corp. | 1998-10-19 |
| SPYGLASS 5 FR ANGIOGRAPHIC CATHETER (K982299) | Daig Corp. | 1998-10-19 |
| SECURALLOY (K982671) | Specialites Septodont | 1998-10-19 |
| GC RELINE (K982695) | GC America, Inc. | 1998-10-19 |
| PERITRON PERINEOMETER MODEL 9300V OR 9300A (K983052) | Cardio Design Pty. , Ltd. | 1998-10-19 |
| DISETRONIC PEN (K982966) | Disetronic Medical Systems | 1998-10-19 |
| BMP CABLE SYSTEM (K982545) | Biomet, Inc. | 1998-10-19 |
| NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID PEROXIDASE AUTOANTIBODIES IMMUNOASSAY, MODEL # 62-701521 (K982866) | Nichols Institute Diagnostics | 1998-10-16 |
| FLEXIMA (K982508) | Boston Scientific Corp | 1998-10-16 |
| Bard 8 Fr., 40cc. & 7Fr., 30cc Intra-Aortic Balloon Catheters (K981660) | C.R. Bard, Inc. | 1998-10-16 |
| GREINER MINICOLLECT EDTA BLOOD COLLECTION TUBE (K982999) | Greiner Meditech, Inc. | 1998-10-16 |
| QUICKSCREEN AT HOME DRUG TEST, MODEL 9149/9150 (K982621) | Phamatech | 1998-10-16 |
| UROSURGE UROTHERM FLUID WARMING SYSTEM (K965136) | Princeton Regulatory Assoc. | 1998-10-16 |
| PENETREASE (K980078) | P.T. Panca Pusaka Deli | 1998-10-16 |
| ARTHROTEK INTERFERENCE SCREW (K982497) | Biomet, Inc. | 1998-10-16 |
| TRACCELL 2000 SLIDE MAPPING SYSTEM (K982786) | Accumed Intl., Inc. | 1998-10-16 |
| AXIS HOMOCYSTEINE ENZYME IMMUNOASSAY (K980907) | Axis Biochemicals, Asa | 1998-10-16 |
| TINAQUANT B 2-MICROGLOBULIN ASSAY (K980724) | Boehringer Mannheim Corp. | 1998-10-16 |
| HOWMEDICA LEIBINGER RESORBABLE FIXATION SYSTEM (K982531) | Howmedica Corp. | 1998-10-16 |
| ENVY GUIDING CATHETER (K974774) | Cook, Inc. | 1998-10-16 |
| COSMO PLUS WITH NICO, MODEL 8200 (K982499) | Novametrix Medical Systems, Inc. | 1998-10-16 |
| SERAQUEST RUBELLA IGM (K982281) | Quest Intl., Inc. | 1998-10-16 |
| B-SYSTEM SILICONE (K982917) | Sybron Dental Specialties, Inc. | 1998-10-16 |
| SULLIVAN MIRAGE FULL FACE MASK (K982530) | Resmed, Ltd. | 1998-10-16 |
| V-CATH PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) SEE APPENDIX 1 (K983409) | Hdc Corp. | 1998-10-16 |
| MYSTIQUE ULTRASONIC NEBULIZER (K983002) | Airsep Corp. | 1998-10-16 |
| BIOCLEAR CONCENTRATE (K981565) | Waggoner Product Development | 1998-10-15 |
| MODEL 2872 BIPOLAR LEAD ADAPTOR KIT (K982220) | Medtronic Vascular | 1998-10-15 |
| KSEA ENDOSCOPES FOR DENTAL PROCEDURES (K982658) | KARL STORZ Endoscopy-America, Inc. | 1998-10-15 |
| IMMULITE 2000 OM-MA MODEL L2KOP2 (K983391) | Diagnostic Products Corp. | 1998-10-15 |
| ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589 (K982209) | Sigma Diagnostics, Inc. | 1998-10-15 |
| SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (ELISA) ASSAY (K982879) | Shield Diagnostics, Ltd. | 1998-10-15 |
| IMCOR DENTAL IMPLANT SYSTEM ACCESSORIES (K982492) | Imcor | 1998-10-15 |
| VINYL PATIENT EXAMINATION GLOVE, POWDERED (K981360) | Glormed Intl., Inc. | 1998-10-15 |
| AUROFLUID CPF (K982606) | Metalor Dental USA Corp. | 1998-10-15 |