| GLUCOSITE TEST SYSTEM (K971145) | Gds Technology, LLC | 1997-09-17 |
| IPS EMPRESS COSMO INGOT (K972827) | Ivoclar North America, Inc. | 1997-09-17 |
| ACS HI-TORQUE RULER GUIDE WIRE (K972290) | Guidant Corp. | 1997-09-17 |
| THE 6.0 X 8.0MM DENTAL IMPLANT SYSTEM (K972417) | Bicon, Inc. | 1997-09-17 |
| NORMA KAMLALI/ALFRED SUNG/ROOTS OF CANADA/STEEL MAXX SUNGLASS (K973016) | Optimaxx Intl. | 1997-09-17 |
| SUNGLASSES (K972850) | Indoptica, S.A. | 1997-09-17 |
| COSMOPOST (K972875) | Ivoclar North America, Inc. | 1997-09-17 |
| OPPURTUNITY TRACHEOSTOMY CARE KIT (K971091) | Opportunity, Inc. | 1997-09-16 |
| THE MAESTRO SYSTEM (K972313) | BioHorizons Implant Systems, Inc. | 1997-09-16 |
| DRAGER-VAPOR 2000 (K971923) | Draeger Medical, Inc. | 1997-09-16 |
| OPPORTUNITY I.V. START KIT (K971093) | Opportunity, Inc. | 1997-09-16 |
| 8 FR. -30CC NARROWFLEX SHEATHLESS INTRA-AORTIC BALLOON CATHETER, PRODUCT NUMBER IAB-04830S (K963865) | Arrow Intl., Inc. | 1997-09-16 |
| OPPORTUNITY SUTURE REMOVAL KIT (K971095) | Opportunity, Inc. | 1997-09-16 |
| LIQCRYLIC PRO DENTAL RESIN (K972573) | Dentsply Intl. | 1997-09-16 |
| HANDIFLEX (K971046) | Handiflex Corp. | 1997-09-16 |
| MICRO21 WITH CEREBROSPINAL FLUID (K971470) | Triangle Biomedical Sciences, Inc. | 1997-09-16 |
| OPPORTUNITY, INC. LACERATION TRAY (K971089) | Opportunity, Inc. | 1997-09-16 |
| ENLIGHT (TENTATIVE NAME) (K972890) | Sybron Dental Specialties, Inc. | 1997-09-16 |
| OPPORTUNITY INCISION AND DRAINAGE TRAY (K971088) | Opportunity, Inc. | 1997-09-16 |
| ABBOTT CELL-DYN 3200 SYSTEM (K972354) | Abbott Laboratories | 1997-09-16 |
| AURECAST 92 (K972943) | Aurex Precious Metal Industries (Pty)Ltd | 1997-09-16 |
| OPPORTUNITY DRESSING CHANGE TRAY (K971090) | Opportunity, Inc. | 1997-09-16 |
| STEALTHSTATION PASSIVE INSTRUMENT OPTION (K972398) | Surgical Navigation Technologies, Inc. | 1997-09-16 |
| 2T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101) (K972592) | Elscint, Inc. | 1997-09-15 |
| RIVETTI-LEVINSON INSTRALUMINAL SHUNT (K972261) | Integra Neurocare, LLC | 1997-09-15 |
| AUXILIARY INSTRUMENTS FOR URS (K971315) | Richard Wolf Medical Instruments Corp. | 1997-09-15 |
| AXSYM CA 15-3 (K963926) | Abbott Laboratories | 1997-09-15 |
| DISETRONIC H-TRON PLUS V 100 INSULIN INFUSION PUMP (K973044) | Disetronic Medical Systems | 1997-09-15 |
| FIRST PICC CATHETER WITH DUAL LUMENS (K972263) | Becton Dickinson Infusion Therapy Systems, Inc. | 1997-09-15 |
| FIRST MIDCATH CATHETER (K972264) | Becton Dickinson Infusion Therapy Systems, Inc. | 1997-09-15 |
| MAGNETIC RESONANCE DIAGNOSTIC SYSTEM (K972296) | Ge Medical Systems, Inc. | 1997-09-15 |
| FIRST PICC CATHETER (K972262) | Becton Dickinson Infusion Therapy Systems, Inc. | 1997-09-15 |
| SIEMENS ORTHOPHOS DS/DS CEPH (K972312) | Siemens AG | 1997-09-15 |
| WAKO NEFA LINEARITY SET (K973072) | Wako Chemicals USA, Inc. | 1997-09-12 |
| FIRST MIDCATH CATHETER (K972254) | Becton Dickinson Infusion Therapy Systems, Inc. | 1997-09-12 |
| BABY DOPPLEX (3000) (K963711) | Huntleigh Healthcare, Inc. | 1997-09-12 |
| LIDOCAINE EIA ASSAY (K973102) | Diagnostic Reagents, Inc. | 1997-09-12 |
| BELLEGLASS HP ENAMEL REPAIR MATERIAL (K971762) | Sybron Dental Specialties, Inc. | 1997-09-12 |
| DENTIN CONDITIONING AND ADHESIVE (BOND 1) (K973388) | Jeneric/Pentron, Inc. | 1997-09-12 |
| ORTHOPHOS PLUS AND ORTHOPHOS PLUS/CD (K972249) | Pelton & Crane Co. | 1997-09-12 |
| NELLCOR PURITAN BENNETT GEMINI (K972248) | Nellcor Puritan Bennett, Inc. | 1997-09-12 |
| AURADAPT AUBTMENT SYSTEM (K972475) | Nobel Biocare Uas, Inc. | 1997-09-12 |
| BIG BAG 3000 PRESSURE INFUSOR (K973133) | Byron Medical | 1997-09-12 |
| FCR FUJI COMPUTED RADIOGRAPHY DMS CRT IMAGE CONSOLE HI-C654 (FOR NETWORKS) (K972256) | Fujifilm Medical System U.S.A., Inc. | 1997-09-12 |
| TELE TRENS TM 10 (K960884) | Life Sensing Instrument Company, Inc. | 1997-09-12 |
| MIDAS REX MOTOR (K972289) | Midas Rex Pneumatic Tools, Inc. | 1997-09-12 |
| PURE ADVANTAGE NITRILE HYPOALLERGENIC SURGICAL GLOVE (K972009) | Tillotson Healthcare Corp. | 1997-09-12 |
| DEPUY DUPONT ORTHOPAEDICS FINGER JOINT PROSTHESIS (K970544) | Depuy, Inc. | 1997-09-12 |
| FLOW-RITE (K971594) | Pulpdent Corp. | 1997-09-12 |
| MODIFICATION OF OPUS FERRITIN TEST SYSTEM (K973202) | Behring Diagnostics, Inc. | 1997-09-12 |
| POWDERFREE COLORED AND FLAVORED NITRILE COPOLYMER PATIENT EXAMINATION GLOVES-MEDICAL DEVICE (K972306) | P.T. Irama Dinamika Latex | 1997-09-12 |
| DCI WATER PURIFIER (K971727) | Dental Components, Inc. | 1997-09-12 |
| ROOT APEX LOCATOR (K972407) | Toei Electric Co., Ltd. | 1997-09-11 |
| SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM (K964624) | Siemens Medical Solutions USA, Inc. | 1997-09-11 |
| TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY (K972666) | Hybritech, Inc. | 1997-09-11 |
| CEILING MOUNTED LATERAL POSITIONER, MODEL NO. 6896.002 (K972442) | Continental X-Ray Corp. | 1997-09-11 |
| ULTIMA AND ULTIMA LX CEMENTED FEMORAL STEM (K972435) | Johnson & Johnson Professionals, Inc. | 1997-09-11 |
| MICROJET CAVITY PREPARATION SYSTEM (K964755) | Midwest Dental Products Corp. | 1997-09-11 |
| INFIMED DENTAL SYSTEM (K962422) | Infimed, Inc. | 1997-09-11 |
| MICROMARK CLIP (K970817) | Biopsys Medical, Inc. | 1997-09-11 |
| BREATH-SO-FRESH TONGUE CLEANER (K972644) | Intl. Dental Design Specialists, Inc. | 1997-09-11 |
| ALTA PLATING SYSTEM (K972479) | Howmedica Corp. | 1997-09-11 |
| FINESSE ALL-CERAMIC SYSTEM (K971869) | Dentsply Intl. | 1997-09-11 |
| KODAK DIGITAL SCIENCE (KDS) MEDICAL IMAGE AND INFORMATION LIBRARY (MIIL) (K972380) | Eastman Kodak Company | 1997-09-11 |
| BIOZ SYSTEM & BIOZ PORTABLE (K972320) | Cardiodynamics International Corp. | 1997-09-11 |
| GETTIG STYRL-JECT DELIVERY SYSTEM (K972285) | Gettig Pharmaceutical Instrument Co. | 1997-09-11 |
| HP ORVUE INTRA-OP (M2510A) (K965160) | Hewlett-Packard GmbH | 1997-09-11 |
| BIOCOR SOFTSHELL VENOUS RESERVOIR (BIOCOR SVR) (K972017) | Minntech Corp. | 1997-09-10 |
| OSTEO BOS SYSTEM (K972323) | Osteonics Corp. | 1997-09-10 |
| PROLENE POLYPROPYLENE MESH HERNIA DEVICE NONABSORBABLE SYNTHETIC SURGICAL MESH (K972412) | ETHICON, Inc. | 1997-09-10 |
| 2D VOG - VIDEO-OCULOGRAPHY (K972243) | Sensomotoric Instruments, GmbH | 1997-09-10 |
| IMPACT AIR 45 HANDPIECE FOR PERIODONTAL USE (K972376) | Glenwood, LLC | 1997-09-10 |
| S3 CYCLIC RPM CONTROL (K971520) | Stoeckert Instrumente | 1997-09-10 |
| NARKOMED M ANESTHESIA SYSTEM (M) (K971425) | Draeger Medical, Inc. | 1997-09-10 |
| IMPACT AIR 45 HANDPIECE FOR ENDODONTIC USE (K972375) | Glenwood, LLC | 1997-09-10 |
| COSMED K4 (K963373) | Cosmed Srl | 1997-09-10 |
| IMPULSE HVG (K970847) | Armstrong Industries, Inc. | 1997-09-10 |
| HTP-1500 LOCALIZED HEAT THERAPY PUMP (K970197) | Adroit Medical Systems, Inc. | 1997-09-10 |
| MODEL CG-2206 PERSONAL ELECTROCARDIOGRAM (ECG) TRANSMITTER DEVICE (MODIFIED) (K963725) | Card Guard , Ltd. | 1997-09-10 |
| MULTIDOS, QC6PLUS (K972211) | Ptw-New York Corp. | 1997-09-10 |
| INNERWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9 (K972429) | Custom Services Intl., Inc. | 1997-09-10 |
| BONE PLATE WITH CABLES (K972223) | Pioneer Surgical Technology | 1997-09-10 |
| 0.015CC PINPOINT IONIZATION CHAMBER, 0.005 CC PINPOINT IONIZATION CHAMBER (K972212) | Ptw-New York Corp. | 1997-09-10 |
| EXTRAWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9 (K972430) | Custom Services Intl., Inc. | 1997-09-10 |
| K&W 2-PIECE TAKE-APART INSTRUMENTS(VARIOUS) (K973259) | Medical Creative Technologies, Inc. | 1997-09-10 |
| AMSINO SUCTION CATHETER (K973199) | Amsino Intl., Inc. | 1997-09-10 |
| VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSES (K971494) | Zymetx, Inc. | 1997-09-10 |
| JIMMY JOHN III RECTAL NOZZEL, MODEL CIT (K972455) | Colon Therapeutics | 1997-09-09 |
| LEADCARE BLOOD LEAD TESTING SYSTEM (K971640) | Esa, Inc. | 1997-09-09 |
| BLOOD MONITOR PUMP (K970591) | Baxter Healthcare Corp | 1997-09-09 |
| CLINITEK MICROALBUMIN REAGENT STRIPS (K972706) | Bayer Corp. | 1997-09-09 |
| VYGON UMBILICAL CATHETHER INSERTION TRAY (K963196) | Vygon Corp. | 1997-09-09 |
| QUICK COUPLING DEVICE FOR DENTAL PROSTHESES (K950260) | Dr. Joseph E. Grasso, D.D.S. | 1997-09-09 |
| SHOE COVER (K972227) | American Seal Co. | 1997-09-09 |
| RHEUMATOID FACTOR LATEX-ENHANCED IMMUNOTURBIDIMETRIC TEST KIT (K972220) | Randox Laboratories, Ltd. | 1997-09-09 |
| AVL OMNI ANALYZER (K972733) | Avl Scientific Corp. | 1997-09-09 |
| DEVICE FOR PROVIDING QUICK COUPLING FOR DENTAL PROSTHESES (K950261) | Dr. Joseph E. Grasso, D.D.S. | 1997-09-09 |
| OPUS D-DIMER (K972316) | Behring Diagnostics, Inc. | 1997-09-09 |
| BOUFFANT CAP (K972187) | American Seal Co. | 1997-09-09 |
| KIS-III NON-SUBMERGED IMPLANT, SCREWS AND CYLINDERS (K961381) | The Emerging Technologies Group | 1997-09-09 |