| VIDAS ROTAVIRUS (RTV) ASSAY (K972895) | Biomerieux Vitek, Inc. | 1997-10-03 |
| TEMP BOND CLEAR (K972844) | Kerr Dental Materials Center | 1997-10-03 |
| CHEMMATE LAMBDA (K973392) | Ventana Medical Systems, Inc. | 1997-10-03 |
| CHEMMATE KAPPA (K973391) | Ventana Medical Systems, Inc. | 1997-10-03 |
| HEWLETT APCKARD SERIES 50 OB TRACEVUE OBSTETRICAL SURVEILLANCE AND ARCHIVING SYSTEM (K970456) | Hewlett-Packard GmbH | 1997-10-03 |
| BABYTHERM 8004 BABYTHERM 8010 (K971198) | Drager, Inc. | 1997-10-03 |
| EYE SPHERE, CONFORMERS (K972661) | Gulden Ophthalmics | 1997-10-03 |
| GE LOGIQ 700 DIAGNOSTIC ULTRASOUND SYSTEM (K964617) | GE Medical Systems | 1997-10-03 |
| CHEMMATE L26 (CD20) (K973390) | Ventana Medical Systems, Inc. | 1997-10-03 |
| NIVP3 (WINDOWS VERSION OF NIVP (K970570) | D. E. Hokanson, Inc. | 1997-10-03 |
| INNOVATOME MICROKERATOME (K973294) | Innovative Optics, Inc. | 1997-10-03 |
| EXPERT-XL TOTAL BODY ACQUISITION AND ANALYSIS SOFTWARE (K965226) | Lunar Corp. | 1997-10-03 |
| MAGELLAN MAGNETIC DISTAL TARGETING SYSTEM(PROPOSED NAME), PRODUCT LINE EXTENSION (K971056) | Wrightmedicaltechnologyinc | 1997-10-03 |
| SENSOR AMPLIFIER (K972515) | Pro-Tech Services, Inc. | 1997-10-02 |
| 2 BOND 2 (K971733) | Heraeus Kulzer, Inc. | 1997-10-02 |
| GENESIS (K972871) | Pacific Rim Dental, Inc. | 1997-10-02 |
| CAVIT-LC (K972892) | Espe GmbH & Co. Kg. | 1997-10-02 |
| ONE STEP URINE DRUG OF ABUSE BARBITURATE TEST (K973047) | Drial Consultants, Inc. | 1997-10-02 |
| BIO TROL (K972723) | Mindmedia Labs, Inc. | 1997-10-02 |
| THUMPER (K972525) | Michigan Instruments, Inc. | 1997-10-02 |
| MEDCORP FLOW I.V. REGULATOR EXTENSION SET (K971004) | Medcorp Intl. | 1997-10-02 |
| PULPDENT OX-OUT (K972445) | Pulpdent Corp. | 1997-10-02 |
| AMSINO I.V. ADMINISTRATION SET (K973107) | Amsino Intl., Inc. | 1997-10-02 |
| CRYOGEN CRYOSURGICAL SYSTEM (K972662) | Cryogen, Inc. | 1997-10-01 |
| HELAX-VISIR (K972617) | Helax AB | 1997-10-01 |
| M-2 ANTERIOR PLATE SYSTEM (K972718) | Acromed Corp. | 1997-10-01 |
| NEEDLE GUIDE/GRID (K973362) | Protek Medical Products, Inc. | 1997-10-01 |
| INFINITECH BULLET ENDO ILLUMINATED PICK MANIPULATOR (K972506) | Infinitech, Inc. | 1997-10-01 |
| PERACT 20 LIQUID STERILANT (K960513) | Minntech Corp. | 1997-10-01 |
| CORE RESISTANT HUBER INFUSION SETS (K972712) | Icu Medical, Inc. | 1997-10-01 |
| ENDOPATH OPTIVIEW OPTICAL SURGICAL OBTURATOR AND SLEEVE (K972578) | Ethicon Endo-Surgery, Inc. | 1997-10-01 |
| REP SPE VIS-60/40 KIT (K973316) | Helena Laboratories | 1997-10-01 |
| LEIBINGER SELF-DRILLING SCREW (K970912) | Howmedica Leibinger, Inc. | 1997-10-01 |
| DISTALLY FIXED HIP STEM (K971523) | Sulzer Orthopedics, Inc. | 1997-10-01 |
| OXI-SNAP (K971184) | Snap Laboratories, LLC | 1997-10-01 |
| MIRAGE (K972886) | Segami Corp., Inc. | 1997-10-01 |
| REDYROB-CLOSED WOUND DRAINAGE SYSTEM (K972703) | B.Braun Medical, Inc. | 1997-10-01 |
| STRYKER HUMMER II MICRODEBRIDER SYSTEM (K972584) | Stryker Endoscopy | 1997-10-01 |
| HIGH DOSE DISCONNECT CAP AND MINICAP WITH POVIDONE-IODINE, HIGH DOSE DISCONNECT CAP WITH POVIDONE-IODINE (K972579) | Baxter Healthcare Corp | 1997-10-01 |
| ULTRACELL SUCTION SPONGE (K972635) | Ultracell Medical Technologies, Inc. | 1997-10-01 |
| NAVIGATOR (STYLET) 2006 (K972521) | Sil-Med Corp. | 1997-10-01 |
| CONVATEC ODOR CONTROL WOUND DRESSING (K972530) | Convatec, A Division of E.R. Squibb & Sons | 1997-10-01 |
| ABUSCREEN ONLINE FOR AMPHETAMINES WITH PERIODATE - OLYMPUS AU800/1000 INSTRUMENT APPLICATION (K972891) | Roche Diagnostic Systems, Inc. | 1997-10-01 |
| HEARTPORT INTRODUCER SHEATH (K972570) | Heartport, Inc. | 1997-10-01 |
| PMT NEW BEGINNINGS GELSHAPES & AMEND (K972597) | Pmt Corp. | 1997-10-01 |
| APOLLO REVISION/CONSTRAINED KNEE SYSTEM (K972501) | Sulzer Orthopedics, Inc. | 1997-10-01 |
| ORIGIN LIGATOR DEVICE (K972685) | Origin Medsystems, Inc. | 1997-10-01 |
| COLORPOINT OR PROFESSIONAL COLORPOINT (K971760) | Seiko Instruments USA, Inc. | 1997-10-01 |
| ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS (K973054) | Emd Chemicals, Inc. | 1997-10-01 |
| B&D ACTIVATED CLOTTING TIME (ACT) TEST TUBES BD-C101 (DIATOMACEOUS EARTH) AND BD-K101 (KAOLIN) (K971935) | B & D Corp. | 1997-10-01 |
| PRECEDENT REVISION HIP SYSTEM (K972637) | Sulzer Orthopedics, Inc. | 1997-10-01 |
| DEPUY DUPONT ABSORBABLE SET SCREW (K972494) | Depuy, Inc. | 1997-10-01 |
| ML-DISPOSABLE PAK (K972522) | Med-Logics, Inc. | 1997-09-30 |
| DEROYAL INDUSTRIES, INC. SURGICAL EYE SPEAR (K972693) | Deroyal Industries, Inc. | 1997-09-30 |
| SUNGLASSES (K973490) | Tong Yang Optical Co. | 1997-09-30 |
| 5 FR AND 6 FR INFINITI ANGIOGRAPHIC CATHETER (K970854) | Cordis Corp. | 1997-09-30 |
| CATARACTSCREENER CT - S (K972440) | Neitz Instruments Company, Ltd. | 1997-09-30 |
| SUNGLASSES (NON-PRESCRIPTION) (K973407) | Pacific Optical Co. , Ltd. | 1997-09-30 |
| ASAHI AM-R SERIES DIALYZERS (K970650) | Asahi Medical Co., Ltd. | 1997-09-30 |
| IMMULITE CAT-SPECIFIC IGE, IMMULITE DOG-SPECIFIC IGE,IMMULITE MITE-SPECIFIC IGE (K973186) | Diagnostic Products Corp. | 1997-09-29 |
| MM-RUBY (K970475) | American Lasers, Inc. | 1997-09-29 |
| ADVANCE KNEE SYSTEM (K972626) | Wrightmedicaltechnologyinc | 1997-09-29 |
| XOMED T-STENT, FRONTAL SINUS STENT (K973273) | Xomed, Inc. | 1997-09-29 |
| ELASTIC MANDIBULAR ADVANCEMENT (EMA) APPLIANCE (K971794) | Frantz Design, Inc. | 1997-09-29 |
| COBE OPTIMA AND COBE CML DUO MEMBRANE OXYGENATORS (K964043) | Cobe Cardiovascular, Inc. | 1997-09-29 |
| SOLITAIRE (K972101) | Heraeus Kulzer, Inc. | 1997-09-29 |
| PROMEX ENT TISSUE REMOVAL SYSTEM (K972865) | Promex, Inc. | 1997-09-29 |
| KINEMATIC POSITIONERS (K972704) | Ge Medical Systems, Inc. | 1997-09-29 |
| ENT IRRIGATING PUMP (70327700) (K973286) | Gyrus Ent LLC | 1997-09-29 |
| OPTIVIEW (K972520) | Optimed Technologies, Inc. | 1997-09-29 |
| NEO-CARE PERITONEAL DIALYSIS ADMINISTRATION SET (K972731) | Klein-Baker Medical, Inc. | 1997-09-29 |
| PROSTATE SPECIFIC ANTIGEN CONTROL (K973099) | Dade Chemistry Systems, Inc. | 1997-09-29 |
| SA-EF MULTI-LUMEN EXTENSION SET (K972957) | Vlv Associates, Inc. | 1997-09-29 |
| RELIANT CHARGER (K971768) | Walling Medical Equipment Co. | 1997-09-29 |
| RETINOL BINDING PROTEIN RBP RID KIT (K973189) | The Binding Site, Ltd. | 1997-09-29 |
| JIMMY JOHN III RECTAL NOZZLE (K973256) | Colon Therapeutics | 1997-09-29 |
| PROSTATE SPECIFIC ANTIGEN (PSA) CALIBRATOR (K973100) | Dade Chemistry Systems, Inc. | 1997-09-29 |
| MAS LIQUID URINALYSIS CONTROL LEVEL 1, LEVEL 2 AND LEVEL 3 (K973451) | Medical Analysis Systems, Inc. | 1997-09-29 |
| SPACE CHAMBER FOR MODEL NUMBER AND ACCESSORIES (K971808) | Monarch Medical | 1997-09-26 |
| POCKET RESCUE (K970688) | Cheen Houng Ent. Co. , Ltd. | 1997-09-26 |
| EMG RETRAINER (K972487) | Chattanooga Group, Inc. | 1997-09-26 |
| NITRILE EXAMINATION GLOVES-PRE POWDERED (K970216) | Influx Pacific Sdn. Bhd. | 1997-09-26 |
| SANPO I (K964541) | Koike Medical Co. | 1997-09-26 |
| COBE CENTRYSYSTEM 3 DIALYSIS CONTROL UNIT/COBE CARTRIDGE BLOOD TUBING SET (K970253) | Gambro Healthcare | 1997-09-26 |
| MIST MICRO INTERCHANGEABLE SCOPE SYSTEM (TM) (K970937) | Mist, Inc. | 1997-09-26 |
| SPORTROL RAPID STERILITY INDICATOR (K962649) | North American Science Assoc., Inc. | 1997-09-26 |
| PLAYTEX TAMPONS #14897/PLAYTEX GENTLE GLIDE,SILK GLIDE, SLIMFITS,SOFT COMFORT AND PORTABLES TAMPONS (K971979) | Playtex Products, Inc. | 1997-09-26 |
| ACS VIKING GUIDING CATHETER (K972484) | Guidant Corp. | 1997-09-26 |
| INNOVASIVE 2.3MM ROC XS SUTURE BONE FASTENER (K972438) | Innovasive Devices, Inc. | 1997-09-26 |
| RAPPORT V.T.D. (K971443) | Owen Mumford USA, Inc. | 1997-09-26 |
| KERR NEXUS ONE BOTTLE ADHESIVE (K972858) | Sybron Dental Specialties, Inc. | 1997-09-26 |
| ASLI (K973473) | Texin Industrial (International) , Ltd. | 1997-09-26 |
| 3M LITTMANN ELECTRONIC STETHOSCOPE (K961848) | Minnesota Mining and Mfg. Co. | 1997-09-26 |
| BLACKSTONE MEDICAL, INC. LAPAROSCOPIC DISC REMOVAL SYSTEM (K972768) | Blackstone Medical, Inc. | 1997-09-25 |
| GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SET (K955497) | Cobe Renal Care, Inc. | 1997-09-25 |
| SHILEY EXTENDED LENGTH, DISPOSABLE CANNULA, TRACHEOSTOMY TUBE: CUFFED, DISTAL EXTENSION, CUFFED, PROXIMAL EXTENSION, CUF (K971267) | Mallinckrodt Medical | 1997-09-25 |
| OSTEO BOS SYSTEM IN STAINLESS STEEL (K973204) | Osteonics Corp. | 1997-09-25 |
| HEARTSTRAMELECTRODE ADAPTER(EA-XX SERIES)/HEARTSTRAM DEFIBRILLATION PADS WITH PREATTACHED ELECTRODE ADAPTER(DP-EAXX) (K972418) | Heartstream, Inc. | 1997-09-25 |
| ORATEC INTERVENTIONS MODEL ORA 40 ELECTROTHERMAL GENERATOR (K973159) | Oratec Interventions, Inc. | 1997-09-25 |
| CHEMMATE LCA (K973393) | Ventana Medical Systems, Inc. | 1997-09-25 |