| SATELLITE (K971331) | Nicolet Biomedical, Inc. | 1997-06-25 |
| MULTIPICS(ME-977) (K971154) | Merlin Engineering Works, Inc. | 1997-06-25 |
| SPLITSCREEN (ME-975) (K971153) | Merlin Engineering Works, Inc. | 1997-06-25 |
| BONE ANCHOR SYSTEM FOR SOFT TISSUE SUPPORT (K971139) | Boston Scientific Corp | 1997-06-25 |
| MULTITAK SS SUTURE SYSTEM (K971144) | Bonutti Research | 1997-06-25 |
| EMIT II OPIATES 300/2000 ASSAY (K971596) | Behring Diagnostics, Inc. | 1997-06-25 |
| SURGICAL DRAPES (K971159) | International Medsurg Connection | 1997-06-24 |
| SUNGLASSES (NON-PRESCRIPTION) (K972014) | Tamfort, Ltd. | 1997-06-24 |
| MOUSE ANTI-HUMAN CD45, LEUCOCYTE COMMON ANTIGEN (LCA)/FITC AND CD14, MONOCYTE/RPE (K964974) | Dako Corp. | 1997-06-24 |
| FILTER (K970102) | Promedic, Inc. | 1997-06-24 |
| KLS-MARTIN RIGID EXTERNAL DISTRACTION DEVICE (K972047) | KLS-Martin L.P. | 1997-06-24 |
| THYROTROPIN(TSH) ELISA (K971780) | Monobind | 1997-06-24 |
| THAIRAPY VEST SYSTEM (K965192) | American Biosystems, Inc. | 1997-06-24 |
| MASTER NEB II (K970542) | Bremed Italia, S.R.L. | 1997-06-24 |
| CLAVE CONNECTOR (K970855) | Icu Medical, Inc. | 1997-06-24 |
| POWDER - FREE LATEX EXAMINATION GLOVES APPLICATION (K964826) | Kossan Latex Industries(M)Sdn Bhd | 1997-06-24 |
| OXYPURE PORTABLE OXYGEN GENERATOR (K971129) | Arbor Research Corp. | 1997-06-24 |
| SEALITE SCIENCES, INC. AQUALITE FERRITIN ASSAY (K970612) | Sealite Sciences, Inc. | 1997-06-24 |
| ABBOTT AXSYM FOLATE (K972232) | Abbott Laboratories | 1997-06-24 |
| ELASTYREN POWDER-FREE PATIENT EXAMINATION GLOVES (K970015) | Eci Medical Technologies, Inc. | 1997-06-24 |
| ENDOLIGHT END IRRIGATING ENDO-ILLUMINATOR (20 GA. AND 19 GA.) (K970882) | American Medical Devices, Inc. | 1997-06-24 |
| PERMALUTE, TRY-IN PASTE (K971898) | Ultradent Products, Inc. | 1997-06-24 |
| PLUSTRON ION TOOTHBRUSH SYSTEM (K971639) | Sas Group, Inc. | 1997-06-24 |
| TOTAL BILIRUBIN REAGENT (K972073) | Carolina Liquid Chemistries Corp. | 1997-06-24 |
| RIVIERA SUNGLASS4ES (K972194) | Riviera Optical Co., Ltd. | 1997-06-24 |
| ORTHOTEC K-CAP SYSTEM (K971453) | Orthotech | 1997-06-24 |
| PROLACTIN (PRL) HORMONE MICROPLATE ELISA (K971921) | Monobind | 1997-06-24 |
| CEBE (K971644) | Suunto USA | 1997-06-24 |
| LASEAWAY LONG PULSE AND Q-SWITCHED RUBY LASER SYSTEM (K971193) | Polytec Pi, Inc. | 1997-06-24 |
| DEGANIA SILICONE SIL-K (K971482) | Degania Silicone , Ltd. | 1997-06-24 |
| SMF TITANIUM (TI) ALLOY BONE SCREWS (K963546) | Synthes (Usa) | 1997-06-24 |
| ROCHE SERUM CONTROL NORMAL (HUMAN), ROCHE SERUM CONTROL PATHOLOGICAL (HUMAN) (K972214) | Roche Diagnostic Systems, Inc. | 1997-06-24 |
| OPUS PSA TEST SYSTEM (K964595) | Behring Diagnostics, Inc. | 1997-06-24 |
| SOMNUS MODEL 215 ELECTROSURGICAL GENERATOR (K971711) | Somnus Medical Technologies, Inc. | 1997-06-24 |
| VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTERONE CALIBRATORS (GEM.C070) (K972133) | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-06-24 |
| QUANTA LITE B2GPI IGG (K970551) | Inova Diagnostics, Inc. | 1997-06-24 |
| SECURE-WRAP (TM) STERILIZATION WRAP (K971483) | American Threshold Industries, Inc. | 1997-06-24 |
| IMAGESCAPE DIGITAL RETINAL IMAGE SYSTEM (K971685) | Tomey Corporation USA | 1997-06-24 |
| LOW PROTEIN LATEX EXAMINATION GLOVES (K970222) | Kossan Latex Industries(M)Sdn Bhd | 1997-06-24 |
| SPACELABS MEDICAL MULTI-DISCLOSURE WORKSTATION (K962811) | Spacelabs Medical, Inc. | 1997-06-24 |
| SYNTHES (USA) [SYNTHES] MINI EXTERNAL FIXATOR (K971987) | Synthes (Usa) | 1997-06-24 |
| LYPHOCHEK REMEDI CONTROL (K972174) | Bio-Rad | 1997-06-24 |
| CALCIUM REAGENT (K971907) | Carolina Liquid Chemistries Corp. | 1997-06-24 |
| VENTED I.V. SET (K965027) | Jms Co., Ltd. | 1997-06-24 |
| HYDROCOLLOID WOUND DRESSINGS (K971126) | Innovative Technologies , Ltd. | 1997-06-24 |
| BROWNE STEAM INDICATOR (K970918) | Board of Directors, Albert Browne , Ltd. | 1997-06-24 |
| EDOSSEOUS DENTAL IMPLANT (K970127) | Sulzer Calcitek, Inc. | 1997-06-23 |
| SVL-9130 DEFIBRILLATION ELECTRODE (K971149) | Survivalink Corp. | 1997-06-23 |
| ARTHROSCOPE (K971083) | Electro-Biology, Inc. | 1997-06-23 |
| SPLINE ENGAGING SHOULDERED ABUTMENT SYSTEM (K970752) | Sulzer Calcitek, Inc. | 1997-06-23 |
| PRIMED PRIME-PLUS COTTON GAUZE SPONGES (K971075) | Primeline Medical Products, Inc. | 1997-06-22 |
| DISPOSABLE TRANSRECTAL/TRANSVAGINAL/ENDOCAVITY ULTRASOUND NEEDLE INSTRUMENT GUIDE (K970514) | CIVCO Medical Instruments Co., Inc. | 1997-06-20 |
| LONG MEDIUM PALMAZ-SCHATZ BALLOON EXPANDABLE STENT (K964688) | Cordis Corp. | 1997-06-20 |
| TONDI, MODELS U-03, U-2M1, U-2M4, KA-01, KA-02, KA-03, KA-03A, KA-04, KA-04A, KA-05 (K971296) | National Hearing Aid Dist., Inc. | 1997-06-20 |
| H.V. PULSE LAVAGE (L31 SERIES) (K970916) | Global Medical Products, Inc. | 1997-06-20 |
| TECA. MILLENNIUM (K965065) | Medelec , Ltd. | 1997-06-20 |
| GENERAL PURPOSE TRANDUCER COVER (K970513) | CIVCO Medical Instruments Co., Inc. | 1997-06-20 |
| BSC, SONICATH ULTRA IMAGING CATHETER 3.2F/20MHZ(37410/456221 & BSC, SONICATH ULTRA IMAGING CATHETER 2.9F/20MHZ/37411/ (K970049) | Cardiovascular Imaging Systems, Inc. | 1997-06-20 |
| SULLIVAN AUTOSET PORTABLE II NASAL CPAP SYSTEM (K970771) | Resmed, Ltd. | 1997-06-20 |
| GLORY (K970680) | Elscint, Inc. | 1997-06-20 |
| ELECT II BLOOD GLUCOSE MONITORING SYSTEM (K970707) | Selfcare, Inc. | 1997-06-20 |
| TRIGLYCERIDES, TG, OR TRIG (K971324) | Carolina Liquid Chemistries Corp. | 1997-06-20 |
| SYNAPTIC 3000 (K940954) | The Synaptic Corp. | 1997-06-20 |
| BLINK EXTERNAL EYELID WEIGHT (K971245) | Ipax, Inc. | 1997-06-20 |
| COAXIAL NEEDLE (K971842) | United States Endoscopy Group, Inc. | 1997-06-20 |
| GENERAL PURPOSE LATEX TRANSDUCER COVERS (K970515) | CIVCO Medical Instruments Co., Inc. | 1997-06-20 |
| NSK PUSH-BUTTON MIDWEST REPLACEMENT TURBINE:FOR QUIETAIR AND TRADITION (K971774) | Nsk Nakanishi, Inc. | 1997-06-20 |
| STRATASYS FDM MEDMODELER SYSTEM (K971290) | Paladin Medical, Inc. | 1997-06-20 |
| PRELOADED SOFT TISSUE ANCHOR (K963932) | Linvatec Corp. | 1997-06-20 |
| FUTURA BIOMEDICAL METAL HEMI TOE IMPLANT (K971047) | Nexa Orthopedics, Inc. | 1997-06-20 |
| NDC DENTAL SYSTEM, VERSION 1.5 X-RAY AND VIDEO (K971714) | National Data Corp. | 1997-06-20 |
| QUANTA LITE RF IGM (K971614) | Inova Diagnostics, Inc. | 1997-06-20 |
| VIRGO AMA ELISA KIT (K971909) | Hemagen Diagnostics, Inc. | 1997-06-20 |
| RESISTICK SOLID LAPAROSCOPIC ELECTRODES (K971621) | Aaron Medical Industries | 1997-06-20 |
| NUCLETRON PLATO EXTERNAL BEAM PLANNING RTS V2 AND RTS 3D V2 (K964206) | Nucletron Corp. | 1997-06-20 |
| DIFFUSION WEIGHTED MR IMAGING /MAGNETOM VISION (K971055) | Siemens Medical Solutions USA, Inc. | 1997-06-20 |
| PHOTON RADIOSURGERY SYSTEM (PRS) (K964947) | Photoelectron Corporation | 1997-06-20 |
| PLANMECA INTRACAM (K972033) | Planmeca Oy | 1997-06-20 |
| MAX-I-PROBE ENDODONTIC SEALER DELIVERY SYSTEM (K971622) | Mpl Technologies, Inc. | 1997-06-20 |
| CHOLESTEROL REAGENT (K971072) | Derma Media Lab., Inc. | 1997-06-20 |
| LEO 7000 QUADRATURE KNEE COIL (K971246) | Usa Instruments, Inc. | 1997-06-20 |
| SURGITRON MODEL FFPF-EMC (K972072) | Ellman Intl., Inc. | 1997-06-19 |
| IMPLEX A-240 HEP ACETABULAR CUP SYSTEM (K964509) | Implex Corp. | 1997-06-19 |
| TCP-COATED POROCOAT AML FEMORAL HIP PROSTHESIS (K964650) | Depuy, Inc. | 1997-06-19 |
| MICROJECT MODEL PCA-1 (K965222) | Microject, Inc. | 1997-06-19 |
| PLAYTEX TAMPONS #11197, PLAYTEX GENTLE GLIDE, SOFT COMFORT AND SLIMFITS TAMPONS (K971547) | Playtex Products, Inc. | 1997-06-19 |
| INDICARD TEST (K964015) | Litmus Concepts, Inc. | 1997-06-19 |
| INFECTION CONTROL CARTRIDGE (K964942) | Dentalpure Corp. | 1997-06-19 |
| LEGIONELLA ELISA TEST SYSTEM (K970149) | Zeus Scientific, Inc. | 1997-06-18 |
| BOVIE MODEL X15 (K972161) | Maxxim Medical | 1997-06-18 |
| GRAFT HARVESTING SAWBLADES (K971978) | Wrightmedicaltechnologyinc | 1997-06-18 |
| SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM) (K971289) | Osteotech, Inc. | 1997-06-18 |
| BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL (K970809) | Somnus Medical Technologies, Inc. | 1997-06-18 |
| PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETERS (K971010) | Cordis Corp. | 1997-06-18 |
| SARNS VENOUS RETURN CATHETERS WITH DURAFLO TREATMENT (K964374) | 3M Healthcare | 1997-06-18 |
| MORPHEE PLUS ALPHA (K964019) | Nellcor Puritan Bennett, Inc. | 1997-06-18 |
| LSF TRIAD TOTAL HIP SYSTEM (K971020) | Osteoimplant Technology, Inc. | 1997-06-18 |
| N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET (K971573) | Genzyme Corp. | 1997-06-18 |
| FOCUS-PV BALLOON DILATATION CATHETER (K971577) | Cardiovascular Dynamics, Inc. | 1997-06-18 |
| OPUS PROGESTERONE (K971725) | Behring Diagnostics, Inc. | 1997-06-18 |