| UNICA 315 M CO2 SURGICAL LASER SYSTEM (K971821) | Reliant Technologies, Inc. | 1997-09-25 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS (K973517) | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-09-25 |
| WAKO CH50 LINEARITY SET (K973055) | Wako Chemicals USA, Inc. | 1997-09-25 |
| W.M.E. GPS 1001 (K961751) | Weaver Medical Electronics, Inc. | 1997-09-25 |
| FRESH CELLS WI-38 (K973212) | Diagnostic Hybrids, Inc. | 1997-09-25 |
| ALCOHOL REAGENT SET (K972725) | Pointe Scientific, Inc., | 1997-09-25 |
| THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY (K972463) | Biomedics | 1997-09-25 |
| SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT (K973109) | Synermed, Inc. | 1997-09-25 |
| STERILE SUPRAFOIL SMOOTH NYLON FOIL SHEETS (K973379) | S. Jackson, Inc. | 1997-09-25 |
| FRESH CELLS MV1LU (K973211) | Diagnostic Hybrids, Inc. | 1997-09-25 |
| A1C 2.2 PLUS - AUTOMATED GLYCOHEMOGLOBIN ANALYZER (K972265) | Tosoh Medics, Inc. | 1997-09-25 |
| FRESH CELLS NCI H292 (K973210) | Diagnostic Hybrids, Inc. | 1997-09-25 |
| ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR (0998-00-0117-XX) (K970061) | Datascope Corp. | 1997-09-25 |
| QUICKSCREEN ONE STEP THC SCREENING TEST (K973122) | Phamatech | 1997-09-25 |
| SIGNAL-AVERAGED HIGH RESOLUTION P WAVE ANALYSIS (K972199) | Marquette Electronics, Inc. | 1997-09-25 |
| SPACELABS MEDICAL PCIS PATIENT MONITORS (K972282) | Spacelabs Medical, Inc. | 1997-09-25 |
| SEALITE SCIENCES, INC. AQUALITE HUMAN GROWTH HORMONE ASSAY (K972761) | Sealite Sciences, Inc. | 1997-09-25 |
| UNIVERSAL REAGENT FACTOR XII (TWELVE) DEFICIENT PLASMA (K973143) | Universal Reagents, Inc. | 1997-09-25 |
| OSTEONICS OMNIFIT-C CEMENTED HIP STEM (LINE EXTENSION) (K972460) | Osteonics Corp. | 1997-09-25 |
| FRESH CELLS VERO (K973209) | Diagnostic Hybrids, Inc. | 1997-09-25 |
| NPB-195 PULSE OXIMETER (K972468) | Nellcor Puritan Bennett, Inc. | 1997-09-25 |
| QUIKCHECK UNASSAYED CHEMISTRY CONTROL LEVELS 1 AND 2, CONFORMANCEMCCLIQUICHEM UNASSAYED LIQUID CHEMISTRY CONTROL LEVELS (K973469) | Consolidated Technologies, Inc. | 1997-09-25 |
| FRESH CELLS HFF (K973214) | Diagnostic Hybrids, Inc. | 1997-09-25 |
| FRESH CELLS LLC-MK2 (K973213) | Diagnostic Hybrids, Inc. | 1997-09-25 |
| AUTOMATED MULTI-POINT BLOOD VOLUME ANALYZER (K964406) | Daxor Corporation | 1997-09-25 |
| DUO-LITE PHOTOTHERAPY SYSTEM (K971256) | Air-Shields, Inc. | 1997-09-24 |
| OLYMPIC BILI-BASSINET (K971601) | Olympic Medical Corp. | 1997-09-24 |
| KONTRON KOLORMON PLUS ECG WITH RESPIRATION MODULE (K971038) | Kontron Instruments , Ltd. | 1997-09-24 |
| CHOLESTEROL RAPID LIQUID REAGENT (K972853) | Reagents Applications, Inc. | 1997-09-24 |
| SPLINT IT (K972985) | Jeneric/Pentron, Inc. | 1997-09-24 |
| VIOLA II DENTAL CAMERA SYSTEM (K973035) | Innovative Medical Systems, Inc. | 1997-09-24 |
| DISETRONIC PENFINE INJECTION PEN NEEDLE (K973339) | Disetronic Medical Systems | 1997-09-24 |
| SANAPHON N (K972378) | Rudolf Riester GmbH & Co. KG | 1997-09-24 |
| PRECISA N (K972379) | Rudolf Riester GmbH & Co. KG | 1997-09-24 |
| RI-MEGA (K972377) | Rudolf Riester GmbH & Co. KG | 1997-09-24 |
| V40 ZIRCONIA FEMORAL HEADS (K972361) | Howmedica, Inc. | 1997-09-23 |
| PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM WITH PARATREND 7 PLUS MULTIPARAMETER SENSOR (K970906) | Diametrics Medical, Ltd. | 1997-09-23 |
| MULTISPECT 2 511 KEV COLLIMATOR (K972360) | Siemens Medical Solutions USA, Inc. | 1997-09-23 |
| SHELHIGH PERICARDIAL PATCH (K964467) | Shelhigh, Inc. | 1997-09-23 |
| ANORECTAL MANOMETRY ANALYSIS MODULE (K972439) | Medtronic-Synectics | 1997-09-23 |
| FOTONA SKINLIGHT PLUS ND: YAG SYSTEM (K972368) | Medical Laser Solutions | 1997-09-23 |
| MICROSPAN GOLD HYSTEROSCOPE AND MICROSPAN HYSTEROSCOPE SHEATH (K972426) | Imagyn Medical, Inc. | 1997-09-23 |
| ANGIOMAT ILLUMENA (K963071) | Mallinckrodt Inc., Liebel-Flarsheim Business | 1997-09-23 |
| IMNET DICOM NETWORK AGENT (K972366) | Imnet Systems, Inc. | 1997-09-23 |
| ADVANTAGE WINDOWS VOLUME RENDERING OPTION (K972399) | Ge Medical Systems, Inc. | 1997-09-23 |
| CAPNOXYGEN MASK (K971229) | Medsys, Inc. | 1997-09-23 |
| EZ SPRAY (K972397) | Intertex Research, Inc. | 1997-09-23 |
| Z DEQ-II (K973266) | Electone, Inc. | 1997-09-23 |
| MIST PANORAMIC LAPAROSCOPE A RIGID LAPAROSCOPE (K971150) | Mist, Inc. | 1997-09-23 |
| SYNCHRON SYSTEMS METHADONE REAGENT (K973069) | Beckman Instruments, Inc. | 1997-09-22 |
| QUICK-DRAW CAPILLARY WHOLE BLOOD COLLECTION SYSTEM (K972969) | Innovative Medical Technologies, Inc. | 1997-09-22 |
| DEOXYPYRIDINOLINE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (K972580) | Bayer Corp. | 1997-09-22 |
| T1 LINE DENTAL HANDPIECES (K972436) | Siemens AG | 1997-09-22 |
| ICS MEDICAL VEMR VIDEO EYE MOVEMENT RECORDER (K972631) | Ics Medical Corp. | 1997-09-22 |
| ULTRASOUND SYSTEMS DRAPE (K970885) | Protek Medical Products, Inc. | 1997-09-22 |
| MODIFIED CEDIA DAU PCP ASSAY (K972963) | Boehringer Mannheim Corp. | 1997-09-22 |
| AFP ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (K972462) | Bayer Corp. | 1997-09-22 |
| IMMULITE CEA (K970877) | Diagnostic Products Corp. | 1997-09-22 |
| SIGMA DIAGNOSTICS CREATININE REAGENT, SIGMA DIAGNOSTICS CREATININE REAGENT (K972743) | Sigma Diagnostics, Inc. | 1997-09-22 |
| ENDOSCOPIC ELECTROSURGICAL INSTRUMENTS AND ELECTRODES (K972008) | European Surgical, Inc. | 1997-09-19 |
| KENTRON'S ISOLATION GOWN (K971917) | Kentron Health Care, Inc. | 1997-09-19 |
| MODIFIED COHERENT VERSAPULSE AESTHETIC SURGICAL LASER (K972347) | Lumenis, Inc. | 1997-09-19 |
| GR100F URINE FLOWMETER (K971913) | Albyn Medical , Ltd. | 1997-09-19 |
| ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM (ETFS) (K972679) | Ethicon Endo-Surgery, Inc. | 1997-09-19 |
| INTER-OP HA POROUS ACETABULAR SYSTEM (HA/CSTI) (K972393) | Sulzer Orthopedics, Inc. | 1997-09-19 |
| IMPERVIOUS ISOLATION GOWN (K972410) | Kentron Health Care, Inc. | 1997-09-19 |
| DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM (K972568) | Depuy, Inc. | 1997-09-19 |
| PULSEMASTER 1000 ST DENTAL LASER SYSTEM (K972325) | American Dental Technologies, Inc. | 1997-09-19 |
| MINISITE*BIPOLAR FORCEPS** DEVICE (K972415) | United States Surgical, A Division of Tyco Healthc | 1997-09-19 |
| PIONEER ELEC-TROCAR DEVICE (K971728) | Pioneer Surgical Technology | 1997-09-19 |
| AMERICAN BIOSURGICAL ELECTROSURGICAL BIPOLAR CABLE/CORD (K972901) | American Biosurgical, Inc. | 1997-09-19 |
| DINAMAP MPS PORTABLE MONITOR (K971569) | Johnson & Johnson Medical, Inc. | 1997-09-19 |
| LYOCELL WOUND DRESSING/SURGICAL SPONGE (K972458) | Courtaulds Fibers, Inc. | 1997-09-19 |
| DIGI-INJECTOR (K971067) | Medical Instrument Development Laboratories, Inc. | 1997-09-19 |
| LYSONIX TTD DELTA SCAVENGER SUCTION/ASPIRATION CANNULAS LYSONIX INFUSION DIAMOND CANNULAS (K972958) | Lysonix, Inc. | 1997-09-19 |
| OT-1 (K972781) | Prism Therapeutics, LLC | 1997-09-19 |
| DIGENE CERVICAL BRUSH (K971586) | Digene Corp. | 1997-09-19 |
| ACUFEX SCREW CANNULA (K972599) | Smith & Nephew Endoscopy, Inc. | 1997-09-19 |
| MARCHETTI-VICENZI INTRAMEDULLARY NAIL, HUMERAL (K972692) | Zimmer, Inc. | 1997-09-19 |
| SILICONE BILIARY STENT/BILIARY CATHETER (K973114) | Specialty Surgical Products, Inc. | 1997-09-19 |
| TST CONTROL INTEGRATOR FOR STEAM AUTOCLAVE (K965154) | Albert Browne , Ltd. | 1997-09-19 |
| IN-SLING (K972651) | Influence, Inc. | 1997-09-19 |
| CONFORM NO POWDER (PROTEIN LABELING CLAIM) EXAMINATION GLOVES (K972785) | Ansell Perry | 1997-09-19 |
| AMPLATZ THROMBECTOMY DEVICE(ATD 603,602,801,802)/FOOT PEDAL ASSEMBLY(AK 200) (K971984) | Microvena Corp. | 1997-09-19 |
| AURELUX BIO Y85PF (K972949) | Aurex Precious Metal Industries (Pty)Ltd | 1997-09-18 |
| LUXMATIC 12-15 ISC PORTABLE ELECTRIC BREAST PUMP (K971543) | Kaweco GmbH | 1997-09-18 |
| RESUABLE HOT BIOPSY FORCEPS (K972505) | United States Endoscopy Group, Inc. | 1997-09-18 |
| SEAGER ELECTROEJACULATOR (K962379) | National Rehab Hospital | 1997-09-18 |
| MODEL 20 BIPOLAR COAGULATOR (K972311) | Boston Surgical Products, Inc. | 1997-09-18 |
| ONE-WAY VALVE (WITH CONNECTOR) (K970780) | Instrumentation Industries, Inc. | 1997-09-18 |
| PHASEAL, SYSTEM FOR SEALED HANDLING OF CHEMOTHERAPEUTIC AGENTS (K972527) | Quality System Consulting | 1997-09-18 |
| PROSTATE SPECIFIC ANTIGEN METHOD (K973101) | Dade Chemistry Systems, Inc. | 1997-09-18 |
| S-357 VIDEO IMAGING SYSTEM (K972540) | Sopro | 1997-09-18 |
| SILENTNITE (K972424) | Glidewell Laboratories | 1997-09-18 |
| MONTGOMERY THYROPLASTY IMPLANT SYSTEM (K972317) | Boston Medical Products, Inc. | 1997-09-18 |
| NIPRO DISPOSABLE SOLUTION INFUSION SET (K972493) | Nipro Medical Corp. | 1997-09-18 |
| MICROETCHER AP (K970589) | Danville Engineering, Inc. | 1997-09-17 |
| BIG BEN SQUARE, BIG BEN ROUND (K972301) | Rudolf Riester GmbH & Co. KG | 1997-09-17 |
| RHMK II CELL CULTURE, AN EXPANDED PRIMARY RHESUS MONKEY KIDNEY CELL CULTURE (K971508) | Bio-Whittaker, Inc., A Cambrex Co. | 1997-09-17 |
| SIMS 1ST RESPONSE MANUAL RESUSCITATOR, ADULT (K972283) | Sims | 1997-09-17 |