| QUIKPAC II ONE STEP COCAINE TEST (K972059) | Drial Consultants, Inc. | 1997-08-28 |
| 50NG/ML COCAINE METABOLITE CALIBRATOR (K972835) | Diagnostic Reagents, Inc. | 1997-08-28 |
| TRADEMARK BLOOD GAS/ELECTROLYTE/GLUCOSE, LACTATE, BUN AND CREATININE CONTROL (K972868) | Bionostics, Inc. | 1997-08-28 |
| REMEL BILE ESCULIN AZIDE AGAR W/6 MCG/ML VANCOMYCIN (K972359) | Remel, L.P. | 1997-08-28 |
| AURECAST 83 (K972942) | Aurex Precious Metal Industries (Pty)Ltd | 1997-08-28 |
| AURECAST 74 (K972941) | Aurex Precious Metal Industries (Pty)Ltd | 1997-08-28 |
| FEMALE EXTERNAL URINARY COLLECTION POUCH (K971499) | Mediquest, Inc. | 1997-08-28 |
| STERILE WATER FOR INHALATION, USP (K972467) | Holopack International, LP | 1997-08-28 |
| RAICHEM PREALBUMIN SPIA (K972812) | Hemagen Diagnostics, Inc. | 1997-08-28 |
| INFUSASLEEVE IIA (IS-2A) (K972175) | Localmed, Inc. | 1997-08-28 |
| COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL,DISPOSABLE SENSOR/COMSAT REUSABLE FINGER SENSOR (K970769) | Aristo Medical | 1997-08-28 |
| Z TECH TRANSCUTANEOUS NEURAL STIMULATION (K965244) | Z Technologies, LLC | 1997-08-27 |
| SHARPLAN EPITOUCH RUBY LASER SYSTEM (K972099) | Sharplan Lasers, Inc. | 1997-08-27 |
| BERGEN MODEL 500 ELECTROSURGERY GENERATOR (K972299) | Bergen Mfg. | 1997-08-27 |
| KARL STORZ MONOPOLAR COAGULATING ELECTRODES/ KARL STORZ MONOPOLAR COAGULATING NEEDLE ELECTRODES (K972497) | KARL STORZ Endoscopy-America, Inc. | 1997-08-27 |
| CYNOSURE DERMATOLOGY LASER COOLING TIP (K972002) | Cynosure, Inc. | 1997-08-27 |
| OPTICAL MEDIASTINOSCOPE WITH PLUG-IN CONNECTION/OCULAR EYEPIECE (K971166) | Richard Wolf Medical Instruments Corp. | 1997-08-27 |
| MEDI-TRACE 1510M COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE (K972970) | Graphic Controls Corp. | 1997-08-27 |
| POLY (VINYL) EXAM GLOVE, POWDERED (K971316) | Copioumed Intl., Inc. | 1997-08-27 |
| THERMOGARD & THERMOGARD PLUS ABC (K972628) | Conmedcorp | 1997-08-27 |
| NURSES BOUFFANT CAP (K965237) | Copioumed Intl., Inc. | 1997-08-27 |
| SELFSHIELD HN SELF SHEATHING HYPODERMIC NEEDLE (K972469) | Beech Medical Products, Inc. | 1997-08-27 |
| MODEL I 100 RF PASSIVE ATTENUATOR/SPLITTER AND MODEL QL 10 LOOP ELECTRODE (K964779) | Quantum Loop, Inc. | 1997-08-27 |
| CARDIOPLEGIA ADAPTERS, VESSEL CANULAE, AND AORTIC ROOT CANNULAE (K972503) | Sorin Group Italia S.R.L. | 1997-08-26 |
| METALPRIMER II (K972594) | GC America, Inc. | 1997-08-26 |
| EVITA 2 DURA (K970165) | Drager, Inc. | 1997-08-26 |
| NATIONAL MEDICAL HEALTHCARE CUSTOM OB/GYN KITS, TRAYS, OR PACKS (K972013) | National Healthcare Mfg. Corp. | 1997-08-26 |
| VALLEY FORGE BIPOLAR LOOP (K971986) | Valley Forge Scientific Corp. | 1997-08-26 |
| 3I INNOVATIVE IMPLANTS AND COVER SCREWS (K972444) | Implant Innovations, Inc. | 1997-08-26 |
| BRUNO ELECTRA-RIDE III STAIRWAY ELEVATOR SYSTEM (K970927) | Bruno Independent Living Aids, Inc. | 1997-08-26 |
| SURGICAL BURS AND SURGICAL DRILL BITS (K972508) | Synvasive Technology, Inc. | 1997-08-26 |
| AURECAST GF (K972319) | Aurex Precious Metal Industries (Pty)Ltd | 1997-08-26 |
| BLOOD COLLECTION TUBE HOLDER VANISHPOINT TUBE HOLDER/SMALL TUBE ADAPTER (K971763) | Retractable Technologies, Inc. | 1997-08-26 |
| MAERSK MEDICAL PURELINE COMFORT SUBCUTANEOUS INFUSION SET (K972135) | P/L Biomedical | 1997-08-26 |
| OPT80 THE TRANSPORTABLE (OPT80) (K972810) | O.P.T. USA, Inc. | 1997-08-26 |
| AURECAST BIO 59PF (K972939) | Aurex Precious Metal Industries (Pty)Ltd | 1997-08-26 |
| TOTALCARE., MODULAR THERAPY SYSTEM (MTS) (K970636) | Hill-Rom, Inc. | 1997-08-26 |
| BAG DECANTER (K972134) | Remington Medical, Inc. | 1997-08-26 |
| IMTEC BIOBARRIER MEMBRANE (K972240) | Imtec Corp. | 1997-08-26 |
| MSI BOTTLEFLOW, TRANSFLOW, VIALFLOW (K972117) | Medical Specialty Innovations, Inc. (Msi) | 1997-08-26 |
| FREQUENCY 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (K973063) | Aspect Vision Care, Ltd. | 1997-08-26 |
| INNOVASIVE 2.3MM ROC EZ SUTURE BONE FASTENER (K972356) | Innovasive Devices, Inc. | 1997-08-26 |
| DEPUY ACE A.I.M. TITANIUM TIBIAL NAIL (K972183) | Ace Medical Co. | 1997-08-26 |
| SYSMEX IMMATURE RETICULOCYTE FRACTION (IRF) PARAMETER (K971736) | Sysmex Corp. | 1997-08-26 |
| AURECAST BIO 69PF (K972940) | Aurex Precious Metal Industries (Pty)Ltd | 1997-08-26 |
| TRUCOUNT ABSOLUTE COUNT TUBES/COUNTING CONTROL BEADS (K970836) | Becton Dickinson Immunocytometry Systems | 1997-08-26 |
| OSOM MONO TEST 143 (K972231) | Wyntek Diagnostics, Inc. | 1997-08-26 |
| VISTA ANTIGEN SALMONELLA O GROUP C (K972388) | Lee Laboratories, Inc. | 1997-08-25 |
| LAPARETTE (K971146) | Rd Chus, Inc. | 1997-08-25 |
| ACCUTEMP-PROBE (K970686) | Kentec Medical, Inc. | 1997-08-25 |
| EXTRAWEAR, GENTLEMEN'S CHOICE (K972428) | Custom Services Intl., Inc. | 1997-08-25 |
| GYREX PRIMA 1TG 1.0T MRI SYSTEM (K970990) | Elscint Mr, Inc. | 1997-08-25 |
| KODAK DIGITAL SCIENCE PRO-MEDICAL THERMAL PRINTER (K971973) | Eastman Kodak Company | 1997-08-25 |
| SAFARI (K970646) | Ranger All Season Corp. | 1997-08-25 |
| VISTA ANTIGEN SALMONELLA O GROUP A (K972387) | Lee Laboratories, Inc. | 1997-08-25 |
| NPB-190 PULSE OXIMETER (NPB-190) (K971946) | Nellcor Puritan Bennett, Inc. | 1997-08-25 |
| VISTA ANTIGEN SALMONELLA H B (K972391) | Lee Laboratories, Inc. | 1997-08-25 |
| VISTA ANTIGEN SALMONELLA H D (K972389) | Lee Laboratories, Inc. | 1997-08-25 |
| AURECAST 4 (K972937) | Aurex Precious Metal Industries (Pty)Ltd | 1997-08-25 |
| OSTEO ANATOMICAL BONE PLATES (K972196) | Osteonics Corp. | 1997-08-25 |
| DASH, SULLIVAN, VITAL GARD (K971044) | Dash Medical Gloves, Inc. | 1997-08-25 |
| VISTA ANTIGEN SALMONELLA H A (K972392) | Lee Laboratories, Inc. | 1997-08-25 |
| VISTA ANTIGEN SALMONELLA H C (K972390) | Lee Laboratories, Inc. | 1997-08-25 |
| THE YELLOW IRIS URINALYSIS WORKSTATION (K972141) | Intl. Remote Imaging Systems | 1997-08-25 |
| VISTA ANTIGEN BRUCELLA ABORTUS (K972394) | Lee Laboratories, Inc. | 1997-08-25 |
| TILT MASTER CG SYSTEM (CENTER OF GRAVITY), TILT-N-SPACE-SEAT (K972564) | Mechanical Application Designs, Inc. | 1997-08-25 |
| SLEEP-IN BONE SCREW SYSTEM (K972023) | Influence, Inc. | 1997-08-25 |
| NEW SOUND HIDDEN AID COMPLETELY IN CANAL (CIC) (K972039) | Nu-Sound | 1997-08-25 |
| RUFF WORK EYEGEAR (K972717) | Ruff House, Inc. | 1997-08-25 |
| REPICCI II UNICONDYLAR KNEE (K971938) | Biomet, Inc. | 1997-08-25 |
| VISTA ANTIGEN SALMONELLA O GROUP B (K972386) | Lee Laboratories, Inc. | 1997-08-25 |
| VIEWCATH 3-D CATHETER PULLBACK (K971397) | Quinton, Inc. | 1997-08-25 |
| AURECAST 10 (K972938) | Aurex Precious Metal Industries (Pty)Ltd | 1997-08-25 |
| AURECAST 2 (K972936) | Aurex Precious Metal Industries (Pty)Ltd | 1997-08-25 |
| VISTA ANTIGEN SALMONELLA O GROUP D (K972395) | Lee Laboratories, Inc. | 1997-08-25 |
| PEACHTREE PROPORTIONAL HEAD CONTROL UNIT (PHC-2) (K972147) | Dynamic Systems, Inc. | 1997-08-25 |
| ACS HI-TORQUE ALL STAR 0.014 GUIDE WIRE WITH MICROGLIDE COATING (K972142) | Guidant Corp. | 1997-08-25 |
| NITRILE GLOVES (K970135) | Sage Products, Inc. | 1997-08-25 |
| VISTA ANTIGEN BRUCELLA MELITENSIS (K972396) | Lee Laboratories, Inc. | 1997-08-25 |
| CRT2000 THERMOGRAPHIC SYSTEM (K971956) | Werner Eidam Medizin-Technologie GmbH | 1997-08-22 |
| CHASE BLOOD VESSEL SHUNT (K972665) | Chase Medical, Inc. | 1997-08-22 |
| IMMULITE 2000 PSA (K972095) | Diagnostic Products Corp. | 1997-08-22 |
| MENICON SF-P AND MENICON Z RIGID GAS PERMEABLE CONTACT LENS (K972443) | Menicon U.S.A., Inc. | 1997-08-22 |
| ACCURUN 146 CMV IGM POSITIVE CONTROL (K972884) | Boston Biomedica, Inc. | 1997-08-22 |
| CAUSSE UNIVERSAL OSSICULAR REPLACEMENT PROSTHESIS (ORP/1) (K963899) | Exmoor Plastics , Ltd. | 1997-08-22 |
| DTX-200 BONE DENSITOMETER (K964562) | Osteometer Meditech A/S | 1997-08-22 |
| WARMETTE (K971117) | Olympic Medical Corp. | 1997-08-22 |
| MEDTRONIC MODEL 3273/3274 RF RECEIVER AND MODEL 3629/3630 SCREENER (K972043) | Medtronic Vascular | 1997-08-22 |
| HEADLOC CERAMIC HEAD (K970675) | Ortho Development Corp. | 1997-08-22 |
| LIFT MASTER (K972563) | Mechanical Application Designs, Inc. | 1997-08-22 |
| DRAPE, SURGICAL-LATEX (K970891) | Protek Medical Products, Inc. | 1997-08-22 |
| ARROWGARD BLUE QUAD-LUMEN CENTRAL VENOUS CATHETER (K962577) | Arrow Intl., Inc. | 1997-08-21 |
| T-WALL UNCUFFED TRACHEAL TUBE (K970196) | Vital Signs, Inc. | 1997-08-21 |
| MODEL 50 BIPOLAR COAGULATOR (K972350) | Boston Surgical Products, Inc. | 1997-08-21 |
| ENDOXANE (K971509) | Novatech SA | 1997-08-21 |
| VENOMIDICARD PEDIATRIC VENOUS RESERVOIR WITH INTEGRALCARDIOTOMY FILTER/MIDICARD PEDIATRIC CARDIOTOMY RESERVOIR WITH FILT (K964907) | Sorin Biomedical, Inc. | 1997-08-21 |
| SCANNING DEVICE ACCESSORY FOR USE WITH THE CB DIODE/532 ND:YAG LASER (K971903) | Continuum Biomedical, Inc. | 1997-08-21 |
| AXT 150M MANUAL COLLIMATOR (AXT 150M) (K972966) | Applied X-Ray Technologies, Inc. | 1997-08-21 |
| RID-DECUBE II (K965207) | Skin Care Management, Inc. | 1997-08-21 |
| SHIELDED SURGICAL TROCAR (K971475) | Ethicon Endo-Surgery, Inc. | 1997-08-21 |