| INNOVA RECTAL REUSABLE ELECTRODE/COMFORTPULSE REGULAR OR SMALL REUSABLE ELECTRODE (K972054) | Empi | 1997-08-14 |
| CONVATEC NON-ADHESIVE DRESSING (K972062) | Convatec, A Division of E.R. Squibb & Sons | 1997-08-14 |
| DEPUY PROXIMAL FEMORAL REPLACEMENT PROSTHESIS (K970241) | Depuy, Inc. | 1997-08-14 |
| LASETTE (K965124) | Cell Robotics, Inc. | 1997-08-14 |
| SYNERGY CARDIOLOGY INFORMATION SYSTEM (00431) (K964784) | Quinton, Inc. | 1997-08-13 |
| REAADS PROTEIN S ANTIGEN TEST KIT (K972482) | Reaads Medical Products, Inc. | 1997-08-13 |
| REAADS VON WILLEBRAND FACTOR ANTIGEN TEST KIT (K972005) | Reaads Medical Products, Inc. | 1997-08-13 |
| ALICE 4R SYSTEM (K971867) | Healthdyne Technologies, Inc. | 1997-08-13 |
| ABBOTT STREP A CONTROLS (K972182) | Abbott Diagnostics | 1997-08-13 |
| VIGIL TDM CONTROLS (K972819) | Beckman Instruments, Inc. | 1997-08-13 |
| TICARCILLIN/CLAVULANIC ACID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K971632) | Oxoid , Ltd. | 1997-08-13 |
| PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR V DEFICIENT PLASMA (THROMBOSDREEN BRAND) (100056) (K972627) | Pacific Hemostasis | 1997-08-13 |
| ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL0810-0115 (K971828) | Alexander Mfg. Co. | 1997-08-12 |
| CHASE PHRENIC NERVE PAD (K971021) | Chase Medical, Inc. | 1997-08-12 |
| ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS311 (K972086) | Alexander Mfg. Co. | 1997-08-12 |
| VISUALINE II METHAMPHETIMINE (K972032) | Sun Biomedical Laboratories, Inc. | 1997-08-12 |
| LAPAROTOMY BLADDER NECK SUSPENSION KIT WITH BONE ANCHORS (K971796) | Louisville Laboratories, Inc. | 1997-08-12 |
| DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES (K970511) | Smith & Nephew, Inc. | 1997-08-12 |
| ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS71764 (K971827) | Alexander Mfg. Co. | 1997-08-12 |
| DERMAGRAN WOUND MANAGEMENT SYSTEM (K970660) | Derma Sciences, Inc. | 1997-08-12 |
| AMERIGEL OINTMENT SATURATED WOUND DRESSING (K971918) | Amerx Health Care Corp. | 1997-08-12 |
| ALTA INTRAMEDULLARY ROD SYSTEM (K972108) | Howmedica Corp. | 1997-08-12 |
| KSEA 15.5 FR. FLEXIBLE CHOLEDOCHO-FIBERSCOPE (K971977) | KARL STORZ Endoscopy-America, Inc. | 1997-08-12 |
| SPECTROLYSE HEPARIN (ANTI-IIA) (K972209) | Medical Diagnostic Technologies, Inc. | 1997-08-12 |
| ACCURUN 117 HBEAG POSITIVE CONTROL (K972048) | Boston Biomedica, Inc. | 1997-08-12 |
| CHLAMYDIATROL AG (K972129) | Blackhawk Biosystems, Inc. | 1997-08-12 |
| ROCHE COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS (K972250) | Roche Diagnostic Systems, Inc. | 1997-08-12 |
| COMEG RESECTOSCOPE AND LASER-RESECTOSCOPE WORKING ELEMENTS/URETHROTOMES/ELECTRODES/ALBARRAB DEFLECTORS (K971881) | Comeg Endoscopy | 1997-08-12 |
| TOOL-LESS WHEEL CHAIR (K972797) | Sunrise Medical, Inc. | 1997-08-12 |
| ECG REVIEW STATION (K942685) | Mortara Instrument, Inc. | 1997-08-12 |
| KARL STORZ MODEL 203020 20 EQUIMAT (K971982) | KARL STORZ Endoscopy-America, Inc. | 1997-08-12 |
| ABBOTT CELL-DYN 4000 IMMATURE RETICULOCYTE FRACTION (IRF) (K971152) | Abbott Laboratories | 1997-08-12 |
| SMITH & NEPHEW IMAGES ENDOSCOPES AND ACCESSORIES (K971850) | Smith & Nephew, Inc. | 1997-08-12 |
| IMZ TWIN PLUS SCREW (K963520) | Imz, GmbH | 1997-08-12 |
| ACCURUN 121 HAV IGM POSITIVE CONTROL (K971657) | Boston Biomedica, Inc. | 1997-08-12 |
| PRECICONTROL TUMOR MARKER 1 AND 2 (K972235) | Boehringer Mannheim Corp. | 1997-08-12 |
| GUERRERO - BELL DISTRACTOR (K972166) | Howmedica Leibinger, Inc. | 1997-08-11 |
| LORENZ PECTUS SUPPORT BAR (K972420) | Walter Lorenz Surgical, Inc. | 1997-08-11 |
| MVM 3.3 MM MICROENDOSCOPE (K972504) | KARL STORZ Endoscopy-America, Inc. | 1997-08-11 |
| QUICKLOCK ORTHOPAEDIC TARGETING SYSTEM (K964444) | Rdh Medical | 1997-08-11 |
| ARRHYTHMIA MAPPING SYSTEM (8100/8300) (K965066) | Cardiac Pathways Corp. | 1997-08-11 |
| METAGEN ACTIVELOCK CERCLAGE SYSTEM (K972327) | Pacific Materials and Interfaces | 1997-08-11 |
| FEMRX FOCUSED MONOPOLAR (FMP) OPERA STAR SYSTEM (K971305) | Gynecare Innovation Center | 1997-08-11 |
| OSTEO KIRSCHNER WIRES (K971962) | Osteonics Corp. | 1997-08-11 |
| ZIP CONDOM CATHETER (K964219) | Goulter Medical, Inc. | 1997-08-11 |
| PERINEOMETER & VAGINAL PROBE (BIOFEEDBACK MONITOR #20 AND VAGINAL PROBE) (K970145) | Biosearch Medical Products, Inc. | 1997-08-11 |
| ANODYNE CC (K963481) | Heyer America, Inc. | 1997-08-11 |
| COHEN DISTRACTOR (K972154) | Howmedica Leibinger, Inc. | 1997-08-11 |
| ZIRCONIA CERAMIC MODULAR HEADS (NORTON ADVANCED CERAMICS) (K964431) | Biomet, Inc. | 1997-08-11 |
| DCLARE IMMUNODIP STICKFOR MICROALBUMINURIA (K972337) | Diagnostic Chemicals , Ltd. | 1997-08-08 |
| CYNOSURE PHOTOGENICA LPIR DERMATOLOGICAL LASER (K971737) | Cynosure, Inc. | 1997-08-08 |
| ELECTROSURGICAL ELECRTRODES (K962271) | Northgate Technologies, Inc. | 1997-08-08 |
| QUICKSCREEN ONE STEP COCAINE SCREENING TEST (9070) (K972618) | Phamatech | 1997-08-08 |
| SURESCAN (K964831) | Clinicon Corp. | 1997-08-08 |
| ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29) (K970695) | Chiron Diagnostics Corp. | 1997-08-08 |
| PIXI YOUNG ADULT REFERENC POPULATION FOR OS CALCIS AND FOREARM (K972053) | Lunar Corp. | 1997-08-08 |
| OXYCOR (BALAFILCON A) VISIBILITY TINTED CONTACT LENS (K972454) | Bausch & Lomb, Inc. | 1997-08-08 |
| THROMBOLYTIC BRUSH CATHETER (K963925) | Micro Therapeutics, Inc. | 1997-08-08 |
| GOLD FINGERS (K971183) | Alliance Rubber Products Sdn. Bhd. | 1997-08-08 |
| FAVC-M: FEMORAL ARTERY VASCULAR CLAMP-MOBILE (MODEL M100-M200) FAVC-M FEMORAL ARTERY VASCULAR CLAMP-MOBILE ADJ BELT 6005 (K970027) | Rmds, Inc. | 1997-08-08 |
| VISION CARDIOPLEGIA DELIVERY SYSTEM (K964571) | Lifestream Int'L, Inc. | 1997-08-08 |
| PRECISION QID BLOOD GLUCOSE TEST STRIP, PRECISION G BLOOD GLUCOSE TEST STRIP (K971812) | Medisense, Inc. | 1997-08-08 |
| QUIKPAC II ONE STEP OPIATE TEST (K972405) | Drial Consultants, Inc. | 1997-08-08 |
| VANTAGE 2.1 EXSPECT (K971878) | Adac Laboratories | 1997-08-08 |
| BACTEC MYCO/F-SPUTA CULTURE VIALS (K972758) | Becton Dickinson Microbiology Systems | 1997-08-08 |
| ROTAVIRUS EIA (K964424) | Trinity Biotech, Inc. | 1997-08-08 |
| SELECT SHOULDER OFFSET HUMERAL HEAD COMPONENTS (K971715) | Sulzer Orthopedics, Inc. | 1997-08-07 |
| JMS AV FISTULA NEEDLE (K970962) | Jms Co., Ltd. | 1997-08-07 |
| INNOVASIVE 2.8MM AND 3.5MM ROC EZ SUTURE BONE FASTENER (K971922) | Innovasive Devices, Inc. | 1997-08-07 |
| RECOVERY PROTRUSIO CAGE (K971890) | Biomet, Inc. | 1997-08-07 |
| ACCURUN 120 HAV IGG POSITIVE CONTROL (K971406) | Boston Biomedica, Inc. | 1997-08-07 |
| QUATROLOC PLASMA SPRAYED FEMORAL COMPONENT (K964616) | Whiteside Biomechanics, Inc. | 1997-08-07 |
| RANSFORD CERVICAL FIXATION SYSTEM (K965221) | Surgicraft , Ltd. | 1997-08-07 |
| ACCURUN 119 ANTI-HEPATITIS B E ANTIGEN (ANTI-HBE) POSITIVE CONTROL (K972307) | Boston Biomedica, Inc. | 1997-08-07 |
| ENDOPATH RESPOSABLE TROCAR SYSTEM (K971738) | Ethicon Endo-Surgery, Inc. | 1997-08-07 |
| IN THE EAR, IN THE CANAL, COMPLETELY IN THE CANAL (K971807) | Hear-Right, Inc. | 1997-08-07 |
| SYNERMED TOTAL BILIRUBIN REAGENT KIT (K972716) | Synermed, Inc. | 1997-08-07 |
| ENDOVIEW SPPHIRE LENS SET (K971853) | American Medical Devices, Inc. | 1997-08-06 |
| HI-TEC CO2 INSUFFLATOR TYPE 1300 (K955477) | Hi Tec Medical Vertriebs-GmbH Fur Innovative Mediz | 1997-08-06 |
| AMR MINI-LAPAROSCOPE (K962777) | Applied Medical Resources | 1997-08-06 |
| IMPLEX HEP ACETABULAR CUP SYSTEM, CEMENTED (K971705) | Implex Corp. | 1997-08-06 |
| SMITH & NEPHEW SUTURE COLLET (K971939) | Smith & Nephew Endoscopy, Inc. | 1997-08-06 |
| COLORFLO OPTION FOR THE ORACLE INVISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEM (K963290) | Endosonics Corp. | 1997-08-06 |
| AQ ONE STEP COCAINE TEST (K972384) | Bionike Laboratories, Inc. | 1997-08-06 |
| ROCHE HEMOGLOBIN A1C CONTROL N AND CONTROL P (K972721) | Roche Diagnostic Systems, Inc. | 1997-08-06 |
| TOM CAT F.L., TOM CAT S.L. (K972245) | A & A Medical, Inc. | 1997-08-06 |
| MODEL HS-2 TENS DEVICE (K962951) | Technalithics Laboratories, Inc. | 1997-08-06 |
| TRINITY SLEEVES, HUNTLEIGH PUMP COMPATIBLE(T.B.D.) (K970014) | Delphi Consulting Group | 1997-08-06 |
| AMSINO URINARY LEG BAG (K971929) | Amsino Intl., Inc. | 1997-08-06 |
| PATIENT RESTRAINT (K971948) | E.M. Adams Co., Inc. | 1997-08-06 |
| VERRES NEEDLE, CANNULA FOR M820, CANNULA W/TRUMPET VALVE FOR M 820 (K971837) | CooperSurgical, Inc. | 1997-08-06 |
| VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAM (K972609) | Bio-Rad | 1997-08-06 |
| CYTOPLAST REGENTEX TITANIUM 250 (K972278) | Osteogenics Co. | 1997-08-06 |
| BARD COMPOSITE PROSTHESIS (K971745) | Davol Inc., Sub. C. R. Bard, Inc. | 1997-08-06 |
| MDILOG, MODEL MDC-511 (K970344) | Medtrak Technologies, Inc. | 1997-08-06 |
| PATIENT LATEX EXAMINATION GLOVE (PREPOWDERED) (K971629) | Besglove Medicare Sdn. Bhd. | 1997-08-06 |
| IMZ TWIN PLUS - CYLINDER (K963521) | Imz, GmbH | 1997-08-06 |
| FLEXILOG LS (K964804) | Oakfield Instruments, Ltd. | 1997-08-06 |
| STRYKER WEDGE INTERFERENCE SCREW SYSTEM (K972233) | Stryker Endoscopy | 1997-08-05 |
| AFFINITY BLOOD PUMP SYSTEM (K964017) | Avecor Cardiovascular, Inc. | 1997-08-05 |