| MODIFIED DURAPHASE(TM) IMPLANTED PENILE PROSTHESIS (K912344) | Dacomed Corp. | 1991-10-11 |
| GORE-TEX EXPANDED POLY. CARD. PATCH 0.6 AND 0.4MM (K912107) | W. L. Gore & Associates, Inc. | 1991-10-11 |
| PCP DIRECT RIA KIT (I-125) (K913864) | Immunalysis Corporation | 1991-10-11 |
| URINE/CSF MICROPROTEIN REAGENT (K913225) | Intersect Systems, Inc. | 1991-10-11 |
| TYPE FA10 AUDIOMETER (K913221) | Frye Electronics, Inc. | 1991-10-11 |
| SIEMENS MODEL LS-I W/INFINITI PROGRAMMABLE OPTION (K914333) | Siemens Hearing Instruments, Inc. | 1991-10-11 |
| BIOSITE DIAGNOSTICS-TRIAGE PANEL FOR DRUGS ABUSE (K914146) | Biosite Incorporated | 1991-10-11 |
| OPTICA 60 ND;YAG SURGICAL LASER SYSTEM (K912703) | Xintec Corporation | 1991-10-11 |
| IL BG3 SYST, MODEL 1420, BLOOD GAS & PH TEST SYST (K913927) | Instrumentation Laboratory CO | 1991-10-11 |
| BARTELS PRIMA SYSTEM ADVANCED SCREENING CARTRIDGE (K914202) | Baxter Diagnostics, Inc. | 1991-10-11 |
| DIFF SAFE (K914129) | Marshall Levinson | 1991-10-11 |
| HYCOR PYLORAGEN HELICOBACTER PYLORI TEST (K912255) | Hycor Biomedical, Inc. | 1991-10-11 |
| VISI-NEISSERIA (K913456) | Kev Connecticut Diagnostics, Inc. | 1991-10-11 |
| NATURAL POROUS HIP SYSTEM (K913060) | Intermedics Orthopedics | 1991-10-11 |
| HAP BIO-GROOVE TOTAL HIP PROSTHESIS (BIO-COAT) (K912369) | Biomet, Inc. | 1991-10-11 |
| TARGET(TM)-HOG (K914303) | V-Tech, Inc. | 1991-10-11 |
| GUARDIAN GEL, SURGEON'S GLOVING CREAM (K910687) | Guardian Angel Products, Inc. | 1991-10-11 |
| CONVERTORS SAFECARE GOWN & DRAPE MATERIAL (K913506) | Baxter Healthcare Corp | 1991-10-11 |
| PROCLINIC ONE STEP PREGNANCY TEST (K914253) | Vanguard Biomedical Corp. | 1991-10-11 |
| APR II NON-POROUS HIP STEM (K913208) | Intermedics Orthopedics | 1991-10-11 |
| ABBOTT QUICKSTART LDH,#5A31 (K914262) | Em Diagnostic Systems, Inc. | 1991-10-11 |
| MARQUETTE PEDIATRIC DEFIBRILLATION/PACING PADS (K911662) | Marquette Electronics, Inc. | 1991-10-10 |
| SCHNEIDER MATCH-35(TM) PERCU TRANS ANGIOPLAS CATH (K913297) | Schneider Intl., Ltd. | 1991-10-10 |
| MEDILASE SEMI-RIGID INSTROD SHEATH SERIES AE1000 (K912265) | Medical Laser, Inc. | 1991-10-10 |
| VER-MED A10020 RESTING EKG ELECTRODE (K911687) | Vermont Medical, Inc. | 1991-10-10 |
| PDM-1 DEVICE:CAPD DISINFECTING DEVICE, MODIFIED (K913110) | Microwave Medical Systems, Inc. | 1991-10-10 |
| AEROSOL MASKS, 81426, 81476, 81490 & 81492 (K913220) | Specialty Packaging Producs, Inc. | 1991-10-10 |
| VITALMAX 830 SERIES (K913263) | Pace Tech, Inc. | 1991-10-10 |
| ARTHRO-FLOW IRRIGATION 2 SYSTEM (K913028) | Davol, Inc. | 1991-10-10 |
| MILITARY RADIOGRAPHIC FLAT TABLE, CAT # T-9130 (K912382) | Continental X-Ray Corp. | 1991-10-10 |
| FLEX-ELBOW (K912652) | Vital Signs, Inc. | 1991-10-10 |
| BIO-SENSOR 01 EKG ELECTRODE (K911472) | Bio-Sensor, Inc. | 1991-10-10 |
| VENTURI OXYGEN MASK (K913275) | Specialty Packaging Producs, Inc. | 1991-10-10 |
| TURBOTRON 20/20 (K902920) | Prestige Manufacturing Snd Bhd | 1991-10-10 |
| BERMAN INTUBATING/PHARYNGEAL AIRWAY (K913680) | Chain Plastics Operations, Inc. | 1991-10-10 |
| MUCOUS SPECIMEN TRAP (K913643) | Medical Device Inspection Co., Inc. | 1991-10-10 |
| MODERN MATERIALS ORTHODONTIC RESIN (K913699) | Heraeus Kulzer, Inc. | 1991-10-09 |
| AEROBIC FOAM SWAB CULTURETTE(R) (K913789) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-10-09 |
| ABBOTT QUICKSTART ALBUMIN BCP (ALBP)#5A16 (K913025) | Em Diagnostic Systems, Inc. | 1991-10-09 |
| FIBRINOSTIKA FBDP MICROELISA SYSTEM (K912876) | Organon Teknika Corp. | 1991-10-09 |
| ICAN CYLINDRICAL SPONGES (K914086) | Icn Pharmaceuticals, Inc. | 1991-10-09 |
| HEMOCARD HEMOGLOBIN S (K911981) | Isolab, Inc. | 1991-10-09 |
| FIBRINOGEN DETERMINATION KIT (K913061) | Sigma Diagnostics, Inc. | 1991-10-09 |
| PEI PLAQUE ELECTRODE ARRAY (K904747) | Prucka Engineering, Inc. | 1991-10-09 |
| A-DEC DECADE 1020 CHAIR (K913535) | A-Dec, Inc. | 1991-10-09 |
| LAPAROSCOPIC BALLOON RETRACTOR (K914203) | Origin Medsystems, Inc. | 1991-10-09 |
| IMPERVA BOND (K913947) | Shofu Dental Corp. | 1991-10-09 |
| ICAN COTTON RAYON BALLS (K914081) | Icn Pharmaceuticals, Inc. | 1991-10-09 |
| NOVOSTE VESSEL DILATER (K912050) | Novaste Corp. | 1991-10-09 |
| GLAUCOMA-SCOPE (K913118) | Ophthalmic Imaging Systems | 1991-10-09 |
| PULPDENT POLYAMIDE DENTIN LINER (K911285) | Pulpdent Corp. | 1991-10-09 |
| ICAN K DISSECTOR SPONGES (K914083) | Icn Pharmaceuticals, Inc. | 1991-10-09 |
| BUTTERFLY DRESSING (K912160) | Durden Enterprises, Inc. | 1991-10-09 |
| IL TEST PROCLOT ASSAY STYSTEM (K912711) | Instrumentation Laboratory CO | 1991-10-09 |
| HEMISPHERE MULTIPLANE ENDORECTAL PROBE (K911043) | Pie Medical Equipment B.V. | 1991-10-09 |
| FST CATH-UD CATHETER, MODIFICATION (K913113) | Fiberoptic Sensor Technlogies, Inc. | 1991-10-09 |
| TRU-VIEW MULTI-CHANNEL DISPLAY (K912008) | General Devices | 1991-10-09 |
| TOTAL PROTEIN REAGENT BECKMAN SYNCHRON CX3 ANALYZE (K913978) | Beckman Instruments, Inc. | 1991-10-09 |
| CCI VIDEOKERATOSCOPE/COMPARATOR (K913022) | Cci | 1991-10-09 |
| AUTOPACK NON-EUGENOL PERIODONTAL DRESSING (K913572) | Specialites Septodont | 1991-10-09 |
| ABBOTT QLUICKSTART IRON TEST, ITEM #5A29 (K913705) | Em Diagnostic Systems, Inc. | 1991-10-09 |
| ACCELAR 20 ADVANCE RAPID CURE REPAIR MATERIAL (K913698) | Heraeus Kulzer, Inc. | 1991-10-09 |
| MODIFIED VERSION IMPLANTABLE VASCULAR ACCESS SYSTE (K912111) | Gerard Medical Enterprises, Inc. | 1991-10-08 |
| MARLOW VERRES NEEDLES (K913586) | Marlo Surgical Technology | 1991-10-08 |
| COHERENT NOVUS 3000 ARGON PHOTOCOAGULATOR (K913127) | Coherent Medical Group | 1991-10-08 |
| BIRD SENTRY AIR/OXYGEN MICROBLENDER (K911962) | Bird Products Corp. | 1991-10-08 |
| A-DEC KNEEBREAK 1030 CHAIR (K913059) | A-Dec, Inc. | 1991-10-08 |
| STERILE CHEST TUBE (K913733) | Vascular Products, Inc. | 1991-10-08 |
| 2 LUMEN ENDOS RETRO CHOLANGIOPANCREA INJEC CATH (K913841) | Endovations | 1991-10-08 |
| ORTHOFUSER WOUND DRAINAGE/AUTOTRANSFUSION SYSTEM (K912019) | Gish Biomedical, Inc. | 1991-10-08 |
| CELSITE(TM) IMPLANTABLE DRUG DELIVERY SYSTEM (K902401) | Burron Medical, Inc. | 1991-10-08 |
| STACLOT(R) PROTEIN S TEST KIT (K913424) | American Bioproducts Co. | 1991-10-08 |
| I.V. STARR KIT (K912161) | Medical Device Inspection Co., Inc. | 1991-10-08 |
| MEGA PARACENTESIS KIT (K913382) | Mega Medical, Inc. | 1991-10-08 |
| MEDARMOR FINGERTIP, PUNC/CUT RESIST SURG EXAM GLOV (K912737) | Medical Armor Corp. | 1991-10-08 |
| PROGUARDII(TM) BLOOD COLLECTION DEVICE (K913914) | Care Medical Devices, Inc. | 1991-10-08 |
| FST CATH - UI USRODYNAMIC CATH INTRODUCER SYSTEM (K913721) | Fiberoptic Sensor Technlogies, Inc. | 1991-10-08 |
| ACS VSW GUIDE WIRE (K913178) | Advanced Cardiovascular Systems, Inc. | 1991-10-08 |
| NOVA CELLTRAK 12 AUTO MULTI-PARA HEMA ANALYZER/CAL (K913259) | Nova Biomedical Corp. | 1991-10-08 |
| ORTHODONTIC WIRE (K911231) | Masel Industries, Inc. | 1991-10-08 |
| LATERALASE(TM) CATHETER WITH THERMAL FEEDBACK (K913109) | Trimedyne, Inc. | 1991-10-08 |
| WOUND CARE TRAY B (K913479) | Catalina Biomedical Corp. | 1991-10-08 |
| RIBBOND(TM) (K913040) | Ribbond, Inc. | 1991-10-07 |
| AMBU SILICONE RESUSCITATOR INFANT/CHILD (K914187) | Ambu, Inc. | 1991-10-07 |
| AUGUSTINE GUIDE KIT WITH GAUZE SPONGE (K914168) | Augustine Medical, Inc. | 1991-10-07 |
| FREEDOM WHEELS AZ 100 (K913901) | Arizona Freedom Wheels, Inc. | 1991-10-07 |
| AFFINITY FREE T4 TEST SYSTEM (K912698) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-10-07 |
| RAHD 3100 (K903313) | Esm , Ltd. | 1991-10-07 |
| DISCOGRAPHY KIT (K910503) | B. Braun of America, Inc. | 1991-10-07 |
| ZIMMON ESOPHAGO-GASTRIC BALLOON TAMPONADE DEVICE (K900623) | Wilson-Cook Medical, Inc. | 1991-10-07 |
| AMIZYME EPSTEIN-BARR VIRUS (EBV) IGM ANTIBODY TEST (K911362) | Amico Laboratories, Inc. | 1991-10-07 |
| VIBRATOUCH II CORDLESS WAND MASSAGER (K912383) | Conair Corp. | 1991-10-07 |
| 7.5 MHZ APAS TRANSDUCER (ART.NOL: 50.04918.1) (K911044) | Pie Medical Equipment B.V. | 1991-10-07 |
| RHINO-GUARD (K911785) | Micromedics, Inc. | 1991-10-07 |
| MS-III MINISTIM (K913184) | Life-Tech Intl., Inc. | 1991-10-07 |
| COX DISPOSABLE BIOPSY FORCEP (K913883) | Cox Medical Ent., Inc. | 1991-10-05 |
| DISPOSABLE BOUFFANT CAP (K913700) | Gem Nonwovews, Inc. | 1991-10-04 |
| THORACIC CATHETER STYLET (K913543) | Intl. Medical Devices , Ltd. | 1991-10-04 |
| URI-THREE(TM), MODIFICATION (K911846) | Culture Kits, Inc. | 1991-10-04 |
| WELLPREP 1 (K913567) | Denley Instruments, Inc. | 1991-10-04 |