FDA 510(k) Decisions During September, 1983  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K832834 09/29/1983 CONCISE 2 SMALL PARTICLE LIGHT CURVED 3M COMPANY
K830361 09/29/1983 MMS ACETABULAR CUPS 3M COMPANY
K832643 09/26/1983 CELL-DYN 900 HEMATOLOGY ANALYZER ABBOTT DIAGNOSTICS
K832631 09/12/1983 A-GENT CARBAMAZEPINE ABBOTT LABORATORIES
K832775 09/29/1983 A-GENT GLYCOSYLATED HEMOGLOBIN ABBOTT LABORATORIES
K832457 09/12/1983 A-GENT PHENOBARBITAL ABBOTT LABORATORIES
K832419 09/01/1983 A-GENT PHERYTOIN ABBOTT LABORATORIES
K832289 09/12/1983 LIFECARE MICRO PUMP ABBOTT LABORATORIES
K832406 09/26/1983 QUANTUM II YEAST IDENT. SYSTEM ABBOTT LABORATORIES
K832581 09/12/1983 DTM-DERMATOPHYTE TEST MEDIUM ACUDERM, INC.
K832582 09/12/1983 MYCOSEL AGAR ACUDERM, INC.
K832583 09/12/1983 SABOURAUD DEXTROSE AGAR ACUDERM, INC.
K832575 09/12/1983 ANTIBIOTIC ASSAY BROTH ACUMEDIA MANUFACTURERS, INC.
K832576 09/12/1983 BASE AGAR ACUMEDIA MANUFACTURERS, INC.
K832572 09/12/1983 BILE ESCULIN AGAR ACUMEDIA MANUFACTURERS, INC.
K832571 09/12/1983 BILE ESCULIN AZIDE AGAR ACUMEDIA MANUFACTURERS, INC.
K832574 09/12/1983 BTB LACTOSE AGAR ACUMEDIA MANUFACTURERS, INC.
K832573 09/12/1983 C.L.E.D. MEDIUM ACUMEDIA MANUFACTURERS, INC.
K832570 09/12/1983 EXTRACT BROTH ACUMEDIA MANUFACTURERS, INC.
K832568 09/12/1983 INDOLE NITRATE MEDIUM ACUMEDIA MANUFACTURERS, INC.
K832569 09/12/1983 INFUSION BROTH ACUMEDIA MANUFACTURERS, INC.
K832577 09/12/1983 SEED AGAR ACUMEDIA MANUFACTURERS, INC.
K832603 09/29/1983 CURIX CAPACITY FILM CENTER AGFA-GEVAERT, INC.
K832565 09/01/1983 OHIO 5400 VOLUME MONITOR AIRCO/OHIO MEDICAL PRODUCTS
K832418 09/12/1983 OHIO TEMPERATURE SIMULATOR AIRCO/OHIO MEDICAL PRODUCTS
K832725 09/20/1983 DUAL DIAL VENTURI STYLE MASK AIRLIFE, INC.
K832411 09/12/1983 GASLINE FILTER #GF-10 AMERICAN BENTLEY
K832040 09/29/1983 STERILE FLUID PRODUCING UNIT #EP550 AMERICAN CYSTOCOPE MAKERS, INC.
K832447 09/12/1983 STRATUS CARBAMAZEPINE FLUROMETRIC AMERICAN DADE
K832493 09/12/1983 QUINIDINE FLUORESCENT IMMUNOASSAY AMERICAN DIAGNOSTIC CORP.
K832554 09/29/1983 FOGARTY 6MM SOFTJAW CLIP AMERICAN EDWARDS LABORATORIES
K832474 09/29/1983 FOGARTY-CHIN PERIPHERAL DILATION CATH AMERICAN EDWARDS LABORATORIES
K832738 09/29/1983 HEYER-SCHULTE AFTERLOADING CATHETER AMERICAN HEYER SCHULTE
K832556 09/12/1983 NEONATAL LUMBAR PUNCTURE TRAY AMERICAN PHARMASEAL DIV. AHSC
K832030 09/29/1983 HEPARIN COATED STAINLESS STEEL/TEFLON ARGON MEDICAL CORP.
K831887 09/26/1983 BACTIGEN S. PNEUMONIAE ARMKEL, LLC.
K832312 09/12/1983 I.V. TRANSFER NEEDLE BAXA CORP., SUB. OF COOK GROUP, INC.
K832347 09/12/1983 TWOFER NEEDLE BAXA CORP., SUB. OF COOK GROUP, INC.
K832332 09/12/1983 VENTED I.V. TRANSFER NEEDLE BAXA CORP., SUB. OF COOK GROUP, INC.
K832955 09/29/1983 BACTEROIDES BILE ESCULIN AGAR BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K831991 09/26/1983 DIRECTIGEN GROUP B STREP TEST KIT-SERUM BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K832655 09/26/1983 ECOLYZER #200/COHB ANALYZER SYS BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K832420 09/01/1983 FACS ANALYZER BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K832228 09/29/1983 RUBASCAN LATEX CARD TEST BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K831930 09/26/1983 TOXO-SCREEN DA TEST BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K832954 09/29/1983 V AGAR BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K831972 09/20/1983 EPSILON TSH TEST KIT BECKMAN INSTRUMENTS, INC.
K831439 09/29/1983 ELASTOPLAST T.P.N. BEIERSDORF, INC.
K832065 09/12/1983 ACURACY 071, DENTAL, INTRAORAL-X-RAY BELMONT EQUIPMENT CORP.
K832567 09/12/1983 ACETAMINOPHEN(PARACETAMOL BIO-ANALYTICS LABORATORIES, INC.
K832333 09/01/1983 FEEDBACK EMG SYSTEM PE-020 BIO-FEEDBACK SYSTEMS, INC.
K832066 09/29/1983 CONTROL 282 BIO-NUSTICS, INC.
K831522 09/12/1983 BIO-TEK PERCENT OXYGEN MONITOR 74222 BIO-TEK INSTRUMENTS, INC.
K832638 09/12/1983 CORTISOL RADIOIMMUNOASSAY KIT BIOCLINICAL GROUP
K831512 09/29/1983 DOSIMETRY RELEASE OF RADIATION STERILIZ BIOMET, INC.
K832069 09/26/1983 TOXO IPA KIT IAN INDIRECT FLUORESCENT BIONETIC LABORATORY PRODUCTS
K831752 09/29/1983 BIOCHECK PEC-108 PROGRAM-PULSE MONITOR BIOTECHNOLOGY, INC.
K832806 09/29/1983 CORONARY ANASTOMOSIS MARKING SYSTEM BIOTRAC LABORATORIES
K832810 09/29/1983 HARD CONTACT LENS CLEANER BLAIREX LABORATORIES, INC.
K832868 09/26/1983 RESUSCITATION VALVE BOEHRINGER LABORATORIES
K831422 09/12/1983 BIOFLOW BOMED MEDICAL MFR., LTD.
K831421 09/12/1983 BOMED BIOCON BOMED MEDICAL MFR., LTD.
K831788 09/12/1983 URODYNAMIC ANALYZER C.R. BARD, INC.
K832629 09/20/1983 INTUBATION KIT CALBIO, INC.
K832443 09/12/1983 ULTRASONIC DENTAL PROPHYLAXIS UNIT CALIFORNIA TECHNICS, INC.
K832618 09/12/1983 BLUE AGAR CARROLL BIOLOGICAL CORP.
K832612 09/12/1983 CHOCOLATE AGAR & THAYER MARTIN AGAR CARROLL BIOLOGICAL CORP.
K832243 09/29/1983 CULTURE MEDIUM FOR ANTIMICROBIAL SUS CARROLL BIOLOGICAL CORP.
K832616 09/12/1983 MACCONKEY AGAR MEDIA CARROLL BIOLOGICAL CORP.
K832613 09/12/1983 MANNITOL SALT AGAR CARROLL BIOLOGICAL CORP.
K832614 09/12/1983 SELENITE BROTH CARROLL BIOLOGICAL CORP.
K832615 09/12/1983 SF BROTH CARROLL BIOLOGICAL CORP.
K832619 09/12/1983 THIOGLYCOLLATE MEDIUM CARROLL BIOLOGICAL CORP.
K832611 09/12/1983 TRYPTIC SOY AGAR CARROLL BIOLOGICAL CORP.
K832620 09/12/1983 TRYPTIC SOY BROTH MEDIA CARROLL BIOLOGICAL CORP.
K832617 09/12/1983 XYLOSE LYSINE DEOXYCHOLATE CARROLL BIOLOGICAL CORP.
K832675 09/12/1983 ANA MICROZYME TEST SYS #1610 CLINICAL SCIENCES, INC.
K832293 09/12/1983 ENTERNAL FEEDING TUBE CONCEPT, INC.
K832278 09/29/1983 LIGHT HANDLE COVER CONCEPT, INC.
K832778 09/26/1983 EPIDURAL SYRINGE CONCORD LABORATORIES, INC.
K832800 09/29/1983 AUTOMATIC TANGENT SCREEN 50 COOPERVISION, INC.
K832381 09/01/1983 CORNING MAGIC SINGLE STEP FREE T4 CORNING MEDICAL & SCIENTIFIC
K832313 09/01/1983 MAGIC TSH 125I RADIOIMMUNOASSAY CORNING MEDICAL & SCIENTIFIC
K832758 09/12/1983 RED COLOR-TINTED TUBING CUSTOM MEDICAL, INC.
K832326 09/29/1983 BEHIND-THE-EAR #123 AGCI DANAVOX, INC.
K832751 09/29/1983 BEHIND-THE-EAR SERIES 125 DANAVOX, INC.
K832113 09/12/1983 NORMAC ANESTHETIC AGENT MONITOR DATEX DIVISION INSTRUMENTARIUM CORP.
K832530 09/29/1983 DEVA 4 DEGUSSA DENTAL, INC.
K830389 09/12/1983 ACCU-RYNGE PUMP SP-250 DELTA MEDICAL INDUSTRIES
K832292 09/01/1983 SOLO-TACH DENTSPLY INTL.
K832881 09/26/1983 ADVANTAGE SERIES CONTOURED LUMBO SACAR DEPUY, INC.
K831982 09/20/1983 BRADFORD SPINAL FRACTURE FIXATION SYS DEPUY, INC.
K831441 09/01/1983 POROCOAT FREEMAN/SAMUELSON TOTAL KNEE DEPUY, INC.
K832545 09/26/1983 ARTERIAL BLOOD SAMPLING KIT DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP.
K832726 09/29/1983 INTRINSIC FACTOR BLOCKING ANTIBODY KIT DIAGNOSTIC PRODUCTS CORP.
K832297 09/01/1983 HYDROXYPROGESTERONE-17 DIAGNOSTICS BIOCHEM CANADA, INC.
K831842 09/26/1983 DRAVON T CLAMP DRAVON MEDICAL, INC.
K832564 09/12/1983 DISCO SUNGLASSES/HEADBAND SUNGLASSES E-TAY INDUSTRIAL CO. LTD.
K832357 09/01/1983 ACA TOTAL BILIRUBIN ANALYTICAL TEST PAK E.I. DUPONT DE NEMOURS & CO., INC.
K832504 09/12/1983 CRONEX LO-DOSE MAMMOGRAPHY E.I. DUPONT DE NEMOURS & CO., INC.
K832246 09/26/1983 DUPONT ISOLATOR 1.5 MICROBIAL TUBE E.I. DUPONT DE NEMOURS & CO., INC.
K831934 09/12/1983 THEOPHYLLINE TEST PACK ACA E.I. DUPONT DE NEMOURS & CO., INC.
K832601 09/29/1983 LEADED X-RAY APRON E.M. ADAMS
K832602 09/29/1983 THYROID PROTECTIVE COLLAR E.M. ADAMS
K831255 09/12/1983 LARYNGOSCOPE ATTACHMENT PH2000 EDER INSTRUMENT CO, INC.
K832370 09/16/1983 EGS MODEL 100-2 ELECTRO-MED HEALTH INDUSTRIES, INC.
K832804 09/20/1983 SESAM TABLE ELECTRO-MED HEALTH INDUSTRIES, INC.
K832803 09/20/1983 STEAM PAK MOIST HEAT ELECTRO-MED HEALTH INDUSTRIES, INC.
K832648 09/20/1983 ACCLAIM ELECTRO-NUCLEONICS LABORATORIES, INC.
K832639 09/12/1983 ALT -LTS ELECTRO-NUCLEONICS LABORATORIES, INC.
K831965 09/12/1983 CREATINE KINASE REAGENT CK LTS ELECTRO-NUCLEONICS LABORATORIES, INC.
K831504 09/20/1983 HERPES IDENT. & TYPING TEST HITT ELECTRO-NUCLEONICS LABORATORIES, INC.
K831743 09/12/1983 STERILE FOLEY CATHETERS & UROLOGICAL ELECTROMEDICS, INC.
K832789 09/29/1983 AFTER LOADING BUCHLER ELLIS PHARMACEUTICAL CONSULTING, INC.
K832314 09/01/1983 CARDIZYME PLUS LD #65094/93 EM INDUSTRIES, INC.
K832479 09/12/1983 TRUST RPR CARD TEST #65144 EMD CHEMICALS INC.
K832480 09/12/1983 TRUST RPR TITRATION CARD TEST #65145 EMD CHEMICALS INC.
K832423 09/12/1983 ENVISION G21 I/A ENPAK ENVISION, INC.
K832424 09/12/1983 ENVISION G31 P.E. PAK ENVISION, INC.
K832727 09/20/1983 MOBIE EVEREST & JENNINGS, INC.
K832053 09/29/1983 SINGLE PATIENT SYS. II MODEL DM-450 EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
K832469 09/12/1983 T3-RIA SINGLE REAGENT FAIRLAKE LABORATORIES
K832468 09/12/1983 T4-RIA SINGLE REAGENT FAIRLAKE LABORATORIES
K832433 09/29/1983 AUTOMATIC SPIROMETER ST-200 FUTURE IMPEX CORP.
K832431 09/29/1983 FUKUNDA SANGYA UNITS PULMOTESTER PM60 FUTURE IMPEX CORP.
K832430 09/29/1983 FUKUNDA SANGYO UNITS ELECTRONIC SPIRO FUTURE IMPEX CORP.
K832432 09/29/1983 SPIRO ANALYZER ST-100 AUTOMATIC SPIRO FUTURE IMPEX CORP.
K832820 09/26/1983 MUL-T-BLANKET GAYMAR INDUSTRIES, INC.
K832819 09/26/1983 MUL-T-PAD GAYMAR INDUSTRIES, INC.
K832597 09/12/1983 GERBER PRECISION CARE BREAST PUMP GERBER PRODUCTS CO.
K832902 09/26/1983 MIDDLEBROOK ADC ENRICHMENT GIBCO LABORATORIES LIFE TECHNOLOGIES, INC.
K832594 09/20/1983 PRE-BYPASS FILTER #EC-PBF SERIES GISH BIOMEDICAL, INC.
K832365 09/01/1983 TCBS AGAR GRANITE DIAGNOSTICS, INC.
K832359 09/26/1983 ORAL SAFE GREAT LAKES ORTHODONTICS, LTD.
K831917 09/26/1983 VILENE COTTON GAUZE II HALL-TECH
K832685 09/20/1983 WHEELCHAIR-VARIOUS MODELS HEALTH AMERICA
K832701 09/29/1983 HSI ELITE #EC CUSTOM CANAL HEAR-AID HEARING SERVICES, INC.
K832496 09/12/1983 BIO SURE STAIN HELENA LABORATORIES
K831787 09/29/1983 PATIENT MONITOR #78353A HEWLETT-PACKARD CO.
K832659 09/20/1983 BIOSPAL 1200S HOSPAL MEDICAL CORP.
K832645 09/20/1983 BIOSPAL 3000 S HOSPAL MEDICAL CORP.
K832681 09/26/1983 UNIVERSAL VOL. VENTILATOR 72" #1626 HUDSON OXYGEN THERAPY SALES CO.
K831795 09/01/1983 FIRST AID KITS I M, INC.
K832696 09/20/1983 RISER STANDUP WHEELCHAIR IMEX MEDICAL SYSTEMS, INC.
K832788 09/15/1983 INFUSE-A-PORT INFUSAID CORP.
K832471 09/12/1983 ADJUSTABLE PHARYNGEAL AIRWAY/BERMAN III INMED CORP.
K832389 09/19/1983 CATHETER CARE TRAY INMED CORP.
K832472 09/20/1983 ELEVATOR CUSHION INMED CORP.
K832672 09/12/1983 FOUR LUMEN BLAKEMORE TUBE INMED CORP.
K832994 09/29/1983 MIDAS 6000 AUTOMATIC STAINER INNOVATIVE MEDICAL SYSTEMS, INC.
K832235 09/29/1983 DISPOSABLE VITRECTOMY HANDPIECE INNOVATIVE SURGICAL PRODUCTS INC.
K832410 09/12/1983 GRASEBY DYNAMICS MS302 SYRINGE DRIVER INTERMEDICS, INC.
K831004 09/12/1983 AUTOMATED 8400 BLOOD CELL SEPARATOR INTL. BUSINESS MACHINES
K832745 09/20/1983 OC3 FLYER INTL. MEDICAL EQUIPMENT CORP.
K832271 09/12/1983 EMERSON MODEL 3MV-AP AND 3V-AP PRESS- J. H. EMERSON CO.
K832176 09/12/1983 NEGATIVE PRESSURE CHEST RESPIRATOR PUMP J. H. EMERSON CO.
K832286 09/26/1983 CERESTORE CORE MATERIAL JOHNSON & JOHNSON PROFESSIONALS, INC.
K832342 09/12/1983 ENDOSCOPIC CAMERA TV W/AUDIO KAMIYA TSUSAN KAISHA, LTD.
K832844 09/29/1983 RUBY KNIVES FOR OPHTH. SURGERY KEELER INSTRUMENTS, INC.
K832667 09/29/1983 LUCAE'S EAR & NASAL APPLICATORS KELLS MEDICAL, INC.
K832735 09/29/1983 KEMTEK 103 RIA GAMMA COUNTER KEMBLE INSTRUMENTS, INC.
K832736 09/29/1983 KEMTEK 104 RIA GAMMA COUNTER KEMBLE INSTRUMENTS, INC.
K832211 09/29/1983 DOSIMETRIC RELEASE OF GAMMA RADIATION KIRSCHNER MEDICAL CORP.
K831215 09/12/1983 DENTACOLOR LIGHT CURING CROWN & BRIDGE KULZER, INC.
K831077 09/12/1983 DENTALON KULZER, INC.
K832436 09/26/1983 SELECTRO-DISC LAB ABILITY, INC.
K832588 09/12/1983 CIN AGAR LABORATORY PRODUCTS, INC.
K832105 09/12/1983 ADMINISTRATIVE IV SET LEE MEDICAL INTL., INC.
K832104 09/12/1983 STERILE DISP. BUTTERFLY INFUSION SET LEE MEDICAL INTL., INC.
K832102 09/01/1983 STERILE DISPOSABLE NEEDLES LEE MEDICAL INTL., INC.
K832101 09/12/1983 STERILE DISPOSABLE SYRINGE LEE MEDICAL INTL., INC.
K832770 09/26/1983 LANE ONE LOREDAN BIOMEDICAL, INC.
K832970 09/29/1983 CANE REACHER MADDAK, INC.
K832968 09/29/1983 PEDAL EXERCISER MADDAK, INC.
K832969 09/29/1983 WALKING CANE MADDAK, INC.
K832288 09/01/1983 HEMOGLOBINOMETER MALLINCKRODT CRITICAL CARE
K832553 09/20/1983 POTASSIUM TEST KIT MALLINCKRODT CRITICAL CARE
K832552 09/20/1983 SODIUM TEST KIT MALLINCKRODT CRITICAL CARE
K831665 09/12/1983 DISPOSABLE NEEDLE HOLDER MEDCARE PRODUCTS
K831664 09/12/1983 PLASTIC THUMB FORCEPS MEDCARE PRODUCTS
K831663 09/26/1983 TISSUE FORCEPS MEDCARE PRODUCTS
K832499 09/12/1983 PHASE II TSH KIT MEDICAL & SCIENTIFIC DESIGNS, INC.
K832527 09/12/1983 PREGNA-TEC MEDILAB CORP.
K832220 09/26/1983 TRAVELER NEBULIZING SYSTEM MEDIX OF FLORIDA, INC.
K830001 09/26/1983 SUPERJET BTD BLEEDING TIME DEVICE DISP MEDPROBE LABORATORIES
K832190 09/12/1983 METAVOX MV-1000 AUDITORY TRAINER METAVOX, INC.
K832505 09/12/1983 IMAGE PROCESSING SYS A3 METRONIC, INC.
K832911 09/29/1983 ABBOTT GLOBE HOLDER MIAMI EYE TECHNOLOGY, INC.
K832650 09/12/1983 UPSHER FIBERBRITE LARYNGOSCOPE MICHAEL S. UPSHER
K832462 09/12/1983 AUTOPAK NEONATAL TSH RIA KIT MICROMEDIC SYSTEMS
K832766 09/29/1983 AMES TDA DISOPYRAMIDE TEST MILES LABORATORIES, INC.
K832769 09/29/1983 AMES TDA KANAMYCIN TEST-CONTROL SERUM MILES LABORATORIES, INC.
K832792 09/29/1983 AMES TDA SISOMICIN TEST-CONTROL SERUM MILES LABORATORIES, INC.
K831600 09/08/1983 DIASTIX REAGENT STRIPS FOR URINALYSIS MILES LABORATORIES, INC.
K832132 09/20/1983 SERA-TEK MYCOPLASMA ANTIBODY TEST MILES LABORATORIES, INC.
K832562 09/12/1983 SERUM HCG ASSAY MONOCLONAL ANTIBODIES, INC.
K831430 09/12/1983 AIR SHIELDS AS-100 MONIORING SYS-AS105 NARCO SCIENTIFIC
K822835 09/29/1983 PZ-800 VOLUME VENTILATOR NARCO SCIENTIFIC
K831816 09/12/1983 PROTEX CONTRACEPT PLUS W/SPERM-LUB NATIONAL SANITARY LABORATORIES, INC.
K832434 09/20/1983 HBO-1 PASS-THROUGH/EXTENSION TUBE NAUSET LABS
K831968 09/01/1983 VIVONEX TUNGSTEN TIP TUBE-BRAIDED NORWICH EATON PHARMACEUTICALS, INC.
K831971 09/01/1983 VIVONEX TUNGSTEN TIP TUBE-TWISTED WIRE NORWICH EATON PHARMACEUTICALS, INC.
K831969 09/01/1983 VIVONEX TUNGSTEN TIP TUBE-WOUND NORWICH EATON PHARMACEUTICALS, INC.
K832495 09/29/1983 FLYNN SERIES III BAG/MASK UNIT- O-TWO SYSTEMS INTL., INC.
K832559 09/29/1983 OCUCARE FREEDOM PACK OCULAR INNOVATIONS, INC.
K830488 09/15/1983 VENTILATOR #1 OHIO MEDICAL PRODUCTS
K831651 09/12/1983 EVOKED POTENTIAL SYSTEM 2000 OPHTHALMETRIC CORP.
K832118 09/26/1983 DIGIDENT ELEKTRONIC APEX LOCATOR ORA-MUSZERIPARI SZOVETKEZET
K832793 09/26/1983 NEOCATH 1000 W/HEPCOTE ORANGE MEDICAL INSTRUMENTS, INC.
K831913 09/26/1983 COLOR-EZE PRE-WASHED LAP SPONGES ORMED MFG., INC.
K831911 09/12/1983 DISPOSABLE FLOOR INSTRUMENTS ORMED MFG., INC.
K831915 09/12/1983 SAFETY PINS & RUBBER BANDS ORMED MFG., INC.
K832047 09/12/1983 STERILE SUTURE REMOVAL SET ORMED MFG., INC.
K832947 09/29/1983 ORTHO CELL CULTURES-MRC-5 HUMAN EMBRYO ORTHO DIAGNOSTIC SYSTEMS, INC.
K832742 09/20/1983 EXTENSION CONTROL KNEE ORTHOSIS ORTHOMEDICS
K832740 09/20/1983 FEMORAL FRACTURE ORTHOSIS ORTHOMEDICS
K832741 09/20/1983 JASON CERVICAL ORTHOSIS ORTHOMEDICS
K831708 09/15/1983 MICRO-STRUCTURED SURFACE HIP PROSTHESIS OSTEONICS CORP.
K832532 09/29/1983 AGAR PLATE XLD OTISVILLE BIOTECH, INC.
K832934 09/29/1983 MACCONKEY'S AGAR PLATE OTISVILLE BIOTECH, INC.
K832948 09/29/1983 NYC-GC MEDIA OTISVILLE BIOTECH, INC.
K832310 09/01/1983 ROGOSA BROTH OXOID U.S.A., INC.
K831445 09/12/1983 INFUSION SETS #'S 124 & 142 PERSONAL PACESETTER SYSTEMS
K831444 09/12/1983 SINGLE USE SYRINGE #103 PERSONAL MEDIC PACESETTER SYSTEMS
K831882 09/20/1983 POSIDYNE SOLUTION CONTAINER FILTER PALL BIOMEDICAL PRODUCTS CO.
K832058 09/12/1983 ANGIO-FLO CONTIN-ARTERIAL FLUSH DEV. PARKE-DAVIS CO.
K832492 09/20/1983 BRONCHO FIBERSCOPE FB-19C PENTAX PRECISION INSTRUMENT CORP.
K832449 09/20/1983 LARYNGOTELESCOPE CURVED MLC-1 PENTAX PRECISION INSTRUMENT CORP.
K832248 09/01/1983 PHADEBACT STREP POSITIVE CONTROLS PHARMACIA, INC.
K831650 09/12/1983 ANESTHESIA/RESPIRATORY DISCONNECT - PLASMEDICS, INC.
K831601 09/26/1983 APNEA ALARM FOR ADULT-PEDIATRIC & NEON PLASMEDICS, INC.
K832870 09/26/1983 DIAZO COLORIMETRY, BILLIRUBIN POINTE SCIENTIFIC, INC.
K832709 09/26/1983 SKIN STAPLING DEVICE SC2000 PROSPER, INC. SYNCARE, INC.
K831998 09/12/1983 BIRTHWELL BIRTHING SYSTEM QULAB CO.
K832463 09/12/1983 RAICHEM ALKALINE PHOSPHATASE REAGENT REAGENTS APPLICATIONS, INC.
K832180 09/29/1983 REXTON RX10, RX20-30 & 40 REXTON, INC.
K831999 09/29/1983 FEMORAL CANAL SUCTION TAMPON RICHARDS MANUFACTURER CO.
K831884 09/20/1983 SPECTRON EXTRA-SMALL, STRAIGHT FEMORAL RICHARDS MANUFACTURER CO.
K832852 09/29/1983 BLAISE-RATHAEL VOICE PROSTHESIS RICHARDS MEDICAL CO., INC.
K832874 09/26/1983 ISOVIS WOUND PROTECTOR RITMED, INC.
K832768 09/20/1983 S & W SW52E W/POWER BACK LIFT S & W ENTERPRISES, INC.
K832660 09/26/1983 OXYGEN CONNECTING TUBESET-RESPIRATORY SAN DIEGO PLASTICS, INC.
K832632 09/12/1983 ALBUMIN PROCEDURE BCP SANDARE CHEMICAL CO., INC.
K832391 09/12/1983 QT-100 ELECTRONIC TEMP. MONITOR SCIENCE DEVELOPMENT CORP.
K832392 09/12/1983 SDC ORAL-RECTAL TEMP. PROBE SCIENCE DEVELOPMENT CORP.
K832460 09/12/1983 TRIGLYCERIDE REAGENT-TRINDER-GPO SEPPIM, INC.
K831525 09/29/1983 H-FLU B ELISA TEST SERAGEN DIAGNOSTICS, INC.
K832415 09/12/1983 DEPROTEINIZING & CLEANING SOLUTION SHABAN MFG. CO.
K832584 09/12/1983 TUBING KIT 446 SHABAN MFG. CO.
K832865 09/29/1983 FLEX BUBBLE TUBING SHERIDAN CATHETER CORP.
K832773 09/12/1983 SHERI-I-SLIP INTUBATING STYLET SHERIDAN CATHETER CORP.
K832683 09/12/1983 MONOJECT INJECTOMATIC SHERWOOD MEDICAL CO.
K832811 09/20/1983 SHILEY 3L CARDF PLUS SHILEY, INC.
K832704 09/29/1983 SHILEY GAS FILTER SHILEY, INC.
K832044 09/29/1983 SHILEY MULTIPRO CATHETER SHILEY, INC.
K832855 09/29/1983 TPE DIAMOND POINTS SHOFU DENTAL CORP.
K832737 09/29/1983 ECT PROCESSOR SIEMENS GAMMASONICS, INC.
K832836 09/29/1983 BASAL MED. #B9763 W/HANKS SALTS W/L-G SIGMA CHEMICAL CO.
K832687 09/12/1983 BASAL MED. EAGLE #B9888 W/L-GLUTAMINE SIGMA CHEMICAL CO.
K832688 09/12/1983 DULBECCO'S MODIFIED EAGLE #D5523- SIGMA CHEMICAL CO.
K832842 09/29/1983 DULBECCOS MODIFIED EAGLES MEDIUM D5648 SIGMA CHEMICAL CO.
K832835 09/29/1983 DULBECCOS PHOSPHATE BUFFERED SALINE SIGMA CHEMICAL CO.
K832838 09/26/1983 EARLES BALANCED SALT MIXTURE #E6132 SIGMA CHEMICAL CO.
K832839 09/26/1983 HANKS BALANCED SALT MIXTURE H6136 SIGMA CHEMICAL CO.
K832689 09/12/1983 MCCOY'S 5A #M4892 W/L-GLUTAMINE AND SIGMA CHEMICAL CO.
K832690 09/12/1983 MINIMUM ESSENTIAL MED. EAGLE M0268 SIGMA CHEMICAL CO.
K832840 09/26/1983 MINIMUM ESSENTIAL MED. EAGLE M4642 W/ SIGMA CHEMICAL CO.
K832953 09/29/1983 MUCICARMINE STAIN, #HT30 SIGMA CHEMICAL CO.
K832837 09/26/1983 NUTRIENT MIXTURE F-10 #N6635 W/L-GLUTA SIGMA CHEMICAL CO.
K832841 09/29/1983 NUTRIENT MIXTURE F12 #N6760 W/L-GLUTAM SIGMA CHEMICAL CO.
K832929 09/29/1983 RISTOCETIN PLATELET AGGREGA-REAGENT TEST SIGMA CHEMICAL CO.
K832930 09/29/1983 SPINNER SALT SOLUTION S-6011 W/EARLES SIGMA CHEMICAL CO.
K831667 09/12/1983 FEMININE HYGIENE DEVICE SNOW WILLOW CO.
K832957 09/29/1983 FLOW-DIRECTED HEPARIN COATED THERMODIL SORENSEN RESEARCH
K832385 09/12/1983 CRYOPROBES MC-1400-CRYOSURG-CONSOLE SPEMBLY MEDICAL LTD.
K831977 09/09/1983 C TEC SERIES 9000 E.C.G. ELECTRODE SPEYWOOD MEDICAL, LTD.
K832557 09/12/1983 FERTITELL DIRECT PREGNANCY TEST #1100 STANBIO LABORATORY
K832481 09/20/1983 SCLERAL BUCKLING IMPLANTS DIF/TYPES STORZ INSTRUMENT CO.
K831764 09/12/1983 URIAS PRESSURE SPLINTS, & FIRST AID SVENOL ANDERSEN
K832079 09/29/1983 COLLECTION KIT CHLAMYDIA TRACHOMATIS SYVA CO.
K832718 09/12/1983 EMIT CAD PROCAINAMIDE ASSAY SYVA CO.
K832078 09/29/1983 MICRO TRAK CHLAMYDIA TRAC CONTROL SLID SYVA CO.
K832077 09/29/1983 MICRO TRAK CHLAMYDIA TRACHOMATIS DIRECT SYVA CO.
K832797 09/29/1983 MODIFICA- OF EMIT AED ETHOSUXIMIDE ASSAY SYVA CO.
K832627 09/12/1983 TECHNICON H6000 SYSTEM TECHNICON INSTRUMENTS CORP.
K832489 09/12/1983 CONVEEN DRIP COLLECTOR/NET PANTS TELCAM MEDICAL DEVICES, INC.
K832537 09/12/1983 CONVEEN LEG BAG W/TUBE-DRAINAGE BAG TELCAM MEDICAL DEVICES, INC.
K831929 09/29/1983 BASIC BREAST PUMP TERAYCO INTL., LTD.
K831756 09/29/1983 ANSPACH 65,000 THE ANSPACH EFFORT, INC.
K832609 09/12/1983 A.V.R. KNEE LENGTH THERAPEUTIC STOCK- THE KENDAL CO.
K832692 09/12/1983 CURITY CATHETER STRAP THE KENDAL CO.
K831420 09/20/1983 HIP PROSTHESIS -VARIOUS THE OEC GROUP
K832762 09/29/1983 MILLER/NADLER GLARE TESTER TITMUS OPTICAL, INC.
K832387 09/12/1983 DENTURE CLEANER TOWER LABORATORIES, LTD.
K832663 09/12/1983 GAMMA STERIL. CAPILLARY FLOW DIALY-G15 TRAVENOL LABORATORIES, S.A.
K831534 09/12/1983 PUMPETTE AS8P-INFUSION PUMP TRAVENOL LABORATORIES, S.A.
K832861 09/26/1983 SABOURAUD DEXTROSE AGAR TROY BIOLOGICALS, INC.
K832863 09/26/1983 STREP ID QUAD TROY BIOLOGICALS, INC.
K832860 09/26/1983 SXT BLOOD AGAR TROY BIOLOGICALS, INC.
K832862 09/26/1983 TRANSGROW MEDIUM TROY BIOLOGICALS, INC.
K832858 09/29/1983 INTRADISCAL THERAPY TRAY ULTI-MED INTL., INC.
K832654 09/26/1983 HEATED GUTTA PERCHA DELIVERY SYSTEM UNITEK CORP.
K832366 09/26/1983 ZOLLER BURNED LIP CONFORMER UNIVERSAL PROSTHETICS, INC.
K832503 09/12/1983 CLINAC 1800 VARIAN ASSOC., INC.
K832502 09/12/1983 ELECTRON BEAM OPTION FOR CLINAC 15 MEV VARIAN ASSOC., INC.
K832732 09/29/1983 RADIOTHERAPY MGMT. SYSTEM RMS-1000 VARIAN ASSOC., INC.
K832216 09/12/1983 VARIAN CLINACOMP 100 TISSUE COMPENSATOR VARIAN ASSOC., INC.
K832218 09/20/1983 ALLERGEN CONTROL INHALENT VENTREX LABORATORIES, INC.
K832217 09/20/1983 VENTRE/SPEC ALLERGEN CONTROL-MOLDS/FOOD VENTREX LABORATORIES, INC.
K832072 09/12/1983 VITA-MIST AIR COMPRESSOR & NEBULIZER VITA MEDICS
K831856 09/26/1983 BREATHING CIRCUIT BACTERIA FILTER VITAL SIGNS, INC.
K831885 09/08/1983 CODE BLUE MANUAL RESUSCITATOR VITAL SIGNS, INC.
K831503 09/12/1983 DOWNS ADJUSTABLE FLOW GENERATOR VITAL SIGNS, INC.
K832526 09/19/1983 UROTRACK PLUS VITALMETRICS, INC.
K831875 09/12/1983 BALLOON DILATION HELICAL STONE EXTRACT VPI
K831878 09/29/1983 CARDIO-SCOPE MINI MONITOR W.E. LEDER ENTERPRISES, INC.
K831981 09/29/1983 LARYNGESCOPE W.E. LEDER ENTERPRISES, INC.
K832599 09/20/1983 EARLY IN HOME PREGNANCY TEST WARNER-LAMBERT CO.
K831780 09/12/1983 METABOLIC EXERCISE TESTING SYSTEM WARREN E. COLLINS, INC.
K831073 09/01/1983 DAC-CEL HCG-MCA KIT RD52 WELLCOME DIAGNOSTICS
K832592 09/29/1983 DIACROM * ATIII WELLCOME DIAGNOSTICS
K832372 09/29/1983 DIACROM * FACTOR X KIT HA31 WELLCOME DIAGNOSTICS
K832373 09/29/1983 DIACROM * HEPARIN WELLCOME DIAGNOSTICS
K832376 09/29/1983 WIDEX HEARING AID MODEL L1 WIDEX HEARING AID CO., INC.
K832452 09/12/1983 ANDROSTENEDIONE TEST SET 125I WIEN LABORATORIES, INC.
K830657 09/16/1983 AMBULATORY MARK XI DRUG INFUSION DEV- WINDSOR MEDICAL, INC.
K832750 09/26/1983 EASYTOUCH HEMOGLOBIN REAGENT WORTHINGTON DIAGNOSTIC SYSTEMS
K832426 09/12/1983 EASYTOUCH TRIGLYCERIDES REAGENT SET WORTHINGTON DIAGNOSTIC SYSTEMS
K832733 09/29/1983 XEROX 120 SYS MAMMOGRAPHIC X-RAY XEROX MEDICAL SYSTEMS
K832404 09/12/1983 RECTAL TEMP. TELEMETRY MONITOR XOMED, INC.
K831886 09/12/1983 FEMORAL CANAL SPONGE ZIMMER, INC.


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