FDA 510(k) Decisions During November, 1981  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K812867 11/02/1981 STERI-VAC #400C GAS STERILIZER 3M COMPANY
K812926 11/06/1981 ALT-QUANTICHROM ABBOTT LABORATORIES
K812874 11/02/1981 PEDIATRIC MICROAGGREGATE BLOOD FILTER ABBOTT LABORATORIES
K812865 11/10/1981 QUANTUMATIC DUAL-WAVELENGTH SPECTRO ABBOTT LABORATORIES
K813175 11/27/1981 20CC GLASS CONTROL SYRINGE ABCO DEALERS, INC.
K812887 11/17/1981 ROBINSON CATHETERS NON-STERILE ABCO DEALERS, INC.
K812809 11/06/1981 STERILE ADHERENT DRAPES ABCO DEALERS, INC.
K812845 11/16/1981 SURGICAL SUCTION INSTRUMENTS-DISPOS. ABCO DEALERS, INC.
K812301 11/16/1981 VARIABLE FOCUS 3.5 MHZ TRANSDUCER ADR ULTRASOUND
K812977 11/16/1981 RESPIRATORY CARE MONITOR ADVANCED MEDICAL EQUIPMENT, INC.
K813034 11/27/1981 POLYSTAN HEART LUNG MACHINE SYS ADVOCACY INTERNATIONAL, LTD.
K813035 11/27/1981 POLYSTAN VERTICLUDE BLOOD PUMP ADVOCACY INTERNATIONAL, LTD.
K812880 11/24/1981 OHIO NON-REUSABLE TRACHEAL TUBE MAJILL AIRCO/OHIO MEDICAL PRODUCTS
K812879 11/24/1981 OHIO NON-REUSABLE TRACHEAL TUBE MURPHY AIRCO/OHIO MEDICAL PRODUCTS
K812556 11/02/1981 DADE IMMU-TRACE TRI-RAC R TRI-LEVEL R.C AMERICAN DADE
K812969 11/06/1981 S/P CAPILLARY TUBES, HEPARINIZED (2A) AMERICAN DADE
K812970 11/06/1981 S/P CAPILLARY TUBES, HEPARINIZED (3A) AMERICAN DADE
K812921 11/06/1981 S/P SURE-CAP AMERICAN DADE
K812922 11/06/1981 S/P SURE-CAP C AMERICAN DADE
K812923 11/06/1981 S/P SURE-CAP N AMERICAN DADE
K813148 11/24/1981 S/P VORTEX MIXER AMERICAN DADE
K813149 11/24/1981 S/P VORTEX MIXER JR. AMERICAN DADE
K812935 11/16/1981 FOGARTY FLEXIBLE PROBE AMERICAN EDWARDS LABORATORIES
K813069 11/16/1981 PERITONEAL DIALYSIS CYCLER SET AMERICAN MEDICAL PRODUCTS, INC.
K813076 11/16/1981 PHOSPHOTUNGSTATE REDUCTION, URIC ACID AMERICAN MONITOR CORP.
K812965 11/02/1981 MODEL SC-6, FLEXIBLE SIAMOIDOSCOPE AMERICAN OPTICAL CORP.
K812567 11/10/1981 "RELIEF" AMERICAN PHARMACEUTICAL CO., INC.
K812927 11/06/1981 ARTERIOGRAM TRAY AMERICAN PHARMASEAL DIV. AHSC
K812895 11/02/1981 YARMO NASAL CARTILAGE SOFTENER AMERICAN V. MUELLER
K812979 11/24/1981 VITAMIN B12/FOLATE DUAL RADIOASSAY KITS AMERSHAM CORP.
K812945 11/06/1981 LIQUILYME BUN REAGENT AMRESCO, INC.
K812841 11/27/1981 TOTAL & DIRECT BILIRUBIN REAGENT SET ANCO MEDICAL REAGENTS & ASSOC.
K812833 11/27/1981 TOTAL PROTEIN REAGENT SET ANCO MEDICAL REAGENTS & ASSOC.
K812878 11/02/1981 THE NEW 1600 ELECTRODE ANDOVER MEDICAL, INC.
K812924 11/02/1981 ANSWER (R) ARMKEL, LLC.
K813013 11/27/1981 GEL ELECTRODE ARNDT AUTOMATION & ASSOC.
K813099 11/24/1981 BACK RIE BACK RITE
K813025 11/10/1981 STANDING FRAME BARNETT MEDICAL
K812137 11/06/1981 B-D HEPARINIZED LONGDWEL I.V. CATHETER BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K812315 11/10/1981 BACTEC RESIN CULTURE MED. 16A BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K813053 11/16/1981 DISPOSABLE BLOOD PRESSURE TRANSDUCER DOM BENTLEY LABORATORIES, INC.
K812389 11/16/1981 SURGICAL LOOPS BERKELEY MEDEVICES
K812388 11/16/1981 SURGICAL PAWS BERKELEY MEDEVICES
K812980 11/06/1981 MA-2 VENTILATOR BIO-MEDICAL REPAIR, INC.
K812643 11/16/1981 LIFESPAN CO2 BIOCHEM INTERNATIONAL, INC.
K813089 11/20/1981 CEMENT RING BIOMET, INC.
K812946 11/06/1981 TRONZO HIP BIOMET, INC.
K812111 11/16/1981 PRUITT ARTERIAL OCCLUSION CHOLANG. CATH BIONOMY, INC.
K812982 11/24/1981 BLOM-SINGER VOICE PROSTHESIS BIVONA MEDICAL TECHNOLOGIES
K812437 11/02/1981 150 DRIVER REAMER BLACK & DECKER(TM)
K812436 11/02/1981 450/800 DRILL BLACK & DECKER(TM)
K812439 11/02/1981 DUAL MPC CHARGER BLACK & DECKER(TM)
K812440 11/02/1981 POWER PACK BLACK & DECKER(TM)
K812438 11/02/1981 SAGITTAL SAW BLACK & DECKER(TM)
K811114 11/23/1981 MODEL P-8 PROFESSIONAL BLOOMEX INTERNATIONAL, INC.
K812978 11/06/1981 URIC ACID SYSTEM PACK TEST BOEHRINGER MANNHEIM CORP.
K813085 11/20/1981 HEPAFIX BIOPSY NEEDLE SET BURRON MEDICAL PRODUCTS, INC.
K813083 11/16/1981 VENOFIX SCALP VEIN SET BURRON MEDICAL PRODUCTS, INC.
K812960 11/16/1981 EAST VENTILARM PRESSURE MONITOR ALARM S. CAIRCO LTD.
K812953 11/27/1981 RADCLIFFE VENTILATOR MARK 5 CAIRCO LTD.
K812702 11/05/1981 TECHNICATOR CAMERON-MILLER, INC.
K811101 11/20/1981 HYDROXYLAPATITE CARBOMEDICS, INC.
K812917 11/06/1981 PORTABLE LIDOCAINE INFUSION PUMP CARDIAC PACEMAKERS, INC.
K813051 11/24/1981 COMPTAR III CGR MEDICAL CORP.
K812963 11/24/1981 IBIS II CGR MEDICAL CORP.
K812908 11/24/1981 ELECTRO-GONIOMETER CHATTANOOGA GROUP, INC.
K812899 11/06/1981 MED-EX CHATTANOOGA GROUP, INC.
K813185 11/24/1981 SALICYLATE STAT-PAK CLINTECH DIAGNOSTICS CORP.
K813123 11/27/1981 EPC FILTER CODMAN & SHURTLEFF, INC.
K812722 11/05/1981 SAFE GUARD CONCEPT, INC.
K812832 11/05/1981 MODEL 325C UNIPOLAR CARDIAC PULSE GEN. COOK PACEMAKER CORP.
K812937 11/06/1981 BEHIND-THE-EAR MODEL 115 DANAVOX, INC.
K812939 11/06/1981 IN-THE-EAR MODEL 101M DANAVOX, INC.
K812938 11/06/1981 IN-THE-EAR MODEL 821 DANAVOX, INC.
K812828 11/16/1981 MODEL 2000 MONITOR DATASCOPE CORP.
K812638 11/16/1981 DIAGNOSTIC MEDICAL COMPUTER DIAGNOSTIC RESOURCES, INC.
K812973 11/16/1981 PERCUTANEOUS INTRODUCER COURNAND STYLE DIP, INC.
K813019 11/16/1981 PERCUTANEOUS INTRODUCER: SELDINGER STYLE DIP, INC.
K812852 11/02/1981 SET FOR ASEPTIC DECANTING OF A FLEX I.V DIP, INC.
K812864 11/24/1981 SILASTIC VOICE PROSTHESIS DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS
K812885 11/24/1981 DULBECCO MINIMUM ESSENTIAL MED NO GLUTAM DUTCHLAND LABORATORIES, INC.
K812626 11/24/1981 ACA ANTITHROMBIN III PLASMINOGEN CALIB E.I. DUPONT DE NEMOURS & CO., INC.
K812628 11/24/1981 ACA FIBRINOGEN CALIBRATOR E.I. DUPONT DE NEMOURS & CO., INC.
K813005 11/24/1981 KODAK CINEFLUOROGRAPHIC FILM SO-274 EASTMAN KODAK COMPANY
K812902 11/10/1981 "ACUPRESS" VIBRATOR EICONA CORP.
K813018 11/06/1981 OXYTRON OXYGEN GENERATOR ELMORE TECHNOLOGY CORP.
K812819 11/20/1981 ETHICON* SURGICAL SUTURES W/COMPRESS BOL ETHICON, INC.
K812323 11/16/1981 PDS* ABSORBABLE LIGATING CLIPS ETHICON, INC.
K813143 11/27/1981 DESILET EXCO, INC.
K813144 11/27/1981 INTRAFLON, INTRAFLUX, INTRAVALVE EXCO, INC.
K813142 11/27/1981 LEADER-CATH EXCO, INC.
K813140 11/27/1981 VYGON EXTENSION TUBES & CONNECTORS EXCO, INC.
K813141 11/27/1981 VYGON STOPCOCKS & RAMPS(MANIFOLDS) EXCO, INC.
K811972 11/16/1981 EXTRASENSR ULTRAFILTRATION MONITOR EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
K812398 11/10/1981 LINUS FISCHER IMAGING CORP.
K812623 11/02/1981 CLEANING SOLUTION FOR RADIOMETER OSM2 FISHER SCIENTIFIC CO., LLC.
K812831 11/06/1981 SURGICAL DRESSINGS FOREIGN TRADE ZONE OF WISCONSIN
K812888 11/10/1981 SYRINGE, PISTON FRISCO PRODUCTS, INC.
K811752 11/02/1981 FE-CULT PLUS GAMMA BIOLOGICALS, INC.
K812916 11/06/1981 MEZLOCILLIN 75MCG ANTIMICROB. SUSCEPT. D GENERAL DIAGNOSTICS
K812993 11/10/1981 MOXALACTOM 30MCG ANTIMICROBIAL SUS. DISK GENERAL DIAGNOSTICS
K812929 11/24/1981 3.5 MHZ BIOPSY TRANSDUCER GENERAL ELECTRIC CO.
K812966 11/24/1981 400T ECT SOFTWARE GENERAL ELECTRIC CO.
K812775 11/06/1981 FLUORICON L300 IMAGE INTENSIFIER GENERAL ELECTRIC CO.
K812915 11/24/1981 MX 125 GENERAL ELECTRIC CO.
K812913 11/24/1981 OMEGA II ANGIOGRAPHIC TABLE GENERAL ELECTRIC CO.
K812911 11/06/1981 BCYE MEDIUM GIBCO LABORATORIES LIFE TECHNOLOGIES, INC.
K812787 11/27/1981 EIA RUBELLA GILFORD
K812912 11/02/1981 GILCHEM ALP REAGENT GILFORD DIAGNOSTICS
K812820 11/10/1981 CHANG MEDIUM HANA BIOLOGICS, INC.
K813044 11/10/1981 ULTRACHEM ALB, ITEM #64970 HARLECO
K813040 11/10/1981 ULTRACHEM CA, ITEM #64975 HARLECO
K813043 11/10/1981 ULTRACHEM CREA ITEM #64972 HARLECO
K813039 11/10/1981 ULTRACHEM E-CHOL, ITEM #65025 HARLECO
K813042 11/10/1981 ULTRACHEM GLUC-DH SET, ITEM #65048 HARLECO
K813038 11/10/1981 ULTRACHEM TP, ITEM #64974 HARLECO
K813041 11/10/1981 ULTRAZYME-GT, ITEM #64959 & 65032 HARLECO
K812700 11/05/1981 URICAR HI CHEM, INC.
K813080 11/17/1981 WOUND DRAINAGE MANAGEMENT SYSTEMS HOWMEDICA CORP.
K812727 11/05/1981 GASTRIN 1-17 BY RADIOIMMUNOASSAY KIT IMMUNO NUCLEAR CORP.
K811021 11/05/1981 HERPES IMMUNO-DIAGNOSTIC PRODUCTS, INC.
K813026 11/17/1981 GUIDE WIRE INMED CORP.
K812990 11/16/1981 INTERMEDICS POLYFLEX-MODEL 483-03 LEAD INTERMEDICS, INC.
K812991 11/16/1981 INTERMEDICS POLYFLEX-MODEL 483-04 LEAD INTERMEDICS, INC.
K812989 11/16/1981 INTERMEDICS POLYFLEX-MODEL 493-03 LEAD INTERMEDICS, INC.
K812755 11/16/1981 MODEL 535-03 TRACE A PACE INTERMEDICS, INC.
K812968 11/06/1981 FIAX RHEUMATOID FACTOR TEST KIT INTL. DIAGNOSTIC TECHNOLOGY
K813104 11/20/1981 POWER DRIVE WHEELCR INTL. MEDICAL EQUIPMENT CORP.
K812017 11/20/1981 X-RAY DETECTABLE BAND ISRAMED, INC.
K812018 11/20/1981 X-RAY DETECTABLE THREAD ISRAMED, INC.
K812745 11/02/1981 WARMING LISTHTS #96H & 96HT J. H. EMERSON CO.
K812362 11/20/1981 DISP. TOOTHBRUSH W/3 G. TUBE OF TOOTHPST JDM COMMODITIES
K812363 11/20/1981 DISP. TOOTHBRUSH W/TOOTHPASTE ATTACHED JDM COMMODITIES
K812364 11/20/1981 PORT. TOOTHBRUSH KIT W/4 G. TOOTHPASTE JDM COMMODITIES
K812361 11/20/1981 PORTABLE TOOTHBRUSH KIT (NO SAMPLE) JDM COMMODITIES
K812827 11/16/1981 ORBIC* SPHERICAL ALLOY JOHNSON & JOHNSON PROFESSIONALS, INC.
K812411 11/10/1981 IMMUNO-CELL IMMUNO-SEP KIT KALLESTAD LABORATORIES, INC.
K812726 11/05/1981 KERMATH THERAPY SIMULATOR KERMATH MFG. CORP.
K813133 11/20/1981 KEYMED KEY LIGHT KEYMED, INC.
K812863 11/06/1981 FETASONDE 5, #30, CENTRAL NURSING STAT KONTRON INSTRUMENTS, INC.
K813032 11/24/1981 ZIKON 100 DIGITAL X-RAY SYSTEM KONTRON INSTRUMENTS, INC.
K812889 11/17/1981 ESTILUX POSTERIOR KULZER, INC.
K813059 11/16/1981 LEECO TESTO-QUANT DIAG. KIT LEECO DIAGNOSTICS, INC.
K812642 11/05/1981 ENGSTROM ERICA LKB INSTRUMENTS, INC.
K812090 11/10/1981 LORENZ BLOOD GAS ANALYZER LORENZ INSTRUMENTS
K813017 11/25/1981 NECKTRAC LOSSING ORTHOPEDIC, INC.
K812219 11/16/1981 MODEL 900S INTRAOCULAR PROBE LUMENIS, INC.
K812875 11/20/1981 SURGICAL LOOPS M-W LABORATORIES, INC.
K812876 11/20/1981 SURGICAL PAWS M-W LABORATORIES, INC.
K812919 11/02/1981 MULTI-GRAM DEVELOPING TANK R-12 & R-3 MARION LABORATORIES, INC.
K812603 11/20/1981 TANARAMA MARKETING CONSULTANTS OF AMERICA
K812248 11/24/1981 COOLEY 2 VASCULAR PROSTHESIS STRAIGHT MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.
K813100 11/27/1981 BIO-STIMULATOR, MODEL 400 MED-WESTERN ELECTRONICS, INC.
K812555 11/16/1981 DISPOSABLE SUTURE REMOVAL SCISSORS MEDCARE PRODUCTS
K812792 11/27/1981 PFT SCREENER (SYSTEM 1100) MEDICAL GRAPHICS CORP.
K812735 11/06/1981 CLOTH SURGICAL GLOVES MEDICAL SYNERGY
K813131 11/27/1981 INTERFACE ARTERIAL BLOOD FILTER MEDICAL, INC.
K812873 11/16/1981 MEDICON #8200 AMS MEDICON, INC.
K812910 11/06/1981 MEDISYSTEMS NEEDLES & SYRINGES MEDISYSTEMS CORP.
K812713 11/05/1981 DRAWER TEST MEDMETRIC CORP.
K812806 11/10/1981 KT-1000 DEVICE MEDMETRIC CORP.
K813012 11/06/1981 STERILE BASIN SETS MEDSPEC CORP.
K812707 11/02/1981 STERILE DISSECTOR SPONGES-X-RAY DETECT MEDSPEC CORP.
K812711 11/02/1981 STERILE GAUZE PADS 12PLY MEDSPEC CORP.
K812710 11/02/1981 STERILE LAPAROTOMY SPONGES-X-RAY DETECT MEDSPEC CORP.
K812725 11/16/1981 MODEL 5867-12 BIPOLAR LOW-PROFILE LEAD MEDTRONIC VASCULAR
K812817 11/10/1981 NEUTRAL DUFFERED FORMA-SCENT MERIDIAN DIAGNOSTICS, INC.
K812944 11/16/1981 MILLAR MIKRO-TIP CATHETER PRESSURE TRAN. MILLAR INSTRUMENTS, INC.
K812706 11/16/1981 MILLER/NADLER GLARE TESTER MOSEBACH ELECTRIC & SUPPLY
K812884 11/02/1981 NARCO TELECARE PRESSURE TRANSDUCER DOME NARCO SCIENTIFIC
K812918 11/06/1981 PILLING "K" KNIFE NARCO SCIENTIFIC
K812883 11/02/1981 TELECARE ISOTEC PRESSURE TRANSDUCER DOME NARCO SCIENTIFIC
K812331 11/16/1981 VTS-1000 VISUAL TESTING SYSTEM NICOLET BIOMEDICAL INSTRUMENTS
K813228 11/27/1981 CONNECTING TUBE NORTHERN MEDICAL INDUSTRIES
K812396 11/20/1981 ARTHRO-PREP REST NORTHWEST SURGICAL CONCEPTS, INC.
K812395 11/20/1981 ARTHRO-PREP REST W/STAND NORTHWEST SURGICAL CONCEPTS, INC.
K812761 11/02/1981 FLOW-DIRECTED BALLOON THERMODILUTION NOVA MEDICAL SPECIALTIES
K812967 11/06/1981 ACCURATE BETA ORGANON, INC.
K813167 11/24/1981 ORTHO UNASSAYED CONTROL SERUM LEVEL II ORTHO DIAGNOSTIC SYSTEMS, INC.
K812566 11/10/1981 UNIVERSAL SUTURE PASSER ORTHO PARED INSTRUMENTS, INC.
K812972 11/06/1981 RA LATEX TEST OXOID U.S.A., INC.
K812894 11/06/1981 VDRL CARBON ANTIGEN OXOID U.S.A., INC.
K810139 11/27/1981 ELECTRODE, PACEMAKER, PERMANENT PACESETTER SYSTEMS
K810286 11/27/1981 PACEPATH IMPLANT. ENDOCARD. PACING LEAD PACESETTER SYSTEMS
K810850 11/06/1981 PERSONAL MEDICATION INFUSER PACESETTER SYSTEMS
K812810 11/17/1981 PENTAX FLEXIBLE DRIODENOFIBERSCOPE PENTAX PRECISION INSTRUMENT CORP.
K813010 11/16/1981 EEG TELEPHONE TRANSMITTER, MODEL #T-7 PHARMAQUEST CORP.
K812983 11/10/1981 DSD PM AMERICA, INC.
K813102 11/24/1981 POLI-MAK II PM AMERICA, INC.
K812943 11/06/1981 SLICK ENDOTRACHEAL TUBE POLAMEDCO, INC.
K813106 11/24/1981 PORT-OP PORTEC, INC.
K813003 11/06/1981 P.P.P. TREATMENT CABINET PRECISION PROFESSIONAL PRODUCTS
K812907 11/02/1981 FEMEX PROMAC
K812890 11/16/1981 HEMASITE GRAFTLESS VASCULAR ACESS RENAL SYSTEMS, INC.
K813237 11/30/1981 HEMASITE VASCULAR ACCESS SHUNT HM-1000 RENAL SYSTEMS, INC.
K812230 11/06/1981 MODEL RS 8300 RENAL SYSTEMS, INC.
K812791 11/24/1981 PORTABLE MEDICAL TABLE RICHARD D. SPRADLIN
K813094 11/20/1981 ACETABULAR CEMENT COMPRESSOR RICHARD'S MEDICAL EQUIP., INC.
K813093 11/20/1981 RICHARDS ACETABULAR BRUSH RICHARD'S MEDICAL EQUIP., INC.
K812822 11/16/1981 RIND AIRWAY RIND MEDICAL DEVELOPMENT
K812951 11/06/1981 RION AUDIOMETER AA-67 RION ACOUSTIC INSTRUMENTS, INC.
K812952 11/06/1981 RION AUDIOMETER AA-68 RION ACOUSTIC INSTRUMENTS, INC.
K813090 11/24/1981 COMPOSITE DENTAL RESTORATIVE MATERIAL SCI-PHARM, INC.
K813091 11/24/1981 FISSURE SEALER & BONDING AGENT SCI-PHARM, INC.
K813066 11/16/1981 ARGYLE YANKAUER SUCTION TUBE SHERWOOD MEDICAL CO.
K812974 11/16/1981 LANCER COAGENT HUMAN FACTOR 1X PLASMA SHERWOOD MEDICAL CO.
K812975 11/16/1981 LANCER COAGENT HUMAN VACTOR VIII PLASMA SHERWOOD MEDICAL CO.
K812933 11/06/1981 LANCER SPECIMEN CONTAINER SHERWOOD MEDICAL CO.
K812934 11/06/1981 MONOJECT PREFILLED SYRINGES SHERWOOD MEDICAL CO.
K812742 11/02/1981 SHILEY ARTERIAL FILTER W/40 MICRON SCREE SHILEY, INC.
K812721 11/04/1981 DIGITRON SIEMENS CORP.
K811842 11/20/1981 IMAGER 2000 REAL TIME SYSTEM SIEMENS GAMMASONICS, INC.
K812646 11/16/1981 SKI 5000 SMITH KLINE DIAGNOSTICS, INC.
K812409 11/02/1981 SPHYGMOMANOMETER SOMATRONIX RESEARCH CORP.
K812720 11/05/1981 BODAI PATIENT COMMUNICATOR SONTEK INDUSTRIES, INC.
K812757 11/02/1981 SORENSON THERMODILUTION CARDIAC COMPUT SORENSEN RESEARCH
K812868 11/25/1981 FETAL PULSE DETECTORS, F50/F60 SOUTH CAROLINA MEDICAL, INC.
K813098 11/20/1981 TENS DEVICE STAODYNAMICS, INC.
K812856 11/06/1981 CHEMICAL INDICATORS STERILIZATION TECHNICAL SERVICES, INC.
K813070 11/20/1981 PERIOGRAF STERLING DRUG, INC.
K812312 11/13/1981 STERILE WATER 4OZ. SUPERIOR PLASTIC PRODUCTS CORP.
K813101 11/27/1981 CARDIOBEEPER MEMORY MONITOR SURVIVAL TECHNOLOGY, INC.
K812691 11/16/1981 SILICONE IMPLANTS SUTTER BIOMEDICAL, INC.
K812263 11/02/1981 KENZ-GELECT SUZUKEN CO., LTD.
K813192 11/27/1981 HDL-C EIKEN SYN-KIT, INC.
K812464 11/16/1981 SYNTHEMED PULSE GENERATOR VVI MODEL 1000 SYNTHEMED CORP.
K813146 11/27/1981 SYVA ADVANCE TM FLUOROMETER SYVA CO.
K812743 11/16/1981 FETAL VITABILITY TM MODE TECHNICARE CORP.
K813077 11/16/1981 TECHNICON RA 1000 SYSTEM TECHNICON CORP.
K812738 11/16/1981 BOUNDARY PROCESS CHANGE THE BUCKEYE CELLULOSE CORP.
K812962 11/20/1981 BOUNDARY SURGICAL DRAPE THE BUCKEYE CELLULOSE CORP.
K813263 11/27/1981 PATIENT UNDERPAD THE BUCKEYE CELLULOSE CORP.
K812736 11/06/1981 SOFTCARE BARRIER WET DRESSING THE KENDAL CO.
K812765 11/16/1981 DATASCRIBE #DS-40 TIMETER INSTRUMENT CORP.
K812767 11/27/1981 SNIFF AIR COMPRESSOR #SF-6 TIMETER INSTRUMENT CORP.
K811924 11/10/1981 PRE-FILLED SYRINGE & CYSTOFLO URINARY BG TRAVENOL LABORATORIES, S.A.
K813001 11/06/1981 FIBRI-FILTER 20 TRI-MED, INC.
K813014 11/10/1981 PROTECT-O-SEAL TRI-MED, INC.
K812964 11/16/1981 INTRODUCER, PERCUTANEOUS SELDINGER TRIAD MEDICAL DIVISION
K812769 11/06/1981 TRIDENT #2001 TRIDENT SURGICAL CORP.
K813067 11/24/1981 SPINAL WRENCH TWIN CITY SURGICAL, INC.
K812209 11/16/1981 ULTRA COM ULTRANAMICS, INC.
K812886 11/16/1981 ENDODONTIC PAPER POINTS UNITED DENTAL MFG., INC.
K812999 11/16/1981 PET POLYETHYLENE TORQUE CATHETER UNIVERSAL MEDICAL INSTRUMENT CORP.
K812213 11/05/1981 AUTOMATED ELECTROCAUTERY SYSTEM UNIVERSITY OF WASHINGTON
K813072 11/10/1981 E2502 & E2502B LECTROSWITCH VALLEYLAB, INC.
K813071 11/10/1981 E2508 DISPOSABLE HANDSWITCHING PENCIL VALLEYLAB, INC.
K812785 11/16/1981 VANCE-AMBROSE RESECTOSCOPE FORCEPS VANCE PRODUCTS, INC.
K812854 11/06/1981 VENTRONICS #5590 ECII OXYGEN MONITOR VENTRONICS, DIV OF HUDSON OXYGEN THERAPY SALES CO.
K812855 11/06/1981 VENTRONICS #5595 ECII OXYGEN ANALYZER VENTRONICS, DIV OF HUDSON OXYGEN THERAPY SALES CO.
K812981 11/06/1981 FLUVEN SETS (EXT-1, EXT-2, EXT-3, EXT-4) VENUSA LTD.
K812121 11/16/1981 DIGICLOT 2-#820 VOLU SOL MEDICAL INDUSTRIES
K812122 11/10/1981 MULTI CLOT-#819 VOLU SOL MEDICAL INDUSTRIES
K813027 11/20/1981 STERILE IRRIGATING SYRINGES, KITS,TRAY WELCON, INC.
K812432 11/06/1981 HEALTH-UP WFX INDUSTRIES, INC.
K812390 11/24/1981 NEUROSPONGE PADDIE WINN HIRSCH & ASSOC.
K812391 11/24/1981 NEUROSPONGES WINN HIRSCH & ASSOC.
K812572 11/02/1981 GAUZE SPONGES WORLDWIDE SURGICAL GAUZE
K812814 11/06/1981 ZEE SURGICAL INSTRUMENTS ZEE MEDICAL PRODUCTS CO., INC.
K813016 11/24/1981 ZEE TRACTION SPLINT ZEE MEDICAL PRODUCTS CO., INC.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact