FDA 510(k) Applications Received During June, 1981

FDA 510(k) Number Submission Date Device Name Applicant Contact
K811670 06/15/1981 STERI-LOK DUAL PURPOSE PACKAGING/8400 3M COMPANY
K811814 06/26/1981 TRIANGULAR BANDAGE ABCO DEALERS, INC.
K811780 06/23/1981 ACCRA-LAB GRAM STAIN SET 55760 ACCRA LABORATORIES, INC.
K811625 06/09/1981 PREP-SITE PROTECTIVE DRESSING WIPE ACME UNITED CORP.
K811528 06/01/1981 RADIATION BOLUS ACTION PRODUCTS, INC.
K811733 06/18/1981 AZIDE BLOOD AGAR BASE ACUMEDIA MANUFACTURERS, INC.
K811730 06/18/1981 BIOSATE ACUMEDIA MANUFACTURERS, INC.
K811654 06/10/1981 BRAIN HEART INFUSION AGAR ACUMEDIA MANUFACTURERS, INC.
K811734 06/18/1981 BRUCELLA BROTH ACUMEDIA MANUFACTURERS, INC.
K811729 06/18/1981 COLUMBIA ACUMEDIA MANUFACTURERS, INC.
K811735 06/18/1981 CTA MEDIUM ACUMEDIA MANUFACTURERS, INC.
K811736 06/18/1981 DCLS AGAR ACUMEDIA MANUFACTURERS, INC.
K811731 06/18/1981 DEXTROSE BROTH ACUMEDIA MANUFACTURERS, INC.
K811648 06/10/1981 ENDO AGAR ACUMEDIA MANUFACTURERS, INC.
K811649 06/10/1981 GELYSATE ACUMEDIA MANUFACTURERS, INC.
K811650 06/10/1981 MACCONKEY BROTH ACUMEDIA MANUFACTURERS, INC.
K811653 06/10/1981 PHYTONE ACUMEDIA MANUFACTURERS, INC.
K811652 06/10/1981 POLYPEPTONE PEPTONE ACUMEDIA MANUFACTURERS, INC.
K811732 06/18/1981 THIOTONE PEPTONE ACUMEDIA MANUFACTURERS, INC.
K811651 06/10/1981 TRYPTICASE ACUMEDIA MANUFACTURERS, INC.
K811572 06/04/1981 ATL'S MARK 100/300 ULTRASOUND SYSTEMS ADVANCED TECHNOLOGY LABORATORIES, INC.
K811711 06/17/1981 PEDIATRIC OXYGEN MASKS AIRLIFE, INC.
K811708 06/16/1981 UNIVERSAL ADAPTER SYSTEM-U/ADAPIT AIRLIFE, INC.
K811589 06/08/1981 ACTIN FS ACTIVATED PTT REAGENT AMERICAN DADE
K811792 06/24/1981 ARRYTHMIA PRINTER OPTION AMERICAN EDWARDS LABORATORIES
K811684 06/15/1981 AMERICAN AIRCARE SYSTEM AMERICAN HAMILTON
K811535 06/01/1981 MODEL FUS-1, FLEXIBLE URETEROSCOPE AMERICAN OPTICAL CORP.
K811658 06/12/1981 ANIS LENS IMPLANT FORCEPS #2 AMERICAN V. MUELLER
K811759 06/22/1981 RETRACTING PROBES AMERICAN V. MUELLER
K811804 06/24/1981 FERRITIN RIA KIT AMERSHAM CORP.
K811592 06/08/1981 LIQUIZYME SINGLE SOLUTION GLUCOSE REAG AMRESCO, INC.
K811828 06/29/1981 SICKLE CELL REAGENT SET ANCO MEDICAL REAGENTS & ASSOC.
K811764 06/22/1981 URIC ACID REAGENT SET ANCO MEDICAL REAGENTS & ASSOC.
K811614 06/08/1981 NERVE STIMULATOR MODEL AA 1050 ANESTHESIA ASSOC., INC.
K811527 06/01/1981 CC-103 ANTHRO-METRICS CORP.
K811627 06/09/1981 ARROW PERITONEAL LAVAGE CATHERIZATION K ARROW INTL., INC.
K811594 06/08/1981 WATER PISTOL AUS-TEX DENTAL MFG. & DESIGN
K811633 06/09/1981 "CIRAS" ULTRASONIC SCANNING SYSTEM AUSONICS PTY LTD.
K811615 06/08/1981 BACH-SIMPSON MODEL BVM30 BACH-SIMPSON LTD.
K811616 06/08/1981 BACH-SIMPSON MODEL TS266 BACH-SIMPSON LTD.
K811694 06/15/1981 CENTRIFICHEM ALT/AGPT OPTIMIZED REAGENT BAKER INSTRUCTIONS CORP.
K811554 06/02/1981 BARNES-HIND SPECTACLE LENS CLEANER BARNES-HIND, INC.
K811591 06/08/1981 B-D DRAKE WILLOCK #7000 SERIES ULTRAF BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K811637 06/10/1981 RUBELLA LATEX CARD TEST BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K811805 06/24/1981 TRYPIN (125I) RIA KIT BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K811692 06/15/1981 GENTAMICIN REAGENT TEST KIT BECKMAN INSTRUMENTS, INC.
K811710 06/17/1981 BIO.RAD HEMOGLOBIN A1 BY COLUMN TEST BIO-RAD
K811787 06/23/1981 QUANTAPHASE T-4 RIA BIO-RAD
K811709 06/17/1981 QUANTIMUNE ESTRIOL RIA BIO-RAD
K811680 06/15/1981 ACCUDEX BIODYNAMICS CORP.
K811738 06/19/1981 COLLARLESS TAPERED STEM HIP PROSTH. DEV BIOMET, INC.
K811718 06/18/1981 SURFACE REPLACEMENT HIP PROSTHESIS BIOMET, INC.
K811760 06/22/1981 CHOLESTEROL DETERMINATION BIORENT DIAGNOSTIC, INC.
K811739 06/19/1981 ENTRI ENTERAL FEEDING PUMP BIOSEARCH MEDICAL PRODUCTS, INC.
K811683 06/15/1981 ENTRI ENTERNAL FEEDING SET BIOSEARCH MEDICAL PRODUCTS, INC.
K811737 06/19/1981 BIO-TONE MODEL 4 BIOTONE INTERNATIONAL, INC.
K811832 06/29/1981 PRECINORM U & PRECIPATH U HUMAN SERUM BOEHRINGER MANNHEIM CORP.
K811553 06/02/1981 REAGENT SET TRIGLYCERIDES BOEHRINGER MANNHEIM CORP.
K811686 06/15/1981 SURGICAL INSTRUMENTS C.V.I., INC.
K811774 06/23/1981 OPEN LOOP AMBULATORY INFUSION DEVICE CARDIAC PACEMAKERS, INC.
K811582 06/05/1981 "THE PLACER CAVITRON CORP.
K811831 06/29/1981 MULTI-PURPOSE DENTAL SYRINGE CENTRIX, INC.
K811723 06/18/1981 WHOLE BODY SCANNER CGR MEDICAL CORP.
K811701 06/16/1981 CHLORIDE/CARBON DIOXIDE RATE REAGENT CHEM-ELEC, INC.
K811742 06/19/1981 HEMOTHERM MODEL 400 CINCINNATI SUB-ZERO
K811743 06/19/1981 MAXITHERM CINCINNATI SUB-ZERO
K811666 06/15/1981 COLTENE COLTEX/COLTOFLAX COLTENE, INC.
K811767 06/22/1981 COLTENE PRESIDENT IMPRESSION MATERIALS COLTENE, INC.
K811667 06/15/1981 COLTENE PRESSURE SPOT INDICATOR COLTENE, INC.
K811803 06/24/1981 JAPANESE HOTZIE CONSOLIDATED HEALTH & SPORTS PROD.
K811830 06/29/1981 C-DAK DUO-FLUX ARTIFICIAL KIDNEY CORDIS CORP.
K811539 06/01/1981 CORDIS ENCOR PEWENOUS VENTRICULAR BIPOL CORDIS CORP.
K811691 06/15/1981 CORDIS OMNI-ARTICOR CARDIAC PACER #308 CORDIS CORP.
K811768 06/22/1981 CORATOMIC MODEL OVALITH-920BP CORPTOMIC
K811693 06/15/1981 FORDER RETRACTOR DACOMED CORP.
K811578 06/05/1981 DAHLBERG MODEL AP HEARING AID DAHLBERG ELECTRONICS, INC.
K811638 06/10/1981 DATASCOPE INTERNAL DEFIBRILLATOR PADDLES DATASCOPE CORP.
K811577 06/05/1981 CROUCH CORNEAL PROTECTOR DENVER BIOMEDICALS, INC.
K811557 06/02/1981 DEPUY HEMODRAIN DEPUY, INC.
K811712 06/17/1981 TIP WIPE DEVON INDUSTRIES, INC.
K811556 06/02/1981 DC-1 CARDIAC IMAGING MODULE DIASONICS, INC.
K811679 06/15/1981 SILASTIC TENDON PASSER H.P. DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS
K811726 06/18/1981 LEKSELL STEREOACTIC SYSTEM DOWNS SURGICAL LTD.
K811791 06/24/1981 PHOSPHATE BUFFERED SALINE (1X) DUTCHLAND LABORATORIES, INC.
K811706 06/16/1981 LACTIC ACID DIALYSATE ADDITIVE EDLAW PHARMACEUTICALS, INC.
K811570 06/04/1981 ANTIBODY TO CHLAMYDIA TRACHOMATIS ELECTRO-NUCLEONICS LABORATORIES, INC.
K811744 06/19/1981 VIRGO IPA FOR DETECTION OF GENTAMICIN ELECTRO-NUCLEONICS LABORATORIES, INC.
K811745 06/19/1981 VIRGO IPA FOR DETECTION OF PHENYTOIN ELECTRO-NUCLEONICS LABORATORIES, INC.
K811809 06/25/1981 ANTI-ARRHYTHMIC CONTROL LEVELS I & II ENVIRONMENTAL CHEMICAL SPECIALTIES
K811811 06/25/1981 TDM ANTI-CONVULSANT CONTROL LEVELS I-II ENVIRONMENTAL CHEMICAL SPECIALTIES
K811810 06/25/1981 URIC ACID TEST ENVIRONMENTAL CHEMICAL SPECIALTIES
K811624 06/09/1981 VISIO-SEAL ESPE-PREMIER SALES CO.
K811639 06/10/1981 ETHIX FEEDING TUBES POLYURETHANE/RADIOP. ETHOX CORP.
K811547 06/01/1981 MATELAS COQUILLE LATTREDE TASSIGNY FIRN-FRANCE
K811678 06/15/1981 GAMBRO WATER PURIFICATION MONITOR WRD GAMBRO, INC.
K811752 06/22/1981 FE-CULT PLUS GAMMA BIOLOGICALS, INC.
K811676 06/15/1981 MAXI CAMERA/D GENERAL ELECTRIC CO.
K811534 06/01/1981 HEMASPINNER GEOMETRIC DATA, DIV. SMITHKLINE CORP.
K811765 06/22/1981 SENSITITIRE AP60 GIBCO LABORATORIES LIFE TECHNOLOGIES, INC.
K811659 06/12/1981 CREATININE REAGENT GILFORD DIAGNOSTICS
K811537 06/01/1981 MODEL SP 5507 5-LUMEN THERMODILUTION CAT GOULD, INC.
K811538 06/01/1981 MODELS TA 1017 & 1017T GRITIFLO DISPOS GOULD, INC.
K811568 06/04/1981 CERVICAL DILATOR GYNEMETRICS, INC.
K811641 06/09/1981 COLUMBIA AGAR BASE HARDY MEDIA
K811642 06/09/1981 EOSIN METHYLENE BLUE AGAR (LEVINE) HARDY MEDIA
K811644 06/09/1981 HEKTOEN ENTERIC AGAR HARDY MEDIA
K811643 06/09/1981 MACCONKEY AGAR HARDY MEDIA
K811640 06/09/1981 MEDICASE SOY AGAR HARDY MEDIA
K811646 06/09/1981 MUELLER HINTON AGAR HARDY MEDIA
K811647 06/09/1981 SALMONELLA-SHIGELLA AGAR HARDY MEDIA
K811645 06/09/1981 THAYER-MARTIN, GC AGAR BASE HARDY MEDIA
K811573 06/04/1981 CARDIOZYME PLUS CK-MB ITEM #65045 HARLECO
K811575 06/04/1981 CARDIOZYME PLUS CK-MB ITEM #65045 (G) HARLECO
K811574 06/04/1981 CARDIOZYME PLUS CK-TOTAL ITEM #65046 HARLECO
K811576 06/04/1981 CARDIOZYME PLUS CK-TOTAL ITEM #65046 (A) HARLECO
K811719 06/18/1981 CUSTOM IN-THE-EAR HEARING AID HEARING HEALTH GROUP, INC.
K811695 06/16/1981 HELENA FETAL-TEK 200 MARKER HELENA LABORATORIES
K811588 06/08/1981 HELENA FETAL-TEK 200 METHOD HELENA LABORATORIES
K811777 06/23/1981 HELENA PLASMINOGEN QUIPLATE PROCEDURE HELENA LABORATORIES
K811595 06/08/1981 SP-100-B SMALL PARTS SCANNER SYSTEM HIGHSTOY
K811581 06/05/1981 ARRHYTHMIA FUNCTION BLOCK HONEYWELL, INC.
K811626 06/09/1981 MEDDARS/ULTRA IMAGER PULSE/PHON MODULE HONEYWELL, INC.
K811630 06/09/1981 KINEMATIC ROTATING HINGE TOTAL KNEE PR. HOWMEDICA CORP.
K811756 06/22/1981 THERAPEUTIC DRUG CONTROL ICL SCIENTIFIC
K811536 06/01/1981 DIRECT TESTOSTERONE RIA IMMUCHEM CORP.
K811721 06/18/1981 H-101 KAPPA,H-102 LAMBDA,H-107 LYSOZME IMMULOK, INC.
K811725 06/18/1981 TBG DIAGNOSTIC KIT IMMUNO ASSAY CORP.
K811565 06/04/1981 ACTH RADIOIMMUNOASSAY KIT IMMUNO NUCLEAR CORP.
K811566 06/04/1981 C-TERMINAL PTH BY RADIOIMMUNOASSAY KIT IMMUNO NUCLEAR CORP.
K811562 06/03/1981 TOXOPLASMOSIS TEST KIT IMMUNO-DIAGNOSTIC PRODUCTS, INC.
K811824 06/29/1981 CAUTERY CADDY PAD INSTRANETICS, INC.
K811823 06/29/1981 SHARPS CADDY FB INSTRANETICS, INC.
K811822 06/29/1981 TIP-VU INSTRANETICS, INC.
K811696 06/16/1981 IL #781, SEMI-AUTOMATED LOADER INSTRUMENTATION LABORATORY CO.
K811665 06/15/1981 SR-ISOCETTE J. ADERER, INC.
K811779 06/23/1981 ROSS-EMERSON PUMP, MODEL 55-R J. H. EMERSON CO.
K811698 06/16/1981 CARL ZEISS INN MYRINGOTOMY TUBE LINE JAMES L. GERACI & ASSOCIATES, INC.
K811546 06/01/1981 NICHOLAS II, VIRAL-BACTERIAL FILTER K & G HEALTHCARE IND., INC.
K811775 06/23/1981 KALLESTAD ANTISERA TO PHENYTOIN KALLESTAD LABORATORIES, INC.
K811776 06/23/1981 KALLESTAD QUANTICOAT 125 DIGOXIN KALLESTAD LABORATORIES, INC.
K811545 06/01/1981 KALLESTAD QUANTITOPE LOW LEVEL IGE REAG KALLESTAD LABORATORIES, INC.
K811740 06/19/1981 KALLESTAD'S ENDOPLATE FACTOR B TEST KALLESTAD LABORATORIES, INC.
K811617 06/08/1981 QUANTIMETRIC C-REACTIVE PROTEIN ASSAY R. KALLESTAD LABORATORIES, INC.
K811613 06/08/1981 72 DETERMIN. SIZE RADIAL IMMUNOD. TEST KENT LABORATORIES, INC.
K811662 06/15/1981 ALBUMIN TEST KING DIAGNOSTICS, INC.
K811664 06/15/1981 CREATININE TEST KING DIAGNOSTICS, INC.
K811748 06/22/1981 KING DIAGNOSTICS CALCIUM TEST KING DIAGNOSTICS, INC.
K811747 06/22/1981 KING DIAGNOSTICS CHOLESTEROL TEST KING DIAGNOSTICS, INC.
K811746 06/22/1981 KING DIAGNOSTICS CHOLESTEROL-FE TEST KING DIAGNOSTICS, INC.
K811749 06/22/1981 KING DIAGNOSTICS PHOSPHORUS TEST KING DIAGNOSTICS, INC.
K811661 06/15/1981 POTASSIUM TEST KING DIAGNOSTICS, INC.
K811673 06/15/1981 TOTAL PROTEIN TEST KING DIAGNOSTICS, INC.
K811687 06/15/1981 URIC ACID TEST KING DIAGNOSTICS, INC.
K811669 06/15/1981 DURAFILL MICROFILL RESTORATIVE MATERIAL KULZER, INC.
K811668 06/15/1981 KULZER TRANSLUX VISIBLE LIGHT CURING KULZER, INC.
K811771 06/22/1981 A.D.T. REUSABLE BONE MARROW NEEDLE LAB INDUSTRIES, INC.
K811560 06/02/1981 AUTOMATED PHYSIOLOGIC PROFILE MONITOR LIFE SCIENCES MANUFACTURING, INC.
K811657 06/11/1981 P.D. CRADLE LUNG CARE, INC.
K811727 06/18/1981 PORTABLE AUDIOMETERS MAICO HEARING INSTRUMENTS, INC.
K811700 06/16/1981 CIRCUIT, BREATHING MARQUEST MEDICAL PRODUCTS, INC.
K811677 06/15/1981 KRYPTON CART MEDI-PHYSICS INC. DBA NYCOMED AMERSHAM IMAGING
K811688 06/15/1981 TUNGSTEN SYRINGE SHIELD MEDI-PHYSICS INC. DBA NYCOMED AMERSHAM IMAGING
K811783 06/23/1981 ENDOPUMP MEDTRON DEVELOPMENT LTD.
K811655 06/11/1981 MYELOSTAT DORSAL CORD STIMULATOR MEDTRONIC VASCULAR
K811722 06/18/1981 PARA-PAK MERIDIAN DIAGNOSTICS, INC.
K811541 06/01/1981 MGN CONNECTING TUBE MGN MEDICAL MANUFACTURING, INC.
K811533 06/01/1981 MGN FEEDING TUBE MGN MEDICAL MANUFACTURING, INC.
K811542 06/01/1981 MGN SUCTION CATHETER MGN MEDICAL MANUFACTURING, INC.
K811600 06/08/1981 BILE ESCULIN MEDIA MICRO MEDIA LABORATORIES
K811607 06/08/1981 COLUMBIA AGAR CNA W/5% SHEEP BLOOD MICRO MEDIA LABORATORIES
K811598 06/08/1981 DNASE AGAR MEDIA MICRO MEDIA LABORATORIES
K811599 06/08/1981 EOSIN METHYLENE BLUE AGAR MICRO MEDIA LABORATORIES
K811610 06/08/1981 EOSIN METHYLENE BLUE AGAR (LEVINE) MICRO MEDIA LABORATORIES
K811606 06/08/1981 FLUID THIOCLYCOLLATE MEDIUM MICRO MEDIA LABORATORIES
K811605 06/08/1981 HEKTOEN ENTERIC AGAR MICRO MEDIA LABORATORIES
K811611 06/08/1981 MACCONKEY AGAR MICRO MEDIA LABORATORIES
K811609 06/08/1981 MANNITOL SALT AGAR MICRO MEDIA LABORATORIES
K811608 06/08/1981 MUELLER-HINTON MICRO MEDIA LABORATORIES
K811601 06/08/1981 PHENYETHYL ALCOHOL AGAR MICRO MEDIA LABORATORIES
K811603 06/08/1981 SALMONELLA SHIGELLA AGAR MICRO MEDIA LABORATORIES
K811612 06/08/1981 TRYPTIC SOY AGAR MICRO MEDIA LABORATORIES
K811602 06/08/1981 TRYPTIC SOY BROTH MICRO MEDIA LABORATORIES
K811597 06/08/1981 UREA AGAR SLANT MICRO MEDIA LABORATORIES
K811604 06/08/1981 XYLOSE LYSINE DEOXYCHOLATE AGAR MICRO MEDIA LABORATORIES
K811834 06/30/1981 MICRO OSCILLATING SAW MICRO-AIRE SURGICAL INSTRUMENTS, INC.
K811808 06/25/1981 AUTOPAK-12 FERRITIN KIT MICROMEDIC SYSTEMS
K811707 06/16/1981 AXICUT DISPOSABLE SCALPEL NEONATAL CORP.
K811757 06/22/1981 NEIA PAP ENZYMEIMMUNOASSAY NEW ENGLAND IMMUNOLOGY ASSOC.
K811820 06/29/1981 BIPOLAR COAGULATING FORCEPS NEW ENGLAND SURGICAL INSTRUMENT CORP.
K811821 06/29/1981 CAROTID ARTERY CLAMP & TOOLS NEW ENGLAND SURGICAL INSTRUMENT CORP.
K811634 06/10/1981 NORELCO ANEROID BLOOD PRESSURE METER NORTH AMERICAN PHILIPS CORP.
K811635 06/10/1981 NORELCO DIGITAL BLOOD PRESSURE METER NORTH AMERICAN PHILIPS CORP.
K811636 06/10/1981 NORELCO ELECTRONIC BLOOD PRESSURE METER NORTH AMERICAN PHILIPS CORP.
K811672 06/15/1981 NORELCO ELECTRONIC DIGITAL THERMOMETER NORTH AMERICAN PHILIPS CORP.
K811558 06/02/1981 TSH-P.E.G. NUCLEAR DIAGNOSTICS, INC.
K811628 06/09/1981 OECO APNEA MONITOR OECO
K811789 06/24/1981 OECO NASAL CANNULA OECO
K811713 06/17/1981 AVI-D CONTROL ORTHO DIAGNOSTIC SYSTEMS, INC.
K811567 06/04/1981 ORTHO* BI-LEVEL ASSAYED GLYCOH. CONTR. S ORTHO DIAGNOSTIC SYSTEMS, INC.
K811766 06/22/1981 CONFI-DRY ADULT UROABSORBENT PADS PERSONAL PRODUCTS CO.
K811629 06/09/1981 DYNA- MO PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K811782 06/23/1981 SOFT & STROKE PHOENIX INTL. MARKETING, INC.
K811660 06/12/1981 PLAYTEX MODIFIED FIBER TAMPONS PLAYTEX, INC.
K811580 06/05/1981 GLASSMAN-DORMIA GALLSTONE EXTRACTOR SET PORGES CATHETER CORP.
K811758 06/22/1981 ACCU-CHEK TRANS-TELEPHONIC PACEMAKER TR POWERS MEDICAL SYSTMES
K811548 06/01/1981 CERVICAL SPATULA PROCEDURE PRODUCTS, INC.
K811761 06/22/1981 THE EMMETT IUD THREAD RETRIEVER PROTO-MED, INC.
K811685 06/15/1981 I.V. ADMINISTRATION SET QUEST MEDICAL, INC.
K811795 06/24/1981 10% NEUTRAL BUFFERED FORMALDEHYDE RICHARD-ALLAN MEDICAL IND., INC.
K811794 06/24/1981 37% FORMALDEHYDE RICHARD-ALLAN MEDICAL IND., INC.
K811800 06/24/1981 BLUING REAGENT RICHARD-ALLAN MEDICAL IND., INC.
K811801 06/24/1981 CAL-RITE RICHARD-ALLAN MEDICAL IND., INC.
K811799 06/24/1981 CLEAR-MOUNT RICHARD-ALLAN MEDICAL IND., INC.
K811798 06/24/1981 CLEAR-RITE RICHARD-ALLAN MEDICAL IND., INC.
K811797 06/24/1981 EOSIN-Y RICHARD-ALLAN MEDICAL IND., INC.
K811793 06/24/1981 FIX-RIGHT 90ML & 180 ML PREFILLED CONT RICHARD-ALLAN MEDICAL IND., INC.
K811796 06/24/1981 FORMAL ALCOHOL RICHARD-ALLAN MEDICAL IND., INC.
K811802 06/24/1981 HEMATOXYLIN RICHARD-ALLAN MEDICAL IND., INC.
K811530 06/01/1981 RIONET HEARING AID HB 69 T RION ACOUSTIC INSTRUMENTS, INC.
K811531 06/01/1981 RIONET HEARING AID HB-69 RION ACOUSTIC INSTRUMENTS, INC.
K811529 06/01/1981 RIONET HEARING AID HB-69S RION ACOUSTIC INSTRUMENTS, INC.
K811631 06/09/1981 THERMOMETER (MADE IN CHINA) ROBERT I. CHIEN & ASSOC., INC.
K811632 06/09/1981 UNSTERILIZED LAPAROTOMY SPONGES (CHINA) ROBERT I. CHIEN & ASSOC., INC.
K811704 06/16/1981 MULTITUBULAR AIR SPLINT KIT ROGER CESTAC & ASSOC.
K811750 06/22/1981 MULTITUBULAR THORACIC AIR SPLINTS ROGER CESTAC & ASSOC.
K811714 06/17/1981 HEP-2-CRITHIDIA LUCILIAE ANA TEST KIT SCRIPPS-MILES, INC.
K811561 06/03/1981 LO-VOL I.V. SETS SEA MEDICAL PRODUCTS, INC.
K811555 06/02/1981 DENTAL FLOSS HOLDER SEWON INDUSTRY
K811587 06/05/1981 SIEMENS ANGIOTRON SIEMENS CORP.
K811807 06/25/1981 UROSKOP C SIEMENS CORP.
K811715 06/18/1981 ROTA CAMERA SIEMENS GAMMASONICS, INC.
K811784 06/23/1981 SIGMA PROCEDURE #890 SIGMA CHEMICAL CO.
K811754 06/22/1981 CRYSTONA SMITH & NEPHEW, INC.
K811623 06/09/1981 SMR PARAGON CHAIR TABLE SMR
K811769 06/22/1981 LAPAROTOMY PADS SOUTH MOUNTAIN MEDICAL
K811540 06/01/1981 SPACELABS' SYSTEM AUTORECORDER SPACELABS, INC.
K811702 06/16/1981 MODEL 381 HOME OXYGEN SENTRY STANLEY AVIATION CORP.
K811741 06/19/1981 CELL-CHEX RBC STRECK LABORATORIES, INC.
K811836 06/30/1981 PO-200 BLOOD OXYGEN MONITOR SUMITOMO ELECTRIC INDUSTRIES, INC.
K811674 06/15/1981 DRUG STANDARDS SUPELCO, INC.
K811690 06/15/1981 ANKLE-FOOT CAST/SPLINT SURGICAL APPLIANCE INDUSTRIES, INC.
K811689 06/15/1981 CYLINDER KNEE CAST/SPLINT SURGICAL APPLIANCE INDUSTRIES, INC.
K811826 06/29/1981 EOSIN Y SURGIPATH
K811825 06/29/1981 ORANGE G-6 SURGIPATH
K811728 06/18/1981 CASTLE & RITTER MINOR SURG. & EXAM LT SYBRON CORP.
K811815 06/26/1981 UROPAPER "EIKEG SYN-KIT, INC.
K811817 06/26/1981 UROPAPER "EIKEN" AG SYN-KIT, INC.
K811818 06/26/1981 UROPAPER "EIKEN" UAG SYN-KIT, INC.
K811816 06/26/1981 UROPAPER "EIKEN" UHAG SYN-KIT, INC.
K811770 06/22/1981 EMIT-CAD PROCAINAMIDE ASSAY SYVA CO.
K811618 06/08/1981 EMIT-CAD PROCAINAMIDE/N-ACETYL. CONTROL SYVA CO.
K811621 06/08/1981 EMIT-ST SERUM PHENOBARBITAL ASSAY SYVA CO.
K811622 06/08/1981 EMIT-ST SERUM PHENOBARBITAL CALIBRATOR SYVA CO.
K811619 06/08/1981 EMIT-ST SERUM PHENOBARBITAL CONTROLS SYVA CO.
K811620 06/08/1981 EMIT-TOX SERUM CALIBRATORS SYVA CO.
K811593 06/08/1981 ATRIAL ENDOCARDIAL ELECTRODE LEAD OF J TELECTRONICS, INC.
K811717 06/18/1981 GATOR DRAPES THE ANSPACH EFFORT, INC.
K811819 06/29/1981 BOUNDARY STERILIZATION WRAP THE BUCKEYE CELLULOSE CORP.
K811778 06/23/1981 MODEL 4100 14 MEV NEUTRON GEN. THERAPY THE CYCLOTRON CORP.
K811806 06/25/1981 QUICK-CHEM COLORIMETER THE DOW CHEMICAL CO.
K811656 06/12/1981 POWERED WHEELCHAIR THE OEC GROUP
K811550 06/02/1981 TIMETER PRODUCED CHEMETRON (NCG) AIR TIMETER INSTRUMENT CORP.
K811551 06/02/1981 TIMETER PRODUCED OHIO OXYGEN ADAPTOR TIMETER INSTRUMENT CORP.
K811549 06/02/1981 TIMETER PRODUCED SCHRADER OXYGEN ADAPTOR TIMETER INSTRUMENT CORP.
K811697 06/16/1981 GUAMSTAINER TOMTEC
K811724 06/18/1981 2M 9810 MICROWAVE OVEN TRAVENOL LABORATORIES, S.A.
K811753 06/22/1981 SURGEON'S GLOVES TRAVENOL LABORATORIES, S.A.
K811773 06/22/1981 BACTAGARD TRI-MED, INC.
K811833 06/30/1981 VNACE FASCIAL DILATOR SET VANCE PRODUCTS, INC.
K811559 06/02/1981 VENTRE/SEP IGE RIA TEST SET VENTREX LABORATORIES, INC.
K811751 06/22/1981 FINETONE MODEL VI HEARING AID VICON INSTRUMENT CO.
K811781 06/23/1981 TENSIOMETER VIVITEK, INC.
K811772 06/22/1981 AUDITORY LOCALIZER WESTERN ADVANCED TECHNOLOGY, INC.
K811790 06/24/1981 OCTOTOXIC SCREENER WESTERN ADVANCED TECHNOLOGY, INC.
K811585 06/05/1981 F72T12/BL-S/HO UVA SUNLAMP WESTINGHOUSE ELECTRIC CORP.
K811586 06/05/1981 F72T12/BL-S/SHO-O UVA SUNLAMP WESTINGHOUSE ELECTRIC CORP.
K811703 06/16/1981 CARDIFF ALDASORBER SYSTEM WILLIAM HARVEY LIFE PRODUCTS CORP.
K811563 06/04/1981 PRESOLDER FOR NON-PRECIOUS DENTAL ALLOYS WILLIAMS GOLD REFINING CO., INC.
K811671 06/15/1981 CYTOMEGALOVIRUS ANTIBODY TEST SYSTEM ZEUS SCIENTIFIC, INC.
K811675 06/15/1981 SURGICAL INSTRUMENTS FOR USE W/ZIMMER ZIMMER, INC.
K811596 06/08/1981 ZIMMER ARTHROSCOPY SYSTEM ZIMMER, INC.


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