FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
K811670 |
07/10/1981 |
STERI-LOK DUAL PURPOSE PACKAGING/8400 |
3M COMPANY |
|
K812003 |
07/27/1981 |
A-GENT THEOPHYLLINE |
ABBOTT LABORATORIES |
|
K812004 |
07/28/1981 |
GASTRIN RIA DIAGNOSTIC KIT |
ABBOTT LABORATORIES |
|
K812078 |
07/23/1981 |
GONOZYME (10 COPIES FRWD. W/ORIG. TO BG) |
ABBOTT LABORATORIES |
|
K811216 |
07/02/1981 |
RESIDENT BEDSIDE MONITOR |
ABBOTT LABORATORIES |
|
K811814 |
07/31/1981 |
TRIANGULAR BANDAGE |
ABCO DEALERS, INC. |
|
K811780 |
07/27/1981 |
ACCRA-LAB GRAM STAIN SET 55760 |
ACCRA LABORATORIES, INC. |
|
K811625 |
07/10/1981 |
PREP-SITE PROTECTIVE DRESSING WIPE |
ACME UNITED CORP. |
|
K811528 |
07/10/1981 |
RADIATION BOLUS |
ACTION PRODUCTS, INC. |
|
K811733 |
07/02/1981 |
AZIDE BLOOD AGAR BASE |
ACUMEDIA MANUFACTURERS, INC. |
|
K811730 |
07/02/1981 |
BIOSATE |
ACUMEDIA MANUFACTURERS, INC. |
|
K811654 |
07/02/1981 |
BRAIN HEART INFUSION AGAR |
ACUMEDIA MANUFACTURERS, INC. |
|
K811734 |
07/02/1981 |
BRUCELLA BROTH |
ACUMEDIA MANUFACTURERS, INC. |
|
K811729 |
07/02/1981 |
COLUMBIA |
ACUMEDIA MANUFACTURERS, INC. |
|
K811735 |
07/02/1981 |
CTA MEDIUM |
ACUMEDIA MANUFACTURERS, INC. |
|
K811736 |
07/02/1981 |
DCLS AGAR |
ACUMEDIA MANUFACTURERS, INC. |
|
K811731 |
07/02/1981 |
DEXTROSE BROTH |
ACUMEDIA MANUFACTURERS, INC. |
|
K811648 |
07/02/1981 |
ENDO AGAR |
ACUMEDIA MANUFACTURERS, INC. |
|
K811649 |
07/02/1981 |
GELYSATE |
ACUMEDIA MANUFACTURERS, INC. |
|
K811650 |
07/02/1981 |
MACCONKEY BROTH |
ACUMEDIA MANUFACTURERS, INC. |
|
K811653 |
07/02/1981 |
PHYTONE |
ACUMEDIA MANUFACTURERS, INC. |
|
K811652 |
07/02/1981 |
POLYPEPTONE PEPTONE |
ACUMEDIA MANUFACTURERS, INC. |
|
K811732 |
07/02/1981 |
THIOTONE PEPTONE |
ACUMEDIA MANUFACTURERS, INC. |
|
K811651 |
07/02/1981 |
TRYPTICASE |
ACUMEDIA MANUFACTURERS, INC. |
|
K811095 |
07/01/1981 |
TRANSCUTANEOUS ELECTRICAL NERVE |
ACUTEC CORPORATION, INC. |
|
K811840 |
07/15/1981 |
BILIRUBINOMETER |
ADVANCED INSTRUMENTS, INC. |
|
K811890 |
07/15/1981 |
DISPOSABLE TRACH T OXYGENATOR |
AIRLIFE, INC. |
|
K811908 |
07/16/1981 |
IMV MANIFOLDS |
AIRLIFE, INC. |
|
K811711 |
07/01/1981 |
PEDIATRIC OXYGEN MASKS |
AIRLIFE, INC. |
|
K811708 |
07/01/1981 |
UNIVERSAL ADAPTER SYSTEM-U/ADAPIT |
AIRLIFE, INC. |
|
K811105 |
07/27/1981 |
SEMI-CONSTRAINT KEE JOINT HINGE PROSTH |
ALLO PRO CORP. |
|
K811119 |
07/20/1981 |
WEBER/STUEHMER HIP JOINT ENDOPROSTHESIS |
ALLO PRO CORP. |
|
K811218 |
07/01/1981 |
ACMI ASPIRATOR KIT #8808 |
AMERICAN CYSTOCOPE MAKERS, INC. |
|
K811589 |
07/16/1981 |
ACTIN FS ACTIVATED PTT REAGENT |
AMERICAN DADE |
|
K811069 |
07/10/1981 |
FIBRINOGEN CONTROL PLASMA |
AMERICAN DADE |
|
K811792 |
07/10/1981 |
ARRYTHMIA PRINTER OPTION |
AMERICAN EDWARDS LABORATORIES |
|
K811094 |
07/28/1981 |
CARDIAC 1000 TM |
AMERICAN EDWARDS LABORATORIES |
|
K811253 |
07/10/1981 |
CASSETTE READER |
AMERICAN EDWARDS LABORATORIES |
|
K811254 |
07/10/1981 |
PAPER CHART RECORDER |
AMERICAN EDWARDS LABORATORIES |
|
K812021 |
07/31/1981 |
VOLUMETRIC INFUSION PUMP |
AMERICAN EDWARDS LABORATORIES |
|
K811684 |
07/02/1981 |
AMERICAN AIRCARE SYSTEM |
AMERICAN HAMILTON |
|
K811936 |
07/28/1981 |
CHEMICAL AUTOCLAVE INDICATOR TAPE |
AMERICAN HOSPITAL SUPPLY CORP. |
|
K811915 |
07/28/1981 |
MONITOR/VITAL SIGNS TRAY |
AMERICAN HOSPITAL SUPPLY CORP. |
|
K811918 |
07/20/1981 |
AMP MARK IV INFUSION PUMP |
AMERICAN MEDICAL PRODUCTS, INC. |
|
K811917 |
07/23/1981 |
I.V. ADMIN. SETS FOR THE AMP MARK IV PMP |
AMERICAN MEDICAL PRODUCTS, INC. |
|
K811117 |
07/16/1981 |
EYE CARE TRAY |
AMERICAN PHARMASEAL DIV. AHSC |
|
K811759 |
07/20/1981 |
RETRACTING PROBES |
AMERICAN V. MUELLER |
|
K811804 |
07/10/1981 |
FERRITIN RIA KIT |
AMERSHAM CORP. |
|
K811592 |
07/01/1981 |
LIQUIZYME SINGLE SOLUTION GLUCOSE REAG |
AMRESCO, INC. |
|
K811998 |
07/28/1981 |
STAPH-IDENT |
ANALYTICAL PRODUCTS, INC. |
|
K811982 |
07/28/1981 |
STAPHASE* |
ANALYTICAL PRODUCTS, INC. |
|
K811990 |
07/27/1981 |
TRACH CLEANING TRAY |
ASSOCIATED MEDICAL PRODUCTS CO. |
|
K811910 |
07/20/1981 |
VEIN-TRAP TM |
ATRIUM MEDICAL CORP. |
|
K811594 |
07/15/1981 |
WATER PISTOL |
AUS-TEX DENTAL MFG. & DESIGN |
|
K811633 |
07/10/1981 |
"CIRAS" ULTRASONIC SCANNING SYSTEM |
AUSONICS PTY LTD. |
|
K811956 |
07/31/1981 |
AUTONORM & NERV-A-NORM |
AUTONOMIC EQUIPMENT SUPPLY CO, |
|
K811933 |
07/20/1981 |
GUARDIAN, VOLUMETRIC CONTROL DELIVERY |
AVI, INC. |
|
K811694 |
07/01/1981 |
CENTRIFICHEM ALT/AGPT OPTIMIZED REAGENT |
BAKER INSTRUCTIONS CORP. |
|
K811554 |
07/02/1981 |
BARNES-HIND SPECTACLE LENS CLEANER |
BARNES-HIND, INC. |
|
K811591 |
07/10/1981 |
B-D DRAKE WILLOCK #7000 SERIES ULTRAF |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K811957 |
07/23/1981 |
CAMPYPAK |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K811421 |
07/10/1981 |
HCG RADIOIMMUNOASSAY KIT (125I) |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K811692 |
07/15/1981 |
GENTAMICIN REAGENT TEST KIT |
BECKMAN INSTRUMENTS, INC. |
|
K812009 |
07/28/1981 |
CARDIOTOMY RESERVOIR W/FILTER#BCR-3500 |
BENTLEY LABORATORIES, INC. |
|
K812008 |
07/28/1981 |
CORDIOTOMY RESERVOIR |
BENTLEY LABORATORIES, INC. |
|
K811710 |
07/15/1981 |
BIO.RAD HEMOGLOBIN A1 BY COLUMN TEST |
BIO-RAD |
|
K811856 |
07/10/1981 |
FLUOROMATIC THEOPHYLLINE FIA |
BIO-RAD |
|
K811787 |
07/10/1981 |
QUANTAPHASE T-4 RIA |
BIO-RAD |
|
K811709 |
07/10/1981 |
QUANTIMUNE ESTRIOL RIA |
BIO-RAD |
|
K811290 |
07/27/1981 |
ARACHIDONIC ACID |
BIO/DATA CORP. |
|
K811109 |
07/16/1981 |
THROMBIN CLOTTING TIME |
BIO/DATA CORP. |
|
K811680 |
07/23/1981 |
ACCUDEX |
BIODYNAMICS CORP. |
|
K811189 |
07/27/1981 |
CHEMSTRIP L |
BIODYNAMICS CORP. |
|
K810803 |
07/21/1981 |
FREEZE DRIED PAPAIN |
BIOLOGICAL CORP. OF AMERICA |
|
K811928 |
07/28/1981 |
LIFESOUND ESOPHAGEAL STETHOSCOPE |
BIOMEDICAL CONCEPTS, INC. |
|
K811738 |
07/20/1981 |
COLLARLESS TAPERED STEM HIP PROSTH. DEV |
BIOMET, INC. |
|
K811760 |
07/10/1981 |
CHOLESTEROL DETERMINATION |
BIORENT DIAGNOSTIC, INC. |
|
K811739 |
07/10/1981 |
ENTRI ENTERAL FEEDING PUMP |
BIOSEARCH MEDICAL PRODUCTS, INC. |
|
K811683 |
07/15/1981 |
ENTRI ENTERNAL FEEDING SET |
BIOSEARCH MEDICAL PRODUCTS, INC. |
|
K811921 |
07/23/1981 |
HITACHI 705 CALIBRATOR |
BOEHRINGER MANNHEIM CORP. |
|
K811832 |
07/15/1981 |
PRECINORM U & PRECIPATH U HUMAN SERUM |
BOEHRINGER MANNHEIM CORP. |
|
K810940 |
07/16/1981 |
THE BETA |
BURDICK CORP. |
|
K811686 |
07/20/1981 |
SURGICAL INSTRUMENTS |
C.V.I., INC. |
|
K811341 |
07/16/1981 |
BIOVISION CARDIAC STROBE |
CARDIAC IMAGING |
|
K811402 |
07/27/1981 |
COMMAND P5(BIPOLAR PULSE GENERATOR) |
CARDIAC PACEMAKERS, INC. |
|
K811401 |
07/27/1981 |
COMMAND P5(UNIPOLAR PULSE GENERATOR) |
CARDIAC PACEMAKERS, INC. |
|
K811774 |
07/10/1981 |
OPEN LOOP AMBULATORY INFUSION DEVICE |
CARDIAC PACEMAKERS, INC. |
|
K811217 |
07/20/1981 |
PACEMAKER PROGRAMMER #2010 |
CARDIAC PACEMAKERS, INC. |
|
K811582 |
07/28/1981 |
"THE PLACER |
CAVITRON CORP. |
|
K811901 |
07/23/1981 |
CENTURY BATHING SYSTEM |
CENTURY MANUFACTURING CO. |
|
K811904 |
07/20/1981 |
CENTURY HYDRO-SAN THERAPY TANK |
CENTURY MANUFACTURING CO. |
|
K811903 |
07/20/1981 |
CENTURY HYDROTHERAPY PUMP |
CENTURY MANUFACTURING CO. |
|
K811899 |
07/23/1981 |
CENTURY LIFT TRANSFER SYSTEM |
CENTURY MANUFACTURING CO. |
|
K811900 |
07/28/1981 |
CENTURY SAF-LIFT & SAF-KARY |
CENTURY MANUFACTURING CO. |
|
K811897 |
07/28/1981 |
LIC TURNOVER BED |
CENTURY MANUFACTURING CO. |
|
K811723 |
07/20/1981 |
WHOLE BODY SCANNER |
CGR MEDICAL CORP. |
|
K811193 |
07/10/1981 |
BUN RATE REAGENT |
CHEM-ELEC, INC. |
|
K811701 |
07/01/1981 |
CHLORIDE/CARBON DIOXIDE RATE REAGENT |
CHEM-ELEC, INC. |
|
K811310 |
07/10/1981 |
SODIUM/POTASSIUM REAGENT KITS |
CHEM-ELEC, INC. |
|
K811743 |
07/16/1981 |
MAXITHERM |
CINCINNATI SUB-ZERO |
|
K810871 |
07/10/1981 |
LIGHTNING DIALYZER |
CLINTOX LABORATORIES, INC. |
|
K811666 |
07/15/1981 |
COLTENE COLTEX/COLTOFLAX |
COLTENE, INC. |
|
K811767 |
07/15/1981 |
COLTENE PRESIDENT IMPRESSION MATERIALS |
COLTENE, INC. |
|
K811667 |
07/15/1981 |
COLTENE PRESSURE SPOT INDICATOR |
COLTENE, INC. |
|
K811803 |
07/31/1981 |
JAPANESE HOTZIE |
CONSOLIDATED HEALTH & SPORTS PROD. |
|
K811892 |
07/31/1981 |
CORDIS DOW SERA FLO TM TRANSDUCER PROT |
CORDIS CORP. |
|
K811539 |
07/01/1981 |
CORDIS ENCOR PEWENOUS VENTRICULAR BIPOL |
CORDIS CORP. |
|
K811691 |
07/20/1981 |
CORDIS OMNI-ARTICOR CARDIAC PACER #308 |
CORDIS CORP. |
|
K811896 |
07/23/1981 |
902 NA/K |
CORNING MEDICAL & SCIENTIFIC |
|
K811953 |
07/23/1981 |
IMMOPHASE INSULIN (125I) RADIOASSAY |
CORNING MEDICAL & SCIENTIFIC |
|
K811768 |
07/20/1981 |
CORATOMIC MODEL OVALITH-920BP |
CORPTOMIC |
|
K803086 |
07/01/1981 |
MYOWIRE-ATEMPORARY CARDIAC PACING WIRE |
CRAIG & CRAIG, INC. |
|
K811578 |
07/01/1981 |
DAHLBERG MODEL AP HEARING AID |
DAHLBERG ELECTRONICS, INC. |
|
K811638 |
07/10/1981 |
DATASCOPE INTERNAL DEFIBRILLATOR PADDLES |
DATASCOPE CORP. |
|
K811258 |
07/23/1981 |
BASE METAL ALLOY |
DENTSPLY INTL. |
|
K811183 |
07/01/1981 |
DENVER PERITONEO-VENOUS SHUNT |
DENVER BIOMEDICALS, INC. |
JOHN B NEWKIRK |
K811557 |
07/20/1981 |
DEPUY HEMODRAIN |
DEPUY, INC. |
|
K811712 |
07/20/1981 |
TIP WIPE |
DEVON INDUSTRIES, INC. |
|
K811922 |
07/23/1981 |
45DEGREES SWIVEL ELBOW |
DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP. |
|
K811860 |
07/16/1981 |
EASY-FLO ARTERIAL BLOOD GAS KIT |
DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP. |
|
K811932 |
07/23/1981 |
COAT-A-COUNT DIGOXIN RIA |
DIAGNOSTIC PRODUCTS CORP. |
|
K811844 |
07/10/1981 |
COAT-A-COUNT GENTAMICIN RIA KIT |
DIAGNOSTIC PRODUCTS CORP. |
|
K811063 |
07/01/1981 |
LASER-CAL |
DIAGNOSTIC TECHNOLOGY, INC. |
|
K811556 |
07/10/1981 |
DC-1 CARDIAC IMAGING MODULE |
DIASONICS, INC. |
|
K811679 |
07/10/1981 |
SILASTIC TENDON PASSER H.P. |
DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS |
|
K811726 |
07/10/1981 |
LEKSELL STEREOACTIC SYSTEM |
DOWNS SURGICAL LTD. |
|
K811919 |
07/23/1981 |
KODAK EKTACHEM 400 ANALYZER |
EASTMAN KODAK COMPANY |
|
K810887 |
07/20/1981 |
ELA MEDICAL UNILITH 7540 PULSE GENERATOR |
ELA MEDICAL, INC. |
|
K811988 |
07/28/1981 |
EAGLE I HEARING AID |
ELECTONE, INC. |
|
K811570 |
07/23/1981 |
ANTIBODY TO CHLAMYDIA TRACHOMATIS |
ELECTRO-NUCLEONICS LABORATORIES, INC. |
|
K811744 |
07/10/1981 |
VIRGO IPA FOR DETECTION OF GENTAMICIN |
ELECTRO-NUCLEONICS LABORATORIES, INC. |
|
K811745 |
07/10/1981 |
VIRGO IPA FOR DETECTION OF PHENYTOIN |
ELECTRO-NUCLEONICS LABORATORIES, INC. |
|
K811250 |
07/24/1981 |
ELECTRONIC MUSCLE STIMULATOR |
ELECTROLA |
|
K811994 |
07/27/1981 |
RADIOIMMUNOASSAY LUTEINIZING HORMONE |
ENDOCRINE-METABOLIC CENTER |
|
K811809 |
07/10/1981 |
ANTI-ARRHYTHMIC CONTROL LEVELS I & II |
ENVIRONMENTAL CHEMICAL SPECIALTIES |
|
K811811 |
07/10/1981 |
TDM ANTI-CONVULSANT CONTROL LEVELS I-II |
ENVIRONMENTAL CHEMICAL SPECIALTIES |
|
K811810 |
07/15/1981 |
URIC ACID TEST |
ENVIRONMENTAL CHEMICAL SPECIALTIES |
|
K811678 |
07/10/1981 |
GAMBRO WATER PURIFICATION MONITOR WRD |
GAMBRO, INC. |
|
K811227 |
07/10/1981 |
CT/T DATALINK-B7875 AA/B7875 AB |
GENERAL ELECTRIC CO. |
|
K811676 |
07/02/1981 |
MAXI CAMERA/D |
GENERAL ELECTRIC CO. |
|
K811886 |
07/23/1981 |
CESIUM DILUENT 7.5M |
GILFORD DIAGNOSTICS |
|
K811397 |
07/02/1981 |
ECA |
GILLCO, INC. |
|
K811568 |
07/16/1981 |
CERVICAL DILATOR |
GYNEMETRICS, INC. |
|
K811980 |
07/28/1981 |
ELECTRONIC BLOOD PRESSURE TRANSDUCER MAN |
H.R. BIOMEDICAL, LTD. |
|
K811449 |
07/01/1981 |
HAEMONETICS 1000ML COMPONENT BAG |
HAEMONETICS CORP. |
|
K811641 |
07/02/1981 |
COLUMBIA AGAR BASE |
HARDY MEDIA |
|
K811642 |
07/02/1981 |
EOSIN METHYLENE BLUE AGAR (LEVINE) |
HARDY MEDIA |
|
K811644 |
07/02/1981 |
HEKTOEN ENTERIC AGAR |
HARDY MEDIA |
|
K811643 |
07/02/1981 |
MACCONKEY AGAR |
HARDY MEDIA |
|
K811640 |
07/02/1981 |
MEDICASE SOY AGAR |
HARDY MEDIA |
|
K811646 |
07/02/1981 |
MUELLER HINTON AGAR |
HARDY MEDIA |
|
K811647 |
07/02/1981 |
SALMONELLA-SHIGELLA AGAR |
HARDY MEDIA |
|
K811645 |
07/02/1981 |
THAYER-MARTIN, GC AGAR BASE |
HARDY MEDIA |
|
K811719 |
07/27/1981 |
CUSTOM IN-THE-EAR HEARING AID |
HEARING HEALTH GROUP, INC. |
|
K811695 |
07/01/1981 |
HELENA FETAL-TEK 200 MARKER |
HELENA LABORATORIES |
|
K811777 |
07/02/1981 |
HELENA PLASMINOGEN QUIPLATE PROCEDURE |
HELENA LABORATORIES |
|
K811912 |
07/23/1981 |
HELENA VMA-SMC CONTROL |
HELENA LABORATORIES |
|
K811626 |
07/01/1981 |
MEDDARS/ULTRA IMAGER PULSE/PHON MODULE |
HONEYWELL, INC. |
|
K811630 |
07/01/1981 |
KINEMATIC ROTATING HINGE TOTAL KNEE PR. |
HOWMEDICA CORP. |
|
K810115 |
07/16/1981 |
DOPPLEX-PLB & PXB |
HUNTLEIGH TECHNOLOGY, INC. |
|
K811756 |
07/15/1981 |
THERAPEUTIC DRUG CONTROL |
ICL SCIENTIFIC |
|
K812035 |
07/28/1981 |
IMED ACCUSET CASSETTE |
IMED CORP. |
|
K811721 |
07/16/1981 |
H-101 KAPPA,H-102 LAMBDA,H-107 LYSOZME |
IMMULOK, INC. |
|
K811906 |
07/23/1981 |
DHEA-SULFATE DIRECT RIA KIT(125I) |
IMMUNALYSIS CORPORATION |
|
K811905 |
07/23/1981 |
FOLLICLE STIMULATING HORMONE DIRECT RIA |
IMMUNALYSIS CORPORATION |
|
K811907 |
07/23/1981 |
PROGESTERONE DIRECT RIA KIT (125I) |
IMMUNALYSIS CORPORATION |
|
K811954 |
07/27/1981 |
COMBO-FER IRON DIAGNOSTIC |
IMMUNO ASSAY CORP. |
|
K811725 |
07/10/1981 |
TBG DIAGNOSTIC KIT |
IMMUNO ASSAY CORP. |
|
K811562 |
07/16/1981 |
TOXOPLASMOSIS TEST KIT |
IMMUNO-DIAGNOSTIC PRODUCTS, INC. |
|
K811824 |
07/20/1981 |
CAUTERY CADDY PAD |
INSTRANETICS, INC. |
|
K811823 |
07/20/1981 |
SHARPS CADDY FB |
INSTRANETICS, INC. |
|
K811822 |
07/20/1981 |
TIP-VU |
INSTRANETICS, INC. |
|
K811696 |
07/01/1981 |
IL #781, SEMI-AUTOMATED LOADER |
INSTRUMENTATION LABORATORY CO. |
|
K811665 |
07/15/1981 |
SR-ISOCETTE |
J. ADERER, INC. |
|
K811779 |
07/13/1981 |
ROSS-EMERSON PUMP, MODEL 55-R |
J. H. EMERSON CO. |
|
K811983 |
07/20/1981 |
JOHNSON & JOHNSON O.B. TAMPONS |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
|
K811775 |
07/10/1981 |
KALLESTAD ANTISERA TO PHENYTOIN |
KALLESTAD LABORATORIES, INC. |
|
K811776 |
07/10/1981 |
KALLESTAD QUANTICOAT 125 DIGOXIN |
KALLESTAD LABORATORIES, INC. |
|
K811740 |
07/16/1981 |
KALLESTAD'S ENDOPLATE FACTOR B TEST |
KALLESTAD LABORATORIES, INC. |
|
K810569 |
07/16/1981 |
CONTACT-MICRO COLPOHYSTEROSCOPE |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
|
K811245 |
07/31/1981 |
OPHTHALMIC SCISSORS |
KEELER INSTRUMENTS, INC. |
|
K811858 |
07/16/1981 |
KHI CPRAM BREATHING CIRCUIT |
KHI, INC. |
|
K811748 |
07/10/1981 |
KING DIAGNOSTICS CALCIUM TEST |
KING DIAGNOSTICS, INC. |
|
K811747 |
07/10/1981 |
KING DIAGNOSTICS CHOLESTEROL TEST |
KING DIAGNOSTICS, INC. |
|
K811746 |
07/10/1981 |
KING DIAGNOSTICS CHOLESTEROL-FE TEST |
KING DIAGNOSTICS, INC. |
|
K811882 |
07/23/1981 |
KING DIAGNOSTICS GLUCOSE TEST |
KING DIAGNOSTICS, INC. |
|
K811883 |
07/23/1981 |
KING DIAGNOSTICS GLUCOSE-O TEST |
KING DIAGNOSTICS, INC. |
|
K811749 |
07/10/1981 |
KING DIAGNOSTICS PHOSPHORUS TEST |
KING DIAGNOSTICS, INC. |
|
K811881 |
07/23/1981 |
KING DIAGNOSTICS TOTAL BILIRUBIN TEST |
KING DIAGNOSTICS, INC. |
|
K811687 |
07/01/1981 |
URIC ACID TEST |
KING DIAGNOSTICS, INC. |
|
K812011 |
07/28/1981 |
BLADE GAUGE |
KOI, INC. |
|
K812010 |
07/28/1981 |
KOI LACRIMAL INTUBATION SYSTEM |
KOI, INC. |
|
K811669 |
07/01/1981 |
DURAFILL MICROFILL RESTORATIVE MATERIAL |
KULZER, INC. |
|
K811668 |
07/28/1981 |
KULZER TRANSLUX VISIBLE LIGHT CURING |
KULZER, INC. |
|
K811771 |
07/10/1981 |
A.D.T. REUSABLE BONE MARROW NEEDLE |
LAB INDUSTRIES, INC. |
|
K803071 |
07/24/1981 |
PLA-MATE |
LABEX, INC. |
|
K811084 |
07/23/1981 |
LABTRONIX PLATELET COUNTER(L/O/C.) |
LABTRONIX CORP. |
|
K812058 |
07/31/1981 |
AKRON URINARY DRAINAGE BAT |
LATEX IND., INC. |
|
K811880 |
07/16/1981 |
LEECO FERRITIN-QUANT DIAG. TEST KIT |
LEECO DIAGNOSTICS, INC. |
|
K810746 |
07/31/1981 |
LUMAC'S BACTERIURIA SCREENING KIT |
LUMAC |
|
K811657 |
07/01/1981 |
P.D. CRADLE |
LUNG CARE, INC. |
|
K811943 |
07/28/1981 |
MACHIDA NASOPHARYNGO-LARYNGOSCOPE |
MACHIDA AMERICA, INC. |
|
K811727 |
07/15/1981 |
PORTABLE AUDIOMETERS |
MAICO HEARING INSTRUMENTS, INC. |
|
K811862 |
07/10/1981 |
HI-LO TEMP ESOPHAGEAL STETHOSCOPE |
MALLINCKRODT CRITICAL CARE |
|
K811888 |
07/23/1981 |
LINDHOLM ANATOMICAL TRACHEAL TUBE |
MALLINCKRODT CRITICAL CARE |
|
K811700 |
07/10/1981 |
CIRCUIT, BREATHING |
MARQUEST MEDICAL PRODUCTS, INC. |
|
K811677 |
07/02/1981 |
KRYPTON CART |
MEDI-PHYSICS INC. DBA NYCOMED AMERSHAM IMAGING |
|
K811688 |
07/02/1981 |
TUNGSTEN SYRINGE SHIELD |
MEDI-PHYSICS INC. DBA NYCOMED AMERSHAM IMAGING |
|
K811837 |
07/10/1981 |
I.V. ADMINISTRATION SET |
MEDISYSTEMS CORP. |
|
K812042 |
07/31/1981 |
INFUSION PUMP MODEL 200/201 |
MEDIX MEDICAL ELECTRONICS (U.S.A.), INC. |
|
K812037 |
07/28/1981 |
TEMPERATURE MONITOR 130/131/133 |
MEDIX MEDICAL ELECTRONICS (U.S.A.), INC. |
|
K811655 |
07/01/1981 |
MYELOSTAT DORSAL CORD STIMULATOR |
MEDTRONIC VASCULAR |
|
K811318 |
07/20/1981 |
TEMPORARY ENDOCARDIAL TRIPOLAR LD. #6880 |
MEDTRONIC VASCULAR |
|
K811350 |
07/01/1981 |
UNIPOLAR SPECTRAX IMPL. PULSE GENERAT. |
MEDTRONIC VASCULAR |
|
K811722 |
07/15/1981 |
PARA-PAK |
MERIDIAN DIAGNOSTICS, INC. |
|
K811533 |
07/10/1981 |
MGN FEEDING TUBE |
MGN MEDICAL MANUFACTURING, INC. |
|
K811909 |
07/16/1981 |
CARDIOPULMUNARY RESUSCITATOR |
MICHIGAN INSTRUMENTS, INC. |
|
K811834 |
07/20/1981 |
MICRO OSCILLATING SAW |
MICRO-AIRE SURGICAL INSTRUMENTS, INC. |
|
K810949 |
07/10/1981 |
MRI PROLACTIN RIA KIT |
MICROANALYTIC RESEARCH, INC. |
|
K811854 |
07/16/1981 |
GALACTOSID-ASE TUBES |
MICROCHEMICAL SPECIALITIES, CO. |
|
K811853 |
07/16/1981 |
PHOLPHORYL-ASE TUBES |
MICROCHEMICAL SPECIALITIES, CO. |
|
K811852 |
07/16/1981 |
REDUCT-ASE TUBES |
MICROCHEMICAL SPECIALITIES, CO. |
|
K811808 |
07/10/1981 |
AUTOPAK-12 FERRITIN KIT |
MICROMEDIC SYSTEMS |
|
K811952 |
07/15/1981 |
AMES TDA CARBAMAZEPINE TEST |
MILES LABORATORIES, INC. |
|
K811432 |
07/13/1981 |
MILLIPORE DUAL RATE INTRAVENOUS CASSETTE |
MILLIPORE CORP. |
|
K811707 |
07/20/1981 |
AXICUT DISPOSABLE SCALPEL |
NEONATAL CORP. |
|
K811820 |
07/28/1981 |
BIPOLAR COAGULATING FORCEPS |
NEW ENGLAND SURGICAL INSTRUMENT CORP. |
|
K811891 |
07/20/1981 |
NORELCO MASSAGER PLUS HEAT BELT |
NORTH AMERICAN PHILIPS CORP. |
|
K811277 |
07/20/1981 |
CATH-DAP |
NORTHWEST ALABAMA UROLOGICAL ASSOC. |
|
K811453 |
07/10/1981 |
NOVATRACER RECORDER |
NOVAMETRIX MEDICAL SYSTEMS, INC. |
|
K811628 |
07/31/1981 |
OECO APNEA MONITOR |
OECO |
|
K811789 |
07/02/1981 |
OECO NASAL CANNULA |
OECO |
|
K811855 |
07/31/1981 |
SKIN SCRUB KITS |
OEM MEDICAL DIV. |
|
K811170 |
07/31/1981 |
D-3160 SORBENT CARTRIDGE |
ORGANON TEKNIKA CORP. |
|
K811941 |
07/27/1981 |
NEOCEPT |
ORGANON, INC. |
|
K811894 |
07/27/1981 |
ORTHO SICKLE CELL CONTROLS |
ORTHO DIAGNOSTIC SYSTEMS, INC. |
|
K811987 |
07/27/1981 |
OXY-QUIK MARK IV OXYGEN INHALATOR |
OXEQUIP HEALTH IND. |
|
K811391 |
07/20/1981 |
OXIMETRIX ACCU SAT CPB |
OXIMETRIX, INC. |
|
K811985 |
07/28/1981 |
ULTIPOR SQ40S BLOOD TRANSFUSION FILTER |
PALL BIOMEDICAL PRODUCTS CO. |
|
K811992 |
07/20/1981 |
ASSURE NATURAL FIT TAMPON |
PERSONAL PRODUCTS CO. |
|
K811766 |
07/10/1981 |
CONFI-DRY ADULT UROABSORBENT PADS |
PERSONAL PRODUCTS CO. |
|
K810694 |
07/23/1981 |
PHADEBAS IGG RAST TEST |
PHARMACIA, INC. |
|
K811782 |
07/31/1981 |
SOFT & STROKE |
PHOENIX INTL. MARKETING, INC. |
|
K811660 |
07/16/1981 |
PLAYTEX MODIFIED FIBER TAMPONS |
PLAYTEX, INC. |
|
K811386 |
07/10/1981 |
PLAYTEX PROCESS MACHINERY CHANGE |
PLAYTEX, INC. |
|
K811868 |
07/16/1981 |
SCENTED MENSTRUAL PADS |
PROCTER & GAMBLE MFG. CO. |
|
K811869 |
07/16/1981 |
UNSCENTED MENSTRUAL PADS |
PROCTER & GAMBLE MFG. CO. |
|
K811424 |
07/09/1981 |
ELECTRONIC APGAR TIMER |
PT&E |
|
K811911 |
07/28/1981 |
SINGLE CHANNEL NON-FADE OSCILLOSCOPE |
QUINTON, INC. |
|
K811108 |
07/01/1981 |
RMI TRANSILLUMINATION LIGHT METER #295 |
RADIATION MEASUREMENTS, INC. |
|
K811272 |
07/10/1981 |
RAZEL MODEL C |
RAZEL SCIENTIFIC INSTRUMENTS, INC. |
|
K811503 |
07/10/1981 |
EPILATOR, BLEND-MODEL EB-200 & ET-1 |
RCX-WESTERN, INC. |
|
K811501 |
07/10/1981 |
EPILATOR, MULTIPLE NEEDLE-MODEL EM-20 |
RCX-WESTERN, INC. |
|
K811502 |
07/24/1981 |
STIMULATOR, FACIAL-MODELS SF-100 & 200 |
RCX-WESTERN, INC. |
|
K811977 |
07/31/1981 |
HEMASITE ACCESS MONITOR (TENT.) #RS-8200 |
RENAL SYSTEMS, INC. |
|
K811384 |
07/31/1981 |
HEMASITE VASCULAR ACCESS SHUNT |
RENAL SYSTEMS, INC. |
|
K811524 |
07/01/1981 |
AQUACADE |
RESPIRATORY CARE, INC. |
|
K811795 |
07/28/1981 |
10% NEUTRAL BUFFERED FORMALDEHYDE |
RICHARD-ALLAN MEDICAL IND., INC. |
|
K811794 |
07/28/1981 |
37% FORMALDEHYDE |
RICHARD-ALLAN MEDICAL IND., INC. |
|
K811801 |
07/28/1981 |
CAL-RITE |
RICHARD-ALLAN MEDICAL IND., INC. |
|
K811799 |
07/31/1981 |
CLEAR-MOUNT |
RICHARD-ALLAN MEDICAL IND., INC. |
|
K811798 |
07/28/1981 |
CLEAR-RITE |
RICHARD-ALLAN MEDICAL IND., INC. |
|
K811797 |
07/28/1981 |
EOSIN-Y |
RICHARD-ALLAN MEDICAL IND., INC. |
|
K811793 |
07/31/1981 |
FIX-RIGHT 90ML & 180 ML PREFILLED CONT |
RICHARD-ALLAN MEDICAL IND., INC. |
|
K811796 |
07/28/1981 |
FORMAL ALCOHOL |
RICHARD-ALLAN MEDICAL IND., INC. |
|
K811802 |
07/28/1981 |
HEMATOXYLIN |
RICHARD-ALLAN MEDICAL IND., INC. |
|
K811631 |
07/20/1981 |
THERMOMETER (MADE IN CHINA) |
ROBERT I. CHIEN & ASSOC., INC. |
|
K811704 |
07/01/1981 |
MULTITUBULAR AIR SPLINT KIT |
ROGER CESTAC & ASSOC. |
|
K811750 |
07/20/1981 |
MULTITUBULAR THORACIC AIR SPLINTS |
ROGER CESTAC & ASSOC. |
|
K811714 |
07/10/1981 |
HEP-2-CRITHIDIA LUCILIAE ANA TEST KIT |
SCRIPPS-MILES, INC. |
|
K811847 |
07/13/1981 |
SEA MEDICAL PRODUCTS LO-VOL |
SEA MEDICAL PRODUCTS, INC. |
|
K811555 |
07/01/1981 |
DENTAL FLOSS HOLDER |
SEWON INDUSTRY |
|
K811926 |
07/28/1981 |
SE WON(ALUMINUM) DENTAL FLOSS HOLDER |
SEWON INDUSTRY |
|
K811937 |
07/31/1981 |
ARGYLE TARTAN TRACHEAL TUBE |
SHERWOOD MEDICAL CO. |
|
K812023 |
07/28/1981 |
MONOJECT STERILE M506 6CC SYRINGES |
SHERWOOD MEDICAL CO. |
|
K811587 |
07/10/1981 |
SIEMENS ANGIOTRON |
SIEMENS CORP. |
|
K811715 |
07/20/1981 |
ROTA CAMERA |
SIEMENS GAMMASONICS, INC. |
|
K811887 |
07/27/1981 |
SKIN STAPLE EXTRACTOR |
SIERRA LABORATORIES, INC. |
|
K811784 |
07/27/1981 |
SIGMA PROCEDURE #890 |
SIGMA CHEMICAL CO. |
|
K811864 |
07/31/1981 |
SIGMA PROCEDURE 265-UV |
SIGMA CHEMICAL CO. |
|
K811754 |
07/20/1981 |
CRYSTONA |
SMITH & NEPHEW, INC. |
|
K811849 |
07/15/1981 |
ESKAFLOW TEST FOR GLUCOSE |
SMITH KLINE DIAGNOSTICS, INC. |
|
K811850 |
07/23/1981 |
ESKAFLOW TEST FOR TRIGLYCERIDES |
SMITH KLINE DIAGNOSTICS, INC. |
|
K811623 |
07/02/1981 |
SMR PARAGON CHAIR TABLE |
SMR |
|
K811520 |
07/02/1981 |
GRAYLINE IMAGING SYSTEM |
SONICS RESEARCH CORP. |
|
K812013 |
07/28/1981 |
FLUORESCENT ANTIBODY CONJUGATE FOR GP.A |
SPRINGWOOD MICROBIOLOGICALS |
|
K811702 |
07/16/1981 |
MODEL 381 HOME OXYGEN SENTRY |
STANLEY AVIATION CORP. |
|
K811345 |
07/10/1981 |
INSIGHT |
STAODYNAMICS, INC. |
|
K811861 |
07/16/1981 |
ARTHROSCOPIC LEG HOLDER |
STRYKER CORP. |
|
K811836 |
07/27/1981 |
PO-200 BLOOD OXYGEN MONITOR |
SUMITOMO ELECTRIC INDUSTRIES, INC. |
|
K811889 |
07/24/1981 |
R & S SERIES FITTING TOOLS |
SUNCOAST DENTAL CORP. |
|
K811923 |
07/24/1981 |
R & S SERIES IMPLANTS |
SUNCOAST DENTAL CORP. |
|
K811674 |
07/15/1981 |
DRUG STANDARDS |
SUPELCO, INC. |
|
K811973 |
07/31/1981 |
FORDER RETRACTOR |
SURGEMED MARKETING, INC. |
|
K810689 |
07/28/1981 |
BALLOON CATHETER |
SURGIMED CORP. |
|
K811826 |
07/10/1981 |
EOSIN Y |
SURGIPATH |
|
K811825 |
07/10/1981 |
ORANGE G-6 |
SURGIPATH |
|
K811728 |
07/20/1981 |
CASTLE & RITTER MINOR SURG. & EXAM LT |
SYBRON CORP. |
|
K811817 |
07/15/1981 |
UROPAPER "EIKEN" AG |
SYN-KIT, INC. |
|
K811818 |
07/23/1981 |
UROPAPER "EIKEN" UAG |
SYN-KIT, INC. |
|
K811770 |
07/10/1981 |
EMIT-CAD PROCAINAMIDE ASSAY |
SYVA CO. |
|
K810697 |
07/13/1981 |
AXISONIC II |
TEKNAR, INC. |
|
K811092 |
07/01/1981 |
STERILE PACKAGING |
TELECTRONICS, INC. |
|
K811031 |
07/01/1981 |
TELESONIC & ARCON |
TELESONIC, INC. |
|
K811717 |
07/20/1981 |
GATOR DRAPES |
THE ANSPACH EFFORT, INC. |
|
K811115 |
07/01/1981 |
SUPERFLOW CANNULA FOR ARTHROS. SURGERY |
THE ANSPACH EFFORT, INC. |
|
K811958 |
07/27/1981 |
BOUNDARY REINFORCED OR GOWN |
THE BUCKEYE CELLULOSE CORP. |
|
K811778 |
07/23/1981 |
MODEL 4100 14 MEV NEUTRON GEN. THERAPY |
THE CYCLOTRON CORP. |
|
K811806 |
07/15/1981 |
QUICK-CHEM COLORIMETER |
THE DOW CHEMICAL CO. |
|
K811697 |
07/02/1981 |
GUAMSTAINER |
TOMTEC |
|
K811724 |
07/10/1981 |
2M 9810 MICROWAVE OVEN |
TRAVENOL LABORATORIES, S.A. |
|
K811078 |
07/02/1981 |
RADIATION STERILIZED ADMIN. SET |
TRAVENOL LABORATORIES, S.A. |
|
K811773 |
07/13/1981 |
BACTAGARD |
TRI-MED, INC. |
|
K812057 |
07/31/1981 |
VANCE CYSTOSCOPIC |
VANCE PRODUCTS, INC. |
|
K811833 |
07/10/1981 |
VNACE FASCIAL DILATOR SET |
VANCE PRODUCTS, INC. |
|
K811559 |
07/10/1981 |
VENTRE/SEP IGE RIA TEST SET |
VENTREX LABORATORIES, INC. |
|
K811351 |
07/30/1981 |
VERI-FIER |
VERITE |
|
K811865 |
07/31/1981 |
VMA PEDIATRIC APNEA MATTRESS |
VICKERS AMERICA MEDICAL CORP. |
|
K811751 |
07/15/1981 |
FINETONE MODEL VI HEARING AID |
VICON INSTRUMENT CO. |
|
K811316 |
07/02/1981 |
TRISCAN, MODELS 38,40,41,43 & 45 |
VISIDYNE CORP. |
|
K811963 |
07/16/1981 |
VISITEC NEEDLE RANGE (ANESTHESIOLOGY) |
VISITEC CO. |
|
K811964 |
07/20/1981 |
VISITEC NEEDLE RANGE (CARDIOVASCULAR) |
VISITEC CO. |
|
K811966 |
07/23/1981 |
VISITEC NEEDLE RANGE (GENERAL HOSPITAL) |
VISITEC CO. |
|
K811961 |
07/20/1981 |
VISITEC NEEDLE RANGE (ORTHOPAEDIC) |
VISITEC CO. |
|
K810928 |
07/02/1981 |
ENDOCARDIAL ELECTRODE |
VITATRON MEDICAL BV |
|
K811939 |
07/23/1981 |
VITATRON 88 |
VITATRONICS |
|
K811781 |
07/10/1981 |
TENSIOMETER |
VIVITEK, INC. |
|
K811975 |
07/27/1981 |
MODEL 480 VARIABLE WAVELENGTH ULTRA VIOL |
WATERS ASSOC., INC. |
|
K811450 |
07/02/1981 |
ALUMINUM FILTRATION SYSTEM |
WEDGE FILTRATION SYSTEM |
|
K811857 |
07/10/1981 |
SELECT-A-FLOW |
WENMAR INTL. CORP. |
|
K811772 |
07/15/1981 |
AUDITORY LOCALIZER |
WESTERN ADVANCED TECHNOLOGY, INC. |
|
K811790 |
07/15/1981 |
OCTOTOXIC SCREENER |
WESTERN ADVANCED TECHNOLOGY, INC. |
|
K811563 |
07/28/1981 |
PRESOLDER FOR NON-PRECIOUS DENTAL ALLOYS |
WILLIAMS GOLD REFINING CO., INC. |
|
K811884 |
07/20/1981 |
IVAC 700 SYRINGE INFUSION PUMP |
Y |
|
K812022 |
07/31/1981 |
ZEE MANUAL RESUSCITATOR |
ZEE MEDICAL PRODUCTS CO., INC. |
|