FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
K842044 |
05/21/1984 |
SARNS EVACUPLEGE CATHETER |
3M HEALTH CARE, SARNS |
|
K842786 |
05/22/1984 |
DYNA-LYTE 2000 |
ABBOTT DIAGNOSTICS |
|
K842080 |
05/23/1984 |
ABBOTT LIFECARE 1050 CONTROLLER |
ABBOTT LABORATORIES |
|
K841916 |
05/09/1984 |
ABBOTT PROJECT I |
ABBOTT LABORATORIES |
|
K842016 |
05/18/1984 |
DISPOS. POLY APRONS |
ABCO DEALERS, INC. |
|
K842064 |
05/21/1984 |
ACU-DERM TRANSPARENT IV DRESSING |
ACME UNITED CORP. |
|
K842101 |
05/25/1984 |
COBA AGAR |
ACUMEDIA MANUFACTURERS, INC. |
|
K842100 |
05/25/1984 |
MACCONKEY AGAR, PLUS |
ACUMEDIA MANUFACTURERS, INC. |
|
K842093 |
05/24/1984 |
MK 700 ULTRASOUND SYSTEM |
ADVANCED TECHNOLOGY LABORATORIES, INC. |
FRANCIS G SMITH |
K842104 |
05/25/1984 |
TOYO JOZO G-GTP TEST |
ADVOCACY INTERNATIONAL, LTD. |
RICHARD T NEY |
K842103 |
05/25/1984 |
TOYO JOZO URIC ACID TEST |
ADVOCACY INTERNATIONAL, LTD. |
RICHARD T NEY |
K841912 |
05/09/1984 |
ALPHA 4 X 4 |
ALPHA UNLIMITED, INC. |
|
K841921 |
05/10/1984 |
ALPHA PLUS 1 |
ALPHA UNLIMITED, INC. |
|
K841911 |
05/09/1984 |
ALPHA PUSH KART |
ALPHA UNLIMITED, INC. |
|
K841919 |
05/10/1984 |
ALPHA TRI-KART |
ALPHA UNLIMITED, INC. |
|
K841920 |
05/10/1984 |
MAC-MULTI-ADJUSTABLE CHAIR |
ALPHA UNLIMITED, INC. |
|
K841811 |
05/01/1984 |
BENTLEY-TRANTEC DISPOS. DOMES D-260- |
AMERICAN BENTLEY |
|
K841938 |
05/11/1984 |
CARDIOPLEGIA RESERVOIR CAS-2000 |
AMERICAN BENTLEY |
|
K841812 |
05/01/1984 |
HOLDER FOR BOS-10, 10S 5S |
AMERICAN BENTLEY |
|
K841887 |
05/07/1984 |
PARAMAX IRON BLANK REAGENT |
AMERICAN DADE |
|
K841886 |
05/07/1984 |
PARAMAX IRON REAGENT |
AMERICAN DADE |
|
K841922 |
05/10/1984 |
ACCUPRO VOLUMETRIC INFUSION PUMP W/RS232 |
AMERICAN EDWARDS LABORATORIES |
|
K842105 |
05/25/1984 |
RIGHT VENTRICULAR EJECTION FRACTION- |
AMERICAN EDWARDS LABORATORIES |
HAYIM ZADACA |
K841855 |
05/03/1984 |
AMER. MED. OPTICS ARGON LASER PHOTO |
AMERICAN MEDICAL OPTICS |
|
K841856 |
05/03/1984 |
AMER. MED. OPTICS ARGON/KRYPTON LASER |
AMERICAN MEDICAL OPTICS |
|
K842250 |
05/30/1984 |
AMER. MEDICAL OPTICS ARGON/KRYPTON LASE |
AMERICAN MEDICAL OPTICS |
|
K842251 |
05/30/1984 |
AMERI. MEDICAL OPTICS ARGON LASER PHOTO |
AMERICAN MEDICAL OPTICS |
|
K842127 |
05/29/1984 |
AMERICAN MEDICAL OPTICS IMAGING SYS |
AMERICAN MEDICAL OPTICS |
|
K842128 |
05/29/1984 |
AMERICAN MEDICAL OPTICS PHOTOKERATO |
AMERICAN MEDICAL OPTICS |
|
K841883 |
05/07/1984 |
SURGEON'S BLADES STERILE BLADE |
AN-MED INTL. |
|
K842039 |
05/21/1984 |
ARGON DUAL LUMEN HEMODIALYSIS, CATHETER |
ARGON MEDICAL CORP. |
DAVE BARANSKI |
K841926 |
05/10/1984 |
HYDROGLIDE SPRING GUIDE WIRES |
ARGON MEDICAL CORP. |
VAN HINE |
K842004 |
05/16/1984 |
PERCUTANEOUS CATHETER INTRODUCER SET |
ARIES MEDICAL, INC. |
|
K841907 |
05/08/1984 |
BACTIGEN - N.MENNINIGITIDIS TEST |
ARMKEL, LLC. |
|
K841991 |
05/09/1984 |
ARM-A-CARE HUMIDIFIER-RESPIRATORY GAS |
ARMOUR PHARMACEUTICAL CO. |
|
K841990 |
05/09/1984 |
ARM-A-CARE NEBULIZER-NEBULIZER |
ARMOUR PHARMACEUTICAL CO. |
|
K841989 |
05/09/1984 |
ARM-A-VIAL LV SODIUM CHLORIDE INHALAT |
ARMOUR PHARMACEUTICAL CO. |
|
K841988 |
05/09/1984 |
ARM-A-VIAL LV SODIUM, CHLORIDE INHALAT |
ARMOUR PHARMACEUTICAL CO. |
|
K841987 |
05/02/1984 |
ARM-A-VIAL LV STERIAL WATER FOR INHALA |
ARMOUR PHARMACEUTICAL CO. |
|
K842119 |
05/23/1984 |
OSTOMY OR UROSTOMY ABDOMINAL BELT OS |
ATLAS SURGICAL BELT CO., INC. |
|
K842098 |
05/25/1984 |
RIM H2S |
AUSTIN BIOLOGICAL LABORATORIES |
|
K842097 |
05/25/1984 |
RIM SPOT INDOLE |
AUSTIN BIOLOGICAL LABORATORIES |
|
K842084 |
05/24/1984 |
AXIOM FEMORAL VENUS CATHETER |
AXIOM MEDICAL, INC. |
|
K841999 |
05/16/1984 |
BGM CELL CULTURE AFRICAN GREEN MONKEY |
BARTELS IMMUNODIAGNOSTIC SUPPLIES, INC. |
|
K842151 |
05/30/1984 |
CHLAMYDIAE IMMUNOPEROXIDASE TEST KIT |
BARTELS IMMUNODIAGNOSTIC SUPPLIES, INC. |
|
K841998 |
05/16/1984 |
IMR-90-DIPLOID-HUMAN FETAL LUNG CELL |
BARTELS IMMUNODIAGNOSTIC SUPPLIES, INC. |
|
K842000 |
05/16/1984 |
PRIMARY RABBITT KIDNEY CELL CULTURE |
BARTELS IMMUNODIAGNOSTIC SUPPLIES, INC. |
|
K842018 |
05/18/1984 |
ISO-SEP SYSTEM |
BERWICK MEDICAL PRODUCTS, INC. |
|
K842033 |
05/21/1984 |
ELECTRODE PLACEMENT ARM PART GARMENT |
BIO-STIMU TREND CORP. |
|
K842085 |
05/24/1984 |
AUTOMATED EIA MICROPLATE READER EL310 |
BIO-TEK INSTRUMENTS, INC. |
|
K841831 |
05/03/1984 |
CANNU-SKREEN-PRELIMINARY |
BIOCHEMICAL DIAGNOSTIC, INC. |
|
K841913 |
05/09/1984 |
TEMPTREND PEDS AXILLARY TEMP. INDICATOR |
BIOSYNERGY, INC. |
SHARON B MUIR |
K841950 |
05/04/1984 |
PULSE GENERATOR KALOS-04 |
BIOTRONIK SALES, INC. |
|
K842087 |
05/24/1984 |
BISFIL-I LIGHT CURABLE POSTERIOR COMPO |
BISCO, INC. |
|
K842142 |
05/30/1984 |
BX-400 |
BLOOMEX INTERNATIONAL, INC. |
|
K841813 |
05/01/1984 |
TISSUE INTEGRATED PROSTHESIS DRILL |
BOFORS NOBELPHARMA, INC. |
|
K842137 |
05/30/1984 |
OCCULT BLOOD TEST |
BREIT LABORATORIES, INC. |
|
K841944 |
05/11/1984 |
DISPOSABLE ECG ELECTRODE |
BRISTOL MEDICAL ELECTRONICS CORP. |
MICHAEL R DUPELLE |
K842090 |
05/24/1984 |
RHINO-LARYNX STROBOSCOPE TYPE 4914 |
BRUEL & KJAER INDUSTRI A/S |
|
K841896 |
05/07/1984 |
EZ EYE DROP AID |
BUCKMAN CO., INC. |
PAMELA M BUCKMAN |
K842288 |
05/07/1984 |
EEG 130 |
CALNOR OF EL PASEO, INC. |
|
K842354 |
05/07/1984 |
EMG MODEL 133 |
CALNOR OF EL PASEO, INC. |
|
K841895 |
05/07/1984 |
GSR, 126, EEG 130-TEMP. 132, EMG 133 |
CALNOR OF EL PASEO, INC. |
|
K842353 |
05/07/1984 |
TEMPERATURE 132 |
CALNOR OF EL PASEO, INC. |
|
K842005 |
05/17/1984 |
MODEL 110-5 & 140-8 |
CAMINO LABORATORIES, INC. |
|
K841861 |
05/04/1984 |
CANON AUTOREF R-10 |
CANON U.S.A., INC. |
|
K841880 |
05/07/1984 |
ERYTHROCATH UMBILICAL CATHETER |
CARDIOSEARCH, INC. |
LARRY H BRIM |
K842133 |
05/30/1984 |
EYRTHROCATH DOUBLE-LUMEN CENTRAL VENOUS |
CARDIOSEARCH, INC. |
LARRY H BRIM |
K842147 |
05/30/1984 |
CATH-TECH CHOLANGIOGRAPHY CATHETER |
CATHETER TECHNOLOGY CORP. |
|
K842007 |
05/17/1984 |
CENTRIMED SYSTEM 1 |
CENTRIMED CORP. |
|
K841901 |
05/07/1984 |
OXYMIZER FLOW RESTRICTOR |
CHAD THERAPEUTICS, INC. |
|
K841871 |
05/07/1984 |
LIQUA-SONIC GEL |
CHESTER LABS, INC. |
HOWARD NEWTON |
K842054 |
05/22/1984 |
COBE AEPS |
COBE LABORATORIES, INC. |
|
K842138 |
05/30/1984 |
COBE EMERGENCY POWER SOURCE 43610-000 |
COBE LABORATORIES, INC. |
|
K842083 |
05/23/1984 |
JIMMY JOHN III |
COLON THERAPEUTICS |
JIMMY GIROUARD |
K842107 |
05/29/1984 |
COMBO SKIN TEST READY TO USE TAPE |
COMBION SYSTEMS, INC. |
|
K841964 |
05/14/1984 |
MICRO DELTA & CELTAPRO |
COMPUTER DESIGN & APPLICATIONS, INC. |
|
K842095 |
05/25/1984 |
EPIDURAL TRAYS |
CONCORD LABORATORIES, INC. |
|
K841928 |
05/10/1984 |
COOK PACEMAKER 215 UNIPOLAR CARDIAC- |
COOK PACEMAKER CORP. |
|
K841983 |
05/15/1984 |
COOK PACEMAKER 216 BIPOLAR CARDIAC - |
COOK PACEMAKER CORP. |
|
K842081 |
05/23/1984 |
COOK PACEMAKER CORP. 115 UNIPOLAR CARDI |
COOK PACEMAKER CORP. |
|
K841869 |
05/04/1984 |
COOPER LASERSONICS, 8000 ND.YAGLASER |
COOPER LASERSONICS, INC. |
|
K841819 |
05/02/1984 |
CORPAK FOLEY CATH TRAY W/16FR. TEFLON |
CORPAK CO. |
|
K841908 |
05/08/1984 |
SPECTACLE FRAMES |
COSMAS OPTICAL USA LTD. |
|
K842075 |
05/23/1984 |
CRITIKON I.V. FILTER |
CRITIKON COMPANY,LLC |
|
K841893 |
05/07/1984 |
MAXAMAN |
CRYO2 CORP. |
|
K841808 |
05/01/1984 |
STROLLER SPRINT |
CRYOGENIC ASSOC. |
|
K842067 |
05/23/1984 |
CALCULATING CUFF INFLATOR TD312 |
D. E. HOKANSON, INC. |
EUGENE HOKANSON |
K841858 |
05/04/1984 |
SPIROLOOP |
DATAMED, INC. |
|
K841878 |
05/07/1984 |
SHEATH REMOVER |
DATASCOPE CORP. |
|
K842139 |
05/30/1984 |
THE DENVER PLEURAL-PERITONEAL SHUNT |
DENVER BIOMEDICALS, INC. |
|
K842160 |
05/30/1984 |
CHOLESTEROL ASSSAY KIT |
DIAGNOSTIC CHEMICALS, LTD. (USA) |
|
K842159 |
05/30/1984 |
CREATININE ASSAY KIT-KINETIC OR ENDPOINT |
DIAGNOSTIC CHEMICALS, LTD. (USA) |
|
K841930 |
05/10/1984 |
ENZYMATIC ACETAMINOPHEN ASSAY |
DIAGNOSTIC CHEMICALS, LTD. (USA) |
|
K842158 |
05/30/1984 |
SALICYLATE ASSAY KIT |
DIAGNOSTIC CHEMICALS, LTD. (USA) |
KAREN MCMAHON |
K842155 |
05/30/1984 |
SERUM IRON & SERUM IRON BINDING CAPACI |
DIAGNOSTIC CHEMICALS, LTD. (USA) |
|
K842156 |
05/30/1984 |
SERUM IRON & SERUM IRON BINDING CAPACITY |
DIAGNOSTIC CHEMICALS, LTD. (USA) |
|
K842157 |
05/30/1984 |
TRIGLYCERIDE ASSAY KIT-COLORIMETRIC |
DIAGNOSTIC CHEMICALS, LTD. (USA) |
|
K842099 |
05/25/1984 |
ACTH STANDARD MATRIX |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
|
K841925 |
05/10/1984 |
DSL FERRITIN IRMA |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
|
K841809 |
05/01/1984 |
COUNT-A-PART PLUS |
DIAGNOSTIC TECHNOLOGY, INC. |
ROBERT E LIND |
K842140 |
05/30/1984 |
PICOSCAL BLOOD CELL COUNTER PS-4 |
DIAGNOSTIC TECHNOLOGY, INC. |
|
K841827 |
05/03/1984 |
ENTEROPORT NUTRITION PUMP |
DIATEK, INC. |
|
K841859 |
05/04/1984 |
SECURA SET |
DIATEK, INC. |
|
K842086 |
05/24/1984 |
SPOTTEST LACTOPHENOL COTTON BLUE STAIN |
DIFCO LABORATORIES, INC. |
|
K842121 |
05/29/1984 |
E-Z-EM SINGLE STICK PUNCTURE/DRAINAGE |
E-Z-EM, INC. |
|
K841955 |
05/14/1984 |
DUPONT ACA MAGNESIUM CALIBRATOR |
E.I. DUPONT DE NEMOURS & CO., INC. |
|
K842019 |
05/18/1984 |
TIBC PRETREATMENT KIT |
E.I. DUPONT DE NEMOURS & CO., INC. |
|
K841884 |
05/07/1984 |
KODAK EKTACHEM CONTROL |
EASTMAN KODAK COMPANY |
|
K841881 |
05/07/1984 |
EASY EYES TM LENS CARRYING CASE |
EATON MEDICAL CORP. |
ANTHONY J MORAVEC |
K842022 |
05/18/1984 |
EEG BIOFEEDBACK DEVICE |
ELECTRONICS RESEARCH & PRODUCTION |
|
K842021 |
05/18/1984 |
EEG BIOFEEDBACK DEVICE ACCESSORY |
ELECTRONICS RESEARCH & PRODUCTION |
|
K842023 |
05/18/1984 |
TEMP. & GSR BIOFEEDBACK DEVICE |
ELECTRONICS RESEARCH & PRODUCTION |
|
K842124 |
05/29/1984 |
EMG MODULE, EMG1, W/OPTIONAL SPEAKER |
ENDOTEK CORP. |
|
K842108 |
05/29/1984 |
UNIVERSAL EXAMINATION TABLE |
ENGINEERING DYNAMICS CORP. |
|
K842048 |
05/22/1984 |
SUN-ONE |
ENSUN MEDICAL PRODUCTS, INC. |
ALLEN KEARNS |
K841805 |
05/01/1984 |
OBSTETRICAL DOPPLER |
EPCOM MEDICAL SYSTEMS, INC. |
|
K841951 |
05/14/1984 |
MICROSURGICAL KNIFE |
ETHICON, INC. |
|
K841830 |
05/03/1984 |
ULTRA-LITE PREMIER |
EVEREST & JENNINGS, INC. |
|
K841994 |
05/15/1984 |
EZY-RAMP |
EZY-RAMP CO. |
|
K842024 |
05/18/1984 |
ULTRASONIC LITHOTRIPTOR 300A |
FIBRA SONICS, INC. |
KIRCHSCHLAGER |
K842049 |
05/22/1984 |
FLUOROSKAN |
FLOW LABORATORIES, INC. |
GERALD A HAHN |
K841903 |
05/07/1984 |
FRASER HARLAKE EMERG. CARE SUCTION SYS |
FRASER HARLAKE, INC. |
|
K841909 |
05/09/1984 |
VAGINAL SPECULUM - DISPOSABLE |
GALENICA ENTERPRISES, INC. |
|
K842052 |
05/22/1984 |
GIARDIA GUARD |
GELMAN SCIENCES, INC. |
|
K841997 |
05/16/1984 |
CT 9800 |
GENERAL ELECTRIC CO. |
|
K841906 |
05/08/1984 |
MAXICAMERA 400 AC |
GENERAL ELECTRIC CO. |
|
K841996 |
05/16/1984 |
MAXICAMERA 400T W/BODY CONTOUR TOMOGRA |
GENERAL ELECTRIC CO. |
|
K841852 |
05/03/1984 |
AUTOLYZER 800 |
GEOMETRIC DATA, DIV. SMITHKLINE CORP. |
|
K842036 |
05/21/1984 |
BIPHASIC BLOOD CULTURE BOTTLE |
GIBCO LABORATORIES LIFE TECHNOLOGIES, INC. |
|
K841943 |
05/11/1984 |
GIBCO HERPES ID KIT |
GIBCO LABORATORIES LIFE TECHNOLOGIES, INC. |
BRUCE H NICHOLS |
K842135 |
05/30/1984 |
HI-LO FLOOR STANDING EXAM. LIGHT |
GOOD-LITE CO. |
|
K842096 |
05/25/1984 |
GLB VARICELLA-ZOSTER VIRUS FLUORESCENT |
GREAT LAKES BIOSCIENCE |
WAYNE E GLEIBER |
K841957 |
05/14/1984 |
BOVINE FACTOR XA-HUMAN FACTOR XA |
HAEMACHEM, INC. |
|
K841956 |
05/14/1984 |
BOVINE THROMBIN, HUMAN THROMBIN |
HAEMACHEM, INC. |
|
K841818 |
05/01/1984 |
IMPULSE VENTILATOR |
HEALTHDYNE, INC. |
|
K842025 |
05/18/1984 |
ION 4 SODIUM/POTASSIUM/CHLORIDE/TOTAL |
HI CHEM, INC. |
|
K842026 |
05/18/1984 |
H-TYPE BRIDGE REMOVER |
HIGA MANUFACTURING LTD. |
|
K841931 |
05/11/1984 |
DISPO. AES DISPOS. SYRINGE W/NEEDLE |
HIRSCH CHEMIE LTD. |
|
K841851 |
05/03/1984 |
HPD HUMIDIFIER WICK |
HPD MEDICAL, INC. |
|
K842079 |
05/23/1984 |
GASTRIN 34 HORMONE BY RADIOUMMUNOASSAY |
IMMUNO NUCLEAR CORP. |
|
K842110 |
05/29/1984 |
SLIDE PREGNANCY TEST |
IMMUNOSTICS CO., INC. |
|
K842050 |
05/22/1984 |
IMPACT MODEL 316 |
IMPACT INSTRUMENTATION, INC. |
|
K841865 |
05/04/1984 |
INNOFLOUR GENTAMICIN |
INNOTRON DIAGNOSTICS |
|
K841866 |
05/04/1984 |
INNOFLOUR TOBRAMYCIN |
INNOTRON DIAGNOSTICS |
|
K842077 |
05/23/1984 |
MIDAS II AUTOMATIC STAINER |
INNOVATIVE MEDICAL SYSTEMS, INC. |
|
K842051 |
05/22/1984 |
EKG TRANSMITTER MODEL 5134 |
INSTROMEDIX, INC. |
SEMLER |
K842042 |
05/21/1984 |
IL 1312, PH BLOOD GAS MANAGER |
INSTRUMENTATION LABORATORY CO. |
|
K842166 |
05/31/1984 |
INTERMED, INS STERILE WATER/SALINE |
INTERMED, INC. |
NORMAN T RUEDT |
K842070 |
05/23/1984 |
IDD DETERGENT |
INTERSCIENCE DIAGNOSTICS, INC. |
|
K842068 |
05/23/1984 |
IDI ISOTONIC DILUENT |
INTERSCIENCE DIAGNOSTICS, INC. |
|
K842069 |
05/23/1984 |
IDL-LYSING REAGENT |
INTERSCIENCE DIAGNOSTICS, INC. |
|
K842071 |
05/23/1984 |
FIAX TRANSFERRIN TEST KIT |
INTL. DIAGNOSTIC TECHNOLOGY |
|
K841853 |
05/03/1984 |
PREG-BETA ONE HOUR TUBE TEST |
INTL. DIAGNOSTIC, INC. |
|
K841953 |
05/14/1984 |
ULTRA SHIELD BRIEFS |
IPCO CORP. |
|
K842072 |
05/23/1984 |
L-ALANINE-4-NITROANILIDE |
IRVINE DIAGNOSTIC SERVICES |
|
K842152 |
05/30/1984 |
SICKLING HEMOGLOBIN CONTROLS, NORMAL |
ISOLAB, INC. |
|
K841849 |
05/03/1984 |
ISOSTATION SHOULDER MACHINE |
ISOTECHNOLOGIES, INC. |
|
K842111 |
05/29/1984 |
KOGAN ENDOSPECULUM 9-1/2 |
J. SKLAR MFG. CO., INC. |
|
K842112 |
05/29/1984 |
TISCHLER CERVICAL BIOPSY PUNCH FORCEPS |
J. SKLAR MFG. CO., INC. |
|
K842009 |
05/17/1984 |
ABDOMINAL PARACENTESIS TRAY |
JAYCO PHARMACEUTICALS |
LESTER J LIFTON |
K842001 |
05/16/1984 |
LIVER BIOPSY TRAY |
JAYCO PHARMACEUTICALS |
|
K841807 |
05/01/1984 |
OPERAID NUCLEUS |
JEDMED INSTRUMENT CO. |
ELI SCHACHET |
K842078 |
05/23/1984 |
JOHNSON & JOHNSON FLAVORED ETCHING GEL |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
|
K842125 |
05/29/1984 |
ALLERCOAT ALLERGEN DISCS |
KALLESTAD LABORATORIES, INC. |
|
K841864 |
05/04/1984 |
QUANTIMETRIC TM 2 KAPPA & LAMBDA KIT |
KALLESTAD LABORATORIES, INC. |
|
K841822 |
05/02/1984 |
KEYMED SIGMOIDOSCOPE SUCTION UNIT |
KEYMED, INC. |
|
K842168 |
05/31/1984 |
ATAGO URINE SPECIFIC GRAVITY & SERUM |
KYOTO DIAGNOSTICS, INC. |
|
K842122 |
05/29/1984 |
4A |
LIFE PRODUCTS, INC. |
DOUGLAS BARNES |
K842037 |
05/11/1984 |
LS 5 |
LIFE SCIENCE INSTRUMENTATION, INC. |
WILLIAM H FLEMING |
K841929 |
05/10/1984 |
LIFEMED LIFECOIL CATHETERS |
LIFEMED OF CALIFORNIA |
|
K842028 |
05/18/1984 |
CM-TRISACRYL M DEAE-TRISACRYL M |
LKB INSTRUMENTS, INC. |
|
K842056 |
05/22/1984 |
ELVI 165 PROTEO SEROSKOP |
LOGOS SCIENTIFIC, INC. |
|
K841804 |
05/01/1984 |
ELVI 70 SAFETY CHAMBER |
LOGOS SCIENTIFIC, INC. |
|
K842102 |
05/25/1984 |
LORAD |
LORAD MEDICAL SYSTEMS, INC. |
|
K842011 |
05/17/1984 |
CHLORIDE TEST KIT |
MALLINCKRODT CRITICAL CARE |
|
K841872 |
05/07/1984 |
UNCUFFED REINFORCED TRACHEAL TUBE |
MALLINCKRODT CRITICAL CARE |
|
K842008 |
05/17/1984 |
MARQUEST MICRO STIK 9000 SERIES |
MARQUEST MEDICAL PRODUCTS, INC. |
|
K841810 |
05/01/1984 |
MARK5 ARTERIAL BLOOD GAS KIT |
MARTELL MEDICAL PRODUCTS, INC. |
|
K841882 |
05/07/1984 |
THREE WAY INFUSION SET |
MED FUSION SYSTEMS, INC. |
|
K841803 |
05/01/1984 |
A1 SYSTEME 8201/2 |
MED USA |
JAMES R RUNDELL |
K841949 |
05/14/1984 |
DOSE RELEASE OF STERILIZATION LOTS |
MEDCARE DISP PRODUCTS, INC. |
|
K842143 |
05/30/1984 |
BENT WINGED MINI-VOL INFUSION SET |
MEDFUSION SYSTEMS, INC. |
|
K842136 |
05/30/1984 |
STERILE PAN SET |
MEDI-PLAST INTL., INC. |
|
K842076 |
05/23/1984 |
MIC GASTROSTOMY TUBE |
MEDICAL INNOVATIONS CORP. |
|
K841879 |
05/07/1984 |
LFT - 212 |
MEDICAL MONITORING SYSTEMS, INC. |
|
K841862 |
05/04/1984 |
IMMU-TEC |
MEDILAB CORP. |
|
K841863 |
05/04/1984 |
MONO-TEC |
MEDILAB CORP. |
|
K842065 |
05/22/1984 |
EPICARDIAL, UNIPOLAR LEAD 4951 |
MEDTRONIC VASCULAR |
EDWARD W NUMAINVILL |
K842032 |
05/18/1984 |
MODELS 4012/4512 TRANSVENOUS TINED- |
MEDTRONIC VASCULAR |
|
K842145 |
05/30/1984 |
TRANSVENOUS TINED VENTRICULAR LEAD |
MEDTRONIC VASCULAR |
EDWARD W NUMAINVILL |
K842031 |
05/18/1984 |
TRANSVENOUS TINED VENTRICULAR/ATRIAL |
MEDTRONIC VASCULAR |
EDWARD W NUMAINVILL |
K842014 |
05/18/1984 |
HOSPITAL'S-SPEC |
MEREX CO. |
|
K842129 |
05/29/1984 |
LYFO-DISK MICROORGANISMS |
MICRO-BIO-LOGICS |
|
K842006 |
05/17/1984 |
CITOJECT CARTRIDGE SYRINGE |
MILES LABORATORIES, INC. |
|
K841815 |
05/01/1984 |
OPTIMATE IGA TEST |
MILES LABORATORIES, INC. |
|
K841816 |
05/01/1984 |
OPTIMATE IGG TEST |
MILES LABORATORIES, INC. |
|
K841814 |
05/01/1984 |
OPTIMATE IGM TEST |
MILES LABORATORIES, INC. |
|
K842092 |
05/24/1984 |
SERALYZER ARIS PHENYTOIN REAGENT STRIPS |
MILES LABORATORIES, INC. |
H ENGELMANN |
K842150 |
05/30/1984 |
TRANSDUCER-MONITOR INTERFACING |
MILLAR INSTRUMENTS, INC. |
HUNTLY D MILLAR |
K841801 |
05/01/1984 |
DENTURE CLEANSER |
MIRACLE CLEAN, INC. |
|
K842130 |
05/30/1984 |
G.I. CLEANSING KIT |
MMI, INC. |
MARTIN MATTLER |
K841877 |
05/07/1984 |
EEG ELECTRODE PAD |
NEUROLOGICS, INC. |
|
K841952 |
05/14/1984 |
MULTI-PURPOSE TASK SUPPORT TABLE |
NEUTRAL POS-CHAIR CO. |
|
K842030 |
05/18/1984 |
NEUTRAL POS-CHAIR SURGEON CHAIR |
NEUTRAL POS-CHAIR CO. |
|
K842010 |
05/17/1984 |
THYROXINE-BINDING GLOBULIN RADIOUMMU |
NICHOLS INSTITUTE DIAGNOSTICS |
|
K841828 |
05/03/1984 |
CENTRAL VENOUS CATHETER W/BIG-GARD |
NORTON PERFORMANCE PLASTICS CORP. |
|
K842003 |
05/16/1984 |
OHIO WASTE GAS SCAVENGING INTERFACE |
OHIO MEDICAL PRODUCTS |
|
K842154 |
05/30/1984 |
PACKETS FOR THE PREP OF DIALYSATES & |
ORGANON TEKNIKA CORP. |
|
K842047 |
05/21/1984 |
ORTHO* RSV ANTIGEN ELISA TEST SYS |
ORTHO DIAGNOSTIC SYSTEMS, INC. |
|
K842163 |
05/30/1984 |
RIDGEMATRIX 20/40 MESH, PERIOMATRIX |
ORTHOMATRIX, INC. |
|
K842074 |
05/23/1984 |
EARETTE HEARING AID OTICON E30V |
OTICON CORP. |
|
K842073 |
05/23/1984 |
EARETTE HEARING AID OTICON E31V |
OTICON CORP. |
|
K841885 |
05/07/1984 |
FASTPASS IMPLANTABLE ENDOCARDIAL PAC |
PACESETTER SYSTEMS |
|
K842141 |
05/30/1984 |
SOLUTION CLARIFICATION UNIT |
PALL BIOMEDICAL PRODUCTS CO. |
|
K841826 |
05/02/1984 |
NATURA-DENT VACUUM-FIRED PORCELAIN TEETH |
PAREXEL INTL. CORP. |
|
K842123 |
05/29/1984 |
PERSONAL CL SINGLE-CHANNEL ELECTROCAR |
PAREXEL INTL. CORP. |
ANNE B SAYIGH |
K841968 |
05/15/1984 |
DESERET DISPOSABLE PRESSURE TRANSDUCER |
PARKE-DAVIS CO. |
|
K841967 |
05/15/1984 |
DESERET THERMODILUTION CARDIAC OUTPUT |
PARKE-DAVIS CO. |
|
K841867 |
05/04/1984 |
KIDD VAGINAL SPECULUM |
PAUL H. SCHNEIDER ENT. |
|
K842058 |
05/22/1984 |
HEMODIALYSIS BATH CONCENTRATE SOLUTION |
PHARMACEUTICAL DEVELOPMENT SYSTEMS |
|
K841829 |
05/03/1984 |
PHADEBAS RAST PHADEZYM RAST ALLERGEN |
PHARMACIA, INC. |
|
K841915 |
05/09/1984 |
PHAMAS ALLERGY MGMT. SYSTEM |
PHARMACIA, INC. |
|
K841824 |
05/02/1984 |
PHARMACIA IGE RIA |
PHARMACIA, INC. |
|
K842055 |
05/22/1984 |
PICKER ARTIS ULTRASOUND IMAGING SYS |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
|
K841874 |
05/07/1984 |
MEGA PULSE THERAPY UNIT |
PHYSIO TECHNOLOGY, INC. |
|
K841875 |
05/07/1984 |
HEART-CHECK ECG TRANSMITTER |
PHYSIO VENTURES, INC. |
|
K841937 |
05/11/1984 |
CODE-A-WELL SERIES 300 PLATE |
PLASTIC INJECTORS, INC. |
|
K842057 |
05/22/1984 |
MACLEAN-FOGG, DISPOS-INOCULA-LOOPS |
POLYMER TECHNOLOGY CORP. |
|
K841954 |
05/14/1984 |
OASIS CLUB HYDROMASSAGE |
PREXCOR AMERICA, INC. |
|
K842173 |
05/15/1984 |
DISPOSABLE STOPCOCKS |
PROCEDURE PRODUCTS, INC. |
|
K842149 |
05/30/1984 |
PMS SUTURE PACK/TRAY;VERTEX SUTURE |
PROFESSIONAL MEDICAL SERVICES |
|
K841986 |
05/15/1984 |
PROTOMED/TOWIC NASOGASTRIC TUBE DRAINAGE BAG |
PROTOMED CORP. |
TOWIC MEDICAL |
K841995 |
05/15/1984 |
10.5 FRENCH DILATOR, 15CM, W/LUER LOCK |
QUINTON, INC. |
|
K841933 |
05/11/1984 |
RADIOEAR M420H |
RADIOEAR CORP. |
|
K841934 |
05/11/1984 |
RADIOEAR M430 PP |
RADIOEAR CORP. |
|
K841892 |
05/07/1984 |
RAICHEM BILIRUBIN REAGENT TOTAL/DIRECT |
REAGENTS APPLICATIONS, INC. |
|
K842029 |
05/18/1984 |
TRIGLYCERIDES-GPO REAGENT |
REAGENTS APPLICATIONS, INC. |
|
K841900 |
05/07/1984 |
FIRST RESPONSE EMERG. EYE INJURIES |
REED PRODUCTS, INC. |
|
K841899 |
05/07/1984 |
FIRST RESPONSE EMERG. MEDICAL SYS BONES |
REED PRODUCTS, INC. |
|
K841897 |
05/07/1984 |
FIRST RESPONSE EMERG. MEDICAL SYSTEM |
REED PRODUCTS, INC. |
|
K841898 |
05/07/1984 |
FIRST RESPONSE EMERG. MEDICSL - BURNS |
REED PRODUCTS, INC. |
|
K841935 |
05/11/1984 |
RIONET HEARING AID HI-03 |
RION ACOUSTIC INSTRUMENTS, INC. |
|
K842131 |
05/30/1984 |
FORMACLEAR- & MULTIPLE |
RNA MEDICAL CORP. |
|
K842015 |
05/18/1984 |
SAWYER FIRST AID KIT |
SAFFETA, INC. |
|
K841961 |
05/14/1984 |
MILLS OPERATIVE PERIPHERAL ANGIOPLASTY |
SCIMED LIFE SYSTEMS, INC. |
MICHAEL T FRANKENBE |
K842041 |
05/21/1984 |
PULMONARY FUNCTION SYSTEM |
SENSOR MEDICS CORP. |
|
K842053 |
05/22/1984 |
PARAPLAST EXTRA TISSUE EMBEDDING MED. |
SHERWOOD MEDICAL CO. |
|
K841905 |
05/07/1984 |
DOT-A, DOT-AR PXP-E, PXP-ER |
SIEMENS GAMMASONICS, INC. |
|
K841868 |
05/04/1984 |
MINGOGRAF 7 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
JOERGEN ANDERSON |
K842002 |
05/16/1984 |
HANKS BALANCED SALTS-HBSS H2387 |
SIGMA CHEMICAL CO. |
|
K842146 |
05/30/1984 |
HISTOPAQUE-1077 |
SIGMA CHEMICAL CO. |
|
K842013 |
05/17/1984 |
SIGMA PROCEDURE 47-UV |
SIGMA CHEMICAL CO. |
|
K841918 |
05/09/1984 |
SIGMA PROCED. 245 ALKALINE PHOSPHATASE |
SIGMA DIAGNOSTICS, INC. |
|
K841917 |
05/09/1984 |
SIGMS PROCED. 228 UV LACTATE DEHYDRO |
SIGMA DIAGNOSTICS, INC. |
|
K842134 |
05/30/1984 |
SOMAS COOMASIE BLUE TOTAL PROTEIN ASSAY |
SOMAS MEDICAL INDUSTRIES, INC. |
|
K841947 |
05/14/1984 |
ESTRADIOL DIRECT RADIOIMMUNOASSAY KIT |
SORIN BIOMEDICA, FIAT, USA, INC. |
|
K841948 |
05/14/1984 |
TESTOSTERONE DIRECT RADIOIMMUNOASSAY |
SORIN BIOMEDICA, FIAT, USA, INC. |
|
K842106 |
05/25/1984 |
LEE BONE MARROW NEEDLES |
SOUTHLAND INSTRUMENTS, INC. |
PETER F LEE |
K841971 |
05/14/1984 |
2.5MM & 4MM PROBE K841969-LABELING |
STAINLESS MFG., INC. |
|
K841981 |
05/14/1984 |
4MM & 5MM FILE |
STAINLESS MFG., INC. |
|
K841979 |
05/14/1984 |
4MM CUP CURRETTE |
STAINLESS MFG., INC. |
|
K841977 |
05/14/1984 |
5MM DOUGLE EDGE RING CURETTE |
STAINLESS MFG., INC. |
|
K841969 |
05/14/1984 |
6.5MM HEX HANDLE |
STAINLESS MFG., INC. |
|
K841972 |
05/14/1984 |
BANANA KNIFE - K841969-LABELING |
STAINLESS MFG., INC. |
|
K841973 |
05/14/1984 |
BANANA KNIFE SERRATED |
STAINLESS MFG., INC. |
|
K841970 |
05/14/1984 |
CAMELBACK HANDLE-K841969-LABELING |
STAINLESS MFG., INC. |
|
K841976 |
05/14/1984 |
HOOK KNIFE 4MM & 5MM |
STAINLESS MFG., INC. |
|
K841978 |
05/14/1984 |
LATERAL RELEASE KNIFE 5MM & 7MM |
STAINLESS MFG., INC. |
|
K841982 |
05/14/1984 |
MENISCOTOME 4MM & 5MM |
STAINLESS MFG., INC. |
|
K841974 |
05/14/1984 |
RETROGRADE KNIFE 4MM & 5MM |
STAINLESS MFG., INC. |
|
K841975 |
05/14/1984 |
ROSETTE KNIFE 4MM |
STAINLESS MFG., INC. |
|
K841980 |
05/14/1984 |
SIDE CUTTING SERRATED BLADE |
STAINLESS MFG., INC. |
|
K842120 |
05/29/1984 |
ZERO-G |
STERIDYNE CORP. |
|
K841850 |
05/03/1984 |
CUSTOM STERILE PROCEDURE TRAYS-MULTI |
STERILCO, INC. |
|
K841959 |
05/14/1984 |
CARDIO METRIC CUSTOM PERFUSION TUBING |
STERILE DESIGN, INC. |
JOHN C HOFFMAN |
K841958 |
05/14/1984 |
CARDIO METRICS CARDIOTOMY RESERVOIR |
STERILE DESIGN, INC. |
JOHN C HOFFMAN |
K841960 |
05/14/1984 |
CARDIO METRICS INVASIVE PRESSURE MONIT |
STERILE DESIGN, INC. |
|
K842017 |
05/18/1984 |
PARA 4 |
STRECK LABORATORIES, INC. |
|
K841945 |
05/11/1984 |
ENTERAL FEEDING BOTTLE |
SUPERIOR PLASTIC PRODUCTS CORP. |
|
K841910 |
05/09/1984 |
KERR SEALAPEX ROOT CANAL SEALER |
SYBRON CORP. |
|
K842132 |
05/30/1984 |
TYCOS SELF-CHECK/DIGITAL FEVER THERMO |
SYBRON CORP. |
|
K841854 |
05/03/1984 |
BHCG RIA |
SYNCOR INTL. CORP. |
|
K841963 |
05/14/1984 |
GASTRIN RIA |
SYNCOR INTL. CORP. |
|
K841927 |
05/10/1984 |
T3 UPTAKE |
SYNCOR INTL. CORP. |
|
K842167 |
05/31/1984 |
TBG RIA |
SYNCOR INTL. CORP. |
|
K841984 |
05/15/1984 |
AUTOFLOUR III SYSTEM |
TECH AMERICA DIAGNOSTICS |
JUDITH A GAWARECKI |
K841817 |
05/01/1984 |
TECHNICARE 248 SL & 260SL |
TECHNICARE CORP. |
|
K842109 |
05/29/1984 |
TECHNICON TEST POINT ASSAYED HEMATOLOGY |
TECHNICON INSTRUMENTS CORP. |
|
K841832 |
05/03/1984 |
GLOTTAL FREQUENCY ANALYSER |
TELTEC ELECTRONIC EQUIPMENT AB |
|
K842091 |
05/24/1984 |
DISPOS. ACU-CUT SOFT TISSUE BIOPSY |
THE HEALTHCARE GROUP LABORATORIES, INC. |
|
K842170 |
05/24/1984 |
EMPTY SOLUTION TRANSFER CONTAINER |
THE HEALTHCARE GROUP LABORATORIES, INC. |
PHIL RALSTON |
K841616 |
05/01/1984 |
TIMEX HEALTHCHECK DIGITAL BP MONITOR |
TIMEX MEDICAL PRODUCTS CORP. |
|
K841923 |
05/10/1984 |
DCX-100 CHEST UNIT-GL-5000M |
TRANSWORLD X-RAY CORP. |
|
K841821 |
05/02/1984 |
CA-1511, IN VITRO RADIOIMMUNOASSAY |
TRAVENOL LABORATORIES, S.A. |
|
K842012 |
05/17/1984 |
UMI CURVED CHEMONUCLEOLYSIS NEEDLE |
UNIVERSAL MEDICAL INSTRUMENT CORP. |
|
K841942 |
05/11/1984 |
SEGURA BASKET |
VAN-TEC, INC. |
|
K841941 |
05/11/1984 |
VAN-TEC OCCLUSION BALLOON CATHETER |
VAN-TEC, INC. |
|
K841940 |
05/11/1984 |
VAN-TEC URETERAL DILATION BALLOON CATH |
VAN-TEC, INC. |
|
K841890 |
05/07/1984 |
VARIAN 2000 LIQUID CHROMATOGRAPHY ANALY |
VARIAN ASSOC., INC. |
|
K841891 |
05/07/1984 |
VARIAN 3300 & 3400 GAS CHROMATOGRAPHS |
VARIAN ASSOC., INC. |
|
K841993 |
05/15/1984 |
HL-1, DEFINED SERUM FREE MEDIA |
VENTREX LABORATORIES, INC. |
|
K842161 |
05/30/1984 |
VENTREZYME PHENYTOIN KIT IMMUNOASSAY |
VENTREX LABORATORIES, INC. |
|
K842088 |
05/24/1984 |
FLU MET 2 |
VENUSA LTD. |
|
K841806 |
05/01/1984 |
WI-38 |
VIROMED LABORATORIES, INC. |
|
K841894 |
05/07/1984 |
VMT HAND HELD NEBULIZER |
VORTRAN MEDICAL TECHNOLOGY 1, INC. |
|
K842144 |
05/30/1984 |
GORE-TEX VASCULAR GRAFT, FEP-RINGED |
W.L. GORE & ASSOCIATES,INC |
|
K841795 |
05/02/1984 |
UV 8001K, PUVA 800, PUVA 180/200 1000 |
WALDMANN LIGHTING CO. |
|
K841876 |
05/07/1984 |
POLYURETHANE THERMAL DILUTION CATHET |
WATERS INSTRUMENTS, INC. |
|
K841802 |
05/01/1984 |
ELECTRODE CATHETER, ORTHOGONAL TYPE |
WEBSTER LABORATORIES, INC. |
JIM TYBERG |
K841794 |
05/02/1984 |
SUNGLASSES |
WHOLE SALE IMPORTERS |
|
K842045 |
05/21/1984 |
WOODLYN CLASSIC EXAM. CHAIR |
WOODLYN, INC. |
|
K842153 |
05/30/1984 |
ULTRASOUND TRANSMISSION GEL |
WPC BRANDS, INC. |
|
K842094 |
05/25/1984 |
XMC-S TUBESTAND XMT-S TABLE XMH-NTWALL |
X-RAY MFG. & SALES, INC. |
|
K841860 |
05/04/1984 |
CO2 SURGICAL LASER SYSTEM XML-10 |
XANAR, INC. |
DALTON |
K842027 |
05/18/1984 |
IVAC 3080 ENTERAL FEEDING PUMP |
Y |
|
K841825 |
05/02/1984 |
SCOPE LIGHT |
ZINNANTI SURGICAL INSTRUMENTS, INC. |
|