FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
K822519 |
10/13/1982 |
HAWKINS EBA -16 MUSCLE STIMULATOR |
A-ZENITH THERAPEUTIC EQUIPMENT/SUPPLY |
|
K822720 |
10/08/1982 |
MODEL 340 SPECTROPHOTOMETER |
ABBOTT DIAGNOSTICS |
|
K822759 |
10/21/1982 |
ABBOTT LABORATORIES PROLACTIN EIA |
ABBOTT LABORATORIES |
|
K822658 |
10/21/1982 |
EXTENSION SET TYPE DP |
ABBOTT LABORATORIES |
|
K822241 |
10/26/1982 |
FOLATE/B12 DUO-BEAD RADIOASSAY |
ABBOTT LABORATORIES |
|
K822827 |
10/27/1982 |
HISH EIA DIAGNOSTIC KIT |
ABBOTT LABORATORIES |
|
K822712 |
10/21/1982 |
INPERSOL-CAPD ADMINIS. SET TYPE DP |
ABBOTT LABORATORIES |
|
K822808 |
10/08/1982 |
TDX KENAMYCIN |
ABBOTT LABORATORIES |
|
K822398 |
10/04/1982 |
ACKRAD BRONCHITRAC |
ACKRAD LABORATORIES |
|
K822865 |
10/18/1982 |
SURGI-SCRUB V |
ACME UNITED CORP. |
|
K822439 |
10/13/1982 |
ACUFEX MAGNETIC RETRIEVER |
ACUFEX MICROSURGICAL, INC. |
|
K822862 |
10/18/1982 |
BRACHIAL CORONARY GUIDING CATHETER |
ADVANCED CARDIOVASCULAR SYSTEMS, INC. |
|
K822707 |
10/18/1982 |
CLEAN-N-SOAK |
ALLERGAN, INC. |
|
K822706 |
10/22/1982 |
PRE-SERT |
ALLERGAN, INC. |
|
K822850 |
10/27/1982 |
MONI-TRO ES CHEMISTRY CONTROL LEVEL IX |
AMERICAN DADE |
|
K822941 |
10/26/1982 |
NETILMICIN FLUORESCENT IMMUNOASSAY |
AMERICAN DIAGNOSTIC CORP. |
|
K822687 |
10/04/1982 |
REUSABLE FOGARTY FLEXIBLE CALIBRATOR |
AMERICAN EDWARDS LABORATORIES |
|
K822723 |
10/15/1982 |
SWAN-GANZ BIPOLAR PACING CATHETER |
AMERICAN EDWARDS LABORATORIES |
|
K822993 |
10/26/1982 |
SENATEK |
AMERICAN HEALTH TECH., INC. |
|
K822754 |
10/04/1982 |
EAR/ULCER SYRINGE |
AMERICAN HOSPITAL SUPPLY CORP. |
|
K822551 |
10/13/1982 |
AMP CAPD UNISPIKE AMINISTRATION SET |
AMERICAN MEDICAL PRODUCTS, INC. |
JOSEPH J BUTLER |
K822543 |
10/13/1982 |
CAPD SAFE LOCK TRANSFER SET |
AMERICAN MEDICAL PRODUCTS, INC. |
JOSEPH J BUTLER |
K822545 |
10/13/1982 |
CCPD CYCLER SET W/5 PRONGED CONNECTOR |
AMERICAN MEDICAL PRODUCTS, INC. |
JOSEPH J BUTLER |
K822549 |
10/13/1982 |
CCPD CYCLER SET W/5 PRONGED SAFE LOCK |
AMERICAN MEDICAL PRODUCTS, INC. |
JOSEPH J BUTLER |
K822548 |
10/13/1982 |
SAFE LOCK CATHETER S-3 |
AMERICAN MEDICAL PRODUCTS, INC. |
JOSEPH J BUTLER |
K822544 |
10/13/1982 |
SAFE LOCK SEALING CAP L |
AMERICAN MEDICAL PRODUCTS, INC. |
JOSEPH J BUTLER |
K822546 |
10/13/1982 |
SAFE LOCK SEALING CAPS |
AMERICAN MEDICAL PRODUCTS, INC. |
JOSEPH J BUTLER |
K822550 |
10/13/1982 |
SAFE LOCK TITANIUM ADAPTER SET |
AMERICAN MEDICAL PRODUCTS, INC. |
JOSEPH J BUTLER |
K822811 |
10/27/1982 |
CONTAINERS OF STERILE WATER OS SALINE |
AMERICAN PHARMASEAL DIV. AHSC |
|
K822091 |
10/18/1982 |
SIEMENS SIRECUST SYSTEM |
ANALOGIC CORP. |
|
K822798 |
10/15/1982 |
DISPOSABLE ELECTRODE #1900 |
ANDOVER MEDICAL, INC. |
|
K822894 |
10/18/1982 |
DIABRITE |
ANTRACO, INC. |
|
K822893 |
10/22/1982 |
G.E.V. DISPOSABLE SCALPELS |
ASCEP, INC. |
|
K822832 |
10/18/1982 |
TICARCILLIN 75MCG. SENSI-DISC |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K822039 |
10/21/1982 |
BECKMAN ASTRA |
BECKMAN INSTRUMENTS, INC. |
|
K822710 |
10/13/1982 |
METABOLIC MEASUREMENT CART |
BECKMAN INSTRUMENTS, INC. |
|
K822556 |
10/18/1982 |
CRITICAL MEASUREMENT UNIT |
BEMIS HEALTH CARE |
|
K822557 |
10/18/1982 |
SPECIMEN ADAPTOR |
BEMIS HEALTH CARE |
|
K822731 |
10/18/1982 |
HEMOTECT |
BIO-CHEM LABORATORIES |
|
K822840 |
10/27/1982 |
RADIOIMMUNOASSAY, HUMAN CHORRIONIC |
BIOCLINICAL GROUP |
|
K822875 |
10/13/1982 |
PEDI-TUBE PEDIATRIC FEEDING TUBE |
BIOSEARCH MEDICAL PRODUCTS, INC. |
|
K822287 |
10/13/1982 |
BX-500 ELECTRONIC MUSCLE EXERCISER |
BLOOMEX INTERNATIONAL, INC. |
|
K822508 |
10/22/1982 |
MINISAMPLER TM |
BMS, INC. |
|
K822441 |
10/08/1982 |
UNIMETER 330K |
BOEHRINGER MANNHEIM CORP. |
|
K822239 |
10/04/1982 |
COAXIAL BIPOLAR PACING ELECTRODE |
BURDITT & CALKINS-SIEMENS-ELEMA |
|
K822309 |
10/04/1982 |
COMMAND NP |
CARDIAC PACEMAKERS, INC. |
|
K821711 |
10/04/1982 |
CARDIO TEHCHANALYZER |
CARDIO TECHNOLOGY LTD. |
|
K820945 |
10/26/1982 |
SERA FOR ANTINUCLEAR ANTIBODIES |
CENTERS FOR DISEASE CONTROL AND PREVENTION |
|
K822911 |
10/22/1982 |
ANAZYME ANA PEROXIDASE TEST SYSTEM |
CLINICAL SCIENCES, INC. |
|
K822992 |
10/27/1982 |
PEOPLE MOVER |
CONVAID PRODUCTS, INC. |
|
K821655 |
10/13/1982 |
DUODERM HYDROACTIVE GRANULES |
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
|
K822652 |
10/04/1982 |
JAIN INSULATING BOOT MODEL 225B |
COOK PACEMAKER CORP. |
|
K822904 |
10/15/1982 |
MODEL 325D UNIPOLAR CARDIAC PULSE GEN |
COOK PACEMAKER CORP. |
|
K822220 |
10/06/1982 |
COOPER VISION I/A SYSTEM III MODEL 1500 |
COOPERVISION, INC. |
|
K822789 |
10/15/1982 |
ROOMATE II |
CRYOGENIC ASSOC. |
|
K827690 |
10/05/1982 |
SPECTRA MINI, ULTRAVIOLET EMITTER FOR DERMATOLOGICAL USE |
DAAVLIN CO. |
|
K820882 |
10/18/1982 |
PECOR, PERCOR-DL, 10.5 FRENCH W/SMEC |
DATASCOPE CORP. |
|
K822848 |
10/15/1982 |
PRIMARY & SECONDARY I.V. TUBING SETS |
DAVID SIMMONDS CO., INC. |
|
K822751 |
10/08/1982 |
DEL MAR AVIONICS MODEL 551 NEUROCORDER |
DEL MAR AVIONICS |
|
K822700 |
10/04/1982 |
DEL MAR MODEL 5500 EEG SCANNER |
DEL MAR AVIONICS |
|
K822815 |
10/22/1982 |
MODEL 700 GASTROREFLUX MONITOR/AMALYZER |
DEL MAR AVIONICS |
|
K822624 |
10/06/1982 |
O.T.E. BIOMEDICA B.A.S.I.S. MODEL 2381 |
DEL MAR AVIONICS |
|
K822858 |
10/18/1982 |
COAT-A-COUNT TOBRAMYCIN RIA KIT |
DIAGNOSTIC PRODUCTS CORP. |
|
K822845 |
10/27/1982 |
SOPHEIA CORTISOL EIA KIT |
DIAGNOSTIC PRODUCTS CORP. |
|
K822767 |
10/06/1982 |
UNIVERSAL DYNASPLINT |
DYNASPLINT SYSTEMS, INC. |
|
K822772 |
10/27/1982 |
MICROFLUOR READER |
DYNATECH CORP. |
|
K822959 |
10/22/1982 |
ENDOSCOPIC VIDEOSYSTEM |
EDER INSTRUMENT CO, INC. |
|
K822823 |
10/18/1982 |
HEMATOLOGY COMPUTER-INTERFACE, VISCOUNT |
EKO SCANN AB |
|
K827744 |
10/07/1982 |
DYNEX ULTRASOUND DIAGNOSTIC SCANNER |
ELSCINT, INC. |
|
K822982 |
10/27/1982 |
MIDAS 100 HEMACOLOR STAIN #66030 |
EMD CHEMICALS INC. |
|
K822981 |
10/27/1982 |
MIDAS 1000 WRIGHT GIEMSA STAIN #66020 |
EMD CHEMICALS INC. |
|
K822980 |
10/27/1982 |
MIDAS 1000 WRIGHT STAIN #66010 |
EMD CHEMICALS INC. |
|
K828313 |
10/07/1982 |
DIGITAL RADIOGRAPHY EXAMINATION TABLE |
ENGINEERING DYNAMICS CORP. |
|
K822796 |
10/18/1982 |
NEGATIVE PRESSURE ARTERIAL BLOOD LINE |
ERIKA, INC. |
|
K822836 |
10/15/1982 |
MICROFLEX-VENOFLUX |
EXCO, INC. |
|
K822724 |
10/13/1982 |
SUCTION TUBES |
EXCO, INC. |
|
K822691 |
10/15/1982 |
VYGON EPIDURAL ANAESTHESIA TRAY |
EXCO, INC. |
|
K822385 |
10/13/1982 |
EXTRAPURE REVERSE OSMOSIS WATER UNIT |
EXTRACORPOREAL MEDICAL SPECIALITIES, INC. |
|
K822816 |
10/22/1982 |
DUAL SERVO HEATED RESPIRATORY HUMIDIFIER |
FISHER & PAYKEL ALLIED PRODUCTS LTD. |
|
K822905 |
10/18/1982 |
LATEST RF KIT FOR RHEUMATOID FACTOR |
FISHER SCIENTIFIC CO., LLC. |
|
K822931 |
10/26/1982 |
SCR WRAP |
FOX CONVERTING, INC. |
|
K822599 |
10/06/1982 |
KEATES I/A SYSTEM FRIGITRONICS 4000 |
FRIGITRONICS OF CONNECTICUT, INC. |
|
K822795 |
10/08/1982 |
GABRIEL DIGITREND |
GABRIEL ENT. |
|
K822821 |
10/18/1982 |
GAMBRO BLOOD LEVEL DETECTOR LCS 10 |
GAMBRO, INC. |
|
K822822 |
10/18/1982 |
GAMBRO PRESSURE MONITOR PRM 10 |
GAMBRO, INC. |
|
K822820 |
10/18/1982 |
GAS-FLOW METER GFL 10 |
GAMBRO, INC. |
|
K822874 |
10/18/1982 |
THERMOSTATIC WATER MIXING VALVE TWV10 |
GAMBRO, INC. |
|
K822739 |
10/18/1982 |
AHBD |
GILFORD DIAGNOSTICS |
|
K822150 |
10/21/1982 |
AMNISTAT-FLM |
HANA BIOLOGICS, INC. |
|
K822852 |
10/27/1982 |
TRIGLYCERIDE CALIBRATOR |
HARLECO DIAGNOSTICS |
|
K822871 |
10/22/1982 |
MODEL BX-3000 OXYGEN CONCENTRATOR |
HEALTHDYNE, INC. |
|
K822623 |
10/13/1982 |
LAPAROTOMY SPONGE |
HERMITAGE HOSPITAL PRODUCTS, INC. |
|
K822876 |
10/18/1982 |
MODEL 78534A PATIENT MONITOR |
HEWLETT-PACKARD CO. |
|
K822878 |
10/18/1982 |
MODEL 78553A PRESSURE PLUG-IN MODULE |
HEWLETT-PACKARD CO. |
|
K822877 |
10/18/1982 |
MODEL 78554A DATA MGMT. PLUG-IN MODULE |
HEWLETT-PACKARD CO. |
|
K822695 |
10/15/1982 |
SIGNAL DISTRIBUTION NETWORK #78581A |
HEWLETT-PACKARD CO. |
|
K821989 |
10/18/1982 |
NON-STETHO 7, UM-15TP |
HIRATA SANGYO CO. USA, INC. |
|
K822571 |
10/08/1982 |
SYRINGE PUMP |
HIRATA SANGYO CO. USA, INC. |
|
K822080 |
10/15/1982 |
ADHESIVE WOUND COVER FILM |
HOLLISTER, INC. |
|
K822590 |
10/04/1982 |
PRESSURE ISOLATION AMPLIFIER #9813 517 |
HONEYWELL, INC. |
|
K827408 |
10/04/1982 |
ULTRA IMAGER |
HONEYWELL, INC. |
|
K822386 |
10/06/1982 |
COTRAL I W/4.5 L/HR. ULTRAFILTRAT. CAPA |
HOSPAL MEDICAL CORP. |
|
K822851 |
10/04/1982 |
DISSCAP 080 |
HOSPAL MEDICAL CORP. |
|
K822943 |
10/27/1982 |
ELLISON VITALLIUM FIXATION STAPLE SYS |
HOWMEDICA CORP. |
|
K823037 |
10/28/1982 |
PLEUR-EVAC A-4005 SYSTEM |
HOWMEDICA CORP. |
|
K822889 |
10/22/1982 |
MODEL #6200 OXYGEN CONCENTRATOR |
HUDSON OXYGEN THERAPY SALES CO. |
|
K822705 |
10/13/1982 |
TAMDEM-R THYROID STIMULATING HORMONE KIT |
HYBRITECH, INC. |
|
K822906 |
10/15/1982 |
PHYSICAL MEDICINE & REHABILITATION EQUIP |
I-REP, INC. |
|
K822346 |
10/08/1982 |
HISTIMUNE ENZYME-ANA TEST |
ICL SCIENTIFIC |
|
K822777 |
10/08/1982 |
THERAPEUTIC DRUG CONTROL |
ICL SCIENTIFIC |
|
K822783 |
10/06/1982 |
FLEX ICE FREEZE PACK |
IGLOO CORP. |
|
K822605 |
10/27/1982 |
TOXOPLASMA GONDII ANTIBODY IGG |
IMMULOK, INC. |
|
K822684 |
10/08/1982 |
ENDAB THYROID UPTAKE |
IMMUNOTECH CORP. |
|
K822574 |
10/13/1982 |
INNOMED PD-1 KIT |
INNOMED CORP. |
|
K822421 |
10/13/1982 |
INNOCOMB LICE COMB |
INNOVATIVE PRODUCTS, INC. |
|
K827704 |
10/07/1982 |
MM-22 MICROTRON |
INSTRUMENT AB SCANDITRONIX |
|
K822608 |
10/04/1982 |
MK 808 SERIES NASAL OXYGEN SAMPLER |
INSTRUMENTATION INDUSTRIES, INC. |
|
K822831 |
10/28/1982 |
RI 300 DIFFERENTIAL TEMPERATURE MONITOR |
INSTRUMENTATION INDUSTRIES, INC. |
|
K822771 |
10/06/1982 |
101 NEER TYPE SHOULDER |
INTERMEDICS ORTHOPEDICS |
|
K822326 |
10/18/1982 |
BLENDED DETERGENT-78N 1912-1 |
INTERSCIENCE, INC. |
|
K822325 |
10/18/1982 |
BLOOD CELL DILUENT 78N 1913 |
INTERSCIENCE, INC. |
|
K822956 |
10/26/1982 |
G CAST |
J. ADERER, INC. |
|
K822957 |
10/26/1982 |
PURCAST |
J. ADERER, INC. |
|
K822947 |
10/26/1982 |
NEPTUNE |
JENERIC IND. |
|
K822948 |
10/22/1982 |
RX BIOCAST |
JENERIC IND. |
|
K822949 |
10/22/1982 |
RX SFC |
JENERIC IND. |
|
K822950 |
10/22/1982 |
RX UNIVERSAL |
JENERIC IND. |
|
K822951 |
10/26/1982 |
SPHEREX E.C.T. |
JENERIC IND. |
|
K822780 |
10/06/1982 |
CERVICAL BRACE |
JEROME MEDICAL |
|
K822613 |
10/22/1982 |
RAST ALLERCOAT ALLERGEN DISCS |
KALLESTAD LABORATORIES, INC. |
|
K820610 |
10/27/1982 |
GELRITE |
KELCO |
|
K822201 |
10/06/1982 |
EAR CANNULAS |
KELLEHER CORP. |
|
K822004 |
10/20/1982 |
FACE SHIELDS |
KELLEHER CORP. |
|
K822259 |
10/22/1982 |
LARYNGEAL SPATULAS |
KELLEHER CORP. |
|
K822185 |
10/18/1982 |
LARYNGEAL SYRINGE |
KELLEHER CORP. |
|
K822264 |
10/13/1982 |
NAGASHIMA SN OPERATOR'S CHAIR |
KELLEHER CORP. |
|
K822267 |
10/13/1982 |
TRANSFORMER |
KELLEHER CORP. |
|
K822569 |
10/06/1982 |
TYMPANOPLASTY & SKIN DISSECTORS |
KELLEHER CORP. |
|
K822017 |
10/27/1982 |
TYMPANOSTOMY TUBES & VARIOUS TYPES |
KELLEHER CORP. |
|
K822257 |
10/26/1982 |
VARIOUS TYPES OF LIGHT SOURCE HANDLES |
KELLEHER CORP. |
|
K822402 |
10/22/1982 |
ROTO REST KINETIC TREATMENT TABLE PEDIA |
KINETIC CONCEPTS, INC. |
|
K828194 |
10/05/1982 |
LASER LAPAROSCOPE |
LASER INDUSTRIES LTD. |
|
K822616 |
10/18/1982 |
LS6 ARRYTHMIA DISCRIMINATOR |
LIFE SCIENCE INSTRUMENTATION, INC. |
|
K822752 |
10/22/1982 |
ANAEROBIC CARBON DIOXIDE |
LIQUID CARBONIC CORP. |
|
K822753 |
10/22/1982 |
BLOOD GAS MIXTURE |
LIQUID CARBONIC CORP. |
|
K822762 |
10/22/1982 |
CLINICAL GAS MIXTURE-FLAMMABLE |
LIQUID CARBONIC CORP. |
|
K822763 |
10/22/1982 |
CLINICAL GAS MIXTURE-NON-FLAMMABLE |
LIQUID CARBONIC CORP. |
|
K822764 |
10/22/1982 |
LUNG DIFFUSION MIXTURE |
LIQUID CARBONIC CORP. |
|
K822718 |
10/04/1982 |
SERIES 7000 BEDSIDE PATIENT MONITOR |
MARQUETTE ELECTRONICS, INC. |
|
K822786 |
10/21/1982 |
MDM ARTERIAL BLOOD GAS KIT |
MARTELL MEDICAL PRODUCTS, INC. |
|
K822577 |
10/22/1982 |
OPERAND SUTURE REMOVAL TRAY |
MEDCARE PRODUCTS |
|
K822591 |
10/13/1982 |
TISSUE FORCEPS |
MEDCARE PRODUCTS |
|
K822510 |
10/13/1982 |
SUCTION CATHETER W/STERILE WATER |
MEDINE DYNACOR |
|
K822454 |
10/18/1982 |
SYRINGE PUMP 209-100 |
MEDIX CORP. |
|
K822297 |
10/04/1982 |
ENERTRAX MODEL 7100E |
MEDTRONIC VASCULAR |
|
K822158 |
10/13/1982 |
OPEN HEART TRAY (CUSTOM DESIGNED) |
MEGAPLAST, INC. |
|
K821992 |
10/18/1982 |
ALPHA-TOXIN DISCS |
MICROCHEMICAL SPECIALITIES, CO. |
|
K822578 |
10/26/1982 |
MICROMEDIC ESTRIOL RIA KIT |
MICROMEDIC SYSTEMS |
|
K822701 |
10/08/1982 |
FLUOROSTAT FLUOROMETER |
MILES LABORATORIES, INC. |
|
K822436 |
10/22/1982 |
DNA MEDICAL DURACATH |
MOOREHEAD HOSPITAL PRODUCTS, INC. |
|
K822656 |
10/18/1982 |
C-200 INFANT INCUBATOR |
NARCO SCIENTIFIC |
|
K822748 |
10/06/1982 |
PILLING COIN-STYLE BLADE GAUGE |
NARCO SCIENTIFIC |
|
K822749 |
10/06/1982 |
PILLING DIAMOND KNIFE |
NARCO SCIENTIFIC |
|
K822747 |
10/18/1982 |
PILLING LACRIMAL INTUBATION SYSTEM(STER. |
NARCO SCIENTIFIC |
|
K822793 |
10/22/1982 |
PIO ROOT CANAL INDICATOR |
NATIONAL PATENT DEVELOPMENT CORP. |
|
K822077 |
10/06/1982 |
RESPIRATION MONITOR TYPE MR-10 |
NEW DIMENSIONS IN MEDICINE, INC. |
|
K822928 |
10/26/1982 |
DISPOSABLE MICRO-INFUSION SYSTEM |
ORANGE MEDICAL INSTRUMENTS, INC. |
|
K822782 |
10/08/1982 |
ACUSCREEN |
ORTHO DIAGNOSTIC SYSTEMS, INC. |
|
K821507 |
10/14/1982 |
SYMPTOTHERM 8 FERTILITY INDICATOR |
OVIX CORP., INC. |
|
K822896 |
10/22/1982 |
CAVIDRY |
PARKER LABORATORIES, INC. |
|
K822844 |
10/26/1982 |
PENTAX BRONCHOFIBERSCOPE #FB-19E |
PENTAX PRECISION INSTRUMENT CORP. |
|
K822846 |
10/22/1982 |
PENTAX FC-38LA & FC-38SA COLONOFIBER |
PENTAX PRECISION INSTRUMENT CORP. |
|
K822779 |
10/04/1982 |
PHONIC EAR-PE 845-PPC |
PHONIC EAR, INC. |
|
K822449 |
10/27/1982 |
TPK 1980/1 |
PLANTEX USA, INC. |
|
K823003 |
10/27/1982 |
Q65 MEDICAL TREADMILL |
QUINTON, INC. |
|
K822854 |
10/15/1982 |
PRO MED 100 |
REBCO TRADING CO. |
|
K822880 |
10/18/1982 |
ARTERIO VENOUS SHUNT CANNULA & ADAPTORS |
RENAL SYSTEMS, INC. |
|
K822794 |
10/22/1982 |
RESPIRONICS ENDO TUBE CONTROL SYS |
RESPIRONICS, INC. |
|
K822583 |
10/04/1982 |
TOTAL KNEE SYSTEM |
RICHARD'S MEDICAL EQUIP., INC. |
|
K822145 |
10/22/1982 |
COMPLETE |
RICHARD-ALLAN MEDICAL IND., INC. |
|
K822828 |
10/29/1982 |
SOFT LENS THERMAL DISINFECTING UNIT, A-C |
SAFEWAY PRODUCTS, INC. |
|
K822692 |
10/15/1982 |
DIGITAL PULSE METER (73 BWS) #HRM-100E |
SANYO ELECTRIC, INC. |
|
K822768 |
10/04/1982 |
ELECTROCARDIOGRAPH (74 DPS) #YM-102 |
SANYO ELECTRIC, INC. |
|
K822417 |
10/21/1982 |
NEW ENZYMATIC SINGLE REAGENT FREE CHOL. |
SCLAVO, INC. |
|
K822363 |
10/04/1982 |
ALTA III ECG RECORDER |
SCOLE ENGINEERING CO. |
|
K822115 |
10/18/1982 |
SERAGAN ACTH125 I-RIA KIT |
SERAGEN DIAGNOSTICS, INC. |
|
K821863 |
10/18/1982 |
DIALYZER REPROCESSING SYSTEM DRS-4 |
SERATRONICS, INC. |
|
K822630 |
10/04/1982 |
MONOJECT PLASTIC HUB SPINAL NEEDLE |
SHERWOOD MEDICAL CO. |
|
K822213 |
10/28/1982 |
SIEMENS-ELEMA AB AGA REVIVATOR |
SIEMENS ELEMA AB |
|
K821884 |
10/08/1982 |
GASTROCCULT TM |
SMITH KLINE DIAGNOSTICS, INC. |
|
K822886 |
10/27/1982 |
GONORRHEA TRANSETTE 3 |
SPECTRUM DIAGNOSTIC, INC. |
|
K827098 |
10/05/1982 |
SUNROOF SUNLAMP |
SUNFUN ENTERPRISES LTD. |
|
K822447 |
10/18/1982 |
SURGICARE MODEL 1000 |
SURGICARE SCIENTIFIC LABORATORY, INC. |
|
K822869 |
10/13/1982 |
COMMAND BONDING RESIN/GLAZE/OPAQUER |
SYBRON CORP. |
|
K822853 |
10/18/1982 |
MODEL 200 SQUID |
SYNEMED, INC. |
|
K822592 |
10/08/1982 |
ADVANCE TM T-3 UPTAKE ASSAY |
SYVA CO. |
|
K822625 |
10/13/1982 |
SYNTEVENT ATOMIZER/NEBULIZER AEROSOL |
SYVA CO. |
|
K822933 |
10/27/1982 |
SYVA ADVANCE EMIT AED VALPROIC ACID ASSA |
SYVA CO. |
|
K822934 |
10/27/1982 |
SYVA ADVANCE EMIT AED VALPROIC ACID CONT |
SYVA CO. |
|
K822847 |
10/08/1982 |
INSTA-HOLD |
TAUB INDUSTRIES |
|
K822884 |
10/27/1982 |
URIC ACID 75CDO |
TECHNICON INSTRUMENTS CORP. |
|
K822130 |
10/13/1982 |
FRANCIS NASAL TUBE |
TEKNA MED CORP. |
|
K822540 |
10/08/1982 |
COUNT-10 TROL |
TEXAS IMMUNOLOGY, INC. |
|
K822056 |
10/06/1982 |
EXER-STIM CONTROLLER |
TH CHARTERS, INC. |
|
K828325 |
10/21/1982 |
YOSHIDA/KAYCOR X-70 X-RAY UNIT |
THE YOSHIDA DENTAL MFG. CO., LTD. |
|
K822769 |
10/06/1982 |
THORATEC GAS SAMPLING CONNECTOR |
THORATEC LABORATORIES CORP. |
|
K822814 |
10/08/1982 |
EMG 100T |
THOUGHT TECHNOLOGY LTD. |
|
K822746 |
10/13/1982 |
RT-200 CALIBRATION ANALYZER |
TIMETER INSTRUMENT CORP. |
|
K822758 |
10/18/1982 |
SYSMEX PDA-410 (PARTICLE DISTRIB. ANALY |
TOA MEDICAL ELECTRONICS USA, INC. |
|
K822562 |
10/06/1982 |
ODONTO-SCOPE |
TREACE MEDICAL, INC. |
|
K822423 |
10/13/1982 |
"BABY TEMP" PACIFIER |
TRP ENERGY SENSORS, INC. |
|
K822800 |
10/27/1982 |
PICOLITE |
UNITED TECHNOLOGIES PACKARD |
|
K822805 |
10/13/1982 |
HEARING AID, UNITRON MODEL UE7 |
UNITRON INDUSTRIES, INC. |
|
K822586 |
10/18/1982 |
TEFLON COATED GUIDE WIRES & CATHETER |
UNIVERSAL MEDICAL INSTRUMENT CORP. |
|
K822425 |
10/04/1982 |
M-MODE ANALYSIS SYSTEM |
USER RESOURCES, INC. |
|
K822860 |
10/27/1982 |
RIA SSIST TI-59 MAGNETIC CARD PROGRAMS |
VENTREX LABORATORIES, INC. |
|
K822654 |
10/04/1982 |
CURING LIGHT |
VENTURE TECHNOLOGY, INC. |
|
K822248 |
10/21/1982 |
DESERET ARTERIAL BLOOD SAMPLING KIT |
WARNER-LAMBERT CO. |
|
K822529 |
10/13/1982 |
SPECIAL EYE MIRROR |
WILMINGTON OPTICS, INC. |
|
K822790 |
10/22/1982 |
MICRO-CRAFT OSCILLATING SAW HANDPIECE |
XOMED, INC. |
|
K822573 |
10/22/1982 |
SUNGLASS LENSES |
ZEISS |
|
K822003 |
10/15/1982 |
BALLOON TEMP. PACING CATHETER |
ZIEHM INTERNATIONAL, INC. |
|
K822002 |
10/15/1982 |
BIPOLAR TEMP. PACING CATHETER W/STYLETET |
ZIEHM INTERNATIONAL, INC. |
|