FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
K831363 |
05/16/1983 |
TESTCORP ASO |
|
|
K831362 |
05/27/1983 |
TESTCORP CRP |
|
|
K831364 |
05/27/1983 |
TESTCORP RA |
|
|
K831367 |
05/25/1983 |
PMN VOLZ CURETTES |
3M COMPANY |
|
K831104 |
05/09/1983 |
TENZCARE MUSCLE STIMULATION ELECTRODES |
3M COMPANY |
|
K821135 |
05/05/1983 |
PREALBUMIN ENZYME IMMUNOASSAY |
ABBOTT LABORATORIES |
|
K830707 |
05/02/1983 |
ACUFEX UNIVERSAL LEG HOLDER |
ACUFEX MICROSURGICAL, INC. |
|
K831068 |
05/09/1983 |
CONTAINER SYSTEM |
ADLER INSTRUMENT CO. |
|
K830375 |
05/25/1983 |
FIRST AID BAGS #1,2,3 |
AKLA, INC. |
|
K830373 |
05/13/1983 |
FIRST AID KIT |
AKLA, INC. |
|
K830374 |
05/13/1983 |
RESCUE PACK |
AKLA, INC. |
|
K831093 |
05/16/1983 |
APELLO, PERSONAL HEALTH SUPPORT SYS. |
ALMICRO ELECTRONICS, INC. |
|
K831138 |
05/18/1983 |
CURVED HEMOSTAT 5 |
ALMORE INTL., INC. |
|
K831137 |
05/18/1983 |
STRAIGHT 5" HEMOSTAT |
ALMORE INTL., INC. |
|
K837304 |
05/09/1983 |
MODELS 246 AND 210F LINEAR ARRAY ULTRASOUND SCANNER |
ALOKA CO., LTD. |
|
K831157 |
05/09/1983 |
BLOOD CARDIOPLEGIA STAINLESS STEEL COOL |
AMERICAN BENTLEY |
|
K830786 |
05/18/1983 |
DISIMETRIC RELEASE OF INSTRANETICS RAD |
AMERICAN CONVERTORS DIV., AMERICAN PHARMASEAL |
|
K831242 |
05/16/1983 |
LITHIUM HEPARINIZED BLOOD COLLECT-TUBE |
AMERICAN DADE |
|
K831177 |
05/17/1983 |
STRATUS DIGOXIN FLUOROMETRIC ENZYME IMM- |
AMERICAN DADE |
|
K830701 |
05/13/1983 |
STRATUS PHENOBARBITAL FLUOROMETRIC ENZ |
AMERICAN DADE |
|
K831154 |
05/16/1983 |
STRATUS PHENYTOIN FLUOROMETRIC ENZYME |
AMERICAN DADE |
|
K830546 |
05/25/1983 |
DOSIMETRIC RELEASE |
AMERICAN HOSPITAL SUPPLY CORP. |
|
K831201 |
05/25/1983 |
SERUM IRON-PTF-600 |
AMERICAN MONITOR CORP. |
|
K831202 |
05/25/1983 |
SERUM UIBC-PTF-600 METHOD |
AMERICAN MONITOR CORP. |
|
K830980 |
05/25/1983 |
AMERLEX FREE T-3 RIA KIT |
AMERSHAM CORP. |
|
K830958 |
05/04/1983 |
FLOW-PAC SGOT REAGENT |
AMRESCO, INC. |
|
K830959 |
05/04/1983 |
FLOW-PAC SGPT REAGENT |
AMRESCO, INC. |
|
K830525 |
05/18/1983 |
API 20GP |
ANALYTICAL PRODUCTS, INC. |
|
K831032 |
05/05/1983 |
API ANAIDENT |
ANALYTICAL PRODUCTS, INC. |
|
K831171 |
05/25/1983 |
DIGICATH |
ARGON MEDICAL CORP. |
|
K831226 |
05/16/1983 |
MEDICAL PRODUCTS FOAM DOUBLE SCRUB #450 |
BALLARD MEDICAL PRODUCTS |
|
K830964 |
05/04/1983 |
ANAEROBE MIC/ID TEMPLATE, & TAXONOMY |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K830510 |
05/02/1983 |
BBL STREP GROUPING KIT |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K831153 |
05/09/1983 |
CEFAXOLIN 30 MCG SENSI-DISC |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K830646 |
05/27/1983 |
DIRECTIGEN NEISSERIA MENINGITIDIS |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K831222 |
05/09/1983 |
CARBAMEZEPINE REAGENT TEST KIT |
BECKMAN INSTRUMENTS, INC. |
|
K831217 |
05/09/1983 |
MODEL BERNAFON T-86 |
BERNAFON, INC. |
|
K831278 |
05/27/1983 |
LIQUI-SERA ANTICONVULSANTS CONTROLS |
BIO DIAGNOSTIC INTL. |
|
K831047 |
05/13/1983 |
BIOLOGIC SYSTEM BL 101 |
BIO-LOGIC SYSTEMS CORP. |
|
K830313 |
05/25/1983 |
CFE TOTAL HIP FEMORAL COMPONENT |
BIOMET, INC. |
|
K830209 |
05/16/1983 |
LUS ACETABULAR COMPONENT |
BIOMET, INC. |
|
K831168 |
05/09/1983 |
ENTERAL DELIVERY SET |
BIOSEARCH MEDICAL PRODUCTS, INC. |
|
K831167 |
05/09/1983 |
ENTERAL PUMP SET |
BIOSEARCH MEDICAL PRODUCTS, INC. |
|
K830862 |
05/25/1983 |
NEDS-01 & EPR-500 |
BIOTRONIK SALES, INC. |
|
K831125 |
05/05/1983 |
BTC URINE LCG ASSAY |
BTC DIAGNOSTICS, INC. |
|
K830344 |
05/27/1983 |
SIEMENS-ELMA PULSE GENERATOR #718 |
BURDITT & CALKINS-SIEMENS-ELEMA |
|
K823487 |
05/27/1983 |
BARD URETERAL STENT |
C.R. BARD, INC. |
|
K831122 |
05/25/1983 |
WILLIAM HARVEY H-1700 ADULT BLOOD OXYG- |
C.R. BARD, INC. |
|
K831231 |
05/16/1983 |
LED GOGGLES |
CADWELL LABORATORIES, INC. |
|
K831160 |
05/09/1983 |
LEAD ADAPTERS #'S 6016,6022,6017 ETC |
CARDIAC PACEMAKERS, INC. |
|
K831259 |
05/09/1983 |
RESERVOIR 1.5CC #9210 W/25 GAUGE/NEEDLE |
CARDIAC PACEMAKERS, INC. |
|
K831184 |
05/09/1983 |
CARDIO DATA PACEMAKER RECORDER |
CARDIO DATA |
|
K831262 |
05/25/1983 |
DATA IV AMBULATORY MONITOR |
CARDIO-SCAN OF TEXAS |
|
K831225 |
05/27/1983 |
GAS-STAT MONITORING SYSTEM |
CARDIOVASCULAR DEVICES, INC. |
|
K831146 |
05/16/1983 |
OXYCOIL |
CHANNING CORP. |
|
K831312 |
05/25/1983 |
LOPEZ-HORN CARRIER |
CHIRON VISION CORP. |
|
K830749 |
05/16/1983 |
PLATELET AGGREGOMETER |
CHRONO-LOG CORP. |
|
K830354 |
05/27/1983 |
COLORECTAL DILATOR |
CLEVELAND MEDICAL SUPPLY & SERVICES |
|
K830190 |
05/27/1983 |
AHR-3000 RE-USE ADAPTOR |
COLORADO MEDICAL, INC. |
|
K830640 |
05/04/1983 |
BOO-BOO STRIP |
COLOSSUS CORP. |
|
K830708 |
05/05/1983 |
DUO DERM FLEX HYDROACTIVE DRESSINGS & |
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
|
K831185 |
05/27/1983 |
CARDIAC OUTPUT MEASURE SYSTEM |
COOK, INC. |
|
K831105 |
05/16/1983 |
CORDIA PAP |
CORDIS CORP. |
|
K830804 |
05/04/1983 |
LABILE REMOVING HEMOLYZING REAGENT |
CORNING MEDICAL & SCIENTIFIC |
|
K830441 |
05/16/1983 |
DIFF 4 SYSTEM |
COULTER ELECTRONICS, INC. |
|
K830182 |
05/09/1983 |
CUSTOM IV SET |
CUSTOM MEDICAL, INC. |
|
K831163 |
05/03/1983 |
LO-COMP RESERVOIR-RE-1000 |
CYGNUS RESEARCH CORP. |
|
K830923 |
05/03/1983 |
TEMP-CHECK ADAPTOR, STRAIGHT CONFIGURA |
CYGNUS RESEARCH CORP. |
|
K830922 |
05/02/1983 |
TEMP-CHECK ADAPTOR, TEE-CONFIGURATION |
CYGNUS RESEARCH CORP. |
|
K830921 |
05/02/1983 |
TEMP-CHECK ADAPTOR, Y-CONFIGURATION |
CYGNUS RESEARCH CORP. |
|
K831247 |
05/16/1983 |
SAFE-SEAT WHEELCHAIR CUSHION |
D.A. SCHULMAN, INC. |
|
K830743 |
05/09/1983 |
POROUS TIP ENDOCARDIAL LEAD |
DAIG CORP. |
|
K830889 |
05/09/1983 |
DEXON 'S' POLYGLYCOLIC ACID MESH |
DAVIS & GECK, INC. |
|
K830439 |
05/09/1983 |
DENTA A-33 |
DENTA, INC. |
|
K831214 |
05/09/1983 |
DELTA TEETH |
DENTSPLY INTL. |
|
K830955 |
05/09/1983 |
DENTAL CERAMIC FOR FABRICATION OF CROWN |
DENTSPLY INTL. |
|
K830489 |
05/25/1983 |
RECORDER DMI |
DIAGNOSTIC MEDICAL INSTRUMENTS |
|
K831107 |
05/18/1983 |
COAT-A-COUNT NEONATAL T4 KIT RIA KIT |
DIAGNOSTIC PRODUCTS CORP. |
|
K831178 |
05/27/1983 |
COAT-A-COUNT NO-EXTRACTION ALDOSTERONE |
DIAGNOSTIC PRODUCTS CORP. |
|
K831180 |
05/27/1983 |
PREGNA-CERT, SLIDE PREGNANCY TEST |
DIAGNOSTIC SPECIALTIES |
|
K831317 |
05/18/1983 |
BIOPSY ATTACHMENT |
DIASONICS, INC. |
|
K831186 |
05/09/1983 |
RAPID NFT |
DMS LABORATORIES |
|
K831187 |
05/09/1983 |
TRP |
DMS LABORATORIES |
|
K831238 |
05/09/1983 |
OXYMED |
DRAEGER MEDICAL, INC. |
|
K831237 |
05/09/1983 |
SPIROMED RESPIROMETER |
DRAEGER MEDICAL, INC. |
|
K831209 |
05/16/1983 |
GENTAMICIN CALIBRATOR -ACA |
E.I. DUPONT DE NEMOURS & CO., INC. |
|
K831210 |
05/25/1983 |
GENTAMICIN TEST PACK-ACA |
E.I. DUPONT DE NEMOURS & CO., INC. |
|
K837085 |
05/09/1983 |
DOPPLER FOR DETECTING OCCLUSIONS AND TAKING SYSTOLIC BLOOD PRESSURE |
E.M. ADAMS |
|
K830735 |
05/02/1983 |
BT 795/A AUTOTRANS |
ELECTROMEDICS, INC. |
|
K830592 |
05/18/1983 |
DISPOS. TYPE T THERMOCOUPLE TEMP.PROBE |
ELECTROMEDICS, INC. |
|
K830639 |
05/25/1983 |
HI FLEX D-700 MODULAR BUBBLE OXYGENA- |
ELECTROMEDICS, INC. |
|
K830795 |
05/18/1983 |
CABINET FOR MULTIPLE FUNCTION BLOCKS |
ELECTRONICS FOR MEDICINE, INC. |
|
K831027 |
05/16/1983 |
EXTRELUT QE EXTRACTION COLUMNS |
EMD CHEMICALS INC. |
|
K831200 |
05/09/1983 |
IMMUNOHEMATOLOGICAL SALINE #97139 |
EMD CHEMICALS INC. |
|
K831162 |
05/09/1983 |
ENERGETIC HI-HUM AERSOL UNIT |
ENERGETIC PULMONARY |
|
K822085 |
05/09/1983 |
PRO-SCOPE |
EXITEC, INC. |
|
K831016 |
05/05/1983 |
BATH CLEAR |
FISHER SCIENTIFIC CO., LLC. |
|
K831017 |
05/09/1983 |
BUFFER PACK FOR ABL-1 & ABL-2 |
FISHER SCIENTIFIC CO., LLC. |
|
K831015 |
05/25/1983 |
DIAGNOSTICS PH ELECTRODE CLEANING SOLUT |
FISHER SCIENTIFIC CO., LLC. |
|
K831010 |
05/05/1983 |
DIAGNOSTICS PO2 ELECTRODE CLEANER |
FISHER SCIENTIFIC CO., LLC. |
|
K831020 |
05/09/1983 |
FLUSH SOLUTION CONCENTRATE |
FISHER SCIENTIFIC CO., LLC. |
|
K831338 |
05/27/1983 |
LUNDIA 10-3-L PARALLEL FLOW DIALYZER |
GAMBRO, INC. |
|
K823904 |
05/25/1983 |
MODEL 515 NEO-TRAK NEONATAL MONITOR |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
|
K830876 |
05/18/1983 |
PREP-CHECK |
GENERAL DEVICES |
|
K831179 |
05/09/1983 |
CEFAZOLIN 30MCG. ANTIMICROBIAL SUSCEP |
GENERAL DIAGNOSTICS |
|
K831220 |
05/09/1983 |
CLOSTRIDIUM DIFFICILE MEDIA |
GIBCO LABORATORIES LIFE TECHNOLOGIES, INC. |
|
K831219 |
05/13/1983 |
CLOSTRIDIUM DIFFICILE SELECTIVE SUPPLE |
GIBCO LABORATORIES LIFE TECHNOLOGIES, INC. |
|
K831279 |
05/13/1983 |
CLOSTRIDIUM DIFFICLE MEDIA |
GIBCO LABORATORIES LIFE TECHNOLOGIES, INC. |
|
K831359 |
05/18/1983 |
MODIFIED NEW YORK MEDIUM |
GIBCO LABORATORIES LIFE TECHNOLOGIES, INC. |
|
K831349 |
05/16/1983 |
STREPTOCOCUS ID PLATE |
GRANITE DIAGNOSTICS, INC. |
|
K830978 |
05/13/1983 |
HELENA BIOSTRIP A |
HELENA LABORATORIES |
|
K830976 |
05/04/1983 |
HELENA BIOSTRIP K |
HELENA LABORATORIES |
|
K830979 |
05/05/1983 |
HELENA BIOSTRIP PH |
HELENA LABORATORIES |
|
K830566 |
05/25/1983 |
CONVERTER UNIT FOR ECG TRACE DISPLAY |
HONEYWELL, INC. |
|
K830779 |
05/09/1983 |
PRESSURE FUNCTION BLOCK FOR BLOOD PRESS |
HONEYWELL, INC. |
|
K830857 |
05/09/1983 |
HARRIS A.R. C. ACETABULAR CUP |
HOWMEDICA CORP. |
|
K830580 |
05/05/1983 |
DIAGNON FERRITIN 125 I RIA KIT |
IAGNON CORP. |
|
K830962 |
05/04/1983 |
IMMUCHEM COVALENT-COAT RIA KIT |
IMMUCHEM CORP. |
|
K830342 |
05/04/1983 |
CULUTURE SET CHLAMYDIA ISOLATION AND |
IMMULOK, INC. |
|
K830664 |
05/09/1983 |
HUMAN INTRACT PARATHYROID HORMONE BY |
IMMUNO NUCLEAR CORP. |
|
K830837 |
05/05/1983 |
LA-HISTO ANTIBODY SYSTEM #HL 1001 |
IMMUNO-MYCOLOGICS, INC. |
|
K831310 |
05/16/1983 |
BRACE C.T. |
INNOVATION SPORTS, INC. |
|
K830477 |
05/09/1983 |
CARDIOMEMO III |
INSTROMEDIX, INC. |
|
K830898 |
05/16/1983 |
SYRINGE 500BC BE #7000 |
INSTRUMENTATION INDUSTRIES, INC. |
|
K830750 |
05/02/1983 |
CEMENTED 101 32 FEMORAL COMPONENT |
INTERMEDICS ORTHOPEDICS |
|
K830711 |
05/02/1983 |
TRACHESTOMY & NASAL SUCTIONING KIT #- |
INTERTEX MEDICAL |
|
K830747 |
05/30/1983 |
PC 2909A-HEALTH PULSE CONTROL STIMULATOR |
J.A. PRESTON CORP. |
|
K830173 |
05/25/1983 |
BERA SH 221 BRIAN STEM AUDIOMETER |
JEDMED INSTRUMENT CO. |
|
K830254 |
05/18/1983 |
LIFE LINE |
KB & ASSOC. |
|
K831207 |
05/16/1983 |
SPUNGUARD SCRUB SUIT |
KIMBERLY-CLARK CORP. |
|
K831005 |
05/18/1983 |
WIRE & STEINMAN PINS |
KIRSCHNER MEDICAL CORP. |
|
K837342 |
05/18/1983 |
SHARPLAN 721 CO2 SURGICAL LASER |
LASER INDUSTRIES LTD. |
|
K831208 |
05/09/1983 |
IGE-QUANT DIAGNOSTIC TEST KIT |
LEECO DIAGNOSTICS, INC. |
|
K831252 |
05/18/1983 |
TUMISTORE RECORDER 1311 |
LIFE-TECH INTL., INC. |
|
K831348 |
05/27/1983 |
FLUID ADMIN. SET AFS-1C |
LINTON BIOMED CORP. |
|
K830823 |
05/18/1983 |
Z VIEW METER MODEL 300 |
LINTRONICS INDUSTRIES, INC. |
|
K830615 |
05/09/1983 |
CYTOMEGELISA STAT |
M.A. BIOPRODUCTS |
|
K830045 |
05/13/1983 |
MUMPSELISA TEST KIT |
M.A. BIOPRODUCTS |
|
K823804 |
05/25/1983 |
MYCOPLASMELISA TEST KIT |
M.A. BIOPRODUCTS |
|
K823805 |
05/05/1983 |
VARICELISA TEST KIT |
M.A. BIOPRODUCTS |
|
K830425 |
05/09/1983 |
TOILET SEAT RAISED |
MADDAK, INC. |
|
K830631 |
05/09/1983 |
TRACHEAL TUBE W/ILLUMINATING LOCATER |
MALLINCKRODT CRITICAL CARE |
|
K830312 |
05/25/1983 |
ASPIRATOR |
MARQUEST MEDICAL PRODUCTS, INC. |
|
K830311 |
05/25/1983 |
AUTO STIK |
MARQUEST MEDICAL PRODUCTS, INC. |
|
K830310 |
05/25/1983 |
OMNISTICK |
MARQUEST MEDICAL PRODUCTS, INC. |
|
K831064 |
05/09/1983 |
PHASE II T3 RADIOIMMUNOASSAY KIT |
MEDICAL & SCIENTIFIC DESIGNS, INC. |
|
K831100 |
05/04/1983 |
MEDICA IIF-MULTIPLE ANTIBODY TEST KIT |
MEDICAL DIAGNOSTICS, CA. |
|
K830884 |
05/09/1983 |
SURGITEKS PERCUTANEOUS ANTEGRADE ALL - |
MEDICAL ENGINEERING CORP. |
|
K831165 |
05/03/1983 |
DUSTCOVERS/STERILITY MAINTENANCE COVERS |
MEDICAL INDUSTRIES PACKAGING, INC. |
|
K831239 |
05/25/1983 |
WALRUS PERCUTANEOUS INTRODUCER SET |
MEDICAL PARAMETERS, INC. |
|
K823295 |
05/06/1983 |
MEDIGROUP 2.2MM NEEDLESCOPE CANNULA& |
MEDIGROUP |
|
K823293 |
05/05/1983 |
MEDIGROUP LG-102 LIGHT GUIDE |
MEDIGROUP |
|
K823294 |
05/09/1983 |
MEDIGROUP LS-110 LIGHT SOURCE |
MEDIGROUP |
|
K823297 |
05/06/1983 |
ST-610 NEEDLESCOPE STERILIZATION TRAY |
MEDIGROUP |
|
K830913 |
05/25/1983 |
MINITROP AEROSAL, PRODOMO AEROSAL AND |
MEDLOG GMBH MARKETING SERVICES |
|
K830983 |
05/09/1983 |
AIRWAYS & NASOPHARYNGEAL TYPE |
MEDOVATIONS, INC. |
|
K831007 |
05/18/1983 |
CONNECTING TUBES |
MEDOVATIONS, INC. |
|
K831008 |
05/09/1983 |
HEAD STRAP |
MEDOVATIONS, INC. |
|
K830987 |
05/27/1983 |
LEVIN TUBE |
MEDOVATIONS, INC. |
|
K830982 |
05/09/1983 |
MASKS |
MEDOVATIONS, INC. |
|
K830984 |
05/18/1983 |
OXYGEN CATHETERS |
MEDOVATIONS, INC. |
|
K830988 |
05/03/1983 |
OXYGEN CONNECTING TUBE |
MEDOVATIONS, INC. |
|
K830986 |
05/27/1983 |
RECTAL TUBES |
MEDOVATIONS, INC. |
|
K830985 |
05/27/1983 |
STOMACH TUBE |
MEDOVATIONS, INC. |
|
K831189 |
05/09/1983 |
ANGIOGRAPHIC NEEDLE |
MEDRAD, INC. |
|
K831188 |
05/09/1983 |
CONNECTOR TUBE |
MEDRAD, INC. |
LARRY KOPYTA |
K831191 |
05/09/1983 |
VASCULAR CATHETER |
MEDRAD, INC. |
|
K831190 |
05/09/1983 |
VESSEL DILATOR |
MEDRAD, INC. |
|
K830784 |
05/25/1983 |
WALK N ROLL |
META-MORRIS |
|
K837344 |
05/09/1983 |
BEAM BLOCK SHAPER |
MICK RADIO-NUCLEAR INSTRUMENTS, INC. |
|
K831230 |
05/18/1983 |
PULSE LAVAGE |
MICRO-AIRE SURGICAL INSTRUMENTS, INC. |
|
K830758 |
05/25/1983 |
AZLIN AZLOCILIN SODIUM-DIAG. REAGENT |
MILES LABORATORIES, INC. |
|
K837230 |
05/18/1983 |
MODEL ND1100 BONE DENSITY SCANNER |
MOLSGAARD MEDICAL |
|
K831028 |
05/09/1983 |
TI-1000 TRANSPORT INCUBATOR |
NARCO SCIENTIFIC |
|
K830975 |
05/04/1983 |
PLAN A LIFE |
NEW DIRECTIONS CO. |
|
K831324 |
05/27/1983 |
EEG 42/2P ELECTRO ENCEPHALOGRAPH |
NIHON KOHDEN AMERICA, INC. |
|
K830686 |
05/18/1983 |
ANEROID BLOOD PRESSURE CUFF #HC1400 |
NORTH AMERICAN PHILIPS CORP. |
|
K830685 |
05/18/1983 |
NORELCO DELUXE DIGITAL BLOOD PRESSURE |
NORTH AMERICAN PHILIPS CORP. |
|
K830687 |
05/18/1983 |
NORELCO ELECTRONIC ANALOG BLOOD PRESS |
NORTH AMERICAN PHILIPS CORP. |
|
K830684 |
05/18/1983 |
NORELCO ELECTRONIC DIGITAL BLOOD PRESS |
NORTH AMERICAN PHILIPS CORP. |
|
K830715 |
05/25/1983 |
NORELCO VIBRATING BOARD V900 |
NORTH AMERICAN PHILIPS CORP. |
|
K830113 |
05/09/1983 |
SEPTOPACK |
NORTH PACIFIC DENTAL, INC. |
|
K830902 |
05/16/1983 |
OCUCARE PACK |
OCULAR INNOVATIONS, INC. |
|
K837378 |
05/18/1983 |
OMNIMEDICAL QUAD II DIGITAL ANGIOGRAPH SYSTEM |
OMNIMEDICAL |
|
K831124 |
05/09/1983 |
BIOCULT - GC CULTURE-PADDLES |
ORION DIAGNOSTICA, INC. |
|
K831042 |
05/16/1983 |
CHEMONUCLEOLYSIS TABLE EXTENSION |
ORTHOPEDIC SYSTEMS, INC. |
|
K831039 |
05/27/1983 |
COMPLUS VARIOUS FORMS |
PARKER LABORATORIES, INC. |
|
K831268 |
05/13/1983 |
TILL-U-TEST G.C. GONOCOCUS SLIDE |
PASCO LABORATORIES, INC. |
|
K837382 |
05/06/1983 |
OPTISON ULTRASONIC SCALER |
PELTON & CRANE CO. |
|
K830513 |
05/09/1983 |
FIRST TM |
PHASEALLOY |
|
K837343 |
05/31/1983 |
PZ-600 COMPUTERIZED AXIAL TOMOGRAPHY SCANNER |
PHOENIX MEDICAL ELECTRONICS |
|
K831119 |
05/09/1983 |
LUO CURRETTES #3211 |
PMT CORP. |
|
K830825 |
05/13/1983 |
YIELD NON-ADHERENT DRESSING |
PROFESSIONAL MEDICAL PRODUCTS, INC. |
|
K830993 |
05/03/1983 |
AMPLIGREFFE |
PROTHIA USA, INC. |
|
K830844 |
05/27/1983 |
PORTABLE OXYGEN SYSTEM |
PURITAN BENNETT CORP. |
|
K831108 |
05/18/1983 |
HOME PREGNANCY TEST KIT |
QUIDEL CORP. |
|
K831051 |
05/18/1983 |
HOME PREGNANCY TEST KIT HPK #1 |
QUIDEL CORP. |
|
K830674 |
05/18/1983 |
MAHURKAR FEMORAL CATHETER |
QUINTON, INC. |
RANDY WALLS |
K831034 |
05/18/1983 |
QUALISTICK ARTERIAL BLOOD SAMPLER |
RADIOMETER AMERICA, INC. |
|
K837331 |
05/09/1983 |
CORNEOMAP 4500 ULTRASOUND MEASUREMENT |
RADIONICS MEDICAL, INC. |
|
K830259 |
05/09/1983 |
PROTET SOAP & WASH MITT |
RITMED, INC. |
|
K831030 |
05/09/1983 |
COBAS STANDARDS FOR GLUCOSE & BUN |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
|
K830873 |
05/13/1983 |
S & W MODEL ASO |
S & W ENTERPRISES, INC. |
|
K831254 |
05/09/1983 |
DENTAL FLOSS HOLDER |
SEWON INDUSTRY |
|
K830794 |
05/18/1983 |
ARGYLE MADEN SILICONE GASTROSTOMY TUBE |
SHERWOOD MEDICAL CO. |
|
K831253 |
05/09/1983 |
LANCER HEMOGLOBIN ANALYZER REAGENTS |
SHERWOOD MEDICAL CO. |
|
K831229 |
05/09/1983 |
SUPER SNAPS |
SHOFU DENTAL CORP. |
|
K830607 |
05/02/1983 |
SUCTION RESERVOIR |
SIL-MED CORP. |
|
K831265 |
05/09/1983 |
DENTOLOCK DENTURE ADHESIVE CREAM |
SOLAR DENTAL CO., INC. |
|
K830563 |
05/13/1983 |
CORTISOL RADIOIMMUNOASSAY KIT-CORTCTK |
SORIN BIOMEDICA, FIAT, USA, INC. |
|
K830994 |
05/27/1983 |
REDOX CONTROLLER |
ST. LOUIS UNIV. MEDICAL CENTER |
|
K830859 |
05/02/1983 |
I/A KIT |
SURGEON SURGICAL INSTRUMENTATION, INC. |
|
K831335 |
05/16/1983 |
DISPOSABLE BASE MOLD |
SURGIPATH MEDICAL INDUSTRIES, INC. |
|
K831308 |
05/16/1983 |
DISPOSABLE MICROTOME BLADE |
SURGIPATH MEDICAL INDUSTRIES, INC. |
|
K831333 |
05/25/1983 |
EMBEDDING RINGS |
SURGIPATH MEDICAL INDUSTRIES, INC. |
|
K831334 |
05/25/1983 |
TISSUE CASSETTES FOR PROCESSING-EM BED |
SURGIPATH MEDICAL INDUSTRIES, INC. |
|
K831354 |
05/27/1983 |
EMIT QST LIDOCAINE ASSAY |
SYVA CO. |
|
K831272 |
05/27/1983 |
EMIT QST THEOPHYLLINE ASSAY |
SYVA CO. |
|
K831141 |
05/27/1983 |
EMIT SRD MANUAL CORTISOL ASSAY |
SYVA CO. |
|
K831037 |
05/09/1983 |
AIR BURBINE HANDPIECE-DENTAL SCALING |
TACO DENTAL, INC. |
|
K837430 |
05/18/1983 |
AUTO D OPTION |
TECHNICARE CORP. |
|
K831149 |
05/03/1983 |
PERSONAL KNEE CRUTCH PAD |
TECNOL NEW JERSEY WOUND CARE, INC. |
|
K831197 |
05/09/1983 |
MODEL 343D HEARING AID |
TELEX COMMUNICATIONS, INC. |
|
K831082 |
05/09/1983 |
CONNECTING TUBING |
THE KENDALL COMPANY DIV. OF TYCO HEALTHCARE GROUP |
|
K831081 |
05/16/1983 |
EZEE FILTER/SEPARATOR |
THE KENDALL COMPANY DIV. OF TYCO HEALTHCARE GROUP |
|
K830505 |
05/09/1983 |
SYSMEX CC-130 |
TOA MEDICAL ELECTRONICS USA, INC. |
|
K830506 |
05/09/1983 |
SYSMEX CC-150 |
TOA MEDICAL ELECTRONICS USA, INC. |
|
K830507 |
05/13/1983 |
SYSMEX CC-170 |
TOA MEDICAL ELECTRONICS USA, INC. |
|
K830508 |
05/09/1983 |
SYSMEX CC-180 |
TOA MEDICAL ELECTRONICS USA, INC. |
|
K830585 |
05/27/1983 |
ANVIL RETRACTOR |
TWIN CITY SURGICAL, INC. |
|
K831195 |
05/09/1983 |
WESTERGREN DISPETTE FOR ESR |
ULSTER SCIENTIFIC, INC. |
|
K830803 |
05/05/1983 |
URINARY DIVERSION STENT |
VAN-TEC, INC. |
|
K831369 |
05/27/1983 |
LATEX URINARY CATHETERS |
WAYNE SURGICAL PRODUCTS |
|
K830465 |
05/09/1983 |
WIDEX HEARING AID #G2H & G2T |
WIDEX HEARING AID CO., INC. |
|
K831303 |
05/25/1983 |
TELECTRONICS #030-253 BIFURCATED |
WILLIAM C. NEALON |
|
K830577 |
05/25/1983 |
LINEAR PUMP #4370975 |
WRIGHT LINEAR PUMP, INC. |
|
K837224 |
05/02/1983 |
UNKNOWN |
XANAR, INC. |
|
K830925 |
05/13/1983 |
MF 380 ELECTROSURGICAL UNIT |
ZIMMER, INC. |
|