| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K820729 |
11/01/1982 |
SARNS PULSATILE PUMP |
3M HEALTH CARE, SARNS |
|
| K823217 |
11/30/1982 |
INPERSOL PERITONEAL DIALSIS CYCLER SET |
ABBOTT LABORATORIES |
|
| K822834 |
11/01/1982 |
ACCESS PERCUTANEOUS INTRODUCER SET |
ACCESS DEVICES, INC. |
|
| K823017 |
11/01/1982 |
INTRAVENOUS CATHETER PLACEMENT UNIT & |
ACCESS DEVICES, INC. |
|
| K822393 |
11/01/1982 |
INTRAOPERATIVE BALLOON DILATION CATH. |
ADVANCED CARDIOVASCULAR SYSTEMS, INC. |
|
| K822970 |
11/03/1982 |
HOLTER RECORDER |
AGILENT TECHNOLOGIES |
|
| K822341 |
11/10/1982 |
ALLERGENETICS IGE-FAST TEST |
ALLERGENETICS |
|
| K823110 |
11/16/1982 |
QAP MICROCOMPUTER SYSTEM |
AMERICAN DADE |
|
| K823062 |
11/10/1982 |
KENAMYCIN FLUORESCENT IMMUNOASSAY FIA |
AMERICAN DIAGNOSTIC CORP. |
|
| K822966 |
11/05/1982 |
CONVERTORS DISPOSABLE DRESSING SPONGE |
AMERICAN HOSPITAL SUPPLY CORP. |
|
| K822988 |
11/05/1982 |
COAGULASE PLASMA-CITRATED & EDTA |
AMERICAN SCIENTIFIC PRODUCTS |
|
| K822870 |
11/01/1982 |
STOOL-COLLECTION/PRESERVATION KIT |
AMERICAN SCIENTIFIC PRODUCTS |
|
| K823074 |
11/08/1982 |
CHEMDI STEAM & GAS STERILIZATION INDICA |
AMERICAN STERILIZER CO. |
|
| K823245 |
11/16/1982 |
THERMAX; THERMAX SYSTEM |
AMERICAN THERMOMETER COMPANY, INC. |
|
| K822671 |
11/17/1982 |
ANTISERUM TO HUMAN GOBULIN |
AMICO LAB, INC. |
|
| K822668 |
11/17/1982 |
ANTISERUM TO HUMAN IGA |
AMICO LAB, INC. |
|
| K822669 |
11/17/1982 |
ANTISERUM TO HUMAN IGG |
AMICO LAB, INC. |
|
| K822670 |
11/17/1982 |
ANTISERUM TO HUMAN IGM |
AMICO LAB, INC. |
|
| K822666 |
11/17/1982 |
ANTISERUM TO HUMAN KAPPA |
AMICO LAB, INC. |
|
| K822667 |
11/17/1982 |
ANTISERUM TO HUMAN LAMBDA |
AMICO LAB, INC. |
|
| K822679 |
11/17/1982 |
FITC ANTISERA TO HUMAN C3 |
AMICO LAB, INC. |
|
| K822678 |
11/17/1982 |
FITC ANTISERA TO HUMAN GOBULIN |
AMICO LAB, INC. |
|
| K822675 |
11/17/1982 |
FITC ANTISERA TO HUMAN IGA |
AMICO LAB, INC. |
|
| K822676 |
11/17/1982 |
FITC ANTISERA TO HUMAN IGG |
AMICO LAB, INC. |
|
| K822677 |
11/17/1982 |
FITC ANTISERA TO HUMAN IGM |
AMICO LAB, INC. |
|
| K822673 |
11/17/1982 |
FITC ANTISERA TO HUMAN KAPPA |
AMICO LAB, INC. |
|
| K822674 |
11/17/1982 |
FITC ANTISERA TO HUMAN LAMBDA |
AMICO LAB, INC. |
|
| K823121 |
11/17/1982 |
RITC-ANTI HUMAN IGA, IGG, KAPPA, LAMBDA |
AMICO LAB, INC. |
|
| K823117 |
11/16/1982 |
HITCH HIKER |
AMIGO SALES, INC. |
|
| K823170 |
11/29/1982 |
LIQUIZYME TOTAL PROTEIN REAGENT |
AMRESCO, INC. |
|
| K822892 |
11/01/1982 |
CORTISOL RIA KIT |
ANTIBODIES INC. |
|
| K823113 |
11/16/1982 |
BRACE-UP ALL PURPOSE WRIST BAND |
ARCO MATIC, INC. |
|
| K823114 |
11/05/1982 |
BRACE-UP STOCKING KNEE BRACE |
ARCO MATIC, INC. |
|
| K823075 |
11/08/1982 |
REXTON |
ARGOSY INTL. (USA), INC. |
|
| K823084 |
11/10/1982 |
CHALLENGER |
BAUER, CHENG & ASSOCIATES, INC. |
|
| K823097 |
11/10/1982 |
NATURELLE |
BAUER, CHENG & ASSOCIATES, INC. |
|
| K823098 |
11/10/1982 |
REX-CAPS |
BAUER, CHENG & ASSOCIATES, INC. |
|
| K823100 |
11/10/1982 |
RX 91 |
BAUER, CHENG & ASSOCIATES, INC. |
|
| K823099 |
11/10/1982 |
RX MIDACAST |
BAUER, CHENG & ASSOCIATES, INC. |
|
| K822946 |
11/12/1982 |
BACTEC NAP TB DIFFERENTIATION TEST |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
| K822728 |
11/05/1982 |
SOLID PHASE SIMUL TRAC VITAMIN B12 |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
| K822912 |
11/16/1982 |
BEAR VM-90 VENTILATION MONITOR |
BEAR MEDICAL SYSTEMS, INC. |
|
| K822984 |
11/10/1982 |
ID-ZONE LD ISOENZYME CONTROL |
BECKMAN INSTRUMENTS, INC. |
|
| K822803 |
11/01/1982 |
BLOOD OXYGENATORS #BOS-105S BOS-5S W/ |
BENTLEY LABORATORIES, INC. |
|
| K823006 |
11/04/1982 |
MEDEVICES ASPIRATION HOSE |
BERKELEY MEDEVICES |
|
| K822977 |
11/16/1982 |
HEMOGLOBIN ALC BY COLUMN TEST |
BIO-RAD |
|
| K823004 |
11/05/1982 |
BIO MAG TOTAL T4 RADIOIMMUNOASSAY KIT |
BIOCLINICAL GROUP |
|
| K823211 |
11/22/1982 |
CK-UV REAGENT |
BIORENT DIAGNOSTIC, INC. |
|
| K823060 |
11/22/1982 |
HEMOGLOBIN REAGENT |
BIORENT DIAGNOSTIC, INC. |
|
| K822907 |
11/01/1982 |
KALOS-03 BIPOLAR |
BIOTRONIK SALES, INC. |
|
| K823087 |
11/18/1982 |
BOEHRINGER MANNEHEIM DIAG. ACID PHOSPHA |
BOEHRINGER MANNHEIM CORP. |
|
| K823213 |
11/22/1982 |
DIAGNOSTICS ALKALINE PHOSPHATASE OPTIMI |
BOEHRINGER MANNHEIM CORP. |
|
| K823196 |
11/29/1982 |
SPECIAL CONTROL SERUM FOR HDL-CHOLES |
BOEHRINGER MANNHEIM CORP. |
|
| K822989 |
11/03/1982 |
HARVARD APPARATUS SINGLE SPEED SYRINGE |
C.R. BARD, INC. |
|
| K821477 |
11/01/1982 |
WM. HARVEY H-1300 INFANT/PEDIATRIC BLOOD |
C.R. BARD, INC. |
|
| K822939 |
11/24/1982 |
HEART RATE & TEMP. MEASUREMENT SYSTEM |
CAMINO LABORATORIES, INC. |
|
| K822774 |
11/03/1982 |
9110 SYRINGE |
CARDIAC PACEMAKERS, INC. |
|
| K823204 |
11/30/1982 |
BETATRON II |
CARDIAC PACEMAKERS, INC. |
|
| K822775 |
11/03/1982 |
INFUS. SETS-9120-50 CM & 9121-100 CM,EXT |
CARDIAC PACEMAKERS, INC. |
|
| K822776 |
11/03/1982 |
TEFLON CANNULA |
CARDIAC PACEMAKERS, INC. |
|
| K823215 |
11/24/1982 |
CKG 8800 |
CARDIOKINETICS, INC. |
|
| K822930 |
11/01/1982 |
CSM CHROMOGENIC B-LACTAMASE DISC |
CARR-SCARBOROUGH MICROBIOLOGICALS, INC. |
|
| K827489 |
11/04/1982 |
HYPERLUX 30 IMAGE SYSTEM |
CGR MEDICAL CORP. |
DENNIS UPRIGHT |
| K822432 |
11/01/1982 |
CENTURION CHART RECORDER |
CLINICAL DATA, INC. |
|
| K823092 |
11/22/1982 |
HEMAFLO BLOOD TUBING SETS |
COBE LABORATORIES, INC. |
|
| K827383 |
11/23/1982 |
MODEL 900 PHOTOCOAGULATOR WITH GREEN-ONLY OPTIONS |
COHERENT RADIATION LABORATORIES |
|
| K823174 |
11/16/1982 |
MICROSURGICAL INSTRUMENTS |
CONCEPT, INC. |
|
| K823138 |
11/29/1982 |
CELL SCRAPER |
CORNING COSTAR CORP. |
|
| K823144 |
11/29/1982 |
SINGLE STEP FREE-T4 125I RADIOIMMUNO- |
CORNING MEDICAL & SCIENTIFIC |
|
| K823193 |
11/30/1982 |
AMBULATORY INSULIN INFUSION PUMP 9205 |
CPI, INC. |
|
| K823433 |
11/30/1982 |
BALLOON THERMODILUTION CATHETER #7164& |
CRITIKON COMPANY,LLC |
|
| K823103 |
11/17/1982 |
DIALYSATE ADDITIVES-POWDER/LIQUID |
DI-CHEM, INC. |
|
| K822882 |
11/05/1982 |
COAT-A-COUNT FREE THYROXINE KIT/COMPONEN |
DIAGNOSTIC PRODUCTS CORP. |
|
| K823201 |
11/29/1982 |
HUMAN PLACENTAL LACTOGEN KIT |
DIAGNOSTIC PRODUCTS CORP. |
|
| K823109 |
11/10/1982 |
GENERIC PREGNANCY TEST |
DIAGNOSTIC SPECIALTIES |
|
| K822891 |
11/24/1982 |
FLO CONTROL |
DNA MEDICAL, INC. |
|
| K822649 |
11/03/1982 |
DEVICE FOR THE TREATMENT OF HEMORRHOIDS |
DUNMORE CORP. |
|
| K823280 |
11/22/1982 |
DISTAFLEX |
DURADENT CORP. |
|
| K822960 |
11/16/1982 |
MICROFLUOR B PLATE & MICRO FLUOR W PLATE |
DYNATECH CORP. |
|
| K822962 |
11/16/1982 |
MICROFLUOR B REMOVAWELL STRIPS |
DYNATECH CORP. |
|
| K823218 |
11/16/1982 |
DISPOSABLE DISPENSE MANIFOLD |
DYNATECH LABORATORIES, INC. |
|
| K823270 |
11/17/1982 |
HEAVY-DUTY I.V. STAND |
E.F. BREWER CO. |
|
| K822841 |
11/16/1982 |
THE EMD TENZ PAIN CONTROL SYSTEM |
ELECTRO MEDICAL DEVELOPMENT |
|
| K823312 |
11/30/1982 |
CADIO-RESPIRATORY MONITOR #CR-2 |
ELECTROMED INTL., LTD. |
|
| K823126 |
11/16/1982 |
MODEL SA-1 STETHOSCOPE AUDIO AMPLIFIER |
ELECTROMEDICS, INC. |
|
| K822937 |
11/05/1982 |
GLUCOSE/UREA NITROGEN STANDARD |
EMD CHEMICALS INC. |
|
| K823247 |
11/16/1982 |
U-WAY QUICKOLLAR |
EMS INDUSTRIES, INC. |
|
| K822879 |
11/16/1982 |
ENTERAL NUTRITION 1 |
EXCO, INC. |
|
| K822087 |
11/17/1982 |
DIA SCOPE |
EXITEC, INC. |
|
| K822086 |
11/08/1982 |
DIA-SPEC |
EXITEC, INC. |
|
| K822340 |
11/03/1982 |
EXTRACORPOREAL SINGLE NEEDLE MODULE |
EXTRACORPOREAL MEDICAL SPECIALITIES, INC. |
JAMES J MCDCRACKEN |
| K823205 |
11/24/1982 |
EXV VENOUS RESERVOIR BAG & HOLDER |
EXTRACORPOREAL MEDICAL SPECIALITIES, INC. |
|
| K823108 |
11/30/1982 |
INTERSEPT PEDIACTRIC EXTRACORPOREAL FILT |
EXTRACORPOREAL MEDICAL SPECIALITIES, INC. |
|
| K823106 |
11/16/1982 |
RERMCO TEST CHLORIDE REAGENT |
FERMCO BIOCHEMICS, INC. |
|
| K823009 |
11/05/1982 |
GAMMA CLQ |
GAMMA MEDICAL PRODUCTS, INC. |
|
| K823210 |
11/24/1982 |
MODEL 525 NEO-TRAK NEONATAL RECORDER |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
|
| K822809 |
11/22/1982 |
AZLOCILLIN 75 MCG SUSCEPTIBILITY DISC |
GENERAL DIAGNOSTICS |
|
| K823050 |
11/16/1982 |
CIN AGAR MEDIUM |
GIBCO LABORATORIES LIFE TECHNOLOGIES, INC. |
|
| K823233 |
11/29/1982 |
SBA 300 CLINICAL CHEMISTRY ANALYZER |
GILFORD INSTRUMENT LABORATORIES, INC. |
|
| K823070 |
11/05/1982 |
ACETAMIDE AGAR SLANT |
GRANITE DIAGNOSTICS, INC. |
|
| K822995 |
11/16/1982 |
ANDRADES FERMENTATION MEDIA |
GRANITE DIAGNOSTICS, INC. |
|
| K822998 |
11/16/1982 |
CHRISTENSENS CITRATE SULFIDE AGAR |
GRANITE DIAGNOSTICS, INC. |
|
| K822994 |
11/16/1982 |
CORN MEAL AGAR W/POLYSORBATE 80 |
GRANITE DIAGNOSTICS, INC. |
|
| K822999 |
11/16/1982 |
DNASE TEST AGAR W/TOLUIDINE BLUE |
GRANITE DIAGNOSTICS, INC. |
|
| K823091 |
11/05/1982 |
H BROTH |
GRANITE DIAGNOSTICS, INC. |
|
| K822996 |
11/16/1982 |
JORDANS TARTRATE AGAR |
GRANITE DIAGNOSTICS, INC. |
|
| K823072 |
11/05/1982 |
LECITHIN LACTOSE AGAR |
GRANITE DIAGNOSTICS, INC. |
|
| K823000 |
11/16/1982 |
MACATE BROTH |
GRANITE DIAGNOSTICS, INC. |
|
| K823001 |
11/16/1982 |
PEPTONE IRON AGAR |
GRANITE DIAGNOSTICS, INC. |
|
| K823071 |
11/05/1982 |
RICE EXTRACT AGAR |
GRANITE DIAGNOSTICS, INC. |
|
| K822997 |
11/17/1982 |
STREP SELECTIVE AGAR |
GRANITE DIAGNOSTICS, INC. |
|
| K822855 |
11/05/1982 |
YERSINIA ISOLATION MEDIUM |
GRANITE DIAGNOSTICS, INC. |
|
| K822750 |
11/01/1982 |
MEDI-TRACE 5' OFFSET ELECTRODE |
GRAPHIC CONTROLS CORP. |
|
| K822315 |
11/16/1982 |
GFB-B CONTACT LENS BLANKS |
HAMEL, PARK, MCCABE & SAUNDERS |
|
| K822688 |
11/05/1982 |
DIGITAL DILUTER/DISPENSERS |
HAMILTON CO. |
|
| K823147 |
11/22/1982 |
URIC ACID STANDARD, 8MG/DL #65078 |
HARLECO DIAGNOSTICS |
|
| K822765 |
11/17/1982 |
SIGMOIDOSCOPE, FLEXIBLE |
HARVARD LABORATORIES |
|
| K823133 |
11/17/1982 |
AIR FLOW I |
HEALTHCO, INC. |
|
| K823134 |
11/17/1982 |
AIR FLOW II |
HEALTHCO, INC. |
|
| K822124 |
11/01/1982 |
TITAN GEL CPK ISOENZYME SYSTEM |
HELENA LABORATORIES |
|
| K822987 |
11/05/1982 |
DRESSING SPONGE |
HERMITAGE HOSPITAL PRODUCTS, INC. |
|
| K823212 |
11/29/1982 |
ABUSCREEN RADIOIMMUNOASSAY - AMPHETAMINE |
HOFFMANN-LA ROCHE, INC. |
|
| K822926 |
11/24/1982 |
MODEL LS-85 & MEDEL 1828 LINESCAN VISCO |
HONEYWELL, INC. |
|
| K823199 |
11/29/1982 |
ENZYME-TEST DIGOXIN |
ICL SCIENTIFIC |
|
| K823026 |
11/22/1982 |
380 PIGGYBACK CONTROLLER |
IMED CORP. |
|
| K823027 |
11/22/1982 |
ACCUDOT 380 SECONDARY I.V. SET |
IMED CORP. |
|
| K823346 |
11/30/1982 |
ACCUSET ADMINISTRATION SET |
IMED CORP. |
|
| K823347 |
11/24/1982 |
MACRODOT ADD-I-MED ADMIN. SET |
IMED CORP. |
|
| K822606 |
11/01/1982 |
CYTOMEGALOVIRUS ANTOBODY IGG |
IMMULOK, INC. |
|
| K823055 |
11/05/1982 |
FLOUROSET IMMUNOFLUORESCENT ANTIBODY |
IMMULOK, INC. |
|
| K822785 |
11/29/1982 |
FLUOROSET IMMUNOFLUORESCENT ANTIBODY |
IMMULOK, INC. |
|
| K823036 |
11/08/1982 |
AUTOCLAVE TESTING ADHESIVE TAPE |
INDUSTRIAS TUK, S.A. DE C.V. |
|
| K823124 |
11/22/1982 |
IMS HEMATOLOGY MIXER |
INNOVATIVE MEDICAL SYSTEMS, INC. |
|
| K822972 |
11/01/1982 |
IL 801 THERMALDILUTION CARDIAC OUTPUT |
INSTRUMENTATION LABORATORY CO. |
|
| K822704 |
11/24/1982 |
MODEL 366-07 ADAPT AID LEAD ADAPTER |
INTERMEDICS, INC. |
|
| K822327 |
11/16/1982 |
CALIBRATOR FOR HEMOGLOBIN & HEMOCRIT |
INTERSCIENCE, INC. |
|
| K822324 |
11/08/1982 |
RED CELL LYSING REAGENT 78N 1915-1 |
INTERSCIENCE, INC. |
|
| K823093 |
11/16/1982 |
CHANNEL BACK |
J.G. SHUMAN ASSOC. |
|
| K820775 |
11/03/1982 |
VESTIBULARISET |
JEDMED INSTRUMENT CO. |
|
| K823008 |
11/03/1982 |
NOVAREX |
JENERIC IND. |
|
| K823041 |
11/24/1982 |
JEOL MODEL #JTG-500M |
JEOL |
|
| K823185 |
11/22/1982 |
GAMMA LIGHT CURING DENTAL RESTORATIVE |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
|
| K823107 |
11/16/1982 |
QUANTIMETRIC 2 CERULOPLASMIN ASSAY |
KALLESTAD LABORATORIES, INC. |
|
| K822252 |
11/22/1982 |
ENT TREATMENT UNITS |
KELLEHER CORP. |
|
| K822272 |
11/10/1982 |
HEAD MIRRORS W/HEAD LAMPS & HEAD BANDS |
KELLEHER CORP. |
|
| K823111 |
11/22/1982 |
NYSTYMOGRAPH ACCESS |
KELLEHER CORP. |
|
| K823227 |
11/22/1982 |
IMPEDANCE METER ON-1 |
KELLS MEDICAL, INC. |
|
| K823226 |
11/22/1982 |
SN-100 DOCTOR'S ROUND |
KELLS MEDICAL, INC. |
|
| K823175 |
11/16/1982 |
SIDEWINDER OMNI WHEELCHAIR DIRECT/POWER |
KINETIC CONCEPTS, INC. |
|
| K823024 |
11/16/1982 |
KM - KAL 1 |
KMN PRODUCTS, INC. |
|
| K823025 |
11/16/1982 |
KM - KAL 2 |
KMN PRODUCTS, INC. |
|
| K823021 |
11/16/1982 |
KM - KAL 5 |
KMN PRODUCTS, INC. |
|
| K823019 |
11/16/1982 |
KM-KAL 3 |
KMN PRODUCTS, INC. |
|
| K823020 |
11/16/1982 |
KM-KAL 4 |
KMN PRODUCTS, INC. |
|
| K823022 |
11/16/1982 |
KM-KAL 6 |
KMN PRODUCTS, INC. |
|
| K823042 |
11/05/1982 |
KM-KAL L1 |
KMN PRODUCTS, INC. |
|
| K823043 |
11/05/1982 |
KM-KAL L2 |
KMN PRODUCTS, INC. |
|
| K823045 |
11/05/1982 |
KM-KAL L4 |
KMN PRODUCTS, INC. |
|
| K823046 |
11/05/1982 |
KM-KAL L5 |
KMN PRODUCTS, INC. |
|
| K823023 |
11/16/1982 |
KM-KAL L6 |
KMN PRODUCTS, INC. |
|
| K822952 |
11/01/1982 |
560 |
KONE INSTRUMENTS, INC. |
|
| K822969 |
11/04/1982 |
GENERATION 5 LINKOW BLADE IMPLANTS |
LEONARD P. LINKOW, D.D.L. |
|
| K823432 |
11/30/1982 |
1512M/F WIRE ELECTRODE NEEDLE SET |
LIFE-TECH INTL., INC. |
|
| K822917 |
11/01/1982 |
MODEL 5400 OPTOKINETIC STIMULATOR |
LIFE-TECH INTL., INC. |
|
| K822861 |
11/03/1982 |
LIFELINE 4800-C DIGITAL SPIROMETER |
LIFELINE CONTROLS |
|
| K822699 |
11/05/1982 |
GLUCOSCAN METER MODEL II |
LIFESCAN, INC. |
|
| K822159 |
11/03/1982 |
ANGIOUROGRAPHY KIT |
MALLINCKRODT CRITICAL CARE |
|
| K822829 |
11/17/1982 |
ROTARY VASCULAR KNIFE |
MEDCO PRODUCTS, CO., INC. |
|
| K822864 |
11/16/1982 |
INTRACRANIAL PRESSURE MONITORING DEVICE |
MEDEX, INC. |
|
| K822102 |
11/24/1982 |
PRESS-O-TEST |
MEDI-SWISS CORP. |
|
| K822986 |
11/16/1982 |
PULMONARY FUNCTION LAB SYSTEM 1070 |
MEDICAL GRAPHICS CORP. |
|
| K823258 |
11/24/1982 |
INTERFACE ARTERIAL BLOOD FILTER #40 |
MEDICAL, INC. |
|
| K823259 |
11/24/1982 |
INTERFACE CARDIOTOMY BLOOD FILTER #50 |
MEDICAL, INC. |
|
| K823260 |
11/24/1982 |
INTERFACE CARDIOTOMY BLOOD FILTER #51 |
MEDICAL, INC. |
|
| K822781 |
11/30/1982 |
MEDTRONIC MODELS 4011 & 4511 |
MEDTRONIC VASCULAR |
|
| K822955 |
11/01/1982 |
MODEL 4242 TELE SYST ARRHYTHMIA MONITOR |
MEDTRONIC VASCULAR |
|
| K823279 |
11/22/1982 |
RESPOND QUADRIFLEX #3129 SINGLE CHANNEL |
MEDTRONIC VASCULAR |
|
| K823198 |
11/16/1982 |
RAPID PRESUMPTIVE IDENT. GPA STREP |
MICROCHEMICAL SPECIALITIES, CO. |
|
| K823112 |
11/29/1982 |
CLINISTAT TDA SERIES |
MILES LABORATORIES, INC. |
|
| K823434 |
11/30/1982 |
MIKRO-TIP CATHETER PRESSURE TRANSDUCER |
MILLAR INSTRUMENTS, INC. |
|
| K823314 |
11/24/1982 |
DENTAL INSTRUMENTS |
MILTEX, INC. |
|
| K823320 |
11/24/1982 |
DENTAL INSTRUMENTS - BONE CHISELS |
MILTEX, INC. |
|
| K823321 |
11/24/1982 |
DENTAL INSTRUMENTS - CARVER |
MILTEX, INC. |
|
| K823326 |
11/24/1982 |
DENTAL INSTRUMENTS - CUTTING INSTRUMENT |
MILTEX, INC. |
|
| K823318 |
11/24/1982 |
DENTAL INSTRUMENTS - EXCAVATORS |
MILTEX, INC. |
|
| K823317 |
11/24/1982 |
DENTAL INSTRUMENTS - EXPLORERS |
MILTEX, INC. |
|
| K823316 |
11/24/1982 |
DENTAL INSTRUMENTS - FILES |
MILTEX, INC. |
|
| K823315 |
11/24/1982 |
DENTAL INSTRUMENTS - KNIVES |
MILTEX, INC. |
|
| K823323 |
11/24/1982 |
DENTAL INSTRUMENTS - PLASTIC INSTRUMENTS |
MILTEX, INC. |
|
| K823322 |
11/24/1982 |
DENTAL INSTRUMENTS - PLUGGERS |
MILTEX, INC. |
|
| K823324 |
11/24/1982 |
DENTAL INSTRUMENTS - PROBES |
MILTEX, INC. |
|
| K823319 |
11/24/1982 |
DENTAL INSTRUMENTS - SCALERS |
MILTEX, INC. |
|
| K823325 |
11/24/1982 |
DENTAL INSTRUMENTS - SURGICAL FORCEPS |
MILTEX, INC. |
|
| K822635 |
11/16/1982 |
225 S.I.M.V. VENTILATOR |
MONAGHAN MEDICAL CORP. |
|
| K822437 |
11/03/1982 |
MONAGHAN AEROCHAMBER |
MONAGHAN MEDICAL CORP. |
|
| K822961 |
11/01/1982 |
PORTA FIB III |
NARCO SCIENTIFIC |
|
| K822909 |
11/01/1982 |
PULSE OXIMETER MODEL 100 |
NELLCOR, INC. |
|
| K823305 |
11/24/1982 |
DENTO SPRAY ORAL IRRIGATOR |
NEO-LIFE CO. OF AMERICA |
|
| K823220 |
11/24/1982 |
COSMOS |
NIHON KOHDEN AMERICA, INC. |
|
| K823249 |
11/24/1982 |
LIFESCOPE II/FOUR |
NIHON KOHDEN AMERICA, INC. |
|
| K822806 |
11/01/1982 |
BALLOON WEDGE PRESSURE, ANGIOGRAPHIC |
NOVA MEDICAL SPECIALTIES |
|
| K823053 |
11/10/1982 |
NML-TETRA-TUBE RIA |
NUCLEAR MEDICAL LABORATORIES, INC. |
|
| K822055 |
11/01/1982 |
CNIBP BLOOD PRESSURE MEASUREMENT SYS |
OHIO MEDICAL PRODUCTS |
|
| K822888 |
11/16/1982 |
OHIO CPU-1 INTENSIVE CARE VENTILATOR |
OHIO MEDICAL PRODUCTS |
|
| K823153 |
11/05/1982 |
BATH TUB SEAT & BATH BOARD |
ORTHION CORP. |
|
| K823156 |
11/05/1982 |
COLLAPSABLE LAVATORY HEIGHTENER |
ORTHION CORP. |
|
| K823155 |
11/05/1982 |
LAVATORY SEAT HEIGHTENER |
ORTHION CORP. |
|
| K823152 |
11/05/1982 |
OB HELP ARM |
ORTHION CORP. |
|
| K823149 |
11/05/1982 |
OB TILT TABLE |
ORTHION CORP. |
|
| K823151 |
11/05/1982 |
OB TRIPP TRANSPORT CHAIR |
ORTHION CORP. |
|
| K823105 |
11/05/1982 |
RESI-WALKER |
ORTHION CORP. |
|
| K823150 |
11/05/1982 |
SESAM TREATMENT TABLE |
ORTHION CORP. |
|
| K823154 |
11/05/1982 |
SHOWER STOOL W/HANDLES |
ORTHION CORP. |
|
| K823397 |
11/29/1982 |
ANATOMIC FRACTURE BRACE |
ORTHOPEDIC SYSTEMS, INC. |
|
| K823400 |
11/29/1982 |
ARTHROSCOPIC LEG HOLDER |
ORTHOPEDIC SYSTEMS, INC. |
|
| K823399 |
11/29/1982 |
COVER LIMB |
ORTHOPEDIC SYSTEMS, INC. |
|
| K823392 |
11/29/1982 |
FOREARM REDUCTION UNIT |
ORTHOPEDIC SYSTEMS, INC. |
|
| K823396 |
11/29/1982 |
FREE FLEX HEEL HEIGHT ADJUSTOR |
ORTHOPEDIC SYSTEMS, INC. |
|
| K822885 |
11/22/1982 |
HALO TRACTION CERVICAL IMMOBILIZATION |
ORTHOPEDIC SYSTEMS, INC. |
|
| K823398 |
11/24/1982 |
LATERAL POSITIONER |
ORTHOPEDIC SYSTEMS, INC. |
|
| K823391 |
11/29/1982 |
LEG PREP HOLDER |
ORTHOPEDIC SYSTEMS, INC. |
|
| K822903 |
11/01/1982 |
AUTOECHO |
OXFORD MEDILOG, INC. |
|
| K823007 |
11/01/1982 |
OPTICATH HEPARIN COATED, FLOW-DIRECT |
OXIMETRIX, INC. |
|
| K823285 |
11/29/1982 |
MODEL WHO1 HEARING AID |
PANASONIC CO. DIV. MATSU ELEC. CORP. AMERICA |
|
| K823066 |
11/17/1982 |
DESERT INSYTE-A HYPERTHERMIA SENSOR ACC |
PARKE-DAVIS CO. |
|
| K822711 |
11/03/1982 |
ANTI-MIST, ANTI-FOG EYEGLASS & DENTAL |
PARKER LABORATORIES, INC. |
|
| K823014 |
11/01/1982 |
DIGOXIN KIT |
PCL-RIA, INC. |
|
| K822935 |
11/01/1982 |
THYROID STIMULATING HORMONE |
PCL-RIA, INC. |
|
| K822938 |
11/05/1982 |
PHADEBASE HUMYLASE CONTROL |
PHARMACIA, INC. |
|
| K822486 |
11/05/1982 |
HOME BLOOD GLUCOSE MONITOR |
PHARMAQUEST CORP. |
|
| K822976 |
11/16/1982 |
HYPOCOUNT A |
PHARMAQUEST CORP. |
|
| K823120 |
11/08/1982 |
EXACTA & CONNECTA STOPCOCKS W/EXTENSION |
PIONEER VIGGO, INC. |
|
| K822784 |
11/05/1982 |
HEMO-DE |
PMP INDUSTRIES |
|
| K822849 |
11/29/1982 |
RAAF DUAL LUMEN CATHETER |
QUINTON, INC. |
|
| K822910 |
11/29/1982 |
RIGHT ARTERIAL CATHETER |
QUINTON, INC. |
RANDY WALLS |
| K822964 |
11/30/1982 |
RIGHT ATRIAL CATHETER |
QUINTON, INC. |
RANDY WALLS |
| K823187 |
11/22/1982 |
CHOLESTEROL HIGH SENSIT. REAGENT ENZYM |
RAI, INC. |
|
| K823090 |
11/22/1982 |
RAICHEM & GT REAGENT |
REAGENTS APPLICATIONS, INC. |
|
| K823180 |
11/22/1982 |
SA-21 DENTAL UNIT |
RITTER CO. |
|
| K822971 |
11/16/1982 |
SALIVA SUBSTITUTE |
ROXANE LABORATORIES, INC. |
|
| K823278 |
11/22/1982 |
DENTAL FLOSS TIP |
SANDERSON CREATIVE PRODUCTS CO. |
|
| K823132 |
11/27/1982 |
SARTOPHOR SYSTEM FOR ELECTROPHORESIS |
SARTORIUS FILTERS, INC. |
|
| K823223 |
11/22/1982 |
VIEW-PACK & MULTI POUCH |
SBW MEDICAL PACKAGING, INC. |
|
| K822088 |
11/03/1982 |
MALE CONDOM |
SCHMID LABORATORIES, INC. |
WAYNE MATELSKI |
| K823061 |
11/05/1982 |
BRUSH, SCRUB, OPERATING ROOM |
SEAMLESS HOSPITAL PRODUCTS CO. |
|
| K823143 |
11/29/1982 |
BUBBLE HUMIDIFIERS |
SEVEN HARVEST INTL. IMPORT & EXPORT |
|
| K823141 |
11/29/1982 |
OXYGEN MASKS |
SEVEN HARVEST INTL. IMPORT & EXPORT |
|
| K823142 |
11/29/1982 |
OXYGEN TUBINGS |
SEVEN HARVEST INTL. IMPORT & EXPORT |
|
| K822958 |
11/05/1982 |
LANCER MSH GLUCOSE DIAG. KIT |
SHERWOOD MEDICAL CO. |
|
| K823176 |
11/22/1982 |
MONOJECT SAMPLETTE CAPILLARY SERUM SEP |
SHERWOOD MEDICAL CO. |
|
| K822983 |
11/24/1982 |
MINGOCARD 7 & MINGOPHONE 7 |
SIEMENS CORP. |
|
| K823179 |
11/16/1982 |
CHLAMYDIA TRANSETTEE 1 & 3 |
SPECTRUM CO. |
|
| K823237 |
11/29/1982 |
BARBITURATE TEST SET #0550-050 |
STANBIO LABORATORY |
|
| K823128 |
11/29/1982 |
ADVANCE EMIT CAD PROCAINAMIDE ASSAY |
SYVA CO. |
|
| K823129 |
11/29/1982 |
ADVANCE EMIT-CAD N-ACETYLPROCAINAMIDE |
SYVA CO. |
|
| K823127 |
11/29/1982 |
ADVANCE EMIT-CAD PROCAINAMIDE/N-ACETYL |
SYVA CO. |
|
| K822932 |
11/05/1982 |
EMIT CLINICAL PROCESSOR #CP-5000 |
SYVA CO. |
|
| K823034 |
11/08/1982 |
SYVA ADVANCE THYROXINE ASSAY |
SYVA CO. |
|
| K823276 |
11/24/1982 |
BED GUARD |
T. S. ENTERPRISES, INC. |
|
| K822744 |
11/03/1982 |
#ST10 PROGR. EVOKED RESPONSE STIMULATOR |
TECA, INC. |
|
| K822900 |
11/08/1982 |
FISCH DRILL PUMP |
TEKNAR, INC. |
|
| K823011 |
11/08/1982 |
VC III |
TEKNAR, INC. |
|
| K822963 |
11/08/1982 |
SURGICAL PRODUCTS, SKIN STAPLE REMOVER |
TEMP-STIK CORP. |
|
| K823125 |
11/24/1982 |
CAPIOX II |
TERUMO MEDICAL CORP. |
|
| K823173 |
11/22/1982 |
ARRIRM SCRUB BRUSH/SPONGE |
THE BUCKEYE CELLULOSE CORP. |
|
| K823056 |
11/03/1982 |
THE INGLEFIELD MAGIC RING |
THE INGLEFIELD CO. |
|
| K823063 |
11/30/1982 |
FLO-GARD 2000 ENTERNAL PUMP & TRAVASORB |
TRAVENOL LABORATORIES, S.A. |
|
| K823082 |
11/16/1982 |
TRAVASORB NASOGASTRIC NASOINTESTINAL |
TRAVENOL LABORATORIES, S.A. |
|
| K823002 |
11/17/1982 |
DENDRITE VM-TRANSCUTANEOUS ELEC. NERVE |
TRI W-G, INC. |
|
| K822819 |
11/04/1982 |
TRIMED 510 APNEA MONITOR |
TRI-MED, INC. |
|
| K822464 |
11/03/1982 |
"OBTURATION GUTTA" |
U.S. SHIZAI CORP. |
|
| K823365 |
11/22/1982 |
HEARING AID UE-10 |
UNITRON INDUSTRIES, INC. |
|
| K823366 |
11/29/1982 |
HEARING AID UE-10-H |
UNITRON INDUSTRIES, INC. |
|
| K822954 |
11/16/1982 |
MICROTECH BACTERIAL CONTROLS |
UNIVERSAL MICRO REFERENCE LABORATORY |
|
| K822929 |
11/17/1982 |
VERIL/PPR PERSONAL PAIN RELIEVER #800 |
VERITE |
|
| K823255 |
11/22/1982 |
NON-STERILE REUSABLE NEEDLES |
VERTEX MEDICAL CORP. |
|
| K823052 |
11/30/1982 |
THE 500 MONITOR SERIES |
VITATEK |
|
| K823164 |
11/16/1982 |
ABDOMINAL BINDER |
WARM & FORM, ORTHOPEDIC MATERIALS |
|
| K823161 |
11/10/1982 |
CERVICAL COLLAR |
WARM & FORM, ORTHOPEDIC MATERIALS |
|
| K823157 |
11/10/1982 |
CLAVICLE SUPPORT |
WARM & FORM, ORTHOPEDIC MATERIALS |
|
| K823159 |
11/10/1982 |
DELUXE KNEE IMMOBILIZER |
WARM & FORM, ORTHOPEDIC MATERIALS |
|
| K823166 |
11/10/1982 |
PELVIC TRACTION BELT |
WARM & FORM, ORTHOPEDIC MATERIALS |
|
| K823158 |
11/10/1982 |
RIB BELT (UNIVERSAL) |
WARM & FORM, ORTHOPEDIC MATERIALS |
|
| K823160 |
11/10/1982 |
ROTATION BOOT |
WARM & FORM, ORTHOPEDIC MATERIALS |
|
| K823163 |
11/10/1982 |
UNIVERSAL BUCKS TRACTION |
WARM & FORM, ORTHOPEDIC MATERIALS |
|
| K823162 |
11/10/1982 |
UNIVERSAL SLING, SLING & SWATHE |
WARM & FORM, ORTHOPEDIC MATERIALS |
|
| K823165 |
11/16/1982 |
WRIST SPLING & FOREARM SPLINT |
WARM & FORM, ORTHOPEDIC MATERIALS |
|
| K823080 |
11/24/1982 |
VAKUTAGE |
WESTON, COPCO, INC. |
|
| K823200 |
11/29/1982 |
125 I-DEHYDROEPIANDROSTERONE SULFATE |
WIEN LABORATORIES, INC. |
|
| K823035 |
11/24/1982 |
COMPUTER INTERFACE MODULE CIM |
Y |
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