FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
K841118 |
03/15/1984 |
PROLACTIN RIABEAD PROLACTIN RADIOIMM |
ABBOTT LABORATORIES |
|
K840941 |
03/05/1984 |
TDX ACETAMINOPHEN |
ABBOTT LABORATORIES |
|
K840953 |
03/05/1984 |
ACCESS SCANHEADSS |
ADVANCED TECHNOLOGY LABORATORIES, INC. |
|
K841283 |
03/28/1984 |
DISPOSABLE SUCTION TUBING SET |
AESTHETECH CORP. |
|
K841083 |
03/13/1984 |
QUIKPAGE ARRHYTHMIA REPORT GENERATOR |
AGILENT TECHNOLOGIES |
WILLIAM B RICH |
K841032 |
03/12/1984 |
HOLDER FOR MODELS AF-10,1025,1040,5 |
AMERICAN BENTLEY |
|
K841031 |
03/12/1984 |
OXYHI CRYSTALLOID CARDIOPLEGIA SOLUT |
AMERICAN BENTLEY |
|
K840957 |
03/06/1984 |
ANTIMICROBIAL INCISE DRAPE |
AMERICAN CONVERTORS DIV., AMERICAN PHARMASEAL |
|
K841047 |
03/12/1984 |
PARAMAX CHLORIDE REAGENT |
AMERICAN DADE |
|
K841384 |
03/20/1984 |
PROXIMA 1 PH MONITOR |
AMERICAN ENDOSCOPY, INC. |
|
K841156 |
03/19/1984 |
VANTAGE E |
AMERICAN STERILIZER CO. |
|
K840982 |
03/06/1984 |
LASER MIRROR |
AMERICAN V. MUELLER |
|
K841220 |
03/22/1984 |
ANAEROBIC TRANSPORT MEDIUM |
ANAEROBE SYSTEMS |
|
K841222 |
03/22/1984 |
BACTEROIDES BILE ESCULIN GAR |
ANAEROBE SYSTEMS |
|
K841221 |
03/22/1984 |
BRAIN HEART INFUSION BROTH |
ANAEROBE SYSTEMS |
|
K841303 |
03/30/1984 |
CAMPYLOBACTER THIOGLYCOLLATE MED |
ANAEROBE SYSTEMS |
|
K841144 |
03/16/1984 |
CHOCOLATE AGAR W/COFACTOR |
ANAEROBE SYSTEMS |
|
K841143 |
03/16/1984 |
COLUMBIA AGAR W/5% SHEEP BLOOD |
ANAEROBE SYSTEMS |
|
K841139 |
03/16/1984 |
COLUMBIA AGAR W/COLISTIN, NALADIXIC |
ANAEROBE SYSTEMS |
|
K841218 |
03/22/1984 |
CYCLOSERINE-CEFOXITIN FRUCTOSE AGAR |
ANAEROBE SYSTEMS |
|
K841132 |
03/16/1984 |
EILE-ESCULIN AZIDE AGAR |
ANAEROBE SYSTEMS |
|
K841129 |
03/16/1984 |
HEKTOEN ENTERIC AGAR |
ANAEROBE SYSTEMS |
|
K841142 |
03/16/1984 |
LEVINE EOSIN METHYLENE BLUE AGAR |
ANAEROBE SYSTEMS |
|
K841141 |
03/16/1984 |
MACCONKEY AGAR |
ANAEROBE SYSTEMS |
|
K841134 |
03/16/1984 |
MANNITOL SALT AGAR |
ANAEROBE SYSTEMS |
|
K841138 |
03/16/1984 |
MUELLER HINTON AGAR W/BLOOD & COFACTOR |
ANAEROBE SYSTEMS |
|
K841137 |
03/16/1984 |
MUELLER HINTON AGAR W/WO BLOOD |
ANAEROBE SYSTEMS |
|
K841135 |
03/16/1984 |
MYCOSEL AGAR W/CHLORAMPHENICOL & |
ANAEROBE SYSTEMS |
|
K841140 |
03/16/1984 |
PHENYLETHYL ALCOHOL BLOOD AGAR |
ANAEROBE SYSTEMS |
|
K841136 |
03/16/1984 |
SABOURAUD DEXTROSE AGAR W/CHLORAMPHE |
ANAEROBE SYSTEMS |
|
K841219 |
03/22/1984 |
SHOPPED MEAT CARBOHYDRATE |
ANAEROBE SYSTEMS |
|
K841133 |
03/16/1984 |
THAYER MARTIN MEDIUM |
ANAEROBE SYSTEMS |
|
K841130 |
03/16/1984 |
TRYPTICASE SOY AGAR W/5% SHEEP BLOOD |
ANAEROBE SYSTEMS |
|
K841131 |
03/16/1984 |
XYLOSE LYSINE DESOXYCHOLATE AGAR |
ANAEROBE SYSTEMS |
|
K841077 |
03/12/1984 |
ARK TONGUE CLEANER |
ARKAY CO. |
|
K841095 |
03/13/1984 |
BP800, 850 1000 |
ASSOCIATED MILLS, INC. |
|
K841100 |
03/13/1984 |
HP-20, 30, 40, 50 & 60 |
ASSOCIATED MILLS, INC. |
|
K841270 |
03/27/1984 |
RIM - NITRATE TEST |
AUSTIN BIOLOGICAL LABORATORIES |
|
K841262 |
03/26/1984 |
RIM-BILE ESCULIN TEST |
AUSTIN BIOLOGICAL LABORATORIES |
|
K841277 |
03/28/1984 |
RIM-HIPPURATE |
AUSTIN BIOLOGICAL LABORATORIES |
|
K840943 |
03/05/1984 |
ENDO-JECT |
AUTOVAGE |
|
K841253 |
03/26/1984 |
COMPRESSION STOCKINGS W/WAIST SUSPENS- |
BAURS KREY ASSOC., INC. |
|
K841252 |
03/26/1984 |
GLATTELAST COMPRESSION PANTY HOSE |
BAURS KREY ASSOC., INC. |
|
K841215 |
03/22/1984 |
GLATTELAST COMPRESSION STOCKINGS |
BAURS KREY ASSOC., INC. |
|
K841171 |
03/19/1984 |
TRILICON BREASE PROSTHESIS DIFFERENT |
BAURS KREY ASSOC., INC. |
|
K841307 |
03/30/1984 |
BBL GASPAK POUCH |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K841308 |
03/30/1984 |
DIRECTIGEN MENNINGITIS TEST KIT |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K840959 |
03/06/1984 |
FREE T3 SOLID PHASE RADIOIMMUNOASSAY |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K841117 |
03/15/1984 |
GASPAK PLUS DISPOS. HYDROGEN & |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K841279 |
03/28/1984 |
BEAR 33 |
BEAR MEDICAL SYSTEMS, INC. |
|
K841181 |
03/20/1984 |
ASTRA SYS INORGANIC PHOSPHORUS CHEM |
BECKMAN INSTRUMENTS, INC. |
|
K841182 |
03/20/1984 |
MULTIPLE CHEM. MODULE FOR ANALYSIS |
BECKMAN INSTRUMENTS, INC. |
|
K841043 |
03/12/1984 |
BEHRING ELISA PROCESSOR M |
BEHRING DIAGNOSTICS, INC. |
|
K841245 |
03/23/1984 |
ENZYGNOST ANTIHERPES SIMPLEX VIRUS |
BEHRING DIAGNOSTICS, INC. |
|
K841243 |
03/23/1984 |
ENZYGNOST ROTAVIRUS AG |
BEHRING DIAGNOSTICS, INC. |
JOHN E HUGHES |
K840952 |
03/05/1984 |
MEDEVICE V-80 VACUUM PUMP |
BERKELEY MEDEVICES |
|
K840918 |
03/01/1984 |
MICRO SPAN TRANSCUTANEOUS OXYGEN MONIT |
BIOCHEM INTERNATIONAL, INC. |
|
K841000 |
03/09/1984 |
BET MODEL 1010 |
BIOELECTRO TECHNOLOGIES |
|
K841273 |
03/27/1984 |
ACCOMMOTRAC VISION TRAINER |
BIOFEEDTRAC, INC. |
|
K841184 |
03/20/1984 |
ELECTRO-NERVE STIMULATOR HL |
BIOMEDICAL LIFE SYSTEMS, INC. |
|
K840936 |
03/05/1984 |
NEEDLE CATHETER JEJUNOSTOMY REPAIR KIT |
BIOSEARCH MEDICAL PRODUCTS, INC. |
|
K840962 |
03/06/1984 |
REFLOCHECK-S |
BOEHRINGER MANNHEIM CORP. |
|
K841295 |
03/29/1984 |
HYPOTHERMIA OXYGEN WARMER-TREATMENT SYS |
BOW/PARM |
|
K842169 |
03/13/1984 |
FCP-11ECG |
BRENTWOOD INSTRUMENTS, INC. |
|
K841079 |
03/13/1984 |
WILLIAM HARVEY H-4700 FILTER/CARDIO |
C.R. BARD, INC. |
|
K841175 |
03/19/1984 |
WILLIAM HARVEY H-4720 NON-FILTERED CAR |
C.R. BARD, INC. |
|
K841042 |
03/12/1984 |
MATCHED COMPONENT SET RADIOIMMUNOASSAY |
CAMBRIDGE MEDICAL TECHNOLOGY |
|
K840976 |
03/06/1984 |
VARIOUS DISPOSABLE KITS/TRAYS/INSTRU |
CARAPACE, INC. |
|
K840969 |
03/06/1984 |
CULTURE MEDIA FOR ANTIMICROBIAL SUSCEP |
CHATHAM BIOLOGICAL |
|
K840970 |
03/06/1984 |
CULTURE MEDIUM FOR PATHOGENIC NEISSER |
CHATHAM BIOLOGICAL |
|
K840971 |
03/06/1984 |
SELECTIVE CULTURE MEDIUM |
CHATHAM BIOLOGICAL |
|
K840965 |
03/06/1984 |
SITE COAXIAL I/A HANDPIECE 30 TIP |
CHIRON VISION CORP. |
|
K841099 |
03/12/1984 |
OCTOPUS 500/500E |
CILCO, INC. |
|
K841272 |
03/27/1984 |
SICKLE-STAT HEMOGLOBIN S SCREEN KIT |
CLINICAL TECHNOLOGY CORP. |
|
K840964 |
03/06/1984 |
SD PLUS CLINICIAN CAT# 78-8015 |
CODMAN & SHURTLEFF, INC. |
|
K840963 |
03/06/1984 |
SD PLUS PATIENT CAT.#78-8010 |
CODMAN & SHURTLEFF, INC. |
|
K841153 |
03/19/1984 |
ADAPTOR HR-3000 REUSE |
COLORADO MEDICAL, INC. |
|
K840988 |
03/07/1984 |
NO POUR BASIN |
CONCORD LABORATORIES, INC. |
|
K840986 |
03/07/1984 |
PREFILLED PULSATOR SYRINGE |
CONCORD LABORATORIES, INC. |
|
K840987 |
03/07/1984 |
VAPORIZED HEPARIN |
CONCORD LABORATORIES, INC. |
|
K841287 |
03/28/1984 |
DUODERM FLEXIBLE HYDROACTIVE DRESSINGS |
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
|
K841076 |
03/12/1984 |
ION SELECTIVE ELECTRODE |
COOPER BIOMEDICAL, INC. |
|
K841239 |
03/23/1984 |
ASSIGNED VALUE FOR MEAN PLATELET |
COULTER ELECTRONICS, INC. |
|
K840919 |
03/01/1984 |
DAYPAK SYS VII CATHETER CARE KIT |
CREATIVE CARE SYSTEMS, INC. |
|
K841242 |
03/23/1984 |
CSPI PREMIUM SURGICAL ASPIRATOR |
CUSTOM SURGICAL PRODUCTS, INC. |
|
K841383 |
03/26/1984 |
CSPI ROTARY SURGICAL ASPIRATOR |
CUSTOM SURGICAL PRODUCTS, INC. |
|
K841249 |
03/21/1984 |
SUCTION CANNULAS |
CUSTOM SURGICAL PRODUCTS, INC. |
PRICE R.N. |
K841202 |
03/21/1984 |
DACOMED RIGISCAN SYSTEM |
DACOMED CORP. |
|
K841167 |
03/19/1984 |
DEMLAR SYS I COMPUTER BASED AUDIOMETER |
DEMLAR MEDICAL, INC. |
|
K841111 |
03/15/1984 |
REMBRANDT SHADE MODIFICATION KIT |
DEN-MAT CORP. |
|
K841302 |
03/30/1984 |
DIAGNON FOLATE 125I RIA KIT |
DIAGNON CORP. |
|
K841094 |
03/13/1984 |
HUMAN GROWTH HORMONE RIA KIT |
DIAGNOSTIC PRODUCTS CORP. |
|
K840927 |
03/02/1984 |
FACTOR DEFICIENT SUBSTRATE PLASMA II |
DIATECH, INC. |
|
K840928 |
03/02/1984 |
FACTOR DEFICIENT SUBSTRATE PLASMA VIII |
DIATECH, INC. |
|
K841260 |
03/26/1984 |
ALBINAR ELECTRONIC DIGITAL THERMOMETER |
DIMENSION SPECIALTY CO., INC. |
|
K841234 |
03/22/1984 |
HALO CO LASER SYSTEM |
DIRECTED ENERGY, INC. |
|
K840923 |
03/02/1984 |
ANGIOGRAPHY NEEDLE W/WO CONNECTION |
DLP, INC. |
|
K840922 |
03/02/1984 |
INTRADISCAL THERAPY NEEDLE 18 GAUGE |
DLP, INC. |
|
K841125 |
03/15/1984 |
HUCKSTEPS STAPLES |
DOWNS SURGICAL LTD. |
|
K841197 |
03/21/1984 |
CYSTO-AID |
E-Z-EM, INC. |
|
K841266 |
03/26/1984 |
MONTGOMERY TRACHEAL T-TUBE |
E. BENSON HOOD LABORATORIES, INC. |
|
K841107 |
03/14/1984 |
ACA DIGOXIN ANALYTICAL TEST PACK |
E.I. DUPONT DE NEMOURS & CO., INC. |
|
K841108 |
03/14/1984 |
ACA DIGOXIN CALLIBRATOR |
E.I. DUPONT DE NEMOURS & CO., INC. |
|
K841127 |
03/16/1984 |
VIRGO REAGENTS INDIRECT FLUORSCENT |
ELECTRO-NUCLEONICS LABORATORIES, INC. |
|
K841173 |
03/19/1984 |
OSTOMY FREEDOM KIT |
ELLENBERG ASSOC. |
|
K841045 |
03/12/1984 |
EMPI MODEL 984 BASIX, TENS |
EMPI |
|
K841290 |
03/29/1984 |
STELDENT - DENTAL ALLOY |
ERIEZ |
|
K841014 |
03/09/1984 |
WEIGHTED FEEDING TUBE W/PRE-INSERTED |
ETHOX CORP. |
|
K840921 |
03/02/1984 |
THERACHEM TDC THERAPEUTIC DRUG CONTROL |
FISHER DIAGNOSTICS |
|
K841104 |
03/14/1984 |
ENTERNAL FEEDING PUMP BATTERY OPER. |
FRESENIUS USA, INC. |
RAINER K CREMERIUS |
K841271 |
03/27/1984 |
INFRA-EYE 160 |
FUJITSU LTD. |
|
K841084 |
03/13/1984 |
ARRHYTHMIA SYSTEM AC-11 |
FUKUDA DENSHI USA, INC. |
ROBERT STEURER |
K840949 |
03/05/1984 |
CLEAR PLASTIC-HYPOALLERGENIC |
GAINOR MEDICAL |
|
K840947 |
03/05/1984 |
CLOTH-HYPOALLERGENIC |
GAINOR MEDICAL |
|
K840951 |
03/05/1984 |
FIRST AID BANDAGE |
GAINOR MEDICAL |
MARK GAINOR |
K840946 |
03/05/1984 |
MICROPOROUS HYPOALLERGENIC |
GAINOR MEDICAL |
|
K840945 |
03/05/1984 |
SKIN CLOSURE |
GAINOR MEDICAL |
MARK GAINOR |
K840950 |
03/05/1984 |
ZINC OXIDE TAPE |
GAINOR MEDICAL |
MARK GAINOR |
K841114 |
03/15/1984 |
ALLO-TYPE HUMAN IMMUNOGLOBULIN- |
GENETIC TESTING INSTITUTE |
|
K841304 |
03/30/1984 |
HAEMOPHILUS ID QUAD-PLATE |
GIBCO LABORATORIES LIFE TECHNOLOGIES, INC. |
|
K841224 |
03/22/1984 |
URO-MALE INCONTINENCE CATHETER |
GIL-MED INDUSTRIES C/O KEGAN & KEGAN, LTD. |
|
K840992 |
03/07/1984 |
THERMODILUTION CATHETER |
GOULD, INC. |
|
K841275 |
03/27/1984 |
FINE NEEDLE ASPIRATION DEVICE |
GYNECO, INC. |
|
K841289 |
03/28/1984 |
RECTAL IRRIGATION TUBE |
HDC CORP. |
|
K840984 |
03/06/1984 |
INTERDENTAL WEDGES |
HEALTHCO, INC. |
|
K841020 |
03/12/1984 |
FIBRINOGEN ASSAY KIT |
HELENA LABORATORIES |
|
K841021 |
03/12/1984 |
HEMOTEC, HEPCON/SYS B-10 HEPARIN/PROTAM |
HEMOTEC, INC. |
|
K841199 |
03/21/1984 |
FIBERGLASS MOUTH MIRRORS |
HENRY SCHEIN, INC. |
|
K841256 |
03/02/1984 |
MODELS 78551A 78552A |
HEWLETT-PACKARD CO. |
|
K841152 |
03/19/1984 |
HOSPAL BIOSPAL SCU/CAVH KIT |
HOSPAL MEDICAL CORP. |
|
K841240 |
03/23/1984 |
DISPOSABLE ANESTHESIA MASK |
HOSPITAK, INC. |
|
K841029 |
03/12/1984 |
BANGORT LIFESTYLE COLOSTOMY POUCHES |
HOWMEDICA CORP. |
|
K841386 |
03/27/1984 |
KOLLMANN URETHRAL DILATOR |
IMM ENTERPRISES LTD. |
|
K841387 |
03/27/1984 |
WESTON RECTAL SNARE |
IMM ENTERPRISES LTD. |
|
K841038 |
03/12/1984 |
BLAKEMORE TUBE |
INMED CORP. |
|
K841039 |
03/12/1984 |
CANTOR TUBE |
INMED CORP. |
|
K840973 |
03/06/1984 |
COLE TUBE-LATEX |
INMED CORP. |
|
K841034 |
03/12/1984 |
DEAVER T-DRAIN & CATTEL T-DRAIN |
INMED CORP. |
|
K841040 |
03/12/1984 |
FOX POST NASAL BALLOON CATHETER |
INMED CORP. |
|
K841033 |
03/12/1984 |
MILLER-ABBOTT TUBE |
INMED CORP. |
|
K841093 |
03/13/1984 |
NASOPHARYNGEAL AIRWAYS |
INMED CORP. |
|
K841037 |
03/12/1984 |
PENROSE DRAINS |
INMED CORP. |
|
K841036 |
03/12/1984 |
RECTAL BALLOON CATHETERS |
INMED CORP. |
|
K841035 |
03/12/1984 |
ULTRA BAKER JEJUNOSTOMY TUBE |
INMED CORP. |
|
K841072 |
03/12/1984 |
IRRIGATION, ASPIRATION TUBING SETS |
INNOVATIVE SURGICAL PRODUCTS INC. |
DUANE MASON |
K840935 |
03/05/1984 |
MANUAL RESUSCITATION SYSTEM |
INSPIRON CORP. |
|
K841158 |
03/19/1984 |
NEBULO 28 NEBULIZER KIT |
INSPIRON CORP. |
|
K841026 |
03/12/1984 |
MANUAL BLOOD CELL COUNTING DEVICE |
INSTRUMENTATION LABORATORY CO. |
|
K841075 |
03/12/1984 |
CARCIAC PULSE GENERATOR 254-20 |
INTERMEDICS, INC. |
|
K841074 |
03/12/1984 |
CARDIAC PULSE GENERATOR 254-18 |
INTERMEDICS, INC. |
|
K841073 |
03/12/1984 |
QUANTUM, UNIPOLAR, MULTI-PROGRAMMABLE |
INTERMEDICS, INC. |
|
K841201 |
03/21/1984 |
POROUS HYDROXYAPATITE BG200 |
INTERPORE INTL. |
|
K841148 |
03/21/1984 |
MINI PECG-MODIFICATION |
INTERSECT SYSTEMS, INC. |
|
K841263 |
03/26/1984 |
CARDIOSCAN - TM BEING APPLIED FOR |
INTERSPEC, INC. |
JOSEPH L WATSON |
K841071 |
03/12/1984 |
PRESSURE MANOMETER |
INTERVENTIONAL MEDICAL, INC. |
|
K841174 |
03/19/1984 |
RUBELLA ANTIBODY FLUOROIMMUNOASSAY |
INTL. DIAGNOSTIC TECHNOLOGY |
|
K840925 |
03/02/1984 |
PEDIA-TRAKE CRICOTHYROTOMY KIT |
INTL. MEDICAL DEVICES LTD. |
|
K840997 |
03/08/1984 |
BATTERY POWERED PATIENT LIFT |
INVACARE CORP. |
|
K841170 |
03/19/1984 |
SICKLE HB ASSAY |
ISOLAB, INC. |
|
K840942 |
03/05/1984 |
IVY COMMANDEER |
IVY MEDICAL, INC. |
|
K840975 |
03/06/1984 |
RICO RESPIRATION MONITOR |
J.M. LABORATORIES, INC. |
|
K841258 |
03/26/1984 |
FOREIGN BODY PROTECTOR |
JAYCO PHARMACEUTICALS |
|
K841022 |
03/12/1984 |
SRC TOTAL KNEE |
JOINT MEDICAL PRODUCTS CORP. |
|
K841294 |
03/29/1984 |
ACU220 CRYO UNIT |
KELLER INSTRUMENTS, INC. |
|
K841293 |
03/29/1984 |
PANORAMIC LOUPES - VARIOUS |
KELLER INSTRUMENTS, INC. |
|
K841292 |
03/29/1984 |
SPECTACLE INDIRECT OPHTHALMOSCOPE |
KELLER INSTRUMENTS, INC. |
|
K840920 |
03/01/1984 |
KEYMED MOBILE ENDOSCOPY PATIENT COUCH |
KEYMED, INC. |
|
K840996 |
03/08/1984 |
URINE ANALYZER SYSTEM |
KYOTO DIAGNOSTICS, INC. |
|
K841214 |
03/22/1984 |
LABSYSTEMS UNISKAN |
LABSYSTEMS, INC. |
|
K841264 |
03/26/1984 |
BABYSET TM & PAC TM -PULMONARY ASSIST |
LIFE DESIGN SYSTEMS, INC. |
|
K841236 |
03/22/1984 |
FILTER-FLEX |
LIFE DESIGN SYSTEMS, INC. |
|
K841089 |
03/13/1984 |
LINEAR CLOUD TONOMETER |
LINEAR TONOMETERS, INC. |
|
K840985 |
03/07/1984 |
TRISACRYL GF 05 & TRISACRYL GF 2000 |
LKB INSTRUMENTS, INC. |
|
K841288 |
03/28/1984 |
ELVI 18 |
LOGOS SCIENTIFIC, INC. |
|
K840995 |
03/08/1984 |
ACUPUNCTURE INSOLES |
LU LU ENTERPRISE CO. LTD. |
|
K841105 |
03/14/1984 |
MULTICHANNEL 2000 FLUOROPTIC THERMOMET |
LUXTRON |
|
K841087 |
03/13/1984 |
FLEXIBLE ORTHOPEDIC ENDOSCOPE ICA-1000 |
MACHIDA AMERICA, INC. |
|
K842113 |
03/19/1984 |
AMENDMENT TO ANGIOGRAPHY KIT W/ADDIT |
MALLINCKRODT CRITICAL CARE |
|
K841187 |
03/20/1984 |
BLOOD COLLECTION SET, STERILE, DISPOS. |
MARBEX, INC. |
|
K841186 |
03/20/1984 |
INFUSION SET SCALP VEIN |
MARBEX, INC. |
|
K841185 |
03/20/1984 |
PLASTIC, STERILE TUBING CLOSED SET |
MARBEX, INC. |
|
K840966 |
03/06/1984 |
ANESTHETIC GAS MONITOR SYS |
MARQUEST MEDICAL PRODUCTS, INC. |
|
K840932 |
03/02/1984 |
MUSE-DP |
MARQUETTE ELECTRONICS, INC. |
TIMOTHY C MICKELSON |
K840980 |
03/06/1984 |
HALF ROUND FILE |
MED-TOOL, INC. |
|
K840979 |
03/06/1984 |
SLIP JOINT PLIER |
MED-TOOL, INC. |
|
K840978 |
03/06/1984 |
TOGGLE LOCKING PLIER |
MED-TOOL, INC. |
|
K840924 |
03/02/1984 |
SYRINGE, PISTON, ARTERIAL BLOOD SAMPL |
MEDCARE DISP PRODUCTS, INC. |
|
K841124 |
03/15/1984 |
DIALYSIS TRAY |
MEDCARE PRODUCTS |
|
K841123 |
03/15/1984 |
DRESSING CHANGE TRAY |
MEDCARE PRODUCTS |
|
K841122 |
03/15/1984 |
TRACHEOSTOMY CARE TRAY |
MEDCARE PRODUCTS |
|
K840944 |
03/05/1984 |
INFUSION NEEDLE IIPN |
MEDI TEX, INC. |
|
K840929 |
03/02/1984 |
FRC 85 SERIES SPIROMETER |
MEDICAL EQUIPMENT DESIGNS, INC. |
|
K841063 |
03/12/1984 |
ALBUMIN REAGENT SET |
MEDICAL SPECIALTIES, INC. |
|
K841064 |
03/12/1984 |
ALKALINE PHOSPHOTASE REAGENT SET |
MEDICAL SPECIALTIES, INC. |
|
K841052 |
03/12/1984 |
CHOLESTEROL REAGENT SET |
MEDICAL SPECIALTIES, INC. |
|
K841053 |
03/12/1984 |
CHOLESTEROL REAGENT SET ENZYMATIC |
MEDICAL SPECIALTIES, INC. |
|
K841070 |
03/12/1984 |
CREATININE REAGENT SET |
MEDICAL SPECIALTIES, INC. |
|
K841054 |
03/12/1984 |
DIRECT GLUCOSE REAGENT SET |
MEDICAL SPECIALTIES, INC. |
|
K841055 |
03/12/1984 |
GLUCOSE ENZYMATIC REAGENT SET |
MEDICAL SPECIALTIES, INC. |
|
K841056 |
03/12/1984 |
HDL PRECIPITANT REAGENT SET |
MEDICAL SPECIALTIES, INC. |
|
K841057 |
03/12/1984 |
HEMOGLOBIN REAGENT SET |
MEDICAL SPECIALTIES, INC. |
|
K841058 |
03/12/1984 |
LDH-UV REAGENT SET |
MEDICAL SPECIALTIES, INC. |
|
K841061 |
03/12/1984 |
PHOPHORUS REAGNET SET |
MEDICAL SPECIALTIES, INC. |
|
K841051 |
03/12/1984 |
SERUM CALCIUM REAGENT SET |
MEDICAL SPECIALTIES, INC. |
|
K841069 |
03/12/1984 |
SERUM TOTAL PROTEIN REAGENT SET |
MEDICAL SPECIALTIES, INC. |
|
K841065 |
03/12/1984 |
SGOT REAGENT SET |
MEDICAL SPECIALTIES, INC. |
|
K841066 |
03/12/1984 |
SGOT-UV REAGENT SET |
MEDICAL SPECIALTIES, INC. |
|
K841059 |
03/12/1984 |
SGPT REAGENT SET |
MEDICAL SPECIALTIES, INC. |
|
K841060 |
03/12/1984 |
SGPT REAGENT SET |
MEDICAL SPECIALTIES, INC. |
|
K841050 |
03/12/1984 |
TOTAL BILIRUBIN REAGENT SET |
MEDICAL SPECIALTIES, INC. |
|
K841062 |
03/12/1984 |
TRIGLYCERIDE REAGENT SET |
MEDICAL SPECIALTIES, INC. |
|
K841068 |
03/12/1984 |
UREA NITROGEN REAGENT SET |
MEDICAL SPECIALTIES, INC. |
|
K841067 |
03/12/1984 |
URIC ACID REAGENT SET |
MEDICAL SPECIALTIES, INC. |
|
K841049 |
03/12/1984 |
URIC ACID REAGENT SET ENZYMATIC |
MEDICAL SPECIALTIES, INC. |
|
K841235 |
03/22/1984 |
MEDO MEDOMER MBF-100 II |
MEDO U.S.A., INC. |
HIROSHI OKAZAKI |
K841101 |
03/13/1984 |
CLAYMAN-PAREL CAPSULE COUPEUR |
MIAMI EYE TECHNOLOGY, INC. |
|
K841178 |
03/20/1984 |
ALU-KART |
MICRO ENCAPSULATION TECH. |
|
K841180 |
03/20/1984 |
DIA-KART |
MICRO ENCAPSULATION TECH. |
|
K841179 |
03/20/1984 |
HEMO-KART |
MICRO ENCAPSULATION TECH. |
|
K841165 |
03/19/1984 |
ELECTRO SURGERY SYSTEM |
MICRO-AIRE SURGICAL INSTRUMENTS, INC. |
|
K840938 |
03/05/1984 |
HIGH SPEED DISPENSER |
MICROMEDIC SYSTEMS |
|
K841041 |
03/12/1984 |
CLINI-TEK AUTO 2000 REFLECTANCE SPECTR |
MILES LABORATORIES, INC. |
|
K841160 |
03/19/1984 |
MORWEL ASPIRATOR |
MORWEL CORP. |
|
K841159 |
03/19/1984 |
SUCTION TIPS |
MORWEL CORP. |
|
K841246 |
03/23/1984 |
PORTABLE NURSING UNIT TERMINAL |
NCR CORP. |
THOMAS P SIMS |
K841146 |
03/16/1984 |
NCS RA LATEX TEST |
NCS DIAGNOSTICS, INC. |
|
K841261 |
03/26/1984 |
COMPUTER, CENTRAL PROCESSING UNIT |
NEM COMPUTER CORP. |
|
K841194 |
03/21/1984 |
MEDICAL CHAIR, MULTIPURPOSE TAST SUPPORT |
NEUTRAL POS-CHAIR CO. |
|
K841088 |
03/13/1984 |
SOMATOMEDIN-C RADIOIMMUNOASSAY KIT |
NICHOLS INSTITUTE DIAGNOSTICS |
ELAINE WALTON |
K841150 |
03/08/1984 |
VASCULAR-ACCESS PORT CHANGE CATHETER |
NORFOLK MEDICAL PRODUCTS, INC. |
|
K841464 |
03/12/1984 |
CHANGES IN THE CHEMICAL COMP. OF 5 |
NOVA BIOMEDICAL CORP. |
|
K840993 |
03/08/1984 |
TRANSCUTANEOUS 800-OXYGEN MONITORS/801 |
NOVAMETRIX MEDICAL SYSTEMS, INC. |
|
K841257 |
03/26/1984 |
STA-POTENT SYSTEM |
NU-POTENT |
JULIAN W OSBON |
K841274 |
03/27/1984 |
BAG-TO-VENTILATOR SELECTOR VALVE |
OHIO MEDICAL PRODUCTS |
|
K840967 |
03/06/1984 |
OHIO HEAT REFLECTING PATCH |
OHIO MEDICAL PRODUCTS |
|
K841163 |
03/19/1984 |
CONTACT LENS INSERTER/REMOVER |
OPTIMUM MANUFACTURERS, INC. |
|
K841200 |
03/21/1984 |
RUBELLA IGG ANTIBODY ELISA TEST SYS |
ORTHO DIAGNOSTIC SYSTEMS, INC. |
|
K841189 |
03/20/1984 |
OEC/REZAIAN SPINAL FIXATOR |
ORTHOPEDIC EQUIPMENT CO., INC. |
|
K840934 |
03/05/1984 |
MEDILOG PH1 |
OXFORD MEDILOG, INC. |
|
K840960 |
03/06/1984 |
PALL COALESCER |
PALL BIOMEDICAL PRODUCTS CO. |
|
K841103 |
03/14/1984 |
NONINVASIVE BLOOD PRESSURE MEASURE SYS |
PANASONIC CO. DIV. MATSU ELEC. CORP. AMERICA |
ROBERT S MARIN |
K841018 |
03/09/1984 |
PANCRETEC PUMP CHECK |
PANCRETEC, INC. |
|
K841028 |
03/12/1984 |
PROVIDER CAP SET |
PANCRETEC, INC. |
|
K841017 |
03/09/1984 |
PROVIDER INFUSION SET |
PANCRETEC, INC. |
|
K841027 |
03/12/1984 |
PROVIDER SITE PREP & CHECK STRIP KIT |
PANCRETEC, INC. |
|
K841161 |
03/19/1984 |
IMMPULSE AMIKACIN ASSAY REAGENTS |
PARAGON DIAGNOSTICS, INC. |
|
K841162 |
03/19/1984 |
IMMPULSE GENTAMICIN ASSAY REAGENTS |
PARAGON DIAGNOSTICS, INC. |
|
K841251 |
03/26/1984 |
DESERET HEPARIN COATED FLOW CATH |
PARKE-DAVIS CO. |
|
K840958 |
03/06/1984 |
DESERET LONG TERM INDWELLING CATHETER |
PARKE-DAVIS CO. |
|
K841168 |
03/19/1984 |
STERILIZATION PROCESS INDICATOR |
PARKE-DAVIS CO. |
|
K841268 |
03/26/1984 |
C-17 |
PENTRON CORP. |
|
K841267 |
03/26/1984 |
C-18 |
PENTRON CORP. |
|
K841269 |
03/26/1984 |
C-19 |
PENTRON CORP. |
|
K841312 |
03/30/1984 |
ASSURE-BREATHABLE PANTY LINERS/SCENT |
PERSONAL PRODUCTS CO. |
|
K841311 |
03/30/1984 |
ASSURE-BREATHABLE PANTY LINERS/UNSCENT |
PERSONAL PRODUCTS CO. |
|
K840999 |
03/09/1984 |
PHILLY INFANT BOLT |
PHILADELPHIA MEDICAL SPECIALTIES |
|
K841048 |
03/12/1984 |
TRANSDUCER 4.OMHZ LA4011 |
PHILIPS ULTRASOUND, INC. |
ROBERT F AVRUTIK |
K841278 |
03/28/1984 |
OMNISTIM III INTERFERENTIAL THERAPY |
PHYSIO TECHNOLOGY, INC. |
|
K841155 |
03/19/1984 |
DEODORANT SLENDER REG. TAMPONS |
PLAYTEX, INC. |
|
K841154 |
03/19/1984 |
PLAYTEX SLENDER REGULAR TAMPONS |
PLAYTEX, INC. |
|
K841300 |
03/30/1984 |
ANTRUM NEEDLE-WOLF TYPE |
POPPER & SONS, INC. |
|
K841299 |
03/30/1984 |
BIERMAN BIOPSY NEEDLE |
POPPER & SONS, INC. |
|
K841301 |
03/30/1984 |
GARDNER TYPE BONE MARROW NEEDLE |
POPPER & SONS, INC. |
|
K841090 |
03/13/1984 |
VENTILATOR EXTERNAL BODY NEGATIVE PRESS |
PORTA-LUNG CO. |
|
K841008 |
03/09/1984 |
BIOPSY PUNCH, VARIOUS |
PREMIER DENTAL PRODUCTS CO. |
|
K841001 |
03/09/1984 |
EAR CURETTE, VARIOUS |
PREMIER DENTAL PRODUCTS CO. |
|
K841006 |
03/09/1984 |
EAR KNIFE-VARIOUS |
PREMIER DENTAL PRODUCTS CO. |
|
K841011 |
03/09/1984 |
ELEVATOR - VARIOUS |
PREMIER DENTAL PRODUCTS CO. |
|
K841002 |
03/09/1984 |
LACHRYMAL PROBES-VARIOUS |
PREMIER DENTAL PRODUCTS CO. |
|
K841007 |
03/09/1984 |
OPHTHALMIC CURETTE-VARIOUS |
PREMIER DENTAL PRODUCTS CO. |
|
K841003 |
03/09/1984 |
PROBES, VARIOUS |
PREMIER DENTAL PRODUCTS CO. |
WILLIAM J FREZEL |
K841004 |
03/09/1984 |
SURGICAL CURETTE, VARIOUS |
PREMIER DENTAL PRODUCTS CO. |
|
K841010 |
03/09/1984 |
SURGICAL HOOKS, VARIOUS |
PREMIER DENTAL PRODUCTS CO. |
|
K841009 |
03/09/1984 |
SURGICAL RETRACTORS-VARIOUS |
PREMIER DENTAL PRODUCTS CO. |
|
K841005 |
03/09/1984 |
TONSIL KNIFE-VARIOUS |
PREMIER DENTAL PRODUCTS CO. |
|
K840991 |
03/07/1984 |
PRESERV BUFFERED GLYCEROL SALINE |
PREVENTIVE DIAGNOSTICS CORP. |
|
K840990 |
03/07/1984 |
PRESERV CARY BLAIR TRANSPORT PACK |
PREVENTIVE DIAGNOSTICS CORP. |
|
K840968 |
03/06/1984 |
PRESERV TRANSPORT & CULTURE PACK |
PREVENTIVE DIAGNOSTICS CORP. |
|
K841255 |
03/26/1984 |
BOUNDARY SINGLE-USE GOWNS |
PROCTER & GAMBLE MFG. CO. |
|
K841217 |
03/22/1984 |
PICKER MYELOGRAM TRAY-PMS MYELOGRAM |
PROFESSIONAL MEDICAL SYSTEMS |
|
K840983 |
03/06/1984 |
PULSELIFE STIMULATOR |
PULSE LIFE, INC. |
|
K841172 |
03/19/1984 |
MONITOR ONE |
QMED, INC. |
RICHARD I LEVINE |
K841848 |
03/28/1984 |
RETIC-SET |
R & D SYSTEMS, INC. |
|
K841183 |
03/20/1984 |
SODIUM CHLORIDE SOLUTION BLOOD CELL |
REAGENT LABORATORY, INC. |
|
K840981 |
03/06/1984 |
NIACIN REAGENT STRIP |
REMEL CO. |
|
K841012 |
03/09/1984 |
RIONET HEARING AID HB-71M |
RION ACOUSTIC INSTRUMENTS, INC. |
|
K841120 |
03/15/1984 |
RES-Q-MATE |
RSQ INDUSTRIES, INC. |
|
K841145 |
03/16/1984 |
TILT TABLE 53 |
S & W ENTERPRISES, INC. |
|
K841085 |
03/13/1984 |
SCANLAN COLORMARK SKIN MARKER |
SCANLAN INTL., INC. |
|
K841086 |
03/13/1984 |
SURGICAL INSTRUMENT DEMAGNETIZER |
SCANLAN INTL., INC. |
|
K841254 |
03/26/1984 |
CARDIOVIT CV-3 |
SCHILLER AG |
PETER WEBER |
K841098 |
03/13/1984 |
SHERIDAN YSI/SONATEMP |
SHERIDAN CATHETER CORP. |
|
K841195 |
03/21/1984 |
GLAS IONOMER CEMENT |
SHOFU DENTAL CORP. |
|
K841196 |
03/21/1984 |
HY-BOND ZINC OXIDE EUGENOL TEMP. |
SHOFU DENTAL CORP. |
|
K841227 |
03/22/1984 |
BIPOLAR ENDOCARDIAL LEAD 406L |
SIEMENS ELEMA AB |
|
K841157 |
03/19/1984 |
HALOTHANE VAPORIZER 950, ENFLURANE |
SIEMENS ELEMA AB |
|
K841233 |
03/22/1984 |
PULSE GENERATOR 678L |
SIEMENS ELEMA AB |
|
K841230 |
03/22/1984 |
PULSE GENERATOR 686, 686B 686L |
SIEMENS ELEMA AB |
|
K841231 |
03/22/1984 |
PULSE GENERATOR 688B & 688L |
SIEMENS ELEMA AB |
|
K841225 |
03/22/1984 |
PULSE GENERATOR 689, 689B & 689L |
SIEMENS ELEMA AB |
JOSEPH R RADZIUS |
K841232 |
03/22/1984 |
PULSE GENERATOR 696, 696B & 696L |
SIEMENS ELEMA AB |
|
K841229 |
03/22/1984 |
PULSE GENERATOR 698, 698B & 698L |
SIEMENS ELEMA AB |
|
K841228 |
03/22/1984 |
PULSE GENERATOR 718B & 718L |
SIEMENS ELEMA AB |
|
K841226 |
03/22/1984 |
PULSE GENERATOR 728, 728B & 728L |
SIEMENS ELEMA AB |
|
K841259 |
03/26/1984 |
DETERMINATION OF MAGNESIUM IN SERUM OR |
SIGMA CHEMICAL CO. |
|
K840926 |
03/02/1984 |
FORMALIN SOLUTION 10% NEUTRAL BUFFER |
SIGMA CHEMICAL CO. |
|
K841280 |
03/28/1984 |
SOLOPAK BRAND FILTER NEEDLE W/5 MICRO |
SMITH & NEPHEW, MPL DIVISION |
|
K841213 |
03/12/1984 |
ANTIMICROBIAL SUSCEPT-CULTURE MEDIA |
SMITH RIVER BIOLOGICALS |
|
K841203 |
03/12/1984 |
GENERAL NUTRIENT BROTH |
SMITH RIVER BIOLOGICALS |
|
K841204 |
03/12/1984 |
MULTIPLE BIOCHEMICAL TEST |
SMITH RIVER BIOLOGICALS |
|
K841205 |
03/12/1984 |
NON PROPAGATING TRANSPORT |
SMITH RIVER BIOLOGICALS |
|
K841206 |
03/12/1984 |
NON-SELECTIVE & DIFFERENTIAL |
SMITH RIVER BIOLOGICALS |
|
K841207 |
03/12/1984 |
NON-SELECTIVE & NON-DIFFERENTIAL |
SMITH RIVER BIOLOGICALS |
|
K841208 |
03/12/1984 |
PROPAGATING TRANSPORT |
SMITH RIVER BIOLOGICALS |
|
K841210 |
03/12/1984 |
SELECTIVE & NON-DIFFERENTIAL |
SMITH RIVER BIOLOGICALS |
|
K841209 |
03/12/1984 |
SELECTIVE AND DIFFERENTIAL |
SMITH RIVER BIOLOGICALS |
|
K841211 |
03/12/1984 |
SELECTIVE BROTH |
SMITH RIVER BIOLOGICALS |
|
K841212 |
03/12/1984 |
SINGLE BIOCHEMICAL TEST |
SMITH RIVER BIOLOGICALS |
|
K841166 |
03/19/1984 |
HEPARIN LOCK FLUSH PROCEDURE PACK |
SOLO PAK LABORATORIES |
|
K841305 |
03/30/1984 |
HEPARIN LOCK FLUSH SOLUTION USP KIT |
SOLO PAK LABORATORIES |
|
K841306 |
03/30/1984 |
HEPARIN LOCK FLUSH SOLUTION USP KIT,100 |
SOLO PAK LABORATORIES |
|
K840974 |
03/06/1984 |
SOMAS HUMAN SPINAL FLUID CONTROL |
SOMAS MEDICAL INDUSTRIES, INC. |
|
K840972 |
03/06/1984 |
SPIROTECH ST-550 |
SPIROTECH, INC. |
|
K841614 |
03/02/1984 |
SUN BEDS |
SUNWORLD CORP. |
|
K841115 |
03/15/1984 |
CHARLES/MCINTYRE GIANT BREAK TABLE |
SURGI-QUIP INC.U |
|
K841116 |
03/15/1984 |
MOBILE OPHTHALMIC OPERATING TABLE |
SURGI-QUIP INC.U |
|
K841241 |
03/23/1984 |
ANTERIOR CRUCIATE LIGAMENT GRASPER |
SURGICAL PRODUCTS CORP. |
RICHARD W BAGGETT |
K841328 |
03/13/1984 |
SPC ARTHROSCOPY TABLE |
SURGICAL PRODUCTS CORP. |
|
K841247 |
03/21/1984 |
SPC DISPOSABLE CUTTER |
SURGICAL PRODUCTS CORP. |
|
K841128 |
03/16/1984 |
RELAX STRESS REDUCTION SYS |
SYNAPSE SOFTWARE CORP. |
|
K840955 |
03/05/1984 |
CONDYLAR PROSTHESIS OF MANDIBLE W/HEAD |
SYNTHES (USA) |
|
K840954 |
03/05/1984 |
DYNAMIC CONDYLAR SCREW OR D.C.S. |
SYNTHES (USA) |
|
K840939 |
03/05/1984 |
EMIT QST PRIMIDONE ASSAY |
SYVA CO. |
|
K841238 |
03/23/1984 |
EMIT ST URINE CANNABINOID ASSAY |
SYVA CO. |
|
K841190 |
03/21/1984 |
MICROTRAK HSV 1 & 2 DIRECT SPECIMAN |
SYVA CO. |
|
K841191 |
03/21/1984 |
MICROTRAKSPECIMAN ID TYPING TEST CONTR |
SYVA CO. |
|
K841265 |
03/26/1984 |
TAGO DIFFU-GEN C-REACTIVE PROTEIN |
TAGO, INC. |
|
K841298 |
03/30/1984 |
HOLE CHAMFERING DEVICE |
TECHMEDICA, INC. |
|
K841297 |
03/30/1984 |
TECHMEDICA DRILL GUIDE |
TECHMEDICA, INC. |
|
K841080 |
03/13/1984 |
TECHNICON RA-1000 SYS CO2 |
TECHNICON INSTRUMENTS CORP. |
|
K841106 |
03/12/1984 |
DELTA MULTIPLE NON RETURN CONNECTOR |
TEFRA MED, INC. |
|
K841296 |
03/30/1984 |
TUBE TENDER |
THE ANSPACH EFFORT, INC. |
|
K841102 |
03/13/1984 |
BUNN 1000 OXYGEN CONCENTRATOR |
THE JOHN BUNN CO. |
|
K841169 |
03/19/1984 |
CURITY RIG FOLEY CATH TRAY |
THE KENDAL CO. |
|
K840977 |
03/06/1984 |
LIQUID CHROMATOGRAPHIC DETECTOR LC-95 |
THE PERKIN-ELMER CORP. |
|
K841112 |
03/15/1984 |
TTI REHABILATATION GYM SYS |
THERAPEUTIC TECHNOLOGIES, INC. |
|
K841310 |
03/30/1984 |
GASTROINTESTINAL DILATOR |
THOMAS J. FOGARTY, M.D. |
|
K841025 |
03/12/1984 |
TOP DISPOSABLE INFUSION SET |
TOP SURGICAL MANUFACTURERS CO. |
|
K841119 |
03/15/1984 |
TOPS DISPOS. INFUSION SET/HEMODIALYSIS |
TOP SURGICAL MANUFACTURERS CO. |
|
K840937 |
03/05/1984 |
CAPILLARY FLOW DIALYZERS |
TRAVENOL LABORATORIES, S.A. |
|
K841092 |
03/13/1984 |
HIGH PRESSURE FLEX. CONNECTING TUBING |
TRONOMED, INC. |
|
K840961 |
03/06/1984 |
ESCHWEILER COMBI-ANALYSER MTA-500 |
U.S. SCIENCE, INC. |
|
K841023 |
03/12/1984 |
COATED TUBE HCG IMMUNOASSAY HCG |
VENTREX LABORATORIES, INC. |
|
K841081 |
03/13/1984 |
VENTREZYME BETA-HCG IMMUNOASSAY HCG |
VENTREX LABORATORIES, INC. |
|
K841024 |
03/12/1984 |
VENTREZYME T4U IMMUNOASSAY T4U |
VENTREX LABORATORIES, INC. |
|
K840917 |
03/01/1984 |
URINARY MONITORING SYS 240 |
VITAL METRICS, INC. |
|
K840931 |
03/02/1984 |
SUN BEDS |
WAKEWOOD SUNBEDS |
|