FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
K831361 |
06/02/1983 |
BETA-PREG |
|
|
K831365 |
06/02/1983 |
TESTCORP ANA |
|
|
K831366 |
06/02/1983 |
TESTCORP PREG |
|
|
K831234 |
06/02/1983 |
GLENOID RESURFACE COMPONENT PMN 3M |
3M COMPANY |
|
K831233 |
06/03/1983 |
GLENOID RESURFACING COMPONENT-3M-10816 |
3M COMPANY |
|
K831203 |
06/03/1983 |
Y-TYPE BACKCHECK MICROBORE EXTEN. SET |
ABBOTT LABORATORIES |
|
K831090 |
06/08/1983 |
HEMATOXYLIN GILL FORMULATION IX#56016 |
ACCRA LABORATORIES, INC. |
|
K831637 |
06/30/1983 |
ACCU-FLUSH |
ACCU-LINE |
|
K830298 |
06/02/1983 |
ACCU-LINE SURGICAL MARKER |
ACCU-LINE |
|
K830720 |
06/16/1983 |
GRAF MENISCAL SUTURE SET |
ACUFEX MICROSURGICAL, INC. |
|
K830719 |
06/16/1983 |
UNIVERSAL CANNULA |
ACUFEX MICROSURGICAL, INC. |
|
K830726 |
06/22/1983 |
MARK I & II TOTAL KNEE REPLACE. SYS |
ADVANCED BIOSEARCH ASSN. |
|
K831563 |
06/30/1983 |
CORONARY GUIDING CATHETER-MODIFIED |
ADVANCED CARDIOVASCULAR SYSTEMS, INC. |
|
K831717 |
06/30/1983 |
CORONARY INFUSION CATHETER |
ADVANCED CARDIOVASCULAR SYSTEMS, INC. |
|
K831403 |
06/08/1983 |
LOW PROFILE STEERABLE BALLOON DILATA |
ADVANCED CARDIOVASCULAR SYSTEMS, INC. |
|
K831136 |
06/08/1983 |
DOUBLE BOW TOOTH SEPARATOR |
ALMORE INTL., INC. |
|
K830812 |
06/08/1983 |
ALPHAMEDIX I/A HAND-PIECE, 500-001 |
ALPHAMEDIX, INC. |
|
K823552 |
06/15/1983 |
APPOSE SKIN STAPLER & REMOVER |
AMERICAN CYANAMID CO. |
|
K831140 |
06/08/1983 |
DADE HEMATOLOGY CALIBRATOR |
AMERICAN DADE |
|
K831480 |
06/22/1983 |
PARAMAX ALKALINE PHOSPHATASE REAGENT- |
AMERICAN DADE |
|
K831536 |
06/17/1983 |
PARAMAX AMALINE REAGENT |
AMERICAN DADE |
|
K831537 |
06/22/1983 |
PARAMAX CREATINE KINASE REAGENT |
AMERICAN DADE |
|
K831297 |
06/08/1983 |
PROTOTRO/PROTEOLYTIC ENZYME CONTROL |
AMERICAN DADE |
|
K831377 |
06/02/1983 |
IGE RADIOIMMUNOASSAY KIT |
AMERICAN DIAGNOSTIC CORP. |
|
K830892 |
06/15/1983 |
THERMODILUTION CARDIAC OUTPUT COMPUTER- |
AMERICAN EDWARDS LABORATORIES |
|
K831244 |
06/17/1983 |
URETERAL STONE EXTRACTOR CATHETER |
AMERICAN EDWARDS LABORATORIES |
|
K831716 |
06/24/1983 |
CAPD - CATHETER ADAPTER |
AMERICAN MCGAW |
|
K830881 |
06/02/1983 |
AMPERCIDE DISINFECTANT ACCESSORY TO - |
AMERICAN MEDICAL PRODUCTS, INC. |
|
K831061 |
06/08/1983 |
PVA FIXATIVE/FORMALIN |
AMERICAN MICRO SCAN |
|
K831058 |
06/08/1983 |
SAF FIXATIVE |
AMERICAN MICRO SCAN |
|
K831060 |
06/08/1983 |
TRICHROME STAIN |
AMERICAN MICRO SCAN |
|
K831569 |
06/30/1983 |
REAGENT CUPS |
AMERICAN SCIENTIFIC PRODUCTS |
|
K831571 |
06/30/1983 |
ROTOR |
AMERICAN SCIENTIFIC PRODUCTS |
|
K831309 |
06/15/1983 |
DELIVERY 4 TABLE |
AMSCO CO. |
|
K831341 |
06/02/1983 |
API UNISCEPT PLUS AUTOINOCULATOR |
ANALYTICAL PRODUCTS, INC. |
|
K831388 |
06/02/1983 |
GLASS FRAMES & COMPONENT PARTS |
ANAMAR |
|
K831785 |
06/30/1983 |
NEURO EASE |
ANDOVER MEDICAL, INC. |
|
K831451 |
06/08/1983 |
SILCATH CENTRAL CATHETER TRAY SIZE- |
ARGON MEDICAL CORP. |
|
K831290 |
06/03/1983 |
ELECTRODE, FLEXIBLE SUCTION COAGULATOR |
ASPEN LABORATORIES, INC. |
|
K831291 |
06/02/1983 |
ELECTROSURGICAL UNIT-MF 380 #60-1700 |
ASPEN LABORATORIES, INC. |
|
K831269 |
06/08/1983 |
VINYLAC PRESS-PACK DENTURE RESIN |
ASTRON DENTAL CORP. |
|
K837347 |
06/24/1983 |
LINEAR ACCELERATOR THERAC 25 |
ATOMIC ENERGY OF CANADA |
THERATRONICS INTL |
K837346 |
06/24/1983 |
MODEL GAMMACELL 1000 |
ATOMIC ENERGY OF CANADA |
|
K831431 |
06/30/1983 |
AUDIOMETER MODEL-500 |
AUDIMAX |
|
K831673 |
06/30/1983 |
OXY-SWAB |
AUSTIN BIOLOGICAL LABORATORIES |
|
K830968 |
06/16/1983 |
RAPID IDENTIFI-METHOD NEISSERIA KIT |
AUSTIN BIOLOGICAL LABORATORIES |
|
K831654 |
06/22/1983 |
RIM BETA LACTAMASE TEST |
AUSTIN BIOLOGICAL LABORATORIES |
|
K831674 |
06/30/1983 |
RIM-CAMP TEST |
AUSTIN BIOLOGICAL LABORATORIES |
|
K831655 |
06/17/1983 |
SPECTRUM-10 |
AUSTIN BIOLOGICAL LABORATORIES |
|
K831672 |
06/22/1983 |
SPECTRUM-10 |
AUSTIN BIOLOGICAL LABORATORIES |
|
K830997 |
06/02/1983 |
ARIA II I-HCG |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K831353 |
06/08/1983 |
ASTRA SYSTEMS ENZYME MODULE |
BECKMAN INSTRUMENTS, INC. |
|
K830963 |
06/30/1983 |
QUINIDINE REAGENT TEST KIT |
BECKMAN INSTRUMENTS, INC. |
|
K831434 |
06/30/1983 |
ISO-SEP SYSTEM |
BERWICK MEDICAL PRODUCTS, INC. |
|
K831289 |
06/16/1983 |
PREFILLED IEC COLUMNS |
BERWICK MEDICAL PRODUCTS, INC. |
|
K831221 |
06/02/1983 |
RIAGEN B-HCG RIA KIT |
BIO GENEX LABORATORIES |
|
K830858 |
06/08/1983 |
BIO-PROBE SYSTEM-BLOOD FLOW PROBE |
BIO MEDICUS, INC. |
|
K831414 |
06/16/1983 |
COLORIMETRIC BUN |
BIO-ANALYTICS LABORATORIES, INC. |
|
K830935 |
06/16/1983 |
HEMOGLOBIN ALC BY COLUMN TEST |
BIO-RAD |
|
K831478 |
06/22/1983 |
LYPHOCHEK HEMOGLOBIN AIC CONTROL HUMAN |
BIO-RAD |
|
K837605 |
06/28/1983 |
MV/CM2 NUMBER X74294 MODEL NUMBER 74229 |
BIO-TEK INSTRUMENTS, INC. |
|
K830911 |
06/10/1983 |
RADIAL IMMUNODIFFUSION PLATES |
BIOCELL LABORATORIES, INC. |
|
K830314 |
06/24/1983 |
MILWAUKEE AUSTIN MOORE TOTAL HIP |
BIOMET, INC. |
|
K831133 |
06/08/1983 |
AMEBIASIS BIO-ENZABEAD SCREEN KIT |
BIONETIC LABORATORY PRODUCTS |
|
K830820 |
06/08/1983 |
LEGIONELLA DFA KIT I |
BIONETIC LABORATORY PRODUCTS |
|
K831582 |
06/15/1983 |
VARI-SUPPORT NECK POSTURE PILLOW |
BODY THERAPEUTICS, INC. |
|
K831592 |
06/16/1983 |
ANHYDRIC INCUBATORS, CULTURE INCUBATOR |
BOEKEL INDUSTRIES, INC. |
|
K830954 |
06/10/1983 |
ACOH WELLNESS TESTER |
BRADLEY, CAMPBELL & CARNEY |
|
K831611 |
06/20/1983 |
UNI-THANE |
CARAPAC SYSTEMS, INC. |
|
K831529 |
06/30/1983 |
CCS MODEL SJ-103 IMPLANTABLE ATRIAL |
CARDIAC CONTROL SYSTEMS, INC. |
|
K831161 |
06/15/1983 |
COMMAND ULTRA I |
CARDIAC PACEMAKERS, INC. |
|
K837329 |
06/07/1983 |
SONACOLOR CD, MODEL 6300 CARDIAC DOPPLER ULTRASOUND |
CAROLINA MEDICAL ELECTRONICS |
|
K831131 |
06/08/1983 |
CASE WRIGHT-GIEMSA STAIN PAK |
CASE INSTRUMENTS |
|
K831595 |
06/15/1983 |
CASTLE MODEL 3341 & 3441 & 4141 GAS AER |
CASTLE CO. |
|
K831198 |
06/24/1983 |
CPR HEARTSAVER AND BREATHOLATOR |
CERVCO CORP. |
|
K837465 |
06/28/1983 |
ALCYON ROTATIONAL COBALT THERAPY |
CGR MEDICAL CORP. |
|
K837412 |
06/28/1983 |
SATURNE I LINEAR ACCELERATOR |
CGR MEDICAL CORP. |
|
K831135 |
06/24/1983 |
SAUNDERS #7080 CERVICAL TRACTION SYS |
CHATTANOOGA GROUP, INC. |
|
K830830 |
06/18/1983 |
CIRCA MED TWO-CHANNEL |
CIRCADIAN, INC. |
|
K831575 |
06/30/1983 |
NU-CAP CALCIUM HYDROX. PULP CAPPING |
COE LABORATORIES, INC. |
|
K830864 |
06/15/1983 |
WHITE BLOOD CELL CONTROL |
CONTROL DIAGNOSTICS |
|
K830740 |
06/02/1983 |
CLERZ LUBRICATING & REWETTING EYE DROPS |
COOPERVISION, INC. |
|
K831836 |
06/30/1983 |
EPSILON ULTRASONIC TIP |
COOPERVISION, INC. |
|
K831450 |
06/02/1983 |
DISPOSABLE STERILE FILTER SYSTEM |
CORNING MEDICAL & SCIENTIFIC |
|
K831533 |
06/30/1983 |
MAGIC T4 125I RADIOIMMUNOASSAY |
CORNING MEDICAL & SCIENTIFIC |
|
K831558 |
06/16/1983 |
E-Z PREP |
COULTER ELECTRONICS, INC. |
|
K831515 |
06/30/1983 |
DINAMAP VITAL SIGNS MONITOR #1846 |
CRITIKON COMPANY,LLC |
|
K830831 |
06/16/1983 |
AUTOMATED BLOOD CELL SEPARATOR |
CRYOSAN, INC. |
|
K831360 |
06/08/1983 |
DATA-ZYME ALKALINE PHOSPHATASE PROCED |
DATA MEDICAL ASSOCIATES, INC. |
|
K831299 |
06/02/1983 |
EVEN-TEMP. CAPACITIVE ADHESIVE PAD |
DELTA MEDICAL ELECTRONICS, INC. |
|
K831183 |
06/08/1983 |
GAUZE SPONGE STERILE SPONGE |
DEN MED, INC. |
|
K831182 |
06/08/1983 |
GAUZE SPONGE-NON-STERILE SPONGE |
DEN MED, INC. |
|
K831647 |
06/30/1983 |
DENTURE RELINING, REPAIR/REBASING RESIN |
DENTSPLY INTL. |
|
K831280 |
06/08/1983 |
NEY-ORO 60 |
DERINGER-NEY INC. |
|
K831142 |
06/03/1983 |
INSPIRATORY RESISTOR KIT |
DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP. |
|
K830628 |
06/02/1983 |
REAL-TIME SPECTRUM ANALYZER |
DIAGNOSTIC ELECTRONICS CORP. |
|
K831342 |
06/02/1983 |
COAT-A-COUNT NO-EXTRACTION TESTOSTERONE |
DIAGNOSTIC PRODUCTS CORP. |
|
K830005 |
06/02/1983 |
IP SPECIFIC G |
DIAGNOSTIC REAGENT TECH. |
|
K831463 |
06/08/1983 |
ANA-CHECK |
DIAGNOSTIC TECHNOLOGY, INC. |
|
K831464 |
06/16/1983 |
ASO-CHECK |
DIAGNOSTIC TECHNOLOGY, INC. |
|
K831468 |
06/22/1983 |
B HCG-CHECK |
DIAGNOSTIC TECHNOLOGY, INC. |
|
K831465 |
06/08/1983 |
CRP-CHECK |
DIAGNOSTIC TECHNOLOGY, INC. |
|
K831466 |
06/22/1983 |
HCG-CHECK |
DIAGNOSTIC TECHNOLOGY, INC. |
|
K831467 |
06/08/1983 |
RA-CHECK |
DIAGNOSTIC TECHNOLOGY, INC. |
|
K831409 |
06/30/1983 |
HAEMOLYTE SOLUTION |
DIALYSIS CLINIC, INC. |
|
K831591 |
06/30/1983 |
AORTIC ROOT CANNULA W/INTEGRAL PRESS |
DLP, INC. |
|
K830430 |
06/10/1983 |
EYELID SPECULUM |
DOUGLAS C. MCKEE & CO. |
|
K831479 |
06/15/1983 |
METAL-BACKED ACETABULAR CUP |
DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS |
|
K831301 |
06/08/1983 |
PEEP SYSTEM D |
DRAEGER MEDICAL, INC. |
|
K837506 |
06/10/1983 |
KODAK T-MAT G FILM SO-381 |
EASTMAN KODAK COMPANY |
|
K831241 |
06/10/1983 |
LASER LAPARAXOPE |
EDER INSTRUMENT CO, INC. |
|
K831615 |
06/15/1983 |
DROP FOOT BRACE |
EDWARD DILAURO, JR. |
|
K831576 |
06/08/1983 |
ORTHOFIX |
ELECTRO-BIOLOGY, INC. |
|
K831144 |
06/30/1983 |
ALPHA-STIM 2000 |
ELECTROMEDICAL PRODUCTS, INC. |
|
K830791 |
06/22/1983 |
UNIVERSAL MEDDARS SYSTEM |
ELECTRONICS FOR MEDICINE, INC. |
|
K831376 |
06/03/1983 |
CDS 2001 ARTIFICIAL KIDNEY |
ELMAR MEDICAL SYSTEMS, LTD. |
|
K837355 |
06/28/1983 |
UNKNOWN |
ELSCINT, INC. |
|
K831112 |
06/30/1983 |
EPCOM VCU-1 VACUUM SYSTEM & CURETTE |
EPCOM MEDICAL SYSTEMS, INC. |
|
K821178 |
06/11/1983 |
ETHICON EXTERNAL FIXATION WIRE |
ETHICON, INC. |
|
K830908 |
06/08/1983 |
BICARBONATE/VARIABLE SODIUM KIT-DM-367 |
EXTRACORPOREAL MEDICAL SPECIALITIES, INC. |
|
K831433 |
06/02/1983 |
EXTRASENSR ULTRAFILTRATION MONITOR |
EXTRACORPOREAL MEDICAL SPECIALITIES, INC. |
|
K831568 |
06/30/1983 |
RELIANCE TEMPO OPHTH. INSTR STAND |
F. & F. KOENIGKRAMER |
|
K830622 |
06/20/1983 |
ORTHO WRAP |
FAST WRAP CO., INC. |
|
K830906 |
06/15/1983 |
PULSAMAT MODEL 1050 |
FERRING LABORATORIES, INC. |
|
K830960 |
06/30/1983 |
CUSTOM IN-THE-EAR HEARING AID |
FINETONE HEARING INSTRUMENTS |
|
K831018 |
06/16/1983 |
CALIBRATING SOLUTION FOR ABL-1 & 2 |
FISHER SCIENTIFIC CO., LLC. |
|
K831021 |
06/16/1983 |
CALIBRATING SOLUTION FOR ABL-1 & 2 |
FISHER SCIENTIFIC CO., LLC. |
|
K831012 |
06/08/1983 |
DIAGNOSTICS PCO2 ELECTROLYTE W/CARBON |
FISHER SCIENTIFIC CO., LLC. |
|
K831013 |
06/08/1983 |
DIAGNOSTICS PO 2 ELECTROLYTE |
FISHER SCIENTIFIC CO., LLC. |
|
K831025 |
06/16/1983 |
ELECTROLYLE CARBON DIOXIDE ELECTRODES |
FISHER SCIENTIFIC CO., LLC. |
|
K831024 |
06/16/1983 |
ELECTROLYTE PO2 FOR OXYGEN ELECTRODES |
FISHER SCIENTIFIC CO., LLC. |
|
K831019 |
06/16/1983 |
PH 6.838 REF. BUFFER |
FISHER SCIENTIFIC CO., LLC. |
|
K831023 |
06/15/1983 |
REFERENCE BUFFER PH 7.382 |
FISHER SCIENTIFIC CO., LLC. |
|
K831476 |
06/10/1983 |
NASOPHARYNGEAL AIRWAY-ROBERTAZZI STYLE |
FLS MEDICAL PRODUCTS, INC. |
|
K831706 |
06/24/1983 |
SATO FAMILY FIRST AID KIT |
FOOD AND DRUG SERVICE, INC. |
|
K831546 |
06/08/1983 |
ADAPTIVE PENS & LAP DESK |
FRED SAMMONS, INC. |
|
K831543 |
06/24/1983 |
ADJUST. WEIGHTS-BK5171-05,10,20 BEOK |
FRED SAMMONS, INC. |
|
K831542 |
06/24/1983 |
ADJUSTABLE POLYCENTRIC ELBOW HINGE |
FRED SAMMONS, INC. |
|
K831549 |
06/30/1983 |
ARM SLINGS |
FRED SAMMONS, INC. |
|
K831540 |
06/08/1983 |
COMPRESSOGRIP ELASTIC STUMP SHRINKER# |
FRED SAMMONS, INC. |
|
K831551 |
06/07/1983 |
COMPRESSOGRIP TUBULAR ELASTIC BANDAGE |
FRED SAMMONS, INC. |
|
K831538 |
06/08/1983 |
DELUXE ADJUST-ANGLE BOARD-BK4066 |
FRED SAMMONS, INC. |
|
K831544 |
06/24/1983 |
DELUXE TRACTION EXERCISE GLOVE BK5035 |
FRED SAMMONS, INC. |
|
K831539 |
06/08/1983 |
ECONOMY PLASTIC SOCK-BK2084-AID |
FRED SAMMONS, INC. |
|
K831550 |
06/24/1983 |
FINGER BONIOMETER BK7506 |
FRED SAMMONS, INC. |
|
K831553 |
06/16/1983 |
LEG DRAINAGE BAG STRAP BK6011 |
FRED SAMMONS, INC. |
|
K831547 |
06/08/1983 |
RAISED TOILET SEATS & NAIL CLIPPERS |
FRED SAMMONS, INC. |
|
K831545 |
06/08/1983 |
REACHER & DOOR OPENER |
FRED SAMMONS, INC. |
|
K831552 |
06/08/1983 |
SORBOTHANE VISCO INNER SOLE PAD |
FRED SAMMONS, INC. |
|
K831548 |
06/27/1983 |
SPLINTS |
FRED SAMMONS, INC. |
|
K831541 |
06/02/1983 |
TUB TRANSFER BENCH BK6481 |
FRED SAMMONS, INC. |
|
K830673 |
06/08/1983 |
CRAFON ARTHROSCOPY LINES |
GAMBRO, INC. |
|
K831606 |
06/24/1983 |
GF-180-L HOLLOW FIBER HEMODIALYSIS |
GAMBRO, INC. |
|
K830877 |
06/08/1983 |
AP-CHECK |
GENERAL DEVICES |
|
K830885 |
06/22/1983 |
GOULD MODEL IM3000-IM3100 BATTERY POWER |
GOULD, INC. |
|
K831306 |
06/16/1983 |
HEMACAL |
HEMATOLOGY MARKETING ASSOC. |
|
K830665 |
06/08/1983 |
HEPCOL SYSTEM B-10 & B-10-P |
HEMOTEC, INC. |
|
K830753 |
06/16/1983 |
NEEDLE GUIDE MODEL 21285A |
HEWLETT-PACKARD CO. |
|
K837422 |
06/10/1983 |
LASER PHOTOCOAGULATOR |
HGM, INC. |
|
K831295 |
06/30/1983 |
AMYLASE REAGENT #88129 |
HI CHEM, INC. |
|
K831270 |
06/08/1983 |
DISPOS. MEDICATION NEBULIZER |
HOSPITAK, INC. |
|
K831383 |
06/22/1983 |
EVENT-TEST SLIDE |
ICL SCIENTIFIC |
|
K830971 |
06/30/1983 |
HERPES SIMPLEX VIRUS TYPING REAGENTS |
IMMULOK, INC. |
|
K831918 |
06/08/1983 |
LA-STAPH IDENTIFICATION SYSTEM |
IMMUNO-MYCOLOGICS, INC. |
|
K830475 |
06/08/1983 |
BRAIN MODULE RJ-Z10 |
INSTRUMENTATION INDUSTRIES, INC. |
|
K831693 |
06/16/1983 |
MAXI PADS SCENTED DEODORIZED |
INT'L CONSUMER DISPOSABLES |
|
K831691 |
06/30/1983 |
PRIVATE LABEL DEODORANT MAXISHIELD |
INT'L CONSUMER DISPOSABLES |
|
K831692 |
06/16/1983 |
PRIVATE LABEL DEODORANT MINISHIELDS |
INT'L CONSUMER DISPOSABLES |
|
K831607 |
06/22/1983 |
FIAX IGA TEST KIT |
INTL. DIAGNOSTIC TECHNOLOGY |
|
K831609 |
06/17/1983 |
FIAX IGG TEST KIT |
INTL. DIAGNOSTIC TECHNOLOGY |
|
K831608 |
06/22/1983 |
FIAX IGM TEST KIT |
INTL. DIAGNOSTIC TECHNOLOGY |
|
K830220 |
06/17/1983 |
YELLOW IRIS TM |
INTL. REMOTE IMAGING SYSTEMS |
|
K831690 |
06/24/1983 |
IPOS ANTI-ADDUCTUS SHOE |
IPOS LUNEBURG |
|
K831213 |
06/30/1983 |
SPECIFIC GRAVITY INSTRUMENT |
IRIS |
|
K831347 |
06/02/1983 |
MICROCAPILLARY INFUSION SYSTEM |
J.S. BIOMEDICALS, INC. |
|
K830737 |
06/02/1983 |
JERMYN OCCLUDERS KIT |
JERMYN SPECIALTIES OF CALIFORNIA |
|
K830738 |
06/10/1983 |
LENSERT CONTACT LENS CLEANING & INSERT |
JERMYN SPECIALTIES OF CALIFORNIA |
|
K831559 |
06/30/1983 |
CERTAIN *DENTAL RESTORATIVE |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
|
K831380 |
06/30/1983 |
DELTON LIGHT CURING PIT & FISSURE |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
|
K831493 |
06/30/1983 |
DENTURE ADHESIVE SEALS |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
|
K831072 |
06/08/1983 |
JURGAN PIN BALL |
JURGAN DEVELOPMENT & MFG., LTD. |
|
K831326 |
06/02/1983 |
ALLERCOAT ALLERGEN DISCS |
KALLESTAD LABORATORIES, INC. |
|
K831206 |
06/02/1983 |
ARUBI FLATTER & ARUBI FLATTER-S |
KC EXPORT MANAGEMENT CO. |
|
K831425 |
06/02/1983 |
MDT CHEMITEST SEE-THRU BAG |
KENPAK CONVERTERS, INC. |
|
K830050 |
06/02/1983 |
MOLNLYCKE MEPORE STERILE SELF-ADHESIVE |
LADA INTL., INC. |
|
K831499 |
06/17/1983 |
GLUCOSE 3, INLAB REAGENT STRIPS-URINALY |
LAPROL SCIENTIFIC, INC. |
|
K831498 |
06/22/1983 |
URI-TEST 3, INLAB REAGENT STRIPS-URINAL |
LAPROL SCIENTIFIC, INC. |
|
K837573 |
06/28/1983 |
SHARPLAN LASER POSITIONING SYSTEM |
LASER INDUSTRIES LTD. |
|
K822824 |
06/02/1983 |
ADHESIVE TAPE/FIRST-BAND |
LEONARD JOSEPH CO. |
|
K830853 |
06/08/1983 |
LAVATORY SEAT HEIGHTENER |
LIC-ORTHION |
|
K831251 |
06/03/1983 |
TUMISENSOR 1524 |
LIFE-TECH INTL., INC. |
|
K831762 |
06/24/1983 |
SITZ BATH, SINGLE PATIENT USE #8100 |
LSL INDUSTRIES, INC. |
|
K831509 |
06/08/1983 |
ANGIOGRAPHY KIT W/ADDIT. COMPONENTS |
MALLINCKRODT CRITICAL CARE |
|
K831456 |
06/30/1983 |
TOXI-LAB CANNABINOID THC SCREEN |
MARION LABORATORIES, INC. |
|
K830517 |
06/15/1983 |
CENTRAL STATION DISPLAY/RECORDER MATRIX |
MARQUETTE ELECTRONICS, INC. |
|
K831003 |
06/20/1983 |
MEASURE-UP MUSCLE STIMULATOR |
MEASURE-UP INTL., INC. |
|
K831446 |
06/22/1983 |
SURGITEK NEPHROSTENT KIT |
MEC/SURGITEK PRODUCTS |
|
K831401 |
06/03/1983 |
SINGLE NEEDLE SUBCLAVIAN VEIN ACCESS |
MED-WEST, INC. |
|
K831440 |
06/03/1983 |
SINGLE NEEDLE SUBCLAVIAN VEIN MWI250/260 |
MED-WEST, INC. |
|
K837481 |
06/24/1983 |
BF24 DOPPLER MODEL P872 AND P874 |
MEDASONICS, INC. |
|
K831393 |
06/16/1983 |
VASCULAB BLOOD PRESSURE CUFF |
MEDASONICS, INC. |
|
K831831 |
06/30/1983 |
TRULIFE SILICONE BREAST FORM |
MEDEERING, LTD. |
|
K831413 |
06/08/1983 |
SPEC IISX |
MEDICAL DEVICES, INC. |
|
K837443 |
06/10/1983 |
OM-1 DIAPHANOGRAPHY LIGHT TRANSILLUMINATION SYSTEM SOR MAMMOGRAPHY |
MEDICAL DIAGNOSTIC INSTRUMENTS, INC. |
|
K831192 |
06/30/1983 |
INFUSION CANNULA |
MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. |
|
K831193 |
06/30/1983 |
SCLERAL PLUG |
MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. |
|
K822413 |
06/08/1983 |
WEYLAND EXTENSION VIBRATOR |
MEDICAL MANAGEMENT SERVICE, INC. |
|
K831325 |
06/02/1983 |
NUTROMAT |
MEDLOG GMBH MARKETING SERVICES |
|
K830989 |
06/02/1983 |
BAKER JEJUNOSTOMY TUBE |
MEDOVATIONS, INC. |
|
K830990 |
06/02/1983 |
BLAKEMORE TUBE |
MEDOVATIONS, INC. |
|
K831009 |
06/02/1983 |
CANTOR TUBE |
MEDOVATIONS, INC. |
|
K830991 |
06/02/1983 |
ESOPHAGEAL BOUGIES |
MEDOVATIONS, INC. |
|
K830998 |
06/02/1983 |
MILLER-ABBOTT TUBE |
MEDOVATIONS, INC. |
|
K831605 |
06/30/1983 |
HEMATOLOGY PAK |
MERCEDES SCIENTIFIC CO., INC. |
|
K831702 |
06/30/1983 |
RARE-EARTH INTRA-OCULAR MAGNET |
MIAMI EYE TECHNOLOGY, INC. |
|
K831675 |
06/30/1983 |
TWIST LOCK DRILL 1120 |
MICRO-AIRE SURGICAL INSTRUMENTS, INC. |
|
K831264 |
06/08/1983 |
BHCG RIA KIT |
MICROMEDIC SYSTEMS |
|
K830981 |
06/03/1983 |
MICROPAK MOIST HEAT PAD |
MICROPAK MANUFACTURERS, INC. |
|
K831385 |
06/02/1983 |
LITHOTOMY CHAIR #415 |
MIDMARK CORP. |
|
K831399 |
06/02/1983 |
AMES TDA N-ACETYL-PROCAINAMIDE TEST |
MILES LABORATORIES, INC. |
|
K831400 |
06/02/1983 |
AMES TDA PROCAINAMIDE TEST |
MILES LABORATORIES, INC. |
|
K831514 |
06/30/1983 |
AMWA TDA THEOPHYLLINE TEST |
MILES LABORATORIES, INC. |
|
K831488 |
06/08/1983 |
DAVRON PROF. SCRUB BRUSH-DRY/STERILE |
MINNETONKA, INC. |
|
K831155 |
06/02/1983 |
B-CLONE HCG ASSAY |
MONOCLONAL ANTIBODIES, INC. |
|
K831520 |
06/20/1983 |
MORWEL CANNULA |
MORWEL CORP. |
|
K830123 |
06/08/1983 |
DISP. YANKAVER SURG. SUCTION INSTRUMENT |
NARCO SCIENTIFIC |
|
K831345 |
06/08/1983 |
RIANEN PROLACTIN 125I KIT |
NEW ENGLAND NUCLEAR |
|
K831236 |
06/02/1983 |
BIPOLAR CARD |
NEW ENGLAND SURGICAL INSTRUMENT CORP. |
|
K831426 |
06/08/1983 |
ORTHOPEDIC/NALEBUFF FINGER INSTRUMENTS |
NEW ENGLAND SURGICAL INSTRUMENT CORP. |
|
K831083 |
06/10/1983 |
AUTO REFRACTOMETER |
NIDEK, INC. |
|
K831084 |
06/30/1983 |
SUN PHOTO-KERATOSCOPE |
NIDEK, INC. |
|
K831055 |
06/08/1983 |
HEMOGLOBIN ELECTROPHORESIS METH ON THE- |
OLYMPUS CORP. |
|
K831617 |
06/16/1983 |
DILUENT |
OMEGA MEDICAL DIAGNOSTICS |
|
K831618 |
06/16/1983 |
HEMOGLOBIN REAGENT |
OMEGA MEDICAL DIAGNOSTICS |
|
K831109 |
06/02/1983 |
DUOCLON SLIDE TEST |
ORGANON, INC. |
|
K831339 |
06/08/1983 |
NEO-PREGNOSTICON DUOCLON TUBE TEST |
ORGANON, INC. |
|
K831500 |
06/30/1983 |
TRI-LEVEL TDM CONTROL & I II III |
ORTHO DIAGNOSTIC SYSTEMS, INC. |
|
K831044 |
06/24/1983 |
LIMITED MOTION FUNCTIONAL KNEE BRACE |
ORTHOPEDIC SYSTEMS, INC. |
|
K831041 |
06/24/1983 |
SAGITTAL KNEE TESTER |
ORTHOPEDIC SYSTEMS, INC. |
|
K831469 |
06/08/1983 |
LEGIONELLA CYE AGAR BASE & BCYE SUPPL |
OXOID U.S.A., INC. |
|
K831436 |
06/08/1983 |
UNIPOLAR ATRIAL J PACING LEAD MODEL 869 |
PACESETTER SYSTEMS |
|
K831435 |
06/08/1983 |
VENTRICULAR PACING LEADS MODELS 865/867 |
PACESETTER SYSTEMS |
|
K831223 |
06/02/1983 |
BETA-QUIK-15 RIA KIT |
PACIFIC BIOTECH, INC. |
|
K831302 |
06/08/1983 |
PBI BHCG RIA KIT |
PACIFIC BIOTECH, INC. |
|
K831286 |
06/08/1983 |
ULTIPORE PREBYPASS PLUS FILTER |
PALL BIOMEDICAL PRODUCTS CO. |
|
K831747 |
06/30/1983 |
PLASMA THERAPY TUBESET-E100 SERIES |
PARKER HANNIFIN CORP. |
|
K831707 |
06/16/1983 |
MODIFIED UNSCENTED MENSTRUAL PADS |
PERSONAL PRODUCTS CO. |
|
K830871 |
06/02/1983 |
PHAKOSYSTEMS MODEL 1000/OMNI PACKS IRRIGATION/ASPIRATION |
PHAKOSYSTEMS, INC. |
|
K831442 |
06/08/1983 |
PHADEBAS & PHADEZYM RAST ALLERGEN DISCS |
PHARMACIA, INC. |
|
K830730 |
06/30/1983 |
PORT-A-CATH IMPLANTABLE CATH. SYS |
PHARMACIA, INC. |
|
K837517 |
06/14/1983 |
INFRADIODE INFRARED LAMP |
PHIMO OF TEXAS, INC. |
|
K831002 |
06/24/1983 |
TPG 1000 |
PHYSICAL DIAGNOSTICS, INC. |
|
K830587 |
06/08/1983 |
VITAL SIGNS MONITOR 2 |
PHYSIO-CONTROL CORP. |
|
K837608 |
06/27/1983 |
PIP X-RAY PROTECTIVE GLASSES |
PINNACLE INTL., INC. |
|
K831372 |
06/24/1983 |
TLS SURGICAL MARKER |
POREX MEDICAL |
|
K831357 |
06/02/1983 |
BOUNDARY HEADWEAR |
PROCTER & GAMBLE MFG. CO. |
|
K831329 |
06/15/1983 |
PMT VAXIOM STEREOTACTIC SYS #FX001 |
PROGRESS MANKIND TECHNOLOGY |
|
K831071 |
06/08/1983 |
UNIVERSAL INSTRU. SET FOR NEUROVASCULAR |
PROTHIA USA, INC. |
|
K831678 |
06/24/1983 |
P-S MEDICAL CSF-FLOW CONTROL VALVE-BUR |
PUDENZ-SCHULTE MEDICAL RESEARCH CORP. |
|
K830472 |
06/08/1983 |
LIPOSOL |
QUEST MEDICAL, INC. |
|
K830655 |
06/15/1983 |
QUIK-SILVER RESTING ECG ELECTRODE |
QUINTON, INC. |
|
K831448 |
06/08/1983 |
SPIA SYS FOR SOLID PHASE IMMUNOASSAYS |
R & D SYSTEMS, INC. |
|
K830321 |
06/03/1983 |
VENTURE II MONITORING SYSTEM |
RAE MEDICAL CORP. |
|
K831470 |
06/22/1983 |
PTH MR |
RAMCO LABORATORIES, INC. |
|
K831585 |
06/16/1983 |
ALBUMIN REAGENT (BCG |
REAGENTS APPLICATIONS, INC. |
|
K831419 |
06/16/1983 |
RAICHEM LDH-P REAGENT W/SEPARATE START- |
REAGENTS APPLICATIONS, INC. |
|
K831285 |
06/03/1983 |
SURGICAL/LID MARGIN COVER & EYELASH- |
RICHARD R. ANTHONY, M.D. |
|
K830793 |
06/16/1983 |
PATIENT GUIDED ELBOW & SHOULDER EXERC |
RICHARD'S MEDICAL EQUIP., INC. |
|
K831656 |
06/30/1983 |
ARTHROSCOPY KNIVES/PROBES/BENDING TOOL |
RICHARDS MANUFACTURER CO. |
|
K830268 |
06/08/1983 |
FLORET CYLINDRICAL/BRONCHOSCOPIC/LAMIN |
RITMED, INC. |
|
K830266 |
06/08/1983 |
FLORET KITTNER OR K DISSECTOR |
RITMED, INC. |
|
K830269 |
06/02/1983 |
FLORET NEURO SPONGE |
RITMED, INC. |
|
K830267 |
06/08/1983 |
FLORET SPECIAL GAUZE SPONGES |
RITMED, INC. |
|
K830261 |
06/08/1983 |
FLORET STRUNG GAUZE SPONGES |
RITMED, INC. |
|
K830264 |
06/03/1983 |
FLORET TONSIL & ADENOID SPONGES |
RITMED, INC. |
|
K830270 |
06/24/1983 |
ISOVIS WOUND PROTECTOR |
RITMED, INC. |
|
K830271 |
06/02/1983 |
LAPET & LAPWALL LAPAROTOMY SPONGES |
RITMED, INC. |
|
K830272 |
06/03/1983 |
PROTET HOLDERS-BLOCKS & ROLL |
RITMED, INC. |
|
K837494 |
06/14/1983 |
BABY LIGHT METER |
ROCKY MOUNTAIN MEDICAL CORP. |
|
K831528 |
06/30/1983 |
MODEL TP THERMISTOR PROBE |
SCIMED LIFE SYSTEMS, INC. |
|
K831260 |
06/03/1983 |
SCI MED TEMPERATURE MONITORING ADAPTOR |
SCIMED LIFE SYSTEMS, INC. |
|
K831261 |
06/03/1983 |
SCI MED TUBING CONNECTORS |
SCIMED LIFE SYSTEMS, INC. |
|
K830362 |
06/03/1983 |
INFANT ELECTRODE BELT |
SENTRY MEDICAL PRODUCTS, INC. |
|
K831332 |
06/30/1983 |
ARGYLE DUAL STAGE VENOUS RETURN CATH. |
SHERWOOD MEDICAL CO. |
|
K831519 |
06/22/1983 |
RPMI-1640 MEDIUM W/L-GLUTAMINE & |
SIGMA CHEMICAL CO. |
|
K831398 |
06/08/1983 |
LINEAR ENZMATIC URIC ACID SYSTEM |
SIMMLER, INC. |
|
K831394 |
06/08/1983 |
SOMATRON |
SOMATRON CO. |
|
K831371 |
06/30/1983 |
MODEL FM5 |
SONICAID, INC. |
|
K831562 |
06/30/1983 |
SONTEK INFUSION CATHETER |
SONTEK CORP. |
|
K831806 |
06/29/1983 |
SUTURE KITS STERILIZED W/GAMA RADIATION |
SOUTH MOUNTAIN MEDICAL |
|
K831579 |
06/17/1983 |
GONORRHEA TRANSETTE 1 & 3 |
SPECTRUM DIAGNOSTIC, INC. |
|
K831497 |
06/24/1983 |
SPIROMETRICS BREON 2400 & SMI 2400 |
SPIROMETRICS, INC. |
|
K823770 |
06/03/1983 |
SPIROTECH ST-5500 |
SPIROTECH, INC. |
|
K830722 |
06/30/1983 |
SPORIDIDIN-D COLD STERILIZING/SOLUTION |
SPORICIDIN INTL. |
|
K831172 |
06/08/1983 |
ULTRAKIT |
STAAR SURGICAL CO. |
|
K831415 |
06/16/1983 |
LACTIC DEHYDROGENASE REAGENT SET |
STERLING BIOCHEMICAL, INC. |
|
K831094 |
06/08/1983 |
PARA LASAR |
STRECK LABORATORIES, INC. |
|
K831340 |
06/08/1983 |
DRAIN-R-DRAPE(EYE |
SUR-TECH, INC. |
|
K831078 |
06/24/1983 |
STRAITH ORAL AIRWAY |
SURGICAL TECHNOLOGY LABORATORIES, INC. |
|
K831580 |
06/17/1983 |
PARAFFIN INFILTRATION MEDIUM |
SURGIPATH MEDICAL INDUSTRIES, INC. |
|
K830824 |
06/12/1983 |
URINE SCREENING KIT |
SYN-KIT, INC. |
|
K831085 |
06/08/1983 |
SYNEVAC VACUUM SOURCE UNIT |
SYNEMED, INC. |
|
K831518 |
06/22/1983 |
AUTO CAROUSE/WASH SOLUTION CONCENTRATE |
SYVA CO. |
|
K831304 |
06/02/1983 |
EMIT QST GENTAMICIN ASSAY |
SYVA CO. |
|
K831355 |
06/02/1983 |
EMIT QST QUINIDINE ASSAY |
SYVA CO. |
|
K831416 |
06/08/1983 |
EMIT QST TOBRAMYCIN ASSAY |
SYVA CO. |
|
K831417 |
06/16/1983 |
EMIT QST TOBRAMYCIN CONTROL |
SYVA CO. |
|
K830953 |
06/22/1983 |
MICRO TRAK HSV1 & 2 CULTURE CONFIRMATION |
SYVA CO. |
|
K831273 |
06/02/1983 |
QST TM SAMPLE PROCESSOR |
SYVA CO. |
|
K831248 |
06/24/1983 |
PATELLAR FAT PAD RETRACTOR |
TECHMEDICA, INC. |
|
K837499 |
06/10/1983 |
AUTOSECTOR |
TECHNICARE CORP. |
|
K831065 |
06/08/1983 |
SECTIONING AID KIT |
TECHNICON INSTRUMENTS CORP. |
|
K831482 |
06/03/1983 |
CLIRANS TAF 120 HOLLOW FIBER DIALYZ. & |
TERUMO MEDICAL CORP. |
|
K831597 |
06/30/1983 |
SERO/TEX RED CELL RF TEST |
TEXAS IMMUNOLOGY, INC. |
|
K830634 |
06/30/1983 |
CARDIOTOMY FILTER |
TEXAS MEDICAL PRODUCTS, INC. |
|
K837440 |
06/10/1983 |
UNKNOWN |
THE S. S. WHITE CO. |
|
K837491 |
06/13/1983 |
REX PEDESTAL INTRA-ORAL X-RAY UNIT |
THE YOSHIDA DENTAL MFG. CO., LTD. |
|
K837413 |
06/10/1983 |
STRETCHER TOP TSI-107 |
THERAPY SERVICES, INC. |
|
K831459 |
06/30/1983 |
FETAL BLOOD SAMPLING KIT #1560 |
TRANSIDYNE GENERAL CORP. |
|
K831258 |
06/30/1983 |
FLO-GARD 6100 VOLUMETRIC INFUSION PUMP |
TRAVENOL LABORATORIES, S.A. |
|
K831311 |
06/08/1983 |
SOLUTION ADMIN. SETS W/FLASHBALL |
TRAVENOL LABORATORIES, S.A. |
|
K823918 |
06/24/1983 |
AUSTIN MODIFIED PARTIAL OSSICULAR RE- |
TREACE MEDICAL, INC. |
|
K823912 |
06/24/1983 |
AUSTIN MODIFIED TOTAL OSSICULAR REPLACE |
TREACE MEDICAL, INC. |
|
K831588 |
06/15/1983 |
INSTRUMENT GUARD CAPSULE |
TREACE MEDICAL, INC. |
|
K823917 |
06/24/1983 |
PARTIAL OSSICULAR REPLACEMENT |
TREACE MEDICAL, INC. |
|
K830584 |
06/02/1983 |
SOILEAU TYTAN BOBBIN VENT TUBE |
TREACE MEDICAL, INC. |
|
K831590 |
06/15/1983 |
T-TUBE INSERTER |
TREACE MEDICAL, INC. |
|
K823919 |
06/24/1983 |
TOTAL OSSICULAR REPLACEMENT |
TREACE MEDICAL, INC. |
|
K831589 |
06/16/1983 |
VENT TUBE FORCEPS |
TREACE MEDICAL, INC. |
|
K830084 |
06/02/1983 |
ANGIOSCOPE |
TRIMEDYNE, INC. |
|
K831412 |
06/03/1983 |
CRM-100 COLOR VIDEO CAMERA |
UMI, INC. |
|
K831075 |
06/22/1983 |
BLOOD GAS & FLAME PHOTOMETER INSTRU- |
UNITED DIAGNOSTICS, INC. |
|
K831097 |
06/15/1983 |
CONCERTO |
UNITEK CORP. |
|
K831098 |
06/16/1983 |
DOMINION |
UNITEK CORP. |
|
K831096 |
06/15/1983 |
STROMA II |
UNITEK CORP. |
|
K831067 |
06/16/1983 |
BREATHING ZONE |
UPPER FOUR, INC. |
MARK BAILY |
K831508 |
06/24/1983 |
MALIS CMC-II BIPOLAR COAGULATOR & CUT |
VALLEY FORGE SCIENTIFIC CORP. |
|
K831554 |
06/08/1983 |
NEIN ALLERGEN DISC IN VAST VENTREX TEST |
VENTREX LABORATORIES, INC. |
|
K831485 |
06/02/1983 |
VENTRE/ZYME IGE KIT |
VENTREX LABORATORIES, INC. |
|
K830748 |
06/22/1983 |
RESUSCITAIRE |
VICKERS AMERICA MEDICAL CORP. |
|
K830713 |
06/08/1983 |
LS-1 PORTABLE BLOOD PRESSURE COMPUTER |
VITA-STAT MEDICAL SERVICES, INC. |
|
K831266 |
06/10/1983 |
MICROSURGICAL KNIFE |
VXTRA CORP. |
|
K831535 |
06/30/1983 |
E.P.T. PLUS TM |
WARNER-LAMBERT CO. |
|
K831492 |
06/30/1983 |
YESONA PLASTER OF PARIS BANDAGE |
WATSON PHILLIPS Y CIA. SUCS., S.A. DE C.V. |
|
K831709 |
06/30/1983 |
AUDIOSCOPE #23000 W/71123 CHARGING STAND |
WELCH ALLYN, INC. |
|
K831069 |
06/16/1983 |
DAC-CEL PTH KIT RD51 |
WELLCOME DIAGNOSTICS |
|
K831227 |
06/02/1983 |
COMPUR EASY TOUCH CHEMISTRY ANALYZER- |
WORTHINGTON DIAGNOSTIC SYSTEMS |
|
K831318 |
06/08/1983 |
COMPUR* M1100 HEMATRCRIT SYSTEM |
WORTHINGTON DIAGNOSTIC SYSTEMS |
|
K831477 |
06/17/1983 |
DEMAND ANALYZER SYSTEM |
WORTHINGTON DIAGNOSTIC SYSTEMS |
|
K837513 |
06/13/1983 |
UNKNOWN |
XEROX CORP. |
|
K837515 |
06/28/1983 |
DENTAL CASSETTE HOLDERS |
XRE CORP. |
|
K831358 |
06/15/1983 |
AUTOANTIBODY SCREEN TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
|
K831026 |
06/22/1983 |
INDIRECT FLUORESCENT ANTIBODY REAGENTS |
ZEUS TECHNOLOGIES |
|
K830926 |
06/02/1983 |
160/260 SUCTION COAGULATOR |
ZIMMER, INC. |
|