| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K821661 |
06/22/1982 |
FLEXIFLO-II |
ABBOTT LABORATORIES |
|
| K821698 |
06/22/1982 |
TDX NETILMICIN |
ABBOTT LABORATORIES |
|
| K821578 |
06/22/1982 |
VENOSET DUAL-RATE PIGGYBACK W/IVEX & |
ABBOTT LABORATORIES |
|
| K821515 |
06/09/1982 |
VENTED NITROGLYCERIN I.V. SET |
ABBOTT LABORATORIES |
|
| K821700 |
06/16/1982 |
LATEX PENROSE DRAIN TUBING |
ABCO DEALERS, INC. |
|
| K821457 |
06/01/1982 |
HEMACOUNT WRIGHTS STAIN PACK II #55952 |
ACCRA LABORATORIES, INC. |
|
| K827502 |
06/09/1982 |
MODEL DPS-4050 DIGITAL RADIOGRAPHY SYSTEM |
ADAC LABORATORIES |
|
| K827525 |
06/18/1982 |
AUTOMATIC EXPOSURE CONTROL TYPE A3300 |
ADVANCED INSTRUMENT DEVELOPMENT, INC. |
|
| K821479 |
06/25/1982 |
CENTRAL DISPLAY SYSTEM #CS400 |
ADVANTAGE MEDICAL SYSTEMS, INC. |
|
| K821580 |
06/25/1982 |
FETAL MONITOR #FM 750 |
ADVANTAGE MEDICAL SYSTEMS, INC. |
|
| K820755 |
06/10/1982 |
THE ORIGINAL LEINBACH PLATFORM TOTAL HIP |
ALLO PRO CORP. |
|
| K821697 |
06/25/1982 |
INJECTION ASPIRATING NEEDLES |
AMERICAN ENDOSCOPY, INC. |
|
| K821665 |
06/24/1982 |
PEDESTAL EXAMINING TABLE |
AMERICAN HAMILTON |
|
| K821715 |
06/25/1982 |
AM-40 SYSTEM |
AMERICAN MIDWEST |
|
| K821660 |
06/25/1982 |
BIO-CHECK GRAM STAIN CONTROL |
AMERICAN SCIENTIFIC PRODUCTS |
|
| K821553 |
06/25/1982 |
ZETAPHASE T3 UPTAKE DIAGNOSTIC KIT |
AMF BIOLOGICAL AND DIAGNOSTICS CO. |
|
| K821554 |
06/25/1982 |
ZETAPHASE T4 RADIOIMMUNOASSAY DIAG. KIT |
AMF BIOLOGICAL AND DIAGNOSTICS CO. |
|
| K821526 |
06/10/1982 |
ACID PHOSPHATASE REAGENT SET |
ANCO MEDICAL REAGENTS & ASSOC. |
|
| K821658 |
06/25/1982 |
HEMOGLOBIN REAGENT |
ANCO MEDICAL REAGENTS & ASSOC. |
|
| K821095 |
06/10/1982 |
SPHYGURITE |
ASSOCIATED MEDICAL DEVICES, INC. |
|
| K820641 |
06/22/1982 |
ACCURETTE |
AXCAN SCIENTIFIC CORP. |
|
| K821069 |
06/10/1982 |
MODEL AS6M INFUSION PUMP |
BAXTER HEALTHCARE CORP. |
|
| K821266 |
06/01/1982 |
BBL DIRECTIGEN MENINGITIS TEST KIT |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
| K821264 |
06/22/1982 |
CEFOPERAZONE 75MCG SENSI-DISC |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
| K821771 |
06/25/1982 |
MACRO-VUE CARD TEST, AMIKACIN |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
| K821433 |
06/02/1982 |
BECKMAN LIQUID-STAT AST-UV LIQUID |
BECKMAN INSTRUMENTS, INC. |
|
| K820343 |
06/17/1982 |
ARTERIAL BLOOD FILTER MODEL #AF-1040 |
BENTLEY LABORATORIES, INC. |
|
| K820044 |
06/29/1982 |
ARTERIAL BLOOD FILTER, #AF-1025 |
BENTLEY LABORATORIES, INC. |
|
| K820679 |
06/17/1982 |
PEDIATRIC ARTERIAL BLOOD FILTER #AF-540 |
BENTLEY LABORATORIES, INC. |
|
| K821447 |
06/09/1982 |
MODEL BERUAFON T85 & T95 |
BERUAFON, INC. |
|
| K821005 |
06/01/1982 |
PLATELET AGGREGATION PROFILER #PAP-4 |
BIO/DATA CORP. |
|
| K821241 |
06/01/1982 |
FREE T4 RADIOIMMUNOASSAY KIT |
BIOCLINICAL GROUP |
|
| K821300 |
06/02/1982 |
#2010 CAMPHYLOBACTER AGAR |
BIOMEDIA, INC. |
|
| K821301 |
06/01/1982 |
#50002 QUAD DIAGNOSTIC SYSTEM |
BIOMEDIA, INC. |
|
| K821302 |
06/01/1982 |
#50003 QUAD DIAGNOSTIC SYSTEM |
BIOMEDIA, INC. |
|
| K820934 |
06/10/1982 |
SYPHILIS BIO-ENZABEAD KIT |
BIOMETICS LABORATORY PRODUCTS |
|
| K821534 |
06/10/1982 |
HEMATOLOGY DATA MANAGEMENT SYS |
BIOVATION, INC. |
|
| K821157 |
06/23/1982 |
HETERODYNAMIC |
BIRTCHER CORP. |
|
| K821584 |
06/14/1982 |
EPISTAXIS CATHETER/KIT |
BIVONA MEDICAL TECHNOLOGIES |
|
| K821476 |
06/23/1982 |
BARD ENDO LINK INTRACONDYLAR ROTATING |
C.R. BARD, INC. |
|
| K821745 |
06/24/1982 |
BARDEX ALL SILICONE PEDIATRIC CATHETER |
C.R. BARD, INC. |
|
| K821272 |
06/22/1982 |
BN-74 COATED BARDEX ALL SILICONE CATH |
C.R. BARD, INC. |
|
| K821442 |
06/17/1982 |
WILLIAM HARVEY FLEX. VENOUS RESERVOIR |
C.R. BARD, INC. |
|
| K820933 |
06/14/1982 |
CILCO I/A HANDPIECE |
CILCO, INC. |
|
| K821381 |
06/14/1982 |
IOL FORCEPS |
CILCO, INC. |
|
| K821611 |
06/24/1982 |
GAMMADAB [125] FSH RADIOIMMUNAY KIT |
CLINICAL ASSAYS, INC. |
|
| K821092 |
06/22/1982 |
GAMMADAB[125]EGE RADIOIMMUNOASSAY IT |
CLINICAL ASSAYS, INC. |
|
| K821354 |
06/03/1982 |
CONPHAR MAYO HEGAR NEEDLE HOLDER |
CONPHAR, INC. |
|
| K821289 |
06/03/1982 |
MAYO-HEGAR NEEDLE HOLDER |
CONPHAR, INC. |
|
| K821295 |
06/03/1982 |
OLSEN HEGAR NEEDLE HOLDERS |
CONPHAR, INC. |
|
| K820939 |
06/22/1982 |
C-101-P |
CORATOMIC, INC. |
|
| K821489 |
06/09/1982 |
CORDIA TG |
CORDIS CORP. |
|
| K821398 |
06/25/1982 |
CORNING CPF 550 LENS |
CORNING MEDICAL & SCIENTIFIC |
|
| K821268 |
06/23/1982 |
TRANSDUCER FILTER |
CP MEDICAL |
|
| K821221 |
06/07/1982 |
DENTAL IMPRESSION MATERIAL |
CROWN DELTA CORP. |
|
| K821550 |
06/14/1982 |
MODEL AH BEHING-THE-EAR-HEARING AID |
DAHLBERG ELECTRONICS, INC. |
|
| K821226 |
06/07/1982 |
DENTAL AMALGAM ALLOY |
DENTAL ALLOYERS INTL., INC. |
|
| K820998 |
06/10/1982 |
DENTRON-DIRECT-TRAY |
DENTRON, INC. |
|
| K820997 |
06/10/1982 |
DENTRON-EXACT - TRAY |
DENTRON, INC. |
|
| K821063 |
06/25/1982 |
SKIN MARKERS |
DEVON INDUSTRIES, INC. |
|
| K821406 |
06/25/1982 |
ARTERIAL BLOOD SAMPLING KIT |
DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP. |
|
| K821725 |
06/24/1982 |
T3 DIAGNOSTIC KIT RIA |
DIAGNOSTIC REAGENTS, INC. |
|
| K821722 |
06/24/1982 |
T3 UPTAKE DIAGNOSTIC KIT |
DIAGNOSTIC REAGENTS, INC. |
|
| K821675 |
06/22/1982 |
CALCITONIN RIA TEST KIT, DLS 1200 |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
|
| K820877 |
06/25/1982 |
AUTOMATIC OBJECTIVE REFRACTOR 2000 |
DICON, INC. |
|
| K821262 |
06/22/1982 |
CEFOPERAZONE 75MCG SENSIT- DISCS |
DIFCO LABORATORIES, INC. |
|
| K821650 |
06/29/1982 |
DRAGER VAPOR 19.1 ANESTHETIC VAPORIZERS |
DRAEGER MEDICAL, INC. |
|
| K821796 |
06/24/1982 |
EZ-FIX I.V. CATHETER HOLDER |
DYNA CARE |
|
| K821458 |
06/09/1982 |
DYNAMIC FUNTIONAL POSITIONER |
DYNAMIC FUNCTIONAL POSITIONER, INC. |
|
| K821439 |
06/01/1982 |
MR 600 MICROPLATE READER |
DYNATECH CORP. |
|
| K821687 |
06/24/1982 |
REMOVAWELL TISSUE CULTURE PLATE W/LID |
DYNATECH CORP. |
|
| K821494 |
06/03/1982 |
RIA STAT 16 |
E. R. SQUIBB & SONS, INC. |
|
| K821390 |
06/07/1982 |
CUSTOM, IN-THE-EAR HEARING AID |
EAR-TRONICS, INC. |
|
| K821544 |
06/10/1982 |
DETECTION OF THEOPHYLLINE |
ELECTRO-NUCLEONICS LABORATORIES, INC. |
|
| K821543 |
06/03/1982 |
IPA FOR DETECTION OF PHENOBARBITAL |
ELECTRO-NUCLEONICS LABORATORIES, INC. |
|
| K821542 |
06/03/1982 |
VIRGO IMMUNO-PRECIPITATION ASSAY TOBRA |
ELECTRO-NUCLEONICS LABORATORIES, INC. |
|
| K821464 |
06/02/1982 |
CARDIOZYME PLUS CK-MB, #65045 |
EMD CHEMICALS INC. |
|
| K821441 |
06/01/1982 |
ENZYMATIC CHOLESTERAL OXIDASE #650550 |
EMD CHEMICALS INC. |
|
| K821472 |
06/03/1982 |
ULTRACHEM CREA #64972 |
EMD CHEMICALS INC. |
|
| K821470 |
06/02/1982 |
ULTRACHEM E-GLU #64976 & 65040 |
EMD CHEMICALS INC. |
|
| K821475 |
06/25/1982 |
ULTRACHEM E-GLU #64976&65040 |
EMD CHEMICALS INC. |
|
| K821461 |
06/02/1982 |
ULTRACHEM E-GLU, #64976 & 65040 |
EMD CHEMICALS INC. |
|
| K821463 |
06/02/1982 |
ULTRACHEM GLUC-DH, #65048 |
EMD CHEMICALS INC. |
|
| K821469 |
06/02/1982 |
ULTRACHEM GLUC-DH, #65048 |
EMD CHEMICALS INC. |
|
| K821462 |
06/01/1982 |
ULTRACHEM T-BILI, #64971 |
EMD CHEMICALS INC. |
|
| K821474 |
06/03/1982 |
ULTRACHEM URIC ACID AIDH #65047 |
EMD CHEMICALS INC. |
|
| K821465 |
06/02/1982 |
ULTRACHEM URIC ACID AIDH, #65047 |
EMD CHEMICALS INC. |
|
| K821471 |
06/02/1982 |
ULTRAZYME PLUS ALP #64962,65029&65030 |
EMD CHEMICALS INC. |
|
| K821460 |
06/01/1982 |
ULTRAZYME PLUS CK-I, #64978,65027&65028 |
EMD CHEMICALS INC. |
|
| K821473 |
06/03/1982 |
ULTRAZYME PLUS CKI, #64978,65027&65028 |
EMD CHEMICALS INC. |
|
| K821467 |
06/01/1982 |
ULTRAZYME PLUS GOT, #64953,65033&65034 |
EMD CHEMICALS INC. |
|
| K821466 |
06/01/1982 |
ULTRAZYME PLUS LDH, #64950,65038&65039 |
EMD CHEMICALS INC. |
|
| K821468 |
06/02/1982 |
ULTRAZYME PLUS-GT, #64959 & 65032 |
EMD CHEMICALS INC. |
|
| K821561 |
06/01/1982 |
VERSACHEM ANALYZER |
EMD CHEMICALS INC. |
|
| K821131 |
06/02/1982 |
RADIOIMMUNOASSAY PARATHYROID HORMONE MID |
ENDOCRINE-METABOLIC CENTER |
|
| K821690 |
06/22/1982 |
ERIKA HPF 100,200,300 DIALYZER |
ERIKA, INC. |
|
| K821587 |
06/25/1982 |
ERIKA HPF 50 DIALYZER |
ERIKA, INC. |
|
| K821310 |
06/11/1982 |
ESPREE' ANESTHESIA BACTERIAL FILTER |
ESP PLASTICS, INC. |
|
| K821481 |
06/14/1982 |
NASAL-THROAT SPRAY IRRIGATION INSTRUM. |
ETHICARE PRODUCTS |
|
| K820827 |
06/25/1982 |
P105 |
EUROTAN INTL. |
|
| K821216 |
06/02/1982 |
INTERPULSE MEMBRANE OXYGENATOR |
EXTRACORPOREAL MEDICAL SPECIALITIES, INC. |
|
| K813432 |
06/23/1982 |
HEMODIALYSIS SYSTEM |
FHK |
|
| K821683 |
06/24/1982 |
REAGENT FOR COULTER COUNTER MODEL 5+11 |
FISHER SCIENTIFIC CO., LLC. |
|
| K821401 |
06/17/1982 |
MALLINCKRODT DIAG. MEDIA WARMER |
FORMA SCIENTIFIC, INC. |
|
| K821616 |
06/16/1982 |
CERVISCOPE OPTICAL SYSTEM |
FOTOMEDICS, INC. |
|
| K827470 |
06/11/1982 |
STATIONARY SPECIAL PURPOSE PODIATRY X-RAY UNIT |
FRANKLIN X-RAY CORP. |
|
| K821744 |
06/25/1982 |
FRASER HARLAKE NITRONOX SCAVENGER |
FRASER HARLAKE, INC. |
|
| K821639 |
06/11/1982 |
ANKLE FOOT ORTHOSIS |
FRED SAMMONS, INC. |
|
| K821636 |
06/11/1982 |
ATTACH-A-PAK |
FRED SAMMONS, INC. |
|
| K821645 |
06/11/1982 |
BACK SKPPORTS |
FRED SAMMONS, INC. |
|
| K821643 |
06/11/1982 |
EATING UTENSILS |
FRED SAMMONS, INC. |
|
| K821634 |
06/11/1982 |
EZ STAND MOBILE STOOL |
FRED SAMMONS, INC. |
|
| K821647 |
06/11/1982 |
FOAM WEDGES |
FRED SAMMONS, INC. |
|
| K821638 |
06/11/1982 |
HYGIENE ADAPTORS |
FRED SAMMONS, INC. |
|
| K821641 |
06/11/1982 |
OBTHOSES |
FRED SAMMONS, INC. |
|
| K821640 |
06/11/1982 |
ORTHOTIC FABRICATION ACCESSORIES |
FRED SAMMONS, INC. |
|
| K821631 |
06/11/1982 |
PINCH GAUGE, 0-301 LBS. |
FRED SAMMONS, INC. |
|
| K821635 |
06/11/1982 |
SOFT ULNAR DEVIATION SPLINTS |
FRED SAMMONS, INC. |
|
| K821632 |
06/24/1982 |
SURGICAL SCISSORS, SET OF 3 |
FRED SAMMONS, INC. |
|
| K821646 |
06/11/1982 |
TINY FLEX-GLASS, SET OF 4 |
FRED SAMMONS, INC. |
|
| K821644 |
06/11/1982 |
VACUUM WAND AND UNI-READER |
FRED SAMMONS, INC. |
|
| K821633 |
06/11/1982 |
VARIABLE SPEED VIBRATOR, 120V 83-117 VIB |
FRED SAMMONS, INC. |
|
| K821642 |
06/11/1982 |
WHEEL CHAIR ACCESSORIES |
FRED SAMMONS, INC. |
|
| K821637 |
06/11/1982 |
WIRE-FOAM MP FLEXION SPRING |
FRED SAMMONS, INC. |
|
| K820375 |
06/14/1982 |
PLASTIC OR GLASS MAGNIFIER |
GAZELLE CORP. |
|
| K821229 |
06/22/1982 |
CEFOPERAZONE 75MCG. ANTIMICROBIAL DISK |
GENERAL DIAGNOSTICS |
|
| K821522 |
06/21/1982 |
CERVITRAC TRACTION FRAME & CORD |
GEORGE W. COTTRELL |
|
| K821591 |
06/22/1982 |
STEAM STERILIZATION EQUIPMENT |
GETINGE INTERNATIONAL, INC. |
|
| K821551 |
06/22/1982 |
MARTIN-LEWIS/PRONG AGAR |
GIBCO LABORATORIES LIFE TECHNOLOGIES, INC. |
|
| K821719 |
06/24/1982 |
AMMONIA REAGENT |
GILFORD DIAGNOSTICS |
|
| K821583 |
06/24/1982 |
AMES/GILFORD OPTIMATE CLIN. CHEM & THER |
GILFORD INSTRUMENT LABORATORIES, INC. |
|
| K821493 |
06/01/1982 |
LITTMAN OXGAL AGAR |
GRANITE DIAGNOSTICS, INC. |
|
| K821688 |
06/22/1982 |
TITAN GEL HIGH RESOLUTION SERUM PROTEIN |
HELENA LABORATORIES |
|
| K821517 |
06/10/1982 |
TITANAN GEL SERUM PROTEIN ELECTROPHORES |
HELENA LABORATORIES |
|
| K820890 |
06/23/1982 |
URETHANE ORTHOPAEDIC CASTING TAPE |
HEXCEL MEDICAL |
& NEPHEW |
| K821680 |
06/24/1982 |
HOLLISTER CATHETER ACCESS. PORT |
HOLLISTER, INC. |
|
| K821704 |
06/24/1982 |
FRACTURE BRACING |
HOSMER DORRANCE CORP. |
|
| K821482 |
06/02/1982 |
STERILE HD PAN SET |
HOSPITAL DISPOSABLES, INC. |
|
| K821252 |
06/22/1982 |
HOFFMAN UNIVERSAL FOOT SUPPORT |
HOWMEDICA CORP. |
|
| K821566 |
06/03/1982 |
ORTHOPEDIC FIXATION DEVICES |
HOWMEDICA CORP. |
|
| K820218 |
06/03/1982 |
PRE-STERILIZATION OF VITALLIUM ALLOY |
HOWMEDICA CORP. |
|
| K820470 |
06/02/1982 |
UNIFLEX |
HOWMEDICA CORP. |
|
| K821366 |
06/10/1982 |
TANDEM - HGH KIT |
HYBRITECH, INC. |
|
| K821545 |
06/11/1982 |
TANDEM PROLACTIN KIT |
HYBRITECH, INC. |
|
| K821411 |
06/25/1982 |
HISTOSET IMMUNOPEROFIDASE TISSUE |
IMMULOK, INC. |
|
| K821567 |
06/25/1982 |
IMMULOK CULTURESET |
IMMULOK, INC. |
|
| K821552 |
06/11/1982 |
PREG-KNOW |
IMMUNO PATHOLOGY LABS |
|
| K821576 |
06/10/1982 |
ANTINUCLEAR ANTIBODY SCREEN FLOURESC |
IMMUNO-PRODUCTS INDUSTRIES |
|
| K821496 |
06/22/1982 |
DISPOSABLE IRRIGA/ASPIR. SYSTEM |
INNOVATIVE SURGICAL PRODUCTS INC. |
|
| K821483 |
06/10/1982 |
IL 1302 PH BLOOD GAS ANALYZER |
INSTRUMENTATION LABORATORY CO. |
|
| K821343 |
06/03/1982 |
BDH FEMORAL COMPONENT |
INTERMEDICS ORTHOPEDICS |
|
| K821341 |
06/03/1982 |
IOI METAL BACKED TIBIAL COMPONENT |
INTERMEDICS ORTHOPEDICS |
|
| K821756 |
06/25/1982 |
IEC CENTRA 4 CENTRIFUGE |
INTERNATIONAL EQUIPMENT CO. |
|
| K821425 |
06/01/1982 |
COLUMBIA BLOOD AGAR W/5% SHEEP BLOOD |
INTERSTATE MEDIA |
|
| K821419 |
06/01/1982 |
EMB AGAR |
INTERSTATE MEDIA |
|
| K821420 |
06/01/1982 |
EMB AGAR |
INTERSTATE MEDIA |
|
| K821421 |
06/01/1982 |
HEKTOEN ENTERIC AGAR |
INTERSTATE MEDIA |
|
| K821423 |
06/01/1982 |
MACCONKEY AGAR |
INTERSTATE MEDIA |
|
| K821427 |
06/01/1982 |
MANNITOL SALT AGAR |
INTERSTATE MEDIA |
|
| K821428 |
06/01/1982 |
MUELLER HINTON CHOCOLATE MED. ENRICHED |
INTERSTATE MEDIA |
|
| K821429 |
06/01/1982 |
MUELLER HINTON MED. W/5% SHEEP BLOOD |
INTERSTATE MEDIA |
|
| K821430 |
06/01/1982 |
MUELLER HINTON MEDIUM |
INTERSTATE MEDIA |
|
| K821422 |
06/01/1982 |
SS AGAR |
INTERSTATE MEDIA |
|
| K821426 |
06/01/1982 |
STAPHYLOCOCCUS MEDIUM 1100 |
INTERSTATE MEDIA |
|
| K821417 |
06/01/1982 |
TRYPTIC SOY AGAR W/10% SHEEP BLOOD |
INTERSTATE MEDIA |
|
| K821424 |
06/01/1982 |
TRYPTIC SOY AGAR W/5% SHEEP BLOOD |
INTERSTATE MEDIA |
|
| K821418 |
06/01/1982 |
TRYPTOSE BLOOD AGAR W/5% SHEEP BLOOD |
INTERSTATE MEDIA |
|
| K821431 |
06/01/1982 |
XLD AGAR |
INTERSTATE MEDIA |
|
| K821503 |
06/03/1982 |
IRIS URINE STAIN |
INTL. REMOTE IMAGING SYSTEMS |
|
| K821002 |
06/22/1982 |
INVERCHAIR |
INVERCHAIR MARKETING, INC. |
|
| K827370 |
06/28/1982 |
IREX SYSTEM II 2D/DOPPLER IMAGING SYSTEM |
IREX CORP. |
|
| K820630 |
06/25/1982 |
QUIK-SEP HEMOGLOBIN F ASSAY & CONTROL |
ISOLAB, INC. |
|
| K821590 |
06/14/1982 |
"PORS-ON" |
J. ADERER, INC. |
|
| K821446 |
06/09/1982 |
DEGUDENT 14 |
J. ADERER, INC. |
|
| K821407 |
06/09/1982 |
DEVA M |
J. ADERER, INC. |
|
| K821572 |
06/14/1982 |
DUALLOR 'R' |
J. ADERER, INC. |
|
| K821613 |
06/04/1982 |
E.G. BRIDGE GOLD |
J. ADERER, INC. |
|
| K821521 |
06/09/1982 |
STABILOR NF |
J. ADERER, INC. |
|
| K821582 |
06/10/1982 |
WARM'N FORM SPORTS SUPPORTS |
JEROME MEDICAL |
|
| K821708 |
06/25/1982 |
NAGASHIMA LIGHT SOURCE UNIT SL-4 |
KELLEHER CORP. |
|
| K821709 |
06/25/1982 |
NAGASHIMA LIGHT SOURCE UNIT SL-5 |
KELLEHER CORP. |
|
| K821710 |
06/25/1982 |
NAGASHIMA NX-150F LIGHT SOURCE UNIT |
KELLEHER CORP. |
|
| K821706 |
06/25/1982 |
NAGASHIMA SFT-I LARYNGOSCOPE RIGHT-ANGL |
KELLEHER CORP. |
|
| K821707 |
06/25/1982 |
NAGASHIMA SFT-II LARYNGOSCOPE STRAIGHT |
KELLEHER CORP. |
|
| K821127 |
06/03/1982 |
KEY DRILL |
KEY MEDICAL, INC. |
|
| K827507 |
06/02/1982 |
ENDOSCOPIC ACCESSORY U/S/ CLEANING MACHINE |
KEYMED HOUSE |
|
| K821396 |
06/09/1982 |
OUT-RITE WASTE DISPOSABLE BAG |
KLEEN TEST PRODUCTS |
|
| K821395 |
06/03/1982 |
SADDLEBAG INSTRUMENT PAD W/POUCHES |
KLEEN TEST PRODUCTS |
|
| K821394 |
06/03/1982 |
SUTURE-SAFE 40 ADHESIVE NEEDLE COUNTER |
KLEEN TEST PRODUCTS |
|
| K827410 |
06/04/1982 |
LITERATURE ON THE SONADENT |
L&R MFG. CO., INC. |
|
| K803031 |
06/29/1982 |
LAURE WRIST IMPLANT |
LAURE PROSTHETICS, INC. |
|
| K820938 |
06/11/1982 |
HAWKINS ELECTROKINETIC BODY ACTIVATING |
LEISURE WAY |
|
| K821443 |
06/02/1982 |
FORMICAL |
LERNER LABORATORIES, INC. |
|
| K821223 |
06/17/1982 |
CR-9 |
LIFE SCIENCE INSTRUMENTATION, INC. |
|
| K821456 |
06/17/1982 |
ENDOTRACHEAL TUBE |
LIFE-LINE PRODUCTS, INC. |
|
| K821624 |
06/22/1982 |
LOW VOLUME INFUSTION SET |
LIFEMED OF CALIFORNIA |
|
| K821365 |
06/29/1982 |
ENGSTOM EDITH |
LKB INSTRUMENTS, INC. |
|
| K821760 |
06/25/1982 |
SERIES M PUSH-PULL INPUT COMPRESSION |
MAICO HEARING INSTRUMENTS, INC. |
|
| K821581 |
06/14/1982 |
DEN TEMP |
MAJESTIC DRUG CO., INC. |
|
| K820725 |
06/01/1982 |
SPAC T4 RIA TEST KIT |
MALLINCKRODT CRITICAL CARE |
|
| K821403 |
06/21/1982 |
LIGHT WEIGHT ALUMINUM CRUTCHES |
MANUCO MANUFACTURING CO., INC. |
|
| K821405 |
06/16/1982 |
MAGUN BASE I.V. POLE |
MANUCO MANUFACTURING CO., INC. |
|
| K821520 |
06/02/1982 |
MODEL 379 FLOW/DIVIDER |
MARATHON |
|
| K821306 |
06/07/1982 |
HEAD-UP SUPINE SAFETY SUPPORT CUSHION |
MED-LIFE, INC. |
|
| K821529 |
06/09/1982 |
DISPOSABLE HYPODERMIC NEEDLES |
MEDCARE DISP PRODUCTS, INC. |
|
| K821528 |
06/09/1982 |
SYRINGE, PISTON |
MEDCARE DISP PRODUCTS, INC. |
|
| K821617 |
06/21/1982 |
DISPOSABLE HEMOSTATS |
MEDCARE PRODUCTS |
|
| K821618 |
06/21/1982 |
DISPOSABLE NEEDLE HOLDERS |
MEDCARE PRODUCTS |
|
| K821348 |
06/10/1982 |
HYPODERMIC NEEDLES & SYRINGES |
MEDI-TECH, INC. |
|
| K821684 |
06/24/1982 |
MCSCP8PS WITH 'Y' HUB |
MEDICAL COMPONENTS, INC. |
|
| K821651 |
06/24/1982 |
E-Z UP ARTHERAPEDIC CHAIR |
MEDICAL DEVICE CONSULTANTS, INC. |
|
| K821081 |
06/14/1982 |
CHART PROJECTOR |
MEDICAL EQUIPMENT DESIGNS, INC. |
|
| K821107 |
06/14/1982 |
EXOPHTHALMOMETER |
MEDICAL EQUIPMENT DESIGNS, INC. |
|
| K821083 |
06/14/1982 |
P.D. METER |
MEDICAL EQUIPMENT DESIGNS, INC. |
|
| K821082 |
06/14/1982 |
TRIAL LENS SET |
MEDICAL EQUIPMENT DESIGNS, INC. |
|
| K821084 |
06/14/1982 |
UNIVERSAL TRIAL FRAMEE |
MEDICAL EQUIPMENT DESIGNS, INC. |
|
| K821330 |
06/07/1982 |
GAS STERILIZATION POUCHES |
MEDICAL INDUSTRIES PACKAGING, INC. |
|
| K821331 |
06/07/1982 |
MEDI-SEAL STERILIZATION POUCHES & TUB |
MEDICAL INDUSTRIES PACKAGING, INC. |
|
| K821764 |
06/29/1982 |
DISPOSABLE INTRAVENOUS INJECTION SYSTEM |
MEDICAL SYSTEMS RESEARCH |
|
| K821506 |
06/17/1982 |
MEDICOTEST ECG ELECTRODES |
MEDICOTEST, INC. |
|
| K821333 |
06/02/1982 |
ATRIAL "J" TEMPORARY PACING ELECTRODESS |
MEDICS INSTRUMENT CORP. |
|
| K821017 |
06/22/1982 |
VARIOUS STERILE BIOPSY ASPIRATION NEED |
MEDSURG INDUSTRIES, INC. |
|
| K820988 |
06/23/1982 |
MEDTRONIC #1992-2 DUAL RATE TRANSMITTER |
MEDTRONIC VASCULAR |
|
| K812262 |
06/17/1982 |
MEDTRONIC A-V PACING SYSTEM ANALYZER |
MEDTRONIC VASCULAR |
|
| K821313 |
06/21/1982 |
SURGICAL UTILITY DRAPE |
MEGAPLAST, INC. |
|
| K827506 |
06/11/1982 |
MODEL ML-820 CARBON DIOXIDE LASER SYSTEM FOR SURGERY |
MERRIMACK LABORATORIES |
|
| K821383 |
06/23/1982 |
ECHO, MODEL MM-1000 |
MESA MEDICAL, INC. |
|
| K821703 |
06/22/1982 |
MGN CONDUCTIVE CONNECTING TUBE, STERILE |
MGN MEDICAL MANUFACTURING, INC. |
|
| K821678 |
06/24/1982 |
AUTOPAK ESTRIOL TEST DELIVERY SYSTEM |
MICROMEDIC SYSTEMS |
|
| K827504 |
06/09/1982 |
SIZE SENSING CASSETTE TRAY |
MIDWEST X-RAY EQUIPMENT CO. |
|
| K821504 |
06/23/1982 |
THERMAL WELL TEMPERATURE SENSOR |
MON-A-THERM, INC. |
|
| K821629 |
06/14/1982 |
"FIXIDENT" |
MOYCO INDUSTRIES, INC. |
|
| K821444 |
06/14/1982 |
COLORED WEDGE USED TO SEPARATE TEETH |
MOYCO INDUSTRIES, INC. |
|
| K821391 |
06/29/1982 |
OPHTHALMIC EYEWEAR |
NORDIC EYEWEAR, INC. |
|
| K821720 |
06/25/1982 |
PHYSIOLOGICAL DISPLAY SYSTEM, MODEL 1000 |
NOVAMETRIX MEDICAL SYSTEMS, INC. |
|
| K821376 |
06/29/1982 |
OHIO 7000 ELECTRONIC ANESTHESIA VENTIL. |
OHIO MEDICAL PRODUCTS |
|
| K821217 |
06/07/1982 |
REIGNING DENTURE |
OKI SHIKS USA LTD. |
|
| K821523 |
06/16/1982 |
OMNI TENS |
OMNI INTL., INC. |
|
| K821806 |
06/25/1982 |
ORTHO CLG IMMUNE COMPLEX TEST SYSTEM |
ORTHO DIAGNOSTIC SYSTEMS, INC. |
|
| K821325 |
06/07/1982 |
OTICON |
OTICON CORP. |
|
| K821549 |
06/02/1982 |
PACEMAKER 445 ADAPTER |
PACESETTER SYSTEMS |
|
| K821548 |
06/02/1982 |
PACEMAKER CONNECTOR PLUG |
PACESETTER SYSTEMS |
|
| K821547 |
06/02/1982 |
PACEMAKER UNIPOLAR ADAPTER |
PACESETTER SYSTEMS |
|
| K821739 |
06/25/1982 |
J. MORITA FLEX M-3 TORX HARDPIECE |
PACIFIC DENTAL CORP. |
|
| K821773 |
06/23/1982 |
PEDICRAFT BED, MODEL B2944 |
PEDICRAFT, INC. |
|
| K821375 |
06/01/1982 |
DEODORANT SURE & NATURAL MAXISHIELDS |
PERSONAL PRODUCTS CO. |
|
| K821044 |
06/23/1982 |
PATIENT PREP KITS/TRAYS-STERILE |
PHOENIX GLOVE CO. |
|
| K821666 |
06/21/1982 |
STERILE SURGICAL DRAPES |
PHOENIX GLOVE CO. |
|
| K821360 |
06/02/1982 |
GLYCO-GEL TEST KIT |
PIERCE CHEMICAL CO. |
|
| K821500 |
06/23/1982 |
STERILE CATH CARE KIT |
PRO-PAK |
|
| K821501 |
06/16/1982 |
STERILE TRACHEOSTOMY CARE KIT |
PRO-PAK |
|
| K821648 |
06/22/1982 |
GAS CHEX PLASTIC BAG |
PROPPER MFG. CO., INC. |
|
| K821400 |
06/23/1982 |
MAHURKAR SUBCLAVIAN CATHETER |
QUINTON, INC. |
RANDY WALLS |
| K821318 |
06/02/1982 |
RETIC SET |
R & D SYSTEMS, INC. |
|
| K821384 |
06/17/1982 |
EXERCISE ECG ELECTRODES, REUSABLE |
RESPIRONICS, INC. |
|
| K821508 |
06/09/1982 |
RIONET HEARING AID |
RION ACOUSTIC INSTRUMENTS, INC. |
|
| K821677 |
06/22/1982 |
THE COMMUNICATOR |
ROBERT SWINNEY. LTD. |
|
| K821625 |
06/14/1982 |
ENDODONTIC PAPERPOINTS |
ROEKO |
|
| K821588 |
06/22/1982 |
SANDHILL DMS |
SANDHILL |
|
| K820570 |
06/03/1982 |
SEAMED, #540 - SIEMENS, #146F TELECTRO |
SEAMED CORP. |
|
| K821134 |
06/22/1982 |
DC PACK TM |
SEAMLESS HOSPITAL PRODUCTS CO. |
|
| K821490 |
06/02/1982 |
SILKAFIX ADHESIVE PLASTER |
SELOMAS, INC. |
|
| K821259 |
06/23/1982 |
VITASAN |
SELOMAS, INC. |
|
| K821260 |
06/23/1982 |
VITOFIT |
SELOMAS, INC. |
|
| K820709 |
06/25/1982 |
AIRWAYS |
SEVEN HARVEST INTL. IMPORT & EXPORT |
|
| K821623 |
06/14/1982 |
NOVA IV FLUIDS PACK & EXTERNAL STANDARDS |
SHABAN MFG. CO. |
|
| K821440 |
06/14/1982 |
V LANCE |
SHARPOINT, INC. |
|
| K821670 |
06/24/1982 |
ARGYLE TARTAN I TRACHEAL TUBE |
SHERWOOD MEDICAL CO. |
|
| K821563 |
06/21/1982 |
ARGYLE VAC-U-CARE 100CC SUCTION RESERV |
SHERWOOD MEDICAL CO. |
|
| K821562 |
06/11/1982 |
LANCER MSA BUN DIAG. KIT |
SHERWOOD MEDICAL CO. |
|
| K821261 |
06/16/1982 |
PUIG MASSANA-SHILEY ANNULOPLASTY RING |
SHILEY, INC. |
|
| K821763 |
06/23/1982 |
SHUR-STRIP APPLICATOR |
SHUR MEDICAL CORP. |
|
| K821574 |
06/10/1982 |
EOSIN Y SOLUTIN, AGUEOUS |
SIGMA CHEMICAL CO. |
|
| K821573 |
06/09/1982 |
EOSIN Y SOLUTION ALCHOLIC |
SIGMA CHEMICAL CO. |
|
| K821320 |
06/02/1982 |
HEMATOXYLIN STAIN |
SIGMA CHEMICAL CO. |
|
| K821674 |
06/22/1982 |
SPINCHEM ACID PHOSPHATASE REAGENT |
SMITH KLINE DIAGNOSTICS, INC. |
|
| K820256 |
06/25/1982 |
MEDILAC #SR4 & SR 40 |
SPELNA, INC. |
|
| K821485 |
06/10/1982 |
DERMABRADERS |
SPIRE MEDICAL, INC. |
DAVID C ESSLINGER |
| K821486 |
06/09/1982 |
MICRO DRILLS |
SPIRE MEDICAL, INC. |
DAVID C ESSLINGER |
| K821570 |
06/03/1982 |
PNEUMO PULSSOR III |
STROM CORP. |
|
| K821682 |
06/24/1982 |
TRUNCAL ORTHOSIS |
SURGICAL APPLIANCE INDUSTRIES, INC. |
|
| K820542 |
06/02/1982 |
SURGIKOS INCISE DRAPE |
SURGIKOS, INC. |
|
| K820854 |
06/01/1982 |
KENZ-45M |
SUZUKEN CO., LTD. |
|
| K821815 |
06/25/1982 |
ADVANCE C-REACTIVE PROTEIN (CRP) ASSAY |
SYVA CO. |
|
| K821766 |
06/24/1982 |
EMIT - ST URINE METHAGUALONE CONTROLS |
SYVA CO. |
|
| K821768 |
06/24/1982 |
EMIT ST URINE METHAGUALONE ASSAY |
SYVA CO. |
|
| K821767 |
06/25/1982 |
EMIT ST URINE METHAGUALONE CALIBRATOR |
SYVA CO. |
|
| K821531 |
06/11/1982 |
EMIT TIMER UNIT #100 |
SYVA CO. |
|
| K821380 |
06/02/1982 |
EMIT TOX ACETAMINOPHEN CONTROL |
SYVA CO. |
|
| K821186 |
06/25/1982 |
PENETRAK TM |
SYVA CO. |
|
| K820941 |
06/16/1982 |
THERMA-SCAN |
T. G. & E. MEDICAL |
|
| K821800 |
06/25/1982 |
REGULAR MAXITHINS PADS & SUPER MAXITHINS |
TAMPAX, INC. |
|
| K827501 |
06/09/1982 |
MODEL 580 DIGITAL RADIOGRAPHY SYSTEM |
TECHNICARE CORP. |
|
| K821686 |
06/25/1982 |
DENSCO PROPHY ANGLE |
TELEDYNE DENSCO |
|
| K820743 |
06/23/1982 |
HOLLOW FIBER DIALYZERS |
TERUMO MEDICAL CORP. |
DAVID MARSH |
| K821387 |
06/02/1982 |
PREG/TEX PREGNANCY TEST |
TEXAS IMMUNOLOGY, INC. |
|
| K821536 |
06/14/1982 |
DOWFLOW ALT-UV DETERMINATION |
THE DOW CHEMICAL CO. |
|
| K821480 |
06/17/1982 |
RIGHT ATRIAL CATHETERS PARENTERAL NUTRIT |
THE HEALTHCARE GROUP LABORATORIES, INC. |
|
| K821256 |
06/23/1982 |
COUNTER-ROTATION SYSTEM |
THE LANGER GROUP |
|
| K821727 |
06/22/1982 |
SERIES 10 LIQUID CHROMOTOGRAPH |
THE PERKIN-ELMER CORP. |
|
| K820782 |
06/03/1982 |
THERATRONIC STIMULATOR |
THERATRONICS, INC. |
|
| K820546 |
06/30/1982 |
CARD U.V. GERMICIDAL CHAMBER II |
TRAVENOL LABORATORIES, S.A. |
|
| K820459 |
06/16/1982 |
VIRAGARD/VIRASHIELD |
TRI-MED, INC. |
|
| K821451 |
06/23/1982 |
VAST VENTREX ALLERGY SYSTEMS TESTS |
VENTREX LABORATORIES, INC. |
|
| K821615 |
06/10/1982 |
VAST VENTREX PD IGE RIA TEST SET |
VENTREX LABORATORIES, INC. |
|
| K820978 |
06/11/1982 |
VENTRE/SPEC ALLERGEN CONTROL-INHALANT |
VENTREX LABORATORIES, INC. |
|
| K820977 |
06/11/1982 |
VENTRE/SPEC ALLERGEN CONTROL-MOLDS/FOOD |
VENTREX LABORATORIES, INC. |
|
| K821667 |
06/24/1982 |
SINGLE USE NON-CONDUCTIVE CIRC. DISCON |
VITAL SIGNS, INC. |
|
| K821533 |
06/10/1982 |
HEMATOXYLIN I |
VOLU SOL MEDICAL INDUSTRIES |
|
| K821540 |
06/10/1982 |
HEMATOXYLIN II |
VOLU SOL MEDICAL INDUSTRIES |
|
| K821541 |
06/10/1982 |
HEMATOXYLIN III |
VOLU SOL MEDICAL INDUSTRIES |
|
| K821753 |
06/24/1982 |
"A O FIBER OPTIC ILLUMINATION," 1185A |
WARNER-LAMBERT CO. |
|
| K821754 |
06/24/1982 |
"A O FIBER OPTIC ILLUMINATOR," 1185B |
WARNER-LAMBERT CO. |
|
| K821577 |
06/16/1982 |
DESERET ANGIO GUIDE |
WARNER-LAMBERT CO. |
|
| K821372 |
06/02/1982 |
DESERET INTRACATH INTRAVENOUS CATHETER |
WARNER-LAMBERT CO. |
|
| K821371 |
06/02/1982 |
DESERET SUBCLAVIAN JUGULAR CATHETER SET |
WARNER-LAMBERT CO. |
|
| K821699 |
06/24/1982 |
DESERET SUBCLAVIAN JUGULAR CATHETER SET |
WARNER-LAMBERT CO. |
|
| K821525 |
06/23/1982 |
DESERET UNIVERSAL LUER LOCK |
WARNER-LAMBERT CO. |
|
| K821546 |
06/09/1982 |
MONITORING DEVICE ENURESIS ALARM & ACC. |
WETBELL, INC. |
|
| K821652 |
06/14/1982 |
DOXEPIN TRI-CY TEST SET |
WIEN LABORATORIES, INC. |
|
| K821653 |
06/14/1982 |
PROTRIPTYLINE TRI-CY TEST SET |
WIEN LABORATORIES, INC. |
|
| K821510 |
06/09/1982 |
A THENIUM |
WILLIAMS GOLD REFINING CO., INC. |
|
| K820857 |
06/01/1982 |
SAFE-T-SEAL |
WISCONSIN SCIENTIFIC CORP. |
|
| K821620 |
06/14/1982 |
(125I) HTSH RADIOIMMUNOASSAY KIT |
YANG LABORATORIES, INC. |
|
| K821192 |
06/14/1982 |
YSI #24 & 24M GLUCOSE ANALYZERS |
YELLOW SPRINGS INSTRUMENT CO., INC. |
|
| K821484 |
06/09/1982 |
DAWN LOW SPEED HANDPIECE SYSTEM |
YOUNG DENTAL MANUFACTURING CO 1, LLC. |
|
| K821263 |
06/10/1982 |
SELECT BIPOLAR COAGULATION FORCEPS |
ZEISS |
|
| K821060 |
06/22/1982 |
FLUORO-CEP |
ZEUS SCIENTIFIC, INC. |
|
