FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
K780637 |
04/17/1978 |
HEMATOLOGY SLIDE STAINER |
A. J. P. SCIENTIFIC, INC. |
|
K780616 |
04/13/1978 |
HYDRON BURN DISPOSABLE DISPENSER SET |
ABBOTT LABORATORIES |
|
K780565 |
04/06/1978 |
SUTURELESS SKIN CLOSURE |
ABBOTT LABORATORIES |
|
K780601 |
04/10/1978 |
AIRWAYS |
ABCO DEALERS, INC. |
|
K780606 |
04/10/1978 |
BANDAGE |
ABCO DEALERS, INC. |
|
K780603 |
04/10/1978 |
COLD PACK |
ABCO DEALERS, INC. |
|
K780597 |
04/10/1978 |
ECG PAPER, 3 CHANNEL |
ABCO DEALERS, INC. |
|
K780613 |
04/10/1978 |
ENEMA, PHOSPHATE |
ABCO DEALERS, INC. |
|
K780608 |
04/10/1978 |
ICE BAG, VINYL |
ABCO DEALERS, INC. |
|
K780610 |
04/10/1978 |
INSTRUMENT LUBRICANT |
ABCO DEALERS, INC. |
|
K780600 |
04/10/1978 |
IRRIGATION TRAY |
ABCO DEALERS, INC. |
|
K780605 |
04/10/1978 |
ISOLATION GOWN |
ABCO DEALERS, INC. |
|
K780609 |
04/10/1978 |
MASK, ISOLATION |
ABCO DEALERS, INC. |
|
K780607 |
04/10/1978 |
MASK, SURGEONS |
ABCO DEALERS, INC. |
|
K780595 |
04/10/1978 |
MINI-IRRIGATION TRAY |
ABCO DEALERS, INC. |
|
K780593 |
04/10/1978 |
PROBE COVER |
ABCO DEALERS, INC. |
|
K780604 |
04/10/1978 |
SHAVE PREP |
ABCO DEALERS, INC. |
|
K780590 |
04/10/1978 |
SHOE COVERS |
ABCO DEALERS, INC. |
|
K780612 |
04/10/1978 |
STOCKINETTE, STERILE |
ABCO DEALERS, INC. |
|
K780596 |
04/10/1978 |
STOPCOCK |
ABCO DEALERS, INC. |
|
K780602 |
04/10/1978 |
SYRINGE (IRRIGATION) |
ABCO DEALERS, INC. |
|
K780599 |
04/10/1978 |
SYRINGE, EAR & ULCER |
ABCO DEALERS, INC. |
|
K780591 |
04/10/1978 |
THERMOMETER KIT |
ABCO DEALERS, INC. |
|
K780592 |
04/10/1978 |
TRANSFER PIPET |
ABCO DEALERS, INC. |
|
K780598 |
04/10/1978 |
TREND II ANEROID |
ABCO DEALERS, INC. |
|
K780594 |
04/10/1978 |
VELKET TOURNIQUET |
ABCO DEALERS, INC. |
|
K780547 |
04/05/1978 |
STERILE ORTHOPEDIC STOCKINETTE |
ALBA-WALDENSIAN, INC. |
|
K780570 |
04/10/1978 |
TUBULAR DRESSING RETAINER |
ALBA-WALDENSIAN, INC. |
|
K780625 |
04/14/1978 |
UNISTAT OXIMETER |
AMERICAN OPTICAL CORP. |
|
K780673 |
04/24/1978 |
CENTRAL CATHETER KIT |
ARGON MEDICAL CORP. |
|
K780532 |
04/04/1978 |
PERCUTANEOUS SHEATH INTRODUCER KIT |
ARROW INTL., INC. |
|
K780558 |
04/05/1978 |
BOTTLE BREATHING DEVICE |
B & F MEDICAL PRODUCTS, INC. |
|
K780617 |
04/13/1978 |
EQUALIZER |
BALLERT ORTHOPEDIC CORP. |
|
K780665 |
04/21/1978 |
RECAP |
BCA BIOLOGICAL CORP. OF AMERICA |
|
K780530 |
04/04/1978 |
AUTOMATED PHYSIOLOGIC PROFILER |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K780557 |
04/05/1978 |
FOLATE REAGENT KIT, ARIA-II SYSTEM |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K780556 |
04/05/1978 |
SPECT RIM (LISS) |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K780573 |
04/10/1978 |
TECHNIQUE, CHROMATOGRAPHIC, HEMOGLOBIN |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K780554 |
04/05/1978 |
CLIN. CHEM. CONTROL SERUM-QUANTITATE |
BECKMAN INSTRUMENTS, INC. |
|
K780552 |
04/05/1978 |
COMP. CLIN. CHEM. CONTROL SERUM-DECISION |
BECKMAN INSTRUMENTS, INC. |
|
K780553 |
04/05/1978 |
COMP. CLIN. CHEM. REF. SERUM-BENCHMARK |
BECKMAN INSTRUMENTS, INC. |
|
K780714 |
04/28/1978 |
PLATELET CONTROL |
BHP DIAGNOSTIX, INC. |
|
K780583 |
04/12/1978 |
FOME-CUF PVC |
BIVONA MEDICAL TECHNOLOGIES |
|
K780635 |
04/17/1978 |
REAGENT SET HDL CHOLESTEROL |
BOEHRINGER MANNHEIM CORP. |
|
K780634 |
04/17/1978 |
SINGLE VIAL 10 SGOT-TRIS |
BOEHRINGER MANNHEIM CORP. |
|
K780636 |
04/17/1978 |
SINGLE VIAL 10 SGPT-TRIS |
BOEHRINGER MANNHEIM CORP. |
|
K780563 |
04/07/1978 |
SINGLE VIAL LACTATE |
BOEHRINGER MANNHEIM CORP. |
|
K780702 |
04/25/1978 |
CSS-60 DIGITAL HEART RATE METER |
BURDICK CORP. |
|
K780571 |
04/10/1978 |
BLOOD PRESSURE MODULE |
C-V MONITORS CORP. |
|
K780572 |
04/10/1978 |
DCG PREAMPLIFIER MODULE |
C-V MONITORS CORP. |
|
K780630 |
04/17/1978 |
CONTROLLER, SERVO, INSPIRON |
C.R. BARD, INC. |
|
K780694 |
04/24/1978 |
HEARING AID BATTERY CHARGER |
CAHILL ENTERPRISES, INC. |
|
K780669 |
04/21/1978 |
HEATING AIDS-MODEL C78A & C78B |
CIRCLE HEARING INSTRUMENTS, INC. |
|
K780709 |
04/26/1978 |
IN VITRO GENTAMICIN RADIOIMMUNOASSY TEST |
CLINICAL ASSAYS, INC. |
|
K780707 |
04/25/1978 |
T4-RIA KIT |
CLINICAL BIORESEARCH |
|
K780653 |
04/19/1978 |
EXTRACORPEAL CARDIOTOMY BLOOD FILTER |
COBE LABORATORIES, INC. |
|
K780627 |
04/14/1978 |
SURG-O-PAK, GOWNS, SHEETS, AND TOWELS |
CONVERTORS |
|
K780569 |
04/11/1978 |
L-12, L-21, AND L-22 ELECTRODES |
CORATOMIC, INC. |
|
K780649 |
04/19/1978 |
FLAME PHOTOMETER, MODEL 435 |
CORNING MEDICAL & SCIENTIFIC |
|
K780650 |
04/19/1978 |
FLAME PHOTOMETER, MODEL 455 |
CORNING MEDICAL & SCIENTIFIC |
|
K780624 |
04/14/1978 |
CULDOCENTESIS TRAY |
CUTTER LABORATORIES, INC. |
|
K780546 |
04/05/1978 |
BEHIND-THE-EAR MASKING AMPLIFIER,735S |
DANAVOX, INC. |
|
K780663 |
04/20/1978 |
CONTACT LENS REMOVER AND INSERTER |
DMV CONTACT LENS CO. |
|
K780664 |
04/20/1978 |
SOFT LENS REMOVER/INSERTER/MANIPULATOR |
DMV CONTACT LENS CO. |
|
K780567 |
04/06/1978 |
AORTIC PUMP |
ETHICON, INC. |
|
K780681 |
04/24/1978 |
ARTERIOVENOUS BLOOD TUBING SETS |
EXTRACORPOREAL MEDICAL SPECIALITIES, INC. |
|
K780682 |
04/24/1978 |
SINGLE PATIENT SYSTEMS |
EXTRACORPOREAL MEDICAL SPECIALITIES, INC. |
|
K780578 |
04/10/1978 |
SONOGRAF EDP REAL-TIME ADAPTER |
FOLEY, LARDNER, HOLLABAUGH & JACOBS |
|
K780677 |
04/24/1978 |
4600 RECORDER |
G & W APPLIED SCIENCE LABORATORIES |
|
K780566 |
04/06/1978 |
HEALTH SEAT SYSTEM |
G & W APPLIED SCIENCE LABORATORIES |
|
K780700 |
04/26/1978 |
LUNDIA PLATE DISPOSABLE DIALYZER |
GAMBRO, INC. |
|
K780577 |
04/10/1978 |
PLATELETS/CU MM |
GEOMETRIC DATA, DIV. SMITHKLINE CORP. |
|
K780533 |
04/04/1978 |
PRE-REDUCED MEDIA |
GIBCO LABORATORIES LIFE TECHNOLOGIES, INC. |
|
K780704 |
04/25/1978 |
COLUMBIA AGAR WITH 5% RABBIT BLOOD |
GRANITE DIAGNOSTICS, INC. |
|
K780708 |
04/25/1978 |
AUTOMATIC RETRACTOR HOLDER |
GREAT EASTERN LUMBER CO., INC. |
|
K780568 |
04/10/1978 |
DURAN FLEXIBLE RING |
HANCOCK LABORATORIES, INC. |
|
K780705 |
04/25/1978 |
INFUSION PUMP-MODEL 2616 |
HARVARD APPARATUS, INC. |
|
K780706 |
04/25/1978 |
LUMBAR NERVE ROOT SHIELD |
HEYER SCHULTE CORP. |
|
K780651 |
04/19/1978 |
ULTRASONIC DIAGNOSTIC TRANSDUCER |
HOFFREL INSTRUMENTS, INC. |
|
K780640 |
04/17/1978 |
DRY SILVER PROCESSOR MODEL 1226 |
HONEYWELL, INC. |
|
K780527 |
04/03/1978 |
CORTRAL I |
HOSPAL MEDICAL CORP. |
|
K780582 |
04/12/1978 |
DETECTOR, BUBBLE & FOAM |
HOSPAL MEDICAL CORP. |
|
K780626 |
04/14/1978 |
VENTURI OXYGEN MASK |
HOSPITAK, INC. |
|
K780711 |
04/27/1978 |
MICRO-RING |
HOWMEDICA CORP. |
|
K780535 |
04/03/1978 |
HUMIDIFIER FILTER |
HUDSON OXYGEN THERAPY SALES CO. |
|
K780744 |
04/13/1978 |
BRINKER TISSUE RETRACTORS |
HYGIENIC DENTAL MFG., CO., THE |
|
K780743 |
04/13/1978 |
CLAMP FORCEPS |
HYGIENIC DENTAL MFG., CO., THE |
|
K780746 |
04/13/1978 |
HYGIENIC RUBBER DAM FRAME |
HYGIENIC DENTAL MFG., CO., THE |
|
K780745 |
04/13/1978 |
RUBBER DAM |
HYGIENIC DENTAL MFG., CO., THE |
|
K780712 |
04/26/1978 |
KERR DISCOVERY DISPOSABLE FLUORIDE TRAY |
KERR CORPORATION (DANBURY) |
|
K780559 |
04/05/1978 |
DISPOSABLE INFUSION SET |
KS MEDICAL SUPPLY CO. |
|
K780560 |
04/05/1978 |
DENTAL AMALGAMATOR |
L.D. CAULK CO. |
|
K780701 |
04/26/1978 |
DENTAL OFFICE ENVIRONMENT CONTROL UNIT |
LAMINAIRE CORP. |
|
K780575 |
04/10/1978 |
LASCHAL SCISSOR |
LASCHAL INSTRUMENT CORP. |
|
K780574 |
04/10/1978 |
SUTURE CUTTER |
LASCHAL INSTRUMENT CORP. |
|
K780585 |
04/11/1978 |
SURGICAL LASER |
LASER INDUSTRIES LTD. |
|
K780538 |
04/03/1978 |
AUDIO MONITOR-MODEL 8309 |
LIFE-TECH INSTRUMENTS, INC. |
|
K780537 |
04/03/1978 |
EAR ELECTRODE-ADULT & PEDIATRIC |
LIFE-TECH INSTRUMENTS, INC. |
|
K780540 |
04/03/1978 |
ELECTRIC RESPONSE AUDIOMETER |
LIFE-TECH INSTRUMENTS, INC. |
|
K780541 |
04/03/1978 |
PRESSURE MODULES MODELS 1855 & 1856 |
LIFE-TECH INSTRUMENTS, INC. |
|
K780539 |
04/03/1978 |
STIMULATOR MODEL 8021 |
LIFE-TECH INSTRUMENTS, INC. |
|
K780659 |
04/20/1978 |
HDL CHOLESTEROL |
MACOMB CHEMICAL CO. |
|
K780534 |
04/03/1978 |
UREA NITROGEN (ENZYMATIC) |
MACOMB CHEMICAL CO. |
|
K780715 |
04/27/1978 |
ANEROID TYPE BLOOD PRESSURE KIT |
MARS METAL CO., LTD. |
|
K780632 |
04/17/1978 |
MAXICEPTOR |
MED GENERAL |
|
K780698 |
04/26/1978 |
STIMULATORS, NERVE, ELECTRICAL |
MED GENERAL |
|
K780615 |
04/13/1978 |
BLOOD CULTURE MEDIA |
MEDA STAT DIAGNOSTICS, INC. |
|
K780548 |
04/05/1978 |
DISPOSA-LOOPS |
MEDI-SPEC |
|
K780646 |
04/17/1978 |
AIR-PWOERED COLDRILL |
MEDISHIELD, INC. |
|
K780645 |
04/17/1978 |
HMD-2000 BATTERY-POWERED MINI-DRILL, THE |
MEDISHIELD, INC. |
|
K780675 |
04/24/1978 |
STERILE 100% SILICONE FOLEY CATHETER |
MEDLINE INDUSTRIES, INC. |
|
K780676 |
04/24/1978 |
STERILE CLOSED SYSTEM |
MEDLINE INDUSTRIES, INC. |
|
K780622 |
04/14/1978 |
BIPOLAR ENDOCARDIAL PACING LEAD, M. 6902 |
MEDTRONIC VASCULAR |
|
K780623 |
04/14/1978 |
ENDOCARDIAL ATRIAL PACING LEAD, M. 6994 |
MEDTRONIC VASCULAR |
|
K780621 |
04/14/1978 |
LEAD, PACING, ATRIAL, ENDOCARDIAL, TINED |
MEDTRONIC VASCULAR |
|
K780579 |
04/10/1978 |
SUBCUPASS TUNNELING TOOL |
MEDTRONIC VASCULAR |
|
K780561 |
04/07/1978 |
VENTRICULAR INHIBITED PULSE GENERATOR |
MEDTRONIC VASCULAR |
|
K780551 |
04/05/1978 |
I.V. ADMINISTRATION SET WITH MINI-SPIKE |
NATIONAL PATENT DEVELOPMENT CORP. |
|
K780549 |
04/05/1978 |
NON-STICK PADS |
NATIONAL PATENT DEVELOPMENT CORP. |
|
K780550 |
04/05/1978 |
STERILE AIR SYRINGE |
NATIONAL PATENT DEVELOPMENT CORP. |
|
K780631 |
04/17/1978 |
NDM INFANT ECG PACKPAD |
NEW DIMENSIONS IN MEDICINE, INC. |
|
K780660 |
04/20/1978 |
NITE TRAIN'R |
NITE TRAIN-R ENTERPRISES, INC. |
|
K780697 |
04/24/1978 |
GOAT ANTI-INFLUENZA ANTISERA ATEXAS |
NORTHEAST BIOMEDICAL LABS., INC. |
|
K780696 |
04/24/1978 |
GOAT ANTIINFLUENZA ANTISERA AUSSR |
NORTHEAST BIOMEDICAL LABS., INC. |
|
K780662 |
04/18/1978 |
SUPPLEMENTAL TYGON PAC-MONITORING LINES |
NORTON PERFORMANCE PLASTICS CORP. |
|
K780644 |
04/17/1978 |
RADIOASSAY FOR TOTAL SERUM THYROXINE |
NUCLEAR DIAGNOSTICS, INC. |
|
K780679 |
04/24/1978 |
B-HCG-RIA |
NUCLEAR MEDICAL SYSTEMS, INC. |
|
K780703 |
04/25/1978 |
CUFF PACER |
OMP LABORATORIES, INC. |
|
K780699 |
04/26/1978 |
EARETTE HEARING AID |
OPTICON CORP. |
|
K780684 |
04/24/1978 |
PATIENT LIFT |
ORTHOPEDIC EQUIPMENT CO., INC. |
|
K780654 |
04/19/1978 |
HEARING AID, EARETTE |
OTICON CORP. |
|
K780564 |
04/06/1978 |
FECATEST |
OTTO C. WATZKA |
|
K780542 |
04/03/1978 |
ALFATEST |
PANMED, INC. |
|
K780576 |
04/10/1978 |
125-I LABELED HUMAN LUTEINIZING HORMONE |
PCL-RIA, INC. |
|
K780587 |
04/11/1978 |
GYNESURG |
POLAMEDCO, INC. |
|
K780528 |
04/03/1978 |
PREMIER CARVERS, STYLE #21C & 21D |
PREMIER DENTAL PRODUCTS CO. |
|
K780683 |
04/24/1978 |
TISSUE PULSATOR |
PULSATOR CORP. |
|
K780643 |
04/17/1978 |
SHADOW-CATHS |
QUINTON, INC. |
|
K780667 |
04/21/1978 |
HEARING AID-MODEL 2010 |
RADIOEAR CORP. |
|
K780671 |
04/24/1978 |
125 I-T3 UPTAKE REAGENT |
RADIOIMMUNOASSAY, INC. |
|
K780672 |
04/24/1978 |
125 I-T4 RIA REAGENT |
RADIOIMMUNOASSAY, INC. |
|
K780562 |
04/07/1978 |
AQUAPAK PREFILLED HUMIDIFIER |
RESPIRATORY CARE, INC. |
|
K780580 |
04/10/1978 |
TEMPERATURE INDICATOR |
RESPIRATORY CARE, INC. |
|
K780586 |
04/12/1978 |
MICROCLIP, WILLIAMS |
RICHARD'S MEDICAL EQUIP., INC. |
|
K780678 |
04/24/1978 |
IMPRESSION TRAY |
ROCKY MOUNTAIN ORTHODONTICS, INC. |
|
K780713 |
04/27/1978 |
CULTURE SWAB |
ROYAL SCIENTIFIC, INC. |
|
K780529 |
04/03/1978 |
MYOCATH KIT |
SORENSEN RESEARCH |
|
K780545 |
04/03/1978 |
SR-PLUS DIRECT CHOLESTEROL TEST |
STANBIO LABORATORY |
|
K780658 |
04/20/1978 |
STERILE BLOOD ADMINISTRATION SET |
SURU CHEMICALS & PHARMACEUTICALS, LTD. |
|
K780657 |
04/20/1978 |
STERILE BLOOD COLLECTION SET |
SURU CHEMICALS & PHARMACEUTICALS, LTD. |
|
K780656 |
04/20/1978 |
STERILE INFUSION SET TYPE J |
SURU CHEMICALS & PHARMACEUTICALS, LTD. |
|
K780655 |
04/20/1978 |
STERILE INFUSION SET TYPE S |
SURU CHEMICALS & PHARMACEUTICALS, LTD. |
|
K780639 |
04/17/1978 |
EMIT CENTRIFICHEM THYROXINE ASSAY |
SYVA CO. |
|
K780648 |
04/17/1978 |
MODIFIED UNTREATED TAMPAX TAMPONS |
TAMPAX, INC. |
|
K780544 |
04/03/1978 |
DISC-PAK ROTATOR |
TECHHNILAB INSTRUMENTS, INC. |
|
K780543 |
04/03/1978 |
THERMAJUST CIRCU-TEMP |
TECHHNILAB INSTRUMENTS, INC. |
|
K780716 |
04/27/1978 |
TECHNICON BGII ANALYZER |
TECHNICON INSTRUMENTS CORP. |
|
K780641 |
04/17/1978 |
DENTAL ROTARY CARBIDE BURS 76EJL |
TELEDYNE DENSCO |
|
K780638 |
04/18/1978 |
ACCESSORY HDL CHOLESTEROL REAGENT SET |
THE DOW CHEMICAL CO. |
|
K780652 |
04/17/1978 |
HEMOGLOBIN CHECK SOLUTIONS, S2100 OSM-2 |
THE LONDON CO. |
|
K780680 |
04/24/1978 |
UNIT, SPECTRA, CORRECTED, DIFFERENTIAL |
THE PERKIN-ELMER CORP. |
|
K780710 |
04/27/1978 |
AIR MASSAGE SYSTEM |
THERACOM C/O ARENT, FOX, KINTNER, PLOTKI |
|
K780619 |
04/13/1978 |
PREFORMED TOOTH POSITIONER |
TP LABORATORIES, INC. |
|
K780668 |
04/21/1978 |
SOLUTIONS FOR RESPIRATORY THERAPY |
TRAVENOL LABORATORIES, S.A. |
|
K780695 |
04/24/1978 |
AUTO SUTURE DISPOSABLE STAPLING INSTRU. |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
|
K780717 |
04/27/1978 |
EXTERNAL TEST PULSE GENERATOR |
VITATRON MEDICAL BV |
|
K780584 |
04/11/1978 |
PULMONARY FUNCTION TESTER |
WARREN E. COLLINS, INC. |
|
K780628 |
04/17/1978 |
HALOGEN EXAM. LITE #48400 |
WELCH ALLYN, INC. |
|
K780642 |
04/17/1978 |
LITECAST SOLDER |
WILLIAMS GOLD REFINING CO., INC. |
|