| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K823888 |
12/27/1982 |
3M FRASCIA STAPLING SYSTEM |
3M COMPANY |
|
| K823689 |
12/07/1982 |
3M SCOTCHPLATE 51148 SMALL CONDUCTIVE |
3M COMPANY |
|
| K823569 |
12/03/1982 |
ABBOTT LABORATORIES STREP A EIA |
ABBOTT LABORATORIES |
|
| K823758 |
12/14/1982 |
CENTRAL VEIN CATHERIZATION KIT |
ACCESS DEVICES, INC. |
|
| K823936 |
12/29/1982 |
CPAP INFANT NASAL CANNULAE SET |
ACKRAD LABORATORIES |
|
| K823733 |
12/13/1982 |
EIKEN KIZAI ARTIFICIAL KIDNEY BLOOD CIR |
ADVOCACY INTERNATIONAL, LTD. |
|
| K823900 |
12/30/1982 |
GLUCOSE-6-PHOSPHATE DEHYDROGENASE |
ALLADIN DIAGNOSTIC, INC. |
|
| K823706 |
12/09/1982 |
ATS AFB STAIN CONTROL SLIDE |
ALPHA-TEC SYSTEMS, INC. |
|
| K823704 |
12/09/1982 |
ATS GRAM STAIN CONTROL SLIDE |
ALPHA-TEC SYSTEMS, INC. |
|
| K823705 |
12/09/1982 |
ATS PARASITOLOGY STAIN CONTROL SLIDE |
ALPHA-TEC SYSTEMS, INC. |
|
| K837029 |
12/10/1982 |
ECHOSINE 1000, PULSED A-MODE ULTRASOUND DEVICE |
AMERICAN ELECTROMEDICS CORP. |
|
| K823790 |
12/16/1982 |
VENTRICULAR ACCESS SYSTEM |
AMERICAN HEYER SCHULTE |
|
| K823827 |
12/20/1982 |
AMP 80/2 OUTFLOW MONITOR MODIFICATION |
AMERICAN MEDICAL PRODUCTS, INC. |
|
| K823687 |
12/07/1982 |
BIO INTERFERENCE BLANKING MATERIAL |
AMERICAN MONITOR CORP. |
|
| K823772 |
12/14/1982 |
AMSCO ORTHOGRAPHIC 2 TABLE |
AMERICAN STERILIZER CO. |
|
| K823902 |
12/30/1982 |
EAGLE STERISET |
AMERICAN STERILIZER CO. |
|
| K823792 |
12/15/1982 |
QUARTZ RETRACTOR/PROBE |
AMERICAN V. MUELLER |
|
| K823881 |
12/27/1982 |
ARTERIOVENOUS BLOOD TUBING SET FOR |
AMICON, INC. |
|
| K823721 |
12/10/1982 |
FLOW-PAC LDH REAGENT SET |
AMRESCO, INC. |
|
| K823786 |
12/16/1982 |
ALKALINE PHOSPHATASE |
ANALYTICAL & RESEARCH CHEMICALS, INC. |
|
| K823806 |
12/16/1982 |
DIRECT CREATININE PROCEDURE |
ANALYTICAL & RESEARCH CHEMICALS, INC. |
|
| K823784 |
12/16/1982 |
ENZYMATIC CHOLESTEROL (COLORIMETRIC |
ANALYTICAL & RESEARCH CHEMICALS, INC. |
|
| K823785 |
12/16/1982 |
API MDS* |
ANALYTICAL PRODUCTS, INC. |
|
| K823774 |
12/14/1982 |
WILSON EUSTACHIAN TUBAL, SONOGRAPH |
ANTARES TECHNICAL ASSOCIATES, INC. |
|
| K823880 |
12/27/1982 |
BACTIGEN-N. MENINGITIDIS |
ARMKEL, LLC. |
|
| K823753 |
12/14/1982 |
GENESIS B-HCG |
ARMKEL, LLC. |
|
| K823923 |
12/28/1982 |
MF 360B ELECTROSURGICAL UNIT |
ASPEN LABORATORIES, INC. |
|
| K823839 |
12/21/1982 |
AMPCO KIDNEY DIALYSIS TRAY |
ASSOCIATED MEDICAL PRODUCTS CO. |
|
| K837111 |
12/27/1982 |
X RAY TUBE HOUSING/INSERT |
ATLANTIC IMAGING CORP. |
|
| K823800 |
12/17/1982 |
AZLOCILLIN 75MCG SENSI-DISC |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
| K823829 |
12/20/1982 |
FERRITIN IMMUNORADIOMETRIC ASSAY KIT |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
| K823718 |
12/10/1982 |
SCEPTOR GRAM-POSITIVE PANEL, MIC/10 TEMP |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
| K823844 |
12/21/1982 |
HORIZON ECG SYSTEM |
BECKMAN INSTRUMENTS, INC. |
JACK SOROKIN |
| K823884 |
12/27/1982 |
PARAGON IMMUNOELECTROPHORESIS REAGENT |
BECKMAN INSTRUMENTS, INC. |
|
| K823926 |
12/29/1982 |
BED-CHECK: II-IFAC |
BED-CHECK CORP. |
|
| K823793 |
12/16/1982 |
ABC BRAND |
BEIERSDORF, INC. |
|
| K823879 |
12/27/1982 |
COVER-ROLL STRETCH |
BEIERSDORF, INC. |
|
| K823874 |
12/28/1982 |
BERKELEY BRAKE |
BERKELEY ELECTRIC WHEELCHAIR CO. |
|
| K823876 |
12/28/1982 |
BERKELEY FORK |
BERKELEY ELECTRIC WHEELCHAIR CO. |
|
| K823877 |
12/28/1982 |
BERKELEY HARNESS |
BERKELEY ELECTRIC WHEELCHAIR CO. |
|
| K823875 |
12/28/1982 |
CHAIN KIT |
BERKELEY ELECTRIC WHEELCHAIR CO. |
|
| K823873 |
12/28/1982 |
CHAIN SILENCER |
BERKELEY ELECTRIC WHEELCHAIR CO. |
|
| K823861 |
12/22/1982 |
ET-3 EMERGENCY TRANSPORT VENTILATOR |
BIO-MED DEVICES, INC. |
|
| K823749 |
12/13/1982 |
LOW PRESSURE BLOM-SINGER VOICE PROSTHES |
BIVONA MEDICAL TECHNOLOGIES |
|
| K823766 |
12/14/1982 |
BLOOD GAS INCUBATOR #260650 |
BOEKEL INDUSTRIES, INC. |
|
| K823585 |
12/06/1982 |
COMPUTER-AIDED ELECTROCARDIOGRAPH FCP-13 |
BRENTWOOD INSTRUMENTS, INC. |
|
| K823586 |
12/06/1982 |
COMPUTER-AIDED ELECTROCARDIOGRAPH FCP200 |
BRENTWOOD INSTRUMENTS, INC. |
|
| K823584 |
12/06/1982 |
FUKUDA DENSHI 6-CHANNEL AUTO. ELECTRO- |
BRENTWOOD INSTRUMENTS, INC. |
|
| K823882 |
12/27/1982 |
M-BRACE |
BUCKMAN CONSULTANTS |
|
| K823591 |
12/06/1982 |
AMEDA HAND BREAST PUMP |
BURDITT & CALKINS-SIEMENS-ELEMA |
|
| K823748 |
12/13/1982 |
EXPANDED PTFE PROSTHESIS BLOOD ACCES |
C.R. BARD, INC. |
|
| K823849 |
12/21/1982 |
FREEDOM |
CARBONITE CORP. |
|
| K823852 |
12/22/1982 |
CHESEBROUGH-POND'S MULTILAYER ELASTIC |
CHESEBROUGH-POND'S U.S.A. CO. |
|
| K823920 |
12/28/1982 |
COEURLOCK STERILE DISPOS. ANGIOGRAPHIC |
COEUR LABORATORIES, INC. |
|
| K823832 |
12/21/1982 |
ESA ARTHROSCOPY CANNULA TRAY |
CONCEPT, INC. |
|
| K828328 |
12/15/1982 |
ULTRASCAN DIGITAL A/SYSTEM III |
COOPER LASERSONICS, INC. |
|
| K823761 |
12/14/1982 |
ERYTHROCYTE & STAND SEDIMENT. RATE TUBE |
CORDIS CORP. |
|
| K823760 |
12/14/1982 |
PRICK-TEST NEEDLE |
CORDIS CORP. |
|
| K823762 |
12/14/1982 |
VARIOUS-ANALYZER CUPS |
CORDIS CORP. |
|
| K823763 |
12/14/1982 |
VARIOUS-SPECIMEN COLLECTORS |
CORDIS CORP. |
|
| K823553 |
12/01/1982 |
CORCATH H & B VASCULAR ACCESS CATHETER |
CORMED, INC., SUB. C.R.BARD, INC. |
|
| K823747 |
12/13/1982 |
24 CELL WELLS TISSUE CULTURE |
CORNING MEDICAL & SCIENTIFIC |
|
| K823570 |
12/03/1982 |
CORNING 170 PH/BLOOD GAS ANALYZER |
CORNING MEDICAL & SCIENTIFIC |
|
| K823688 |
12/07/1982 |
DOUBLE ANTIBODY TSH I-125 RADIOIMMUNO |
CORNING MEDICAL & SCIENTIFIC |
|
| K823810 |
12/17/1982 |
A.C. SPLINT |
DANEK MEDICAL, INC. |
|
| K823820 |
12/17/1982 |
ABDUCTION PILLOW |
DANEK MEDICAL, INC. |
|
| K823822 |
12/17/1982 |
ANKLE WEIGHTS |
DANEK MEDICAL, INC. |
|
| K823819 |
12/17/1982 |
CAST TOE COVER |
DANEK MEDICAL, INC. |
|
| K823818 |
12/17/1982 |
CATHETER HOLDER |
DANEK MEDICAL, INC. |
|
| K823809 |
12/17/1982 |
CLAVICAL STRAP |
DANEK MEDICAL, INC. |
|
| K823814 |
12/17/1982 |
HOT/COLD PACK HOLDERS |
DANEK MEDICAL, INC. |
|
| K823823 |
12/17/1982 |
LUMBOSACRAL SUPPORT |
DANEK MEDICAL, INC. |
|
| K823811 |
12/17/1982 |
OVERHEAD ARM SLINGS |
DANEK MEDICAL, INC. |
|
| K823821 |
12/17/1982 |
SIDE RAIL PADS |
DANEK MEDICAL, INC. |
|
| K823813 |
12/17/1982 |
TRACTION ACCESSORIES |
DANEK MEDICAL, INC. |
|
| K823808 |
12/17/1982 |
VARIOUS ARM SLING |
DANEK MEDICAL, INC. |
|
| K823812 |
12/17/1982 |
VARIOUS SUPPORTS AND SPLINTS |
DANEK MEDICAL, INC. |
|
| K823816 |
12/17/1982 |
WHEELCHAIR PATIENT RESTRAINTS |
DANEK MEDICAL, INC. |
|
| K823744 |
12/13/1982 |
PORCELAIN ARTIFICIAL TEETH |
DENTSPLY INTL. |
|
| K823928 |
12/29/1982 |
TOOTH CONDITIONER |
DENTSPLY INTL. |
|
| K823843 |
12/21/1982 |
FREEMAN ACETABULAR CUP |
DEPUY, INC. |
|
| K823905 |
12/28/1982 |
SURGICAL BLADES |
DESIGNS IN MEDICINE |
|
| K823673 |
12/07/1982 |
LITE GUARD |
DEVON INDUSTRIES, INC. |
|
| K823680 |
12/07/1982 |
COAT-A-COUNT MORPHINE KIT & COMPONENTS |
DIAGNOSTIC PRODUCTS CORP. |
|
| K823751 |
12/14/1982 |
SOPHEIA THYROXINE EIA KIT |
DIAGNOSTIC PRODUCTS CORP. |
|
| K823896 |
12/27/1982 |
MODEL FF..D & FX..D PACEMAKER LEADS |
DR. ING. P. OSYPKA, GMBH |
|
| K823894 |
12/27/1982 |
MODEL RZ PACEMAKER LEAD VARIOUS |
DR. ING. P. OSYPKA, GMBH |
|
| K823892 |
12/27/1982 |
MODEL SZ PACEMAKER LEAD-VARIOUS |
DR. ING. P. OSYPKA, GMBH |
|
| K823903 |
12/28/1982 |
RUBBER INFLATABLE RING |
DURO-MED IND., INC. |
|
| K823787 |
12/16/1982 |
HANDI-WASH |
DYNATECH CORP. |
|
| K823833 |
12/21/1982 |
MICRO STIX #011-010-5000 & HOLDER#5100 |
DYNATECH CORP. |
|
| K823773 |
12/14/1982 |
PROVIAL II #006-010-0201 |
DYNATECH CORP. |
|
| K823557 |
12/02/1982 |
REMOVAWELL PLATE LID |
DYNATECH CORP. |
|
| K823697 |
12/09/1982 |
PREP TYPE A EXTRACTION CARTRIDGE |
E.I. DUPONT DE NEMOURS & CO., INC. |
|
| K823901 |
12/30/1982 |
TREPHINE BLADES-VARIOUS MODELS |
EDWARD WECK, INC. |
|
| K823681 |
12/07/1982 |
MODEL ICPM & ACCESSORIES |
ELECTROMEDICS, INC. |
|
| K823756 |
12/14/1982 |
ULTRA CHEM CRESOLPHTHALEIN CALCIUM 65082 |
EM INDUSTRIES, INC. |
|
| K823883 |
12/27/1982 |
ULTRAZYME PLUS GAMMA-GT, #64959/65032 |
EMD CHEMICALS INC. |
|
| K823754 |
12/14/1982 |
SAHOTA-KAPLAN HEMOSTAT |
ERICKSON INDUSTRIES, INC. |
|
| K823752 |
12/14/1982 |
EXTRACORPOREAL SUBCLAVIAN CATHETER KIT |
EXTRACORPOREAL MEDICAL SPECIALITIES, INC. |
|
| K823930 |
12/29/1982 |
HEMATOLOGY QUALITY CONTROL MIXTURE |
FISHER SCIENTIFIC CO., LLC. |
|
| K823558 |
12/02/1982 |
MICRO-HEMATOCRIT CENTRIFUGE 335/336 |
FISHER SCIENTIFIC CO., LLC. |
|
| K823929 |
12/29/1982 |
MULTIANALYTE CONTROLS-ALL KINDS |
FISHER SCIENTIFIC CO., LLC. |
|
| K823612 |
12/06/1982 |
ADJ. WOODEN BOARD FOR WRITING |
FRED SAMMONS, INC. |
|
| K823638 |
12/06/1982 |
ARM THROUGH FOR WHEELCHAIR BK 6454-01 & |
FRED SAMMONS, INC. |
|
| K823637 |
12/06/1982 |
ARM THROUGH FOR WHEELCHAIR BK-6458-01 |
FRED SAMMONS, INC. |
|
| K823636 |
12/06/1982 |
ARM THROUGH FOR WHEELCHAIR BK-6459-01 & |
FRED SAMMONS, INC. |
|
| K823640 |
12/06/1982 |
BATH TUB SAFETY BAR |
FRED SAMMONS, INC. |
|
| K823641 |
12/06/1982 |
BATHING CHAIR FOR CHILD |
FRED SAMMONS, INC. |
|
| K823610 |
12/06/1982 |
BK-4015 ECONOMY COMMUNICATION SHEET |
FRED SAMMONS, INC. |
|
| K823639 |
12/06/1982 |
BOARD TO TRANSFER PARALYZED PATIENT FROM |
FRED SAMMONS, INC. |
|
| K823655 |
12/06/1982 |
BOOK ON MGMT. OF THE BURN PATIENT |
FRED SAMMONS, INC. |
|
| K823657 |
12/06/1982 |
CARD HOLDER FOR QUADS |
FRED SAMMONS, INC. |
|
| K823607 |
12/06/1982 |
CARPET SWEEPER |
FRED SAMMONS, INC. |
|
| K823634 |
12/06/1982 |
CHAIR OR BED LEG EXTENDERS |
FRED SAMMONS, INC. |
|
| K823596 |
12/06/1982 |
CLAMP ON HOLDER FOR A GLASS OR CUP |
FRED SAMMONS, INC. |
|
| K823635 |
12/06/1982 |
CUSHIONS FOR WHEELCHAIR ARMS |
FRED SAMMONS, INC. |
|
| K823626 |
12/06/1982 |
DISPOSABLE TOOTH BRUSH |
FRED SAMMONS, INC. |
|
| K823647 |
12/06/1982 |
FINGER EXTENSION SPLINT |
FRED SAMMONS, INC. |
|
| K823644 |
12/06/1982 |
FINGER FLEXION SPLINT |
FRED SAMMONS, INC. |
|
| K823614 |
12/06/1982 |
FLEXIBLE HOLDER TO HOLD PHONE RECEIVER |
FRED SAMMONS, INC. |
|
| K823603 |
12/06/1982 |
FORMED PLASTIC PANTY HOSE AID |
FRED SAMMONS, INC. |
|
| K823629 |
12/06/1982 |
FORMED STEEL DEVICE KEEP LEGS SEPARATED |
FRED SAMMONS, INC. |
|
| K823646 |
12/06/1982 |
FRICTION FEEDER |
FRED SAMMONS, INC. |
|
| K823595 |
12/06/1982 |
HEAD SUPPORT FOR WHEELCHAIR |
FRED SAMMONS, INC. |
|
| K823624 |
12/06/1982 |
HOLDER FOR MOUTH STICK |
FRED SAMMONS, INC. |
|
| K823623 |
12/06/1982 |
INFLATABLE HEAVY PLASTIC EXERCISER |
FRED SAMMONS, INC. |
|
| K823643 |
12/06/1982 |
INFLATABLE PILLOW |
FRED SAMMONS, INC. |
|
| K823622 |
12/06/1982 |
INSULATED THERMOELASTOMER MITT |
FRED SAMMONS, INC. |
|
| K823609 |
12/06/1982 |
KIT OF WORDS & LTRS TO RE-LEARN-BK4014 |
FRED SAMMONS, INC. |
|
| K823598 |
12/06/1982 |
LARGE TERRYCLOTH BIB |
FRED SAMMONS, INC. |
|
| K823628 |
12/06/1982 |
LEATHER & VELCRO SHOE FASTENER |
FRED SAMMONS, INC. |
|
| K823627 |
12/06/1982 |
LEATHER I VELCRO SHOE FASTENER REPAIR |
FRED SAMMONS, INC. |
|
| K823632 |
12/06/1982 |
LONG HANDLED FOLDING HAIRBRUSH |
FRED SAMMONS, INC. |
|
| K823625 |
12/06/1982 |
MOUTH STICK KIT |
FRED SAMMONS, INC. |
|
| K823631 |
12/06/1982 |
NON-SLIP VINYL BATH MAT |
FRED SAMMONS, INC. |
|
| K823608 |
12/06/1982 |
PICTURES & WORD IDENTIFICATION CVA PAT |
FRED SAMMONS, INC. |
|
| K823606 |
12/06/1982 |
PLASTIC BREAK RESISTANT MIRROR |
FRED SAMMONS, INC. |
|
| K823594 |
12/06/1982 |
PLASTIC BUILT-UP HANDLE EATING UTENSILS |
FRED SAMMONS, INC. |
|
| K823619 |
12/06/1982 |
PLASTIC ELASTOMER ENCASED IN TERRY CLOTH |
FRED SAMMONS, INC. |
|
| K823620 |
12/06/1982 |
PLASTIC ELASTOMER IN CUBE FORM EXERCISE |
FRED SAMMONS, INC. |
|
| K823616 |
12/06/1982 |
PLASTIC SLIP-ON PEN/PENCIL HOLDER |
FRED SAMMONS, INC. |
|
| K823617 |
12/06/1982 |
PLASTIC SLIP-ON POINTS W/RUBBER TIP FOR |
FRED SAMMONS, INC. |
|
| K823613 |
12/06/1982 |
PLASTIC STOP TO HOLD TELEPHONE BUTTON |
FRED SAMMONS, INC. |
|
| K823605 |
12/06/1982 |
PORTABLE ELECTRIC CAN OPENER |
FRED SAMMONS, INC. |
|
| K823652 |
12/06/1982 |
PRIMARY SOLUTION SALVENT BASED COAT- MET |
FRED SAMMONS, INC. |
|
| K823618 |
12/06/1982 |
PROGRESSIVE RESISTANCE EXERCISE CUFF |
FRED SAMMONS, INC. |
|
| K823602 |
12/06/1982 |
REGULAR SHOE HORN W/CYLINDRICAL HANDLE |
FRED SAMMONS, INC. |
|
| K823604 |
12/06/1982 |
ROD W/HOOK TO PULL CLOTHES ON |
FRED SAMMONS, INC. |
|
| K823651 |
12/06/1982 |
SCISSORS |
FRED SAMMONS, INC. |
|
| K823654 |
12/06/1982 |
SLIP-ON SANDALS FOR MEASURING SHORTNESS |
FRED SAMMONS, INC. |
|
| K823656 |
12/06/1982 |
SOFT CATCHER'S MITT |
FRED SAMMONS, INC. |
|
| K823600 |
12/06/1982 |
SOLID WOOD CONE |
FRED SAMMONS, INC. |
|
| K823648 |
12/06/1982 |
SURGICAL TUBING |
FRED SAMMONS, INC. |
|
| K823615 |
12/06/1982 |
TELEPHONE ADAPTOR-PERSONS CANT ANSWER |
FRED SAMMONS, INC. |
|
| K823649 |
12/06/1982 |
THERMOELASTOMER HOT/COLD COMPRESS BK7186 |
FRED SAMMONS, INC. |
|
| K823650 |
12/06/1982 |
THERMOELASTOMER HOT/COLD COMPRESS-7187- |
FRED SAMMONS, INC. |
|
| K823653 |
12/06/1982 |
THINNING SOLUTION SALVENT BASED COAT-MAT |
FRED SAMMONS, INC. |
|
| K823633 |
12/06/1982 |
TURNERS FOR KNOBS |
FRED SAMMONS, INC. |
|
| K823645 |
12/06/1982 |
VELCRO STRAPS TO HOLD ARM TO WHEELCHAIR |
FRED SAMMONS, INC. |
|
| K823601 |
12/06/1982 |
WRIST SUPPORT |
FRED SAMMONS, INC. |
|
| K823848 |
12/21/1982 |
CRAFTON ARTHROSCOPY PUMP AP-10 |
GAMBRO, INC. |
|
| K823791 |
12/16/1982 |
LUNDIA 10-5-L PARRALLE FLOW DIALYZER |
GAMBRO, INC. |
|
| K823904 |
12/28/1982 |
MODEL 515 NEO-TRAK NEONATAL MONITOR |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
|
| K823568 |
12/03/1982 |
POLY-TONE DENTURE BASE RESIN |
GENERAL DENTAL PRODUCTS, INC. |
|
| K823794 |
12/16/1982 |
CONTROL TM 8 |
GENERAL DIAGNOSTICS |
|
| K823859 |
12/22/1982 |
MIDDLEBROOK 7H10 AGAR BASE-LOWPH |
GIBCO LABORATORIES LIFE TECHNOLOGIES, INC. |
|
| K823885 |
12/27/1982 |
SELECTIVE LEGIONELLA MEDIA |
GIBCO LABORATORIES LIFE TECHNOLOGIES, INC. |
|
| K823709 |
12/09/1982 |
TRIGLYCERIDE REAGENT (UV) |
GILFORD DIAGNOSTICS |
|
| K823737 |
12/13/1982 |
MADE-TO-MEASURE SURGICAL ELASTIC SUPPORT |
GOTFRIED MEDICAL, INC. |
|
| K823710 |
12/09/1982 |
DISPOSABLE AIRWAY ADEJUNCT |
GROVES MEDICAL SUPPLY, INC. |
|
| K823937 |
12/29/1982 |
SEMINAL COLLECTION DEVICE |
HEALTH DEVELOPMENT CORP. |
|
| K823870 |
12/23/1982 |
BETA THALQUIK COLUMN #5341 |
HELENA LABORATORIES |
|
| K823869 |
12/23/1982 |
GLYCO HB QUIK COLUMN PROCEDURE |
HELENA LABORATORIES |
|
| K823574 |
12/06/1982 |
COBAS REAGENT FOR ALBUMIN |
HOFFMANN-LA ROCHE, INC. |
|
| K823577 |
12/06/1982 |
COBAS REAGENT FOR CALCIUM |
HOFFMANN-LA ROCHE, INC. |
|
| K823573 |
12/06/1982 |
COBAS REAGENT FOR CREATININE |
HOFFMANN-LA ROCHE, INC. |
|
| K823580 |
12/06/1982 |
COBAS REAGENT FOR INORGANIC PHOSPHORUS |
HOFFMANN-LA ROCHE, INC. |
|
| K823579 |
12/06/1982 |
COBAS REAGENT FOR TOTAL PROTEIN |
HOFFMANN-LA ROCHE, INC. |
|
| K823576 |
12/06/1982 |
COBAS STANDARD FOR TOTAL PROTEIN |
HOFFMANN-LA ROCHE, INC. |
|
| K823575 |
12/06/1982 |
COBAS STANDARDS FOR ALBUMIN |
HOFFMANN-LA ROCHE, INC. |
|
| K823578 |
12/06/1982 |
COBAS STANDARDS FOR CALCIUM-IN-ORGANIC |
HOFFMANN-LA ROCHE, INC. |
|
| K823572 |
12/06/1982 |
COBAS STANDARDS FOR CREATININE |
HOFFMANN-LA ROCHE, INC. |
|
| K823589 |
12/06/1982 |
H 12 07 |
HOSPAL MEDICAL CORP. |
|
| K823707 |
12/09/1982 |
HOSPAL BLOOD LINES |
HOSPAL MEDICAL CORP. |
|
| K823696 |
12/08/1982 |
MICRO Z BLOOD COLLECTING NEEDLES |
HOSPITAL PRODUCTS CO. |
|
| K823871 |
12/23/1982 |
TANDEM-E -FER IMMUNOENZYMETRIC KIT |
HYBRITECH, INC. |
|
| K823857 |
12/22/1982 |
IMPRA PERITONEAL CATHETER |
IMPRA, INC. |
|
| K823838 |
12/28/1982 |
INFUSE-A-PORT |
INFUSAID CORP. |
|
| K823863 |
12/22/1982 |
CYBERLITH IX QUANTUM-UNIPOLAR CARDIAC |
INTERMEDICS, INC. |
|
| K823678 |
12/06/1982 |
TELEMETRY DECODER #540-02 |
INTERMEDICS, INC. |
|
| K823851 |
12/22/1982 |
ORTHODAPTIC* BONDING ADHESIVE |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
|
| K823835 |
12/21/1982 |
SPEMBLY 140 CRYOSYSTEM PROBES & TIPS |
KELLER INSTRUMENTS, INC. |
|
| K823765 |
12/14/1982 |
ANTI SERA TO HUMAN OROSCOMUCOID |
KENT LABORATORIES, INC. |
|
| K828056 |
12/06/1982 |
MODEL 716 MICROMANIPULATOR |
LASER INDUSTRIES LTD. |
|
| K823767 |
12/14/1982 |
ERG-JET ELECTRODE |
LIFE-TECH INTL., INC. |
|
| K823582 |
12/06/1982 |
OXYGEN CONCENTRATOR UCC-100 |
LINDE DIV. UNION CARBIDE CORP. |
|
| K823804 |
12/17/1982 |
MYCOPLASMELISA TEST KIT |
M.A. BIOPRODUCTS |
|
| K823805 |
12/17/1982 |
VARICELISA TEST KIT |
M.A. BIOPRODUCTS |
|
| K823720 |
12/10/1982 |
SPECTROPHOTOMETER |
MACOMB CHEMICAL CO. |
|
| K823886 |
12/27/1982 |
PROFILE 750 BLOOD CELL COUNTER |
MALLINCKRODT CRITICAL CARE |
|
| K823850 |
12/21/1982 |
BAC-T-SCREEN BACTERIURIA DETECTION DEV |
MARION LABORATORIES, INC. |
|
| K823714 |
12/10/1982 |
DISPOSABLE NON-REBREATHING ANES. CIRCUIT |
MARQUEST MEDICAL PRODUCTS, INC. |
|
| K823593 |
12/06/1982 |
INHALANT PROFILE-ALLERGEN-SPECIFIC IGE |
MAST IMMUNOSYSTEMS |
|
| K823565 |
12/03/1982 |
MULTI-LUMEN INTRAVENOUS CATHETER |
MCPHERSON ENTERPRISES, INC. |
|
| K823788 |
12/16/1982 |
MECON I |
MECON LABS |
|
| K823856 |
12/22/1982 |
MEDCARE GENERAL PURPOSE TRAY |
MEDCARE PRODUCTS |
|
| K823855 |
12/22/1982 |
MEDCARE INCISION & DRAINAGE TRAY |
MEDCARE PRODUCTS |
|
| K823854 |
12/22/1982 |
MEDCARE SUTURE REMOVAL TRAYS |
MEDCARE PRODUCTS |
|
| K823853 |
12/22/1982 |
MEDCARE WOUND CLOSURE TRAY |
MEDCARE PRODUCTS |
|
| K823840 |
12/21/1982 |
MEDELA NAMUAL BREAST PUMP |
MEDELA, INC. |
|
| K823925 |
12/29/1982 |
CART |
MEDICAL ASSOC. INTL., INC. |
|
| K823757 |
12/14/1982 |
SURGITEK ENDOTRACHEAL TUBE, LASER RESIS |
MEDICAL ENGINEERING CORP. |
|
| K823587 |
12/06/1982 |
UNI-CELL |
MEDICAL SPECIALTIES LABORATORIES |
|
| K823695 |
12/08/1982 |
CPM METABOLIC MONITOR |
MEDICOR USA LTD. |
|
| K837030 |
12/20/1982 |
MODEL ML-4000 OPHTHALMIC LASER WITH FIBER OPTIC DELIVERY SYSTEM |
MEDITEC, INC. |
|
| K823831 |
12/21/1982 |
MEDTRONIC MODELS 59401 5941 |
MEDTRONIC VASCULAR |
|
| K823742 |
12/13/1982 |
NEUROMOD COMPLEMENT #7724 DUAL CHANNEL |
MEDTRONIC VASCULAR |
|
| K823738 |
12/13/1982 |
GRAM NEGATIVE BACTERIAL IDENTIF- PANELS |
MICRO-MEDIA SYSTEMS, INC. |
|
| K823801 |
12/17/1982 |
AMES TDA ETHOSUXIMIDE TEST |
MILES LABORATORIES, INC. |
|
| K823701 |
12/08/1982 |
MOTILITY CATHETERS |
MUI SCIENTIFIC |
|
| K823899 |
12/27/1982 |
INFANT CARE SYSTEM |
NARCO SCIENTIFIC |
|
| K823927 |
12/29/1982 |
HIPUSH HANDHELD MASSAGER |
NEW AGE CORP. |
|
| K823563 |
12/02/1982 |
EEG & RESPIRATION MODULES POLYGRAPH |
NIHON KOHDEN AMERICA, INC. |
|
| K823562 |
12/02/1982 |
EMG MODULES FOR POLYGRAPH SYSTEM |
NIHON KOHDEN AMERICA, INC. |
|
| K823561 |
12/02/1982 |
URETHRAL PRESSURE PROFILE & TEMP. MODUL |
NIHON KOHDEN AMERICA, INC. |
|
| K823719 |
12/10/1982 |
AML (ANGLE MAGNIFYING LENS |
NIKON INC. |
|
| K823845 |
12/21/1982 |
PORT-LOCK |
NORFOLK MEDICAL PRODUCTS, INC. |
|
| K823860 |
12/22/1982 |
NUCLIPASE (I125) PANCREATIC LIPASE |
NUCLEAR DIAGNOSTICS, INC. |
|
| K823679 |
12/07/1982 |
NML 6000 CT |
NUCLEAR MEDICAL LABORATORIES, INC. |
|
| K823554 |
12/01/1982 |
ACOH WELLNESS TESTER |
OCCUPATIONAL HEALTH, INC. |
|
| K823693 |
12/08/1982 |
MYELOGRAPHY NEEDLE |
OCEAN MEDICAL PRODUCTS, LTD. |
|
| K823692 |
12/08/1982 |
SPINAL NEEDLE |
OCEAN MEDICAL PRODUCTS, LTD. |
|
| K823934 |
12/29/1982 |
CARIEL F12 |
ODAM |
REITHLER |
| K823931 |
12/29/1982 |
DEFIGARD M(OR DEFISCOPE M |
ODAM |
|
| K823933 |
12/29/1982 |
MINIDEF (OR DEFIPORT |
ODAM |
|
| K837028 |
12/10/1982 |
PARKINSON NEUROSURGICAL HEADCLAMP FOR SERIAL ANGIOGRAPHY |
OHIO MEDICAL INSTRUMENT CO., INC. |
|
| K823922 |
12/28/1982 |
COMPUTERIZED SPIROMETRY SYSTEM |
OHIO MEDICAL PRODUCTS |
|
| K823691 |
12/08/1982 |
PHOSPHORUS REAGENT SET |
OMEGA MEDICAL ELECTRONICS |
|
| K823872 |
12/27/1982 |
EMERGENCY TRACHEOSTOMY KIT |
OMNICON MEDICAL CORP. |
|
| K823682 |
12/07/1982 |
BETA FFIRM TEST |
ORGANON, INC. |
|
| K823590 |
12/06/1982 |
MANUALISA MICROTITRATION PLATE READER |
ORTHO DIAGNOSTIC SYSTEMS, INC. |
|
| K823789 |
12/16/1982 |
ELASTIC COMPRESSION ANKLET |
ORTHOPAEDIC RESOURCES CORP. |
|
| K823889 |
12/27/1982 |
MODEL JY PACEMAKER LEAD - VARIOUS |
OSCOR INC. |
|
| K823891 |
12/27/1982 |
MODEL KY PACEMAKER LEAD - VARIOUS |
OSCOR INC. |
|
| K823898 |
12/27/1982 |
MODEL MF..D & MX..D PACEMAKER LEADS |
OSCOR INC. |
|
| K823893 |
12/27/1982 |
MODEL MZ PACEMAKER LEAD-VARIOUS |
OSCOR INC. |
|
| K823895 |
12/27/1982 |
MODEL RF. D&RX..D PACEMAKER LEADS |
OSCOR INC. |
|
| K823897 |
12/27/1982 |
MODEL SF. D&SX.D PACEMAKER LEADS |
OSCOR INC. |
|
| K823890 |
12/27/1982 |
MODEL ZY PACEMAKER LEAD-VARIOUS |
OSCOR INC. |
|
| K823559 |
12/02/1982 |
AFP PULSE GENERATOR |
PACESETTER SYSTEMS |
|
| K823878 |
12/27/1982 |
IMPLANTABLE PACEMAKER PULSE GEN, MODELS 241 & 242 |
PACESETTER SYSTEMS |
DIANA UPP |
| K823825 |
12/20/1982 |
NOSITE UV INTERIM SPECTACLES |
PATTON, BOGGS & BLOW |
|
| K823555 |
12/01/1982 |
MAGTARAK RESPIRATORY MONITOR & FLOW SENS |
PENLON, INC. |
|
| K823592 |
12/06/1982 |
PHADEBAS & PHADEZYM RAST TEST ALLERG |
PHARMACIA, INC. |
|
| K823841 |
12/21/1982 |
PHADEBAS RAST ALLERGEN DISCS |
PHARMACIA, INC. |
|
| K823842 |
12/21/1982 |
PHADEZYM RAST ALLERGEN DISCS |
PHARMACIA, INC. |
|
| K823581 |
12/06/1982 |
ELPHA 500 |
PROTHIA USA, INC. |
|
| K823583 |
12/06/1982 |
MYOTEST NERVE STIMULATOR |
PROTHIA USA, INC. |
|
| K823858 |
12/22/1982 |
VOLUME VENTILATOR |
PURITAN BENNETT CORP. |
|
| K823674 |
12/07/1982 |
HIGH FREQUENCY EPILATOR CB-2 |
R. A. FISCHER CO. CORP. |
|
| K823712 |
12/10/1982 |
BEL BLOOD LEVEL DETECTOR |
R. SCOTT BELL |
|
| K837033 |
12/14/1982 |
ROTATABLE HALF BEAM SHIELDING BLOCK MODEL 440 |
RADIATION MEASUREMENTS, INC. |
|
| K827577 |
12/20/1982 |
VARIABLE CONTRAST ACUIOMETER, DIAGNOSTIC LASER INTERFEROMETER |
RANDWAL INSTRUMENT CO., INC. |
|
| K827346 |
12/22/1982 |
SPIRAFLOW 2001, MULTI-DIRECTIONAL TOMOGRAPHIC UNIT |
RAYFLOW ITALIA S.R.L. |
|
| K823779 |
12/15/1982 |
DIALYTE |
RENAL DYNAMICS, INC. |
|
| K823783 |
12/15/1982 |
RESPICOMB |
RESPITRACE CORP. |
WILLIAM GRUEN |
| K823780 |
12/15/1982 |
RESPITRACE 300SC |
RESPITRACE CORP. |
WILLIAM GRUEN |
| K823782 |
12/15/1982 |
RESPITRACE SYSTEM |
RESPITRACE CORP. |
|
| K823837 |
12/21/1982 |
RMC TOTAL KNEE SYSTEM |
RICHARD'S MEDICAL EQUIP., INC. |
|
| K823726 |
12/10/1982 |
SPECTRON CONVERSION ENDOPROSTHESIS CUP |
RICHARD'S MEDICAL EQUIP., INC. |
|
| K823722 |
12/10/1982 |
SPECTRON LONG, STRAIGHT FEMORAL PROSTHES |
RICHARD'S MEDICAL EQUIP., INC. |
|
| K823729 |
12/10/1982 |
SPECTRON METAL BACK ACETABULAR COMPONENT |
RICHARD'S MEDICAL EQUIP., INC. |
|
| K823724 |
12/10/1982 |
SPECTRON NECK REPLACEMENT PROSTHESIS |
RICHARD'S MEDICAL EQUIP., INC. |
|
| K823728 |
12/10/1982 |
SPECTRON POLYETHYLENE ACCTUBULAR COMPON |
RICHARD'S MEDICAL EQUIP., INC. |
|
| K823727 |
12/10/1982 |
SPECTRON PRIMARY STEM FEMORAL PROSTHES |
RICHARD'S MEDICAL EQUIP., INC. |
|
| K823725 |
12/10/1982 |
SPECTRON PROTRUSIO CUP |
RICHARD'S MEDICAL EQUIP., INC. |
|
| K823723 |
12/10/1982 |
SPECTRON PROXIMAL FEMORAL PROSTHESIS |
RICHARD'S MEDICAL EQUIP., INC. |
|
| K823803 |
12/17/1982 |
RIONET HEARING AID HB-32P |
RION ACOUSTIC INSTRUMENTS, INC. |
|
| K823847 |
12/21/1982 |
RIONET HEARING AID HB-69CI |
RION ACOUSTIC INSTRUMENTS, INC. |
|
| K823588 |
12/06/1982 |
PERSONAL ROMEAR |
ROMEAR MFG., INC. |
|
| K823702 |
12/09/1982 |
EPIDURAL CATHETER |
RSP, INC. |
|
| K823703 |
12/09/1982 |
ESOPHAGEAL STETHOSCOPE |
RSP, INC. |
|
| K823715 |
12/10/1982 |
SINGLE ACCESS DEVICE (SSAD) |
SAMARITAN HOSPITAL |
|
| K823921 |
12/28/1982 |
PHYSICIANS CHOICE SILICONE EAR PUTTY |
SANTA BARBARA MEDCO, INC. |
|
| K823846 |
12/21/1982 |
URIC ACID TEST |
SCALAVO, INC. |
|
| K823764 |
12/14/1982 |
SCANLAN SINGLE-USE AORTA PUNCH |
SCANLAN INTL., INC. |
|
| K823694 |
12/08/1982 |
VASCU-STATT APPROXIMATOR |
SCANLAN INTL., INC. |
|
| K823935 |
12/29/1982 |
MICRO JOIN, CROWN & BRIDGE ADHESIVE |
SCI-PHARM, INC. |
|
| K823732 |
12/10/1982 |
CBM, CORE BUILD-UP MATERIAL |
SCIENTIFIC PHARMACEUTICALS, INC. |
|
| K823750 |
12/14/1982 |
CLEANING AGENT |
SHABAN MFG. CO. |
|
| K823836 |
12/21/1982 |
MONOJECT SAMPLETTE CAPILLARY BLOOD COLL |
SHERWOOD MEDICAL CO. |
|
| K823731 |
12/10/1982 |
CARDF |
SHILEY, INC. |
|
| K823828 |
12/20/1982 |
THERACARD 400 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
|
| K823739 |
12/13/1982 |
INTRA-AORTIC BALLOON SYSTEM |
SMEC, INC. |
|
| K823771 |
12/14/1982 |
SPIROTECH 300 |
SPIROTECH, INC. |
|
| K823770 |
12/14/1982 |
SPIROTECH ST-5500 |
SPIROTECH, INC. |
|
| K823755 |
12/14/1982 |
BICEPS ELECTROCAUTERY SYSTEM |
SQUIBB DIAGNOSTICS |
|
| K823776 |
12/15/1982 |
PI-PNEUMO-INTESTINAL INSTRUMENT SET |
SURGEONS CHOICE, INC. |
|
| K823670 |
12/07/1982 |
E.S. PENCIL |
SURGICARE SCIENTIFIC LABORATORY, INC. |
|
| K823671 |
12/07/1982 |
NO-GAUZE LAPAROTOMY SPONGE |
SURGILITE INTL., INC. |
|
| K823795 |
12/27/1982 |
EVERBOND GLASS IONOMER CEMENT |
SYBRON CORP. |
|
| K823887 |
12/27/1982 |
ADVANCE EMIT CAD DISOPYRAMIDE ASSAY |
SYVA CO. |
|
| K823866 |
12/23/1982 |
ADVANCE EMIT CAD LIDOCAINE ASSAY |
SYVA CO. |
|
| K823745 |
12/13/1982 |
ADVANCE EMIT-AED ETHOSUXIMIDE |
SYVA CO. |
|
| K823741 |
12/13/1982 |
ADVANCE EMIT-AED PRIMEDONE ASSAY |
SYVA CO. |
|
| K823746 |
12/13/1982 |
ADVANCE SYS. EMIT-AED ANTIEPILEPTIC DRUG |
SYVA CO. |
|
| K823865 |
12/23/1982 |
ADVANCE SYS. EMIT-CAD LIDOCAINE CONTROL |
SYVA CO. |
|
| K823740 |
12/13/1982 |
ADVANCE SYSTEM EMITAED ANTIEPILEPTIC |
SYVA CO. |
|
| K823567 |
12/03/1982 |
IMMUNOGLOBULIN ASSAYS-IGG, IGA, IGM |
SYVA CO. |
|
| K823566 |
12/03/1982 |
IMMUNOGLOBULIN CONTROL |
SYVA CO. |
|
| K823768 |
12/14/1982 |
CLIRANS TE08 HOLLOW FIBER DIALYZER |
TERUMO MEDICAL CORP. |
|
| K823775 |
12/14/1982 |
BORDON GAGE REGULATOR #BG |
TIMETER INSTRUMENT CORP. |
|
| K823676 |
12/07/1982 |
DISC NEEDLE SET #TX-8220 |
TODAY'S MACHINING & DESIGN, INC. |
|
| K823675 |
12/07/1982 |
FRONING GUIDANCE SYSTEM #TX-8200 |
TODAY'S MACHINING & DESIGN, INC. |
|
| K823906 |
12/28/1982 |
TELEMETRY SYSTEM |
TRANSKINETIC SYSTEMS, INC. |
|
| K823826 |
12/20/1982 |
CAPILLARY FLOW DIALYZERS |
TRAVENOL LABORATORIES, S.A. |
|
| K823716 |
12/10/1982 |
CYSTOFLO URINARY DRAINAGE BAG W/ANTIMIC |
TRAVENOL LABORATORIES, S.A. |
|
| K823778 |
12/15/1982 |
GAMMA STERILIZED CAPILLARY FLOW DIALYZ |
TRAVENOL LABORATORIES, S.A. |
|
| K823777 |
12/15/1982 |
STERILE, DISPOS. SPIKE PROTECTOR-5C4138 |
TRAVENOL LABORATORIES, S.A. |
|
| K823918 |
12/28/1982 |
AUSTIN MODIFIED PARTIAL OSSICULAR RE- |
TREACE MEDICAL, INC. |
|
| K823912 |
12/28/1982 |
AUSTIN MODIFIED TOTAL OSSICULAR REPLACE |
TREACE MEDICAL, INC. |
|
| K823907 |
12/28/1982 |
COLLAR BUTTON VENT TUBE |
TREACE MEDICAL, INC. |
|
| K823910 |
12/28/1982 |
DONALDSON VENT TUBE |
TREACE MEDICAL, INC. |
|
| K823914 |
12/28/1982 |
EXPLORER TIP |
TREACE MEDICAL, INC. |
|
| K823908 |
12/28/1982 |
GROMMET VENT TUBE |
TREACE MEDICAL, INC. |
|
| K823911 |
12/28/1982 |
KNIFE BLADE TIP |
TREACE MEDICAL, INC. |
|
| K823915 |
12/28/1982 |
MIRROR TIP |
TREACE MEDICAL, INC. |
|
| K823917 |
12/28/1982 |
PARTIAL OSSICULAR REPLACEMENT |
TREACE MEDICAL, INC. |
|
| K823913 |
12/28/1982 |
SOFT GRIP UNI-HANDLE |
TREACE MEDICAL, INC. |
|
| K823909 |
12/28/1982 |
T-TUBE VENT TUBE |
TREACE MEDICAL, INC. |
|
| K823919 |
12/28/1982 |
TOTAL OSSICULAR REPLACEMENT |
TREACE MEDICAL, INC. |
|
| K823916 |
12/28/1982 |
WAX CURETTE TIP |
TREACE MEDICAL, INC. |
|
| K823690 |
12/08/1982 |
IVFLO-HP & IVFIL-HP |
TRI-MED, INC. |
|
| K823685 |
12/07/1982 |
FILE TYPE H (HEDSTROEM) ENDODONTIC |
UNITED DENTAL MFG., INC. |
|
| K823684 |
12/07/1982 |
FILE TYPE K ENDODONTIC |
UNITED DENTAL MFG., INC. |
|
| K823686 |
12/07/1982 |
REAMER TYPE K ENDODONTIC |
UNITED DENTAL MFG., INC. |
|
| K823669 |
12/07/1982 |
HEARING AID UNITRON #UE4-H |
UNITRON INDUSTRIES, INC. |
|
| K823924 |
12/28/1982 |
MODEL SSE4 ELECTROSURGICAL GENERATOR |
VALLEYLAB, INC. |
|
| K823683 |
12/07/1982 |
VITALOGRAPH PFT PRINTER |
VITALOGRAPH LTD. |
|
| K823939 |
12/29/1982 |
WAKO INSULIN TEST |
WAKO CHEMICALS, USA, INC. |
|
| K823663 |
12/06/1982 |
ABDOMINAL BINDER |
WARM & FORM, ORTHOPEDIC MATERIALS |
|
| K823667 |
12/06/1982 |
CERVICAL COLLAR |
WARM & FORM, ORTHOPEDIC MATERIALS |
|
| K823661 |
12/06/1982 |
CLAVICLE SUPPORT |
WARM & FORM, ORTHOPEDIC MATERIALS |
|
| K823658 |
12/06/1982 |
DELUXE KNEE IMMOBILIZER(UNIVERSAL) |
WARM & FORM, ORTHOPEDIC MATERIALS |
|
| K823659 |
12/06/1982 |
PELVIC TRACTION BELT |
WARM & FORM, ORTHOPEDIC MATERIALS |
|
| K823662 |
12/06/1982 |
RIB BELT (UNIVERSAL) |
WARM & FORM, ORTHOPEDIC MATERIALS |
|
| K823665 |
12/06/1982 |
ROTATION BOOT |
WARM & FORM, ORTHOPEDIC MATERIALS |
|
| K823660 |
12/06/1982 |
UNIVERSAL BUCKS TRACTION |
WARM & FORM, ORTHOPEDIC MATERIALS |
|
| K823664 |
12/06/1982 |
UNIVERSAL SLING, SLING & SWATHE |
WARM & FORM, ORTHOPEDIC MATERIALS |
|
| K823666 |
12/06/1982 |
UNIVERSAL WRIST SPLINT & FOREARM SPLINT |
WARM & FORM, ORTHOPEDIC MATERIALS |
|
| K823743 |
12/13/1982 |
MODEL 40-80-2 DISPOS. ESOPHAGEAL STETHO |
Y |
|
