FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
K801754 |
08/20/1980 |
ADT BONE MARROW ASPIRATION NEEDLE |
A.D.T. LAB INDUSTRIES |
|
K801753 |
08/20/1980 |
ADT BONE MARROW BIOPSY-ASPIR. NEELDE |
A.D.T. LAB INDUSTRIES |
|
K801441 |
08/12/1980 |
ABBOTT/SHAW LIFE CARE PUMP MODEL 3 |
ABBOTT LABORATORIES |
|
K801676 |
08/20/1980 |
FERRIZYME FERRITIN ENZYME IMMUNOASSAY |
ABBOTT LABORATORIES |
|
K800993 |
08/12/1980 |
INPERSOL CAPD ADMIN. SET & CATHETER ADAP |
ABBOTT LABORATORIES |
|
K801694 |
08/27/1980 |
FLOTATION PAD FOR OPERATING TABLE |
ACTION PRODUCTS, INC. |
|
K801931 |
08/27/1980 |
MARTIN TRACH-SECURE |
ACUCARE MEDICAL, INC. |
|
K801622 |
08/14/1980 |
ADEL MEDICAL BIRTHING BED, MOD. LD-400 |
ADEL MEDICAL LTD. |
|
K801598 |
08/20/1980 |
MARK V DUPLEX ULTRASONIC SCANNING SYSTEM |
ADVANCED TECHNOLOGY LABORATORIES, INC. |
|
K801541 |
08/20/1980 |
WALL MOUNTED LASER POSITIONING DEVICE |
ADVANTAGE MEDICAL SYSTEMS, INC. |
|
K801886 |
08/20/1980 |
BURR, DENTAL |
AESCULAP INSTRUMENTS CORP. |
|
K801887 |
08/20/1980 |
DRILL, DENTAL |
AESCULAP INSTRUMENTS CORP. |
|
K801888 |
08/20/1980 |
HANDPIECE, DENTAL |
AESCULAP INSTRUMENTS CORP. |
|
K801875 |
08/14/1980 |
CIRCUITS, BREATHING W/CONNECTORS, ADAPT |
AIRLIFE, INC. |
|
K801743 |
08/07/1980 |
PLASTAZOTE SHOE |
ALIMED, INC. |
|
K801142 |
08/07/1980 |
PALODENT MATRICES & BITINE RINGS |
ALVIN MEYER, D.D.S. |
|
K801766 |
08/20/1980 |
JACKSON-PRATT LARGE VOL. CLOSED WOUND |
AMERICAN HEYER SCHULTE |
|
K801540 |
08/12/1980 |
MCGRAW I.V. ADMINISTRATION SET |
AMERICAN HOSPITAL SUPPLY CORP. |
|
K801220 |
08/12/1980 |
PERITONEAL DIALYSIS CYCLER SET W/PUMP |
AMERICAN MEDICAL PRODUCTS, INC. |
|
K801638 |
08/13/1980 |
A O CUSTOM II CHAIR AND STAND |
AMERICAN OPTICAL CORP. |
|
K801428 |
08/13/1980 |
CHEMDI |
AMERICAN STERILIZER CO. |
|
K801759 |
08/20/1980 |
EFFRON PAROTID RETRACTOR |
AMERICAN V. MUELLER |
|
K801561 |
08/12/1980 |
GLYCOSYLATED HEMOGLOBIN KIT |
AMERSHAM CORP. |
|
K801737 |
08/20/1980 |
STERNUM SAW |
AMSCO CO. |
|
K801555 |
08/04/1980 |
COMPACT MODEL 360 GALVANIC EPILATOR |
ASSOCIATED ELECTROLYSIS GROUP |
|
K801333 |
08/22/1980 |
AMPCO DRESSING CHANGE TRAYS |
ASSOCIATED MEDICAL PRODUCTS CO. |
|
K801331 |
08/20/1980 |
AMPCO HYPERALIMENTATION SUBCLAVIAN TRAYS |
ASSOCIATED MEDICAL PRODUCTS CO. |
|
K801868 |
08/27/1980 |
CAL-COUNT |
BAYSHORE SYSTEMS CORP. |
|
K801701 |
08/07/1980 |
BAUER & BLACK RIGID WRIST BRACE |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K801693 |
08/27/1980 |
SALMONELLA FLAGELLAR A ANTIGEN & B |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K801648 |
08/13/1980 |
TRIMETHROPRIM 5MCG. SENSI DISC. |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K801700 |
08/07/1980 |
UNI-RECORD I |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K801632 |
08/04/1980 |
THE BELLCO FISTULA NEEDLES |
BELLCO ARTIFIDIAL ORGAN SPEC., INC. |
|
K801923 |
08/27/1980 |
BIOMEGA #423-B BLOOD PRESSURE & PULSE CK |
BIO MEGA DIAGNOSTIC, INC. |
|
K801657 |
08/20/1980 |
NON-INVASIVE, BLOOD PRESSURE MONITOR |
BIOCHEM INTERNATIONAL, INC. |
|
K801481 |
08/20/1980 |
BMC RIAFLO SYSTEM |
BOEHRINGER MANNHEIM CORP. |
|
K801697 |
08/07/1980 |
MODEL BP-200 INFANT PRESSURE VENTILATOR |
BOURNS MEDICAL SYSTEMS, INC. |
|
K801605 |
08/12/1980 |
BIMECO FILTERED EXTENSION SET |
BURRON MEDICAL PRODUCTS, INC. |
|
K801941 |
08/27/1980 |
BURRON MICROCATH INTRA. CATH. PLACEMENTT |
BURRON MEDICAL PRODUCTS, INC. |
|
K801853 |
08/13/1980 |
PARALLEL-A-PREP |
C.D. CHARLES, INC. |
|
K801637 |
08/27/1980 |
FLUORO-MARK RADIOPAQUE ANATOMICAL MKR. |
C.R. BARD, INC. |
|
K801647 |
08/20/1980 |
SONACOLOR 6100 |
CAROLINA MEDICAL ELECTRONICS |
|
K801790 |
08/20/1980 |
INTELECT |
CHATTANOOGA GROUP, INC. |
|
K801725 |
08/13/1980 |
KANGAROO ENTERAL FEEDING PUMP |
CHESEBROUGH-POND'S U.S.A. CO. |
|
K801521 |
08/20/1980 |
CLASSIC TAN TANNING BOOTH |
CLASSIC TAN, INC. |
|
K801894 |
08/27/1980 |
RESPONDER II |
CLINICAL MICROSYSTEMS INTL. |
|
K801906 |
08/27/1980 |
DIOPTRON III AUTOREFRACTOR |
COHERENT MEDICAL DIVISION |
|
K801814 |
08/14/1980 |
CATHETER SUCTION TRACHEOBRONCHIAL |
CONCORD LABORATORIES, INC. |
|
K801731 |
08/13/1980 |
C-DAK DUO-FLUX ARTIFICIAL KIDNEY |
CORDIS CORP. |
|
K801865 |
08/20/1980 |
CORDIS FLOW DIRECTED BALLOON CATHETER |
CORDIS CORP. |
|
K801599 |
08/20/1980 |
CORNING 184 BLOOD GAS TONOMETER |
CORNING MEDICAL & SCIENTIFIC |
|
K801357 |
08/14/1980 |
MODIFIED BLOOD CELL COUNTING & LYSING |
COULTER ELECTRONICS, INC. |
|
K801546 |
08/27/1980 |
THE SIMPLICITY PUMP #2100 INFUSION PUMP |
CRITIKON COMPANY,LLC |
|
K801730 |
08/13/1980 |
KRYMED SYSTEM 4001 TILT SCOPE |
CRYOMEDICS, INC. |
|
K801651 |
08/13/1980 |
CUTTER JET |
CUTTER LABORATORIES, INC. |
|
K801652 |
08/27/1980 |
TOTAL PARENTERAL NUTRITION SET BAG |
CUTTER LABORATORIES, INC. |
|
K801377 |
08/27/1980 |
CYBER 120 HEMODIALYZER |
CYBEREX CORP. |
|
K801821 |
08/13/1980 |
FLOW MED 150 |
D.R.O. MEDICAL, INC. |
|
K801832 |
08/27/1980 |
MODEL 9200 VIS-U-SCAN |
DEL MAR AVIONICS |
|
K801830 |
08/27/1980 |
MODEL 9300 ELECTROCARDIOVALIDATOR |
DEL MAR AVIONICS |
|
K801770 |
08/07/1980 |
ARTERIAL BUBBLE TRAP |
DELTA MEDICAL INDUSTRIES |
|
K801704 |
08/13/1980 |
OPEN-LOOP INSULIN DELIVERY SYSTEM |
DELTA MEDICAL INDUSTRIES |
|
K801732 |
08/07/1980 |
PRISMA-FIL |
DENTSPLY INTL. |
|
K801157 |
08/04/1980 |
WEBER-MAYO WRIST |
DEPUY, INC. |
|
K801650 |
08/04/1980 |
DESERET EMBOLECTOMY/THROMBECTOMY CATH. |
DESERET MEDICAL, INC. |
|
K801746 |
08/20/1980 |
SUTURE REMOVAL PAK |
DEVCO MEDICAL INDUSTRIES, INC. |
|
K801580 |
08/13/1980 |
FERRITIN RIA KIT |
DIAGNOSTIC PRODUCTS CORP. |
|
K801474 |
08/13/1980 |
TRIMETHOPRIM 5MCG. SENSITIVITY DISCS |
DIFCO LABORATORIES, INC. |
|
K801855 |
08/13/1980 |
CYCLOPAC TENS |
DOW CORNING WRIGHT |
|
K800602 |
08/27/1980 |
TALEISNIK TOTAL WRIST PROSTHESIS |
DOW CORNING WRIGHT |
|
K801564 |
08/20/1980 |
PHOTOMETER LP 1 |
DR. BRUNO LANGE GMBH |
|
K801563 |
08/20/1980 |
PHOTOMETER LP 3 |
DR. BRUNO LANGE GMBH |
|
K801562 |
08/20/1980 |
PHOTOMETER LP 6 |
DR. BRUNO LANGE GMBH |
|
K801702 |
08/27/1980 |
SUR-FIT SYSTEM PRE-OPERATION SET |
E. R. SQUIBB & SONS, INC. |
|
K801649 |
08/20/1980 |
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES |
EASTMAN KODAK COMPANY |
|
K801610 |
08/04/1980 |
CHILDREN'S HOSPITAL PEDIATRIC RETRACTOR |
EDWARD WECK, INC. |
|
K801611 |
08/04/1980 |
DEEP BALFOUR BLADE FOR WILKINSON RETRACT |
EDWARD WECK, INC. |
|
K801468 |
08/12/1980 |
FRAZIER-FERGUSON SUCTION TUBES |
EDWARD WECK, INC. |
|
K801612 |
08/04/1980 |
FRAZIER-FERGUSON SUCTION TUBES (DISP.) |
EDWARD WECK, INC. |
|
K801609 |
08/13/1980 |
MADDOX LENS SPATULA CAT. #7245 |
EDWARD WECK, INC. |
|
K801608 |
08/12/1980 |
MCCULLEY CONTINUOUS SUTURE TIGHTNER |
EDWARD WECK, INC. |
|
K801660 |
08/13/1980 |
PROXIMATE * PSD PURSE-STRING DEVICE |
ETHICON, INC. |
|
K801705 |
08/07/1980 |
BK-1424 INNER LIP PLATE, CERAMIC |
FRED SAMMONS, INC. |
|
K801706 |
08/07/1980 |
BK-1426-00-01 STONYBROOK/HI-WALL PLATE |
FRED SAMMONS, INC. |
|
K801707 |
08/20/1980 |
BK-1499 KAY-KPLINT HAND CONE/BK-1500 |
FRED SAMMONS, INC. |
|
K801708 |
08/07/1980 |
BK-1520-01 ECONOMY WRIST SUPPORT, CHILD |
FRED SAMMONS, INC. |
|
K801709 |
08/07/1980 |
BK-5058-01 QUAD-QUIP WHEELCHAIR CUFF |
FRED SAMMONS, INC. |
|
K801710 |
08/07/1980 |
BK-5315-01 FOAM HAND EXERCISER, SMALL |
FRED SAMMONS, INC. |
|
K801711 |
08/13/1980 |
BK-6010 CATHETER TUBE HOLDER |
FRED SAMMONS, INC. |
|
K801713 |
08/07/1980 |
BK-6157-02 C.V.A SLING, MEDIUM&LARGE |
FRED SAMMONS, INC. |
|
K801715 |
08/04/1980 |
BK-7497 BULB DYNAMOMETER |
FRED SAMMONS, INC. |
|
K801716 |
08/04/1980 |
BK-7505 RADIOPAQUE GONIOMETER, 8" |
FRED SAMMONS, INC. |
|
K801717 |
08/04/1980 |
BK-7511 BRASS GONIOMETER |
FRED SAMMONS, INC. |
|
K801718 |
08/04/1980 |
BK-7513 STAINLESS STEEL GONIOMETER |
FRED SAMMONS, INC. |
|
K801719 |
08/04/1980 |
BK-7531 PAIN THRESHOLD/FINGER FORCE GAUG |
FRED SAMMONS, INC. |
|
K801712 |
08/07/1980 |
LUMBOSACRAL SUPPORTS & THORACO-LUMBO-SAC |
FRED SAMMONS, INC. |
|
K801714 |
08/07/1980 |
TRANS DISTAL JOINT FINGER EXTEN. SPLINT |
FRED SAMMONS, INC. |
|
K801905 |
08/27/1980 |
FONIX TYPE 5100 HEARING AID ANALYZER |
FRYE ELECTRONICS, INC. |
|
K801414 |
08/13/1980 |
ERYTHROCATH INTRAVENOUS CATHETER PLA. U. |
G.D. SEARLE AND CO. |
|
K801415 |
08/20/1980 |
LATEX FOLEY CATHETER (HYDROMER COATED) |
G.D. SEARLE AND CO. |
|
K801480 |
08/27/1980 |
GAMBRO LUNDIA MAJOR HIGH FLUX HEMODIALYZ |
GAMBRO, INC. |
|
K801479 |
08/27/1980 |
GAMBRO LUNDIA PLATE HIGH FLUX HEMODIAL- |
GAMBRO, INC. |
|
K801653 |
08/20/1980 |
MAXI CAMERA 37 |
GENERAL ELECTRIC CO. |
|
K801654 |
08/20/1980 |
MAXI CAMERA 61 |
GENERAL ELECTRIC CO. |
|
K801762 |
08/27/1980 |
MICRO-PROCESSOR UNIT #A3600AC |
GENERAL ELECTRIC CO. |
|
K801761 |
08/20/1980 |
PDS COMPUTER UNIT/VIDEO TERMINAL |
GENERAL ELECTRIC CO. |
|
K801796 |
08/13/1980 |
THE COMFORT LIFT |
GETTNER ENTERPRISES, INC. |
|
K801600 |
08/27/1980 |
GLUCOSE (TRINDER) REAGENT |
GILFORD DIAGNOSTICS |
|
K801829 |
08/27/1980 |
MEDI-TRACE DISP. FLUSHING DEV./MONITOR |
GRAPHIC CONTROLS CORP. |
|
K801828 |
08/27/1980 |
MEDI-TRACE DISP. STOPCOCKS/PHYSIO. PRESS |
GRAPHIC CONTROLS CORP. |
|
K801635 |
08/04/1980 |
BIOBRANE BRAND TEMPORARY WOUND-DRESSING |
HALL-WOODROOF, INC. |
|
K801904 |
08/27/1980 |
SYRINGE INFUSION PUMP #2716 |
HARVARD APPARATUS, INC. |
|
K801504 |
08/12/1980 |
HOLLISTER DRAINAGE POUCH |
HOLLISTER, INC. |
|
K801503 |
08/13/1980 |
HOLLISTER KARAYA SEAL RING |
HOLLISTER, INC. |
|
K801788 |
08/07/1980 |
HUMEROUS FRACTURE BRACE, ULNA FRACTURE |
HOSMER DORRANCE CORP. |
|
K800536 |
08/07/1980 |
MODEL H 607-.67M2 30 MICRON RP AN69 MEM |
HOSPAL MEDICAL CORP. |
|
K801602 |
08/27/1980 |
DESERET I.V. FILTER |
HOSPITAL PRODUCTS CO. |
|
K801867 |
08/20/1980 |
DISPOSABLE MEDICATION NEBULIZER |
HOSPITAX |
|
K801969 |
08/27/1980 |
ASNIS GUIDED SCREW SYSTEMS |
HOWMEDICA CORP. |
|
K801911 |
08/27/1980 |
HOWMEDICA BITE BLOCK |
HOWMEDICA CORP. |
|
K801666 |
08/27/1980 |
TESTOSTERONE KIT |
IMMUCHEM CORP. |
|
K801933 |
08/27/1980 |
DRUALIFT 500 |
INDEPENDENT TRANSFER EQUIPMENT CO. |
|
K800696 |
08/14/1980 |
ELECTRONIC PACEMAKER WAVEFORM ANALYZER |
INSTROMEDIX, INC. |
|
K801065 |
08/07/1980 |
NIKKISO PARALLEL FLOW DIALYZERS |
INT'L MARKETING & SALES CORP. |
|
K801576 |
08/14/1980 |
NEUROGAR III-TRANSCUT. ELEC. NERVE STIM |
INTER MED INDUSTRIES, INC. |
|
K801577 |
08/27/1980 |
NEUROGAR IV-EXTERNAL NEURO-MUSCLE STIM. |
INTER MED INDUSTRIES, INC. |
|
K801450 |
08/14/1980 |
INTERMEDICS THIN LITH IV SERIES UNIPOLAR |
INTERMEDICS, INC. |
|
K801642 |
08/27/1980 |
FIAX TEST KIT FOR THEOPHYLLINE QUANT. |
INTL. DIAGNOSTIC TECHNOLOGY |
|
K801742 |
08/13/1980 |
NEW FINE MODEL ENT TREATMENT UNIT |
JEDMED INSTRUMENT CO. |
|
K801738 |
08/13/1980 |
NOBLE MEDEL ENT TREATMENT UNIT |
JEDMED INSTRUMENT CO. |
|
K801739 |
08/13/1980 |
NOBLE MODEL DOUBLESIDED TREATMENT UNIT |
JEDMED INSTRUMENT CO. |
|
K801741 |
08/13/1980 |
PRETTY MODEL ENT TREATMENT UNIT |
JEDMED INSTRUMENT CO. |
|
K801740 |
08/13/1980 |
TREATMENT UNIT FOR DOCTOR'S ROUNDS |
JEDMED INSTRUMENT CO. |
|
K801824 |
08/20/1980 |
BAND-AID BRAND FLEXIBLE FABRIC BANDAGE |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
|
K801823 |
08/20/1980 |
BAND-AID BRAND TRICOT MESH BANDAGES |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
|
K801690 |
08/13/1980 |
VALIANT |
L.D. CAULK CO. |
|
K801668 |
08/13/1980 |
"QUICK CEPT" |
LABORATORY DIAGNOSTICS CO., INC. |
|
K801624 |
08/20/1980 |
SHARPLAN 723 CO2 LASER SURGICAL SYSTEM |
LASER INDUSTRIES LTD. |
|
K801349 |
08/07/1980 |
LOSEFF BALLOON TYPE SELF-RETENTION WOUND |
LOSEFF MEDICAL DESIGNERS, LTD. |
|
K801575 |
08/20/1980 |
L-CATH INTRAVENOUS PLACEMENT UNIT |
LUTHER MEDICAL PRODUCTS, INC. |
|
K801554 |
08/04/1980 |
STERILE CAST PADDING |
MEDI-SPEC |
|
K801758 |
08/14/1980 |
MMI/GAELTEC CATHETER INTRAUTERINE |
MEDICAL MEASUREMENTS, INC. |
|
K801757 |
08/27/1980 |
MMI/GAELTEC CATHETER TIP PRESS. TRANSDU |
MEDICAL MEASUREMENTS, INC. |
|
K801755 |
08/13/1980 |
MMI/GAELTEC CATHETER TIP PRESSURE |
MEDICAL MEASUREMENTS, INC. |
|
K801756 |
08/20/1980 |
MMI/GAELTEC CATHETER TIP TRANSDUC |
MEDICAL MEASUREMENTS, INC. |
|
K801880 |
08/14/1980 |
MMI/GAELTEC SERIES 8T DIFF. PRESS. TRANS |
MEDICAL MEASUREMENTS, INC. |
|
K801572 |
08/04/1980 |
SURG-ASSIST |
MEDMETRIC CORP. |
|
K801491 |
08/13/1980 |
MRI HCG-BETA RIA KIT CAT. #MR-10100 |
MICROANALYTIC RESEARCH, INC. |
|
K801915 |
08/20/1980 |
ENZYME-ASE I TUBES |
MICROCHEMICAL SPECIALITIES, CO. |
|
K801916 |
08/20/1980 |
ORNITH-ASE TUBES |
MICROCHEMICAL SPECIALITIES, CO. |
|
K801736 |
08/20/1980 |
AMES TDA TM PHENYTOIN TEST |
MILES LABORATORIES, INC. |
|
K801928 |
08/20/1980 |
LAB-TEK FTA-ABS KIT |
MILES LABORATORIES, INC. |
|
K801665 |
08/20/1980 |
SERALYZER GLUCOSE CALIBRATORS(LOW&HIGH) |
MILES LABORATORIES, INC. |
|
K801663 |
08/20/1980 |
SERALYZER GLUCOSE REAGENT STRIPS |
MILES LABORATORIES, INC. |
|
K801664 |
08/20/1980 |
SERALYZER GLUCOSE TEST MODULE |
MILES LABORATORIES, INC. |
|
K801500 |
08/20/1980 |
ULTRAFREE CALCIUM FILTER |
MILLIPORE CORP. |
|
K801619 |
08/04/1980 |
MIST2GEN TEMPTROL 10 |
MISTOGEN EQUIPMENT CO. |
|
K801512 |
08/20/1980 |
DOPPLER ULTRASONIC STETHOSCOPE |
MOUNTAIN MEDICAL EQUIPMENT, INC. |
|
K801459 |
08/20/1980 |
ELECTRO-ACUSCOPE-70 |
NEBRENSKY CORP. |
|
K801607 |
08/07/1980 |
MOM 2 |
NEOTRONICS, INC. |
|
K801671 |
08/04/1980 |
ESG-1 (EVOKED RESPONSE STIMULUS GENER) |
NEURO DIAGNOSTICS, INC. |
|
K801670 |
08/04/1980 |
NDI-IKE EMG |
NEURO DIAGNOSTICS, INC. |
|
K801604 |
08/04/1980 |
PATHFINDER ELECTRODIAGNOSTIC SYSTEM |
NICOLET BIOMEDICAL INSTRUMENTS |
|
K801677 |
08/07/1980 |
ELECTROCARDIOGRAPH, MODEL ECG-5503 |
NIHON KOHDEN AMERICA, INC. |
|
K801346 |
08/12/1980 |
NSI REAGENT SYSTEM FOR ORTHO ELT-8 HEMA |
NOBEL SCIENTIFIC INDUSTRIES, INC. |
|
K800587 |
08/08/1980 |
NSI WASH SOLUTION CONCENTRATE |
NOBEL SCIENTIFIC INDUSTRIES, INC. |
|
K801804 |
08/13/1980 |
ANESTHESIA BACTERIA FILTER |
OMNICON MEDICAL CORP. |
|
K801803 |
08/13/1980 |
MAINFLOW BACTERIA FILTER |
OMNICON MEDICAL CORP. |
|
K801507 |
08/20/1980 |
ANTIGEN CONTROL CELLS |
ORTHO DIAGNOSTICS, INC. |
|
K801780 |
08/07/1980 |
OXY CUSTOM TRAY RESIN |
OXY DENTAL PRODUCTS, INC. |
|
K801779 |
08/07/1980 |
OXYDENTAL ZINC OXIDE EUGENOL(ZOE)CEMENT |
OXY DENTAL PRODUCTS, INC. |
|
K801763 |
08/27/1980 |
VIVALITH 5, - MDL-201A & TDL-201A |
PACESETTER SYSTEMS |
|
K801684 |
08/04/1980 |
ASTRON AIR POWERED HIGH SPEED DE PIECE |
PACIFIC DENTAL CORP. |
|
K801683 |
08/04/1980 |
LUNA-VUE DENTAL OPERATING LIGHT |
PACIFIC DENTAL CORP. |
|
K801685 |
08/04/1980 |
SPACELINE DENTAL CHAIR-UNIT |
PACIFIC DENTAL CORP. |
|
K801682 |
08/04/1980 |
SPACELINE HIGH VOLUME EVACUATION HANDPIE |
PACIFIC DENTAL CORP. |
|
K801686 |
08/04/1980 |
SPACELINE THREE WAY SYRINGE |
PACIFIC DENTAL CORP. |
|
K801688 |
08/04/1980 |
TORX HANDPIECE CONTRA ANGLES ATTACHMENTS |
PACIFIC DENTAL CORP. |
|
K801687 |
08/04/1980 |
TORX MICRO-MOTOR LOW SPEED HANDPIECE |
PACIFIC DENTAL CORP. |
|
K800737 |
08/04/1980 |
DEBRISAN (DEXTRANOMER) PASTE |
PHARMASEAL LABORATORIES |
|
K801617 |
08/04/1980 |
CONDUCTIVE SHOE COVERS |
PROCTER & GAMBLE MFG. CO. |
|
K801616 |
08/04/1980 |
NON-CONDUCTIVE SHOE COVERS |
PROCTER & GAMBLE MFG. CO. |
|
K801680 |
08/04/1980 |
BETA-CAP II ADAPTER |
QUINTON, INC. |
|
K801817 |
08/27/1980 |
MICROBIOLOGY CULTURE MEDIA, C.L.E.D. |
RADIATION TECHNOLOGY, INC. |
|
K801772 |
08/20/1980 |
MICROBIOLOGY CULTURE MEDIA-MACCONKEY AG |
RADIATION TECHNOLOGY, INC. |
|
K801901 |
08/20/1980 |
MUELLER HINTON AGAR |
RADIATION TECHNOLOGY, INC. |
|
K801847 |
08/13/1980 |
TRIPLE SUGAR IRON AGAR(MICRO/CULT/MEDIA |
RADIATION TECHNOLOGY, INC. |
|
K801493 |
08/13/1980 |
ALA SWAB |
REMEL CO. |
|
K801492 |
08/13/1980 |
PORPHYRIN (ALA) DISK |
REMEL CO. |
|
K801423 |
08/27/1980 |
RTM SYSTEM (REMOTE TEMPERATURE MONITOR) |
REMOTE TECHNOLOGIES, INC. |
|
K801691 |
08/27/1980 |
TSH RIASSAY |
RIA DIAGNOSTICS |
|
K801692 |
08/14/1980 |
RIONET HEARING AID AND/OR RION #HB-70 |
RION ACOUSTIC INSTRUMENTS, INC. |
|
K801238 |
08/12/1980 |
ACCU-PAP T ZONE SAMPLER |
ROBERT HASSELBRACK, M.D. |
|
K801819 |
08/20/1980 |
SURGICAL INSTRUMENTS |
ROBERT I. CHIEN & ASSOC., INC. |
|
K801453 |
08/04/1980 |
FINGER, HAND & WRIST EXERCISER |
ROBERT W. SLACK |
|
K801365 |
08/07/1980 |
KOLD WRAP |
ROMAINE, INC. |
|
K801798 |
08/07/1980 |
COMPOSITE RESTORATIVE, PASTE/PASTE TYPE |
SCIENTIFIC PHARMACEUTICALS, INC. |
|
K801797 |
08/07/1980 |
SCI-PHARM PAINT-ON RESTORATIVE |
SCIENTIFIC PHARMACEUTICALS, INC. |
|
K801618 |
08/13/1980 |
ARGYLE A-V MEDI-WING HEMODIALYSIS SET |
SHERWOOD MEDICAL CO. |
|
K801764 |
08/13/1980 |
IONESCU-SHILEY PERICARDIAL PATCH |
SHILEY, INC. |
|
K801723 |
08/13/1980 |
UR 150-UR 150T |
SIEMENS CORP. |
|
K801794 |
08/13/1980 |
ELASTIC ADHESIVE BANDAGES(STERILE) |
SMITH & NEPHEW, INC. |
|
K801520 |
08/20/1980 |
SOLAR PACIFIC UVA SUNLAMP DEVICE |
SOLAR PACIFIC |
|
K801478 |
08/27/1980 |
SSC8 SORENSON SUBCLAVIAN CATHETER |
SORENSEN RESEARCH |
|
K801639 |
08/27/1980 |
PERMITE DENTAL AMALGAM ALLOY |
SOUTHERN DENTAL INDUSTRIES, INC. |
|
K801518 |
08/04/1980 |
SPAN-AID BRIDGING PILLOW SYSTEM |
SPAN-AMERICA MEDICAL SYSTEMS, INC. |
|
K801597 |
08/04/1980 |
PFT CALIBRATOR |
SPITAL MEDICAL, INC. |
|
K801678 |
08/13/1980 |
SPOR-TEST-STRIP |
STERILIZATION TECHNICAL SERVICES, INC. |
|
K801809 |
08/13/1980 |
ORTHODONTIC BRACKET/SPEED/HANSON SPEED |
STRITE INDUSTRIES LTD. |
|
K801776 |
08/07/1980 |
COLD PACK #589 |
SUNBEAM CORP. |
|
K801542 |
08/20/1980 |
SUNBED/SUNROOF OR SUNCOUCH/SUNSKY |
SUNFIT, INC. |
|
K801833 |
08/27/1980 |
GAS-CHROMATOGRAPHIC PACKING |
SUPELCO, INC. |
|
K801864 |
08/20/1980 |
BARRIER APERTURED DRAPE |
SURGIKOS, INC. |
|
K801863 |
08/20/1980 |
BARRIER TOWEL DRAPE |
SURGIKOS, INC. |
|
K801529 |
08/04/1980 |
KERR CORE COMPOSITE |
SYBRON CORP. |
|
K801499 |
08/13/1980 |
AGA UV PHOTOMETER |
SYVA CO. |
|
K801593 |
08/20/1980 |
LEBODY BY WATER PIK |
TELEDYNE, INC. |
|
K801194 |
08/12/1980 |
CLIRANS TE07 HOLLOW FIBER DIALYZER |
TERUMO AMERICA, INC. |
|
K801192 |
08/12/1980 |
CLIRANS TE10 HOLLOW FIBER DIALYZER |
TERUMO AMERICA, INC. |
|
K801193 |
08/12/1980 |
CLIRANS TE15 HOLLOW FIBER DIALYZER |
TERUMO AMERICA, INC. |
|
K801747 |
08/13/1980 |
TERUMO FETAL MONITOR # FHM-602 |
TERUMO MEDICAL CORP. |
|
K801768 |
08/20/1980 |
CONTAIN X-RAY DETECTABLE LAP SPONGE |
THE BUCKEYE CELLULOSE CORP. |
|
K801781 |
08/13/1980 |
CATHETER IRRIGATION SYRINGES, #3100,3110 |
THE HEALTHCARE GROUP LABORATORIES, INC. |
|
K801783 |
08/13/1980 |
CATHETER IRRIGATION TRAYS, #3300, 3310 & |
THE HEALTHCARE GROUP LABORATORIES, INC. |
|
K801782 |
08/13/1980 |
GENERAL PURPOSE IRRIGATING/ASPIR SYR. |
THE HEALTHCARE GROUP LABORATORIES, INC. |
|
K801784 |
08/13/1980 |
URINARY CATHETERS #3400,3410 &3420 |
THE HEALTHCARE GROUP LABORATORIES, INC. |
|
K801724 |
08/07/1980 |
CURITY PARACERVICAL/PUDENDAL BLOCK ANES |
THE KENDAL CO. |
|
K801628 |
08/07/1980 |
RESTRAINT, PROTECTIVE |
THE OWENBY CO. |
|
K801629 |
08/12/1980 |
COVER-ALL MALE INCONTINENCE DEVICE |
THE UROLOGY GROUP |
|
K801858 |
08/13/1980 |
OXYMETER & TRANSOXODE |
THORACEL |
|
K801589 |
08/04/1980 |
AUTO SUTURE DISP. 30, ETC. & SURG. STAP |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
|
K801590 |
08/04/1980 |
AUTO SUTURE DISPOSABLE GIA SURG. STAPLER |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
|
K801745 |
08/20/1980 |
VISTA 44 GAS CHROMATOGRAPHY ANALYSIS |
VARIAN ASSOC., INC. |
|
K801560 |
08/13/1980 |
VENTREX/SEP TSH TEST SET |
VENTREX LABORATORIES, INC. |
|
K801227 |
08/12/1980 |
SILICAP |
VIVADENT (USA), INC. |
|
K801936 |
08/27/1980 |
PAD, EXAMINING TABLE |
VOLUNTEER BLIND INDUSTRIES, INC. |
|
K801935 |
08/27/1980 |
PAD, HOSPITAL STRETCHER |
VOLUNTEER BLIND INDUSTRIES, INC. |
|
K801852 |
08/20/1980 |
MRM-2 OXYGEN CONSUMPTION MONITOR |
WATERS ASSOC., INC. |
|
K801431 |
08/12/1980 |
PAN-AM MYELOGRAM TRAY |
WATERS ASSOC., INC. |
|
K801861 |
08/27/1980 |
IVAC 260 SERIES VOLUME TRIC INFUSION CON |
Y |
|
K801614 |
08/13/1980 |
MODEL 40-30-2 AIR ELIMINATING FILTER SET |
Y |
|
K801613 |
08/12/1980 |
MODEL 72-81-0 UNVENTED SOLUTION ADM. SET |
Y |
|
K801872 |
08/27/1980 |
MODEL 86-01-1 260 SOLUTION ADMIN. SET |
Y |
|
K801873 |
08/27/1980 |
MODEL 86-21-0 260 SECONDARY MEDICATION |
Y |
|
K801874 |
08/27/1980 |
MODEL 86-21-1 260 APPROX. 60 DROPS/VENTD |
Y |
|
K801871 |
08/27/1980 |
PRIMARY SOLUTION ADMIN. SET-#86-01-0 260 |
Y |
|