FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
K801550 |
07/03/1980 |
3M GERMICIDAL SURGICAL INCISE DRAPE |
3M COMPANY |
|
K801748 |
07/28/1980 |
3M I-125 SEEDS IN ABSORBABLE CARRIER |
3M COMPANY |
|
K801754 |
07/28/1980 |
ADT BONE MARROW ASPIRATION NEEDLE |
A.D.T. LAB INDUSTRIES |
|
K801753 |
07/28/1980 |
ADT BONE MARROW BIOPSY-ASPIR. NEELDE |
A.D.T. LAB INDUSTRIES |
|
K801566 |
07/08/1980 |
CYBREX PHENOBARBITAL |
ABBOTT LABORATORIES |
|
K801565 |
07/08/1980 |
CYBREX PHENYTOIN |
ABBOTT LABORATORIES |
|
K801567 |
07/08/1980 |
CYBREX THEOPHYLLINE |
ABBOTT LABORATORIES |
|
K801676 |
07/22/1980 |
FERRIZYME FERRITIN ENZYME IMMUNOASSAY |
ABBOTT LABORATORIES |
|
K801820 |
07/31/1980 |
FOLEY CATHETERIZATION TRAY |
ABCO DEALERS, INC. |
|
K801594 |
07/14/1980 |
ACE FISCHER EXTERNAL FIXATION DEVICE |
ACE ORTHOPEDIC MANUFACTURING CO. |
|
K801694 |
07/23/1980 |
FLOTATION PAD FOR OPERATING TABLE |
ACTION PRODUCTS, INC. |
|
K801622 |
07/15/1980 |
ADEL MEDICAL BIRTHING BED, MOD. LD-400 |
ADEL MEDICAL LTD. |
|
K801598 |
07/14/1980 |
MARK V DUPLEX ULTRASONIC SCANNING SYSTEM |
ADVANCED TECHNOLOGY LABORATORIES, INC. |
|
K801541 |
07/03/1980 |
WALL MOUNTED LASER POSITIONING DEVICE |
ADVANTAGE MEDICAL SYSTEMS, INC. |
|
K801886 |
07/28/1980 |
BURR, DENTAL |
AESCULAP INSTRUMENTS CORP. |
|
K801887 |
07/28/1980 |
DRILL, DENTAL |
AESCULAP INSTRUMENTS CORP. |
|
K801888 |
07/28/1980 |
HANDPIECE, DENTAL |
AESCULAP INSTRUMENTS CORP. |
|
K801743 |
07/28/1980 |
PLASTAZOTE SHOE |
ALIMED, INC. |
|
K801570 |
07/08/1980 |
SHIELD DISP. PATIENTS PONCHO GOWNS |
AMERICAN CONVERTORS DIV., AMERICAN PHARMASEAL |
|
K801568 |
07/08/1980 |
SHIELD DISPOSABLE BLOOD PRESSURE CUFF |
AMERICAN CONVERTORS DIV., AMERICAN PHARMASEAL |
|
K801569 |
07/08/1980 |
VAL-U-WRAP CSR WRAP |
AMERICAN CONVERTORS DIV., AMERICAN PHARMASEAL |
|
K801766 |
07/28/1980 |
JACKSON-PRATT LARGE VOL. CLOSED WOUND |
AMERICAN HEYER SCHULTE |
|
K801540 |
07/03/1980 |
MCGRAW I.V. ADMINISTRATION SET |
AMERICAN HOSPITAL SUPPLY CORP. |
|
K801638 |
07/17/1980 |
A O CUSTOM II CHAIR AND STAND |
AMERICAN OPTICAL CORP. |
|
K801759 |
07/28/1980 |
EFFRON PAROTID RETRACTOR |
AMERICAN V. MUELLER |
|
K801760 |
07/28/1980 |
FIELD-LEE BRAIN BIOPSY NEEDLE |
AMERICAN V. MUELLER |
|
K801561 |
07/08/1980 |
GLYCOSYLATED HEMOGLOBIN KIT |
AMERSHAM CORP. |
|
K801737 |
07/25/1980 |
STERNUM SAW |
AMSCO CO. |
|
K801806 |
07/30/1980 |
EXTERNAL SILASTIC BOOT FOR CARDIAC PULSE |
ARCO MEDICAL PRODUCTS CO. |
|
K801555 |
07/08/1980 |
COMPACT MODEL 360 GALVANIC EPILATOR |
ASSOCIATED ELECTROLYSIS GROUP |
|
K801675 |
07/22/1980 |
U.I. OCTOSON |
AUSONICS PTY LTD. |
|
K801735 |
07/25/1980 |
ARIA II 125- I-ESTRIOL SYSTEM |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K801701 |
07/24/1980 |
BAUER & BLACK RIGID WRIST BRACE |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K801693 |
07/23/1980 |
SALMONELLA FLAGELLAR A ANTIGEN & B |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K801648 |
07/18/1980 |
TRIMETHROPRIM 5MCG. SENSI DISC. |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K801700 |
07/24/1980 |
UNI-RECORD I |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K801750 |
07/28/1980 |
BECKMAN ASTRA SYSTEMS ALBUMIN CHEMISTRY |
BECKMAN INSTRUMENTS, INC. |
|
K801749 |
07/28/1980 |
BECKMAN ASTRA SYSTEMS TOTAL PROTEIN CHEM |
BECKMAN INSTRUMENTS, INC. |
|
K801632 |
07/15/1980 |
THE BELLCO FISTULA NEEDLES |
BELLCO ARTIFIDIAL ORGAN SPEC., INC. |
|
K801633 |
07/15/1980 |
THE BRAVO NEW PARALLEL FLOW DIALYZER |
BELLCO ARTIFIDIAL ORGAN SPEC., INC. |
|
K801634 |
07/15/1980 |
THE VITA 2 DISPOSABLE DIALYZER |
BELLCO ARTIFIDIAL ORGAN SPEC., INC. |
|
K801640 |
07/17/1980 |
SORIN PULSE GENERATOR, MODEL #LIT-214 |
BENTLEY LABORATORIES, INC. |
|
K801657 |
07/21/1980 |
NON-INVASIVE, BLOOD PRESSURE MONITOR |
BIOCHEM INTERNATIONAL, INC. |
|
K801558 |
07/08/1980 |
ENTERIC FEEDING TUBE W/SEGM. FLEX. WT. |
BIOSEARCH MEDICAL PRODUCTS, INC. |
|
K801697 |
07/23/1980 |
MODEL BP-200 INFANT PRESSURE VENTILATOR |
BOURNS MEDICAL SYSTEMS, INC. |
|
K801536 |
07/03/1980 |
BLOOD GLUCOSE TESTER |
BROOMER RESEARCH CORP. |
|
K801605 |
07/15/1980 |
BIMECO FILTERED EXTENSION SET |
BURRON MEDICAL PRODUCTS, INC. |
|
K801637 |
07/17/1980 |
FLUORO-MARK RADIOPAQUE ANATOMICAL MKR. |
C.R. BARD, INC. |
|
K801573 |
07/09/1980 |
SAPCRILL THERMODETECT BREAST SCANNER DEV |
CALIFORNIA CARDIAC SYSTEMS, INC. |
|
K801647 |
07/18/1980 |
SONACOLOR 6100 |
CAROLINA MEDICAL ELECTRONICS |
|
K801623 |
07/15/1980 |
CAVITRON ULTRASONIC SURG. ASPIR. CUSA |
CAVITRON CORP. |
|
K801790 |
07/29/1980 |
INTELECT |
CHATTANOOGA GROUP, INC. |
|
K801643 |
07/17/1980 |
TRITON |
CHATTANOOGA GROUP, INC. |
|
K801725 |
07/24/1980 |
KANGAROO ENTERAL FEEDING PUMP |
CHESEBROUGH-POND'S U.S.A. CO. |
|
K801521 |
07/01/1980 |
CLASSIC TAN TANNING BOOTH |
CLASSIC TAN, INC. |
|
K801667 |
07/21/1980 |
GAMMA COAT(125 I) RUBELLA ANTIBODY |
CLINICAL ASSAYS, INC. |
|
K801659 |
07/21/1980 |
BIOPHTAL CLINICAL ENDOTHELIAL MICROSCOPE |
COBURN OPTICAL IND., INC. |
|
K801814 |
07/30/1980 |
CATHETER SUCTION TRACHEOBRONCHIAL |
CONCORD LABORATORIES, INC. |
|
K801731 |
07/25/1980 |
C-DAK DUO-FLUX ARTIFICIAL KIDNEY |
CORDIS CORP. |
|
K801599 |
07/14/1980 |
CORNING 184 BLOOD GAS TONOMETER |
CORNING MEDICAL & SCIENTIFIC |
|
K801546 |
07/07/1980 |
THE SIMPLICITY PUMP #2100 INFUSION PUMP |
CRITIKON COMPANY,LLC |
|
K801730 |
07/25/1980 |
KRYMED SYSTEM 4001 TILT SCOPE |
CRYOMEDICS, INC. |
|
K801651 |
07/18/1980 |
CUTTER JET |
CUTTER LABORATORIES, INC. |
|
K801652 |
07/18/1980 |
TOTAL PARENTERAL NUTRITION SET BAG |
CUTTER LABORATORIES, INC. |
|
K801596 |
07/14/1980 |
CYNERGY MODEL 184 |
CYNERGY |
|
K801821 |
07/31/1980 |
FLOW MED 150 |
D.R.O. MEDICAL, INC. |
|
K801727 |
07/24/1980 |
DATA-ZYME UREA NITROGEN, COLORIMETRIC |
DATA MEDICAL ASSOCIATES, INC. |
|
K801601 |
07/14/1980 |
DATASCOPE/AVCO CONNECTOR |
DATASCOPE CORP. |
|
K801770 |
07/28/1980 |
ARTERIAL BUBBLE TRAP |
DELTA MEDICAL INDUSTRIES |
|
K801704 |
07/24/1980 |
OPEN-LOOP INSULIN DELIVERY SYSTEM |
DELTA MEDICAL INDUSTRIES |
|
K801587 |
07/11/1980 |
ASH BLUEPRINT ALGINATE IMPRESSION MATER. |
DENTSPLY INTL. |
|
K801588 |
07/11/1980 |
CAULK PRISMA-LITE |
DENTSPLY INTL. |
|
K801548 |
07/07/1980 |
PERF-LOCK IMPRESSION TRAY |
DENTSPLY INTL. |
|
K801732 |
07/25/1980 |
PRISMA-FIL |
DENTSPLY INTL. |
|
K801650 |
07/18/1980 |
DESERET EMBOLECTOMY/THROMBECTOMY CATH. |
DESERET MEDICAL, INC. |
|
K801746 |
07/28/1980 |
SUTURE REMOVAL PAK |
DEVCO MEDICAL INDUSTRIES, INC. |
|
K801580 |
07/10/1980 |
FERRITIN RIA KIT |
DIAGNOSTIC PRODUCTS CORP. |
|
K801729 |
07/24/1980 |
ANDROSTENEDIONE RADIOIMMUNOASSAY KIT |
DIAGNOSTICS BIOCHEM CANADA, INC. |
|
K801564 |
07/08/1980 |
PHOTOMETER LP 1 |
DR. BRUNO LANGE GMBH |
|
K801563 |
07/08/1980 |
PHOTOMETER LP 3 |
DR. BRUNO LANGE GMBH |
|
K801562 |
07/08/1980 |
PHOTOMETER LP 6 |
DR. BRUNO LANGE GMBH |
|
K801702 |
07/24/1980 |
SUR-FIT SYSTEM PRE-OPERATION SET |
E. R. SQUIBB & SONS, INC. |
|
K801703 |
07/24/1980 |
SUR-FIT SYSTEM STERILE O.R. SETS |
E. R. SQUIBB & SONS, INC. |
|
K801649 |
07/18/1980 |
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES |
EASTMAN KODAK COMPANY |
|
K801610 |
07/15/1980 |
CHILDREN'S HOSPITAL PEDIATRIC RETRACTOR |
EDWARD WECK, INC. |
|
K801611 |
07/15/1980 |
DEEP BALFOUR BLADE FOR WILKINSON RETRACT |
EDWARD WECK, INC. |
|
K801612 |
07/15/1980 |
FRAZIER-FERGUSON SUCTION TUBES (DISP.) |
EDWARD WECK, INC. |
|
K801609 |
07/15/1980 |
MADDOX LENS SPATULA CAT. #7245 |
EDWARD WECK, INC. |
|
K801608 |
07/15/1980 |
MCCULLEY CONTINUOUS SUTURE TIGHTNER |
EDWARD WECK, INC. |
|
K801552 |
07/08/1980 |
MOD. 9542 FLOW-THRU INJECT. TEMP. SENSOR |
EDWARDS LABORATORIES |
|
K801699 |
07/23/1980 |
ETHICON RETRACTION TAPE |
ETHICON, INC. |
|
K801660 |
07/21/1980 |
PROXIMATE * PSD PURSE-STRING DEVICE |
ETHICON, INC. |
|
K801705 |
07/24/1980 |
BK-1424 INNER LIP PLATE, CERAMIC |
FRED SAMMONS, INC. |
|
K801706 |
07/24/1980 |
BK-1426-00-01 STONYBROOK/HI-WALL PLATE |
FRED SAMMONS, INC. |
|
K801707 |
07/24/1980 |
BK-1499 KAY-KPLINT HAND CONE/BK-1500 |
FRED SAMMONS, INC. |
|
K801708 |
07/24/1980 |
BK-1520-01 ECONOMY WRIST SUPPORT, CHILD |
FRED SAMMONS, INC. |
|
K801709 |
07/24/1980 |
BK-5058-01 QUAD-QUIP WHEELCHAIR CUFF |
FRED SAMMONS, INC. |
|
K801710 |
07/24/1980 |
BK-5315-01 FOAM HAND EXERCISER, SMALL |
FRED SAMMONS, INC. |
|
K801711 |
07/24/1980 |
BK-6010 CATHETER TUBE HOLDER |
FRED SAMMONS, INC. |
|
K801713 |
07/24/1980 |
BK-6157-02 C.V.A SLING, MEDIUM&LARGE |
FRED SAMMONS, INC. |
|
K801715 |
07/24/1980 |
BK-7497 BULB DYNAMOMETER |
FRED SAMMONS, INC. |
|
K801716 |
07/24/1980 |
BK-7505 RADIOPAQUE GONIOMETER, 8" |
FRED SAMMONS, INC. |
|
K801717 |
07/24/1980 |
BK-7511 BRASS GONIOMETER |
FRED SAMMONS, INC. |
|
K801718 |
07/24/1980 |
BK-7513 STAINLESS STEEL GONIOMETER |
FRED SAMMONS, INC. |
|
K801719 |
07/24/1980 |
BK-7531 PAIN THRESHOLD/FINGER FORCE GAUG |
FRED SAMMONS, INC. |
|
K801712 |
07/24/1980 |
LUMBOSACRAL SUPPORTS & THORACO-LUMBO-SAC |
FRED SAMMONS, INC. |
|
K801714 |
07/24/1980 |
TRANS DISTAL JOINT FINGER EXTEN. SPLINT |
FRED SAMMONS, INC. |
|
K801805 |
07/29/1980 |
METRONIDAZOLE DISCS |
G.D. SEARLE AND CO. |
|
K801653 |
07/18/1980 |
MAXI CAMERA 37 |
GENERAL ELECTRIC CO. |
|
K801654 |
07/18/1980 |
MAXI CAMERA 61 |
GENERAL ELECTRIC CO. |
|
K801762 |
07/28/1980 |
MICRO-PROCESSOR UNIT #A3600AC |
GENERAL ELECTRIC CO. |
|
K801761 |
07/28/1980 |
PDS COMPUTER UNIT/VIDEO TERMINAL |
GENERAL ELECTRIC CO. |
|
K801796 |
07/29/1980 |
THE COMFORT LIFT |
GETTNER ENTERPRISES, INC. |
|
K801600 |
07/14/1980 |
GLUCOSE (TRINDER) REAGENT |
GILFORD DIAGNOSTICS |
|
K801829 |
07/31/1980 |
MEDI-TRACE DISP. FLUSHING DEV./MONITOR |
GRAPHIC CONTROLS CORP. |
|
K801828 |
07/31/1980 |
MEDI-TRACE DISP. STOPCOCKS/PHYSIO. PRESS |
GRAPHIC CONTROLS CORP. |
|
K801635 |
07/15/1980 |
BIOBRANE BRAND TEMPORARY WOUND-DRESSING |
HALL-WOODROOF, INC. |
|
K801788 |
07/29/1980 |
HUMEROUS FRACTURE BRACE, ULNA FRACTURE |
HOSMER DORRANCE CORP. |
|
K801553 |
07/08/1980 |
THERMOCOMP |
HOSPITAL FINANCIAL CORP. |
|
K801602 |
07/14/1980 |
DESERET I.V. FILTER |
HOSPITAL PRODUCTS CO. |
|
K801511 |
07/01/1980 |
NASO-GARD NASOGASTRIC TUBE HOLDER |
HOWMEDICA CORP. |
|
K801734 |
07/25/1980 |
IMED DROP RATE CALCULATOR #340 |
IMED CORP. |
|
K801666 |
07/21/1980 |
TESTOSTERONE KIT |
IMMUCHEM CORP. |
|
K801621 |
07/15/1980 |
VASCULAR GRAFT PROSTH. OF EXP. MICRO. |
IMPRA, INC. |
|
K801576 |
07/09/1980 |
NEUROGAR III-TRANSCUT. ELEC. NERVE STIM |
INTER MED INDUSTRIES, INC. |
|
K801577 |
07/09/1980 |
NEUROGAR IV-EXTERNAL NEURO-MUSCLE STIM. |
INTER MED INDUSTRIES, INC. |
|
K801642 |
07/17/1980 |
FIAX TEST KIT FOR THEOPHYLLINE QUANT. |
INTL. DIAGNOSTIC TECHNOLOGY |
|
K801728 |
07/24/1980 |
EMBRIA-CK |
INTL. IMMUNOASSAY LABORATORIES, INC. |
|
K801557 |
07/08/1980 |
ROLLS ROLLITE WHEELCHAIR |
INVACARE CORP. |
|
K801771 |
07/28/1980 |
ALPHA-THAL SCREEN 20 TEST KIT & 100 KIT |
ISOLAB, INC. |
|
K801795 |
07/29/1980 |
BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT. |
J.T. BAKER CHEMICAL CO. |
|
K801669 |
07/22/1980 |
J.T. BAKER ALPHA-1-ANTITRYPSIN NEPHELO |
J.T. BAKER CHEMICAL CO. |
|
K801662 |
07/21/1980 |
J.T. BAKER ALPHA-2-MACROGLOBULIN NEPH. |
J.T. BAKER CHEMICAL CO. |
|
K801661 |
07/21/1980 |
J.T. BAKER CERULOPLASMIN NEPHELOMETRIC |
J.T. BAKER CHEMICAL CO. |
|
K801742 |
07/25/1980 |
NEW FINE MODEL ENT TREATMENT UNIT |
JEDMED INSTRUMENT CO. |
|
K801738 |
07/25/1980 |
NOBLE MEDEL ENT TREATMENT UNIT |
JEDMED INSTRUMENT CO. |
|
K801739 |
07/25/1980 |
NOBLE MODEL DOUBLESIDED TREATMENT UNIT |
JEDMED INSTRUMENT CO. |
|
K801741 |
07/25/1980 |
PRETTY MODEL ENT TREATMENT UNIT |
JEDMED INSTRUMENT CO. |
|
K801740 |
07/25/1980 |
TREATMENT UNIT FOR DOCTOR'S ROUNDS |
JEDMED INSTRUMENT CO. |
|
K801824 |
07/31/1980 |
BAND-AID BRAND FLEXIBLE FABRIC BANDAGE |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
|
K801823 |
07/31/1980 |
BAND-AID BRAND TRICOT MESH BANDAGES |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
|
K801690 |
07/23/1980 |
VALIANT |
L.D. CAULK CO. |
|
K801668 |
07/21/1980 |
"QUICK CEPT" |
LABORATORY DIAGNOSTICS CO., INC. |
|
K801592 |
07/11/1980 |
FIBER OPTIC HOSE |
LARES MANUFACTURING CO., INC. |
|
K801591 |
07/11/1980 |
FIBER OPTIC ILLUMINATOR |
LARES MANUFACTURING CO., INC. |
|
K801534 |
07/03/1980 |
LARES AIR PRESSURE GAUGE |
LARES MANUFACTURING CO., INC. |
|
K801535 |
07/03/1980 |
LARES HANDPIECE OIL |
LARES MANUFACTURING CO., INC. |
|
K801624 |
07/15/1980 |
SHARPLAN 723 CO2 LASER SURGICAL SYSTEM |
LASER INDUSTRIES LTD. |
|
K801722 |
07/23/1980 |
CMV BIO-BEAD TITRATION KIT |
LITTON BIONETICS |
|
K801721 |
07/23/1980 |
HSV BIO-BEAD TITRATION KIT |
LITTON BIONETICS |
|
K801720 |
07/23/1980 |
TOXO BIO-BEAD TITRATION KIT |
LITTON BIONETICS |
|
K801575 |
07/08/1980 |
L-CATH INTRAVENOUS PLACEMENT UNIT |
LUTHER MEDICAL PRODUCTS, INC. |
|
K801726 |
07/24/1980 |
HDL CHOLESTEROL TEST KIT |
MALLINCKRODT CRITICAL CARE |
|
K801620 |
07/15/1980 |
ASPIRATOR |
MARQUEST MEDICAL PRODUCTS, INC. |
|
K801549 |
07/07/1980 |
MODEL R11 SINGLE CHANNEL CHART RECORDER |
MEDASONICS, INC. |
|
K801554 |
07/08/1980 |
STERILE CAST PADDING |
MEDI-SPEC |
|
K801672 |
07/22/1980 |
MEDCOMP SUBCLAVIAN CATHETER |
MEDICAL COMPONENTS, INC. |
|
K801811 |
07/08/1980 |
PALPATION ENHANCER |
MEDICAL HORIZONS CO. |
|
K801758 |
07/28/1980 |
MMI/GAELTEC CATHETER INTRAUTERINE |
MEDICAL MEASUREMENTS, INC. |
|
K801757 |
07/28/1980 |
MMI/GAELTEC CATHETER TIP PRESS. TRANSDU |
MEDICAL MEASUREMENTS, INC. |
|
K801755 |
07/28/1980 |
MMI/GAELTEC CATHETER TIP PRESSURE |
MEDICAL MEASUREMENTS, INC. |
|
K801756 |
07/28/1980 |
MMI/GAELTEC CATHETER TIP TRANSDUC |
MEDICAL MEASUREMENTS, INC. |
|
K801799 |
07/29/1980 |
ATRIAL/VENTRICULAR SEQENTIAL #080-20000 |
MEDICAL TESTING SYSTEM, INC. |
|
K801802 |
07/29/1980 |
ELECTROMAGNETIC BLOOD & ARTERIAL GAUGE |
MEDICAL TESTING SYSTEM, INC. |
|
K801800 |
07/29/1980 |
UNIVERSAL TEMP. PACING ELECT. #080-10000 |
MEDICAL TESTING SYSTEM, INC. |
|
K801572 |
07/09/1980 |
SURG-ASSIST |
MEDMETRIC CORP. |
|
K801584 |
07/11/1980 |
MULTI-PROGRAMMABLE PACEMAKER & PROGRMR. |
MEDTRONIC VASCULAR |
|
K801547 |
07/07/1980 |
TEST PANEL FOR PRESUMP. ID/BACT. ORG |
MICRO-MEDIA SYSTEMS, INC. |
|
K801736 |
07/25/1980 |
AMES TDA TM PHENYTOIN TEST |
MILES LABORATORIES, INC. |
|
K801665 |
07/21/1980 |
SERALYZER GLUCOSE CALIBRATORS(LOW&HIGH) |
MILES LABORATORIES, INC. |
|
K801663 |
07/21/1980 |
SERALYZER GLUCOSE REAGENT STRIPS |
MILES LABORATORIES, INC. |
|
K801664 |
07/21/1980 |
SERALYZER GLUCOSE TEST MODULE |
MILES LABORATORIES, INC. |
|
K801619 |
07/15/1980 |
MIST2GEN TEMPTROL 10 |
MISTOGEN EQUIPMENT CO. |
|
K801544 |
07/07/1980 |
PORTA-FIB LPD |
NARCO BIO-SYSTEMS |
|
K801607 |
07/15/1980 |
MOM 2 |
NEOTRONICS, INC. |
|
K801671 |
07/22/1980 |
ESG-1 (EVOKED RESPONSE STIMULUS GENER) |
NEURO DIAGNOSTICS, INC. |
|
K801670 |
07/22/1980 |
NDI-IKE EMG |
NEURO DIAGNOSTICS, INC. |
|
K801604 |
07/14/1980 |
PATHFINDER ELECTRODIAGNOSTIC SYSTEM |
NICOLET BIOMEDICAL INSTRUMENTS |
|
K801677 |
07/22/1980 |
ELECTROCARDIOGRAPH, MODEL ECG-5503 |
NIHON KOHDEN AMERICA, INC. |
|
K801641 |
07/17/1980 |
OHIO DISPOSABLE CLEAR SUCTION INSTRUMENT |
OHIO MEDICAL PRODUCTS |
|
K801804 |
07/29/1980 |
ANESTHESIA BACTERIA FILTER |
OMNICON MEDICAL CORP. |
|
K801803 |
07/29/1980 |
MAINFLOW BACTERIA FILTER |
OMNICON MEDICAL CORP. |
|
K801606 |
07/15/1980 |
RETREAT |
OMNITRONICS RESEARCH CORP. |
|
K801545 |
07/07/1980 |
ORTHO AUTOMATED CELL COUNTER |
ORTHO INSTRUMENTS |
|
K801780 |
07/28/1980 |
OXY CUSTOM TRAY RESIN |
OXY DENTAL PRODUCTS, INC. |
|
K801779 |
07/28/1980 |
OXYDENTAL ZINC OXIDE EUGENOL(ZOE)CEMENT |
OXY DENTAL PRODUCTS, INC. |
|
K801763 |
07/28/1980 |
VIVALITH 5, - MDL-201A & TDL-201A |
PACESETTER SYSTEMS |
|
K801684 |
07/21/1980 |
ASTRON AIR POWERED HIGH SPEED DE PIECE |
PACIFIC DENTAL CORP. |
|
K801683 |
07/21/1980 |
LUNA-VUE DENTAL OPERATING LIGHT |
PACIFIC DENTAL CORP. |
|
K801685 |
07/21/1980 |
SPACELINE DENTAL CHAIR-UNIT |
PACIFIC DENTAL CORP. |
|
K801682 |
07/21/1980 |
SPACELINE HIGH VOLUME EVACUATION HANDPIE |
PACIFIC DENTAL CORP. |
|
K801686 |
07/21/1980 |
SPACELINE THREE WAY SYRINGE |
PACIFIC DENTAL CORP. |
|
K801688 |
07/21/1980 |
TORX HANDPIECE CONTRA ANGLES ATTACHMENTS |
PACIFIC DENTAL CORP. |
|
K801687 |
07/21/1980 |
TORX MICRO-MOTOR LOW SPEED HANDPIECE |
PACIFIC DENTAL CORP. |
|
K801537 |
07/03/1980 |
START IT WITH & WITHOUT I.V. CATH. UNIT |
PIONEER VIGGO, INC. |
|
K801516 |
07/01/1980 |
PRE-DENT SYSTEM MODIFIED |
PRE-DENT SYSTEM |
|
K801585 |
07/11/1980 |
HESSBURG-BFRRON TREPHINE |
PRECISION INSTRUMENTS, INC. |
|
K801617 |
07/15/1980 |
CONDUCTIVE SHOE COVERS |
PROCTER & GAMBLE MFG. CO. |
|
K801616 |
07/15/1980 |
NON-CONDUCTIVE SHOE COVERS |
PROCTER & GAMBLE MFG. CO. |
|
K801679 |
07/22/1980 |
BETA-CAP II |
QUINTON, INC. |
|
K801680 |
07/22/1980 |
BETA-CAP II ADAPTER |
QUINTON, INC. |
|
K801817 |
07/31/1980 |
MICROBIOLOGY CULTURE MEDIA, C.L.E.D. |
RADIATION TECHNOLOGY, INC. |
|
K801772 |
07/28/1980 |
MICROBIOLOGY CULTURE MEDIA-MACCONKEY AG |
RADIATION TECHNOLOGY, INC. |
|
K801752 |
07/28/1980 |
RAMI TAN ULTRAVIOLET B BOOTH |
RAMI-TAN |
|
K801751 |
07/28/1980 |
RAMI ULTRAVIOLET A BOOTH |
RAMI-TAN |
|
K801765 |
07/28/1980 |
GLUCOSE REAGENT(UV-HEXOKINASE) |
REAGENTS APPLICATIONS, INC. |
|
K801559 |
07/08/1980 |
HOLLO FIBER DIALYZER |
RENAL DEVICES, INC. |
|
K801827 |
07/31/1980 |
RENAFLO HOLLOW FIBER DIALYZER #100.1 |
RENAL SYSTEMS, INC. |
|
K801826 |
07/31/1980 |
RENAFLO HOLLOW FIBER DIALYZERS #MP 140 |
RENAL SYSTEMS, INC. |
|
K801825 |
07/31/1980 |
RENAFLO HOLLOW FIBER DIALYZERS S.M.A.D. |
RENAL SYSTEMS, INC. |
|
K801691 |
07/23/1980 |
TSH RIASSAY |
RIA DIAGNOSTICS |
|
K801578 |
07/09/1980 |
COMBOSTAT - NO-BOIL KIT |
RIA PRODUCTS, INC. |
|
K801579 |
07/09/1980 |
VITAMIN B12 - NO-BOIL KIT |
RIA PRODUCTS, INC. |
|
K801692 |
07/23/1980 |
RIONET HEARING AID AND/OR RION #HB-70 |
RION ACOUSTIC INSTRUMENTS, INC. |
|
K801556 |
07/08/1980 |
RIONET HEARING AID HB-66 |
RION ACOUSTIC INSTRUMENTS, INC. |
|
K801958 |
07/23/1980 |
RIONET HEARING AID HB-70H |
RION ACOUSTIC INSTRUMENTS, INC. |
|
K801733 |
07/25/1980 |
FENZL RETICLE |
ROBERT E. FENZL, M.D. |
|
K801819 |
07/31/1980 |
SURGICAL INSTRUMENTS |
ROBERT I. CHIEN & ASSOC., INC. |
|
K801775 |
07/28/1980 |
SERO STREP KIT |
SACKS FARMS BIOLOGICAL PRODUCTS |
|
K801798 |
07/29/1980 |
COMPOSITE RESTORATIVE, PASTE/PASTE TYPE |
SCIENTIFIC PHARMACEUTICALS, INC. |
|
K801797 |
07/29/1980 |
SCI-PHARM PAINT-ON RESTORATIVE |
SCIENTIFIC PHARMACEUTICALS, INC. |
|
K801618 |
07/15/1980 |
ARGYLE A-V MEDI-WING HEMODIALYSIS SET |
SHERWOOD MEDICAL CO. |
|
K801522 |
07/01/1980 |
ARGYLE RIGID URINE MEASURING/COLL. DEV. |
SHERWOOD MEDICAL CO. |
|
K801551 |
07/08/1980 |
ARGYLE SAF-T-MARK SUCTION CATHETER |
SHERWOOD MEDICAL CO. |
|
K801764 |
07/28/1980 |
IONESCU-SHILEY PERICARDIAL PATCH |
SHILEY, INC. |
|
K801723 |
07/24/1980 |
UR 150-UR 150T |
SIEMENS CORP. |
|
K801810 |
07/30/1980 |
PACEMAKER PATIENT MGMT. SYSTEM |
SIEMENS ELEMA AB |
|
K801818 |
07/31/1980 |
TENCKHOFF CATHETER |
SIL-MED CORP. |
|
K801689 |
07/23/1980 |
SONATRON ULTRASONIC DENTAL SCANNER |
SIMPLIFIED SYSTEMS, INC. |
|
K801794 |
07/29/1980 |
ELASTIC ADHESIVE BANDAGES(STERILE) |
SMITH & NEPHEW, INC. |
|
K801767 |
07/28/1980 |
DIMENSION I REFRACTION SYSTEM |
SMR |
|
K801520 |
07/01/1980 |
SOLAR PACIFIC UVA SUNLAMP DEVICE |
SOLAR PACIFIC |
|
K801639 |
07/17/1980 |
PERMITE DENTAL AMALGAM ALLOY |
SOUTHERN DENTAL INDUSTRIES, INC. |
|
K801518 |
07/01/1980 |
SPAN-AID BRIDGING PILLOW SYSTEM |
SPAN-AMERICA MEDICAL SYSTEMS, INC. |
|
K801523 |
07/01/1980 |
MODEL 379 WXYGEN CONCENTRATOR |
STANLEY AVIATION CORP. |
|
K801678 |
07/22/1980 |
SPOR-TEST-STRIP |
STERILIZATION TECHNICAL SERVICES, INC. |
|
K801809 |
07/30/1980 |
ORTHODONTIC BRACKET/SPEED/HANSON SPEED |
STRITE INDUSTRIES LTD. |
|
K801822 |
07/31/1980 |
NU-VISION DISP. OPHTHALMIC DRESSING TRAY |
SUMMIT OPTICS, INC. |
|
K801674 |
07/22/1980 |
SUN ROOM TANNING BOOTH |
SUN TAN ENTERPRISES, INC. |
|
K801543 |
07/07/1980 |
SUN VALLEY TANS |
SUN VALLEY TANS, INC. |
|
K801776 |
07/28/1980 |
COLD PACK #589 |
SUNBEAM CORP. |
|
K801542 |
07/07/1980 |
SUNBED/SUNROOF OR SUNCOUCH/SUNSKY |
SUNFIT, INC. |
|
K801530 |
07/02/1980 |
COREFORM MOLDS |
SYBRON CORP. |
|
K801529 |
07/02/1980 |
KERR CORE COMPOSITE |
SYBRON CORP. |
|
K801792 |
07/29/1980 |
IMPLANTABLE ENDOCARDIAL POROUS TIP ELEC. |
TELECTRONICS, INC. |
|
K801593 |
07/14/1980 |
LEBODY BY WATER PIK |
TELEDYNE, INC. |
|
K801791 |
07/29/1980 |
FERTILITY AWARENESS METHOD KIT |
TELESIS CORP. |
|
K801747 |
07/28/1980 |
TERUMO FETAL MONITOR # FHM-602 |
TERUMO MEDICAL CORP. |
|
K801768 |
07/28/1980 |
CONTAIN X-RAY DETECTABLE LAP SPONGE |
THE BUCKEYE CELLULOSE CORP. |
|
K801526 |
07/02/1980 |
SURVEYOR I, RESPIRATORY COMPUTER SYSTEM |
THE DEVILBISS CO. |
|
K801781 |
07/28/1980 |
CATHETER IRRIGATION SYRINGES, #3100,3110 |
THE HEALTHCARE GROUP LABORATORIES, INC. |
|
K801783 |
07/28/1980 |
CATHETER IRRIGATION TRAYS, #3300, 3310 & |
THE HEALTHCARE GROUP LABORATORIES, INC. |
|
K801782 |
07/28/1980 |
GENERAL PURPOSE IRRIGATING/ASPIR SYR. |
THE HEALTHCARE GROUP LABORATORIES, INC. |
|
K801785 |
07/28/1980 |
URETHRAL CATHETERIZATION TRAYS |
THE HEALTHCARE GROUP LABORATORIES, INC. |
|
K801787 |
07/28/1980 |
URINARY CATHETER CARE TRAYS #3700&3710 |
THE HEALTHCARE GROUP LABORATORIES, INC. |
|
K801784 |
07/28/1980 |
URINARY CATHETERS #3400,3410 &3420 |
THE HEALTHCARE GROUP LABORATORIES, INC. |
|
K801786 |
07/28/1980 |
URINE COLLECTION CONTAINERS, #3600 &3610 |
THE HEALTHCARE GROUP LABORATORIES, INC. |
|
K801724 |
07/24/1980 |
CURITY PARACERVICAL/PUDENDAL BLOCK ANES |
THE KENDAL CO. |
|
K801531 |
07/01/1980 |
ARM SLING |
THE OWENBY CO. |
|
K801626 |
07/15/1980 |
ARM SLING |
THE OWENBY CO. |
|
K801627 |
07/15/1980 |
COVER, LIMB |
THE OWENBY CO. |
|
K801628 |
07/15/1980 |
RESTRAINT, PROTECTIVE |
THE OWENBY CO. |
|
K801532 |
07/01/1980 |
STOCKINETTE, STERILE TWO PLY W/PULL TABS |
THE OWENBY CO. |
|
K801629 |
07/15/1980 |
COVER-ALL MALE INCONTINENCE DEVICE |
THE UROLOGY GROUP |
|
K801625 |
07/15/1980 |
THERMOLATOR HEATING UNIT |
TRU-EZE MFG. CO., INC. |
|
K801815 |
07/30/1980 |
AUTOLET |
ULSTER SCIENTIFIC, INC. |
|
K801655 |
07/21/1980 |
AUTO SECTOR SCANNER |
UNIRAD CORP. |
|
K801656 |
07/21/1980 |
EDP 1200 SECTOR SCANNER OPTION |
UNIRAD CORP. |
|
K801589 |
07/11/1980 |
AUTO SUTURE DISP. 30, ETC. & SURG. STAP |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
|
K801590 |
07/11/1980 |
AUTO SUTURE DISPOSABLE GIA SURG. STAPLER |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
|
K801808 |
07/30/1980 |
BR 2002 X-RAY GENERATOR SYSTEM |
VALMET INDUS. MACH. & PROD., INC. |
|
K801745 |
07/28/1980 |
VISTA 44 GAS CHROMATOGRAPHY ANALYSIS |
VARIAN ASSOC., INC. |
|
K801560 |
07/08/1980 |
VENTREX/SEP TSH TEST SET |
VENTREX LABORATORIES, INC. |
|
K801538 |
07/03/1980 |
ASSURE LEVEL I PROD. #30171 |
WARNER-LAMBERT CO. |
|
K801539 |
07/03/1980 |
ASSURE LEVEL II PROD. #30172 |
WARNER-LAMBERT CO. |
|
K801517 |
07/01/1980 |
BED ROCKING DEVICE |
WESLER |
|
K801614 |
07/15/1980 |
MODEL 40-30-2 AIR ELIMINATING FILTER SET |
Y |
|
K801613 |
07/15/1980 |
MODEL 72-81-0 UNVENTED SOLUTION ADM. SET |
Y |
|
K801525 |
07/01/1980 |
ZEST ENDODONTIC STABILIZER |
ZEST ANCHORS, INC. |
|
K801524 |
07/01/1980 |
ZEST PLANT |
ZEST ANCHORS, INC. |
|
K801574 |
07/09/1980 |
DEPALMA ELBOW |
ZIMMER, INC. |
|
K801603 |
07/14/1980 |
POLYETHYLENE FILLED BONE PLATE |
ZIMMER, INC. |
|