FDA 510(k) Decisions During March, 1983  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K830360 03/01/1983 3M OSTEOTOMY GUIDE 3M COMPANY
K823569 03/01/1983 ABBOTT LABORATORIES STREP A EIA ABBOTT LABORATORIES
K830766 03/29/1983 ABBOTT PATIENT ASSIST DEVICE ABBOTT LABORATORIES
K830002 03/11/1983 CAPD COLOR-GUARD SYSTEM PREPKIT ABBOTT LABORATORIES
K823135 03/07/1983 DOUBLE LUMEN SUBCLAVIAN CATHETER ABBOTT LABORATORIES
K830398 03/10/1983 TDX METHOTREXATE ABBOTT LABORATORIES
K830765 03/31/1983 WINGED CATHETER ABBOTT LABORATORIES
K830444 03/09/1983 STERILE, ALL PURPOSE URETHRAL CATHETER ABCO DEALERS, INC.
K830378 03/24/1983 STERILE, DISPOSABLE, HYPODERMIC NEEDLES ABCO DEALERS, INC.
K830542 03/17/1983 HEMAQUIK II STAINING SOLUTION #55961 ACCRA LABORATORIES, INC.
K830089 03/08/1983 BURN DRESSING ACTION MEDICAL SYSTEMS, INC.
K830183 03/17/1983 ASAHI HOLLOW FIBER KIDNEYS NR SERIES ADVOCACY INTERNATIONAL, LTD.
K830231 03/17/1983 ASAHI HOLLOW FIBER KIDNEYS, AM-SERIES ADVOCACY INTERNATIONAL, LTD.
K830446 03/24/1983 OXYGEN MONITOR OHIO 5100 AIRCO/OHIO MEDICAL PRODUCTS
K830327 03/24/1983 DOSIMETRIC RELEASE OF RADIATION DEV AMERICAN BENTLEY
K830167 03/11/1983 HOLDER FOR BOS-2S INFANT BUBBLE OXYGENA- AMERICAN BENTLEY
K830645 03/17/1983 BLEEDING TIME DEVICE DISPOSABLE AMERICAN DADE
K830318 03/07/1983 PARAMAX ANALYTICAL SYS AMERICAN DADE
K837029 03/22/1983 ECHOSINE 1000, PULSED A-MODE ULTRASOUND DEVICE AMERICAN ELECTROMEDICS CORP.
K830343 03/17/1983 CONTAINER W/PRIMING SOLUTION AMERICAN HOSPITAL SUPPLY CORP.
K823827 03/17/1983 AMP 80/2 OUTFLOW MONITOR MODIFICATION AMERICAN MEDICAL PRODUCTS, INC.
K830447 03/24/1983 KINETIC CREATININE AMERICAN MONITOR CORP.
K830345 03/10/1983 SCOOTER, VEHICLE MOTORIZED AMIGO SALES, INC.
K823136 03/31/1983 ORAL SPONGE AMISPLINT
K830555 03/24/1983 AMRESCO UREA NITROGEN REAGENT SET AMRESCO, INC.
K830536 03/24/1983 FLOW-PAC ALBUMIN REAGENT AMRESCO, INC.
K830535 03/24/1983 FLOW-PAC ALKALINE PHOSPHATE REAGENT SET AMRESCO, INC.
K830537 03/24/1983 FLOW-PAC CREATININE REAGENT SET AMRESCO, INC.
K830538 03/24/1983 FLOW-PAC TOTAL PROTEIN REAGENT SET AMRESCO, INC.
K830029 03/31/1983 SIRECUST 400 ANALOGIC CORP.
K830211 03/24/1983 API TB-IDENT* ANALYTICAL PRODUCTS, INC.
K830253 03/31/1983 END TIDAL CO2 ANALYZER #411 ANDROS INCORPORATED
K830691 03/31/1983 PRIME ANSELL, INC.
K823880 03/09/1983 BACTIGEN-N. MENINGITIDIS ARMKEL, LLC.
K830056 03/09/1983 ARTEC TWIST VALVE ARTEC ENVIRONMENTAL MONITORING DIVISION
K823839 03/29/1983 AMPCO KIDNEY DIALYSIS TRAY ASSOCIATED MEDICAL PRODUCTS CO.
K837111 03/09/1983 X RAY TUBE HOUSING/INSERT ATLANTIC IMAGING CORP.
K837152 03/22/1983 THERAC 25 LINEAR ACCELERATOR ATOMIC ENERGY OF CANADA
K830418 03/10/1983 TACTAID AUDIOLOGICAL ENGINEERING CORP.
K837171 03/17/1983 ULTRASONIC ECHOSCOPE AUSONICS PTY LTD.
K830363 03/24/1983 BACTEC 170 TRYPTIC SOY BROTH W/RESINS BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K830695 03/29/1983 BETA-COTE B-HCG PREGNANCY SCREENING SYS BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K823829 03/11/1983 FERRITIN IMMUNORADIOMETRIC ASSAY KIT BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K822721 03/10/1983 NO-BOIL SOLID PHASE SIMUL TRAC B12 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K823884 03/07/1983 PARAGON IMMUNOELECTROPHORESIS REAGENT BECKMAN INSTRUMENTS, INC.
K823879 03/09/1983 COVER-ROLL STRETCH BEIERSDORF, INC.
K830443 03/10/1983 LATERAL POSITIONING ATTACHMENT BERIVON CO.
K830325 03/01/1983 TIGER PULSE BERTONE & ASSOC.
K830285 03/09/1983 REGNELL HYDRAULIC FEMORAL PROTHESIS BESCO FINANCIAL SERVICE
K830605 03/31/1983 PUMP PALL AMBULATORY INSULIN INFUSION BIO MEDICAL DEVICES, INC.
K837110 03/11/1983 MODEL 4100 MICROSURGICAL CO2 LASER SYSTEM BIO QUANTUM TECHNOLOGIES, INC.
K830369 03/08/1983 POWER FLEX BIODYNAMIC TECHNOLOGIES OF FLORIDA
K823059 03/17/1983 DOSIMETRY RELEASE OF RADIATION STERIL. BIOMET, INC.
K830227 03/10/1983 AUTOMATED ELISA READER LBI 300 BIONETIC LABORATORY PRODUCTS
K830405 03/10/1983 LBI-100 37DEGREES INCUBATOR BIONETIC LABORATORY PRODUCTS
K830356 03/09/1983 TITANIUM M.E. MULLER TYPE TOTAL HIP BOEHRINGER MANNHEIM CORP.
K830414 03/24/1983 TITANALOY SUBMERSIBLE IMPLANT SYSTEM BOEHRINGER/MITER, INC.
K830792 03/29/1983 PULSETTE 110 TRANSCUTANEOUS ELEC-NERVE BOMED MEDICAL MFR., LTD.
K837151 03/22/1983 BLUE GREEN FILTER SYSTEM TO MODEL 152 AND 150 LASER SYSTEM BRITT CORP., INC.
K830221 03/17/1983 BEDSIDE N.P.T. 9900 - PRINTER 9800 BROWNE MEDICAL, INC.
K830316 03/24/1983 UNIFLEX BUCKMAN CONSULTANTS
K830571 03/24/1983 BOTTLE ADAPTER BURRON MEDICAL PRODUCTS, INC.
K830193 03/09/1983 CAT 3040 BURRON MEDICAL PRODUCTS, INC.
K830572 03/17/1983 CLEAN-FLUSH BURRON MEDICAL PRODUCTS, INC.
K830386 03/29/1983 DAVOL SURGICAL SUCTION IRRIGATION INSTR C.R. BARD, INC.
K830545 03/29/1983 DISPERSIVE ELECTRODE C.R. BARD, INC.
K830671 03/29/1983 THORAX-KLEX CHEST DRAINAGE UNIT C.R. BARD, INC.
K830608 03/24/1983 USCI GRUNTZIG DILACA BALLOON DILATION C.R. BARD, INC.
K823357 03/11/1983 VARIOUS CARDIOVASCULAR PRODUCTS C.R. BARD, INC.
K830214 03/09/1983 AFT SYSTEM III CALBIOCHEM-BEHRING CORP.
K830223 03/07/1983 FECAL OCCULT SLIDE TEST KIT CAMBRIDGE CHEMICAL PRODUCTS, INC.
K830382 03/17/1983 COMMAND ULTRA II CARDIAC PACEMAKERS, INC.
K823466 03/07/1983 AUTO-TENS MODEL III DUAL CHANNEL REPLACE CBC CORP.
K823057 03/31/1983 MEDICATED ADHESIVE STRIP CEDERROTH, INC. USA
K830330 03/17/1983 SAVETT ALCOHOL PREP CEDERROTH, INC. USA
K830633 03/10/1983 LIC TILT BED CENTURY MANUFACTURING CO.
K823852 03/17/1983 CHESEBROUGH-POND'S MULTILAYER ELASTIC CHESEBROUGH-POND'S U.S.A. CO.
K830357 03/17/1983 RADIOIMMUNOASSAY IMMUNOGLOBULINS D.E CLINETICS CORP.
K823077 03/09/1983 URINARY BLADDER TEMP. SENSOR #81-003 CLINICAL TECHNOLOGY CORP.
K830476 03/31/1983 OR PREP KIT CLINIPAD CORP.
K837125 03/04/1983 SYSTEM 900 TWO ROOM REMOTE FIBERS COHERENT RADIATION LABORATORIES
K830499 03/17/1983 ESA ELECTROSURGICAL ARTHROSCOPY GENERA CONCEPT, INC.
K823424 03/17/1983 MENISCECTOMY TRAY #9715 CONCEPT, INC.
K828328 03/03/1983 ULTRASCAN DIGITAL A/SYSTEM III COOPER LASERSONICS, INC.
K830729 03/29/1983 C-DAK ARTIFICIAL KIDNEY CORDIS CORP.
K830296 03/25/1983 CORNING 102 PRINTER CORNING MEDICAL & SCIENTIFIC
K830591 03/24/1983 CORNING FERRITIN 125I RADIOIMMUNOASSAY CORNING MEDICAL & SCIENTIFIC
K823527 03/31/1983 SUBCLAVIAN INSERTION KIT CUNNINGHAM WOODLAND, INC.
K830333 03/31/1983 ABG KITS - CMS 4000 SERIES CURRIE MEDICAL SPECIALTIES, INC.
K830464 03/16/1983 PACEMAKER ELECTRODE PERM. & TEMP DAIG CORP.
K830350 03/09/1983 CERVICAL PILLOW DEIP ENTERPRISES, INC.
K830351 03/09/1983 DISPOSABLE EXTRICATION COLLAR DEIP ENTERPRISES, INC.
K830349 03/09/1983 SAC-RO-FORM INSERT & BINDER DEIP ENTERPRISES, INC.
K830348 03/09/1983 VINYL EXTRICATION COLLAR DEIP ENTERPRISES, INC.
K830450 03/01/1983 DELMED IV CONTAINER DELMED, INC.
K830689 03/29/1983 EMPTY DIALYSATE CONTAINER BB-69 DELMED, INC.
K830442 03/17/1983 PRISMA-FINE DENTSPLY INTL.
K823843 03/29/1983 FREEMAN ACETABULAR CUP DEPUY, INC.
K823905 03/24/1983 SURGICAL BLADES DESIGNS IN MEDICINE
K830248 03/08/1983 DEVO'N LOOPS DEVON INDUSTRIES, INC.
K830381 03/24/1983 STERILE SAFETY PINS DEVON INDUSTRIES, INC.
K830407 03/24/1983 ECLIPSE DIAGNOSTIC MEDICAL INSTRUMENTS
K830355 03/01/1983 SECURA IV VOLUMETRIC INFUSION PUMP DIATEK, INC.
K830377 03/01/1983 SECURA SET PRIMARY ADMIN. SET DIATEK, INC.
K830565 03/09/1983 SECURA SET SECONDARY ADMIN. SET DIATEK, INC.
K830143 03/09/1983 PNEUMATIC ANTERIOR CHAMBER MAINTAINER DIVERSATRONICS, INC.
K830437 03/17/1983 CHS DMS LABORATORIES
K830496 03/09/1983 DMV ANGLER DMV CONTACT LENS CO.
K830469 03/24/1983 BILIRUBIN STANDARD-LYOPHILIZED DOW INSTRUMENTS & REAGENTS, INC.
K837100 03/24/1983 DIGITIZING COLORIZING APPLE COMPUTER SYSTEM FOR RE-VIEW OF NORMAL ROENTGEN FILM DR. JOHN D. REID B.A., D.C.
K830395 03/11/1983 PEEPER DUPACO, INC.
K823787 03/09/1983 HANDI-WASH DYNATECH CORP.
K823833 03/08/1983 MICRO STIX #011-010-5000 & HOLDER#5100 DYNATECH CORP.
K822873 03/24/1983 DEVETHERM EKO SCANN AB
K830457 03/17/1983 PACING LEAD #PMA F 860 ELA MEDICAL, INC.
K830401 03/17/1983 UNILITH PULSE GENERATOR VVI #7542 ELA MEDICAL, INC.
K837106 03/22/1983 ELDER PSORALITE SERIES 2000 UVA IRRADIATION SYSTEM ELDER PHARMACEUTICALS, INC.
K837105 03/07/1983 ELDER PSORALITE, SERIES 43000 ELDER PHARMACEUTICALS, INC.
K837108 03/22/1983 ULTRAVIOLET ELDER PSORALITE SERIES 3000 UVA ELDER PHARMACEUTICALS, INC.
K837109 03/22/1983 UNKNOWN ELDER PHARMACEUTICALS, INC.
K830303 03/07/1983 800 BLUE ELECTONE, INC.
K837175 03/17/1983 ARMEX LS-51 ELSCINT, INC.
K837177 03/17/1983 CONTROLLEX LS-5 ELSCINT, INC.
K837176 03/17/1983 EXOR LS-24 ELSCINT, INC.
K837183 03/17/1983 HI-LO RADIOLOGICAL STRETCHER ELSCINT, INC.
K837178 03/22/1983 STANDEX SYSTEM ELSCINT, INC.
K837179 03/17/1983 TAURUS LS THREE-PHASE GENERATORS ELSCINT, INC.
K837182 03/17/1983 TOMAX LS-20 ELSCINT, INC.
K837180 03/17/1983 TREPHIX THREE PHSE GENERATORS AND EXONON SINGLE PHASE GENERATORS ELSCINT, INC.
K830139 03/09/1983 ENDECO ACOUSTIC OTOSCOPE ENDECO MEDICAL, INC.
K823754 03/24/1983 SAHOTA-KAPLAN HEMOSTAT ERICKSON INDUSTRIES, INC.
K830503 03/08/1983 LIGACLIP TITANIUM LIGATING CLIP ETHICON, INC.
K837139 03/04/1983 MODELS EUROSUN 2400 AND 800 EUROSUN SCAENDA SOL
K830256 03/01/1983 NON-STERILE BROVIAC PARENTERAL ALIMI- EVERMED, INC.
K830406 03/01/1983 NON-STERILE CATHETER REPAIR KITS EVERMED, INC.
K830612 03/29/1983 CHEMO-TABLE FABRICATIONS UNLTD.
K830578 03/24/1983 MICROHEMATOCRIT READER FISHER SCIENTIFIC CO., LLC.
K830509 03/29/1983 EMERGENCY TRACHEOSTOMY & CRICOTHYROIDO- FREDERIC J. TOYE, M.D.
K830696 03/31/1983 VENES ANTI EMBOLISM STOCKINGS FUTURO DIV. JUNG CORP.
K830559 03/09/1983 HEALTHCARE MODEL #175/176 BED SERIES G.W. HEALTHCARE, INC.
K823848 03/08/1983 CRAFTON ARTHROSCOPY PUMP AP-10 GAMBRO, INC.
K830284 03/02/1983 FH 101, FH 202 & FH 303 FIBER HEMOFILTER GAMBRO, INC.
K822735 03/09/1983 SURE-COUNT DISPOSABLE NEEDLE COUNTER GENEVA LABORATORIES, INC.
K830383 03/08/1983 FILDES ENRICHMENT SOLUTON GIBCO LABORATORIES LIFE TECHNOLOGIES, INC.
K830384 03/07/1983 LEGIONELLA SELECTIVE SUPPLEMENTS GIBCO LABORATORIES LIFE TECHNOLOGIES, INC.
K823859 03/08/1983 MIDDLEBROOK 7H10 AGAR BASE-LOWPH GIBCO LABORATORIES LIFE TECHNOLOGIES, INC.
K823885 03/08/1983 SELECTIVE LEGIONELLA MEDIA GIBCO LABORATORIES LIFE TECHNOLOGIES, INC.
K830523 03/16/1983 CATHETER CONNECTION W/INTEGRAL INJECTATE GOULD, INC.
K830252 03/07/1983 DIPCHEX DIP-SLIDE CULTURE SYS GRANITE DIAGNOSTICS, INC.
K830594 03/24/1983 TITAN IMMUNO-FIX HELENA LABORATORIES
K830187 03/01/1983 FOCUS FLUID HEMATOLOGY MARKETING ASSOC.
K830188 03/01/1983 OSMOCEL + HEMATOLOGY MARKETING ASSOC.
K830315 03/31/1983 DUAL CHANNEL RECORDER #78574A HEWLETT-PACKARD CO.
K830460 03/24/1983 ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE HOFFMANN-LA ROCHE, INC.
K830482 03/24/1983 ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINE HOFFMANN-LA ROCHE, INC.
K830479 03/10/1983 ABUSCREEN RADIOIMMUNOASSAY-BARBITURATE HOFFMANN-LA ROCHE, INC.
K830480 03/24/1983 ABUSCREEN RADIOIMMUNOASSAY-COCAINE META HOFFMANN-LA ROCHE, INC.
K830481 03/24/1983 ABUSCREEN RADIOIMMUNOASSAY-PHENCYCLIDINE HOFFMANN-LA ROCHE, INC.
K830462 03/24/1983 ABUSCREEN RADIOUMMUNOASSAY--URINE HOFFMANN-LA ROCHE, INC.
K830461 03/24/1983 ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE HOFFMANN-LA ROCHE, INC.
K837142 03/23/1983 TRANSDUCERS MODELS 421, 419 AND 420 FOR IREX SYSTEM HOFFREL INSTRUMENTS, INC.
K830648 03/29/1983 H1207 HOSPAL MEDICAL CORP.
K830647 03/29/1983 H1210 HOSPAL MEDICAL CORP.
K830307 03/10/1983 AUFRANC-TURNER ATS TOTAL HIP SYSTEM HOWMEDICA CORP.
K837102 03/14/1983 MODEL 2100 FETAL MONITOR HUNTLEIGH GROUP LTD.
K830194 03/29/1983 IDAS INFUSION SET IDAS AMERICA, LTD.
K830652 03/24/1983 ANTI N DNA-HCP IMMUNO-PRODUCTS INDUSTRIES
K830456 03/09/1983 STAPLE INSERTER-EXTRACTOR FOR ARTHROS INSTRUMENT MAKAR, INC.
K830455 03/09/1983 STAPLES DESIGNED FOR ARTHROSCOPIC SURG INSTRUMENT MAKAR, INC.
K830185 03/09/1983 UNIV. KNEE, CUTTING INSTRUMENTATION INTERMEDICS ORTHOPEDICS
K823863 03/10/1983 CYBERLITH IX QUANTUM-UNIPOLAR CARDIAC INTERMEDICS, INC.
K830423 03/07/1983 SYRINGE DRIVER MS-16 INTERMEDICS, INC.
K830609 03/24/1983 INFLATION DEVICE INTERVENTIONAL MEDICAL, INC.
K830471 03/24/1983 KELLY-WICK TANNELER INTL. MEDICAL PROSTHETICS RESEARCH
K830130 03/07/1983 MINIATURE ION SELECTIVE ELECTRODES IONETICS, INC.
K830606 03/24/1983 QUIK-SEP IGM ISOLATION SYSTEM ISOLAB, INC.
K830289 03/25/1983 PDB II J.A. GERBER THERAPEUTICAL, LTD.
K830781 03/31/1983 ENDO-GUARD JAYCO PHARMACEUTICALS
K830216 03/09/1983 DORC COMPACT MICRO SURGICAL SYSTEM JEDMED INSTRUMENT CO.
K830290 03/09/1983 DORC CONTACT/PHOTO DERATOSCOPE JEDMED INSTRUMENT CO.
K830335 03/09/1983 DORC CORNEAL PUNCH BLOCK JEDMED INSTRUMENT CO.
K830336 03/09/1983 DORC INTRAOCULAR ELECTROMAGNET JEDMED INSTRUMENT CO.
K830215 03/09/1983 DORC LIGHTWEIGHT BINOCULAR OPHTHALMOSCOP JEDMED INSTRUMENT CO.
K830491 03/17/1983 JOHNSON & JOHNSON OPAQUE COLOR MODIFI JOHNSON & JOHNSON PROFESSIONALS, INC.
K830380 03/17/1983 MICRODAPT DENTAL RESTORATIVE JOHNSON & JOHNSON PROFESSIONALS, INC.
K830387 03/17/1983 MICRODAPT DENTAL RESTORATIVE BONDING JOHNSON & JOHNSON PROFESSIONALS, INC.
K830494 03/11/1983 CONTOX DRUG SCREEN CONTROL KAULSON LABORATORIES, INC.
K830492 03/11/1983 CONTOX DURG CONTROL KAULSON LABORATORIES, INC.
K830466 03/09/1983 BARS, PARALLEL, EXERCISE KAYE PRODUCTS, INC.
K830560 03/09/1983 EXERCISER, PASSIVE, NON MEASURING KAYE PRODUCTS, INC.
K830247 03/15/1983 SPLIT COLON STIFFENING TUBE KEYMED, INC.
K830586 03/24/1983 TRI-DILS-TRIPLE OLIVE-ESOPHAGEAL DILATOR KEYMED, INC.
K830399 03/10/1983 COUPLING/VALVE KHI, INC.
K830404 03/17/1983 RAD VALVE KHI, INC.
K823362 03/09/1983 ENDOMED 433 KIPP & ZONEN
K830366 03/09/1983 DIAMOND KNIFE KOI, INC.
K830432 03/24/1983 CENTRAL STATION 590 KONE INSTRUMENTS, INC.
K830433 03/24/1983 PATIENT MONITOR 575 KONE INSTRUMENTS, INC.
K830539 03/17/1983 INTRAVASCULAR CATHETER SET LAB-A-CATH CORP.
K823512 03/01/1983 MR 600 MICROPLATE READER LABORATORY AND MEDICAL PRODUCTS GROUP
K830416 03/10/1983 ICY COLD ICE CAP LADORA ENT.
K837081 03/09/1983 MICROSCAN 771 MANIPULATOR LASER INDUSTRIES LTD.
K828326 03/04/1983 UNKNOWN LASERTEK OY
K830427 03/29/1983 ARM CUSHION MADDAK, INC.
K830400 03/09/1983 MADDATRAINER HAND EXERCISER MADDAK, INC.
K823886 03/01/1983 PROFILE 750 BLOOD CELL COUNTER MALLINCKRODT CRITICAL CARE
K830229 03/09/1983 ROENTGENOGRAPHY SET MALLINCKRODT CRITICAL CARE
K823850 03/01/1983 BAC-T-SCREEN BACTERIURIA DETECTION DEV MARION LABORATORIES, INC.
K830120 03/17/1983 IMPROVED ARTHROSCOPE MARKOPTIC
K830164 03/01/1983 DENSITOMETRIC INHALENT PROFILE SLLER MAST IMMUNOSYSTEMS
K823788 03/29/1983 MECON I MECON LABS
K830438 03/17/1983 MCDLSCK 126 DOUBLE LUMEN SUBCLAVIAN-FEM MED COMP
K823854 03/31/1983 MEDCARE SUTURE REMOVAL TRAYS MEDCARE PRODUCTS
K830324 03/10/1983 AIRCARE 300 MEDCOM
K830483 03/09/1983 COONS SOFT STENT MEDI-TECH, INC.
K830365 03/10/1983 KINETI COUNT 48 IMMUNOASSAY SYSTEM MEDICAL & SCIENTIFIC DESIGNS, INC.
K823925 03/28/1983 CART MEDICAL ASSOC. INTL., INC.
K830025 03/31/1983 DIGITAL SUBTRACTION ANGIOGRAPHY CONVEN- MEDRAD/TECHNOLOGY FOR PEOPLE
K823831 03/16/1983 MEDTRONIC MODELS 59401 5941 MEDTRONIC VASCULAR
K830003 03/10/1983 MICRO FITNESS COMPUTER MICROFIT, INC.
K830157 03/10/1983 DIGIFLEX AUTOMATIC PIPETTE MICROMEDIC SYSTEMS
K830228 03/07/1983 OTOLOGICAL VENTILATION TUBES-VARIOUS MICROMEDICS, INC.
K837117 03/09/1983 3M FERLIC CHEST FILTER, X-RAY COMPENSATING FILTER MINNESOTA MINING AND MFG. CO.
K830470 03/24/1983 ANESTHESIA BREATHING CIRCUITS MON-A-THERM, INC.
K830552 03/17/1983 LUER LOCK TEMPERATURE SENSOR MON-A-THERM, INC.
K830654 03/24/1983 INFUSION PUMP RETROGRADE EXTEN. AS 715 NARCO SCIENTIFIC
K823511 03/31/1983 EMG BIOFEEDBACK DEVICE NEMECTRON MEDICAL, INC.
K830688 03/31/1983 COMBION SKIN TEST NICHOLAS H. MAGANIAS
K830579 03/08/1983 MULTI-SIGNAL AUDITORY STIMULATOR SM700 NICOLET BIOMEDICAL INSTRUMENTS
K823845 03/01/1983 PORT-LOCK NORFOLK MEDICAL PRODUCTS, INC.
K830000 03/01/1983 VASCULAR-ACCESS-PORT NORFOLK MEDICAL PRODUCTS, INC.
K830109 03/01/1983 CIMPAT NORTH PACIFIC DENTAL, INC.
K830117 03/01/1983 ENDOMET NORTH PACIFIC DENTAL, INC.
K830114 03/01/1983 GUTTA PERCHA POINTS NORTH PACIFIC DENTAL, INC.
K830115 03/01/1983 PAPER POINTS NORTH PACIFIC DENTAL, INC.
K830111 03/24/1983 SEPTOCAL NORTH PACIFIC DENTAL, INC.
K830106 03/07/1983 UNICIDE NORTH PACIFIC DENTAL, INC.
K830105 03/01/1983 VITATHYL NORTH PACIFIC DENTAL, INC.
K830502 03/24/1983 NOVA 8 IONIZED CALCIUM/PH ANALYZER NOVA BIOMEDICAL CORP.
K830436 03/10/1983 OTICON, E-27P OCTICON CORP.
K830435 03/10/1983 OTICON, E25P OCTICON CORP.
K830332 03/02/1983 BUDDE-HALO RETRACTOR OHIO MEDICAL INSTRUMENT CO., INC.
K837028 03/09/1983 PARKINSON NEUROSURGICAL HEADCLAMP FOR SERIAL ANGIOGRAPHY OHIO MEDICAL INSTRUMENT CO., INC.
K830484 03/24/1983 OMED IDENT-I-BAND OMEGA-MED INTL., INC.
K830459 03/07/1983 BEHIND THE EAR HEARING AID OMNI #OS OMNI HEARING SYSTEMS
K823385 03/09/1983 ALES OMS
K822342 03/17/1983 ORTHO RUBELLA ELISA TEST SYSTEM ORTHO DIAGNOSTIC SYSTEMS, INC.
K823891 03/31/1983 MODEL KY PACEMAKER LEAD - VARIOUS OSCOR INC.
K823890 03/31/1983 MODEL ZY PACEMAKER LEAD-VARIOUS OSCOR INC.
K830295 03/24/1983 MEDILOG 9000 SYSTEM OXFORD MEDILOG, INC.
K830364 03/08/1983 NEISSERIA IDENTIFICATION DISCS OXOID U.S.A., INC.
K823463 03/17/1983 RIGHT TIME RHYTHM CLOCK P.K. MORGAN INSTRUMENTS, INC.
K823878 03/24/1983 IMPLANTABLE PACEMAKER PULSE GEN, MODELS 241 & 242 PACESETTER SYSTEMS DIANA UPP
K830570 03/24/1983 PERSONAL MEDICATION INFUSER PACESETTER SYSTEMS
K830155 03/10/1983 PHADEBAS & PHADEZYM RAST ALLERGEN DISCS PHARMACIA, INC.
K823592 03/24/1983 PHADEBAS & PHADEZYM RAST TEST ALLERG PHARMACIA, INC.
K830280 03/25/1983 PHADEZYM B2 MICRO TEST 100 PHARMACIA, INC.
K830660 03/17/1983 STERILE SURGICAL DRAPES PHOENIX GLOVE CO.
K830319 03/29/1983 AUTO PREP PM AMERICA, INC.
K830556 03/24/1983 CREATININE POINTE SCIENTIFIC, INC.
K830352 03/08/1983 REINFORCED SILICONE TRACHEAL TUBE PORTEX, INC.
K830597 03/24/1983 BABY CAP, ELECTRODE SET & BOARD ADAPTOR PRECISION CAP SYSTEMS
K830598 03/24/1983 EVOKED POTENTIAL CAP W/EVOKED POTENTIAL PRECISION CAP SYSTEMS
K830601 03/24/1983 FOAMIES DIAPOS. FOAM RUBBER PADS PRECISION CAP SYSTEMS
K830599 03/24/1983 LOCALIZING ELECTRODE PRECISION CAP SYSTEMS
K830602 03/24/1983 PRECISION CAP STRAPS PRECISION CAP SYSTEMS
K830521 03/24/1983 PRECISION EEG CAP W/ELECTRODE SET AND PRECISION CAP SYSTEMS
K830600 03/24/1983 REFERENCE & MONITORING ELECTRODE PRECISION CAP SYSTEMS
K830467 03/31/1983 TOURNIQUET/LATEX TOURNIQUET PRIMELINE INDUSTRIES, INC.
K830637 03/24/1983 VERTEX DIGITAL SUBSTRATION KIT PROFESSIONAL MEDICAL SERVICES
K830417 03/24/1983 RESPI-NEB-AEROSOL SYSTEM PROFESSIONAL MEDICAL SUPPLY, INC.
K823581 03/24/1983 ELPHA 500 PROTHIA USA, INC.
K830058 03/07/1983 MYOGRAPH 2000 PROTHIA USA, INC.
K823334 03/24/1983 PHYSIOLOGICAL PRESS. TRANSDUCER PCM3630 PSITRON
K823503 03/09/1983 P-S CSF-VENTRICULAR CATHETER, FLANGED PUDENZ-SCHULTE MEDICAL RESEARCH CORP.
K830498 03/10/1983 LIQUID OXYGEN SYSTEM PURITAN BENNETT CORP.
K830208 03/07/1983 BETA-CAP D ADAPTER QUINTON, INC.
K837033 03/09/1983 ROTATABLE HALF BEAM SHIELDING BLOCK MODEL 440 RADIATION MEASUREMENTS, INC.
K830207 03/21/1983 RAICHEM HDL-CHOLESTEROL REAGENT REAGENTS APPLICATIONS, INC.
K830529 03/24/1983 BIOFEEDBACK-TRAINING INSTRUMENT RELAXOMAT, INC.
K830322 03/28/1983 C.A.T. REAGENT KIT REMEL CO.
K830396 03/08/1983 UREA-PDA DISK REMEL CO.
K830575 03/31/1983 RENALIN (TENTATIVE RENAL SYSTEMS, INC.
K830574 03/29/1983 RENATRON DIALYZER REPROCESSING SYS RENAL SYSTEMS, INC.
K830540 03/17/1983 RENNCO MODEL LS LIFT SEAL HEAT SEALER RENNCO, INC.
K823782 03/07/1983 RESPITRACE SYSTEM RESPITRACE CORP.
K830055 03/10/1983 RICH-MAR HV 20 RICH-MAR CORP.
K823837 03/29/1983 RMC TOTAL KNEE SYSTEM RICHARD'S MEDICAL EQUIP., INC.
K823726 03/09/1983 SPECTRON CONVERSION ENDOPROSTHESIS CUP RICHARD'S MEDICAL EQUIP., INC.
K823722 03/08/1983 SPECTRON LONG, STRAIGHT FEMORAL PROSTHES RICHARD'S MEDICAL EQUIP., INC.
K823724 03/09/1983 SPECTRON NECK REPLACEMENT PROSTHESIS RICHARD'S MEDICAL EQUIP., INC.
K823727 03/08/1983 SPECTRON PRIMARY STEM FEMORAL PROSTHES RICHARD'S MEDICAL EQUIP., INC.
K823723 03/09/1983 SPECTRON PROXIMAL FEMORAL PROSTHESIS RICHARD'S MEDICAL EQUIP., INC.
K830627 03/24/1983 CLARIFIER-RICHARD-ALLAN RICHARD-ALLAN MEDICAL IND., INC.
K830625 03/24/1983 CYTO-STAIN RICHARD-ALLAN MEDICAL IND., INC.
K830236 03/24/1983 RIONET HEARING AID RION ACOUSTIC INSTRUMENTS, INC.
K830277 03/08/1983 DUOWIPE CAUTERY TIP & INSTRUMENT CLEANER RITMED, INC.
K830265 03/29/1983 FLORET DRAIN/TRACHEOTOMY SPONGE RITMED, INC.
K830278 03/29/1983 FLORET GAUZE PACKING RITMED, INC.
K830263 03/24/1983 FLORET NASAL TAMPON RITMED, INC.
K830274 03/08/1983 FLORET PEANUT SPONGE/STICK & GAUZE PREP RITMED, INC.
K830260 03/17/1983 FLORET VAGINAL PACKING/TAMPONS RITMED, INC.
K830275 03/08/1983 NEEDELET HANDLER FOR SHARPS RITMED, INC.
K830276 03/29/1983 SECURET DRAPE & INSTRUMENT RETAINER/INCL RITMED, INC.
K823413 03/29/1983 MOUTH CARE KIT W/TOOTHBRUSH SAGE PRODUCTS, INC.
K823921 03/28/1983 PHYSICIANS CHOICE SILICONE EAR PUTTY SANTA BARBARA MEDCO, INC.
K830300 03/01/1983 FREHAN INC. I.V. FILTER HOLDER SAXNOR CORP.
K823764 03/24/1983 SCANLAN SINGLE-USE AORTA PUNCH SCANLAN INTL., INC.
K830329 03/11/1983 ESOPHAGEAL STETHOSCOPE SCIENCE DEVELOPMENT CORP.
K837097 03/22/1983 2D CARDIAC SECTOR SCANNER SECOND FOUNDATION, INC.
K830341 03/10/1983 SALT BRIDGE SOLUTION & URINE DILUENT SHABAN MFG. CO.
K830522 03/31/1983 STAINLESS STEEL SUTURE 316L SHARPOINT, INC.
K830218 03/09/1983 SHERIDAN/ESOPHAGEAL STETHOSCOPE SHERIDAN CATHETER CORP.
K830710 03/29/1983 ARGYLE SILICONE SALEM SUMP TUBE SHERWOOD MEDICAL CO.
K830709 03/29/1983 ARGYLE SUCTION CATHETERS SHERWOOD MEDICAL CO.
K823345 03/10/1983 PATCH SHILEY, INC.
K837107 03/09/1983 SOMATOM DRI X-RAY CT SCANNER SIEMENS MEDICAL SOLUTIONS USA, INC.
K823828 03/17/1983 THERACARD 400 SIEMENS MEDICAL SOLUTIONS USA, INC.
K830610 03/29/1983 FLAT SUCTION DRAIN SIL-MED CORP.
K830524 03/24/1983 HENKE JECT PRESSURE SYRINGE SMITH & NEPHEW, MPL DIVISION
K830306 03/17/1983 HEARTRATE PLUS ECG CARDULE #1918 SPACELABS, INC.
K830739 03/29/1983 PRO-GUARD SURGICOT, INC.
K830659 03/17/1983 CLEARIUM, MOUNTING MEDIUM SURGIPATH MEDICAL INDUSTRIES, INC.
K830582 03/17/1983 MILLONIG'S MODIFIED PHOSPHATE BUFFERED SURGIPATH MEDICAL INDUSTRIES, INC.
K830514 03/08/1983 MILLONIGS MODIFIED PHOSPHATE BUFFERED SURGIPATH MEDICAL INDUSTRIES, INC.
K830583 03/17/1983 NEUTRAL BUFFERED FORMALIN 10% SURGIPATH MEDICAL INDUSTRIES, INC.
K830515 03/31/1983 SCOTTS TAP WATER SUBSTITUTE CONCENTRATE SURGIPATH MEDICAL INDUSTRIES, INC.
K830649 03/17/1983 SUTTER CPM 2000 SUTTER BIOMEDICAL, INC.
K830531 03/17/1983 MONO SCREENING TEST TAGO, INC.
K830611 03/24/1983 RA SCREENING TEST TAGO, INC.
K830573 03/29/1983 PRE VUE TAUT, INC.
K830255 03/09/1983 OSTEOTOMY BONE STAPLE TECHMEDICA, INC.
K830390 03/24/1983 IMPLANTABLE BIPOLAR CARDIAC PULSE GEN TELECTRONICS, INC.
K830189 03/24/1983 CARDIOVASCULAR SAW BLADES TEMP MEDICAL PRODUCTS, INC.
K830087 03/01/1983 INTRAMEDULLARY ROD THE DECA CO.
K830757 03/29/1983 HOT/ICE THERMOTEMP, INC.
K823906 03/09/1983 TELEMETRY SYSTEM TRANSKINETIC SYSTEMS, INC.
K823909 03/17/1983 T-TUBE VENT TUBE TREACE MEDICAL, INC.
K830337 03/17/1983 MARK III OXYGEN WALKER SYS-LOW PRESS UNION CARBIDE CORP.
K830675 03/24/1983 ORAL SPONGE UNISPLINT CORP.
K830402 03/07/1983 HEARING AID, #UE7-D UNITRON INDUSTRIES, INC.
K830557 03/31/1983 ERG-JET ELECTRODE UNIVERSO S.A.
K830576 03/17/1983 LYMPHANGIOGRAPHY SET VERTEX MEDICAL CORP.
K830368 03/31/1983 AMBULATORY BLOOD PRESSURE MONITOR VITA-STAT MEDICAL SERVICES, INC.
K830161 03/09/1983 ANESTHESIA APATATUS #D-25 W.E. LEDER ENTERPRISES, INC.
K830160 03/09/1983 ANESTHESIA APPARATUS #FO 20S W.E. LEDER ENTERPRISES, INC.
K830159 03/09/1983 ANESTHESIA APPARATUS PH-35 W.E. LEDER ENTERPRISES, INC.
K830291 03/29/1983 WAK WEARABLE ARTIFICIAL KIDNEY WAK-UTAH
K830564 03/29/1983 FEB TEST WAKO CHEMICALS, USA, INC.
K830243 03/08/1983 ABDUCTION PILLOW WARM & FORM, ORTHOPEDIC MATERIALS
K830245 03/09/1983 HEAD HALTER WARM & FORM, ORTHOPEDIC MATERIALS
K830244 03/09/1983 TRACTION ACCESSORIES WARM & FORM, ORTHOPEDIC MATERIALS
K830359 03/17/1983 STERILE CATHERIZATION PROCEDURE TRAYS WELCON, INC.
K830767 03/31/1983 WILLIAMS AIRWAY INTUBATOR WILLIAMS AIRWAY INTUBATOR
K822842 03/24/1983 AMBULATORY MARK I WINDSOR MEDICAL, INC.
K830317 03/31/1983 INFUSION PUMP ACCESS. #60-01-5 WINDSOR MEDICAL, INC.
K830490 03/31/1983 MODEL 50-01-27 WINDSOR MEDICAL, INC.
K830544 03/31/1983 WINDSOR MEDICAL, INC. 50-01-028 WINDSOR MEDICAL, INC.
K830511 03/17/1983 ZANLEX, ZAN-TEX & ZANDEX WINN HIRSCH & ASSOC. WIN HIRSCH
K830561 03/24/1983 DISPOSABLE TEMP. PROBE & CABLE MODELS YELLOW SPRINGS INSTRUMENT CO., INC.
K830454 03/31/1983 IMS MINIATURE VOLUMETRIC INFUSION PUMP ZIEHM INTERNATIONAL, INC.
K830196 03/25/1983 CORSTREN COMPRESSION TUBE & PLATE ZIMMER, INC.
K830287 03/09/1983 ZIMMER SKIN PROTECTOR ZIMMER, INC.
K830281 03/11/1983 SKIN SCRUB PREP. TRAY ZOA, INC.


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