FDA 510(k) Decisions During July, 1984  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K842523 07/11/1984 BIRD HEATED HUMIDIFIER 3201 3M COMPANY
K842080 07/18/1984 ABBOTT LIFECARE 1050 CONTROLLER ABBOTT LABORATORIES
K842016 07/03/1984 DISPOS. POLY APRONS ABCO DEALERS, INC.
K841678 07/19/1984 STERILE, FOLEY CATHETERS W/PTFE COAT ABCO DEALERS, INC.
K841773 07/26/1984 INFANT NASAL CANNULAE ASSEMBLY ACKRAD LABORATORIES
K840795 07/02/1984 ACS SOF-T GUIDE WIREE ADVANCED CARDIOVASCULAR SYSTEMS, INC.
K842195 07/13/1984 ADVANCED CARDIOVASCULAR-CORONARY GUID ADVANCED CARDIOVASCULAR SYSTEMS, INC.
K842265 07/17/1984 ORTHO BRAND HOME PREGNANCY TEST ADVANCED CARE PRODUCTS
K841322 07/18/1984 OPTIMIST SIZED PARTICLE AEROSOL NEBULIZ AIRMED CORP.
K842415 07/06/1984 ALL-HANDS TRACHEOSTOMY CARE SET 0101 ALL-HANDS MEDICAL SUPPLY, INC.
K842608 07/23/1984 INFANT PERCUSSOR PA-010 ALPHA MEDICAL SYSTEMS
K842196 07/11/1984 STRATUS PRIMIDONE FLOROMETRIC ENZY AMERICAN DADE
K841922 07/13/1984 ACCUPRO VOLUMETRIC INFUSION PUMP W/RS232 AMERICAN EDWARDS LABORATORIES
K841384 07/19/1984 PROXIMA 1 PH MONITOR AMERICAN ENDOSCOPY, INC.
K842492 07/06/1984 AMER. MEDICAL PLASTICS CO 20100 AMERICAN MEDICAL PLASTICS CO.
K841544 07/09/1984 AMER. PHARMASEAL SILICONIZED LATEX AMERICAN PHARMASEAL DIV. AHSC
K841562 07/23/1984 HESUNG BLOOD TRANSFUSION SETS AMKOR TRADING CO.
K841566 07/17/1984 HESUNG DISPOSABLE SYRINGE AMKOR TRADING CO.
K841564 07/17/1984 HESUNG SCALP VEIN SET AMKOR TRADING CO.
K841565 07/17/1984 HESUNG'S HYPERDERMIC NEEDLES AMKOR TRADING CO.
K841563 07/17/1984 HESUNG'S SOLUTION INFUSION SETS AMKOR TRADING CO.
K842440 07/27/1984 SICKLE CELL STAT A/S HETEROZYGOUS-ERYTH ANCO MEDICAL REAGENTS & ASSOC.
K842591 07/23/1984 ULTRASOUND PROBE COVERS-STERILE APPLIED MEDICAL DEVICES, INC.
K842004 07/13/1984 PERCUTANEOUS CATHETER INTRODUCER SET ARIES MEDICAL, INC.
K841077 07/02/1984 ARK TONGUE CLEANER ARKAY CO.
K841907 07/06/1984 BACTIGEN - N.MENNINIGITIDIS TEST ARMKEL, LLC.
K841991 07/27/1984 ARM-A-CARE HUMIDIFIER-RESPIRATORY GAS ARMOUR PHARMACEUTICAL CO.
K841990 07/27/1984 ARM-A-CARE NEBULIZER-NEBULIZER ARMOUR PHARMACEUTICAL CO.
K841989 07/27/1984 ARM-A-VIAL LV SODIUM CHLORIDE INHALAT ARMOUR PHARMACEUTICAL CO.
K841988 07/27/1984 ARM-A-VIAL LV SODIUM, CHLORIDE INHALAT ARMOUR PHARMACEUTICAL CO.
K841987 07/27/1984 ARM-A-VIAL LV STERIAL WATER FOR INHALA ARMOUR PHARMACEUTICAL CO.
K831356 07/18/1984 STEAM STERILIZER ARS ENTERPRISES, INC.
K841558 07/16/1984 BANANA CUFF ASPEN LABORATORIES, INC.
K833270 07/19/1984 ASTRON 77 INJECTION DENTURE RESIN ASTRON DENTAL CORP.
K842451 07/02/1984 RIM STREP KIT AUSTIN BIOLOGICAL LABORATORIES
K842778 07/26/1984 AVATRON UNIVERSAL ADULT VOL. VENTILATOR AVATRON, INC.
K842441 07/25/1984 AXIOM STABLE II CHOLESTEROL TEST AXIOM, INC.
K842151 07/20/1984 CHLAMYDIAE IMMUNOPEROXIDASE TEST KIT BARTELS IMMUNODIAGNOSTIC SUPPLIES, INC.
K842279 07/20/1984 BECTEC NR-660 BACTERIAL DETECT SYS BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K842685 07/10/1984 BECTON DICKINSON 1000 INSULIN PUMP BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K842252 07/20/1984 CEFONICID 30 MCG SENSI-DISC BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K842688 07/26/1984 BEAR JET-150 VENTILATOR BEAR MEDICAL SYSTEMS, INC.
K842340 07/17/1984 VH820 HUMIDIFIER BEAR MEDICAL SYSTEMS, INC.
K841043 07/06/1984 BEHRING ELISA PROCESSOR M BEHRING DIAGNOSTICS, INC.
K841559 07/17/1984 CONFORMA BEIERSDORF, INC.
K842033 07/26/1984 ELECTRODE PLACEMENT ARM PART GARMENT BIO-STIMU TREND CORP.
K841831 07/06/1984 CANNU-SKREEN-PRELIMINARY BIOCHEMICAL DIAGNOSTIC, INC.
K842579 07/27/1984 B.E.C. GROWTH CHEK MICROBIAL SUSPENSIONS BIOLOGICAL & ENVIRONMENTAL CONTROL LABORATORIES
K842087 07/12/1984 BISFIL-I LIGHT CURABLE POSTERIOR COMPO BISCO, INC.
K841605 07/06/1984 BP TRAUMA AIR PANTS BP MEDICAL SYSTEMS, INC.
K841731 07/16/1984 BRIMFIELD FIBEROPTIC LIGHT SCOURCE BRIMFIELD SCIENTIFIC INSTRUMENTS
K842090 07/18/1984 RHINO-LARYNX STROBOSCOPE TYPE 4914 BRUEL & KJAER INDUSTRI A/S
K841491 07/13/1984 CONVENTIONAL PLASTIC DENTAL TRAYS BUFFALO DENTAL MFG. CO., INC.
K841428 07/09/1984 JEJUNOSTOMY SET FOR TUBE FEEDING BURRON MEDICAL PRODUCTS, INC.
K842288 07/17/1984 EEG 130 CALNOR OF EL PASEO, INC.
K842354 07/17/1984 EMG MODEL 133 CALNOR OF EL PASEO, INC.
K841895 07/17/1984 GSR, 126, EEG 130-TEMP. 132, EMG 133 CALNOR OF EL PASEO, INC.
K842353 07/17/1984 TEMPERATURE 132 CALNOR OF EL PASEO, INC.
K841556 07/19/1984 HEART - AID ALS, 95 CARDIAC RESUCITATOR CORP.
K840339 07/25/1984 UMBILICAL VESSEL CATHETER CATHETER TECHNOLOGY CORP.
K841901 07/23/1984 OXYMIZER FLOW RESTRICTOR CHAD THERAPEUTICS, INC.
K842553 07/20/1984 CHESEBROUGH-POND'S REUSABLE URINARY LEG CHESEBROUGH-POND'S U.S.A. CO.
K841248 07/27/1984 SUNGLASSES CHINA TOY & NOVELTY CO., LTD.
K840875 07/06/1984 MULTIVARIATE DIGITAL CARDIOGRAPH CLINICAL MICROSYSTEMS INTL.
K842541 07/26/1984 RAPID PLASMA REAGIN CARD TEST CLINICAL SCIENCES, INC.
K842774 07/27/1984 CODMAN SUCTION PUNCH-PRODUCT CODES CODMAN & SHURTLEFF, INC.
K840613 07/17/1984 COLON IRRIGATION UNIT COLENZ CO.
K841153 07/16/1984 ADAPTOR HR-3000 REUSE COLORADO MEDICAL, INC.
K842095 07/03/1984 EPIDURAL TRAYS CONCORD LABORATORIES, INC.
K841928 07/11/1984 COOK PACEMAKER 215 UNIPOLAR CARDIAC- COOK PACEMAKER CORP.
K841983 07/11/1984 COOK PACEMAKER 216 BIPOLAR CARDIAC - COOK PACEMAKER CORP.
K842081 07/06/1984 COOK PACEMAKER CORP. 115 UNIPOLAR CARDI COOK PACEMAKER CORP.
K843001 07/30/1984 COOK PACEMAKER CORP. 116 BIOPOLAR CARDI COOK PACEMAKER CORP.
K842484 07/11/1984 LEAP LE TEST KIT COOPER BIOMEDICAL, INC.
K841819 07/19/1984 CORPAK FOLEY CATH TRAY W/16FR. TEFLON CORPAK CO.
K842756 07/23/1984 BUTTERFLY II PN INFUSION NEEDLE COSMETIC SCIENCES, INC.
K842346 07/27/1984 COULTER AUTOMATIC SAMPLE HANDLER COULTER ELECTRONICS, INC.
K841742 07/06/1984 NON-CORING NEEDLE CREATIVE CARE SYSTEMS, INC.
K842316 07/20/1984 CRITIKON TRIPLE-LUMEN CENTRAL VENOUS CRITIKON COMPANY,LLC
K842760 07/26/1984 LUNG ANALYZER CM-310 CYBERMEDIC, INC.
K841202 07/06/1984 DACOMED RIGISCAN SYSTEM DACOMED CORP.
K840649 07/19/1984 DANAM ELEC. SA-1000 DANAM ELECTRONICS
K841858 07/11/1984 SPIROLOOP DATAMED, INC.
K841878 07/13/1984 SHEATH REMOVER DATASCOPE CORP.
K840622 07/02/1984 CARDIO EXPRESS 100 HOLTER SCANNER DEL MAR AVIONICS
K842377 07/31/1984 MS NONPRECIOUS CROWN & BRIDGE ALLOY DENTAL VENTURES OF AMERICA, INC.
K842273 07/31/1984 CROWN INDEX TRAY DI-EQUI DENTAL PRODUCTS
K842274 07/31/1984 F-G-P TRAY DI-EQUI DENTAL PRODUCTS
K842241 07/18/1984 ALANINE AMINOTRANSFERASE ASSAY KIT DIAGNOSTIC CHEMICALS, LTD. (USA)
K842243 07/18/1984 ALKALINE PHOSPHATASE ASSAY KIT DIAGNOSTIC CHEMICALS, LTD. (USA)
K842245 07/18/1984 ASPARTATE AMINOTRANSFERASE ASSAY KIT DIAGNOSTIC CHEMICALS, LTD. (USA)
K842509 07/20/1984 CALCIUM ASSAY KIT DIAGNOSTIC CHEMICALS, LTD. (USA)
K842508 07/20/1984 CREATINE KINASE ASSAY KIT NAC DIAGNOSTIC CHEMICALS, LTD. (USA)
K842510 07/20/1984 GLUCOSE ASSAY KIT-HEXOKINASE DIAGNOSTIC CHEMICALS, LTD. (USA)
K842506 07/19/1984 GLUCOSE-TRINDER-ADDAY KIT DIAGNOSTIC CHEMICALS, LTD. (USA)
K842507 07/20/1984 LACTATE DEHYDROGENASE ASSAY KIT DIAGNOSTIC CHEMICALS, LTD. (USA)
K842244 07/18/1984 LACTATE DENYDRO GENASE ASSAY KIT DIAGNOSTIC CHEMICALS, LTD. (USA)
K842242 07/18/1984 UREA ASSAY KIT DIAGNOSTIC CHEMICALS, LTD. (USA)
K842246 07/18/1984 URIC ACID ASSAY KIT DIAGNOSTIC CHEMICALS, LTD. (USA)
K842383 07/02/1984 PATHO DX LATEX AGGLUTINATION STREP A DIAGNOSTIC PRODUCTS CORP.
K841827 07/27/1984 ENTEROPORT NUTRITION PUMP DIATEK, INC.
K841859 07/03/1984 SECURA SET DIATEK, INC.
K842292 07/26/1984 CEFONICID 30 MCG SENSITIVITY DISCS DIFCO LABORATORIES, INC.
K842086 07/03/1984 SPOTTEST LACTOPHENOL COTTON BLUE STAIN DIFCO LABORATORIES, INC.
K841234 07/09/1984 HALO CO LASER SYSTEM DIRECTED ENERGY, INC.
K842472 07/06/1984 DRYDEN INFLATABLE MASK DRYDEN CORP.
K842843 07/27/1984 DRYDEN SCAVENGER INTERFACE SYSTEM DRYDEN CORP.
K842271 07/20/1984 ELECTRODE, SURFACE EEG ELECTRODE DURDEN ENTERPRISES, INC.
K842920 07/25/1984 SAFRANIN, 1% W/V E K IND., INC.
K842600 07/11/1984 STREP-A-CHEK E-Y LABORATORIES, INC.
K841197 07/09/1984 CYSTO-AID E-Z-EM, INC.
K841720 07/26/1984 E-Z-EM PERCUTANEOUS NEPHROSTOMY SETS E-Z-EM, INC.
K841349 07/23/1984 ESOPHAGEAL TUBE E. BENSON HOOD LABORATORIES, INC.
K841350 07/26/1984 SALIVARY BYPASS TUBE E. BENSON HOOD LABORATORIES, INC.
K841884 07/06/1984 KODAK EKTACHEM CONTROL EASTMAN KODAK COMPANY
K840885 07/12/1984 LAKEVILLE BODY VENTILATOR EDWARDS VENTILATOR CO.
K840840 07/12/1984 GENERATED RETINAL REFLEX IMAGERY SYS ELECTRO OPTICAL INSTRUMENTS
K842696 07/27/1984 LIFE-MASK INFANT RESUSCITATOR ELECTRONIC MONITORS, INC.
K842022 07/20/1984 EEG BIOFEEDBACK DEVICE ELECTRONICS RESEARCH & PRODUCTION
K842021 07/20/1984 EEG BIOFEEDBACK DEVICE ACCESSORY ELECTRONICS RESEARCH & PRODUCTION
K842023 07/20/1984 TEMP. & GSR BIOFEEDBACK DEVICE ELECTRONICS RESEARCH & PRODUCTION
K841173 07/09/1984 OSTOMY FREEDOM KIT ELLENBERG ASSOC.
K842211 07/06/1984 ULTRA CHEM ENZYMATIC TRIGLYCERIDE EM DIAGNOSTIC SYSTEMS, INC.
K842202 07/20/1984 NEW JERSEY ACETABULAR COMPONENT & ENDOMEDICS, INC.
K842233 07/20/1984 NEW JERSEY FEMORAL RESURFACING COMPONENT ENDOMEDICS, INC.
K842234 07/20/1984 NEW JERSEY FEMORAL STEM ENDOMEDICS, INC.
K842108 07/17/1984 UNIVERSAL EXAMINATION TABLE ENGINEERING DYNAMICS CORP.
K842436 07/13/1984 ERIKA NEGATIVE PRESS. ARTERIAL BLOOD ERIKA, INC.
K840846 07/06/1984 STERILE HICHMAN/BROVIAC INJECTION CAP EVERMED, INC.
K841780 07/06/1984 CLINICAL ELECTRONIC THERMOMETER FIDELITY MEDICAL, INC.
K841631 07/03/1984 MODEL 3014 SUCTION UNIT FORMA SCIENTIFIC, INC.
K841671 07/03/1984 FALL-SAFE MONITOR FSM CORP.
K841672 07/03/1984 FALL-SAFE VEST FSM CORP.
K841271 07/28/1984 INFRA-EYE 160 FUJITSU LTD.
K841909 07/31/1984 VAGINAL SPECULUM - DISPOSABLE GALENICA ENTERPRISES, INC.
K842307 07/20/1984 GENERAL DIAG. CEFONICID 30MCG ANTIMIC GENERAL DIAGNOSTICS
K841465 07/02/1984 GENERAL DIAGNOSTICS PLATELET ANTIBODY GENERAL DIAGNOSTICS
K841906 07/06/1984 MAXICAMERA 400 AC GENERAL ELECTRIC CO.
K841996 07/16/1984 MAXICAMERA 400T W/BODY CONTOUR TOMOGRA GENERAL ELECTRIC CO.
K842184 07/17/1984 SPOT-FILM DEVICE 8835 GENERAL ELECTRIC CO.
K842135 07/06/1984 HI-LO FLOOR STANDING EXAM. LIGHT GOOD-LITE CO.
K842719 07/25/1984 STANDARD WHEELCHAIR GREENE INTERNATIONAL CORP.
K834455 07/31/1984 MONOXYCHLOROSENE WAREXIN GUARDIAN CHEMICAL
K841957 07/19/1984 BOVINE FACTOR XA-HUMAN FACTOR XA HAEMACHEM, INC.
K841956 07/19/1984 BOVINE THROMBIN, HUMAN THROMBIN HAEMACHEM, INC.
K840542 07/16/1984 MINI-DOPPLER ES-100 HAYASHI DENKI CO., LTD.
K841289 07/06/1984 RECTAL IRRIGATION TUBE HDC CORP.
K842642 07/25/1984 BALSAN 700 HEDDERNHEIMER METALLWARENFABRIK GMBH
K842641 07/25/1984 HYDRO/BUBBLE BATH DEVICE 300 HEDDERNHEIMER METALLWARENFABRIK GMBH
K842643 07/25/1984 MASSAPED HEDDERNHEIMER METALLWARENFABRIK GMBH
K842026 07/11/1984 H-TYPE BRIDGE REMOVER HIGA MANUFACTURING LTD.
K842289 07/25/1984 SR- MODEL 230 HIRATA SANGYO CO. USA, INC.
K841931 07/06/1984 DISPO. AES DISPOS. SYRINGE W/NEEDLE HIRSCH CHEMIE LTD.
K842311 07/25/1984 CHEMISTRY ANALYZER, GEN. PURPOSE HML INC/BIOTECHNOLOGY TRANSFER
K841152 07/06/1984 HOSPAL BIOSPAL SCU/CAVH KIT HOSPAL MEDICAL CORP.
K841791 07/09/1984 PLUME FISTULA NEEDLE HOSPAL MEDICAL CORP.
K841682 07/03/1984 UTERINE INJECTOR 4.0MM HUMI CORP.
K842268 07/20/1984 VACUPULSE VACUUM UNIT I-REP, INC.
K842110 07/12/1984 SLIDE PREGNANCY TEST IMMUNOSTICS CO., INC.
K842077 07/27/1984 MIDAS II AUTOMATIC STAINER INNOVATIVE MEDICAL SYSTEMS, INC.
K842042 07/11/1984 IL 1312, PH BLOOD GAS MANAGER INSTRUMENTATION LABORATORY CO.
K841647 07/03/1984 NEUROMEDICS ULTRASTIM 650-01 INTERMEDICS, INC.
K842070 07/02/1984 IDD DETERGENT INTERSCIENCE DIAGNOSTICS, INC.
K842068 07/02/1984 IDI ISOTONIC DILUENT INTERSCIENCE DIAGNOSTICS, INC.
K842069 07/02/1984 IDL-LYSING REAGENT INTERSCIENCE DIAGNOSTICS, INC.
K842071 07/11/1984 FIAX TRANSFERRIN TEST KIT INTL. DIAGNOSTIC TECHNOLOGY
K841443 07/27/1984 REDO CENTRAL VENOUS CATHETER-NEONATE INTL. HOSPITAL PRODUCTS, INC.
K841327 07/03/1984 DENTAL COTTON ROLLS INTL. VERBANDSTOFF-FABRIK SCHAFFHAU
K841953 07/19/1984 ULTRA SHIELD BRIEFS IPCO CORP.
K842210 07/25/1984 IVENT 302VC DUAL CONTROLLER IVENT CORP.
K842604 07/20/1984 EMERSON MOTION BED 6-MS & 6-ME J. H. EMERSON CO.
K842488 07/06/1984 SAMSON 1000 ANESTHESIA CIRCUIT J. H. EMERSON CO.
K842487 07/06/1984 SAMSON'S NEWBORN LUNG INFLATOR 340-1000 J. H. EMERSON CO.
K842112 07/03/1984 TISCHLER CERVICAL BIOPSY PUNCH FORCEPS J. SKLAR MFG. CO., INC.
K841258 07/09/1984 FOREIGN BODY PROTECTOR JAYCO PHARMACEUTICALS
K842392 07/26/1984 DELTON * OPAQUE LIGHT CURING PIT JOHNSON & JOHNSON PROFESSIONALS, INC.
K842078 07/12/1984 JOHNSON & JOHNSON FLAVORED ETCHING GEL JOHNSON & JOHNSON PROFESSIONALS, INC.
K842480 07/03/1984 SURE & NATURAL MAXI-SHIELD JOHNSON & JOHNSON PROFESSIONALS, INC.
K841864 07/11/1984 QUANTIMETRIC TM 2 KAPPA & LAMBDA KIT KALLESTAD LABORATORIES, INC.
K840874 07/23/1984 RODY BREAST PUMP KEAN-RODY MANUFACTURER
K841399 07/18/1984 BRONCHOSCOPE SUCTION UNIT KEYMED, INC.
K841822 07/27/1984 KEYMED SIGMOIDOSCOPE SUCTION UNIT KEYMED, INC.
K841331 07/19/1984 OLYMPUS KC-10 MOBILE DISINFEC-STAT KEYMED, INC.
K840208 07/19/1984 CODE 17-ENDOSCOPE DEODORANT KNOX LABORATORIES
K842168 07/16/1984 ATAGO URINE SPECIFIC GRAVITY & SERUM KYOTO DIAGNOSTICS, INC.
K841772 07/06/1984 HEPARIN CAP, INJECTION CAP MALE LUER- LINTON BIOMED CORP.
K842368 07/20/1984 SICKLE CELL REAGENT SET LIVONIA DIAGNOSTICS, INC.
K842102 07/17/1984 LORAD LORAD MEDICAL SYSTEMS, INC.
K841105 07/03/1984 MULTICHANNEL 2000 FLUOROPTIC THERMOMET LUXTRON
K841568 07/18/1984 IMPEDANCE/PURE TONE AUDIOMETER MA620 MAICO HEARING INSTRUMENTS, INC.
K842113 07/13/1984 AMENDMENT TO ANGIOGRAPHY KIT W/ADDIT MALLINCKRODT CRITICAL CARE
K842464 07/06/1984 TRACHEAL TUBE/STETHOSCOPE MALLINCKRODT CRITICAL CARE
K841872 07/26/1984 UNCUFFED REINFORCED TRACHEAL TUBE MALLINCKRODT CRITICAL CARE
K841705 07/13/1984 WEDGE PRESSURE CATHETER FLOW DIRECTED MANSFIELD SCIENTIFIC, INC.
K841810 07/06/1984 MARK5 ARTERIAL BLOOD GAS KIT MARTELL MEDICAL PRODUCTS, INC.
K840271 07/03/1984 CEMENTLESS HIP PROSTHESIS MECRON MEDICAL PRODUCTS, INC.
K842143 07/20/1984 BENT WINGED MINI-VOL INFUSION SET MEDFUSION SYSTEMS, INC.
K842136 07/06/1984 STERILE PAN SET MEDI-PLAST INTL., INC.
K842416 07/26/1984 DUO FLOW CATHETER-MC 54 MEDICAL COMPONENTS, INC.
K841879 07/26/1984 LFT - 212 MEDICAL MONITORING SYSTEMS, INC.
K841484 07/02/1984 STERILE O.R. BASIN KIT PRODUCT LINE MEDLINE INDUSTRIES, INC.
K841708 07/19/1984 MELOY IMMUNOSTAT MONOCLONAL FACTOR VIII MELOY LABORATORIES, INC.
K842129 07/03/1984 LYFO-DISK MICROORGANISMS MICRO-BIO-LOGICS
K842006 07/16/1984 CITOJECT CARTRIDGE SYRINGE MILES LABORATORIES, INC.
K842238 07/25/1984 CLINITEK 10 SEMI-AUTO URINALYSIS SYS MILES LABORATORIES, INC.
K841403 07/06/1984 HEMO-RO WATER PURIFICATION SYS MILLIPORE CORP.
K842336 07/13/1984 DISPOSABLE PILLOW MONTEREY MILLS, INC.
K842276 07/16/1984 SUNMASTER MT. HOOD MFR., INC.
K842185 07/31/1984 PROTEX CONTRACEPT PLUS W/SPERM-LUB NATIONAL SANITARY LABORATORIES, INC.
K841877 07/19/1984 EEG ELECTRODE PAD NEUROLOGICS, INC.
K841790 07/12/1984 LIFESCAN EEG MONITOR NEUROMETRICS
K842030 07/23/1984 NEUTRAL POS-CHAIR SURGEON CHAIR NEUTRAL POS-CHAIR CO.
K842611 07/20/1984 CA2000 NICOLET BIOMEDICAL INSTRUMENTS
K842612 07/20/1984 COMPACT AUDITORY NICOLET BIOMEDICAL INSTRUMENTS
K842613 07/20/1984 COMPACT VISUAL NICOLET BIOMEDICAL INSTRUMENTS
K841463 07/17/1984 BONE DENSITOMETER NORLAND CORP.
K841828 07/13/1984 CENTRAL VENOUS CATHETER W/BIG-GARD NORTON PERFORMANCE PLASTICS CORP.
K841733 07/11/1984 OHIO WASTE GAS SCAVENGING RESERVOIR OHIO MEDICAL PRODUCTS
K842154 07/31/1984 PACKETS FOR THE PREP OF DIALYSATES & ORGANON TEKNIKA CORP.
K842424 07/02/1984 BIOTIS LD-PRESUMPTO QUADRANT PLATE OTISVILLE BIOTECH, INC.
K842400 07/02/1984 BIOTIS N.Y.C. CARBOHYDRATE FERMENTA- OTISVILLE BIOTECH, INC.
K841826 07/12/1984 NATURA-DENT VACUUM-FIRED PORCELAIN TEETH PAREXEL INTL. CORP.
K842208 07/31/1984 NATURA-TONE OR LUXOPAL CL ACRYLIC PAREXEL INTL. CORP.
K841741 07/23/1984 SINGLE HAIR TRANSPLANT GRAFT PARIS PRODUCTS, INC.
K841867 07/13/1984 KIDD VAGINAL SPECULUM PAUL H. SCHNEIDER ENT.
K842535 07/13/1984 PENTAD VOCALIZER PENTAD CORP.
K842058 07/26/1984 HEMODIALYSIS BATH CONCENTRATE SOLUTION PHARMACEUTICAL DEVELOPMENT SYSTEMS
K842457 07/02/1984 PHADEXACT SERUM, ALLERGEN SPECIFIC IGE PHARMACIA, INC.
K841717 07/23/1984 INTRAVENOUS INJECTION SET PHILADELPHIA BIOLOGICS CENTER
K842358 07/31/1984 ISOLIGHT PLANMECA USA, INC.
K841619 07/11/1984 DRILL GUIDE PLASTAFIL, INC.
K841623 07/11/1984 SLOTTED SOFT-TISSUE INSTRUMENT PLASTAFIL, INC.
K841622 07/11/1984 SOFT-TISSUE INSTRUMENT PLASTAFIL, INC.
K841628 07/23/1984 WIRE PLASTAFIL, INC.
K840593 07/13/1984 DISPOSA-SPEC PLASTI-PRODUCTS, INC.
K842456 07/06/1984 JET VENTILATION ADAPTOR PORTEX, INC.
K842149 07/23/1984 PMS SUTURE PACK/TRAY;VERTEX SUTURE PROFESSIONAL MEDICAL SERVICES
K832327 07/09/1984 SILA CLEAN 20/20 PROFESSIONAL SUPPLIES, INC.
K841172 07/27/1984 MONITOR ONE QMED, INC. RICHARD I LEVINE
K841415 07/11/1984 BETA STICK, PREGNANCY TEST QUIDEL CORP.
K841995 07/02/1984 10.5 FRENCH DILATOR, 15CM, W/LUER LOCK QUINTON, INC.
K842176 07/13/1984 RAAF DUAL LUMEN CATHETER QUINTON, INC.
K842414 07/27/1984 ECHO PULSE BURST RABAR, INC.
K841785 07/16/1984 RADCAL MODEL 4046 RADIONUCLIDE CALIBR RADCAL CORP.
K841787 07/16/1984 RADCAL MODEL 4050 RADIONUCLIDE CALIB RADCAL CORP.
K841786 07/16/1984 RADCAL MODEL 4051 RADIONUCLIDE CALIBRA RADCAL CORP.
K842029 07/09/1984 TRIGLYCERIDES-GPO REAGENT REAGENTS APPLICATIONS, INC.
K841900 07/23/1984 FIRST RESPONSE EMERG. EYE INJURIES REED PRODUCTS, INC.
K841899 07/23/1984 FIRST RESPONSE EMERG. MEDICAL SYS BONES REED PRODUCTS, INC.
K841897 07/23/1984 FIRST RESPONSE EMERG. MEDICAL SYSTEM REED PRODUCTS, INC.
K834479 07/11/1984 RELIABLE RELIABLE HEARING AIDE
K842258 07/06/1984 RENATRON RENAL SYSTEMS, INC.
K842605 07/27/1984 RESPIRONICS VENT EASY OXYGEN ENRICHME RESPIRONICS, INC.
K842015 07/06/1984 SAWYER FIRST AID KIT SAFFETA, INC.
K841513 07/06/1984 SCANLAN ATRAUM INSTRUMENT JAW COVER SCANLAN INTL., INC.
K841575 07/06/1984 SENTECH'S ULAB 1000 CLINICAL CHEM. SENTECH MEDICAL CORP.
K842199 07/18/1984 ELEC. DIGITAL THERMOMETER MT-20 & 30 SHARP ELECTRONICS CORP.
K842635 07/25/1984 SHERIDAN/ENDO-PAK SHERIDAN CATHETER CORP.
K842558 07/11/1984 SHERIDAN/INTENSA TUBE SHERIDAN CATHETER CORP.
K841789 07/26/1984 SECHRIST AIR-OXYGEN MIXER & ANCILLARY SHILEY, INC.
K841233 07/06/1984 PULSE GENERATOR 678L SIEMENS ELEMA AB
K842671 07/20/1984 BASAL MED. EAGLE B8265, W/EARLS SALTS SIGMA CHEMICAL CO.
K842146 07/27/1984 HISTOPAQUE-1077 SIGMA CHEMICAL CO.
K842672 07/20/1984 MINIMUM ESSENTIAL MED. M0769 W/WO SIGMA CHEMICAL CO.
K842134 07/06/1984 SOMAS COOMASIE BLUE TOTAL PROTEIN ASSAY SOMAS MEDICAL INDUSTRIES, INC.
K842631 07/26/1984 STERELIS SEALING EQUIPMENT STERELIS CORP.
K841531 07/27/1984 PARA-TEK STRECK LABORATORIES, INC.
K840377 07/23/1984 SURG-A-STAT CARDIOVASCULAR TIP SUNCOAST MEDICAL MANUFACTURERS, INC.
K840375 07/23/1984 SURG-A-STAT LOOP TIP 15" SUNCOAST MEDICAL MANUFACTURERS, INC.
K840387 07/23/1984 SURG-A-STAT LOOP TIP 2" SUNCOAST MEDICAL MANUFACTURERS, INC.
K840370 07/23/1984 SURG-A-STAT VASECTOMY TIP SUNCOAST MEDICAL MANUFACTURERS, INC.
K841945 07/26/1984 ENTERAL FEEDING BOTTLE SUPERIOR PLASTIC PRODUCTS CORP.
K840762 07/13/1984 SILVERTORQUE CEREBRAL CATHETER SURGIMED CORP.
K841910 07/13/1984 KERR SEALAPEX ROOT CANAL SEALER SYBRON CORP.
K842132 07/18/1984 TYCOS SELF-CHECK/DIGITAL FEVER THERMO SYBRON CORP.
K841128 07/16/1984 RELAX STRESS REDUCTION SYS SYNAPSE SOFTWARE CORP.
K842598 07/26/1984 STAR HCG MONOCLONAL ANTIBODY IMMUNO SYNCOR INTL. CORP.
K842167 07/09/1984 TBG RIA SYNCOR INTL. CORP.
K842390 07/25/1984 SYVA IQ 190 DIGITAL PIPETTER DILUTER SYVA CO.
K841756 07/06/1984 LIEBEL-FLARSHEIM ACS 1000 CHEST X-RAY SYVRON CORP.
K831632 07/23/1984 MEDICAL RUBBER GLOVES-STERILE-SURGEONS TAGUM RUBBER INDUSTRIES, LTD.
K842619 07/26/1984 REGULAR PETAL SOFT PLASTIC APPLICATOR TAMBRANDS, INC.
K842618 07/26/1984 SUPER PETAL SOFT PLASTIC APPLICATOR TAMP TAMBRANDS, INC.
K842227 07/23/1984 AIMED DISPOSABLE SYRINGE, VARIOUS SIZES TECH-CONS LTD., INTL.
K842636 07/27/1984 TECHNICON H*1 SYSTEM TECHNICON INSTRUMENTS CORP.
K842109 07/27/1984 TECHNICON TEST POINT ASSAYED HEMATOLOGY TECHNICON INSTRUMENTS CORP.
K831148 07/17/1984 HIGH FILTRATION ISO-MASK TECNOL NEW JERSEY WOUND CARE, INC.
K841832 07/18/1984 GLOTTAL FREQUENCY ANALYSER TELTEC ELECTRONIC EQUIPMENT AB
K841740 07/18/1984 TERUMO DIGITAL CLINICAL THERMOMETER TERUMO MEDICAL CORP.
K841431 07/06/1984 RADIOGRAPHIC FILM PROCESSOR M-30CR & THE ALLEN PRODUCTS CO.
K842091 07/23/1984 DISPOS. ACU-CUT SOFT TISSUE BIOPSY THE HEALTHCARE GROUP LABORATORIES, INC.
K840742 07/13/1984 RIGHT ATRIAL CATHETER THE HEALTHCARE GROUP LABORATORIES, INC.
K841169 07/06/1984 CURITY RIG FOLEY CATH TRAY THE KENDAL CO.
K841310 07/31/1984 GASTROINTESTINAL DILATOR THOMAS J. FOGARTY, M.D.
K832290 07/31/1984 CYSTOFLO ANTIMICROBIAL URINARY DRAINAGE TRAVENOL LABORATORIES, S.A.
K841353 07/06/1984 CAUSSE SPONGE BOAT TREACE MEDICAL, INC.
K841354 07/06/1984 CURETTE TREACE MEDICAL, INC.
K841356 07/18/1984 ELEVATOR TREACE MEDICAL, INC.
K841359 07/18/1984 FENESTRA HOOK TREACE MEDICAL, INC.
K841355 07/03/1984 RIGHT ANGLED PICK TREACE MEDICAL, INC.
K841318 07/18/1984 A.S.A.P. TRIMEDYNE, INC.
K842012 07/06/1984 UMI CURVED CHEMONUCLEOLYSIS NEEDLE UNIVERSAL MEDICAL INSTRUMENT CORP.
K841942 07/19/1984 SEGURA BASKET VAN-TEC, INC.
K841891 07/09/1984 VARIAN 3300 & 3400 GAS CHROMATOGRAPHS VARIAN ASSOC., INC.
K842239 07/02/1984 VENTRESCREEN STREP A TEST VENTREX LABORATORIES, INC.
K842161 07/09/1984 VENTREZYME PHENYTOIN KIT IMMUNOASSAY VENTREX LABORATORIES, INC.
K840098 07/17/1984 MODEL 811 VERI/TENS & PO VERITE
K842584 07/27/1984 HEK VIROMED LABORATORIES, INC.
K842583 07/27/1984 SIRC VIROMED LABORATORIES, INC.
K842587 07/20/1984 GNC PLUS VITEK SYSTEMS, INC.
K842221 07/12/1984 WAKO GLUCOSE C WAKO PURE CHEMICAL INDUSTRIES, LTD.
K841511 07/12/1984 HAEMATURIA CATHETERS WARNE SURGICAL PRODUCTS, LTD.
K841876 07/13/1984 POLYURETHANE THERMAL DILUTION CATHET WATERS INSTRUMENTS, INC.
K840882 07/18/1984 HOME CARE WATER FLOTATION BED HC4/TC/H WESTERN MEDICAL, LTD.
K840881 07/18/1984 WATER FLOATION BED 800/TC/H WESTERN MEDICAL, LTD.
K842153 07/18/1984 ULTRASOUND TRANSMISSION GEL WPC BRANDS, INC.
K842027 07/18/1984 IVAC 3080 ENTERAL FEEDING PUMP Y
K842317 07/18/1984 SIGNAL ELECTRONIC CLINICAL THERMOMETER YUKOSHA CO., INC.
K842263 07/25/1984 MTP E.V. INFUSION PUMP ZIEHM INTERNATIONAL, INC.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact