FDA 510(k) Applications Received During February, 1978

FDA 510(k) Number Submission Date Device Name Applicant Contact
K782115 12/27/1978 ASTRA-VAC AB ASTRA
K782015 12/05/1978 A-GENT CK-MB ABBOTT LABORATORIES
K782014 12/05/1978 ANALYZER ABA-200 ABBOTT LABORATORIES
K782049 12/08/1978 BIOASSAY SYSTEM, MS-2 SERUM ABBOTT LABORATORIES
K782008 12/01/1978 DRESSING, ENVIRON WOUND ABBOTT LABORATORIES
K782013 12/05/1978 GONO-CELL ABBOTT LABORATORIES
K782113 12/19/1978 CAP, TAMPER PROOF PLASTIC ACACIA, INC.
K782005 12/04/1978 RADIATION ONCOLOGY SYSTEM ADAC LABORATORIES
K780336 02/28/1978 URINE SAMPLE KIT AMERICAN HOSPITAL SUPPLY CORP.
K782136 12/27/1978 GLUCOSE REAGENT SYSTEM AMERICAN MONITOR CORP.
K782118 12/27/1978 FUL-VUE AMERICAN OPTICAL CORP.
K782064 12/13/1978 TABLE, EXAMINING-TWO EIGHTY AMSCO CO.
K782092 12/14/1978 ARMBOARD CVER, DISPOSABLE ANAGO, INC.
K782144 12/27/1978 DISPOSABLE SURGICAL INSTRUMENT TIP ANAGO, INC.
K782091 12/14/1978 STOCKINETTE, DISPOSABLESURGICAL ANAGO, INC.
K782073 12/13/1978 DINAMAP MODELS 1160 AND 1165 APPLIED MEDICAL RESEARCH
K780307 02/21/1978 CARDIAC MINIGRAPH ARCO MEDICAL PRODUCTS CO.
K780297 02/21/1978 CARDIAC MINISCOPE & MINIGRAPH ARCO MEDICAL PRODUCTS CO.
K782146 12/27/1978 PACEMAKER, MODEL DDP ELECTRONIC CIRCUIT ARCO MEDICAL PRODUCTS CO.
K780259 02/15/1978 CATHETERIZATION TRAY & KIT ARGON MEDICAL CORP.
K782129 12/27/1978 LUPO-TEC ARMKEL, LLC.
K782001 12/04/1978 ROSEALAE ASMB
K780312 02/15/1978 AUTONOM AUTONOMIC EQUIPMENT SUPPLY CO,
K780190 02/06/1978 CATHETER STRAP & RUINARY BAY HOLDER BAKA MANUFACTURING CO., INC.
K782034 12/06/1978 INFUSION PUMP, MODEL AS*5 BAXTER HEALTHCARE CORP.
K780303 02/23/1978 AUTO ISO-FILTER COLLECTION TUBE CAP BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K780253 02/14/1978 REAGENT SYSTEM, ARIA II T3 UPTAKE BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K780260 02/15/1978 TEMP. SENSOR W/22MM FITTINGS BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K782138 12/27/1978 MONITOR, BECKMAN LB-3CO2 BECKMAN INSTRUMENTS, INC.
K782037 12/06/1978 SERACON-A BHP DIAGNOSTIX, INC.
K782038 12/06/1978 SERACON-C BHP DIAGNOSTIX, INC.
K782171 12/29/1978 SERACON-HDL BHP DIAGNOSTIX, INC.
K782170 12/29/1978 SERACON-LP BHP DIAGNOSTIX, INC.
K782039 12/06/1978 SERACON-N BHP DIAGNOSTIX, INC.
K780229 02/09/1978 ABDOMINAL BELT BIOMET, INC.
K780227 02/09/1978 BANDAGE SPREADER BLOCK BIOMET, INC.
K780231 02/09/1978 BANDAGE, ELASTIC BIOMET, INC.
K780230 02/09/1978 BED BOARD BIOMET, INC.
K780235 02/13/1978 ORTHOPEDIC DEVICES BIOMET, INC.
K780225 02/09/1978 ORTHOSISES DEVICES BIOMET, INC.
K780232 02/09/1978 RESTRAINT, PROTECTIVE BIOMET, INC.
K780226 02/09/1978 SPREADER BARS BIOMET, INC.
K780234 02/09/1978 TRACTION BELT, PELVIC BIOMET, INC.
K780228 02/09/1978 TRACTION UNITS BIOMET, INC.
K780233 02/09/1978 TRACTION WEIGHT BAGS BIOMET, INC.
K782145 12/27/1978 SPIROMETER, MINI POSITIVE BOEHRINGER LABORATORIES
K780214 02/08/1978 HEMO FEC BOEHRINGER MANNHEIM CORP.
K782032 12/06/1978 UNITEST AMYLASE BOEHRINGER MANNHEIM CORP.
K782156 12/22/1978 UNITEST CREATINE KINASE BOEHRINGER MANNHEIM CORP.
K782067 12/13/1978 DILATOR, MIZUTANI LAMINARIA TENT BRITISH MARKETING ENT., LTD.
K782059 12/07/1978 TRANSMITTER, TR-1 ECG BURDICK CORP.
K780167 02/02/1978 CATH KIT, URINE SPECIMEN C.R. BARD, INC.
K782082 12/14/1978 CATHETER, DIGITAL POSITRAL II C.R. BARD, INC.
K782071 12/13/1978 CATHETER, USCI GRUNTZIG/BALLOON C.R. BARD, INC.
K782107 12/19/1978 LAP SPONGE CARAPACE, INC.
K782022 12/05/1978 MICROLITH A MODEL 703 CARDIAC PACEMAKERS, INC.
K782023 12/05/1978 MICROLITH A MODEL 803 CARDIAC PACEMAKERS, INC.
K782062 12/07/1978 ANALYZER, OXYGEN MODEL M25RA & M25RAD CATALYST RESEARCH CORP.
K782080 12/13/1978 VENEER SYSTEM, MOSTIQUE LAMINATE CAULK CO., DIV. DENTSPLY
K782054 12/07/1978 LASER, CO2 SURGICAL CAVITRON CORP.
K782065 12/13/1978 LASER, PHOTOCOAGULATION CAVITRON CORP.
K780294 02/21/1978 G WRAP CEL-FIBE
K782153 12/26/1978 IMPRESSION TRAY, MDDS CUSTOM CHAYET AND SONNENRICH, P.C.
K780265 02/17/1978 FLOW REDUCING ANGULATION STAND CHESEBROUGH-POND'S U.S.A. CO.
K780264 02/17/1978 NEBULIZATION KIT & ADAPTER KIT CHESEBROUGH-POND'S U.S.A. CO.
K782109 12/19/1978 RIA KIT, GAMMACOAT CLINICAL ASSAYS, INC.
K780271 02/17/1978 COBE STOPCOCK COBE LABORATORIES, INC.
K782163 12/21/1978 THE BLUE MASK COLLECTOVAC, INC.
K782036 12/05/1978 TREMOR MONITOR COLUMBUS INSTRUMENTS INTL. CORP.
K782046 12/08/1978 C-CORD CONCEPT, INC.
K782090 12/14/1978 CLAMP, DISPOSABLE CONCORD LABORATORIES, INC.
K782155 12/22/1978 GENERAL EQUIPMENT COVER CONTOUR FABRICATORS, INC.
K780296 02/21/1978 THERAPY SCOOTER CONVAID PRODUCT DEVELOPMENT
K780169 02/02/1978 MASK, SURGICAL CONVERTORS
K782021 12/05/1978 A.V. FISTULA NEEDLE SET CORDIS CORP.
K782151 12/26/1978 ARTIFICIAL KIDNEY, C-DAK 0.6D CORDIS CORP.
K782114 12/20/1978 MONITOR, OXYCHEK OXYGEN CRITIKON COMPANY,LLC
K780208 02/07/1978 ASPIRATOR, MANUEL DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K782150 12/26/1978 FLUROMETER, DADE DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K780281 02/21/1978 IMMUFUGE DISP. LINER DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K782098 12/18/1978 REAGENT, LYSING AND HEMOGLOBIN DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K782122 12/27/1978 HEARING AID, MODEL AA DAHLBERG ELECTRONICS, INC.
K782121 12/27/1978 HEARING AID, MODEL GB DAHLBERG ELECTRONICS, INC.
K782087 12/14/1978 LEAD, SUTURELESS MYOCARDIAL DAIG CORP.
K782004 12/04/1978 LEAD, TIMED PACING, IMPLANTABLE DAIG CORP.
K780246 02/13/1978 PACEMAKER, ELECTRODE, PERMANENT & TEMP. DAIG CORP.
K782124 12/27/1978 IEC CENTRA-7 CENTRIFUGE MODEL 2362 DAMON CORP.
K780207 02/07/1978 LIQUISOL DIGOXIN RIA TEST KIT DAMON CORP.
K780280 02/21/1978 BALLOON PUMP DATASCOPE CORP.
K782026 12/05/1978 FLAT SILICONE DRAIN DAVOL, INC.
K782027 12/05/1978 HYSTERECTOMY "T" DRAIN DAVOL, INC.
K782028 12/05/1978 ROUND SILICONE DRAIN DAVOL, INC.
K780217 02/10/1978 ANTERIORS AND POSTERIORS, PLASTIC DENTSPLY INTL.
K782068 12/13/1978 MVS UNIT, MODEL SEU-8 AND DEU-8, "80" DENTSPLY INTL.
K780283 02/21/1978 INSERTER, PLUG, BONE, LIDGE DEPUY, INC.
K782123 12/27/1978 MULTIPLICITY OF PRODUCTS DEPUY, INC.
K780284 02/21/1978 TIBIAL PLATEU DEPUY, INC.
K780329 02/27/1978 TOTAL HIP, NEW ENGLAND BAPTIST DEPUY, INC.
K782172 12/29/1978 BRUSH/SPONGE, DISPOSABLE DEXIDE, INC.
K782173 12/29/1978 SURGERY BRUSH DEXIDE, INC.
K782125 12/27/1978 RIA KIT, KANAMYCIN DIAGNOSTIC PRODUCTS CORP.
K782126 12/27/1978 RIA KIT, SISOMICIN DIAGNOSTIC PRODUCTS CORP.
K782058 12/07/1978 CATHETER, BETA-CAP-PERITONEAL DRAVON MEDICAL, INC.
K782057 12/07/1978 CATHETER, RADIOPAQUE TENCKHOFF DRAVON MEDICAL, INC.
K780305 02/23/1978 CELL DYNATECH LABORATORIES, INC.
K782130 12/27/1978 MINI-DILUTER 2 DYNATECH LABORATORIES, INC.
K780295 02/21/1978 CALIBRATORS, CARBON DIOXIDE E.I. DUPONT DE NEMOURS & CO., INC.
K780248 02/13/1978 CRONEX QC-1 PROCESSOR E.I. DUPONT DE NEMOURS & CO., INC.
K780288 02/21/1978 BRACHEAL-LARGE VESSEL CLIP EDWARD WECK, INC.
K780286 02/21/1978 BRACHIAL-LARGE VESSEL APPROXIMATOR EDWARD WECK, INC.
K780287 02/21/1978 DAY HEAR HOOK EDWARD WECK, INC.
K780289 02/21/1978 NERVE APPROXIMATER EDWARD WECK, INC.
K780291 02/21/1978 ULNAR-RADIAL APPROXIMATER EDWARD WECK, INC.
K780290 02/21/1978 ULNAR-RADIAL CLIP EDWARD WECK, INC.
K780238 02/13/1978 PACEMAKER, PROLITH 23U. PULSE GENERATOR EDWARDS PACEMAKER SYSTEMS
K780173 02/02/1978 LYPOPROTEIN CHOLESTEROL TEST KIT ENVIRONMENTAL CHEMICAL SPECIALTIES
K780244 02/13/1978 CATHETERS, ARTERIAL EMBOLECTOMY EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
K782128 12/27/1978 THERA CHEM FISHER SCIENTIFIC CO., LLC.
K782160 12/21/1978 TOTAL IRON IN SERUM FISHER SCIENTIFIC CO., LLC.
K780272 02/17/1978 INFLUENZA HA ANTIGEN FLOW LABORATORIES, INC.
K780275 02/17/1978 INFLUENZA HA ANTIGEN A/USSR FLOW LABORATORIES, INC.
K780274 02/17/1978 INFLUENZA HI ANTISERUM FLOW LABORATORIES, INC.
K780276 02/17/1978 INFLUENZA HI ANTISERUM A/TEXAS FLOW LABORATORIES, INC.
K780273 02/17/1978 INFLUENZA HI PRESERUM FLOW LABORATORIES, INC.
K780277 02/17/1978 INFLUENZA HI PRESERUM A/TEXAS FLOW LABORATORIES, INC.
K780176 02/03/1978 DISPLAY SYSTEM MODEL 428 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K780177 02/03/1978 FETAL MONITOR MODEL 112 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K780285 02/21/1978 SOLUBLE COLLAGEN GENERAL DIAGNOSTICS
K780326 02/27/1978 GE CT/T 8800 SYSTEM GENERAL ELECTRIC CO.
K782029 12/05/1978 MAXI CAMERA 400T GENERAL ELECTRIC CO.
K780306 02/23/1978 LYOPHILIZED VIALS OF VCA AND VCAT GIBCO LABORATORIES LIFE TECHNOLOGIES, INC.
K782093 12/14/1978 DETECTOR PAD HALPERIN INSTITUTE, LTD, THE
K780172 02/02/1978 TRIGLYCERIDE INSTRUMENT APPLICATION HARLECO
K782053 12/07/1978 HEARING AID, POST-AURICULAR HC ELECTRONICS
K782076 12/13/1978 HT-110 MICROMINI HEALTH TECH
K780256 02/13/1978 HDL CHOLESTEROL METHOD HELENA LABORATORIES
K782035 12/06/1978 HEMESPEC HELENA LABORATORIES
K780324 02/27/1978 CAPNOMETER MODEL 47210A HEWLETT-PACKARD CO.
K780332 02/28/1978 CATHODE RAY TUBE DISPLAY MODEL 1340A HEWLETT-PACKARD CO.
K782094 12/14/1978 HILAR HI CHEM, INC.
K782105 12/19/1978 CATHETERS, H-H VENTRICULAR HOLTER-HAUSNER INTL.
K780320 02/24/1978 PASSIVE TENDON IMPLANT HOLTER-HAUSNER INTL.
K780322 02/27/1978 ANALYZER, PULMONARY FUNCTION HOSPAL MEDICAL CORP.
K780187 02/06/1978 NAIL, MASSIE II HOWMEDICA CORP.
K780317 02/24/1978 TOTAL HIP SYSTEM, HARRIS HD2 HOWMEDICA CORP.
K780330 02/28/1978 TOTAL HIP, LORD MADREPORIC HOWMEDICA CORP.
K782158 12/22/1978 SCANNER-SV HRL, INC.
K780216 02/10/1978 LIFESAVER, MANUAL #5160 HUDSON OXYGEN THERAPY SALES CO.
K780262 02/17/1978 DIRECT UREA NITROGEN TEST HYCEL, INC.
K782102 12/18/1978 HYCEL COUNTER 211 HYCEL, INC.
K782101 12/18/1978 HYCEL COUNTER 222 HYCEL, INC.
K782100 12/18/1978 HYCEL COUNTER 333 HYCEL, INC.
K782176 12/28/1978 HYCEL LDH-INT TEST HYCEL, INC.
K782116 12/27/1978 KETOSTEROID TEST, HYCEL-17 HYCEL, INC.
K780204 02/07/1978 CHEMISTRY CONTROL & REFERENCE SERUMS HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
K780335 02/28/1978 LAS-R HUMAN C1 ESTERASE INHIBITOR TEST HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
K780203 02/07/1978 THROMBOPLASTIN DRIED HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
K782070 12/12/1978 REAGENT, COCCI LATEX I M, INC.
K780325 02/27/1978 RID SYSTEM-HUMAN C-REACTIVE PROTEIN ICL SCIENTIFIC
K782041 12/07/1978 FIAX TEST KIT IDT, A DIVISION OF WHITTAKER M.A. BIOPRODUCTS
K782033 12/06/1978 CARDIAC CARE Q/C TEST KIT INSTRUMENTATION LABORATORY CO.
K780175 02/03/1978 RATE PROGRAMMER MODEL 520 INTERMEDICS, INC.
K780321 02/24/1978 PREGNANCY TEST KIT, OVER-THE-COUNTER INTL. DIAGNOSTIC, INC.
K782112 12/18/1978 PADS, MINI, MAXI INTL. PLAYTEX, INC.
K782111 12/18/1978 PADS, MINI, MAXI DEODORANT INTL. PLAYTEX, INC.
K782164 12/22/1978 STIMULATOR, MODEL 1-600 ELECTRIC NERVR IPCO CORP.
K782081 12/13/1978 RIA SYSTEM, PARATHYROID HORMONE ISO-TEX DIAGNOSTICS
K782003 12/04/1978 BAND AID* ADHESIVE BANDAGES JOHNSON & JOHNSON PROFESSIONALS, INC.
K780298 02/22/1978 ELECTRO-SURGICAL GROUNDING PAD JOHNSON & JOHNSON PROFESSIONALS, INC.
K780250 02/14/1978 HEMOPEXIN NEPHELOMETRIC ASSAYS KALLESTAD LABORATORIES, INC.
K780251 02/14/1978 NEPHELOMETER KALLESTAD LABORATORIES, INC.
K782052 12/07/1978 PROCESSOR, K750 COMPUTER/DATA KALLESTAD LABORATORIES, INC.
K780323 02/27/1978 QUANTITOPE 125-I GENTAMICIN RIA KIT KALLESTAD LABORATORIES, INC.
K782141 12/27/1978 LEVIGATOR, KEELER PHOKO KEELER OPTICAL PRODUCTS LTD.
K780211 02/08/1978 4-IN-1 DISP. CROWN & BRIDGE TRAY KERR CORPORATION (DANBURY)
K780213 02/08/1978 HANDPIECE, LIFT, ENDO KERR CORPORATION (DANBURY)
K782002 12/04/1978 TRACH-COLLAR KINETIC CONCEPTS, INC.
K780201 02/08/1978 SPEAKER-AMPLIFIER & RECORDER INTERFACE L&M ULTRASCOPE LIFE MONITORING SYS.
K780200 02/08/1978 ULTRASCOPE L&M ULTRASCOPE LIFE MONITORING SYS.
K780301 02/22/1978 CAULK TYLOK L.D. CAULK CO.
K782030 12/05/1978 LASER SYSTEM, SHARPLAN 791/HE, CO2 LASER INDUSTRIES LTD.
K782106 12/13/1978 COAGULATOR, MODEL 40 AARGON LASERTEK OY
K780268 02/17/1978 BLADDER CATH KIT W/OUT CATHETER LATEX IND., INC.
K780267 02/17/1978 CATH TRAY W/OUT CATHETER LATEX IND., INC.
K782159 12/22/1978 DIAGNOSTIC KIT, FERRITAB-FE-59 LEECO DIAGNOSTICS, INC.
K780263 02/17/1978 SHIELD LORVIC CORP.
K782154 12/22/1978 COLOSTOMY DEVICE, MACLET MAGNETIC MACLET MEDICAL DEVICES, INC.
K780269 02/21/1978 COMPUTER AUDIOMETER - MA25 MAICO HEARING INSTRUMENTS, INC.
K780270 02/21/1978 COMPUTER AUDIOMETER - MA26 MAICO HEARING INSTRUMENTS, INC.
K782051 12/08/1978 DRAPES, DISPOSABLE SURGICAL MARCO MFG.
K780222 02/09/1978 I.V. START KIT MARION LABORATORIES, INC.
K782016 12/05/1978 SPIROCARE 108-B MARION LABORATORIES, INC.
K782119 12/27/1978 DEBUTRON MARTIN ELECTRIC CO.
K782066 12/13/1978 EXETRELUT MCB MANUFACTURING CHEMISTS, INC.
K782140 12/27/1978 REMOVER, SOFT-SERT CONTACT LENS MCMURRAY AND PENDERGOST
K782133 12/27/1978 ODONTOSON 3 MDT CORP., INC.
K782006 12/01/1978 MEDGENERAL SINGLE-USE BULLDOG MED GENERAL
K782132 12/27/1978 PLETHYSMOGRAPH, STRAIN GAUGE MEDASONICS, INC.
K782168 12/29/1978 3-WAY STOPCOCK MEDEX, INC.
K782167 12/29/1978 DELTA FLOW MEDEX, INC.
K782048 12/08/1978 TEST KIT, IIF-ANA MEDICA CORP.
K782060 12/08/1978 MULTIFORMAT FILM CASSETTE TRANSPORT MEDISCAN, INC.
K780202 02/07/1978 MONOMER EVACUATION SYSTEM MEDISHIELD, INC.
K782120 12/27/1978 SPONGE SYSTEM, ROSERING CONTAIN-COUNT MEDLINE INDUSTRIES, INC.
K780302 02/22/1978 BLOOD FLOWMETER SYSTEM MEDTRONIC VASCULAR
K780327 02/27/1978 GENERATORS, ATRIAL INHIBITED PULSE MEDTRONIC VASCULAR
K782137 12/27/1978 MEDTRONIC MODEL 3797 ELECTRODE MEDTRONIC VASCULAR
K782108 12/19/1978 MEDTRONIC MODEL 546 MEDTRONIC VASCULAR
K780186 02/06/1978 NEUROMOD STIMULATOR MODEL 3723 MEDTRONIC VASCULAR
K782047 12/08/1978 PROCESSING SYSTEM, A2 IMAGE MEDTRONIC VASCULAR
K782075 12/13/1978 STIMULATOR, MODEL 7727 MEDTRONIC VASCULAR
K782043 12/08/1978 INDICATOR, BIPOLAR TEMPERATURE MICRONEX, INC.
K780310 02/21/1978 DERMATRON IONTOPHORESIS DEVICE MOTION CONTROL, INC.
K782095 12/18/1978 STOPCOCKS, MANIFOLDS NAMIC
K782152 12/26/1978 VALVE, AMBU PEEP NARCO AIR-SHIELDS
K782110 12/19/1978 RIA KIT, RIANEN CORTISOL NEW ENGLAND NUCLEAR
K780182 02/03/1978 TOBRAMYCIN 125I RIA KIT NEW ENGLAND NUCLEAR
K780279 02/21/1978 ICE-PAK, PDI NICE-PAK PRODUCTS, INC.
K782010 12/01/1978 HORMONE KIT, PARATHYROID NICHOLS INSTITUTE DIAGNOSTICS
K780174 02/02/1978 ORABRITE NORCLIFF THAYER, INC.
K782157 12/22/1978 IRMA TEST, NORDICLAB FERRITIN NORDICLAB INTL.
K782099 12/18/1978 RIA TEST, NORDICALB HPL NORDICLAB INTL.
K780292 02/21/1978 TRIA-PEG RIA DIAG. KIT NUCLEAR DIAGNOSTICS, INC.
K780308 02/23/1978 OREIA-T4 ORGANON, INC.
K780240 02/13/1978 PREDICTOR ORGANON, INC.
K780239 02/13/1978 BRACKET, METAL REINFORCED PLASTIC ORMCO CORP.
K782063 12/11/1978 PREGNANCY, SENSIDEX TUBE TEST ORTHO DIAGNOSTICS, INC.
K782166 12/29/1978 SLIDE TEST FOR PREGNANCY, GRAVINDEX 90 ORTHO DIAGNOSTICS, INC.
K780193 02/03/1978 HEEL LOOPS ORTHOPEDIC EQUIPMENT CO., INC.
K780192 02/03/1978 LEGREST, ELEVATING ORTHOPEDIC EQUIPMENT CO., INC.
K780191 02/03/1978 STRAP, LEGREST ORTHOPEDIC EQUIPMENT CO., INC.
K780194 02/03/1978 TOE LOOPS ORTHOPEDIC EQUIPMENT CO., INC.
K780184 02/03/1978 WHEELCHAIR ACCESSORIES ORTHOPEDIC EQUIPMENT CO., INC.
K780195 02/03/1978 WHEELCHAIR MUFF ORTHOPEDIC EQUIPMENT CO., INC.
K780183 02/03/1978 WHEELCHAIRS, MECHANICAL ORTHOPEDIC EQUIPMENT CO., INC.
K782018 12/05/1978 LEADS, IMPLANTABLE CARDIAC PACEMAKERS OSCOR INC.
K780197 02/06/1978 HEARING AID, BODY WORN OTICON CORP.
K780237 02/13/1978 DISPOSABLE CONTROLLED DROP PASTEUR PIPET OWENS-ILLINOIS, INC.
K782148 12/22/1978 HR UNIT PARKE-DAVIS CO.
K782055 12/11/1978 CREAM, SIGNA PARKER LABORATORIES, INC.
K780316 02/24/1978 RABBIT ANTIBODY TO DIGOXIN PCL-RIA, INC.
K780278 02/17/1978 RADIATION THERAPY TREAT. PLAN. SYS. PFIZER MEDICAL SYSTEMS, INC.
K782086 12/14/1978 AM-PEN SCREEN PFIZER, INC.
K782069 12/13/1978 TRAY, AUXILLARY BLOCK PHARMASEAL DIV., BAXTER HEALTHCARE CORP.
K782165 12/26/1978 PHASEAFILL PHASEALLOY
K780313 02/24/1978 HITACHI TECH-MOBLE DHC-121 PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K780319 02/24/1978 ORBITOME-UG PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K780331 02/28/1978 CHOLESTEROL RAPID SLAT KIT HDL PIERCE CHEMICAL CO.
K780168 02/02/1978 PARAMEDIC O2 KIT POHLMANN RESCUE PRODUCTS, INC.
K782139 12/27/1978 ZYLOX PREMIER DENTAL PRODUCTS CO.
K782117 12/27/1978 MARTIN-LEWIS MEDIUM PREPARED MEDIA LABORATORY, INC.
K780243 02/13/1978 TAMPON, RELY MODIFIED PROCTER & GAMBLE MFG. CO.
K780241 02/13/1978 COMPRESSION MULTISONIC QUALITONE
K782079 12/13/1978 ELECTRODE SYSTEM, QUIK-PREP QUINTON, INC.
K782072 12/13/1978 QUINTON STATUS 1000 QUINTON, INC.
K780166 02/01/1978 STRESS TEST SYSTEM QUINTON, INC.
K780199 02/07/1978 PROPHY ANGLES, R&R RANSOM AND RANDOLPH
K780198 02/07/1978 PROPHY CUPS, R&R RANSOM AND RANDOLPH
K780300 02/22/1978 HIP PLATE REMOVAL INSTRUMENT RICHARD'S MEDICAL EQUIP., INC.
K780299 02/22/1978 TOTAL KNEE SYSTEM RICHARD'S MEDICAL EQUIP., INC.
K780254 02/16/1978 DENTURE CLEANSER & TOOTHPASTE IN ONE RICHARDSON MERREL, INC.
K780293 02/21/1978 ELECTROSURGICAL UNIT RITTER CO.
K780179 02/03/1978 LIQUID SCINTILLATION COUNTER ROCHE MEDICAL ELECTRONICS, INC.
K782089 12/14/1978 MONITOR, HEART RATE MODEL 103 ROCHE MEDICAL ELECTRONICS, INC.
K782088 12/14/1978 MONITOR, HEART RATE MODEL 105 ROCHE MEDICAL ELECTRONICS, INC.
K780334 02/28/1978 ADHESIVE, BRACKET AND CONDITIONER RESIN ROCKY MOUNTAIN ORTHODONTICS, INC.
K780170 02/02/1978 ORTHODONTIC BRACKET PADS ROCKY MOUNTAIN ORTHODONTICS, INC.
K780205 02/07/1978 ORTHODONTIC BUCCAL TUBE ROCKY MOUNTAIN ORTHODONTICS, INC.
K782074 12/13/1978 VENTILATOR, MODEL AVA-1, ADULT RULE MEDICAL INSTRUMENTS, INC.
K780255 02/16/1978 NEEDLE DRIVER SCANLAN INTL., INC.
K782045 12/08/1978 MONITOR HS7 SCIENTIFIC & GENERAL PTY. LTD.
K782044 12/08/1978 MONITOR HS8 SCIENTIFIC & GENERAL PTY. LTD.
K780311 02/24/1978 DIAGNOSTIC KIT, CPK SCLAVO, INC.
K780188 02/06/1978 INFANT VENTILATOR MODEL 100 SECHRIST INDUSTRIES, INC.
K782143 12/27/1978 RIA KIT, GLUCOSE SERONO LABORATORIES, INC.
K782103 12/15/1978 RIA KIT, NEONATAL T4 SERONO LABORATORIES, INC.
K780261 02/16/1978 COVERSLIPPER SHANDON, INC.
K782077 12/13/1978 LANCER ICE CUBE SHERWOOD MEDICAL INDUSTRIES
K780220 02/10/1978 HOOD, INFANT OXYGEN SHILEY, INC.
K780185 02/06/1978 OXYGEN ANALYZER 110 SIEMENS CORP.
K782019 12/05/1978 CUTTER 888-00 INFUSION PUMP SIGMAMOTOR, INC.
K782020 12/05/1978 INFUSION PUMP, MODEL 5000 SIGMAMOTOR, INC.
K782127 12/27/1978 STIMULATOR, ELECTRICAL NERVE SOMATRONICS, INC.
K780257 02/15/1978 MICROSPEARS SPARTA INSTRUMENT CORP.
K780258 02/15/1978 MILK BATH CONCENTRATE SPARTA INSTRUMENT CORP.
K782007 12/01/1978 ROTARY SCALER STAR DENTAL MFG. CO.
K780309 02/23/1978 IN-THE-EAR HEARING AID, MODEL CE-3 STARKEY LABORATORIES, INC.
K780171 02/02/1978 ELBOW PROTECTOR STAT MEDICAL CORP.
K780209 02/06/1978 DILUTION SPIKE STERLING DRUG, INC.
K782061 12/11/1978 SPINAL SURGERY INSTRUMENTATION STUART DRUG & SURGICAL SUPPLY, INC.
K780282 02/21/1978 BARRIER HIP PACK W/ FABRIC 450 SURGIKOS, INC.
K780219 02/10/1978 ANALYSIS SYS., EMIT MAN. THYROXINE ASSAY SYVA CO.
K780218 02/10/1978 ANALYZER, EMIT AED ASSAYS TO CENTRIFICHE SYVA CO.
K782084 12/14/1978 EMIT PROCAINAMIDE CONTROL SET SYVA CO.
K782085 12/14/1978 EMIT THYROXINE ASSAY SYVA CO.
K782025 12/05/1978 GENTAMICIN FLUROIMMUNASSAY KIT TECHNIA DIAGNOSTICS LTD.
K782024 12/05/1978 RIA KIT, VITAMIN B12 TECHNIA DIAGNOSTICS LTD.
K782050 12/08/1978 PRINTER, TEK PRO TEK TALLY II TEKPRO
K782162 12/21/1978 BATTERY CHARGER, 171 PACEMAKER TELECTRONICS, INC.
K782097 12/18/1978 ELECTRODE LEAD MODEL 030-198 TELECTRONICS, INC.
K782149 12/26/1978 PULSE GENERATOR, IMPLANTABLE CARDIAC TELECTRONICS, INC.
K782161 12/21/1978 PULSE GENERATOR, MODEL 171 TELECTRONICS, INC.
K780333 02/28/1978 GAS CHROMATOGRAPHY HEAD SPACE SAMP. HS6 THE PERKIN-ELMER CORP.
K780242 02/13/1978 SPECTROPHOTOMETER, FLUORESCENCE M.650-10 THE PERKIN-ELMER CORP.
K782009 12/01/1978 RIA KIT, PROGESTERONE THE UPJOHN CO.
K782174 12/19/1978 PRESSURE ALARM THOMPSON RESPIRATION PRODUCTS, INC.
K780247 02/13/1978 IMPCO DISPOSABLE AORTIC PUNCH THORATEC LABORATORIES CORP.
K780181 02/03/1978 GLOVES, FLOOR TILLOTSON RUBBER CO., INC.
K780224 02/03/1978 MICROCELL COUNTER MODEL CC-108 TOA MEDICAL ELECTRONICS USA, INC.
K780318 02/24/1978 MODULAR SCANNING DENSITOMETER SYS. TRANSIDYNE GENERAL CORP.
K782134 12/27/1978 FILTER FOR HYPERALIMENTATION SET TRAVENOL LABORATORIES, S.A.
K780223 02/09/1978 PARENTERAL INFUSION CONTROLLER TRAVENOL LABORATORIES, S.A.
K780189 02/06/1978 PLATELET ROTATOR TRAVENOL LABORATORIES, S.A.
K782083 12/14/1978 VAGATEX VAGATEX
K780206 02/07/1978 GENERATOR, ELECTROSURGICAL VALLEYLAB, INC.
K782131 12/27/1978 PULSETAKER VAN, COTT, BAGLEY, CORNWALL & MCCARTH
K790243 12/29/1978 CANNULAS VISITEC CO.
K790244 12/29/1978 CYSTOTOMES VISITEC CO.
K782169 12/29/1978 NEEDLES, CANNULAS, CYSTOTOMES VISITEC CO.
K780215 02/09/1978 EYESCOPE VISUAL METHODS, INC.
K782056 12/11/1978 CORD, ENTEROBACTERIACEAE BIOCHEMICAL VITEK SYSTEMS, INC.
K780328 02/27/1978 PULMONARY FUNCTION TESTER, COMPUTERIZED WARREN E. COLLINS, INC.
K782175 12/28/1978 CARTRIDGE HOLDER, RCM 100 WATERS ASSOC., INC.
K780245 02/13/1978 RECORDER, RE-100P HOT STYLUS STRIP CHART WATERS ASSOC., INC.
K782142 12/27/1978 ILLIMINATOR, MODEL 265 NASAL WELCH ALLYN, INC.
K782104 12/19/1978 PASTE, PRO CARE PROPHYLAXIS YOUNG DENTAL MANUFACTURING CO 1, LLC.
K782096 12/18/1978 INSTRUMENTS, OVERREFRACTION SYSTEM ZEISS HUMPHREY SYSTEM
K780178 02/03/1978 TEST SYS. FOR NDNA ANTIBODY DETERM. ZEUS SCIENTIFIC, INC.
K780266 02/17/1978 BONE CEMENT APPLICATOR ZIMMER, INC.


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