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. |
|