FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
K771320 |
12/06/1977 |
CRYOSURGICAL EQUIPMENT |
A.S.M.O.T. |
|
K771909 |
12/20/1977 |
DUAL WAVELENGTH PHOTOMETER, 1177 |
ABBOTT LABORATORIES |
|
K772094 |
12/08/1977 |
LIFECARE I.V. PUMP - MODEL III |
ABBOTT LABORATORIES |
|
K772193 |
12/02/1977 |
NASSAL PRESSURE/FLOW RECORDER |
ADCO LABS. |
|
K772200 |
12/08/1977 |
YASARGIL ANEURYSM CLIPS |
AESCULAP INSTRUMENTS CORP. |
|
K772227 |
12/20/1977 |
CATH KIT, SUPERPUBIC |
AMERICAN HOSPITAL SUPPLY CORP. |
|
K772215 |
12/22/1977 |
UNCONJUGATED ESTRIOL RIA KIT |
AMERSHAM CORP. |
|
K772135 |
12/08/1977 |
BIOLOGICAL/CHEMICAL INDICATOR |
AMSCO CO. |
|
K772169 |
12/02/1977 |
AUDIOMETER, RECORDING, AUTOMATIC |
B&K INSTRUMENTS, INC. |
|
K772098 |
12/20/1977 |
DIGOXIN REAG. KIT FOR USE W/ARIA-II SYS |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K771737 |
12/20/1977 |
SUCTION CANISTER |
BEMIS HEALTH CARE |
|
K771894 |
12/22/1977 |
LDH ISOENZYME CONTROL |
BIO-REAGENTS & DIAGNOSTICS, INC. |
|
K772235 |
12/13/1977 |
HAND CONTROL ACCESS.-ELECTROSURG. UNITS |
CAMERON-MILLER, INC. |
|
K771043 |
12/20/1977 |
SWAN GANZ |
CLINCAL INSTRUMENTS CORP. |
|
K772109 |
12/06/1977 |
IN VITRO HUMAN TSH RIA TEST |
CLINICAL ASSAYS, INC. |
|
K772218 |
12/13/1977 |
CATHETER, SILICONE COATED |
CONCORD LABORATORIES, INC. |
|
K771609 |
12/20/1977 |
PEDIATRIC THYROXINE TEST SYS. T4 |
CORNING MEDICAL & SCIENTIFIC |
|
K772183 |
12/20/1977 |
THYROID BINDING GLOBULIN |
CORNING MEDICAL & SCIENTIFIC |
|
K772225 |
12/08/1977 |
PATELLAR PROSTHESIS |
CUTTER LABORATORIES, INC. |
|
K772292 |
12/20/1977 |
T-TUBE WHELAN-MOSS |
DAVOL, INC. |
|
K772120 |
12/20/1977 |
TOTAL HIP, CHARNELY TYPE |
DEPUY, INC. |
|
K772129 |
12/08/1977 |
MEDI-JECTOR |
DERATA CORP. |
|
K772188 |
12/22/1977 |
FSH RIA KIT (125I) |
DIAGNOSTIC PRODUCTS CORP. |
|
K772307 |
12/22/1977 |
PCO 2 ELECTROLYTE |
FISHER SCIENTIFIC CO., LLC. |
|
K772106 |
12/06/1977 |
PH CALIBRATION BUFFERS |
GENERAL DIAGNOSTICS |
|
K772283 |
12/15/1977 |
RX PEDESTAL TABLE |
GENERAL ELECTRIC CO. |
|
K772184 |
12/22/1977 |
X-RAY SYSTEM FOR DENTAL APPLICATION |
GENERAL ELECTRIC CO. |
|
K772232 |
12/15/1977 |
LIQUID NITROGEN SPRAY UNIT |
GILMORE LIQUID AIR CO. |
|
K772243 |
12/22/1977 |
TOXO TEST |
GULL LABORATORIES, INC. |
|
K772157 |
12/06/1977 |
CREATININE, 64972 |
HARLECO |
|
K772156 |
12/06/1977 |
ULTRACHEM PHOSPHORUS, 64973 |
HARLECO |
|
K772155 |
12/06/1977 |
ULTRACHEM TOTAL PROTEIN, #64974 |
HARLECO |
|
K772286 |
12/20/1977 |
FORCEPS, SUTURE, AUTO |
HARTMANN GROUP, INC. |
|
K772140 |
12/05/1977 |
SCANNING SYS., AUTO. COMP., ACS1000 |
HONEYWELL, INC. |
|
K772217 |
12/13/1977 |
TEMPERATURE MONITOR |
HUDSON OXYGEN THERAPY SALES CO. |
|
K771445 |
12/14/1977 |
HERPES I.D. TM TEST |
HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES |
|
K772233 |
12/20/1977 |
THERMOMETER RECAL ADAPTER |
INFO-CHEM |
|
K772199 |
12/13/1977 |
CAUTERIES, HOT WIRE, DISP. |
INTERMEDICS, INC. |
|
K772172 |
12/06/1977 |
DYNAZYME TM II CARDIAK-MB |
J.T. BAKER CHEMICAL CO. |
|
K771874 |
12/02/1977 |
J-VAC VACUUM TUBE |
JELCO LABORATORIES |
|
K772248 |
12/22/1977 |
ALBUMIN NEPHELOMETRIC ASSAY |
KALLESTAD LABORATORIES, INC. |
|
K772250 |
12/22/1977 |
ALPHA-1-ANTITRYPSIN NEPHEL. ASSAY |
KALLESTAD LABORATORIES, INC. |
|
K772246 |
12/22/1977 |
ALPHA-2-MACROGLOBULIN NEPHEL. ASSAY |
KALLESTAD LABORATORIES, INC. |
|
K772249 |
12/22/1977 |
COMPLEMENT C3 NEPHELOMETRIC ASSAY |
KALLESTAD LABORATORIES, INC. |
|
K772247 |
12/22/1977 |
COMPLEMENT C4 NEPHELOMETRIC ASSAY |
KALLESTAD LABORATORIES, INC. |
|
K772245 |
12/22/1977 |
HAPTOGLOBIN NEPHELOMETRIC ASSAY |
KALLESTAD LABORATORIES, INC. |
|
K772251 |
12/22/1977 |
IMMUNOGLOBULIN A NEPHEL. ASSAY |
KALLESTAD LABORATORIES, INC. |
|
K772252 |
12/22/1977 |
IMMUNOGLOBULIN G NEPHEL. ASSAY |
KALLESTAD LABORATORIES, INC. |
|
K772254 |
12/22/1977 |
IMMUNOGLOBULIN M NEPHEL. ASSAY |
KALLESTAD LABORATORIES, INC. |
|
K772253 |
12/22/1977 |
TRANSFERRIN NEPHELOMETRIC ASSAY |
KALLESTAD LABORATORIES, INC. |
|
K772242 |
12/20/1977 |
LAPAROSCOPY CONSOLE MODEL VIII |
KLI |
|
K772220 |
12/13/1977 |
PROBE, COAGULATION ACCESSORY |
KLI |
|
K772176 |
12/20/1977 |
CYSTIC FIBROSIS TESTING INSTRUMENT |
LABORATORY EQUIPMENT DESIGN CO. |
|
K771662 |
12/06/1977 |
AUTOMATIC ANALYZER |
LACHAT CHEMICALS, INC. |
|
K772211 |
12/22/1977 |
TEMP. ACRYLIC |
LACTONG CORP. |
|
K772201 |
12/20/1977 |
HEARING AID, BODY TYPE, MODEL H |
MAICO HEARING INSTRUMENTS, INC. |
|
K771701 |
12/13/1977 |
VESSEL-CLUDE |
MED GENERAL |
|
K771702 |
12/13/1977 |
VESSEL-STABILIZER |
MED GENERAL |
|
K772268 |
12/20/1977 |
DEMI-WALKER (REGULAR) |
MEDFUSION SYSTEMS, INC. |
|
K772267 |
12/20/1977 |
QUADRAPLEGIC WALKING AID |
MEDFUSION SYSTEMS, INC. |
|
K772269 |
12/20/1977 |
SETUP WALKER ADJUSTABLE |
MEDFUSION SYSTEMS, INC. |
|
K772270 |
12/20/1977 |
SETUP WALKER OVER TOILET CONSTRUC. |
MEDFUSION SYSTEMS, INC. |
|
K772271 |
12/20/1977 |
WALKER FOLDING ADJUSTABLE |
MEDFUSION SYSTEMS, INC. |
|
K771935 |
12/08/1977 |
DIGITAL THERMOMETER |
MEDICAL NETWORKS |
|
K772138 |
12/20/1977 |
ENDOTRACHEAL TUBE |
MEDLINE INDUSTRIES, INC. |
|
K771911 |
12/08/1977 |
PLASTIC STOPCOCK W/ EXTENSION TUBE |
MEDON CORP. |
|
K772202 |
12/20/1977 |
PULSE GENERATOR, A-V SEQ. |
MEDTRONIC VASCULAR |
|
K772088 |
12/06/1977 |
AMES T-3 UPTAKE STRIP TEST |
MILES LABORATORIES, INC. |
|
K771672 |
12/09/1977 |
MICROCULT-ID |
MILES LABORATORIES, INC. |
|
K771854 |
12/22/1977 |
SPINSEP-T3 |
NUCLEAR DIAGNOSTICS, INC. |
|
K772177 |
12/22/1977 |
TRI-TAB-RIA |
NUCLEAR MEDICAL LABORATORIES, INC. |
|
K772181 |
12/20/1977 |
PROPHYLACTIC |
OM INDUSTRIES, INC. |
|
K772060 |
12/20/1977 |
PROTECT IV GARD |
OMNICON MEDICAL CORP. |
|
K772289 |
12/21/1977 |
SCANNER, CT, 0400 |
PFIZER MEDICAL SYSTEMS, INC. |
|
K772291 |
12/21/1977 |
DIAG. CONSOLE, INDEPENDENT |
PFIZER, INC. |
|
K772136 |
12/20/1977 |
PERITONEAL CYCLER & MANIFOLD SET |
PHYSIO-CONTROL CORP. |
|
K772209 |
12/20/1977 |
CULTURE COLLEC. TRANS. SYS., DOUBLE DRY |
PRECISION DYNAMICS CORP. |
|
K772205 |
12/09/1977 |
CULTURE COLLEC. TRANS. SYS., DOUBLE WET |
PRECISION DYNAMICS CORP. |
|
K772210 |
12/09/1977 |
CULTURE COLLEC. TRANS. SYS., DOUBLE WET |
PRECISION DYNAMICS CORP. |
|
K772208 |
12/09/1977 |
CULTURE COLLEC. TRANS. SYS., SINGLE DRY |
PRECISION DYNAMICS CORP. |
|
K772206 |
12/09/1977 |
CULTURE COLLEC. TRANS. SYS., SINGLE WET |
PRECISION DYNAMICS CORP. |
|
K772207 |
12/20/1977 |
CULTURE COLLEC. TRANS. SYS., SINGLE WET |
PRECISION DYNAMICS CORP. |
|
K772301 |
12/20/1977 |
LAPAROSCOPY DRAPE, BOUNDARY |
PROCTER & GAMBLE MFG. CO. |
|
K771429 |
12/22/1977 |
DISP. TEFLON CONNHCTOR |
QUINTON, INC. |
|
K771426 |
12/20/1977 |
PEDIATRIC INFUSION "T" |
QUINTON, INC. |
|
K771574 |
12/06/1977 |
LEE ASPIRATION NEEDLE |
RADIATION DEVELOPMENT CO., INC. |
|
K772066 |
12/20/1977 |
PULLEN PLASTIC-PORE PLUGS |
RICHARD'S MEDICAL EQUIP., INC. |
|
K771936 |
12/06/1977 |
MICROBIOLOGICAL CULTURE MEDIUM |
SCOTT LABORATORIES, INC. |
|
K772237 |
12/13/1977 |
OXYGENATOR, BUBBLE |
SHILEY, INC. |
|
K771904 |
12/06/1977 |
GLYCEROL KINASE |
SIMMLER & SON, INC. |
|
K771905 |
12/06/1977 |
GLYCEROL SUBSTRATE |
SIMMLER & SON, INC. |
|
K771903 |
12/06/1977 |
LIPASE |
SIMMLER & SON, INC. |
|
K771906 |
12/06/1977 |
PHOSPHATE |
SIMMLER & SON, INC. |
|
K772196 |
12/22/1977 |
RECEPTAL ATS TRAUMA KGA1900L |
SORENSEN RESEARCH |
|
K772257 |
12/22/1977 |
ALKALINE PHOSPHATASE TEST SET |
STANBIO LABORATORY |
|
K771300 |
12/08/1977 |
INTRAVENOUS INFUSION PUMP |
STEWART-NAUMANN LABORATORIES |
|
K772224 |
12/15/1977 |
NERVE STIMULATOR, ELEC. TRANSCUTANEOUS |
STIMULATION TECHNOLOGY, INC. |
|
K772182 |
12/08/1977 |
SURGICAL GOWN, REINFORCED |
SURGIKOS, INC. |
|
K772178 |
12/08/1977 |
PACER MONITOR, PULSE WIDTH |
SURVIVAL TECHNOLOGY, INC. |
|
K772164 |
12/02/1977 |
PANORAMIC X-RAY SYSTEM MODEL A |
SYBRON CORP. |
|
K772179 |
12/20/1977 |
EMIT ANTIEPILEPTIC DRUG ASSAYS |
SYVA CO. |
|
K772170 |
12/22/1977 |
EMIT CENTRIFICHEM THYROXINE ASSAY |
SYVA CO. |
|
K772222 |
12/22/1977 |
NEBULIZER SET-2C7105 |
TRAVENOL LABORATORIES, S.A. |
|
K771589 |
12/13/1977 |
AUTO SUTURE |
U. S. SURGICAL CORP. |
|
K772299 |
12/21/1977 |
TRANSPARENT MANIFOLD |
UNI-RESEARCH |
|
K771823 |
12/20/1977 |
CATHETER, CARDIOVASCULAR |
USCI, DIV. C.R. BARD, INC. |
|
K772198 |
12/05/1977 |
CT SCANNER DIAGNOSTIC CONSOLE, REMOTE |
VARIAN ASSOC., INC. |
|
K772213 |
12/13/1977 |
LAMP DELIVERY SYS.-PHOTOCOAGULATION |
VARIAN ASSOC., INC. |
|
K772214 |
12/13/1977 |
OPHTHALMOSCOPE, BINOCULAR, INDIRECT |
VARIAN ASSOC., INC. |
|
K772306 |
12/22/1977 |
125I DIGOXIN TEST SET |
WIEN LABORATORIES, INC. |
|