| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K813265 |
11/20/1981 |
3M STERI-STRIP ANTIMICROBIAL SKIN CLOS |
3M COMPANY |
|
| K813180 |
11/12/1981 |
SCOTCHBOND DENTAL ADHESIVE |
3M COMPANY |
|
| K813218 |
11/09/1981 |
TDX VANCOMYCIN |
ABBOTT LABORATORIES |
|
| K813175 |
11/09/1981 |
20CC GLASS CONTROL SYRINGE |
ABCO DEALERS, INC. |
|
| K813323 |
11/24/1981 |
THIGH CUFF: X-LARGE CUFF |
ABCO DEALERS, INC. |
|
| K813103 |
11/03/1981 |
ACKRAD INCISION & DRAIN SET |
ACKRAD LABORATORIES |
|
| K813128 |
11/05/1981 |
MOBIL-AID AUTOMATIC EXPOSURE CONTROL |
ADVANCED INSTRUMENT DEVELOPMENT, INC. |
|
| K813356 |
11/27/1981 |
DEVICE FOR REPOSITIONING A BET PATIENT |
ALI-OOP CO., INC. |
|
| K813127 |
11/05/1981 |
SODIUM & POTASSIUM PRODUCTS |
ALKO DIAGNOSTIC CORP. |
|
| K813333 |
11/24/1981 |
ALPHATEMP CLINICAL THERMOMETER |
ALPHA OMEGA ENGINEERING CORP. |
|
| K813078 |
11/02/1981 |
CONTURA DISPOS. SURG. FACE MASK |
AMERICAN CONVERTORS DIV., AMERICAN PHARMASEAL |
|
| K813296 |
11/23/1981 |
CONVERTORS STERILE DISP. LAP SPONGE II |
AMERICAN CONVERTORS DIV., AMERICAN PHARMASEAL |
|
| K813148 |
11/06/1981 |
S/P VORTEX MIXER |
AMERICAN DADE |
|
| K813149 |
11/06/1981 |
S/P VORTEX MIXER JR. |
AMERICAN DADE |
|
| K813092 |
11/02/1981 |
ACCUPRO I.V. ADMINISTRATION SET |
AMERICAN MCGAW |
|
| K813076 |
11/02/1981 |
PHOSPHOTUNGSTATE REDUCTION, URIC ACID |
AMERICAN MONITOR CORP. |
|
| K813215 |
11/09/1981 |
Y-GLUTAMYLTRANSFERASE |
AMERICAN MONITOR CORP. |
|
| K813338 |
11/24/1981 |
BIOPSY NEEDLES & TRAYS |
AMERICAN PHARMASEAL DIV. AHSC |
|
| K813336 |
11/24/1981 |
LAZARUS-NELSON PERITONEAL LAVAGE TRAY |
AMERICAN PHARMASEAL DIV. AHSC |
|
| K813335 |
11/24/1981 |
PERCUTANEOUS TRANSHEPATIC CHOLANG. TRAY |
AMERICAN PHARMASEAL DIV. AHSC |
|
| K813337 |
11/24/1981 |
SKINNY CHIBA NEEDLE & TRAY |
AMERICAN PHARMASEAL DIV. AHSC |
|
| K813168 |
11/16/1981 |
LIQUIZYME GLUCOSE REAGENT |
AMERICAN RESEARCH PRODUCTS CO. |
|
| K813359 |
11/30/1981 |
MYCO-IMMUNE TM HISTOPLASMIN LATEX AGGL |
AMERICAN SCIENTIFIC PRODUCTS |
|
| K813097 |
11/03/1981 |
ANAGO STERILE PRODUCTS; STOCKINETTES |
ANAGO, INC. |
|
| K813287 |
11/23/1981 |
CC-201 ECG MONITORING SYSTEMS |
ANTHRO-METRICS CORP. |
|
| K813231 |
11/17/1981 |
TOURNIQUET |
ASPEN LABORATORIES, INC. |
|
| K813099 |
11/03/1981 |
BACK RIE |
BACK RITE |
|
| K813194 |
11/17/1981 |
AUTO-SYRINGE SUB-CUTEANEOUS SET |
BAXTER HEALTHCARE CORP. |
|
| K813369 |
11/30/1981 |
GRAM STAIN REAGENTS AND KIT |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
| K813220 |
11/09/1981 |
REGU-VAC OXYGENATING SUCTION CATHETER |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
| K813160 |
11/16/1981 |
BECKMAN SYSTEM E4A |
BECKMAN INSTRUMENTS, INC. |
|
| K813216 |
11/09/1981 |
SECURE FDI TEST KIT |
BECKMAN INSTRUMENTS, INC. |
|
| K813253 |
11/19/1981 |
IC-5 VENTILATOR |
BIO-MED DEVICES, INC. |
|
| K813202 |
11/13/1981 |
THERMALOG S STEAM STERILIZATION INTEGRA |
BIO-MEDICAL SCIENCES, INC. |
|
| K813171 |
11/16/1981 |
PHENYLALANINE UV KINETIC TEST KIT |
BIOCHEMICALS, INC. |
|
| K813261 |
11/20/1981 |
RIAGEN PAP RIA |
BIOGENEX LABORATORIES |
|
| K813089 |
11/02/1981 |
CEMENT RING |
BIOMET, INC. |
|
| K813244 |
11/18/1981 |
UV URIC ACID DETERMINATION |
BIORENT DIAGNOSTIC, INC. |
|
| K813084 |
11/02/1981 |
CYSTOFIX SUPRAPUBIC BLADDER DRAIN SET |
BURRON MEDICAL PRODUCTS, INC. |
|
| K813236 |
11/10/1981 |
EPICAN EPIDURAL CANNULA, BEVEL ACCORD |
BURRON MEDICAL PRODUCTS, INC. |
|
| K813085 |
11/02/1981 |
HEPAFIX BIOPSY NEEDLE SET |
BURRON MEDICAL PRODUCTS, INC. |
|
| K813081 |
11/02/1981 |
HISTOCAN BIOPSY NEEDLE |
BURRON MEDICAL PRODUCTS, INC. |
|
| K813259 |
11/20/1981 |
IN-STOPPER (INJECTION CAP |
BURRON MEDICAL PRODUCTS, INC. |
|
| K813195 |
11/12/1981 |
MEDIFIX GRADUATED SCALE |
BURRON MEDICAL PRODUCTS, INC. |
|
| K813186 |
11/16/1981 |
PERFIX SET FOR EPIDURAL ANESTHESIA W/TUO |
BURRON MEDICAL PRODUCTS, INC. |
|
| K813179 |
11/12/1981 |
PERICAN, EPIDURAL CANNULA |
BURRON MEDICAL PRODUCTS, INC. |
|
| K813165 |
11/10/1981 |
PLEXUFIX BRACHIAL PLEXUS ANESTH. NEEDLE |
BURRON MEDICAL PRODUCTS, INC. |
|
| K813082 |
11/02/1981 |
UREOFIX 500 URINE MEASURING SYSTEM |
BURRON MEDICAL PRODUCTS, INC. |
|
| K813083 |
11/02/1981 |
VENOFIX SCALP VEIN SET |
BURRON MEDICAL PRODUCTS, INC. |
|
| K813272 |
11/20/1981 |
A-1 IN-HOME PREGNANCY TEST |
C.F. MEDICAL, INC. |
|
| K813105 |
11/03/1981 |
PRESSURE INFUSION PUMP |
CALBIO, INC. |
|
| K813219 |
11/09/1981 |
CARAFLEX ELASTIC POLYMER PLASTER BANDA |
CARAPACE, INC. |
|
| K813361 |
11/30/1981 |
ADHESIVE STRIP(MULTIPLE) |
CEDERROTH, INC. USA |
|
| K813364 |
11/30/1981 |
MEDICAL TAPE (MULTIPLE) |
CEDERROTH, INC. USA |
|
| K813365 |
11/30/1981 |
MULTIPLE BANDAGE OR DRESSING |
CEDERROTH, INC. USA |
|
| K813456 |
11/27/1981 |
HIGH VOLTAGE GALVANIC STIMULATOR 550 |
CHATTANOOGA GROUP, INC. |
|
| K813593 |
11/27/1981 |
INTELECT MODEL 200 |
CHATTANOOGA GROUP, INC. |
|
| K813594 |
11/27/1981 |
INTELECT MODEL 700 |
CHATTANOOGA GROUP, INC. |
|
| K813172 |
11/16/1981 |
CONDOM-MULTIPAL STYLES |
CIRCLE RUBBER CORP. |
|
| K813185 |
11/16/1981 |
SALICYLATE STAT-PAK |
CLINTECH DIAGNOSTICS CORP. |
|
| K813123 |
11/04/1981 |
EPC FILTER |
CODMAN & SHURTLEFF, INC. |
|
| K813107 |
11/03/1981 |
COMPUDIAL/KP-1 |
COMPUTER DIALYSIS SYSTEMS, INC. |
|
| K813298 |
11/23/1981 |
CONPHAR DELEE HILLIS STETHOSCOPE |
CONPHAR, INC. |
|
| K813306 |
11/23/1981 |
CONPHAR DIGITAL THERMOMETER |
CONPHAR, INC. |
|
| K813297 |
11/23/1981 |
CONPHAR LARYNGOSCOPE |
CONPHAR, INC. |
|
| K813305 |
11/23/1981 |
CONPHAR OTOSCOPE |
CONPHAR, INC. |
|
| K813299 |
11/23/1981 |
CONPHAR OTOSCOPE/OPTHALMASCOPE |
CONPHAR, INC. |
|
| K813302 |
11/23/1981 |
CONPHAR PALM ANEROID SPHYGMOMANOMETER |
CONPHAR, INC. |
|
| K813304 |
11/23/1981 |
CONPHAR, TUNING FORKS |
CONPHAR, INC. |
|
| K813303 |
11/23/1981 |
CONPHAR, WALL ANEROID SPHYGMOMANOMETER |
CONPHAR, INC. |
|
| K813183 |
11/16/1981 |
NO-BOIL VITABIN B12 5760 FOLATE 125I |
CORNING MEDICAL & SCIENTIFIC |
|
| K813345 |
11/25/1981 |
CRITIKON I.V. CATHETER PLACEMENT UNIT |
CRITIKON COMPANY,LLC |
|
| K813347 |
11/27/1981 |
CRITIKON TRANSCUTANEOUS GAS MONITORS |
CRITIKON COMPANY,LLC |
|
| K813286 |
11/23/1981 |
PRE-PACK TENS |
CUNNINGHAM WOODLAND, INC. |
|
| K813284 |
11/23/1981 |
VENOUS CANNULA TRAY |
CUNNINGHAM WOODLAND, INC. |
|
| K813161 |
11/10/1981 |
FLO TEM II (BLOOD/FLUID WARMER |
DATACHEM, INC. |
|
| K813182 |
11/12/1981 |
DATASCOPE MODIFIED #82 IABP SYSTEM |
DATASCOPE CORP. |
|
| K813222 |
11/09/1981 |
MODEL 4200 ELLESTAD STRESS TEST ANALYZER |
DEL MAR AVIONICS |
|
| K813357 |
11/27/1981 |
CAULK OPAQUER |
DENTSPLY INTL. |
|
| K813313 |
11/24/1981 |
BIOMICROSCOPY CONTACT LENS |
DESIGN RESEARCH ASSOC., INC. |
|
| K813315 |
11/24/1981 |
CALIPER-OPTHALMIC |
DESIGN RESEARCH ASSOC., INC. |
|
| K813314 |
11/24/1981 |
NLD IMPLANT SET |
DESIGN RESEARCH ASSOC., INC. |
|
| K813203 |
11/13/1981 |
C-TERMINAL PTH RIA TEST KIT, DSL-1000 |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
|
| K813217 |
11/09/1981 |
DIGITAL FLUROGRAPHIC IMAGING SYSTEM |
DIASONICS, INC. |
|
| K813267 |
11/20/1981 |
DISPOSABLE DIAPHRAGM DOMES |
DIO-MED CORP. |
|
| K813367 |
11/30/1981 |
CUATICO MYELOGRAPHY NEEDLES |
DLP, INC. |
|
| K813368 |
11/30/1981 |
DISPOSABLE CHIBA-TYPE NEEDLE |
DLP, INC. |
|
| K813174 |
11/06/1981 |
BRADYCARDIA ALARM |
DOUGLAS SCIENTIFIC PRODUCTS |
|
| K813206 |
11/13/1981 |
HEARING AID CUSTOM ITE |
DUVAN ACOUSTICS, INC. |
|
| K813176 |
11/12/1981 |
GEL ELECTRODE |
DYN-A-MED PRODUCTS |
|
| K813318 |
11/24/1981 |
MINI-SHAKER |
DYNATECH CORP. |
|
| K813260 |
11/20/1981 |
TRACHEOSTOMY CARE TRAY |
E.M. ADAMS |
|
| K813147 |
11/06/1981 |
KODAK INTENSIFYING SCREEN 80-175 |
EASTMAN KODAK COMPANY |
|
| K813139 |
11/06/1981 |
KODAK INTENSIFYING SCREEN SO-168 |
EASTMAN KODAK COMPANY |
|
| K813095 |
11/03/1981 |
GASTRIC JUICES SUCTION PUMP |
EGNELL, INC. |
|
| K813312 |
11/24/1981 |
UNIVERSAL SUCTION PUMP TYPE EUS |
EGNELL, INC. |
|
| K813246 |
11/18/1981 |
MEDICAL MULTILITH PULSE GENERA-1140 |
ELA MEDICAL, INC. |
|
| K813181 |
11/12/1981 |
ELECTROC-GYM |
ELECTROLA |
|
| K813264 |
11/20/1981 |
D6ZO DISPOSABLE HEAT EXCHANGER |
ELECTROMEDICS, INC. |
|
| K813275 |
11/23/1981 |
EPCOM EMS SCAN II |
EPCOM MEDICAL SYSTEMS, INC. |
|
| K813230 |
11/10/1981 |
AFTERLOADING GYNECOLOGICAL APPLICATOR |
ESI |
|
| K813124 |
11/04/1981 |
ETHICON* SKIN CLOSURE TAPE |
ETHICON, INC. |
|
| K813138 |
11/06/1981 |
ETHICON* TEMP. CARDIAC PACING WIRE |
ETHICON, INC. |
|
| K813360 |
11/30/1981 |
DERMAFILE (CAT. # 38 |
EXCO, INC. |
|
| K813143 |
11/05/1981 |
DESILET |
EXCO, INC. |
|
| K813144 |
11/05/1981 |
INTRAFLON, INTRAFLUX, INTRAVALVE |
EXCO, INC. |
|
| K813142 |
11/05/1981 |
LEADER-CATH |
EXCO, INC. |
|
| K813140 |
11/05/1981 |
VYGON EXTENSION TUBES & CONNECTORS |
EXCO, INC. |
|
| K813141 |
11/05/1981 |
VYGON STOPCOCKS & RAMPS(MANIFOLDS) |
EXCO, INC. |
|
| K813205 |
11/13/1981 |
INTERSEPT CARDIOTOMY RESERVOIR/FILTER |
EXTRACORPOREAL MEDICAL SPECIALITIES, INC. |
|
| K813198 |
11/13/1981 |
RESPIRATOR MONITOR |
FLORIDA MEDICAL EQUIPMENT REPAIR, INC. |
|
| K813249 |
11/18/1981 |
HELP-MATE |
G & W APPLIED SCIENCE LABORATORIES |
|
| K813342 |
11/25/1981 |
GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION |
GAMMA BIOLOGICALS, INC. |
|
| K813159 |
11/16/1981 |
VACUSHIELD TM |
GELMAN SCIENCES, INC. |
|
| K813173 |
11/16/1981 |
VRT TABLE W/INTEGRATING TUBE STAND/ELEV |
GENERAL ELECTRIC CO. |
|
| K813358 |
11/30/1981 |
GERARD MEDICAL ELECTRODE TESTER |
GERARD MEDICAL ENTERPRISES, INC. |
|
| K813258 |
11/19/1981 |
ULTIMATE-AIRE |
HAWKINS INTL. |
|
| K813254 |
11/19/1981 |
JET VENTILATOR |
HEALTHDYNE, INC. |
|
| K813341 |
11/25/1981 |
WOUND-EVAC |
HERITAGE MEDICAL PRODUCTS |
|
| K813370 |
11/30/1981 |
ELECTROLYTE GEL |
HI CHEM, INC. |
|
| K813270 |
11/20/1981 |
FECAL INCONTINENCE COLLATOR |
HOLLISTER, INC. |
|
| K813269 |
11/20/1981 |
TWO PIECE OSTOMY SYSTEM |
HOLLISTER, INC. |
|
| K813125 |
11/04/1981 |
MICRO TRANSDUCER CATHETERS |
HONEYWELL, INC. |
|
| K813371 |
11/30/1981 |
GROSSE AND KEMPF LOCKING NAIL SYS. |
HOWMEDICA CORP. |
|
| K813328 |
11/24/1981 |
MYERSON/KENSON GP POLYMER |
HOWMEDICA CORP. |
|
| K813080 |
11/02/1981 |
WOUND DRAINAGE MANAGEMENT SYSTEMS |
HOWMEDICA CORP. |
|
| K813320 |
11/24/1981 |
MODEL 6200 OXYGEN CONCENTRATOR |
HUDSON OXYGEN THERAPY SALES CO. |
|
| K813209 |
11/06/1981 |
TRACHEOBRONCHIAL SUCTION CATHETER |
HYDROMER, INC. |
|
| K813251 |
11/19/1981 |
UNSCENTED MENSTRUAL PADS-MAXI PADS |
I.C.D. INDUSTRIES, INC. |
|
| K813252 |
11/19/1981 |
UNSCENTED MENSTRUAL PADS-MINI PADS |
I.C.D. INDUSTRIES, INC. |
|
| K813332 |
11/24/1981 |
BRISTOL BALLON INTRODUCER, MANDRIL SET |
INMED CORP. |
|
| K813169 |
11/12/1981 |
CELESTIN PULSION ESOPHOGEAL PROSTHESIS |
INMED CORP. |
|
| K813317 |
11/24/1981 |
DISP. HYPERINFLATION BAG SYSTEM |
INTEC MEDICAL, INC. |
|
| K813162 |
11/10/1981 |
INTERAD WHOLE BODY CT SCANNER |
INTERAD SYSTEMS, INC. |
|
| K813135 |
11/05/1981 |
MODEL 486-01 PACEMAKER LEAD |
INTERMEDICS, INC. |
|
| K813136 |
11/05/1981 |
MODEL 492-01 PACEMAKER LEAD |
INTERMEDICS, INC. |
|
| K813087 |
11/02/1981 |
ABURIA-CK RIA TEST KIT |
INTL. IMMUNOASSAY LABORATORIES, INC. |
|
| K813086 |
11/02/1981 |
ANDRIA-FSH RIA TEST KIT |
INTL. IMMUNOASSAY LABORATORIES, INC. |
|
| K813213 |
11/09/1981 |
SHARIA-LH RIA KIT FOR QUANTITATION HORMO |
INTL. IMMUNOASSAY LABORATORIES, INC. |
|
| K813104 |
11/03/1981 |
POWER DRIVE WHEELCR |
INTL. MEDICAL EQUIPMENT CORP. |
|
| K813319 |
11/24/1981 |
ASPIRATOR VENTURI SYSTEM MODEL 55-JV |
J. H. EMERSON CO. |
|
| K813225 |
11/10/1981 |
GEL FLOTATION CUSHION |
JEFFERSON INDUSTRIES, INC. |
|
| K813226 |
11/10/1981 |
GEL FLOTATION MATTRESS |
JEFFERSON INDUSTRIES, INC. |
|
| K813242 |
11/17/1981 |
QUANTIMETRIC 2 TEST KIT |
KALLESTAD LABORATORIES, INC. |
|
| K813348 |
11/27/1981 |
YOSHIDA RIDO-F, MODEL LM-01 |
KAYCOR INTL., LTD. |
|
| K813325 |
11/24/1981 |
KEY MED FOREIGN BODY REMOVAL TUBE |
KEYMED, INC. |
|
| K813133 |
11/05/1981 |
KEYMED KEY LIGHT |
KEYMED, INC. |
|
| K813207 |
11/18/1981 |
K51,K52 ENVIRONMENT ENCLOSURE |
KOHLER |
|
| K813208 |
11/18/1981 |
K60 HABITAT ENVIRONMENT ENCLOSURE |
KOHLER |
|
| K813331 |
11/24/1981 |
P51 ANGIOPLASTY PRESSURE TRANSDUCER |
KONIGSBERG INSTRUMENTS, INC. |
|
| K813326 |
11/24/1981 |
TROCKI BODY VENTRILATOR |
L.T.D. 3 CO. |
|
| K813191 |
11/17/1981 |
SHIGELLA SERA-CHEK |
LAB ABILITY, INC. |
|
| K813190 |
11/16/1981 |
SOFT PLATE CUSHION |
LEONARD RUSSO CO. |
|
| K813221 |
11/09/1981 |
TOXOELISA TEST KIT |
M.A. BIOPRODUCTS |
|
| K813158 |
11/16/1981 |
RDP-2000 |
MACHLETT LABORATORIES, INC. |
|
| K813247 |
11/18/1981 |
KANESON/COMFORT PLUS MANUAL BREAST PUMP |
MARSHALL ELECTRONICS, INC. |
|
| K813100 |
11/03/1981 |
BIO-STIMULATOR, MODEL 400 |
MED-WESTERN ELECTRONICS, INC. |
|
| K813131 |
11/05/1981 |
INTERFACE ARTERIAL BLOOD FILTER |
MEDICAL, INC. |
|
| K813455 |
11/30/1981 |
PUMP & DETECTOR |
MEDLOG GMBH MARKETING SERVICES |
|
| K813188 |
11/16/1981 |
INFANT PHOTOTHERAPY LIGHT |
MONTROSE PHOTOTHERAPY SUPPLY |
|
| K813214 |
11/09/1981 |
INFANT PHOTOTHERAPY MASK |
MONTROSE PHOTOTHERAPY SUPPLY |
|
| K813187 |
11/16/1981 |
PILLING LACRIMAL INTUBATION SYSTEM |
NARCO SCIENTIFIC |
|
| K813256 |
11/19/1981 |
HYPODERMIC & SUTURE NEEDLES |
NEEDLE INDUSTRIES(USA), INC. |
|
| K813288 |
11/23/1981 |
NEIA TRANSFERRIN ENZYMEIMMUNOASSAY |
NEW ENGLAND IMMUNOLOGY ASSOC. |
|
| K813200 |
11/13/1981 |
GDC-1136 CASTING ALLOY FOR PORCELAIN-FU |
NEY |
|
| K813266 |
11/20/1981 |
NIHON KOHDEN ELECTROCARDIOGRAPH |
NIHON KOHDEN AMERICA, INC. |
|
| K813228 |
11/10/1981 |
CONNECTING TUBE |
NORTHERN MEDICAL INDUSTRIES |
|
| K813197 |
11/13/1981 |
OXYGEN CONNECTING TUBE |
NORTHERN MEDICAL INDUSTRIES |
|
| K813163 |
11/10/1981 |
SUCTION CATHETER |
NORTHERN MEDICAL INDUSTRIES |
|
| K813137 |
11/05/1981 |
CORREC TORR TM |
NORTON PERFORMANCE PLASTICS CORP. |
|
| K813350 |
11/27/1981 |
NOVAMETRIX MODEL 807 TRANSCUT. MONITOR |
NOVAMETRIX MEDICAL SYSTEMS, INC. |
|
| K813352 |
11/27/1981 |
NOVAMETRIX MODEL 816A TRANSCUT. OXYGEN |
NOVAMETRIX MEDICAL SYSTEMS, INC. |
|
| K813351 |
11/27/1981 |
NOVAMETRIX NAVAGRAPH MODEL 312 RECORDER |
NOVAMETRIX MEDICAL SYSTEMS, INC. |
|
| K813274 |
11/23/1981 |
BLOOD POOL & SUBVETINAL FLUID ASPIRATOR |
OPTICAL MICRO SYSTEMS, INC. |
|
| K813273 |
11/20/1981 |
EMERGENCY POWER PAC (EMPAC) |
OPTICAL MICRO SYSTEMS, INC. |
|
| K813293 |
11/23/1981 |
ORTHO CO2 DILUENT LEVEL I |
ORTHO DIAGNOSTIC SYSTEMS, INC. |
|
| K813294 |
11/23/1981 |
ORTHO CO2 DILUENT LEVEL II |
ORTHO DIAGNOSTIC SYSTEMS, INC. |
|
| K813295 |
11/23/1981 |
ORTHO CO2 DILUENT LEVEL III |
ORTHO DIAGNOSTIC SYSTEMS, INC. |
|
| K813167 |
11/12/1981 |
ORTHO UNASSAYED CONTROL SERUM LEVEL II |
ORTHO DIAGNOSTIC SYSTEMS, INC. |
|
| K813321 |
11/24/1981 |
ORTHO* UNASSAYED CONTROL SERUM LEVEL I |
ORTHO DIAGNOSTIC SYSTEMS, INC. |
|
| K813322 |
11/24/1981 |
ORTHO* UNASSAYED CONTROL SERUM LEVEL III |
ORTHO DIAGNOSTIC SYSTEMS, INC. |
|
| K813232 |
11/17/1981 |
COOKED MEAT MEDIUM |
OXOID U.S.A., INC. |
|
| K813154 |
11/06/1981 |
ADAPTING SLEEVE |
PACESETTER SYSTEMS |
|
| K813150 |
11/06/1981 |
DIRECTIONAL BOOT |
PACESETTER SYSTEMS |
|
| K813152 |
11/06/1981 |
ELECTRODE TERMINAL CAP |
PACESETTER SYSTEMS |
|
| K813153 |
11/06/1981 |
TEST MAGNET |
PACESETTER SYSTEMS |
|
| K813151 |
11/06/1981 |
VITATRON INSERT |
PACESETTER SYSTEMS |
|
| K813227 |
11/10/1981 |
INTRAOSSEOUS DENTAL IMPLANT |
PACIFIC IMPLANT, INC. |
|
| K813130 |
11/05/1981 |
SUNGLASSES |
PANLIN CORP. |
|
| K813189 |
11/16/1981 |
PHADEBAS/PHADEZYM IGE REAGENTS |
PHARMACIA, INC. |
|
| K813279 |
11/23/1981 |
ELECTROCARDIOGRAPH CM3000 |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
|
| K813102 |
11/03/1981 |
POLI-MAK II |
PM AMERICA, INC. |
|
| K813106 |
11/03/1981 |
PORT-OP |
PORTEC, INC. |
|
| K813204 |
11/13/1981 |
SERACULT OCCULT BLOOF TEST |
PROPPER MFG. CO., INC. |
|
| K813237 |
11/10/1981 |
HEMASITE VASCULAR ACCESS SHUNT HM-1000 |
RENAL SYSTEMS, INC. |
|
| K813310 |
11/24/1981 |
NO-HOIL COMBOSTAT II KIT |
RIA PRODUCTS, INC. |
|
| K813094 |
11/03/1981 |
ACETABULAR CEMENT COMPRESSOR |
RICHARD'S MEDICAL EQUIP., INC. |
|
| K813093 |
11/02/1981 |
RICHARDS ACETABULAR BRUSH |
RICHARD'S MEDICAL EQUIP., INC. |
|
| K813157 |
11/06/1981 |
COLORLESS DISPOSIBLE PLASTIC SYRINGES |
SAM JOO INDUSTRIAL CO., LTD. |
|
| K813223 |
11/09/1981 |
DISPOSABLE PLASTIC SYRINGE W/NEEDLE |
SAM JOO INDUSTRIAL CO., LTD. |
|
| K813308 |
11/23/1981 |
DOUBLE SEAL TUBEGUAZE STERILE BANDAGE |
SCHOLL, INC. |
|
| K813090 |
11/02/1981 |
COMPOSITE DENTAL RESTORATIVE MATERIAL |
SCI-PHARM, INC. |
|
| K813091 |
11/02/1981 |
FISSURE SEALER & BONDING AGENT |
SCI-PHARM, INC. |
|
| K813268 |
11/20/1981 |
SC-2500F CARDIOTOMY RESERVIOR |
SCIMED LIFE SYSTEMS, INC. |
|
| K813327 |
11/24/1981 |
SEPCOR TEMPERATURE MONITOR |
SEPARATION SCIENCE CORP. |
|
| K813074 |
11/02/1981 |
CONNECTORS & ADAPTERS |
SEVEN HARVEST INTL. IMPORT & EXPORT |
|
| K813248 |
11/19/1981 |
DENTAL FLOSS HOLDER |
SEWON INDUSTRY |
|
| K813276 |
11/23/1981 |
IONESCU-SHILEY VALVE HOLDER & HANDLE |
SHILEY, INC. |
|
| K813245 |
11/18/1981 |
O'CONNOR HOOK PUNCH FORCEP |
SHUTT INSTRUMENTS |
|
| K813243 |
11/18/1981 |
CERAL-BASE METAL ALLOY |
SILLARD PRODUCTS, INC. |
|
| K813355 |
11/27/1981 |
MODIFICATION OF THE PERCUTAN-BALLOON |
SMEC, INC. |
|
| K813324 |
11/24/1981 |
BODAI SWIVEL Y |
SONTEK INDUSTRIES, INC. |
|
| K813339 |
11/24/1981 |
DIRECT FA CONJUGATE FOR LEGIONELLA SP |
SPRINGWOOD MICROBIOLOGICALS |
|
| K813349 |
11/27/1981 |
BI-LEVEL ACETAMINOPHEN-SALICYLATE CNRL |
STANBIO LABORATORY |
|
| K813283 |
11/23/1981 |
10D (TENS DEVICE) |
STAODYNAMICS, INC. |
|
| K813098 |
11/03/1981 |
TENS DEVICE |
STAODYNAMICS, INC. |
|
| K813257 |
11/19/1981 |
ALVEOGRAF DURAPATITE(18-40 MESH) |
STERLING DRUG, INC. |
|
| K813070 |
11/02/1981 |
PERIOGRAF |
STERLING DRUG, INC. |
|
| K813307 |
11/23/1981 |
UVA HEX UNIT |
SUN SHANTY, INC. |
|
| K813309 |
11/24/1981 |
RA-80 POSITIVE CONTROL |
SUN-KIT |
|
| K813170 |
11/17/1981 |
ILA(INVERTED LINEAR ANASTOMOSIS) STAPLER |
SURGEONS CHOICE, INC. |
|
| K813101 |
11/03/1981 |
CARDIOBEEPER MEMORY MONITOR |
SURVIVAL TECHNOLOGY, INC. |
|
| K813201 |
11/13/1981 |
CASTLE #3241 GAS AERATOR |
SYBRON CORP. |
|
| K813192 |
11/17/1981 |
HDL-C EIKEN |
SYN-KIT, INC. |
|
| K813164 |
11/10/1981 |
SYSTEK #1 EIKEN |
SYN-KIT, INC. |
|
| K813282 |
11/17/1981 |
SYNEVAC VACUUM CURETTAGE SYSTEMS |
SYNEMED, INC. |
|
| K813240 |
11/17/1981 |
EMIT-AAD THEOPHYLLINE ASSAY |
SYVA CO. |
|
| K813241 |
11/17/1981 |
EMIT-AAD THEOPHYLLINE CONTROL |
SYVA CO. |
|
| K813146 |
11/06/1981 |
SYVA ADVANCE TM FLUOROMETER |
SYVA CO. |
|
| K813199 |
11/13/1981 |
SKIN TEMPERATURE SENSING VINYL STRIP |
T. G. & E. MEDICAL |
|
| K813196 |
11/12/1981 |
IMAGE ANALYSIS CENTER |
TECHNICARE CORP. |
|
| K813073 |
11/02/1981 |
OMEGA 500 RECTANGULAR FIELD CAMERA W/SC |
TECHNICARE CORP. |
|
| K813077 |
11/02/1981 |
TECHNICON RA 1000 SYSTEM |
TECHNICON CORP. |
|
| K813134 |
11/05/1981 |
ATRIAL ENDOCARDIAL ELECTRODE LEAD J-TIP |
TELECTRONICS, INC. |
|
| K813079 |
11/02/1981 |
BIPOLAR OPTIMA MP #255 |
TELECTRONICS, INC. |
|
| K813316 |
11/24/1981 |
CUSTOM-IN-THE-EAR HEARING AID |
TELESONIC, INC. |
|
| K813344 |
11/25/1981 |
POST-AURICULAR HEARING AID MODEL ASP-103 |
TELESONIC, INC. |
|
| K813329 |
11/24/1981 |
POST-AURICULAR HEARING AID MODEL P-101 |
TELESONIC, INC. |
|
| K813330 |
11/24/1981 |
POST-AURICULAR HEARING AID MODEL S-101 |
TELESONIC, INC. |
|
| K813311 |
11/24/1981 |
COMPRESSOR, AIR, PORTABLE |
THE BIOMED GROUP |
|
| K813277 |
11/23/1981 |
BOUNDARY DRAPE TAPE |
THE BUCKEYE CELLULOSE CORP. |
|
| K813263 |
11/20/1981 |
PATIENT UNDERPAD |
THE BUCKEYE CELLULOSE CORP. |
|
| K813340 |
11/25/1981 |
HIP PIN |
THE DECA CO. |
|
| K813235 |
11/17/1981 |
DISS FEMALE AIR ADAPTOR |
TIMETER INSTRUMENT CORP. |
|
| K813234 |
11/17/1981 |
OHIO AIR ADAPTOR |
TIMETER INSTRUMENT CORP. |
|
| K813255 |
11/19/1981 |
LPM/50 MEMBRANE OXYGENATOR |
TRAVENOL LABORATORIES, S.A. |
|
| K813155 |
11/06/1981 |
PEDIATRIC VENTILATOR CIRCUIT 2C7131 |
TRAVENOL LABORATORIES, S.A. |
|
| K813075 |
11/02/1981 |
TRITEC DOC TM |
TRI-TECH, INC. |
|
| K813177 |
11/12/1981 |
US ALOKA SSD-256 ULTRASONIC SCANNER |
U. S. A. IMAGING CORP. |
|
| K813229 |
11/10/1981 |
HEARING AID MODEL UE9-R |
UNITRON INDUSTRIES, INC. |
|
| K813132 |
11/05/1981 |
THE CHICAGO GULLET |
UNIVERSAL PROSTHETICS, INC. |
|
| K813072 |
11/02/1981 |
E2502 & E2502B LECTROSWITCH |
VALLEYLAB, INC. |
|
| K813071 |
11/02/1981 |
E2508 DISPOSABLE HANDSWITCHING PENCIL |
VALLEYLAB, INC. |
|
| K813278 |
11/23/1981 |
VPI URETERAL DILATATION BALLON CATHETER |
VANCE PRODUCTS, INC. |
|
| K813108 |
11/03/1981 |
MODEL 500 VERI/500 |
VERITE |
|
| K813238 |
11/17/1981 |
NEOCARE BABY-CONTROLLED INCUBATOR |
VICKERS AMERICA MEDICAL CORP. |
|
| K813239 |
11/17/1981 |
OXYGENAIRE NURING INCUBATOR |
VICKERS AMERICA MEDICAL CORP. |
|
| K813366 |
11/30/1981 |
AMMONIA TEST |
WAKO PURE CHEMICAL INDUSTRIES, LTD. |
|
| K813088 |
11/02/1981 |
DESERET NEOLON SURGICAL GLOVES |
WARNER-LAMBERT CO. |
|
| K813271 |
11/20/1981 |
TEMPERATURE PROBES |
WEBSTER LABORATORIES, INC. |
|
| K813224 |
11/09/1981 |
CERAVITAL CERAMIC EAR CANAL WALL PROSTH |
XOMED, INC. |
|
| K813156 |
11/06/1981 |
ULTRA-WIDE SAFETY SPECTACLE FRAME |
ZEE MEDICAL PRODUCTS CO., INC. |
|
