FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
K813597 |
12/28/1981 |
TDX PRIMIDONE |
ABBOTT LABORATORIES |
|
K813376 |
12/01/1981 |
EYE CHARTS |
ABCO DEALERS, INC. |
|
K813421 |
12/07/1981 |
NON-ADHER PADS |
ABCO DEALERS, INC. |
|
K813422 |
12/07/1981 |
SCALPEL |
ABCO DEALERS, INC. |
|
K813423 |
12/07/1981 |
THERMOMETER SHEATHS |
ABCO DEALERS, INC. |
|
K813424 |
12/07/1981 |
THERMOMETERS |
ABCO DEALERS, INC. |
|
K813487 |
12/01/1981 |
CATHETER BUBBLE STAND |
ACCURATE SURGICAL INSTRUMENTS CO. |
|
K813488 |
12/01/1981 |
CATHETER REGULAR |
ACCURATE SURGICAL INSTRUMENTS CO. |
|
K813554 |
12/22/1981 |
ACE/KYLE CAPTURED HIP SCREW |
ACE ORTHOPEDIC MANUFACTURING CO. |
|
K813607 |
12/29/1981 |
ACKRAD N-DO VAGE TUBE |
ACKRAD LABORATORIES |
|
K813439 |
12/08/1981 |
RTP-5000 |
ADAC LABORATORIES |
|
K813543 |
12/21/1981 |
ADR ULTRASOUND MODELS 4000S & 4000S/L |
ADR ULTRASOUND |
|
K813624 |
12/29/1981 |
ADVANCED CATHETER SYSTEMS CORONARY GUID |
ADVANCED CATHETER SYSTEMS |
|
K813578 |
12/23/1981 |
HEMOSTATIC SIDE-ARM ADAPTER |
ADVANCED CATHETER SYSTEMS |
|
K813622 |
12/29/1981 |
INDEFLATOR |
ADVANCED CATHETER SYSTEMS |
|
K813577 |
12/23/1981 |
PRESSURE INDICATOR-REGULATOR |
ADVANCED CATHETER SYSTEMS |
|
K813623 |
12/29/1981 |
SIMPSON-ROBERT CORONARY GUIDING CATHET |
ADVANCED CATHETER SYSTEMS |
|
K813476 |
12/01/1981 |
OHIO VOLUME INCENTIVE SPIROMETER |
AIRCO/OHIO MEDICAL PRODUCTS |
|
K813419 |
12/07/1981 |
COMFORT CUSHION DRY BURN PAD III |
AMERICAN CONVERTORS DIV., AMERICAN PHARMASEAL |
|
K813529 |
12/17/1981 |
DADE COLORIMETRIC AMYLASE |
AMERICAN DADE |
|
K813530 |
12/17/1981 |
HEMOTOLOGY CALIBRATOR |
AMERICAN DADE |
|
K813413 |
12/07/1981 |
LECTIN H |
AMERICAN DADE |
|
K813540 |
12/21/1981 |
A FLUOROMETER |
AMERICAN DIAGNOSTIC CORP. |
|
K813541 |
12/21/1981 |
AMIKACIN FLUORESCENT IMMUNOASSAY |
AMERICAN DIAGNOSTIC CORP. |
|
K813539 |
12/21/1981 |
GENTAMICIN FLUORESCENT IMMUNOASSAY |
AMERICAN DIAGNOSTIC CORP. |
|
K813538 |
12/21/1981 |
PHENYTOIN FLUORESCENT IMMUNOASSAY |
AMERICAN DIAGNOSTIC CORP. |
|
K813542 |
12/21/1981 |
TOBRAMYCIN FLUORESCENT IMMUNOASSAY |
AMERICAN DIAGNOSTIC CORP. |
|
K813514 |
12/15/1981 |
EDSLAB CATHETER COVER |
AMERICAN EDWARDS LABORATORIES |
|
K813521 |
12/16/1981 |
TRANSLUMINAL BIPOLAR PACING PROBE |
AMERICAN EDWARDS LABORATORIES |
|
K813429 |
12/08/1981 |
LASER PHOTOCOAGULATOR ARGON MED. LASER |
AMERICAN LASER CORP. |
|
K813430 |
12/08/1981 |
TISSUE PROCESSING CASSETTES & ACCESS |
AMERICAN OPTICAL CORP. |
|
K813591 |
12/28/1981 |
HEMOFILTERS |
AMICON, INC. |
|
K813560 |
12/22/1981 |
LIQUIZYME CREATININE REAGENT SET |
AMRESCO, INC. |
|
K813400 |
12/04/1981 |
INORGANIC PHOSPHORUS REAGENT SET |
ANCO MEDICAL REAGENTS & ASSOC. |
|
K813415 |
12/07/1981 |
UREA NITROGEN REAGENT SET |
ANCO MEDICAL REAGENTS & ASSOC. |
|
K813602 |
12/28/1981 |
HOLTER PERFORMER |
APPLIED CARDIAC SYSTEMS |
|
K813548 |
12/21/1981 |
UVEX MINI-SPECS |
BACOU USA, INC. AND UVEX SAFETY, INC. |
|
K813435 |
12/08/1981 |
BAXA ADLI SEAL |
BAXA CORP., SUB. OF COOK GROUP, INC. |
|
K813473 |
12/14/1981 |
5B SLAVE MODULE SYRINGE PUMP |
BAXTER HEALTHCARE CORP. |
|
K813590 |
12/28/1981 |
MODEL AS6B INFUSION PUMP |
BAXTER HEALTHCARE CORP. |
|
K813547 |
12/21/1981 |
THERMASCAN |
BCD PRODUCTS, INC. |
|
K813442 |
12/10/1981 |
CEFINASE TM DISCS |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K813387 |
12/02/1981 |
METRONIDAZOLE 80MCG. SENSI-DISC |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K813441 |
12/10/1981 |
PIPERACILLIN 100 MCG. SENSI DISC |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K813472 |
12/14/1981 |
LS 5800 SERIES LIQUID SCINTILLATION |
BECKMAN INSTRUMENTS, INC. |
|
K813391 |
12/03/1981 |
TOBRAMYCIN REAGENT TEST KIT |
BECKMAN INSTRUMENTS, INC. |
|
K813524 |
12/16/1981 |
"CENTIDISC |
BEL-ART PRODUCTS |
|
K813556 |
12/22/1981 |
MOD. 587 BLOOD PRESSURE & PULSE MONITOR |
BIO MEGA DIAGNOSTIC, INC. |
|
K813469 |
12/11/1981 |
LIPID PROFILE |
BIO-ANALYTICS LABORATORIES, INC. |
|
K813431 |
12/08/1981 |
SALICYLATES |
BIO-ANALYTICS LABORATORIES, INC. |
|
K813404 |
12/07/1981 |
FREEZE DRIED FICIN |
BIOLOGICAL CORP. OF AMERICA |
|
K813581 |
12/28/1981 |
CRUCIATE LIGAMENT BUTTON |
BIOMET, INC. |
|
K813555 |
12/22/1981 |
GLUCOSE ENZYME-COLOR REAGENT SET |
BIORENT DIAGNOSTIC, INC. |
|
K813414 |
12/07/1981 |
PEAK FLOW MONITOR |
BIOTRINE CORP. |
|
K813380 |
12/01/1981 |
CAVIDENTIN |
BITAN INT'L MARKETING CO. |
|
K813410 |
12/04/1981 |
BX-400 JESSE JIMBODY |
BLOOMEX INTERNATIONAL, INC. |
|
K813443 |
12/09/1981 |
BX-400 SPORT |
BLOOMEX INTERNATIONAL, INC. |
|
K813506 |
12/15/1981 |
FARRORS TMJ CASSETTE HOLDER |
BRELL MAR PRODUCTS, INC. |
|
K813507 |
12/15/1981 |
INFALERT |
BRIOX TECHNOLOGIES, INC. |
|
K813492 |
12/11/1981 |
BRITT KRYPTON LASERS 150K & 152K |
BRITT CORP., INC. |
|
K813498 |
12/14/1981 |
MEDIFIX |
BURRON MEDICAL PRODUCTS, INC. |
|
K813396 |
12/04/1981 |
VERSCHLUBSTOPFEN COMB-CLOSING STOPPER |
BURRON MEDICAL PRODUCTS, INC. |
|
K813508 |
12/15/1981 |
SAC-CEL |
BURROUGHS WELLCOME CO. |
|
K813463 |
12/11/1981 |
SIL-V-UR CHEST CATHETER |
C.R. BARD, INC. |
|
K813493 |
12/14/1981 |
ENZYGNOST TM RUBELLA IGM |
CALBIOCHEM-BEHRING CORP. |
|
K813534 |
12/17/1981 |
COMMAND P5 |
CARDIAC PACEMAKERS, INC. |
|
K813553 |
12/22/1981 |
PACE *AID |
CARDIAC RESUCITATOR CORP. |
|
K813566 |
12/22/1981 |
CARDIO-BAND |
CARDIO-BAND, INC. |
|
K813603 |
12/28/1981 |
LINQUAL-ORAL TRAINING SPLINT |
CHARLES F. SAMELSON, M.D. |
|
K813619 |
12/29/1981 |
CONPHAR-SCHIOETZ TONOMETER |
CONPHAR, INC. |
|
K813385 |
12/02/1981 |
DIGITAL BLOOD PRESSURE UNIT |
CONPHAR, INC. |
|
K813573 |
12/22/1981 |
CARDIOTRAC CORNING CK ISOENZYME SUBST |
CORNING MEDICAL & SCIENTIFIC |
|
K813375 |
12/01/1981 |
HEMATOLOGY CALIBRATOR S-CAL |
COULTER ELECTRONICS, INC. |
|
K813394 |
12/04/1981 |
DS-7 CLOSED WOUND SUCTION DRAIN SYSTEM |
COX-UPHUFF INTL. |
|
K813458 |
12/10/1981 |
FETASCAN 1000, 1000A OBSTETRICAL DATA |
CRANBURY MEDICAL LABS, INC. |
|
K813457 |
12/10/1981 |
FETASCAN 2000,2000A OBSTETRICAL DATA |
CRANBURY MEDICAL LABS, INC. |
|
K813527 |
12/16/1981 |
DINAMAP ADULT/PED./NEONATAL VITAL SIGNS |
CRITIKON COMPANY,LLC |
|
K813489 |
12/01/1981 |
ROCKING/CIRCULATING CYTO-THERM II 3570 |
CRYOSAN, INC. |
|
K813519 |
12/16/1981 |
NON-ABSORBENT TOWELS |
CUNNINGHAM WOODLAND, INC. |
|
K813532 |
12/17/1981 |
CUTTERBOND ZINC PHOSPHATE CEMENT |
CUTTER LABORATORIES, INC. |
|
K813550 |
12/21/1981 |
HYBRID DENTAL PRODUCT |
DENTSPLY INTL. |
|
K813595 |
12/28/1981 |
PARKE-DAVIS AEGIS ABOSRBENT SPONGES |
DESERET MEDICAL, INC. |
|
K813401 |
12/04/1981 |
COAT-A-COUNT TESTOSTERONE RIA KIT |
DIAGNOSTIC PRODUCTS CORP. |
|
K813412 |
12/04/1981 |
GLUCOSE ENZYME-COLOR REAGENT SET |
DIAGNOSTIC SPECIALTIES |
|
K813608 |
12/29/1981 |
POTASSIUM REAGENT SET |
DIAGNOSTIC SPECIALTIES |
|
K813468 |
12/11/1981 |
ACC-U-THERM TEMPERATURE MONITOR |
DIATEK, INC. |
|
K813586 |
12/28/1981 |
DIALYSIS CONCENTRATE |
DIVERSIFIED MEDICAL SERVICES |
|
K813611 |
12/29/1981 |
CHE |
DMS LABORATORIES |
|
K813615 |
12/29/1981 |
CHL |
DMS LABORATORIES |
|
K813613 |
12/29/1981 |
RAPID CH |
DMS LABORATORIES |
|
K813609 |
12/29/1981 |
RAPID E |
DMS LABORATORIES |
|
K813610 |
12/29/1981 |
RAPID STREP |
DMS LABORATORIES |
|
K813612 |
12/29/1981 |
RAPID ZYME |
DMS LABORATORIES |
|
K813614 |
12/29/1981 |
STAPH TRAC |
DMS LABORATORIES |
|
K813513 |
12/15/1981 |
AFRICAN GREEN MONKEY BLOOD IN ALSERVERS |
DUTCHLAND LABORATORIES, INC. |
|
K813512 |
12/15/1981 |
RHESUS MONKEY BLOOD IN ALSEVER'S |
DUTCHLAND LABORATORIES, INC. |
|
K813640 |
12/31/1981 |
MINIWASH II |
DYNATECH CORP. |
|
K813388 |
12/02/1981 |
HEMODIALYSATE |
EDLAW PHARMACEUTICALS, INC. |
|
K813569 |
12/22/1981 |
EMOTENS |
ELECTRO MEDICA OFFICE |
|
K813459 |
12/01/1981 |
REUSABLE & DISPOSABLE TEMP. PROBES |
ELECTROMEDICS, INC. |
|
K813601 |
12/28/1981 |
E.W.L. P-TENS MODEL(TENS |
ELECTRONIC WAVEFORM LABORATORY, INC. |
|
K813501 |
12/14/1981 |
TRANSCUTANEOUS ELEC. NERVE STIMULATOR |
EMPI |
|
K813374 |
12/01/1981 |
NUTRICATH |
EXCO, INC. |
|
K813373 |
12/01/1981 |
VYGON ENDOTRACHEAL TUBES |
EXCO, INC. |
|
K813432 |
12/08/1981 |
HEMODIALYSIS SYSTEM |
FHK |
|
K813389 |
12/03/1981 |
ULTRASONIC FRAGMENTOR |
FIBRA SONICS, INC. |
|
K813505 |
12/15/1981 |
FLAME PHOTOMETER CALIBRATION STANDARDS |
FISHER SCIENTIFIC CO., LLC. |
|
K813426 |
12/07/1981 |
MULTIWASH |
FLOW LABORATORIES, INC. |
|
K813630 |
12/29/1981 |
BK-1129 BOTTLE STRAW |
FRED SAMMONS, INC. |
|
K813629 |
12/29/1981 |
BK-6111 HI-D TRANSFER BOARD |
FRED SAMMONS, INC. |
|
K813627 |
12/29/1981 |
BK-6453 RIMMED ACRYLIC LAP TRAY KIT |
FRED SAMMONS, INC. |
|
K813636 |
12/29/1981 |
BK-6470 ADJUSTABLE ELEVATING WHEELCHAIR |
FRED SAMMONS, INC. |
|
K813628 |
12/29/1981 |
BK-7182 INSTANT COLD PACK |
FRED SAMMONS, INC. |
|
K813635 |
12/29/1981 |
CHILDS TOILET TRAINER HYGIENE AIDS |
FRED SAMMONS, INC. |
|
K813632 |
12/29/1981 |
COLOR CODED WEIGHT CUFFS |
FRED SAMMONS, INC. |
|
K813631 |
12/29/1981 |
JAR HOLDER & OPENER |
FRED SAMMONS, INC. |
|
K813633 |
12/29/1981 |
MODELING COMPOUND AND FOAM EXERCISER |
FRED SAMMONS, INC. |
|
K813634 |
12/29/1981 |
ONE HANDED SHOE FASTENER |
FRED SAMMONS, INC. |
|
K813564 |
12/22/1981 |
COAG-A-MATE X2 |
GENERAL DIAGNOSTICS |
|
K813478 |
12/01/1981 |
TRIGLYCERIDE CALIBRATORS |
GILFORD DIAGNOSTICS |
|
K813427 |
12/07/1981 |
ULTRACHEM GLUC-DH |
HARLECO |
|
K813644 |
12/31/1981 |
MODEL 2650 HIGH CAPACITY DUAL SYRINGE |
HARVARD APPARATUS, INC. |
|
K813395 |
12/04/1981 |
CELLULOSE ACETATE-CITRATE AGAR HEMOGLO |
HELENA LABORATORIES |
|
K813536 |
12/18/1981 |
ASTRA TOTAL PROTEIN REAGENT |
HI CHEM, INC. |
|
K813436 |
12/08/1981 |
OXYCON |
HOME MEDICAL MFG., CO., INC. |
|
K813616 |
12/29/1981 |
TEKNA MED MYRINGOTOMY DISPOS-OTO KIT |
HUMBOLDT PRODUCTS |
|
K813446 |
12/09/1981 |
IV FILTERSET 0.22 MICROMETER |
IMED CORP. |
|
K813445 |
12/09/1981 |
IV FILTERSET 5 MICROMETER |
IMED CORP. |
|
K813484 |
12/01/1981 |
PROGESTERONE KIT BY RIA |
IMMUCHEM CORP. |
|
K813382 |
12/02/1981 |
DISPOSABLE ADULT ANES. CIRCUIT |
INTEC. |
|
K813384 |
12/02/1981 |
DISPOSABLE NEONATAL VENTILATION CIRCUIT |
INTEC. |
|
K813383 |
12/02/1981 |
DISPOSABLE TRACH SWIVEL CONNECTOR |
INTEC. |
|
K813598 |
12/28/1981 |
101 TOTAL CONDYLAR KNEE SYSTEM |
INTERMEDICS ORTHOPEDICS |
|
K813599 |
12/28/1981 |
101-32 FEMORAL COMPONENT |
INTERMEDICS ORTHOPEDICS |
|
K813600 |
12/28/1981 |
AUFRANC-TURNER TYPE ACETABULAR COMPON |
INTERMEDICS ORTHOPEDICS |
|
K813518 |
12/16/1981 |
IMPLANT AID SPLICING CRIMP & SLEEVE |
INTERMEDICS, INC. |
|
K813544 |
12/21/1981 |
IREX 2D/DOPPLER PHASE ARRAY IMAGING SYS. |
IREX CORP. |
|
K813537 |
12/18/1981 |
URIFIX |
ISRAMED, INC. |
|
K813418 |
12/07/1981 |
INZOMA NP |
J. ADERER, INC. |
|
K813417 |
12/07/1981 |
INZOMA P |
J. ADERER, INC. |
|
K813592 |
12/28/1981 |
QUANTAFLUOR FLUORESCENT TEST REAGENTS |
KALLESTAD LABORATORIES, INC. |
|
K813568 |
12/22/1981 |
ESTILUX POSTERIOR XR |
KULZER, INC. |
|
K813551 |
12/21/1981 |
"SHEETS |
LANCASTER COUNTY ASSOC. FOR THE BLIND |
|
K813392 |
12/03/1981 |
RADIOIMMUNOASSAY FOR HUMAN THYROID |
LEECO DIAGNOSTICS, INC. |
|
K813526 |
12/16/1981 |
"FECAL" SANITARY TUBE |
LEON'S FECAL SANITARY TUB MFG. |
|
K813552 |
12/21/1981 |
MODEL 3000C CALORIC IRRIGATOR |
LIFE-TECH INTL., INC. |
|
K813379 |
12/01/1981 |
RADIONUCLIDE DOSE CALIBRATOR |
MEDI NUCLEAR CORP., INC. |
|
K813511 |
12/15/1981 |
URIC-ACID |
MEDICAL ANALYSIS SYSTEMS, INC. |
|
K813562 |
12/22/1981 |
SYRINGE DRIVER 209 |
MEDIX MEDICAL ELECTRONICS (U.S.A.), INC. |
|
K813516 |
12/15/1981 |
MRI TOBRAMYCIN RIA KIT |
MICROANALYTIC RESEARCH, INC. |
|
K813525 |
12/16/1981 |
IN VITRO DIAGNOSTIC RADIOIMMUNOASSAY |
MICROMEDIC SYSTEMS |
|
K813645 |
12/31/1981 |
MICROMEDIC HTSH RIA KIT |
MICROMEDIC SYSTEMS |
|
K813504 |
12/15/1981 |
ACESSORY TO MODIFIED FREEDING JEJUNOSTO |
MIDWEST METABOLIC SUPPORT GROUP |
|
K813580 |
12/24/1981 |
Q-LINE LTC |
MILES LABORATORIES, INC. |
|
K813533 |
12/17/1981 |
ELECTRIC MUSCLE STIMULATOR |
MYO-TRONICS RESEARCH, INC. |
|
K813549 |
12/21/1981 |
CONTINUOUS FLUSH DEVICE |
NAMIC |
|
K813502 |
12/15/1981 |
NARCO TELECARE ISOFLO PRESSURE MONITOR |
NARCO BIO-SYSTEMS |
|
K813471 |
12/14/1981 |
LINE POWERED LOW ENERGY DEFIBRILLATOR II |
NARCO SCIENTIFIC |
|
K813399 |
12/04/1981 |
ERG-JET ELECTRODE |
NICOLET BIOMEDICAL INSTRUMENTS |
|
K813444 |
12/09/1981 |
NIHON KOHDEN HEART MONITORS OMP 7101-02 |
NIHON KOHDEN AMERICA, INC. |
|
K813451 |
12/10/1981 |
UVA FLUORESCENT TANNING LAMPS |
NORTH AMERICAN PHILIPS CORP. |
|
K813411 |
12/04/1981 |
DOCUMENT LINEARITY TEST STANDARDS |
NORTH AMERICAN STANDARDS |
|
K813460 |
12/11/1981 |
CHIBA SKINNY NEEDLE |
OCEAN MEDICAL PRODUCTS, LTD. |
|
K813462 |
12/11/1981 |
MADAYAG TYPE NEEDLE |
OCEAN MEDICAL PRODUCTS, LTD. |
|
K813461 |
12/11/1981 |
PERCUTANEOUS ENTRY NEEDLE, SELDINGER |
OCEAN MEDICAL PRODUCTS, LTD. |
|
K813448 |
12/11/1981 |
POTTS-COURNAND STYLE NEEDLE |
OCEAN MEDICAL PRODUCTS, LTD. |
|
K813499 |
12/14/1981 |
OMED DISPOSABLE BULLDOG |
OMEGA-MED INTL., INC. |
|
K813604 |
12/28/1981 |
OMNI STIM II |
OMNI INTL., INC. |
|
K813545 |
12/21/1981 |
HYPOSERMIC NEEDLES |
OPTICAL MICRO SYSTEMS, INC. |
|
K813483 |
12/01/1981 |
OMS ANTERIOR CHAMBER INFUSION NEEDLE |
OPTICAL MICRO SYSTEMS, INC. |
|
K813481 |
12/01/1981 |
OMS INFUSION CANNULA ASSEMBLE |
OPTICAL MICRO SYSTEMS, INC. |
|
K813500 |
12/14/1981 |
OMS INFUSION-ASPIRATION HANDLE |
OPTICAL MICRO SYSTEMS, INC. |
|
K813574 |
12/23/1981 |
SORB II |
ORGANON TEKNIKA CORP. |
|
K813509 |
12/15/1981 |
METRONIDAZOLE DIAGNOSTIC DISCS |
OXOID U.S.A., INC. |
|
K813449 |
12/10/1981 |
PHE/TYR KINETIC UV TEST SET |
P-L BIOCHEMICALS, INC. |
|
K813453 |
12/10/1981 |
UNIT, LIQUID, OXYGEN, PORTABLE |
PENSEE MEDICAL CORP. |
|
K813563 |
12/22/1981 |
PHADEZYM ANALYZER |
PHARMACIA, INC. |
|
K813646 |
12/31/1981 |
JMS DISPOSABLE SYRINGE |
PHILADELPHIA BIOLOGICS CENTER |
|
K813648 |
12/31/1981 |
JMS NEEDLE & MAC JECT |
PHILADELPHIA BIOLOGICS CENTER |
|
K813649 |
12/31/1981 |
PBC NEEDLE |
PHILADELPHIA BIOLOGICS CENTER |
|
K813647 |
12/31/1981 |
PBC SYRINGE |
PHILADELPHIA BIOLOGICS CENTER |
|
K813440 |
12/08/1981 |
PHILLY BOLT |
PHILADELPHIA MEDICAL SPECIALTIES |
|
K813583 |
12/28/1981 |
PHONIC EAR MODEL PE805CD |
PHONIC EAR, INC. |
|
K813454 |
12/10/1981 |
I.V. FILTER-PREVENT |
PIONEER VIGGO, INC. |
|
K813495 |
12/14/1981 |
ALT (SGPT) |
POINTE SCIENTIFIC, INC. |
|
K813405 |
12/07/1981 |
AST(SGOT) IN VITRO DIAG. REAGENT SET |
POINTE SCIENTIFIC, INC. |
|
K813406 |
12/07/1981 |
CPK(CK) IN VITRO DIAG. REAGENT SET |
POINTE SCIENTIFIC, INC. |
|
K813496 |
12/14/1981 |
LDH-L |
POINTE SCIENTIFIC, INC. |
|
K813434 |
12/08/1981 |
ELECTROSURGICAL DISP. DISPERSIVE PAD |
PROMEDICON, INC. |
|
K813377 |
12/01/1981 |
PS-ROUND SURG. DRAIN & CONNECTOR |
PUDENZ-SCHULTE MEDICAL RESEARCH CORP. |
|
K813606 |
12/29/1981 |
SILICONE ELASTOMER INFUSION CATHETER |
QUEST MEDICAL, INC. |
|
K813428 |
12/08/1981 |
SHUNT ADAPTER |
QUINTON, INC. |
|
K813378 |
12/01/1981 |
UNI-BITE DENTAL X-RAY FILM HOLDER |
RINN CORP. |
|
K813546 |
12/21/1981 |
RIONET HEARING AID HI-62 |
RION ACOUSTIC INSTRUMENTS, INC. |
|
K813447 |
12/01/1981 |
SOLUTIONS & BUFFERS FOR BLOOD GAS INSTR |
RNA MEDICAL CORP. |
|
K813589 |
12/28/1981 |
SHARTPOINT EYED NEEDLES |
S. JACKSON, INC. |
|
K813467 |
12/11/1981 |
2002 ADJUSTABLE FLOW REGULATOR |
SAFETY LABORATORIES WEST |
|
K813466 |
12/11/1981 |
4004 CONSTANT FLOW REGULATOR |
SAFETY LABORATORIES WEST |
|
K813408 |
12/07/1981 |
SAGE 2200 STERILE SPECIMEN CONTAINER |
SAGE PRODUCTS, INC. |
|
K813479 |
12/01/1981 |
ARGYLE PEDIATRIC URINE COLLECTOR |
SHERWOOD MEDICAL CO. |
|
K813480 |
12/01/1981 |
MONOJECT M560 60CC SYRINGES |
SHERWOOD MEDICAL CO. |
|
K813576 |
12/23/1981 |
SIEMENS-ELEMA PULSE GENERATOR 659 |
SIEMENS ELEMA AB |
|
K813464 |
12/11/1981 |
DISPOSABLE TRANSDUCER |
SORENSEN RESEARCH |
|
K813561 |
12/22/1981 |
SPECTRUM PEDIATRIC CARDLE TABLE |
SPECTRUM X-RAY CORP. |
|
K813510 |
12/15/1981 |
CARDIOSONIC ACOUSTIC AMPLIFIER |
SRS CO. |
|
K813437 |
12/08/1981 |
PAN SET |
STERILE DESIGN, INC. |
|
K813637 |
12/30/1981 |
STOLTRONICS-LRS |
STOLTRONIC SYSTEMS, INC. |
|
K813438 |
12/08/1981 |
PNEUMO PULSSOR |
STROM CORP. |
|
K813485 |
12/01/1981 |
SAS EDUCATIONAL CHART |
STRUCTURAL ANALYSIS SYSTEMS, INC. |
|
K813486 |
12/01/1981 |
TELETRED GAIT ANALYSIS SYSTEM |
STRUCTURAL ANALYSIS SYSTEMS, INC. |
|
K813575 |
12/23/1981 |
LIQUID CHROMATOGRAPHY (HPLC) COLUMNS |
SUPELCO, INC. |
|
K813416 |
12/07/1981 |
EXTERNAL BREAST PROSTHESIS |
SURGICAL APPLIANCE INDUSTRIES, INC. |
|
K813642 |
12/30/1981 |
PETAL SOFT PLASTIC APPLICATOR TAMPAX |
TAMPAX, INC. |
|
K813523 |
12/16/1981 |
ELECTRIC SELF STERILIZATION INOCUL. LOOP |
TECHHNILAB INSTRUMENTS, INC. |
|
K813567 |
12/22/1981 |
TECHMEDIA BONE STAPLE |
TECHMEDICA, INC. |
|
K813596 |
12/28/1981 |
AUTO SECTOR MCU |
TECHNICARE CORP. |
|
K827036 |
12/28/1981 |
AUTO SECTOR MCU |
TECHNICARE CORP. |
|
K813587 |
12/28/1981 |
DISPOSABLE THORACIC CATHETER |
TEXAS MEDICAL PRODUCTS, INC. |
|
K813390 |
12/03/1981 |
BONDARY SINGLE-USE OR GOWN |
THE BUCKEYE CELLULOSE CORP. |
|
K813450 |
12/10/1981 |
BOUNDARY SINGLE-USE DRAPES |
THE BUCKEYE CELLULOSE CORP. |
|
K813621 |
12/29/1981 |
CURITY BEDSIDE DRAINAGE BAG |
THE KENDAL CO. |
|
K813528 |
12/17/1981 |
LENS-PAC |
THE PLACTORY |
|
K813638 |
12/30/1981 |
MULTI-UNIT, MULTI-PURPOSE DEVICE |
THE SCOTT & FETZER CO. |
|
K813490 |
12/04/1981 |
VERSION OF A CLOSED-FLOW SYS. CALORIC |
THOMAS M. FOTI, M.D. |
|
K813588 |
12/28/1981 |
CTF MODEL 9300 |
THOMSON-CSF BROADCAST, INC. |
|
K813407 |
12/07/1981 |
AIR MATTRESS |
TRANS WORLD AGENCY, INC. |
|
K813403 |
12/07/1981 |
FLO-GARD 8000 INFUSION PUMP SYSTEM |
TRAVENOL LABORATORIES, S.A. |
|
K813565 |
12/22/1981 |
RADIATION STERILIZED SURGEON'S GLOVES |
TRAVENOL LABORATORIES, S.A. |
|
K813497 |
12/14/1981 |
RHYTHM WHEEL |
TROPICAL ENTERPRISES, INC. |
|
K813398 |
12/04/1981 |
SSD-203 ULTRASONIC SCANNER |
U. S. A. IMAGING CORP. |
|
K813397 |
12/04/1981 |
SSD-240 ULTRASONIC SCANNER |
U. S. A. IMAGING CORP. |
|
K813584 |
12/28/1981 |
CLINITRON AIR FLUIDIZED SUPPORT SYSTEM |
UHI CORP. |
|
K813517 |
12/16/1981 |
BLOOD GAS ANALYSIS, STANDARDS CONTROLS |
UNITED DIAGNOSTICS, INC. |
|
K813572 |
12/22/1981 |
CENTRIA PROLACTIN TEST SET |
VENTREX LABORATORIES, INC. |
|
K813465 |
12/11/1981 |
FREE T4 RIA TEST SET |
VENTREX LABORATORIES, INC. |
|
K813515 |
12/15/1981 |
VERI/DFS TM #817 |
VERITE |
|
K813641 |
12/30/1981 |
VITAL METRICS URINE MONITORING SYSTEM |
VITAL METRICS, INC. |
|
K813522 |
12/16/1981 |
AUTOMATED BLOOD PRESSURE SPHYGMOMANOMTR |
VITAR |
|
K813535 |
12/17/1981 |
XEROFORM DRESSING |
W.G. WHITNEY CORP. |
|
K813402 |
12/04/1981 |
WA-2000 TEMPERATURE INDICATOR |
WALLACH SURGICAL DEVICES, INC. |
|
K813494 |
12/14/1981 |
WATERS ILEAL RESERVOIR CATHETER |
WATERS INSTRUMENTS, INC. |
|
K813585 |
12/28/1981 |
WATERS ILEOSTOMY VALVE |
WATERS INSTRUMENTS, INC. |
|
K813557 |
12/22/1981 |
AUDITORY STIMULATOR |
WESTERN ADVANCED TECHNOLOGY, INC. |
|
K813474 |
12/01/1981 |
MAXILL-AIR SINUS VENTILATION TUBE |
XOMED, INC. |
|
K813475 |
12/01/1981 |
XOMED MICRO-IRRIGATOR |
XOMED, INC. |
|
K813409 |
12/04/1981 |
MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER |
YELLOW SPRINGS INSTRUMENT CO., INC. |
|
K813639 |
12/31/1981 |
SERIES 400 DISPOSABLE TEMPERATURE PROBE |
YELLOW SPRINGS INSTRUMENT CO., INC. |
|