| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K821909 |
06/28/1982 |
LITTMAN TUNABLE STETHOSCOPE 2136 |
3M COMPANY |
|
| K821661 |
06/04/1982 |
FLEXIFLO-II |
ABBOTT LABORATORIES |
|
| K821698 |
06/08/1982 |
TDX NETILMICIN |
ABBOTT LABORATORIES |
|
| K821700 |
06/08/1982 |
LATEX PENROSE DRAIN TUBING |
ABCO DEALERS, INC. |
|
| K827581 |
06/14/1982 |
ADAC MODEL DPS-2800 DIGITAL PROCESSING SYSTEM |
ADAC LABORATORIES |
|
| K827580 |
06/14/1982 |
ADAC MODEL DPS-3300 DIGITAL PROCESSING SYSTEM |
ADAC LABORATORIES |
|
| K827572 |
06/01/1982 |
ADAC MODEL DPS-6100 MULTI MODALITY DIGITAL PROCESING SYSTEMS |
ADAC LABORATORIES |
|
| K827663 |
06/30/1982 |
SINUSON 810 ULTRASOUND SCANNER |
AM LABS, INC. |
|
| K821807 |
06/17/1982 |
AMERIFLOUR FLUOROMETER |
AMERICAN DIAGNOSTIC CORP. |
|
| K821945 |
06/29/1982 |
CARBAMAZEPINE FLOURESCENT IMMUNOASSAY |
AMERICAN DIAGNOSTIC CORP. |
|
| K821697 |
06/08/1982 |
INJECTION ASPIRATING NEEDLES |
AMERICAN ENDOSCOPY, INC. |
|
| K821817 |
06/21/1982 |
PIGTAIL NASAL CATHETERS |
AMERICAN ENDOSCOPY, INC. |
|
| K821819 |
06/21/1982 |
PIGTAIL STENTS |
AMERICAN ENDOSCOPY, INC. |
|
| K821818 |
06/21/1982 |
RETRIEVAL BALLOONS |
AMERICAN ENDOSCOPY, INC. |
|
| K821665 |
06/04/1982 |
PEDESTAL EXAMINING TABLE |
AMERICAN HAMILTON |
|
| K821627 |
06/02/1982 |
THE ARTIFICIAL URINARY SPHINCTER |
AMERICAN MEDICAL SYSTEMS, INC. |
|
| K821628 |
06/02/1982 |
THE INFLATABLE PENILE PROSTHESIS |
AMERICAN MEDICAL SYSTEMS, INC. |
|
| K821895 |
06/28/1982 |
AH-1 LIGHT-CURE DENTAL COMPOSITE RESTOR |
AMERICAN MIDWEST |
|
| K821715 |
06/10/1982 |
AM-40 SYSTEM |
AMERICAN MIDWEST |
|
| K821905 |
06/28/1982 |
BIURET (COLORIMETRIC) TOTAL PROTEIN |
AMERICAN MONITOR CORP. |
|
| K821791 |
06/17/1982 |
EXTERNAL PULSE GENERATOR - EV4542 |
AMERICAN PACEMAKER CORP. |
|
| K821894 |
06/28/1982 |
DISPOSABLE TRANSDUCER DOMES & KITS |
AMERICAN PHARMASEAL DIV. AHSC |
|
| K821660 |
06/04/1982 |
BIO-CHECK GRAM STAIN CONTROL |
AMERICAN SCIENTIFIC PRODUCTS |
|
| K821749 |
06/15/1982 |
AMSCO ENDOSCOPY TABLE |
AMERICAN STERILIZER CO. |
|
| K821931 |
06/29/1982 |
ZETA-CORT |
AMF BIOLOGICAL AND DIAGNOSTICS CO. |
|
| K821907 |
06/28/1982 |
NEIDENT* |
ANALYTICAL PRODUCTS, INC. |
|
| K821658 |
06/04/1982 |
HEMOGLOBIN REAGENT |
ANCO MEDICAL REAGENTS & ASSOC. |
|
| K821742 |
06/14/1982 |
POSITIVE & NEGATIVE HCG URINE CONTROLS |
ARMKEL, LLC. |
|
| K821941 |
06/29/1982 |
RHEUMATOID FACTOR REFERENCE PREPARA. |
ARMKEL, LLC. |
|
| K821694 |
06/08/1982 |
ARTHROLUX ARTHROSCOPE |
ARTHRO-TECH, INC. |
|
| K821885 |
06/25/1982 |
REF. ELECTRODE SOL'N.;STANDARD B |
AVL SCIENTIFIC CORP. |
|
| K821956 |
06/30/1982 |
HAEM-C PLUS BLOOD REFERENCE CONTROLS |
BAKER INSTRUCTIONS CORP. |
|
| K821771 |
06/16/1982 |
MACRO-VUE CARD TEST, AMIKACIN |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
| K821803 |
06/16/1982 |
QBC CENTRIFUGAL HEMATOLOGY SYSTEM |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
| K821812 |
06/18/1982 |
BECKMAN URIC ACID REAGENT |
BECKMAN INSTRUMENTS, INC. |
|
| K821813 |
06/18/1982 |
BECKMAN URIC ACID STANDARD |
BECKMAN INSTRUMENTS, INC. |
|
| K821801 |
06/15/1982 |
NORSEN DEBRIDER |
BEL-MED, INC. |
|
| K827662 |
06/30/1982 |
AUTO-TECH GENERATOR |
BENNETT X-RAY CORP. |
|
| K821676 |
06/08/1982 |
PREG-PHILE B |
BIO DIAGNOSTIC SYSTEMS, INC. |
|
| K821934 |
06/29/1982 |
BIO-CAL OPERATION CHECK KIT |
BIO-ANALYTICS LABORATORIES, INC. |
|
| K821741 |
06/14/1982 |
URICACID |
BIODYNAMICS CORP. |
|
| K821657 |
06/04/1982 |
RIAGEN B-HCG RIA |
BIOGENEX LABORATORIES |
|
| K821769 |
06/10/1982 |
MICROKNIFE |
BIOLOGICAL & ENVIRONMENTAL CONTROL LABORATORIES |
|
| K821849 |
06/23/1982 |
EBV-VCA ANTIBODY ASSAY KIT |
BIOTECH RESEARCH LABORATORIES, INC. |
|
| K821692 |
06/08/1982 |
PASSIVE HEAT PADS |
BIOTONE INTERNATIONAL, INC. |
|
| K821691 |
06/08/1982 |
STIMRITE |
BIOTONE INTERNATIONAL, INC. |
|
| K821888 |
06/25/1982 |
AUTOMATIC SINGLE CHANNEL ECG #399 |
BIRTCHER CORP. |
|
| K821584 |
06/01/1982 |
EPISTAXIS CATHETER/KIT |
BIVONA MEDICAL TECHNOLOGIES |
|
| K821836 |
06/22/1982 |
PREGNANCY (W) EDGE |
BODY THERAPEUTICS, INC. |
|
| K821838 |
06/22/1982 |
VARI-SUPPORT LOW BACK POSTURE PILLOW |
BODY THERAPEUTICS, INC. |
|
| K821837 |
06/22/1982 |
VARI-SUPPORT NECK POSTURE PILLOW |
BODY THERAPEUTICS, INC. |
|
| K821852 |
06/23/1982 |
DIAGNOSTICS HDL CHOLESTEROL PRECIPITANT |
BOEHRINGER MANNHEIM CORP. |
|
| K821805 |
06/17/1982 |
PYRIDOXAL-5-PHOSPHATE STRIPES |
BOEHRINGER MANNHEIM CORP. |
|
| K821829 |
06/22/1982 |
UROGARD |
BUCKMAN CONSULTANTS |
|
| K821755 |
06/15/1982 |
TELCOR 2 |
BURDICK CORP. |
|
| K821712 |
06/09/1982 |
INFORMED REMOTE FIELD UNIT MODEL IFM1000 |
BURDITT & CALKINS-SIEMENS-ELEMA |
|
| K821716 |
06/10/1982 |
BARD PTFE VASCULAR PROSTHESIS |
C.R. BARD, INC. |
|
| K821745 |
06/14/1982 |
BARDEX ALL SILICONE PEDIATRIC CATHETER |
C.R. BARD, INC. |
|
| K821811 |
06/18/1982 |
125I DIGOXIN RADIOIMMUNOASSAY KIT |
CAMBRIDGE MEDICAL TECHNOLOGY |
|
| K821673 |
06/07/1982 |
HEART*AID, ALS, MODEL 95 |
CARDIAC RESUCITATOR CORP. |
|
| K821711 |
06/09/1982 |
CARDIO TEHCHANALYZER |
CARDIO TECHNOLOGY LTD. |
|
| K821611 |
06/02/1982 |
GAMMADAB [125] FSH RADIOIMMUNAY KIT |
CLINICAL ASSAYS, INC. |
|
| K821802 |
06/15/1982 |
CENTURION ELECTRODE BELT |
CLINICAL DATA, INC. |
|
| K821721 |
06/10/1982 |
CLINICAL DATA APNEA DETECTOR |
CLINICAL DATA, INC. |
|
| K821737 |
06/14/1982 |
DISP. MICROSURGICAL KNIVES |
COBURN OPTICAL IND., INC. |
|
| K821701 |
06/08/1982 |
RAPIDO-LASTIC IN STERILE FORM |
CONCO MEDICAL CO. |
|
| K821825 |
06/22/1982 |
CONPHAR SILICONE FEEDING TUBE |
CONPHAR, INC. |
|
| K821656 |
06/04/1982 |
DUODERM FLEXIBLE HYDROACTIVE DRESSINGS |
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
|
| K821655 |
06/04/1982 |
DUODERM HYDROACTIVE GRANULES |
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
|
| K821824 |
06/22/1982 |
TEM-STIK |
CORALITE DENTAL PRODUCTS, INC. |
|
| K821889 |
06/25/1982 |
POROUS SURFACED PLATINUM IRIDIUM |
CORDIS CORP. |
|
| K821906 |
06/28/1982 |
CORPAK ENTERIC FEEDING TUBE W/GUIDE TIP |
CORPAK CO. |
|
| K827718 |
06/22/1982 |
UNKNOWN |
CRANBURY MEDICAL LABS, INC. |
|
| K827712 |
06/22/1982 |
LIGHT PEN ACCESSORY FOR USE WITH FETASCAN 800 SERIES |
CRANSTON MEDICAL LABORATORY |
|
| K821890 |
06/25/1982 |
CRITIKON #817 ESOPHAGEAL MULTI-PROBE |
CRITIKON COMPANY,LLC |
|
| K821936 |
06/29/1982 |
CRITIKON OXYGEN MONITOR, MODEL 8030 |
CRITIKON COMPANY,LLC |
|
| K821951 |
06/30/1982 |
DATASCOPE MODEL 83 IABP SYSTEM |
DATASCOPE CORP. |
|
| K821910 |
06/28/1982 |
ANESTHESIA & BRAIN MONITOR |
DATEX DIVISION INSTRUMENTARIUM CORP. |
|
| K821713 |
06/10/1982 |
POROCOAT LOW PROFILE METAL BACKED CUP |
DEPUY, INC. |
|
| K821714 |
06/10/1982 |
POROCOAT STANDARD METAL BACKED CUP |
DEPUY, INC. |
|
| K821752 |
06/15/1982 |
SYNTHOGRAFT LG-AUGMENTATION & BONE FILL |
DEPUY, INC. |
|
| K821861 |
06/24/1982 |
COAT-A-COUNT INSULIN KIT |
DIAGNOSTIC PRODUCTS CORP. |
|
| K821725 |
06/08/1982 |
T3 DIAGNOSTIC KIT RIA |
DIAGNOSTIC REAGENTS, INC. |
|
| K821722 |
06/10/1982 |
T3 UPTAKE DIAGNOSTIC KIT |
DIAGNOSTIC REAGENTS, INC. |
|
| K821675 |
06/08/1982 |
CALCITONIN RIA TEST KIT, DLS 1200 |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
|
| K821929 |
06/29/1982 |
SUBCLAVIAN |
DNA MEDICAL, INC. |
|
| K821772 |
06/16/1982 |
SURGITA/MIZHO MICRONEUROSURGERY HEAD FR |
DOWNS SURGICAL LTD. |
|
| K821650 |
06/04/1982 |
DRAGER VAPOR 19.1 ANESTHETIC VAPORIZERS |
DRAEGER MEDICAL, INC. |
|
| K821915 |
06/28/1982 |
BME AUTOCLAVABLE MEDIUM |
DUTCHLAND LABORATORIES, INC. |
|
| K821914 |
06/28/1982 |
COON'S F-12 POWDER MEDIUM |
DUTCHLAND LABORATORIES, INC. |
|
| K821916 |
06/28/1982 |
IMPROVED MEM-RICHTER'S POWDER MODIF. |
DUTCHLAND LABORATORIES, INC. |
|
| K821913 |
06/28/1982 |
ISCOVE'S MODIFIED DULBECCO POWDER MEDIUM |
DUTCHLAND LABORATORIES, INC. |
|
| K821912 |
06/28/1982 |
MCCOY'S POWDER MEDIUM 5A SUSPENSION |
DUTCHLAND LABORATORIES, INC. |
|
| K821918 |
06/28/1982 |
POWDERED RPMI-1603 MEDIUM |
DUTCHLAND LABORATORIES, INC. |
|
| K821919 |
06/28/1982 |
POWDERED RPMI-1634 MEDIUM |
DUTCHLAND LABORATORIES, INC. |
|
| K821911 |
06/28/1982 |
S-MEM-JOKLIK'S POWDER |
DUTCHLAND LABORATORIES, INC. |
|
| K821917 |
06/28/1982 |
WAYMOUTH'S POWDER MEDIUM |
DUTCHLAND LABORATORIES, INC. |
|
| K821796 |
06/18/1982 |
EZ-FIX I.V. CATHETER HOLDER |
DYNA CARE |
|
| K821687 |
06/08/1982 |
REMOVAWELL TISSUE CULTURE PLATE W/LID |
DYNATECH CORP. |
|
| K821959 |
06/30/1982 |
CARDIO-RESPIRATORY MONITOR MODEL CR-1 |
ELECTROMED INTL., LTD. |
|
| K821921 |
06/29/1982 |
STAND, SURG. INSTRUMENT & DRESSING |
EMERSON-SACK-WARNER CORP. |
|
| K821924 |
06/29/1982 |
TABLE, OPERATING, FIELD 6530-00-709-8155 |
EMERSON-SACK-WARNER CORP. |
|
| K821923 |
06/29/1982 |
TABLE, OPERATING, FIELD 6530-00-709-8175 |
EMERSON-SACK-WARNER CORP. |
|
| K821927 |
06/29/1982 |
TABLE, SURG. INSTRUMENT & DRESSING |
EMERSON-SACK-WARNER CORP. |
|
| K821690 |
06/08/1982 |
ERIKA HPF 100,200,300 DIALYZER |
ERIKA, INC. |
|
| K821587 |
06/01/1982 |
ERIKA HPF 50 DIALYZER |
ERIKA, INC. |
|
| K821723 |
06/09/1982 |
BI-4520 DUAL IMPEDOMETER |
FARRALL INSTRUMENTS, INC. |
|
| K821683 |
06/08/1982 |
REAGENT FOR COULTER COUNTER MODEL 5+11 |
FISHER SCIENTIFIC CO., LLC. |
|
| K821616 |
06/02/1982 |
CERVISCOPE OPTICAL SYSTEM |
FOTOMEDICS, INC. |
|
| K821744 |
06/14/1982 |
FRASER HARLAKE NITRONOX SCAVENGER |
FRASER HARLAKE, INC. |
|
| K821639 |
06/03/1982 |
ANKLE FOOT ORTHOSIS |
FRED SAMMONS, INC. |
|
| K821636 |
06/03/1982 |
ATTACH-A-PAK |
FRED SAMMONS, INC. |
|
| K821645 |
06/03/1982 |
BACK SKPPORTS |
FRED SAMMONS, INC. |
|
| K821856 |
06/23/1982 |
BK-2082 FOLDING STOCKING AID |
FRED SAMMONS, INC. |
|
| K821857 |
06/23/1982 |
BK-5305 MULTIPLE HAND GRID |
FRED SAMMONS, INC. |
|
| K821860 |
06/23/1982 |
BK-6477 THE DERBY RAISED TOILET SEAT |
FRED SAMMONS, INC. |
|
| K821643 |
06/03/1982 |
EATING UTENSILS |
FRED SAMMONS, INC. |
|
| K821634 |
06/03/1982 |
EZ STAND MOBILE STOOL |
FRED SAMMONS, INC. |
|
| K821647 |
06/03/1982 |
FOAM WEDGES |
FRED SAMMONS, INC. |
|
| K821638 |
06/03/1982 |
HYGIENE ADAPTORS |
FRED SAMMONS, INC. |
|
| K821858 |
06/23/1982 |
NOTIE STRETCH-LACE-VARIOUS MODELS |
FRED SAMMONS, INC. |
|
| K821641 |
06/03/1982 |
OBTHOSES |
FRED SAMMONS, INC. |
|
| K821859 |
06/23/1982 |
ORTHOLACE 4,5.6 EYELET |
FRED SAMMONS, INC. |
|
| K821640 |
06/03/1982 |
ORTHOTIC FABRICATION ACCESSORIES |
FRED SAMMONS, INC. |
|
| K821631 |
06/03/1982 |
PINCH GAUGE, 0-301 LBS. |
FRED SAMMONS, INC. |
|
| K821635 |
06/03/1982 |
SOFT ULNAR DEVIATION SPLINTS |
FRED SAMMONS, INC. |
|
| K821632 |
06/03/1982 |
SURGICAL SCISSORS, SET OF 3 |
FRED SAMMONS, INC. |
|
| K821646 |
06/03/1982 |
TINY FLEX-GLASS, SET OF 4 |
FRED SAMMONS, INC. |
|
| K821644 |
06/03/1982 |
VACUUM WAND AND UNI-READER |
FRED SAMMONS, INC. |
|
| K821633 |
06/03/1982 |
VARIABLE SPEED VIBRATOR, 120V 83-117 VIB |
FRED SAMMONS, INC. |
|
| K821855 |
06/23/1982 |
VISCO HANDEX-VARIOUS MODELS |
FRED SAMMONS, INC. |
|
| K821642 |
06/03/1982 |
WHEEL CHAIR ACCESSORIES |
FRED SAMMONS, INC. |
|
| K821637 |
06/03/1982 |
WIRE-FOAM MP FLEXION SPRING |
FRED SAMMONS, INC. |
|
| K821821 |
06/22/1982 |
PERCUTANEOUS TRACHEOSTOMY DEVICE |
FREDERIC J. TOYE, M.D. |
|
| K821850 |
06/23/1982 |
GALTEL-18 |
GALVANIC MEDICAL INSTRUMENTS, INC. |
|
| K821842 |
06/22/1982 |
GAS STERILIZATION EQUIPMENT |
GETINGE INTERNATIONAL, INC. |
|
| K821591 |
06/01/1982 |
STEAM STERILIZATION EQUIPMENT |
GETINGE INTERNATIONAL, INC. |
|
| K821719 |
06/10/1982 |
AMMONIA REAGENT |
GILFORD DIAGNOSTICS |
|
| K821845 |
06/22/1982 |
EGG YOLK AGAR (PLATE) |
GRANITE DIAGNOSTICS, INC. |
|
| K821775 |
06/17/1982 |
TERGITOL 7 AGAR WITH TTC |
GRANITE DIAGNOSTICS, INC. |
|
| K821864 |
06/24/1982 |
THIOGLYCOLLATE MED. W/VITAMIN K-1 |
GRANITE DIAGNOSTICS, INC. |
|
| K821809 |
06/18/1982 |
THERMOFONTE AIR MESSAGE BATH |
GREENFIELDS |
|
| K821696 |
06/08/1982 |
THE SOFT PEDAL |
HABCO PRODUCTS, INC. |
|
| K821880 |
06/25/1982 |
ULTRA CHEM ALB |
HARLECO DIAGNOSTICS |
|
| K821881 |
06/25/1982 |
ULTRACHEM CREA |
HARLECO DIAGNOSTICS |
|
| K821868 |
06/25/1982 |
ULTRACHEM E-GLU |
HARLECO DIAGNOSTICS |
|
| K821867 |
06/25/1982 |
ULTRACHEM GLUC-DH |
HARLECO DIAGNOSTICS |
|
| K821874 |
06/25/1982 |
ULTRACHEM PHOS |
HARLECO DIAGNOSTICS |
|
| K821873 |
06/25/1982 |
ULTRACHEM T-BILI |
HARLECO DIAGNOSTICS |
|
| K821879 |
06/25/1982 |
ULTRACHEM T.P. |
HARLECO DIAGNOSTICS |
|
| K821875 |
06/25/1982 |
ULTRACHEM TRI-ES |
HARLECO DIAGNOSTICS |
|
| K821872 |
06/25/1982 |
ULTRACHEM URIC ACID AIDH |
HARLECO DIAGNOSTICS |
|
| K821871 |
06/25/1982 |
ULTRAZYME PLUS 2GT |
HARLECO DIAGNOSTICS |
|
| K821870 |
06/25/1982 |
ULTRAZYME PLUS ALP |
HARLECO DIAGNOSTICS |
|
| K821869 |
06/25/1982 |
ULTRAZYME PLUS AMYL |
HARLECO DIAGNOSTICS |
|
| K821883 |
06/25/1982 |
ULTRAZYME PLUS CK-I |
HARLECO DIAGNOSTICS |
|
| K821876 |
06/25/1982 |
ULTRAZYME PLUS GOT |
HARLECO DIAGNOSTICS |
|
| K821882 |
06/25/1982 |
ULTRAZYME PLUS GPT |
HARLECO DIAGNOSTICS |
|
| K821877 |
06/25/1982 |
ULTRAZYME PLUS HBD |
HARLECO DIAGNOSTICS |
|
| K821878 |
06/25/1982 |
ULTRAZYME PLUS LDH |
HARLECO DIAGNOSTICS |
|
| K821942 |
06/29/1982 |
HARVEY-BOSTWICK BRADY CARDIA MONIT. HB85 |
HARVEY-BOSTWICK, INC. |
|
| K821810 |
06/15/1982 |
"PIEZON" ULTRASONIC SCALER |
HEALTHCO, INC. |
|
| K821731 |
06/01/1982 |
HEALTHDYNE MODEL 16900 INFANT MONITOR |
HEALTHDYNE, INC. |
|
| K821612 |
06/02/1982 |
MODEL 16800 TREND RECORDER |
HEALTHDYNE, INC. |
|
| K827584 |
06/14/1982 |
JAPANESE MADE MICROWAVE THERAPY EQUIPMENT |
HEIWA ELECTRONIC INDUSTRIAL CO., LTD. |
|
| K821688 |
06/08/1982 |
TITAN GEL HIGH RESOLUTION SERUM PROTEIN |
HELENA LABORATORIES |
|
| K821671 |
06/07/1982 |
DISPO. AES. |
HIRAOKA NEW YORK, INC. |
|
| K821680 |
06/08/1982 |
HOLLISTER CATHETER ACCESS. PORT |
HOLLISTER, INC. |
|
| K821704 |
06/02/1982 |
FRACTURE BRACING |
HOSMER DORRANCE CORP. |
|
| K821957 |
06/30/1982 |
CATH-LOK |
HPD MEDICAL, INC. |
|
| K821944 |
06/29/1982 |
TANDEM HCG IMMUNOEZYMETRIC ASSAY KIT |
HYBRITECH, INC. |
|
| K821851 |
06/23/1982 |
CONTROL DIAGNOSTICS PLATELET CONTROL |
IMMUNOGENETICS |
|
| K821830 |
06/22/1982 |
MI DAS 1000 AUTOMATIC SLIDE STAINER |
INNOVATIVE MEDICAL SYSTEMS, INC. |
|
| K821847 |
06/22/1982 |
I.M. ARTHROSCOPE |
INSTRUMENT MAKAR, INC. |
|
| K821814 |
06/18/1982 |
"HEMO-NATE" L-P KIT |
INT'L CORP. |
|
| K821726 |
06/11/1982 |
MODEL 535-02 TRACE-A-PACE TRANSMITTER |
INTERMEDICS, INC. |
|
| K821756 |
06/15/1982 |
IEC CENTRA 4 CENTRIFUGE |
INTERNATIONAL EQUIPMENT CO. |
|
| K821590 |
06/01/1982 |
"PORS-ON" |
J. ADERER, INC. |
|
| K821798 |
06/18/1982 |
82 ALLOY |
J. ADERER, INC. |
|
| K821832 |
06/22/1982 |
DEGUCAST "U" |
J. ADERER, INC. |
|
| K821613 |
06/02/1982 |
E.G. BRIDGE GOLD |
J. ADERER, INC. |
|
| K821797 |
06/18/1982 |
ACTISORB* ACTIVATED CHARCOAL CLOTH DRSG. |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
|
| K821693 |
06/08/1982 |
J & J DIP WATER ADDITIVE |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
|
| K821862 |
06/24/1982 |
QUANTICOAT 125 I-THEOPHYLLINE RADIOIMM. |
KALLESTAD LABORATORIES, INC. |
|
| K821705 |
06/09/1982 |
NAGASHIMA F60MM ATTACH. LENS |
KELLEHER CORP. |
|
| K821708 |
06/09/1982 |
NAGASHIMA LIGHT SOURCE UNIT SL-4 |
KELLEHER CORP. |
|
| K821709 |
06/09/1982 |
NAGASHIMA LIGHT SOURCE UNIT SL-5 |
KELLEHER CORP. |
|
| K821710 |
06/09/1982 |
NAGASHIMA NX-150F LIGHT SOURCE UNIT |
KELLEHER CORP. |
|
| K821706 |
06/09/1982 |
NAGASHIMA SFT-I LARYNGOSCOPE RIGHT-ANGL |
KELLEHER CORP. |
|
| K821707 |
06/09/1982 |
NAGASHIMA SFT-II LARYNGOSCOPE STRAIGHT |
KELLEHER CORP. |
|
| K827607 |
06/04/1982 |
MODEL 712 MICROMANIPULATOR |
LASER INDUSTRIES LTD. |
|
| K821920 |
06/28/1982 |
I.C.E. BOX |
LHS INDUSTRIES |
|
| K821846 |
06/22/1982 |
LDS MONITORING ELECTRODE |
LIFE DESIGN SYSTEMS, INC. |
|
| K821939 |
06/29/1982 |
UROCOMP MODEL 1404 |
LIFE-TECH INTL., INC. |
|
| K821624 |
06/02/1982 |
LOW VOLUME INFUSTION SET |
LIFEMED OF CALIFORNIA |
|
| K821841 |
06/22/1982 |
MEDIGAS SUCTION/DRAINAGE EQUIPMENT |
LINDE DIV. UNION CARBIDE CORP. |
|
| K821804 |
06/17/1982 |
RUBELLA RQ BIO-ENZABEAD KIT |
LITTON BIONETICS |
|
| K821892 |
06/28/1982 |
PHILLIPS RADIATION MEASURING INSTRUMENT |
LONG ISLAND SCIENTIFIC |
|
| K821903 |
06/28/1982 |
DISC-O-AID |
M. DAHM INTERNATIONAL APS |
|
| K821762 |
06/15/1982 |
MEASELISA TEST KIT |
M.A. BIOPRODUCTS |
|
| K821621 |
06/02/1982 |
PREGNOPOST |
M.M. WOLFRED, PH.D. |
|
| K821760 |
06/15/1982 |
SERIES M PUSH-PULL INPUT COMPRESSION |
MAICO HEARING INSTRUMENTS, INC. |
|
| K821833 |
06/22/1982 |
HI-LO TEMP SKIN TEMPERATURE SENSOR |
MALLINCKRODT CRITICAL CARE |
|
| K821955 |
06/30/1982 |
MCSCK638 CATHETER IN A TRAY (KIT) |
MED COMP |
|
| K821954 |
06/30/1982 |
MCSCK838 CATHETER IN A TRAY (KIT) |
MED COMP |
|
| K821617 |
06/02/1982 |
DISPOSABLE HEMOSTATS |
MEDCARE PRODUCTS |
|
| K821618 |
06/02/1982 |
DISPOSABLE NEEDLE HOLDERS |
MEDCARE PRODUCTS |
|
| K821816 |
06/21/1982 |
ANGIOGRAPHIC CATHETER |
MEDI-TECH, INC. |
|
| K821820 |
06/21/1982 |
MCSC6PS MEDICAL COMPONENTS |
MEDICAL COMPONENTS, INC. |
|
| K821684 |
06/08/1982 |
MCSCP8PS WITH 'Y' HUB |
MEDICAL COMPONENTS, INC. |
|
| K821848 |
06/22/1982 |
ASSURE-MALE EXTERNAL INCONTINCE CATHETER |
MEDICAL DESIGN & MANUFACTURING CORP. |
|
| K821651 |
06/04/1982 |
E-Z UP ARTHERAPEDIC CHAIR |
MEDICAL DEVICE CONSULTANTS, INC. |
|
| K821776 |
06/17/1982 |
SURGITEK PERCUTANEOUS NEPHROST. STENT |
MEDICAL ENGINEERING CORP. |
|
| K821764 |
06/09/1982 |
DISPOSABLE INTRAVENOUS INJECTION SYSTEM |
MEDICAL SYSTEMS RESEARCH |
|
| K821853 |
06/23/1982 |
U-100 BAG |
MEDICAL TECHNOLOGIES OF GEORGIA |
|
| K821854 |
06/23/1982 |
U-200 BAG |
MEDICAL TECHNOLOGIES OF GEORGIA |
|
| K821932 |
06/29/1982 |
MENTOR POTENTIAL ACUITY METER |
MENTOR O & O, INC. |
|
| K821703 |
06/02/1982 |
MGN CONDUCTIVE CONNECTING TUBE, STERILE |
MGN MEDICAL MANUFACTURING, INC. |
|
| K821695 |
06/08/1982 |
MICRO-AIRE REPLAC. DRILL BURS FOR ZIMMER |
MICRO-AIRE SURGICAL INSTRUMENTS, INC. |
|
| K821678 |
06/08/1982 |
AUTOPAK ESTRIOL TEST DELIVERY SYSTEM |
MICROMEDIC SYSTEMS |
|
| K827609 |
06/08/1982 |
MIDWEST AUTOMATIC BUCKY EQUIPPED WITH GRID AND SIZE-O-MATIC TRAY |
MIDWEST X-RAY EQUIPMENT CO. |
|
| K821669 |
06/07/1982 |
AMES TDA GENTAMICIN TEST |
MILES LABORATORIES, INC. |
|
| K821738 |
06/14/1982 |
CLINI-TEK SEMI-AUTOMATED URINALYSIS SYST |
MILES LABORATORIES, INC. |
|
| K821649 |
06/04/1982 |
MONAGHAN'S PRESSURE ALARM |
MONAGHAN MEDICAL CORP. |
|
| K821897 |
06/28/1982 |
"LENS |
MORTAN, INC. |
|
| K821629 |
06/02/1982 |
"FIXIDENT" |
MOYCO INDUSTRIES, INC. |
|
| K821614 |
06/02/1982 |
AS20 MONITORING SYSTEM |
NARCO SCIENTIFIC |
|
| K821896 |
06/28/1982 |
C-300 INFANT INCUBATOR |
NARCO SCIENTIFIC |
|
| K821679 |
06/08/1982 |
LEONARD/NORTON HYPERALIMENTATION CATHET. |
NORTON PERFORMANCE PLASTICS CORP. |
|
| K821720 |
06/10/1982 |
PHYSIOLOGICAL DISPLAY SYSTEM, MODEL 1000 |
NOVAMETRIX MEDICAL SYSTEMS, INC. |
|
| K821659 |
06/04/1982 |
RESPIRACULT-STREP DEEP BED CULTURE PAD |
ORION DIAGNOSTICA, INC. |
|
| K821898 |
06/28/1982 |
ORTHO CLASSICAL PATHWAY COMPL. TEST |
ORTHO DIAGNOSTIC SYSTEMS, INC. |
|
| K821806 |
06/17/1982 |
ORTHO CLG IMMUNE COMPLEX TEST SYSTEM |
ORTHO DIAGNOSTIC SYSTEMS, INC. |
|
| K821949 |
06/30/1982 |
ORTHO* ALTERNATIVE PATHWAY COMPL. TEST |
ORTHO DIAGNOSTIC SYSTEMS, INC. |
|
| K827286 |
06/15/1982 |
MODEL 8000 SECTOR IMAGER SYSTEM |
OTE BIOMEDICA |
|
| K827287 |
06/15/1982 |
MODEL 8100 SECTOR IMAGER |
OTE BIOMEDICA |
|
| K821947 |
06/30/1982 |
FASTPASS IMPLANTABLE ENDOCARD. PACING |
PACESETTER SYSTEMS |
|
| K821779 |
06/17/1982 |
BEACH AMALGAM CARRIER, GUN TYPE |
PACIFIC DENTAL CORP. |
|
| K821785 |
06/17/1982 |
BEACH AMALGAM CARVER |
PACIFIC DENTAL CORP. |
|
| K821782 |
06/17/1982 |
BEACH ANESTHETIC SYRINGE CARTR. TYPE |
PACIFIC DENTAL CORP. |
|
| K821789 |
06/17/1982 |
BEACH CURETTE NO. 2 AND NO. 3 T.G. |
PACIFIC DENTAL CORP. |
|
| K821788 |
06/17/1982 |
BEACH DERIOSTEAL ELEVATOR, #2 STRAIGHT |
PACIFIC DENTAL CORP. |
|
| K821778 |
06/17/1982 |
BEACH DRESSING PLIER |
PACIFIC DENTAL CORP. |
|
| K821790 |
06/17/1982 |
BEACH EXCAVATOR'S NO. 1 & NO. 2 |
PACIFIC DENTAL CORP. |
|
| K821780 |
06/17/1982 |
BEACH EXPLORER NO. 23T.G. |
PACIFIC DENTAL CORP. |
|
| K821781 |
06/17/1982 |
BEACH FORCEP NO. 150 AND NO. 151 |
PACIFIC DENTAL CORP. |
|
| K821784 |
06/17/1982 |
BEACH GINGIVAL RETRACTION INSTR. TYPE B |
PACIFIC DENTAL CORP. |
|
| K821777 |
06/17/1982 |
BEACH MOUTH MIRROR |
PACIFIC DENTAL CORP. |
|
| K821786 |
06/17/1982 |
BEACH SCALERS |
PACIFIC DENTAL CORP. |
|
| K821783 |
06/17/1982 |
BEACH SILICATE FILLING & LINING APPLIC. |
PACIFIC DENTAL CORP. |
|
| K821787 |
06/17/1982 |
BEACH SURGICAL PLIERS NON-HOOK |
PACIFIC DENTAL CORP. |
|
| K821739 |
06/14/1982 |
J. MORITA FLEX M-3 TORX HARDPIECE |
PACIFIC DENTAL CORP. |
|
| K821799 |
06/18/1982 |
FITKIT I CHECKUP KIT |
PATTON, BOGGS & BLOW |
|
| K821773 |
06/16/1982 |
PEDICRAFT BED, MODEL B2944 |
PEDICRAFT, INC. |
|
| K821866 |
06/24/1982 |
OXY-PMMA |
PETRARCH SYSTEMS & PROFESSIONAL PHARM |
|
| K821666 |
06/07/1982 |
STERILE SURGICAL DRAPES |
PHOENIX GLOVE CO. |
|
| K827713 |
06/22/1982 |
SCANNER 560 ULTRASOUND SCANNER |
PIE DATA, INC. |
|
| K821933 |
06/29/1982 |
OMNISURG SIDE MOUNTING CLAMP & RAIL EXT. |
POLAMEDCO, INC. |
|
| K821827 |
06/22/1982 |
GENTLE-LIFT CHAIR |
PRIDE HEALTH CARE EQUIPMENT |
|
| K821648 |
06/04/1982 |
GAS CHEX PLASTIC BAG |
PROPPER MFG. CO., INC. |
|
| K821757 |
06/15/1982 |
QUIK - PREP2 ELECTRODE |
QUINTON, INC. |
|
| K821758 |
06/15/1982 |
QUINTON Q, SCAN MODELS 900 & 901 |
QUINTON, INC. |
|
| K821736 |
06/14/1982 |
ECHO-PULSE KM555 |
RABAR, INC. |
BERNARD WEINSTEIN |
| K821677 |
06/08/1982 |
THE COMMUNICATOR |
ROBERT SWINNEY. LTD. |
|
| K821625 |
06/02/1982 |
ENDODONTIC PAPERPOINTS |
ROEKO |
|
| K821765 |
06/14/1982 |
PHOTOTHERAPY EYE PROTECTION FOR INFANTS |
RUSSELL TERRY CO. |
|
| K821588 |
06/01/1982 |
SANDHILL DMS |
SANDHILL |
|
| K821887 |
06/25/1982 |
SCANLAN SUTURE-STATT |
SCANLAN INTL., INC. |
|
| K821930 |
06/29/1982 |
SECHRIST MODEL 990 JET VENTILATOR |
SECHRIST INDUSTRIES, INC. |
|
| K821863 |
06/24/1982 |
DIALYZER REPROCESSING SYSTEM DRS-4 |
SERATRONICS, INC. |
|
| K821623 |
06/02/1982 |
NOVA IV FLUIDS PACK & EXTERNAL STANDARDS |
SHABAN MFG. CO. |
|
| K821794 |
06/18/1982 |
NOVA V FLUIDS PACK & EXTERNAL STANDARDS |
SHABAN MFG. CO. |
|
| K821732 |
06/14/1982 |
ARGYLE GERZOF ABCESS DRAINAGE CATHETER |
SHERWOOD MEDICAL CO. |
|
| K821670 |
06/02/1982 |
ARGYLE TARTAN I TRACHEAL TUBE |
SHERWOOD MEDICAL CO. |
|
| K821763 |
06/15/1982 |
SHUR-STRIP APPLICATOR |
SHUR MEDICAL CORP. |
|
| K827455 |
06/17/1982 |
SONOLINE 3000 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
|
| K821884 |
06/25/1982 |
GASTROCCULT TM |
SMITH KLINE DIAGNOSTICS, INC. |
|
| K821674 |
06/07/1982 |
SPINCHEM ACID PHOSPHATASE REAGENT |
SMITH KLINE DIAGNOSTICS, INC. |
|
| K821908 |
06/28/1982 |
STARKEY MODEL HAL-1 |
STARKEY LABORATORIES, INC. |
|
| K821682 |
06/08/1982 |
TRUNCAL ORTHOSIS |
SURGICAL APPLIANCE INDUSTRIES, INC. |
|
| K821815 |
06/18/1982 |
ADVANCE C-REACTIVE PROTEIN (CRP) ASSAY |
SYVA CO. |
|
| K821766 |
06/15/1982 |
EMIT - ST URINE METHAGUALONE CONTROLS |
SYVA CO. |
|
| K821768 |
06/15/1982 |
EMIT ST URINE METHAGUALONE ASSAY |
SYVA CO. |
|
| K821767 |
06/15/1982 |
EMIT ST URINE METHAGUALONE CALIBRATOR |
SYVA CO. |
|
| K821743 |
06/14/1982 |
EMIT-TOX SERUM TRICYCLIC ANTIDEPR. ASSAY |
SYVA CO. |
|
| K821937 |
06/29/1982 |
SYVA ADVANCE STANDARDIZATION KIT #2 |
SYVA CO. |
|
| K821938 |
06/29/1982 |
SYVA ADVANCE STANDARDIZATION KIT #3 |
SYVA CO. |
|
| K821800 |
06/07/1982 |
REGULAR MAXITHINS PADS & SUPER MAXITHINS |
TAMPAX, INC. |
|
| K821702 |
06/08/1982 |
POWER SUTURE |
TAYLOR H. HAYNES, M.D. |
|
| K827644 |
06/24/1982 |
DELTASCAN HPS CT SCANNER |
TECHNICARE CORP. |
|
| K827571 |
06/02/1982 |
MOBILE DIGITAL RECEPTOR |
TECHNICARE CORP. |
|
| K827652 |
06/28/1982 |
TECHNICARE ULTRASOUND AUTO SECTOR B-SCAN ARM OPTION |
TECHNICARE CORP. |
|
| K827610 |
06/15/1982 |
ULTRASOUND AUTO SECTOR CARDIAC MODULE |
TECHNICARE CORP. |
|
| K821686 |
06/08/1982 |
DENSCO PROPHY ANGLE |
TELEDYNE DENSCO |
|
| K821823 |
06/22/1982 |
I.V. SENTINEL |
THE JOHN BUNN CO. |
|
| K821689 |
06/08/1982 |
LEBANON MICROSCOPE |
THE LEBANON CORP. |
|
| K821727 |
06/11/1982 |
SERIES 10 LIQUID CHROMOTOGRAPH |
THE PERKIN-ELMER CORP. |
|
| K821808 |
06/18/1982 |
MILBURN'S BACKEASER |
THE T. MILBURN CO. LTD. |
|
| K821619 |
06/02/1982 |
THE SPORTS HAND |
THERAPEUTIC RECREATION SYSTEMS, INC. |
|
| K821822 |
06/22/1982 |
MODEL 1020 NA/K ANALYZER |
THERMO ORION |
|
| K821685 |
06/08/1982 |
TOM'S NATURALLY WAXED FLOSSING TAPE |
TOM'S OF MAINE, INC. |
|
| K821946 |
06/30/1982 |
ALT ENZYME ASSAY KIT |
TRAVENOL LABORATORIES, S.A. |
|
| K821950 |
06/30/1982 |
Q-PAK URINE TOXICOLOGY CONTROL UNASSAYED |
TRAVENOL LABORATORIES, S.A. |
|
| K821735 |
06/14/1982 |
TROPIC AIR HEAT-ECHANGER BREATHING AID |
TROPIC AIR |
|
| K821835 |
06/22/1982 |
BARRIER BURN SHEET |
UHI CORP. |
|
| K821792 |
06/17/1982 |
NEUMOVENT 980 |
ULTRAMAR MARKETING CORP. |
|
| K821900 |
06/28/1982 |
HEARING AID, UNITRON MODEL UE5 |
UNITRON INDUSTRIES, INC. |
|
| K821899 |
06/28/1982 |
HEARING AID, UNITRON MODELS UE3/3-N |
UNITRON INDUSTRIES, INC. |
|
| K821672 |
06/09/1982 |
PROFLEX |
UTAH MEDICAL PRODUCTS, INC. |
|
| K821615 |
06/02/1982 |
VAST VENTREX PD IGE RIA TEST SET |
VENTREX LABORATORIES, INC. |
|
| K821667 |
06/07/1982 |
SINGLE USE NON-CONDUCTIVE CIRC. DISCON |
VITAL SIGNS, INC. |
|
| K821826 |
06/22/1982 |
FEP-RINGED "GORE-TEX@ VASCULAR GRAFT" |
W.L. GORE & ASSOCIATES,INC |
|
| K821717 |
06/10/1982 |
GORE-TES EXPANDED PTFE PATCH |
W.L. GORE & ASSOCIATES,INC |
|
| K821753 |
06/15/1982 |
"A O FIBER OPTIC ILLUMINATION," 1185A |
WARNER-LAMBERT CO. |
|
| K821754 |
06/15/1982 |
"A O FIBER OPTIC ILLUMINATOR," 1185B |
WARNER-LAMBERT CO. |
|
| K821831 |
06/22/1982 |
A O HISTOSTAT EMBEDDING CTR #8030,32,34 |
WARNER-LAMBERT CO. |
|
| K821865 |
06/24/1982 |
A O MICROSCOPE VIDEO SYSTEM |
WARNER-LAMBERT CO. |
|
| K821750 |
06/15/1982 |
DESERET E-Z SET INFUSION SET |
WARNER-LAMBERT CO. |
|
| K821886 |
06/25/1982 |
DESERET INSYTE HYPERTHERMIA CATHETER |
WARNER-LAMBERT CO. |
|
| K821699 |
06/08/1982 |
DESERET SUBCLAVIAN JUGULAR CATHETER SET |
WARNER-LAMBERT CO. |
|
| K821834 |
06/22/1982 |
MODEL 100 BICARBONATE CONDUCTIVITY |
WESTERN LABORATORIES CORP. |
|
| K821652 |
06/03/1982 |
DOXEPIN TRI-CY TEST SET |
WIEN LABORATORIES, INC. |
|
| K821653 |
06/03/1982 |
PROTRIPTYLINE TRI-CY TEST SET |
WIEN LABORATORIES, INC. |
|
| K821904 |
06/28/1982 |
XOMED MANDIBULAR TRAY |
XOMED, INC. |
|
| K827292 |
06/07/1982 |
MODEL IC 3000 |
XONICS MEDICAL SYSTEMS, INC. |
|
| K821620 |
06/02/1982 |
(125I) HTSH RADIOIMMUNOASSAY KIT |
YANG LABORATORIES, INC. |
|
| K821940 |
06/29/1982 |
THE HUMPHREY FIELD ANALYZER MODEL 610 |
ZEISS HUMPHREY SYSTEM |
|
| K821893 |
06/28/1982 |
ZIMMER METAL BACKED ACETABULAR CUP |
ZIMMER, INC. |
|
