FDA 510(k) Applications for Medical Device Product Code "LDQ"

FDA 510(k) Number Applicant Device Name Decision Date
K892052 3M COMPANY SARNS MEDICAL CART 06/15/1989
K842016 ABCO DEALERS, INC. DISPOS. POLY APRONS 07/03/1984
K904598 ACCU-PATH ACCU PATH STERILE LABEL 10/30/1990
K854441 ALPHA THERAPEUTIC CORP. STUART GILMAN'S WEIGHT LOSS PLAN 02/10/1986
K770381 AMERICAN HOSPITAL SUPPLY CORP. ISOLATION KIT 04/05/1977
K802366 AMERICAN HOSPITAL SUPPLY CORP. NU-BORN BABY BATH KIT 10/10/1980
K822484 AMERICAN THRESHOLD INDUSTRIES, INC. INFECTION CONTROL TOWEL 09/30/1982
K924837 ASSOCIATED ENT., INC. DISP MONIT POUCH /GLOVE CK PAT EXAM GLOVE LEAK DET 10/12/1993
K915636 ASSOCIATED ENT., INC. GLOVE CHECK PATIENT EXAMINATION GLOVE LEAK DETECT. 07/13/1992
K802041 ASSOCIATED MEDICAL PRODUCTS CO. AMPCO SHAVE PREP TRAYS, CAT.#SP4020 10/23/1980
K802044 ASSOCIATED MEDICAL PRODUCTS CO. AMPCO SKIN SCRUB TRAYS, CAT.#SS612 09/09/1980
K802042 ASSOCIATED MEDICAL PRODUCTS CO. AMPCO SKIN SCRUB TRAYS, CAT.#SS824 09/16/1980
K802043 ASSOCIATED MEDICAL PRODUCTS CO. AMPCO SKIN SCRUB TRAYS, CAT.#SS843 09/16/1980
K810570 ASSOCIATED MEDICAL PRODUCTS CO. DRESSING CHANGE TRAY-MEDIUM 03/30/1981
K934703 AVC REGULATORY COMPLIANCE/TECHNICAL SERVICES MEDICOOL PROTECTALL 01/26/1994
K760073 BEMIS HEALTH CARE BASIN, WASH, 6-QT RECTANGULAR 07/20/1976
K863633 BIOLOGICAL & ENVIRONMENTAL CONTROL LABORATORIES SAFETY PINS, ELASTIC BANDAGES & STOCKINETTES 10/16/1986
K851390 BIOLOGICAL & ENVIRONMENTAL CONTROL LABORATORIES STERILE GENERAL HOSPITAL SUPPLIES 05/29/1985
K882388 BURNEY PRODUCTS CORP. MR. RAZOR II TWIN 07/13/1988
K874186 BUSSE HOSPITAL DISPOSABLES, INC. BOWL, SPONGE, DISPOSABLE, STERILE & NON-STERILE 12/29/1987
K813566 CARDIO-BAND, INC. CARDIO-BAND 02/22/1982
K791798 CONPHAR, INC. CONPHAR SURGICAL RAZORR 02/01/1980
K880048 CRESCENT CORP. BLADE, SURGICAL PREP RAZOR STRAIGHT 03/04/1988
K811088 CUNNINGHAM WOODLAND, INC. DRESSING TRAY MERCY HOSPITAL 05/08/1981
K811090 CUNNINGHAM WOODLAND, INC. MAJOR DRESSING TRAY 05/08/1981
K811091 CUNNINGHAM WOODLAND, INC. MINOR DRESSING TRAY 05/08/1981
K811089 CUNNINGHAM WOODLAND, INC. ONE STEP PREP KIT 05/08/1981
K944961 CYTOPROBE CORP. PERSONAL ALARM SYSTEM (PAS) 08/07/1995
K812216 DARCY, INC. CUDDLE CAP 08/20/1981
K901486 DAVID AYRES MEDICAL CO. WEINSTEIN STYLE INSTRUMENT HOLDER 05/02/1990
K760328 DEVON INDUSTRIES, INC. RAZOR, DISPOSABLE 08/11/1976
K834062 DEVON INDUSTRIES, INC. STERILE LABELS 02/04/1984
K834063 DEVON INDUSTRIES, INC. STERILE RUBBER BANDS 12/22/1983
K801421 DEVON INDUSTRIES, INC. TUBE HOLDER 07/28/1980
K864015 DIVERSATRONICS, INC. STERILABELS 12/12/1986
K790504 DR. BERTRAM L. STEEL "SANDEE" SANDING BLOCK 06/11/1979
K802837 DR. MICHAEL'S FOOT-CARE PRODUCTS DR. MICHAEL'S FOOT HELPER 12/10/1980
K885055 DYNEX TRADING CO. INSU COOL 04/26/1989
K813260 E.M. ADAMS TRACHEOSTOMY CARE TRAY 12/31/1981
K832272 ELECTROMEDICS, INC. TOURNIQUET CUFF PRESSURE MONITOR #TCPM 11/28/1983
K930884 ENPAK MEDICAL CORP. MEDICAL PROCEDURE TRAY, MODIFICATION 03/21/1995
K993797 ENTHERMICS MEDICAL SYSTEMS, INC. EC-7701 FLUID WARMING CABINET 01/20/2000
K945374 EVA-HEALTH USA, INC. ACU-HALT 08/09/1995
K894570 EXPANDED OPTICS, INC. UNIVERSAL LIGHT CABLE 10/13/1989
K772403 FRED SAMMONS, INC. CUT-DOWN BUILT-UP TOILET SEAT 02/21/1978
K955661 GLEDERER & CO., INC. ACU-HALT 12/30/1996
K955776 GLEDERER & CO., INC. ACU-LAB 06/05/1996
K831799 I M, INC. PLASTIC DISPOSABLE RAZOR 07/18/1983
K931153 IGEA, S.R.L. ELPER(TM) BARRIER INTEGRITY MONITORING 11/18/1993
K915662 INCOMED, INC. BARRIER INTEGRITY MONITOR 06/25/1992
K992258 INFRA-MED TECHNOLOGIES, INC. HOT SHOT FLUID WARMER IV FLUIDS 01/12/2000
K902682 INTEGRATED MEDICAL SYSTEMS, INC. STICK-GARD STERILE CAP 09/26/1990
K790085 KAGER INTL. KAGER TRAPDUST 05/29/1979
K821396 KLEEN TEST PRODUCTS OUT-RITE WASTE DISPOSABLE BAG 06/09/1982
K760052 M-C IND., INC. KIT, PREP SHAVE 07/16/1976
K812482 MADDAK, INC. FOAM WEDGE 09/24/1981
K812479 MADDAK, INC. POSTURE MIRROR 12/09/1981
K884630 MED-DEX INTL. MULTI-PURPOSE HOLDER 11/22/1988
K772276 MEDFUSION SYSTEMS, INC. RAISED TOILET SEAT 03/14/1978
K772275 MEDFUSION SYSTEMS, INC. TOILET SAFETY RAIL 03/14/1978
K981032 MEDICAL SOLUTIONS, INC. PIV SYSTEM 09/02/1998
K895674 MEDICOOL, INC. MEDICOOL, CONTAINER FOR STORING INSULIN 01/11/1990
K813012 MEDSPEC CORP. STERILE BASIN SETS 11/06/1981
K925588 NORTH AMERICAN STERILIZATION & PACKAGING CO. NORTEC STER SALINE-O.9% SODIUM CHLOR FOR DEV IRRI 12/03/1993
K925593 NORTH AMERICAN STERILIZATION & PACKAGING CO. NORTEC STERILE WATER FOR DEVICE IRRIGATION 12/03/1993
K930514 NOVATEC MEDICAL PRODUCTS, INC.--GLOVE MONITOR SURGIC-ALERT MONITOR 08/19/1993
K911955 OLYMPIC MEDICAL CORP. OLYMPIC WARMETTE 07/19/1991
K942810 PALCO LABORATORIES, INC. PALCO LABS COLD POUCH 06/28/1995
K760342 PARKE-DAVIS CO. RAZOR, SCHICK DISPOSABLE 08/11/1976
K802003 POLLAK (INTL.), LTD. PLASTIC DISPOSABLE RAZOR CAT.#1017,1018 09/09/1980
K820490 SEAMLESS HOSPITAL PRODUCTS CO. IV START TRAY 03/16/1982
K901321 SHARP SAFE, INC. SHARP-SAFE, BIODEGRADEABLE,DISP., NEEDLE DISP. BOX 05/11/1990
K891023 SIEMENS MEDICAL ELECTRONICS SIEMENS CEILING STAND 800F, 800 AND 810 07/25/1989
K973747 SMITH CONTROLLED TEMPERATURE CABINET SYSTEM 05/07/1998
K902410 SOREX MEDICAL MEDICAL PROCEDURE TRAY 11/20/1990
K851276 SOUTH MOUNTAIN MEDICAL ACTION PAC 05/15/1985
K820052 STAN-PAK ENT. SAFETY PINS 02/04/1982
K932714 SURFACE MOUNT TECHNOLOGY, INC. ELECTRONIC GLOVE INTEGRITY MONITOR (EGIM) 12/01/1993
K853185 THE CUDDLE CO. CUDDLE CUSHION 08/20/1985
K901237 UTAH MEDICAL PRODUCTS, INC. GLOVE LEAK DETECTOR 08/21/1990
K913696 VERTEX TECHNICAL GROUP, INC. GLOVE-CHEK PORTABLE FLUID LEAKAGE SENSING DEVICE 02/18/1992
K781437 WARREN J. GROSJEAN SURGICAL PREP RAZOR 12/05/1978


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