FDA 510(k) Applications Submitted by ART WARD

FDA 510(k) Number Submission Date Device Name Applicant
K000050 01/07/2000 TOP QUALITY CHLORINATED-POWDERFREE EXAMINATION GLOVES TOP QUALITY MFG., INC.
K000108 01/14/2000 RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100 BHK HOLDING
K010139 01/17/2001 ZURICH DISTRACTION SYSTEM KLS-MARTIN L.P.
K020318 01/30/2002 SCIVOLUTIONS VARIOUS ANTIBACTERIAL BANDAGES SCIVOLUTIONS, INC
K000369 02/04/2000 VACUFLOW+ BLOOD COLLECTION SET, MODEL 52221/3/5; VACUFLOW+ WITH HOLDER BLOOD COLLECTION SET, MODEL 82021/3/5 WITH HOLDER MEDPRO TECHNOLOGIES, INC.
K000580 02/22/2000 ZURICH PEDIATRIC MAXILLARY DISTRACTOR, MODELS 51-550-15 AND 51-551-15 KLS-MARTIN L.P.
K000714 03/02/2000 VACUFLOW+SAFE BLOOD COLLECTION SET AND VACUFLOW+SAFE WITH HOLDER BLOOD COLLECTION SET MED-PRO TECHNOLOGIES, INC.
K000960 03/24/2000 BARZELL-WHITMORE MAROON BELLS, INC. COLO-RECTAL MOVER, MODEL 3900 BARZELL-WHITMORE MAROON BELLS, INC.
K000981 03/27/2000 CERAMIX EZ CAST, CERAMIX EZ CAST SOLDER, CERAMIX EZ CAST FLUX C-MIX
K000983 03/27/2000 CERAMIX PORCELAIN SYSTEM C-MIX
K000995 03/28/2000 NARKOMAT, MODEL 2000 HEYER AMERICA, INC.
K011205 04/19/2001 ISOAID IODINE BRACHTHERAPY SEEDS, MODEL ADVANTAGE I-125 ISOAID
K001631 05/26/2000 CORTEX METAMAX CORTEX BIOPHYSIK GMBH
K001727 06/06/2000 MODIFICATION TO BLEASE FRONTLINE GENIUS RANGE, ANESTHESIA MACHINES BLEASE MEDICAL EQUIPMENT LTD.
K001892 06/21/2000 WHITE KNIGHT MASKS (21 MODELS, VARIOUS COLORS WITH AND WITHOUT FACE SHIELDS) WHITE KNIGHT HEALTHCARE, INC.
K001893 06/21/2000 WHITE KNIGHT MASKS, BLUE, PINK, YELLOW, WHITE MASKS (13 MODELS) WHITE KNIGHT HEALTHCARE, INC.
K012006 06/27/2001 MEDICAL DEPOT POWER NEB 1 MEDICAL DEPOT, INC.
K001988 06/29/2000 MODULAR HEYER AMERICA, INC.
K001997 06/30/2000 WHITE KNIGHT BLUE, GREEN FACE MASK, (4 MODELS) WHITE KNIGHT HEALTHCARE, INC.
K002152 07/17/2000 TRACK 1.0 & 1.5 MM SYSTEMS-TISSUE REGENERATION BY ALVEOLAR CALLUS DISTRACTION KLS-MARTIN L.P.
K002319 07/31/2000 PURILENS SALINE SOLUTION PURILENS, INC.
K002405 08/07/2000 SPINAL EPIDURAL NEEDLES TE ME NA S.A.R.L.
K012882 08/28/2001 BITEM ANGEL RELINE KIT, BITEM LABORATORY KIT, MODELS 120110, 120060 THERMOELASTIC TECHNOLOGIES, INC.
K013151 09/20/2001 ASMOTOM AUTOMATED TREPHINE SYSTEM BKG OPTHALMICS USA, INC.
K013254 09/28/2001 POLYCOAT POWDERED LATEX EXAMINATION GLOVE WITH ALOE VERA & PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) TOP QUALITY MFG., INC.
K003251 10/17/2000 BLEASE FRONTLINE PLUS RANGE, ANESTHESIA MACHINES, MODEL 440, 560 AND 690 BLEASE MEDICAL EQUIPMENT LTD.
K003344 10/25/2000 MEDICAL DEPOT NEBULIZER, MODEL POWER NEB 2 MEDICAL DEPOT, INC.
K993641 10/28/1999 METALYZER, MODEL 2; METALYZER, MODEL 3 CORTEX BIOPHYSIK GMBH
K003783 12/07/2000 MEDICAL DEPOT-WHEELCHAIRS, MODEL SENTRA,ASTAIRE AND VIPER MEDICAL DEPOT, INC.
K994357 12/27/1999 BITEM LOCK, MODELS SW006, SW012 THERMOELASTIC TECHNOLOGIES, INC.
K004018 12/27/2000 SKINGARD POLYCOAT GLOVE TOP QUALITY MFG., INC.
K014268 12/27/2001 NORAPAD PLAIN; NORAPAD TA PERLEI MEDICAL, INC.
K080072 01/11/2008 MRI PATIENT POSITIONING DEVICES CIVCO MEDICAL INSTRUMENTS CO., INC.
K060186 01/24/2006 POLYPLEX STIMULATING CATHETER SYSTEM TE ME NA SAS
K080391 02/13/2008 DRIVE SOLSTICE OXYGEN CONCENTRATOR MEDICAL DEPOT
K080603 03/03/2008 HYBRID NERVE LOCATION NEEDLE COATED AND UNCOATED TE ME NA SAS
K060821 03/27/2006 SPECIALEYES 50 AND SPECIALEYES 49 SHPERE AND TORIC SOFT CONTACT LENSES SPECIALEYES LLC
K031553 05/19/2003 SILICONE FOAM CUFF TRACHEOSTOMY TUBES, SILICONE CUFFLESS NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES ARCADIA MEDICAL CORPORATION
K091516 05/22/2009 WELL LEAD SILICONE CATHETER WITH TEMPERATURE SENSOR WELL LEAD MEDICAL CO. LTD
K011590 05/23/2001 RESORB-X RESORBABLE PLATING SYSTEM KLS-MARTIN L.P.
K081603 06/06/2008 DIGITAL BALLISTOCARDIOGRAPH, MODEL DGB 300 HEARTFORCE MEDICAL, INC.
K101721 06/18/2010 WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA REGULATORY AND MARKETING SERVICES, INC.
K081889 07/02/2008 RHAPSODY CT GRANTADLER CORPORATION
K032169 07/16/2003 CARBON FIBER COMPOSITE CIRCULAR FIXATION (CIRFIX) DEVICE (HALF RING) CYBERORTHOLOGY, INC.
K062100 07/24/2006 ARJOWRAP 47/100 AND 47/88 ARJO WIGGINS MEDICAL, INC.
K062112 07/24/2006 SUNMED FOLEY CATHETERS SUNMED, INC.
K082126 07/29/2008 RHAPSODY MRI GRANTADLER CORPORATION
K082208 08/05/2008 DOCTORS CHOICE SLOW HEALING BANDAGE WITH SPRAY ON REMOVER SCIVOLUTIONS, INC.
K042278 08/23/2004 ORAL OSTEODISTRACTION ROD APPLIANCE (ROD 5) ORAL OSTEODISTRACTION, L.P.
K022833 08/26/2002 BENJAMIN ENVOY PHACO HANDPIECE BENJAMIN BIOMEDICAL, INC.
K092886 09/21/2009 WELL LEAD ENDOBRONCHIAL TUBES WELL LEAD INSTRUMENTS
K032983 09/24/2003 SENSITIVE SKIN ANTIBACTERIAL BANDAGES SCIVOLUTION, INC.
K092938 09/24/2009 HEPARIN LOCK FLUSH SOLUTION USP, MODELS 504401, 504411, 504505, 505701, 504901, 1710 APP PHARMACEUTICALS, LLC
K082818 09/25/2008 SUBCUTANEOUS NEEDLE INFUSION SET MARCAL MEDICAL, INC.
K042683 09/29/2004 WELL LEAD ENDOTRACHEAL TUBE WELL LEAD MEDICAL INSTRUMENTS
K042684 09/29/2004 WELL LEAD TRACHEOSTOMY TUBE WELL LEAD MEDICAL INSTRUMENTS
K102874 09/30/2010 NEW STETIC ACRYLICS NEW STETIC
K093713 12/01/2009 ULTRASOUND GENERAL PURPOSE GUIDANCE SYSTEM CIVCO MEDICAL INSTRUMENTS
K043328 12/02/2004 MICROFLO-SAFE SCALP VEIN SET DKS LOVERSAN INDUSTRIA BIOMEDICA SPA
K043330 12/02/2004 POLYPROPILENE SURGICAL SUTURES DEMETECH CORP.
K014001 12/04/2001 DISTRACTION OSTEOGENESIS ROD APPLIANCES, MODELS 1, 2, AND 3 ORAL OSTEODISTRACTION, L.P.
K994154 12/09/1999 MOD LINE OF MOLINA DISTRACTORS, 51-600 SERIES KLS-MARTIN L.P.
K043539 12/22/2004 DEMETECH STERILE SYNTHETIC ABSORBABLE SUTURES (PGA) AND NEEDLES DEMETECH CORP.
K034045 12/29/2003 ORAL OSTEODISTRACTION DISTRACTION ROD APPLIANCES, ROD 4 ORAL OSTEODISTRACTION, L.P.
K990667 03/02/1999 KLS-MARTIN TEMPORARY CONDYLAR IMPLANT KLS-MARTIN L.P.
K970756 03/03/1997 MERCURY MEDICAL REUSABLE CPR BAG MERCURY MEDICAL
K041430 05/28/2004 BLEASE SIRIUS ANESTHESIA SYSTEM, MODELS 3000 AND 2000 BLEASE MEDICAL EQUIPMENT LTD.
K051629 06/20/2005 BLEAS ESIRIUC ANAESTHSIA SYSTEM, MODELS 3000, 2000 BLEASE USA, INC.
K062854 09/25/2006 BENZ-G 4X HIOXIFILCON D BENZ RESEARCH AND DEVELOPMENT CORP.
K073383 12/03/2007 WELL LEAD REINFORCED ENDOTRACHEAL TUBE WELL LEAD MEDICAL INSTRUMENTS


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