FDA 510(k) Applications Submitted by Paul Dryden

FDA 510(k) Number Submission Date Device Name Applicant
K020005 01/02/2002 INFANT FEEDING TUBES PROMEDIC, INC.
K110015 01/03/2011 VITALSENS, AINGEAL, V-POD INTELESENS LIMITED
K110068 01/10/2011 MODEL PM3030 OMRON HEALTHCARE, INC.
K140062 01/10/2014 FSC ANTI-STATIC VALVED COLLAPSIBLE HOLDING CHAMBER FSC LABORATORIES, INC.
K080100 01/14/2008 WATCHHALER ACTIVAERO AMERICA, INC.
K130091 01/15/2013 PULMOSAL PHARMACARIBE
K120216 01/24/2012 GENOSYL MV-1000 GENO LLC
K080230 01/30/2008 NEB-U-MASK SYSTEM, MODELS 1895, 1896 Teleflex Medical, Inc.
K080256 01/31/2008 PULMODYNE CHF FLOW GENERATOR SYSTEM PULMODYNE
K080289 02/04/2008 1500 PRO OMRON HEALTHCARE, INC.
K100343 02/05/2010 PAP-CAP PUR-SLEEP, INC.
K130304 02/07/2013 LMA FAMILY OF AIRWAYS THE LARYNGEAL MASK CO.,LTD.
K140370 02/14/2014 DISPOSABLE PRESSURE MANOMETER BESMED HEALTH BUSINESS CORP.
K120463 02/15/2012 MOJO, VERASEAL SLEEPNET CORPORATION
K070467 02/16/2007 HEALTH MASK POLAR WRAP LLC
K090421 02/18/2009 MODEL 350G GAS CONSERVER INSPIRED TECHNOLOGIES, INC.
K070490 02/20/2007 CIRQLATOR INTRATHORACIC PRESSURE REGULATOR (ITPR) ADVANCED CIRCULATORY SYSTEMS, INC.
K070498 02/20/2007 HYPER SAL PARI INNOVATIVE MANUFACTURERS, INC.
K120516 02/21/2012 LONG LIFE PADTM OMRON HEALTHCARE, INC.
K140435 02/21/2014 MEDLEY GOLD AMERICAN DENTAL SLEEP MEDICINE, IP, LLC
K110501 02/22/2011 HEM-4030 OMRON HEALTHCARE, INC.
K060497 02/24/2006 BABYAIR PROMEDIC, INC.
K110531 02/24/2011 ENDOFLIP ECD CROSPON, LTD.
K110529 02/24/2011 ENDOFLIP GASTRIC TUBE CROSPON, LTD.
K080516 02/25/2008 LAMIN AIR REMGENIC LLC
K060526 02/27/2006 TIPI CONTIPI LTD.
K070596 03/02/2007 TOPICAL APPLICATOR SHARN, INC.
K130598 03/07/2013 INSPIRACHAMBER ANTI-STATIC VALVED HOLDING CHAMBER INSPIRX, INC.
K030747 03/10/2003 PRODOSE AAD SYSTEM PROFILE THERAPEUTICS PLC
K130664 03/12/2013 HYRDROMAX HMEF A-M SYSTEMS
K110728 03/16/2011 IMESH TACKER EASYLAP LTD.
K040712 03/18/2004 AIR SAFETY HEPA, MODEL 3500 AIR SAFETY LTD
K090710 03/18/2009 MERCURY CPAP MERCURY MEDICAL
K090730 03/19/2009 AKITA JET ACTIVAERO AMERICA, INC.
K090738 03/20/2009 THERMOFLO HCH, THERMOFLO FILTER ARC MEDICAL, INC.
K000959 03/24/2000 CRITERION 60 OR PM 60 CARADYNE, LTD.
K060811 03/24/2006 OMRON COMPRESSOR SYSTEMS, MODELS NE-C28,NE-C30 OMRON HEALTHCARE, INC.
K090791 03/24/2009 DAKIN'S ANTIMICROBIAL WOUND CLEANSER, MODEL 0.0125% TO 5% CENTURY PHARMACEUTICALS, INC.
K060842 03/28/2006 REVJET TURBO PROMEDIC, INC.
K120937 03/28/2012 SUNFLOWER WARNER ATOM MEDICAL CORPORATION
K110860 03/29/2011 COMP A-I-R OMRON HEALTHCARE, INC.
K140788 03/31/2014 P-STIM BIEGLER GMBH
K130906 04/01/2013 ENDOFLIP CATHETER CROSPON, LTD.
K070918 04/02/2007 4DDOME COUSIN BIOTECH
K090935 04/02/2009 MINIME PEDIATRIC MASK SLEEPNET CORPORATION
K120997 04/02/2012 BAROSTAT SOFTWARE OPTION CROSPON, LTD.
K100995 04/09/2010 SHIKANI SPEAKING VALVE SHIKANI MEDICAL, LLC
K131000 04/10/2013 V-PATCH SYSTEM INTELESENS LIMITED
K131016 04/11/2013 ROGS MOLECULAR PRODUCTS LTD.
K140951 04/14/2014 YEESCOPE LARYNGOSCOPES YEESCOPE PTY. LTD.
K050953 04/15/2005 AIR SAFETY MODEL 3000/06 FILTER HEPA REUSABLE AIR SAFETY LTD
K121170 04/17/2012 RESIN 11 RESPINNOVATION SAS
K121198 04/19/2012 BW685, BW685S BIEGLER GMBH
K101094 04/20/2010 CLEARJET EASYGLIDE LTD.
K111110 04/20/2011 APNEA GUARD ADVANCED BRAIN MONITORING, INC.
K101136 04/22/2010 FISIO CHAMBER SPACE KOO(SHANGHAI)INDUSTRIES CO., LTD.
K121239 04/24/2012 MRI MULTI-CHANNEL OPTICAL COMMUNICATION (MOC) SYSTEM IMROC/IMROC IR WIRLESS OPTOACTIVE OPTOACOUSTICS LTD
K121321 05/02/2012 HARD SHELL VENTED NASAL MASK SLEEPNET CORPORATION
K141140 05/02/2014 COMP A-I-R OMRON HEALTHCARE, INC.
K091305 05/04/2009 CLEARPATH EASYGLIDE LTD.
K031409 05/05/2003 URINARY CATHETERS PROMEDIC, INC.
K131282 05/06/2013 NEXUS HEMORRHOID LIGATOR INX MEDICAL
K121378 05/08/2012 AIRTRAQ SP AIRTRAQ AVANT PRODOL MEDITEC LTD.
K131339 05/09/2013 CAPNOMASK MEDIPLUS LTD.
K081330 05/12/2008 CAREVENT PAR (PUBLIC ACCESS RESUSCITATOR) O-TWO MEDICAL TECHNOLOGIES, INC.
K001546 05/18/2000 ALLON 2001 MTRE ADVANCED TECHNOLOGY LTD.
K101424 05/20/2010 PHARMACARIBE INHALED SALINE SOLUTIONS PHARMACARIBE
K091519 05/22/2009 HAEMOBAND MULTI-LIGATOR HAEMOBAND SURGICAL LTD.
K061422 05/23/2006 SURGICAL DRAPES AUSTIN MEDICAL, INC.
K141355 05/23/2014 VOLUMETRIC INCENTIVE SPIROMETER BESMED HEALTH BUSINESS CORPORATION
K131502 05/24/2013 SEATTLE - PAP SEATTLE CHILDRENS HOSPITAL
K071461 05/25/2007 MODEL 300D HOME OXYGEN LIQUEFIER COPD PARTNERS, INC.
K121587 05/31/2012 BREATH SHAKE CHEEN HOUNG ENT. CO. LTD.
K101568 06/02/2010 MODEL SB100II FINGER PULSE OXIMETER ATLANTEAN
K101532 06/03/2010 NESSI OTC SPACER PHARMACARIBE
K111547 06/03/2011 BILI-THERAPY PAD TYPE ATOM MEDICAL CORPORATION
K121692 06/07/2012 MINIME 2 NASAL MASK SLEEPNET CORPORATION
K091676 06/09/2009 MC-245, MC-246, MC-247, MC-341, MC-343, MC-344 OMRON HEALTHCARE, INC.
K081654 06/12/2008 HEM-9000AI OMRON HEALTHCARE, INC.
K131742 06/13/2013 HEM-6131 OMRON HEALTHCARE, INC.
K131745 06/13/2013 BLOM-SINGER SEPTAL PERFORATION PROSTHESIS HELIX MEDICAL, LLC
K131749 06/14/2013 HEM-6221 OMRON HEALTHCARE, INC.
K071645 06/15/2007 MODEL HBP T-105 SERIES, MODEL T-105 AND T-105S OMRON HEALTHCARE, INC.
K091871 06/23/2009 DK50 DS EKOM S.R.O.
K091862 06/23/2009 NESSI SPACER PHARMACARIBE
K131877 06/25/2013 SAVE II, SAVE II BASIC AUTOMEDX INC.
K131889 06/25/2013 EUM 100PRO PROMEDIC, INC.
K081805 06/26/2008 CUFFALERT SUNMED
K051712 06/27/2005 MODEL 2800 PFT FILTER AIR SAFETY LTD
K131990 06/28/2013 OXYGEN GENERATOR LIQUEFIER - (OGL) ESSEX CRYOGENICS OF MISSOURI, INC.
K071773 06/29/2007 CPAP NASAL MASK WITH PILLOWS LIFESOURCE
K121932 07/02/2012 HEM-7200-Z (BP742) OMRON HEALTHCARE, INC.
K222018 07/08/2022 Breathe+ PEEP Medical LLC dba GO2 Devices
K071915 07/11/2007 CPAP MASK ARCIMED LABORATORIES LLC
K101953 07/12/2010 SMDIA-1000 SOUTHMEDIC, INC.
K062020 07/17/2006 LIFESOUND ESOPHAGEAL STETHOSCOPE NOVAMED, LLC
K112041 07/18/2011 KOO SMALL VOLUME NEBULIZER (SVN) KOO(SHANGHAI)INDUSTRIES CO., LTD.
K141967 07/21/2014 PUREFILL OXYGEN COMPRESSOR INOVO, INC.
K141978 07/21/2014 MAXPOWER RELIEF OMRON HEALTHCARE, INC.
K082065 07/22/2008 WELL LIFE SELF ADHESIVE ELECTRODE / MODELS: CM, FA, PU AND SP WELL-LIFE HEALTHCARE LIMITED
K072011 07/23/2007 COPD LIQUID OXYGEN PORTABLE, MODEL 300P COPD PARTNERS, INC.
K072019 07/23/2007 AKITA2 APIXNEB ACTIVAERO AMERICA, INC.
K102063 07/23/2010 HEALTH-E-CONNECT SYSTEM ALR TECHNOLOGIES
K142000 07/23/2014 ESOFLIP ES CROSPON, LTD.
K062104 07/24/2006 TALKING TRACH ENGINEERED MEDICAL SYSTEMS, INC.
K132337 07/26/2013 ESOFLIP BALLOON DILATION CATHETER CROSPON, LTD.
K062153 07/27/2006 PORTABLE OXYGEN GENERATOR SYSTEM MOLECULAR PRODUCTS LTD.
K142059 07/29/2014 FOX MOBILE VECTURA GMBH
K142096 08/01/2014 T-PIECE RESUSCITATOR MERCURY MEDICAL
K142103 08/01/2014 CUFF PILOT, SURE SEAL Teleflex Medical, Inc.
K122350 08/03/2012 TAP PAP NASAL PILLOW MASK AIRWAY MANAGEMENT, INC.
K102214 08/06/2010 ENDO FLIP CROSPON, LTD.
K112318 08/11/2011 CLEARPATH 24 PROMEDIC, INC.
K102317 08/16/2010 IQ VENTILATION NASAL MASK SLEEPNET CORPORATION
K092628 08/27/2009 ENTERAL FEEDING TUBE AND ACCESSORIES, FEEDING TUBE EXTENSION SET ALAN REID
K102454 08/27/2010 I-NEB AAD SYSTEM WITH TIM; I-NEB INSIGHT AAD SYSTEM RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD.
K062523 08/28/2006 TRU-MR LARYNGOSCOPE SET TRUPHATEK INTERNATIONAL, LTD.
K102542 09/03/2010 RESUSCI FLOW; RESUSCI FLOW 104 ATOM MEDICAL CORPORATION
K072582 09/13/2007 PROVOX MICRON HME ATOS MEDICAL AB
K092850 09/16/2009 ENDOFLIP CROSPON, LTD.
K132890 09/16/2013 SUPRAPUBIC CATHETER AND INTRODUCER SET MEDIPLUS LTD.
K132903 09/16/2013 DRE VENTURA DRE MEDICAL, INC.
K013089 09/17/2001 EMS HEPA FILTER AND HME COMBINATIONS ENGINEERED MEDICAL SYSTEMS
K013123 09/19/2001 EMS PULMONARY FUNCTION TESTING FILTER ENGINEERED MEDICAL SYSTEMS
K013122 09/19/2001 EMS ELECTROSTATIC FLITER AND HME COMBINATION ENGINEERED MEDICAL SYSTEMS
K102710 09/20/2010 NEO-SERVO I ATOM MEDICAL CORPORATION
K102704 09/20/2010 EASY CUFF JOAN SPIEGEL, MD
K102750 09/23/2010 O2-IN-A-BOX, O2-IN-A-BOX GETO2, INC.
K082812 09/24/2008 OMRON MODEL HBP-2070 VITAL SIGNS MONITOR OMRON HEALTHCARE, INC.
K033008 09/26/2003 AIR SAFETY HEPA AND NON-HEPA FILTERS AIR SAFETY LTD
K072756 09/27/2007 NON-IV ADAPTER FOR INFANT NG TUBE PROMEDIC, INC.
K072755 09/27/2007 GALEMED CPAP MASK GALEMED CORP.
K133057 09/27/2013 VIBRALUNG ACOUSTICAL PERCUSSOR Westmed, Inc.
K062977 09/29/2006 CRITIVIEW, MODEL CRV3 CRITISENSE LTD.
K082853 09/29/2008 CLINICAL OXYGEN DOSE RECORDER (CODR), MODEL 300-CR INSPIRED TECHNOLOGIES, INC.
K082968 10/06/2008 APNEICARE CONNECTION CENTER/INTERNET ANALYSIS APNEICARE, LLC
K063125 10/13/2006 FILTERFLO HEPA; THERMOFLO HEPA (FILTER / HME) ARC MEDICAL, INC.
K113050 10/13/2011 CLEARPATH LOWER GI EASYGLIDE LTD.
K052903 10/14/2005 PEDIATRIC FEEDING TUBE PROMEDIC, INC.
K083056 10/14/2008 NEO-STAT CO2 MERCURY MEDICAL
K023565 10/23/2002 OXICHECK CARADYNE, LTD.
K023579 10/24/2002 GAS SAMPLING LINES PROMEDIC, INC.
K003349 10/26/2000 ALLON 2001 MODIFIED MTRE ADVANCED TECHNOLOGY LTD.
K113166 10/27/2011 CLEARPATH UPPER GI EASYGLIDE LTD.
K113185 10/28/2011 MODEL HBP-1300 OMRON HEALTHCARE, INC.
K023658 10/31/2002 STERILIZATION CASES AND TRAYS CARR METAL PRODUCTS, INC.
K023683 11/01/2002 MULTI-STRAP FULL FACE MASK ENGINEERED MEDICAL SYSTEMS
K063309 11/02/2006 TRU-CABLE TRUPHATEK INTERNATIONAL, LTD.
K083233 11/03/2008 THE PFT FILTER PULMONARY FILTRATION TECHNOLOGIES LLC
K093426 11/03/2009 BACT-TRAP HEPA MIDI PHARMA SYSTEMS AB
K133379 11/04/2013 HEM-7311 OMRON HEALTHCARE, INC.
K133383 11/04/2013 HEM-7320 OMRON HEALTHCARE, INC.
K123410 11/05/2012 HEALTHY SLEEP APPLIANCE HEALTHY SLEEP DENTAL LABORATORY
K013728 11/09/2001 TRACH VOX ENGINEERED MEDICAL SYSTEMS
K103317 11/10/2010 RESUSCITATION UNIT 105 ATOM MEDICAL CORPORATION
K003497 11/13/2000 DISPOSABLE PRESSURE MONITOR ENGINEERED MEDICAL SYSTEMS
K123498 11/13/2012 BP652N (HEM-6300-Z) OMRON HEALTHCARE, INC.
K063477 11/16/2006 NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET NOVAMED, LLC
K063488 11/17/2006 MAXO2 CU MAXTEC, INC.
K133540 11/18/2013 FLOCAP MAXTEC, INC.
K093779 12/09/2009 CLEARPATH UGI EASYGLIDE LTD.
K123855 12/14/2012 WATER-FILLED TEETHER SOLID TOYS IND. LTD.
K083702 12/15/2008 TRACH-ASSIST MERGENET MEDICAL
K024190 12/19/2002 FENESTRATED INFUSION CATHETER PROMEDIC, INC.
K123937 12/20/2012 ATOM TRANSCAPSULE V-707 ATOM MEDICAL CORPORATION
K133873 12/20/2013 TRIBALL INCENTIVE SPIROMETER BESMED HEALTH BUSINESS CORP.
K033967 12/22/2003 TELETHERMOGRAPHIC CAMERA, SERIES A, E, S AND P FLIR SYSTEMS
K093913 12/22/2009 MERCURY MEDICAL T-PIECE RESUSCITATOR MERCURY MEDICAL, INC.
K133957 12/23/2013 DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE GALEMED CORP.
K014281 12/27/2001 GARD FILTER, COMBIGARD FILTE / HME MUNKTELL FILTER AB
K014282 12/27/2001 BACSTOP FILTER,BACSTOP FILTER/HME MUNKTELL FILTER AB
K103828 12/28/2010 BILI-THERAPY SPOT TYPE ATOM MEDICAL CORPORATION
K124032 12/28/2012 METANEB HILL-ROM SERVICES PTE LTD
K073694 12/31/2007 IVENT 2001 MRI CONDITIONAL VERSAMED MEDICAL SYSTEMS, INC.
K970102 01/13/1997 FILTER PROMEDIC, INC.
K970991 03/19/1997 DATEX ENGSTOM MANUAL RESUSCITATOR PROMEDIC, INC.
K050803 03/30/2005 PEDIATRIC CUFFED AND UNCUFFED ET TUBES; STANDARD CUFFED AND UNCUFFED ET TUBES VITAID, LTD.
K001409 05/04/2000 GAMOW BAG, HYPER OXY, HYPER OXY P/T, PRESSURE-CIZER HYPERBARIC TECHNOLOGIES, INC.
K051145 05/04/2005 CRITIVIEW CRITISENSE LTD.
K961879 05/15/1996 ELECTRONIC THERMOMETER WILTEC INDUSTRIES LTD.
K991685 05/17/1999 HALOLITE AAD SYSTEM WITH DEDICATED COMPRESSOR MEDIC-AID LTD.
K981772 05/19/1998 HALOLITE AAD SYSTEM MEDIC-AID LTD.
K991725 05/20/1999 SIDESTREAM NEBULIZER INSPIRED MEDICAL PRODUCTS LTD.
K971933 05/27/1997 PORT-NEB MEDIC-AID LTD.
K962182 06/06/1996 BURLEW INFANT HOOD PROMEDIC, INC.
K051506 06/07/2005 MIELO-CAN, BEST-LISAS, BEN - BONE BIOPSY. FAST-CUT, COLT, SPRING-CUT, BIO-CUT - SOFT TISSUE BIOPSY STERYLAB S.R.L.
K051522 06/08/2005 SILBRONCHO DOUBLE LUMEN TUBE FUJI SYSTEMS CORP.
K992101 06/22/1999 CRITERION 40 OR PM 40 CARADYNE, LTD.
K982283 06/30/1998 WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW OXYGEN FLOW GENERATOR - FIXED MODEL WF 8530 WH CARADYNE, LTD.
K953230 07/10/1995 CPR SUPER POCKET PACK FORMOSA-CJ HEALTH BUSINESS CORP.
K982446 07/15/1998 DYNAMIC SHIELDING RADIATION TABLE AMERICAN BIOPHYSICS, INC.
K042245 08/19/2004 VAPOTHERM MODEL#2000I, 200H VAPOTHERM, INC.
K964204 08/29/1996 ENGSTROM HMEF 1000 DATEX ENGSTROM AB
K993463 10/13/1999 INTRAVASCULAR ADMINISTRATION SET CUSTOM ASSEMBLIES, INC.
K013486 10/19/2001 VAPOTHERM 2000H VAPOTHERM, INC.
K955645 12/12/1995 CATH-GUIDE HUDSON RESPIRATORY CARE, INC.
K003854 12/13/2000 INTRAVASCULAR ADMINISTRATION SET INFUSION DEVICES, INC.
K014211 12/21/2001 OXYARM CO2 SOUTHMEDIC, INC.
K043615 12/30/2004 OXYTEC, MODEL 900 OXYTEC MEDICAL CORPORATION


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