FDA 510(k) Applications Submitted by PAUL E 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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