FDA 510(k) Applications Submitted by E.J. SMITH

FDA 510(k) Number Submission Date Device Name Applicant
K970037 01/06/1997 TARGOGRID DAUM GMBH
K050039 01/07/2005 MS-930 MARS INFLATE-READ BLOOD PRESSURE MONITOR MARS MEDICAL PRODUCTS
K050040 01/07/2005 MS-753 MARS INFLATE-READ BLOOD PRESSURE MONITOR MARS MEDICAL PRODUCTS
K090098 01/15/2009 MAXIM HYGIENE ORGANICALLY GROWN COTTON TAMPON MAXIM HYGIENE PRODUCTS, INC.
K980221 01/22/1998 SILIMED NASAL RETAINER SILIMED, LLC.
K070259 01/26/2007 EC50 TOXCO+ BREATH CARBON MONOXIDE MONITOR BEDFONT SCIENTIFIC LTD.
K990278 01/28/1999 DAUM NEUROCUT NEUROBIOPSYNEEDLE DAUM CORP.
K990298 02/01/1999 TOPOGRAPHIC IMAGING MARKER I.Z.I. MEDICAL PRODUCTS CORP.
K980550 02/12/1998 WHISTLE WATCH HARWILL MEDICAL (PTY) LTD.
K010401 02/12/2001 TRI-PLEX ADAPTER THE MEDICAL DEVICE GROUP, INC.
K000581 02/22/2000 MAEDA NEW NEEDLE DISPOSABLE MAEDA TOYOKICHI SHOTEN
K140592 03/07/2014 CERAGEM AUTOMATIC THERMAL MASSAGER CERAGEM INTERNATIONAL, INC.
K990782 03/09/1999 DAUM NEUROGATE TROCAR DAUM GMBH
K110704 03/14/2011 SENSI DIACOUSTIC MEDICAL DEVICES (PTY) LTD.
K110766 03/18/2011 KOLPLUX SYSTEM KOLPLAST CI LTDA
K971092 03/26/1997 QA-ES SMITH
K040784 03/29/2004 PROTAB ECG TABB ELECTRODE BIO PROTECH, INC.
K070881 03/30/2007 LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660 SAPI MED S.P.A
K971231 04/03/1997 WHITE RIVER MINI MANUAL BREAST PUMP WHITE RIVER CONCEPTS
K011073 04/09/2001 CRYOPLAN SYSTEM CRYOMEDICAL SCIENCES, INC.
K981307 04/10/1998 INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL RESUSCIATOR INTERNATIONAL RESPIRATORY SYSTEMS, INC.
K981308 04/10/1998 INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL PULMONARY RESUSCITATOR WITH RUBBER COMPRESSION BAG INTERNATIONAL RESPIRATORY SYSTEMS, INC.
K021185 04/15/2002 NERVUS MONITOR TAUGAGREINING HF
K991366 04/20/1999 DAUM MRI/CONVENTIONAL BIOPSY KIT DAUM GMBH
K971495 04/24/1997 PATHFINDER SUNGLASSES COIL
K011273 04/26/2001 SI ASCOPE ASTRON CLINICA LIMITED
K121266 04/26/2012 CARDIOSCOPE PULSECOR LIMITED
K091338 05/06/2009 COLLASORB COLLAGEN WOUND DRESSING HARTMANN-CONCO INC.
K131287 05/06/2013 CARDIOSLEEVE RIJUVEN CORP
K021471 05/08/2002 MARQUETTE HUBER TRAP SAFETY INFUSION SET MARQUETTE MEDICAL, INC.
K021569 05/14/2002 RESTFUL NIGHTS, IST-APPLIANCE OTTAWA DENTAL LABORATORY
K041353 05/20/2004 FURLONG H-AC TOTAL HIP REPLACEMENT SYSTEM JRI MANUFACTURING LTD
K981833 05/26/1998 SILIMED NASAL L SHAPED IMPLANT SILIMED, LLC.
K981835 05/26/1998 SILIMED MALAR IMPLANT SILIMED, LLC.
K981850 05/26/1998 SILIMED CHIN IMPLANTS SILIMED, LLC.
K981851 05/26/1998 SILIMED SILICONE CARVING BLOCK SILIMED, LLC.
K981852 05/26/1998 SILIMED TISSUE EXPANDER SILIMED, LLC.
K981944 06/03/1998 BREATHERITE VENTLAB CORP.
K972123 06/05/1997 PROTECTIVE RESTRAINT MODELS #302,440,750,850,AND905 SMITH
K982020 06/09/1998 METRON QA-IDS I.V. PUMP TESTER METRON U.S., INC.
K021904 06/10/2002 MAEDA SILVER ACUPUNCTURE NEEDLE MAEDA TOYOKICHI SHOTEN
K041646 06/17/2004 THERMOTEK Q5 SAAT LTD.
K051608 06/17/2005 STAR 50 MONITORING SYSTEM LARSEN & TOUBRO LIMITED
K972338 06/23/1997 PROTECTIVE RESTRAINT(MODELS #302,440,750 AND A30 X 30 BELT. GERIATRIC PRODUCTS, INC.
K131860 06/24/2013 VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDING US VASCULAR, LLC
K131866 06/24/2013 SUSTAIN HOLLENDER SUSTAINABLE BRANDS LLC
K061849 06/30/2006 MESODERM AA ADVANCED TECHNOLOGY INC.
K041839 07/08/2004 8NONE MEDICAL SOLUTIONS, INC.
K992417 07/20/1999 ROYAL SHIELD NON-STERILE POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABELING CLAIM) 200 MCGM OR LESS OF TOTAL WATER EXTR SHIELD GLOVES MANUFACTURER (M) SDN BHD
K992418 07/20/1999 ROYAL SHIELD NON-STERILE PINK COLORED POWDERED LATEX EXAMINATION GLOVE WITH AND WITHOUT STRAWBERRY SCENT AND WITH PROTEI SHIELD GLOVES MANUFACTURER (M) SDN BHD
K992419 07/20/1999 ROYAL SHIELD NON-STERILE BLUE COLORED POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MCGM OR SHIELD GLOVES MANUFACTURER (M) SDN BHD
K051979 07/21/2005 ORS MODEL 6000 ENDOSCOPE HOLDER O.R. SOLUTIONS, INC.
K082080 07/23/2008 ALCO TUBE PLUS ALCOTEST QUEBEC
K102073 07/23/2010 MED-RX TRANSFER SET, MODELS 10-1227TS, 10-1300TS, 10-1305TS AND 10-1306TS BENLAN, INC.
K112178 07/28/2011 JMS APHERESIS NEEDLE SET WINGEATER(R) V2 JMS NORTH AMERICA CORPORATION
K042054 07/30/2004 SILIMED PECTORAL IMPLANT SILIMED, INC.
K122338 08/02/2012 PREFERRED BLOOD GLUCOSE MONITORING SYSTEM PRODIGY DIABETES CARE, LLC
K992607 08/03/1999 SONICAID SYSTEM 8002 OXFORD INSTRUMENTS MEDICAL SYSTEMS
K992618 08/04/1999 RESPALERT HARWILL MEDICAL (PTY) LTD.
K092625 08/27/2009 WAVESTATE NEUROMONITOR WAVESTATE INC
K112513 08/30/2011 EBONY PTA 0.014 PERIPHERAL DILATATION CATHETER NATEC MEDICAL LTD
K062616 09/05/2006 WELLNESSPRO 2010 INTELSOURCE GROUP, INC.
K032825 09/10/2003 VITAL VISION ARTERIAL HARDNESS AND BLOOD PRESSURE MONITOR MARS MEDICAL PRODUCTS CO., LTD.
K983182 09/11/1998 ALOE THERAPY ORAL RINSE CARRINGTON LABORATORIES, INC.
K032832 09/11/2003 IRRIGATION SETS VITAL CONCEPTS, INC.
K062736 09/13/2006 SIASCOPE V ASTRON CLINICA LIMITED
K983202 09/14/1998 HARWILL MEDICAL CERVITULA CERVICAL SPATULA HARWILL MEDICAL (PTY) LTD.
K983204 09/14/1998 HARWILL MEDICAL U-KLIP UMBILICAL CLAMP HARWILL MEDICAL (PTY) LTD.
K032867 09/15/2003 STAR (LUNAR SERIES) MONITORING SYSTEM LARSEN & TOUBRO LIMITED
K032871 09/15/2003 PLANET MONITORING SYSTEM LARSEN & TOUBRO LIMITED
K112735 09/20/2011 TAMARIN BLUE PTCA RX DILATATION CATHETER NATEC MEDICAL LTD
K983350 09/23/1998 ILO292 DP ECHOPORT PLUS OAE SYSTEM OTODYNAMICS, LTD.
K983351 09/23/1998 ILO292 DP ECHOPORT PLUS OAE SYSTEM OTODYNAMICS, LTD.
K983352 09/23/1998 ILO2088 ENCHOCHECK OR ILO2088 OTOCHECK OTODYNAMICS, LTD.
K092992 09/28/2009 A4-XLR8 FOAM DRESSING GENADYNE BIOTECHNOLOGIES, INC.
K093017 09/29/2009 STELLAR 300 LARSEN & TOUBRO LIMITED
K102849 09/29/2010 ACCULMAING RADIOLOGY INFORMATION SYSTEMS, INC.
K993316 10/04/1999 UEDA UDEX SUPER BP-2000 AUTOMATIC BLOOD PRESSURE RECORDING DEVICE UEDA AVANCER CORP.
K042746 10/04/2004 PET-DOSE COMECER S.R.L.
K093168 10/07/2009 MEDIFLASH AND ESTEFLASH DERMEO
K973843 10/08/1997 MSI PRESSURE INFUSOR SMITH ASSOC.
K993389 10/08/1999 REMED MALE TUTTI FRUTTI CONDOM (BANANA), PREVENTOR, LUCKY BOY, SUMMIT REMED PHARMA
K993390 10/08/1999 REMED MALE LATEX CONDOM (SUPER DUPER) PREVENTOR, LUCKY BOY, AND SUMMIT REMED PHARMA
K993395 10/08/1999 REMED MALE LATEX CONDOM (DOUBLE WHOOPER) PREVENTOR, LUCKY BOY AND SUMMIT REMED PHARMA
K993396 10/08/1999 REMED MALE EXTRA STRENGTH CONDOM PREVENTOR, LUCKY BOY, SUMMIT REMED PHARMA
K993403 10/08/1999 REMED MALE TUTTI FRUTTI CONDOM (STRAWBERRY) PREVENTOR, LUCKY BOY, SUMMIT REMED PHARMA
K993404 10/08/1999 REMED MALE LATEX CONDOM (CLASSIC) PREVENTOR, LUCKY BOY, AND SUMMIT REMED PHARMA
K993405 10/08/1999 REMED MALE DOTTED CONDOM PREVENTOR, LUCKY BOY, SUMMIT REMED PHARMA
K993408 10/08/1999 REMED MALE RIBBED CONDOM PREVENTOR, LUCKY BOY SUMMIT REMED PHARMA
K993409 10/08/1999 REMED MALE TUTTI FRUTTI CONDOM (COCONUT) PREVENTOR, LUCKY BOY, SUMMIT REMED PHARMA
K983608 10/14/1998 EVERGREEN NON-STERILE, POWDER-FREE, PROTEIN CONTENT LABELING CLAIM EXAMINATION GLOVES: NATURAL, BLUE & PINK YTY INDUSTRY (MANJUNG) SDN. BHD.
K983616 10/14/1998 DAIWA MODEL 180 DAIWA PRODUCTS, INC.
K973991 10/21/1997 METRON QA-510 SPO2 ANALYZER METRON U.S., INC.
K023510 10/21/2002 TRUTEK SELECT MODEL TT-1001 TRUTEK, INC.
K042907 10/21/2004 NEEDLE INCAPACITATOR (NEEDLE GUARD) PDMP, INC.
K103115 10/21/2010 PRODIGY DIABETES MANAGEMENT SOFTWARE PRODIGY DIABETES CARE, LLC.
K113135 10/24/2011 UNISTRIP 1 UNISTRIP TECHNOLOGIES, LLC
K053011 10/26/2005 PRO-NEO NEONATAL ECG ELECTRODE, MODELS SG15 AND SR20 BIO PROTECH, INC.
K964316 10/29/1996 PLASTIC SUNGLASSES MEDICAL REPORTS EXCHANGE, INC.
K133333 10/29/2013 UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT BLUE OCEAN MEDICAL PRODUCT, LLC.
K113199 10/31/2011 KEVO NPWT-AHEMO30 AND A HEMO45 FOAM DRESSING KIT KEVO MEDICAL SUPPLIES
K993742 11/04/1999 SUPER TISSUE I.Z.I. CORP.
K023729 11/06/2002 SIASCOPE II ASTRON CLINICA LIMITED
K103354 11/16/2010 EBONY PTA .035 PERIPHERAL DILATATION CATHETER NATEC MEDICAL LTD
K993906 11/17/1999 NANMA NON-ADJUSTABLE CONSTRICTION RING NANMA MFG CO., LTD.
K993908 11/17/1999 NANMA AJUSTABLE CONSTRICTION RING NANMA MFG CO., LTD.
K993909 11/17/1999 NANMA VACUUM PUMP NANMA MFG CO., LTD.
K993912 11/17/1999 AMBIDERM POWDER FREE LATEX EXAMINATION GLOVES (VIOLET, BLUE, GREEN AND PINK), WITH PROTEIN CONTENT LABELING CLAIM (50 MI LATEXX PARTNERS, INC.
K964679 11/21/1996 WHITE RIVER AUTOMATIC BREAST PUMP WHITE RIVER CONCEPTS
K073360 11/30/2007 PROPLATE BIO PROTECH, INC.
K103575 12/06/2010 SPIRO PD PMD HEALTHCARE
K073438 12/07/2007 PROSTIM 1000/2000 BIO PROTECH, INC.
K974574 12/08/1997 DAUM NEUROPUNCTURE NEEDLE DAUM CORP.
K974575 12/08/1997 DAUM ASPIRATIONBIOPSY NEEDLE DAUM CORP.
K974576 12/08/1997 DAUM BIOPSYGUN DAUM CORP.
K043370 12/08/2004 PLANET 50 MONITORING SYSTEM LARSEN & TOUBRO LIMITED
K024080 12/10/2002 SECQUIRE CELL SEPARATOR PERFUSION PARTNERS & ASSOC. INC.
K964972 12/12/1996 SHADOWFORM I.Z.I. MEDICAL PRODUCTS CORP.
K974631 12/12/1997 DAUM NEUROBIOPSY NEEDLE DAUM CORP.
K103763 12/23/2010 STELLAR 300 LARSEN & TOUBRO LIMITED
K094022 12/30/2009 THE WATER LILY CLEARWATER PRODUCTS, LLC


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