FDA 510(k) Applications Submitted by Harry Harry
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K130135 |
01/18/2013 |
DANA REUSABLE BI TEST PACK |
DANA PRODUCTS, INC. |
K110253 |
01/28/2011 |
REUSABLE TEST PACK FOR DANA EMULATING INDICATORS |
DANA PRODUCTS, INC. |
K120592 |
02/28/2012 |
DANA REUSABLE BOWIE TEST PACK FOR DANA BOWIE DICK INDICATORS |
DANA PRODUCTS, INC. |
K100891 |
03/31/2010 |
DANA EMULATING INDICATOR |
DANA PRODUCTS, INC. |
K012195 |
07/13/2001 |
STEAM STERILIZATION INTERGRATOR |
DANA PRODUCTS, INC. |
K102761 |
09/23/2010 |
DANA REUSABLE TEST PACK FOR STEAM STERILIZATION |
DANA PRODUCTS, INC. |
K092944 |
09/24/2009 |
DANA REUSABLE TEST PACK FOR STEAM STERILIZATION |
DANA PRODUCTS, INC. |
K133267 |
10/24/2013 |
DANA REUSABLE TEST PACK |
DANA PRODUCTS, INC. |
K103321 |
11/12/2010 |
DANA REUSABLE TESTPACK FOR STEAM STERILIZATION FOR 10 MINUTE EXTENDED CYCLES |
DANA PRODUCTS, INC. |
K020400 |
02/06/2002 |
DIGITIMER D185 MULTIPULSE CORTICAL STIMULATOR |
MEPS, LLC. |
K121007 |
04/03/2012 |
NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE 1, NEO DELTA SELF SAFE 1 |
DELTA MED SRL |
K060058 |
01/09/2006 |
STELLAR 404T |
LARSEN & TOUBRO LIMITED |
K042560 |
09/21/2004 |
STELLAR 404 MONITORING SYSTEM |
LARSEN & TOUBRO LIMITED |
K212717 |
08/27/2021 |
Paneffort AAMI Level 3 Isolation Gown |
Paneffort, LLC |
K120437 |
02/13/2012 |
TWISTER SIDE-FIRE FIBER OPTIC DELIVERY SYSTEM |
BIOLITEC SIA (LATVIA) |
K130681 |
03/13/2013 |
ENDOVASCULAR LASER VENOUS SYSTEM KIT WITH 2 RING RADIAL EMITTING FIBER |
BIOLITEC SIA |
K100726 |
03/15/2010 |
CERALAS D/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS E/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS HPD/ 980NM |
BIOLITEC, INC. |
K101712 |
06/18/2010 |
ENDOVASCULAR LAER VEIN SYSTEM KIT |
BIOLITEC, INC. |
K112013 |
07/14/2011 |
EVOLVE(R) HPD 980/1470NM MULTIWAVELENGTH DIODE LASER |
BIOLITEC, INC. |
K112253 |
08/05/2011 |
CERALAS 147NM DIODE LASER SYSTEM |
BIOLITEC, INC. |
K112299 |
08/10/2011 |
ENDOVASCULAR LASER VEIN SYSTEM KIT |
BIOLITEC MEDICAL DEVICES, INC |
K112324 |
08/12/2011 |
CERALAS 980NM DIODE LASER FAMILY |
BIOLITEC MEDICAL DEVICES, INC |
K112442 |
08/24/2011 |
RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM |
BIOLITEC MEDICAL DEVICES, INC |
K113688 |
12/15/2011 |
MEGABEAM REUSABLE FIBER OPTIC DELIVERY SYSTEM |
BIOLITEC MEDICAL DEVICES, INC |
K113709 |
12/19/2011 |
MEGABEAM FIBER OPTIC DELIVERY SYSTEM WITH ADDITIONAL TIPS & HANDPIECE |
BIOLITEC MEDICAL DEVICES, INC |
K113792 |
12/23/2011 |
MEGABEAM ENDOCULAR PROBE AND ASPIRATING ENDOCULAR PROBE |
BIOLITEC MEDICAL DEVICES, INC |
K113858 |
12/30/2011 |
MEGABEAM ENDO-ENT PROBE |
BIOLITEC MEDICAL DEVICES, INC |
K120231 |
01/25/2012 |
EVOLVE HPD 980/ 1470NM MULTIWAVELENGTH DIODE LASER (EVOLVE DUAL) |
BIOLITEC MEDICAL DEVICES, INC |
K990015 |
01/04/1999 |
ELECTRODE NEEDLES |
TECHNOMED EUROPE |
K964060 |
10/09/1996 |
COPAXONE (COPOLYMER-1 FOR INJECTION) SELF-INJECTION ADMINISTRATION PACKAGE |
TRAVENOL LABORATORIES (ISRAEL) LTD. |
K974171 |
11/05/1997 |
COPAXONE (GLATIRAMER ACETATE FOR INJECTION) EZ-JECT FROM SHARED SOLUTIONS |
TEVA MEDICAL, LTD. |
K221409 |
05/16/2022 |
Paneffort 3-ply Surgical and Procedural Masks |
Paneffort, LLC |
K072385 |
08/24/2007 |
HEARTEVENT, MODEL AT |
DIAGNOSTIC DEVICES PTY LTD |
K113316 |
11/09/2011 |
DCS LACRIMAL STENT |
DCS SURGICAL INC |
K071613 |
06/13/2007 |
AMIGO INSULIN PUMP |
NIPRO DIABETES SYSTEMS, INC. |
K990389 |
02/08/1999 |
MOSS GASTROSTOMY TUBE |
MOSS TUBES, INC. |
K984628 |
12/30/1998 |
MODIFICATION OF MOSS P.E.G. TRAY |
MOSS TUBES, INC. |
K984629 |
12/30/1998 |
MOSS TUBES, INC. NASAL TUBE - MARK IV |
MOSS TUBES, INC. |
K102114 |
07/28/2010 |
MEDRANGE ELECTROSURGICAL GENERATOR |
MEDRANGE CORPORATION |
K954112 |
07/31/1995 |
VYGON LIFEVAC MID-LINE TRAY |
VYGON CORP. |
K954302 |
09/13/1995 |
VYGON PREMI-CATH - LONG TERM CATHETER |
VYGON CORP. |
K984310 |
12/02/1998 |
MOSS TUBES, INC, ALL SILICONE GASTROSTOMY TUBE |
MOSS TUBES, INC. |
K983683 |
10/20/1998 |
UNIK TONGUE CLEANER |
UNIK PRODUCTS, INC. |
K051357 |
05/24/2005 |
DS7A CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7A; DS7AH CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7AH |
DIGITIMER LTD. |
K030218 |
01/21/2003 |
PER, MODEL MEMO |
MEDICAL MONITORS PTY., LTD. |
K010751 |
03/13/2001 |
BPFONE, MODEL UA 767IT |
MEDICAL MONITORS PTY LIMITED |
K071472 |
05/29/2007 |
PLANET 55 |
LARSEN & TOUBRO LIMITED |
K061816 |
06/28/2006 |
GALAXY |
LARSEN & TOUBRO LIMITED |
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