FDA 510(k) Applications Submitted by PAMELA L PAPINEAU
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K080042 |
01/08/2008 |
SPIRUS MEDICAL SURGICAL INSTRUMENT |
SPIRUS MEDICAL, INC. |
K080050 |
01/08/2008 |
SPIRUS MEDICAL ENDO-EASE ENDOSCOPIC OVERTUBE |
SPIRUS MEDICAL, INC. |
K060075 |
01/10/2006 |
FIBER-METAL POST |
FOREMOST DENTAL LLC. |
K100062 |
01/11/2010 |
INFILTRATION KIT |
DMG USA, INC. |
K010219 |
01/24/2001 |
CHALLENGER DIRECT COMPOSITE |
INTERNATIONAL DENTAL RESEARCH |
K090193 |
01/27/2009 |
CONDUCTOR CORONARY GUIDEWIRE |
CONCERT MEDICAL, LLC |
K040215 |
01/30/2004 |
VISION-SCIENCES CST-2000 FLEXIBLE CYSTOSCOPE WITH SLIDE-ON ENDOSHEATH SYSTEM |
VISION-SCIENCES, INC. |
K060235 |
01/30/2006 |
ENDO-EASE ENDOSCOPIC OVERTUBE |
SPIRUS MEDICAL, INC. |
K990354 |
02/05/1999 |
ENDOSHEATH |
VISION-SCIENCES, INC. |
K950809 |
02/22/1995 |
VISION-SCIENCES DISPOSABLE ENDOSHEATH FOR FLEXIBLE NASOPHARYNGO-LARYNGOSCOPES |
VISION-SCIENCES, INC. |
K080480 |
02/22/2008 |
NANOCOMPOSITE RESTORATIVE KIT |
DMG USA, INC. |
K080479 |
02/22/2008 |
DENTAL CERAMIC |
DMG USA, INC. |
K980804 |
03/02/1998 |
SABRE BT BLUNT0TIP SURGICAL TROCAR |
ENDOSCOPIC CONCEPTS, INC. |
K060552 |
03/02/2006 |
BC100 BODY COMPOSITION ANALYSIS SYSTEM |
ATHLETIC IQ, INC. |
K080645 |
03/06/2008 |
STD MED PRIMO PORT POLY |
STD MED, INC. |
K110759 |
03/18/2011 |
TEMPOCEM |
DMG USA, INC. |
K000878 |
03/20/2000 |
HONIGUM |
DMG USA, INC. |
K000951 |
03/23/2000 |
LUXAFORM |
DMG USA, INC. |
K991098 |
04/01/1999 |
DIFOTI SYSTEM |
ELECTRO-OPTICAL SCIENCES, INC. |
K080905 |
04/01/2008 |
QUANTUM/ CANON CXDI INTEGRATION SYSTEM, MODEL QG-DIG-CXDI |
QUANTUM MEDICAL IMAGING, LLC. |
K070911 |
04/02/2007 |
STD MED PRIMO PORT |
STD MED, INC. |
K991172 |
04/07/1999 |
IONOSIT BOND |
DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH |
K031128 |
04/09/2003 |
B-SMART, MODEL B-01 |
MACOSTA MEDICAL USA, LLC |
K040984 |
04/15/2004 |
VISION SCIENCES MODEL ENT-2000V FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE |
VISION-SCIENCES, INC. |
K050972 |
04/18/2005 |
VISION-SCIENCES ENT-3000 SCOPE |
VISION-SCIENCES, INC. |
K011211 |
04/19/2001 |
FLOWABLE COMPOSITE/ ECUFLOW/ LUXAFLOW |
DMG USA, INC. |
K031292 |
04/23/2003 |
MODIFICATION TO FOSSA URETERAL STONE SWEEPER |
FOSSA MEDICAL, INC. |
K071127 |
04/23/2007 |
FLEXIBLE HYSTEROSCOPE WITH ENDOSHEATH SYSTEM |
VISION-SCIENCES, INC. |
K021344 |
04/29/2002 |
B-F200 BRONCHOSCOPE WITH BSS-F21 ENDOSHEATH SYSTEM |
VISION-SCIENCES, INC. |
K041271 |
05/12/2004 |
STERNGOLD 3.25 ERA DENTAL IMPLANT SYSTEM |
STERNGOLD |
K021602 |
05/15/2002 |
FOSSA URETERAL STONE SWEEPER |
FOSSA INDUSTRIES, INC. |
K081493 |
05/28/2008 |
INFILTRATION KIT |
DMG USA, INC. |
K001723 |
06/06/2000 |
COOL-TEC ELECTRODES |
SEEDLING ENTERPRISES. LLC. |
K051503 |
06/07/2005 |
UGYTEX SUAL KNIT MESH |
SOFRADIM PRODUCTION |
K071579 |
06/08/2007 |
PEF TUBE |
N.M. BEALE CO. INC. |
K031786 |
06/10/2003 |
TNE-2000 ESOPHAGOSCOPE WITH ECS-D ENDOSHEATH SYSTEM |
VISION-SCIENCES, INC. |
K031790 |
06/10/2003 |
SLIDE-ON ENDOSHEATH SYSTEM FOR SENSORY TESTING |
VISION-SCIENCES, INC. |
K101710 |
06/17/2010 |
LUXATEMP ULTRA /STAR |
DMG USA, INC. |
K002086 |
07/10/2000 |
PRIMAFLOW |
DMG USA, INC. |
K071903 |
07/10/2007 |
ENDOSHEATH SYSTEMS FOR USE WITH VISION-SCIENCES TNE SCOPE |
VISION-SCIENCES, INC. |
K041960 |
07/21/2004 |
COMPOSITE/COMPOMER REPAIR KIT |
DMG USA, INC. |
K012307 |
07/23/2001 |
LUXACORE/LUXACORE DUAL |
DMG USA, INC. |
K012316 |
07/23/2001 |
PERMACEM / PERMACEM DUAL |
DMG USA, INC. |
K982626 |
07/28/1998 |
URETHROPEXY SUTURE PLACEMENT KIT MODEL NUMBERS UM-300, MW-100, MINI-LAPAROTOMY MMK KIT MODEL UM-250, LAPAROSCOPIC BURCH0 |
MEDWORKS CORP. |
K982628 |
07/28/1998 |
MEDWORKS INSEMINATION CATHETER |
MEDWORKS CORP. |
K982630 |
07/28/1998 |
MEDWORKS VISUALIZATION INSEMINATION CATHETER |
MEDWORKS CORP. |
K072073 |
07/30/2007 |
VISION-SCIENCES ENT-5000 AND ENT-5100 VIDEO ENT SCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR |
VISION-SCIENCES, INC. |
K072088 |
07/30/2007 |
FLEXIBLE TRANS-NASAL VIDEO ESOPHAGOSCOPE WITH DIGITAL VIDEO PROCESSOR AND DISPOSABLE ENDOSHEATH SYSTEMS |
VISION-SCIENCES, INC. |
K052084 |
08/02/2005 |
ENDO-EASE ENDOSCOPIC OVERTUBE |
SPIRUS MEDICAL, INC. |
K982692 |
08/03/1998 |
STERNOMEGA BONDING AGENT, STERNOMEGA COMPOSITE LC, STERNOMEGA COMPOMER LC |
STERNGOLD/IMPLAMED |
K072180 |
08/06/2007 |
VISION-SCIENCES CST-5000 VIDEO CYSTOSCOPE WITH ENDOSHEATH SYSTEM |
VISION-SCIENCES, INC. |
K982895 |
08/17/1998 |
STERNOMEGA COMPOMER CEMENT |
STERNGOLD/IMPLAMED |
K963344 |
08/26/1996 |
DISPOSABLE SS-F32 ENDOSHEATH FOR USE WITH THE S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE |
VISION-SCIENCES, INC. |
K992879 |
08/26/1999 |
ECUSIT COMPOSITE REPAIR |
DMG HAMBURG |
K102603 |
09/10/2010 |
SA FLOWABLE ADHESIVE |
DMG USA, INC. |
K002841 |
09/12/2000 |
COOL-TEC ELECTRODES |
SEEDLING ENTERPRISES. LLC. |
K062805 |
09/19/2006 |
MODIFICATION TO ENDO-EASE |
SPIRUS MEDICAL, INC. |
K013179 |
09/24/2001 |
LUXAGLAZE |
DMG USA, INC. |
K013236 |
09/28/2001 |
LUXABITE |
DMG USA, INC. |
K013237 |
09/28/2001 |
STATUSBLUE |
DMG USA, INC. |
K973734 |
09/30/1997 |
STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATION |
WELCON, INC. |
K052800 |
10/03/2005 |
PROVISIONAL INLAY/ONLAY KIT |
DMG USA, INC. |
K033227 |
10/06/2003 |
LUXAFORM PLUS |
DMG USA, INC. |
K964100 |
10/11/1996 |
VISION-SCIENCES MODEL SS-U32 ENDO SHEATH FOR USE WITH THE VSI S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE AND VSI S-V100 |
VISION-SCIENCES, INC. |
K093338 |
10/23/2009 |
SELF ADHESIVE COMPOSITE LUTING CEMENT |
DMG USA, INC. |
K023580 |
10/24/2002 |
STERNGOLD ACID ETCH DENTAL IMPLANT SYSTEM |
STERNGOLD |
K093329 |
10/26/2009 |
SCOPE INTRODUCER MODEL 7400 |
N.M. BEALE CO. INC. |
K013571 |
10/29/2001 |
MAGICFIL |
DMG USA, INC. |
K964326 |
10/30/1996 |
VISION-SCIENCES MODEL S-V200 COLOR MVIDEO FLEXIBLE SIGMOIDOSCOPE WITH ENDOSHEATH SYSTEM |
VISION-SCIENCES, INC. |
K023649 |
10/30/2002 |
VITIQUE SYSTEM |
DMG USA, INC. |
K003402 |
11/01/2000 |
WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION |
WELCON, INC. |
K964397 |
11/04/1996 |
THERAPIK |
THE JENEX CORPORATION |
K013674 |
11/07/2001 |
LUXATEMP/LUXATEMP SOLAR/INSTATEMP |
DMG USA, INC. |
K093477 |
11/09/2009 |
SHIELD KYPHOPLASTY SYSTEM |
SOTEIRA, INC. |
K063444 |
11/15/2006 |
TOTAL ETCH BONDING AGENT |
DMG USA, INC. |
K093587 |
11/19/2009 |
DENTAL MERCURY |
DMG USA, INC. |
K093584 |
11/19/2009 |
EZ-MISTER |
N.M. BEALE CO. INC. |
K053412 |
12/07/2005 |
FLEXISCOPE, MODELS 50MH AND 50 MHC |
SCHOELLY IMAGING, INC. |
K024095 |
12/12/2002 |
MODIFICATION TO VISION SCIENCES ENDOSHEATH SYSTEM |
VISION-SCIENCES, INC. |
K024165 |
12/17/2002 |
DUAL-LUMEN CATHETER |
BISTECH, INC. |
K053560 |
12/21/2005 |
MODIFIED ENDOSHEATH SYSTEM FOR VSI FLEXIBLE CYSTOSCOPE |
VISION-SCIENCES, INC. |
K130580 |
03/05/2013 |
RETRACTION PASTE |
DMG USA, INC. |
K141400 |
05/28/2014 |
DCCERAM SYSTEM |
CERAMAY GMBH & CO.KG |
K132009 |
07/01/2013 |
CMOS VIDEO NASOPHARYNGOSCOPE SYSTEM |
SCHOELLY FIBEROPTIC, GMBH |
K082504 |
08/29/2008 |
APOLLO ANTERIOR CERVICAL PLATE SYSTEM |
APOLLO SPINE, INC. |
K133682 |
12/02/2013 |
SCHOELLY ARTHROSCOPE |
SCHOLLY FIBEROPTIC GMBH |
K961591 |
04/24/1996 |
DISPOSABLE ENDOSHEATH FOR E-F100 FLEXIBLE NASOPHARYNGOSCOPE |
VISION-SCIENCES, INC. |
K963795 |
09/23/1996 |
VISION-SCIENCES MODEL B-F100 BRONCHOSCOPE WITH MODEL BS-F21 DISPOSABLE ENDOSHEATH |
VISION-SCIENCES, INC. |
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