| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K111267 |
11/08/2011 |
CONCISE, SILICONE HYDROGEL DAILY WEAR SOFT CONTACT LENS (EFROFILCON A) |
ABBCONCISE OPTICAL GROUP, LLC |
MARTIN DALSINGH |
| K111882 |
11/07/2011 |
LAMINAR FLOW PHACO TIPS |
ABBOTT MEDICAL OPTICS INC |
ROSANNE M YETEMIAN |
| K112957 |
11/08/2011 |
HI-TORQUE POWERTURN |
ABBOTT VASCULAR-CARDIAC THERAPIES |
KAY SETZER |
| K112273 |
11/22/2011 |
ACCUMED UPPER ARM AUTOMATIC BLOOD PRESSURE MONITOR |
ACCUMED HEALTHCARE (SHANGHAI) INC. |
CYNTHIA (CINDY) GREEN |
| K112270 |
11/22/2011 |
ACCUMED WRIST AUTOMATIC BLOOD PRESSURE MONITOR |
ACCUMED HEALTHCARE (SHANGHAI) INC. |
CYNTHIA (CINDY) GREEN |
| K110765 |
11/04/2011 |
FXA (TM) |
ACES GMBH |
FRANK T TRAUTWEIN |
| K111930 |
11/08/2011 |
ACKERMANN EUROPCLIP |
ACKERMANN INSTRUMENTE GMBH |
KAREN E WARDEN, PHD |
| K113063 |
11/10/2011 |
CT-GUIDE NEEDLE GUIDANCE SYSTEM |
ACTIVIEWS LTD |
JOHN J SMITH |
| K112111 |
11/14/2011 |
ACU-SINCH REPAIR SYSTEM AND ACUMED SUTURE ANCHOR |
ACUMED LLC |
LINO TSAI |
| K112551 |
11/21/2011 |
S4 SPINAL SYSTEM |
AESCULAP IMPLANT SYSTEM, INC. |
LISA M BOYLE |
| K103058 |
11/10/2011 |
MULTIFUNCTION KEITO |
AGUIFLAI IBERICA S.L. |
XAVIER CASALS |
| K112425 |
11/21/2011 |
INFINITI VISION SYSTEM EVERGREEN II AUTOSERT IOL INJECTOR HANDPIECE |
ALCON MANUFACTURING, LTD. |
MARTIN A KAUFMAN |
| K112361 |
11/30/2011 |
ALAMO C |
ALLIANCE PARTNERS, LLC |
JENNIFER PALINCHIK |
| K110170 |
11/28/2011 |
RAPTOR FACET FIXATION SYSTEM |
ALPHATEC SPINE, INC. |
OLGA LEWIS |
| K110962 |
11/18/2011 |
AMBU ASCOPE 2 |
AMBU A/S |
SANJAY PARIKH |
| K113046 |
11/10/2011 |
AMEDITECH IMMUTEST MILTI-DRUG SCREEN |
AMEDITECH, INC. |
Greg Cerra |
| DEN100026 |
11/21/2011 |
APTUS STEERABLE ENDOGUIDE WITH OBTURATOR, APTUS ENDOSTAPLE APPLIER WITH ENDOSTAPLE CASSETTE, APTUS ENDOSTAPLE CASSETTE |
APTUS ENDOSYSTEMS, INC. |
BURT GOODSON |
| K113263 |
11/14/2011 |
ARGES IMAGING CONTRAST SPRAY |
ARGES IMAGING, INC |
Rebecca K Pine |
| K111356 |
11/09/2011 |
ASIMANAGER - AT |
ARLINGTON SCIENTIFIC, INC. |
DAVID BINKS |
| K113110 |
11/09/2011 |
AXERA ACCESS SYSTEM |
ARSTASIS, INC. |
DEBRA COGAN |
| K112278 |
11/04/2011 |
ASCENSION NUGRIP CMC IMPLANT |
ASCENSION ORTHOPEDIC |
BRADLEY W STRASSER |
| K111600 |
11/15/2011 |
REPROCESSED HAND ACTIVATE SEALER/DIVIDER |
ASCENT HEALTHCARE SOLUTIONS |
RAMONA KULIK |
| K113112 |
11/17/2011 |
CLEARWAY RX NB CATHETER |
ATRIUM MEDICAL CORP. |
MEGAN MCCAGH |
| K112488 |
11/23/2011 |
HOTDOG PATIENT WARMING SYSTEM |
AUGUSTINE BIOMEDICAL & DESIGN, LLC |
WENDY NELSON |
| K112636 |
11/26/2011 |
CYTOGUARD(TM) CLOSED LUER CONNECTOR |
B. BRAUN MEDICAL, INC. |
ANGELA J CARAVELLA |
| K112603 |
11/04/2011 |
ACCESS HYBRITECH P2PSA QC ON THE ACCESS IMMUNOASSAY SYSTEMS |
BECKMAN COULTER, INC. |
CINDY MCGUIRE |
| K113241 |
11/28/2011 |
BD EMERALD SINGLE USE, HYPODERMIC SYRINGE |
BECTON DICKINSON |
KARA MCKEE |
| K112639 |
11/16/2011 |
THE BELMONT BUDDY LITE FLUID WARMER |
BELMONT INSTRUMENT CORP. |
URAIWAN P LABADINI |
| K103031 |
11/10/2011 |
BMR FACE |
BIO-MEDICAL RESEARCH, LTD. |
ANNE-MARIE KEENAN |
| K103691 |
11/03/2011 |
BIOHORIZONS ABUTMENTS FOR ZIMMER |
BIOHORIZONS IMPLANT SYSTEMS, INC. |
MICHAEL DAVIS |
| K103291 |
11/04/2011 |
BIOHORIZONS LASER-LOK ABUTMENTS FOR NOBEL BIOCARE |
BIOHORIZONS IMPLANT SYSTEMS, INC. |
MICHAEL DAVIS |
| K110619 |
11/23/2011 |
ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS, VITAMIN D CONTROLS |
BIOKIT S.A. |
JOAN GUIXER |
| K112299 |
11/03/2011 |
ENDOVASCULAR LASER VEIN SYSTEM KIT |
BIOLITEC MEDICAL DEVICES, INC |
HARRY HAYES |
| K112186 |
11/08/2011 |
FIBER DISK AND BLOCK |
BIOLOREN SRL |
ANDREA RATTI |
| K110106 |
11/30/2011 |
VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOAZOLE |
BIOMERIEUX, INC. |
JOLYN TENLLADO |
| K111216 |
11/18/2011 |
OSSEOTITE 2 DENTAL IMPLANTS |
BIOMET 3I, INC. |
MARTHA I GARAY |
| K111908 |
11/29/2011 |
BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM |
BIOMET MICROFIXATION, INC. |
KIM REED |
| K112050 |
11/18/2011 |
SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER |
BIOSENSE WEBSTER, INC. |
MARINA GUEVREKIAN |
| K112118 |
11/17/2011 |
DREAMBOND |
BISCO, INC. |
Michelle Schiltz-Taing |
| K110426 |
11/02/2011 |
DYNA-EXTOR II |
BK MEDITECH CO., LTD. |
ELAINE DUNCAN |
| K111593 |
11/18/2011 |
GUARDIAN INFLATABLE BONE EXPANDER SYSTEM |
BM KOREA CO., LTD. |
RONALD D ARKIN |
| K112697 |
11/30/2011 |
CHARGER PTA BALLON DILATATION CATHETER |
BOSTON SCIENTIFIC |
GLENN JACQUES |
| K112303 |
11/09/2011 |
RUBICON SUPPORT CATHETER |
BOSTON SCIENTIFIC |
GLENN JACQUES |
| K111648 |
11/03/2011 |
BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATOR |
BRACCO DIAGNOSTIC, INC. |
TRACEY ALEXANDER |
| K103418 |
11/30/2011 |
DESARA MINI |
CALDERA MEDICAL, INC. |
VICKI GAIL |
| K112768 |
11/18/2011 |
CALYPSO SYSTEMS WITH DYNAMIC EDGE GATING |
CALYPSO MEDICAL TECHNOLOGIES INC |
MARCIA PAGE |
| K112321 |
11/10/2011 |
CS 1200 |
CARESTREAM HEALTH,INC. |
DANIEL HOEFER |
| K103472 |
11/07/2011 |
NUFACE PLUS |
Carol Cole Company |
BOB DUFFY |
| K112985 |
11/09/2011 |
CATHETER CONNECTIONS' DUALCAP DUO |
CATHETER CONNECTIONS, INC. |
DONALD D SOLOMON |
| K103820 |
11/03/2011 |
REPROBONE DENTAL GRAFTING MATERIAL |
CERAMISYS LTD |
HILLARD W WELCH |
| K110554 |
11/02/2011 |
BIOCERAMIC ORBITAL IMPLANT, ORBTEX |
CERAMISYS LTD. |
HILLARD W WELCH |
| K111690 |
11/22/2011 |
DEVINE SPINAL SYSTEM |
CHANGZHOU ORTHMED MEDICAL INSTRUMENT CO., LTD. |
Diana Hong |
| K102756 |
11/29/2011 |
SURECORE BIOPSY DEVICE |
CHEST INNOVATIONS INC |
SALMAAN HAMEED |
| K113212 |
11/16/2011 |
DENTAL LASER THERAPY SYSTEM |
CHINA DAHENG GROUP, INC. |
Diana Hong |
| K110605 |
11/23/2011 |
ROM PLUS |
CLINICAL INNOVATIONS, LLC |
DEAN WALLACE |
| K112168 |
11/21/2011 |
COMPONEER |
COLTENE/WHALEDENT AG |
MARK VAN METER |
| K112838 |
11/10/2011 |
VASOPRESS REPROCESSED DVT LEG / FOOT GARMENTS |
COMPRESSION THERAPY CONCEPTS, INC. |
LEONARD NASS |
| K112205 |
11/16/2011 |
SNORERX 9.0 |
CONSUMER HEALTH PRODUCTS, INC |
GARY MOCNIK |
| K112185 |
11/02/2011 |
FOURSNARE VASCULAR RETRIEVAL SNARE |
COOK, INC. |
MOLLY BUSENBARK |
| K111716 |
11/10/2011 |
KNOTLESS SUTURE FIXATION SYSTEM |
CORE ESSENCE ORTHOPAEDICS |
JEFF MILLER |
| K111901 |
11/09/2011 |
ASA 'MPHI FAMILY DIODE LASER |
CYNOSURE, INC. |
ANTHONY BURNS |
| K112152 |
11/09/2011 |
CERCON HT |
DENTSPLY INTERNATIONAL, INC. |
HELEN LEWIS |
| K112220 |
11/22/2011 |
DEVILBISS INTELLIPAP / SLEEPCUBE AUTO BILEVEL |
DEVILBISS HEALTHCARE LLC |
JAMES P FROEHLICH |
| K102524 |
11/03/2011 |
FUTURA |
DR. OLIVER WENKER, M.D., M.B.A. |
COURTLAND IMEL |
| K111655 |
11/30/2011 |
FLAATZ 760 |
DRTECH CORP. |
CHOUL-WOO SHIN |
| K112354 |
11/30/2011 |
5MP MONOCHROME LCD MONITOR, RADIFORCE GX530 |
EIZO NANAO CORPORATION |
HIROAKI HASHIMOTO |
| K111960 |
11/18/2011 |
ELITECH CLINICAL SYSTEMS CARBON DIOXIDE ELECTRODE, ELITECH CLINICAL SYSTEMS ISE CALIBRATORS |
ELITECHGROUP |
DEBRA K HUTSON |
| K112069 |
11/15/2011 |
RSP GLENOID BASEPLATE POROUS COATED |
ENCORE MEDICAL, L.P. |
WILLIAM GARZON |
| K112033 |
11/08/2011 |
ENSEAL G2 TISSUS SEALERS |
ETHICON ENDO-SUGERY, LLC |
DONOVAN MAY |
| K112097 |
11/21/2011 |
GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5 |
EXACTECH, INC. |
VLADISLAVA ZAITSEVA |
| K111474 |
11/02/2011 |
BINGO PRO |
FORUM ENGINEERING TECHNOLOGIES (96) LTD. |
YULIYA YUTKEVICH |
| K102833 |
11/18/2011 |
DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS |
FOSHAN NANHAI BAI HE MEDICAL TECHNOLOGY CO., LTD |
Diana Hong |
| K111645 |
11/09/2011 |
FD TENS 2050 OR SLIDE TENS MODEL FD2050 |
FUJI DYNAMICS LTD |
CHING KONG (FELIX) LEE |
| K111097 |
11/09/2011 |
HUMELOCK CEMENTED SHOULDER PROSTHESIS |
FX SOLUTIONS |
CHERYL HASTINGS |
| K112570 |
11/30/2011 |
CENTRICITY CARDIO IMAGING |
GE HEALTHCARE INTEGRATED IT SOLUTIONS |
JOHN MANARIK |
| K111290 |
11/18/2011 |
PIEZO BONE SURGERY |
GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD |
CHARLIE MACK |
| K103803 |
11/23/2011 |
HAMILTON-G5 |
HAMILTON MEDICAL AG |
FREDERIKE BRUEHSCHWEIN |
| K110276 |
11/09/2011 |
POWERPRESS UNIT |
HANURI DISTRIBUTION, INC |
JUNG HYUN MOON |
| K113129 |
11/08/2011 |
SPECTRALIS ANTERIOR SEGMENT MODULE (SPECTRALIS ASM) |
HEIDELBERG ENGINEERING GMBH |
GERHARD ZINSER |
| K103788 |
11/08/2011 |
PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT |
HORIBA ABX SAS |
CAROLINE FERRER |
| K100811 |
11/04/2011 |
IMPEDIMED - EXTRACELLULAR FLUID ANALYZER MODEL: L-DEX U400 |
IMPEDIMED LIMITED |
ALDEN KAY |
| K103021 |
11/04/2011 |
ELEMENT PLUS BLOOD GLUCOSE MONITORING SYSTEM |
INFOPIA CO., LTD |
Priscilla Chung |
| K102047 |
11/01/2011 |
LCI OPTION FOR INNOCOR |
INNOVISION A/S |
H. CARL JENKINS |
| K112945 |
11/03/2011 |
ELITECORE FULL CORE BIOPSY DEVICE 18GAX10CM, 18GAX15CM, 18GAX20, WITH/HILITIER 18GAX10CM , W/HILITER 18GAX15CM |
INRAD INC. |
RYAN GOOSEN |
| K112601 |
11/09/2011 |
INTRICON DATRIX SIRONA EVENT/ HOLTER RECORDER |
INTRICON DATRIX CORPORATION |
TANYA O'BRIEN |
| K111748 |
11/23/2011 |
RECOVERY+ MODEL PS 511, DVTHERAPY MODEL PS 511A |
JOY LONG |
JOY LONG |
| K113279 |
11/14/2011 |
IDENTIUM HEAVY, IDENTIUM MEDIUM, IDENTIUM SCAN HEAVY, IDENTIUM SCAN MEDIUM, IDENTIUM SCAN LIGHT |
KETTENBACH GMBH & CO KG |
SIMONE MATUSCHKA |
| K113036 |
11/02/2011 |
U BY KOTEX CLICK UNSCENTED MENSTRUAL TAMPONS |
KIMBERLY-CLARK CORPORATION |
LORI BARR |
| K111982 |
11/17/2011 |
CLEARFIL DC CORE PLUS |
KURARAY AMERICA, INC. |
KIYOYUKI ARIKAWA |
| K112381 |
11/03/2011 |
HI TORQUE CONNECT GUIDEWIRE |
LAKE REGION MEDICAL |
KENNY WALSH |
| K112397 |
11/04/2011 |
ORTHO-JET CRYSTAL |
LANG DENTAL MFG. CO., INC. |
DAVID LANG |
| K112357 |
11/10/2011 |
VESSEL GUARDIAN |
LEXION MEDICAL, LLC. |
BERNARD HORWATH |
| K103547 |
11/03/2011 |
LIGHTLAS MULTI-WAVELENGTH MEDICAL LASER SYSTEM |
LIGHTMED CORP. |
JOCELYN LIU |
| K113139 |
11/22/2011 |
LZI COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAY,CALIBRATORS,CONTROLS |
Lin-Zhi International, Inc. |
BERNICE LIN |
| K112965 |
11/02/2011 |
NANO SUTURE ANCHOR |
LINVATEC CORPORATION D/B/A CONMED LINVATEC |
ASHLEA RICCI |
| K110424 |
11/30/2011 |
DIGNITY MINI PORT- ATTACHABLE; DIGNITY MINI PORT- PRE ATTACHED; DIGNITY LOW PROFILE PORT- ATTACHABLE; DIGNITY LOW PROFIL |
MEDCOMP (MEDICAL COMPONENTS) |
JEAN CALLOW |
| K110612 |
11/08/2011 |
FM20 |
MEDIANA CO., LTD. |
AMY KIM |
| K112190 |
11/09/2011 |
PATIENT MONITOR |
MEDIANA CO., LTD. |
CHARLIE MACK |
| K111005 |
11/15/2011 |
ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL |
MEDICA CORP. |
Photios Makris |
| K112210 |
11/22/2011 |
FRAXION |
MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH |
MICHAEL WOLFF |
| K103530 |
11/21/2011 |
SPIRODOC |
MEDICAL INTERNATIONAL RESEARCH USA, INC. |
ED KOHERE |
| K112132 |
11/18/2011 |
KRYSTALRAD 660 DIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM |
MEDICATECH USA |
DANIEL KAMM |
| K112493 |
11/21/2011 |
PASS LP SPINAL SYSTEM |
MEDICREA INTERNATIONAL |
J.D. WEBB |
| K111955 |
11/16/2011 |
MEDLINE PNEUMOPERITONEUM NEEDLE |
MEDLINE, INDUSTRIES, INC. |
MATT CLAUSEN |
| K112724 |
11/21/2011 |
DEPUY PULSE ANTERIOR CERICAL PLATE SYSTEM |
MEDOS INTERNATIONAL SARL |
EUGENE BANG |
| K110560 |
11/18/2011 |
MEDTRONIC ARES ANTIBIOTIC-IMPREGNATED CATHETER |
MEDTRONIC NEUROSURGERY |
JEFFREY HENDERSON |
| K112444 |
11/15/2011 |
ANATOMIC PEEK CERVICAL FUSION SYSTEM |
MEDTRONIC SOFAMOR DANCK USA, INC. |
BECKY RONNER |
| K110562 |
11/09/2011 |
TELAMON PEEK SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA |
REGINA HOLMES |
| K113174 |
11/21/2011 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
CHRIS MCKEE |
| K112405 |
11/21/2011 |
CLYDESDALES SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
JULIE BASSETT |
| K110955 |
11/22/2011 |
ANYRIDGE INTERNAL IMPLANT SYSTEM |
MEGAGEN CO., LTD. |
APRIL LEE |
| K112197 |
11/17/2011 |
MEMOMETAL INTRA-MEDULLARY BONE FASTENER |
MEMOMETAL TECHNOLOGIES |
GILLES AUDIC |
| K110738 |
11/03/2011 |
THERMO SCIENTIFIC MAS OMNI-CORE |
Microgenics Corporation |
LISA CHARTER |
| K112380 |
11/22/2011 |
CLEARVISION |
MIDMARK CORP. |
LISA BARTAKOVICS |
| K111066 |
11/22/2011 |
MIGRA TAB, QUICKSPLINT MIGRAINE |
MIGRATHERAPY LLC |
BRADLEY ELI |
| K110715 |
11/04/2011 |
INTERDRY SILVER |
MILLIKEN HEALTHCARE PRODUCTS, LLC |
BRIAN J LINDSAY |
| K113234 |
11/17/2011 |
MOBCARDIO SYSTEM |
MOBHEALTH INCORPORATION |
PATRICIA LIN |
| K102827 |
11/02/2011 |
MEDICAL MAGGOTS, LESOC |
MONARCH LABS, LLC. |
RONALD SHERMAN |
| K112282 |
11/04/2011 |
M VISUM ALERT ALARM MANAGEMENT SYSTEM |
MVISUM, INC. |
PRAVEEN DALA |
| K110442 |
11/09/2011 |
NANOVIS INTERVERTEBRAL BODY FUSION SYSTEM |
NANOVIS, LLC |
KEVIN A THOMAS, PHD |
| K113198 |
11/28/2011 |
NMI CONTROL SYRINGE, 7 ML NMI CONTROL SYRINGE, 8 ML |
NAVILYST MEDICAL, INC. |
MARION W GORDON |
| K110989 |
11/03/2011 |
NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE |
NEUROVISION MEDICAL PRODUCTS, INC. |
CHRISTINE VERGELY |
| K103338 |
11/01/2011 |
COOLTOUCH |
NEW STAR LASERS, INC. |
NATALIE R VOLLRATH |
| K102925 |
11/10/2011 |
NEXGEN EXPANDABLE CATHETER |
NEXGEN MEDICAL SYSTEMS, INC. |
CRAIG PAGAN |
| K112359 |
11/08/2011 |
PROW FUSION |
NLT SPINE LTD |
JOHN J SMITH |
| K111487 |
11/10/2011 |
NH-301 AMBULATORY ECG ANALYSIS SOFTWARE |
NORAV MEDICAL CORP. |
BENNY ARAZY |
| K110463 |
11/10/2011 |
PCECG-1200 SYSTEM WITH MODULAR ECG ANALYSIS SYSTEM (MEANS) |
NORAV MEDICAL LTD. |
BENRY ARAZY |
| K112988 |
11/09/2011 |
POWDER FREE LATEX PATIENT EXAM GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS PER DM SQUARED OR LESS OF WATER SOLUBLE |
NORTHSTAR HEALTHCARE HOLDINGS LIMITED |
ANTONIO L GIACCIO |
| K112420 |
11/18/2011 |
ONCENTRA PROSTATE 4.0 |
NUCLETRON |
MICHAEL PAUL |
| K112564 |
11/23/2011 |
QUIXIE NEBULIZER |
ODYSSEY MEDICAL TECHNOLOGIES |
DAVID PIPER |
| K111161 |
11/04/2011 |
PERFSCAPE V2.0 |
OLEA MEDICAL |
KRISTI GUSMAN |
| K110294 |
11/18/2011 |
HIGH FLOW INSUFFLATION UNIT UHI-4 |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
STACY ABBATIELLO KLUESNER |
| K111087 |
11/29/2011 |
FOUNDATION |
OLYMPUS TERUMO BIOMATERIALS CORPORATION |
PATSY J TRISLER |
| K110221 |
11/01/2011 |
EYE-CEPT STERILE SALINE SOLUTION |
OPTICS LABORATORY, INC |
PATRICIA CHIU |
| K111643 |
11/03/2011 |
OPTO MITRA YELLOW LASER |
OPTO ELECTRONICA SA |
PAULO ANEAS LICHTI |
| K112640 |
11/16/2011 |
HYPERELASTIC WIRE |
ORMCO CORP. |
Wendy Garman |
| K110661 |
11/17/2011 |
ACCELEDENT |
ORTHOACCEL TECHNOLOGIES, INC |
MICHAEL E KAUFMAN |
| K112053 |
11/18/2011 |
OBC BONE ANCHORED HEARING SYSTEM |
OTICON MEDICAL AB |
KAROLIN ISBERG JERNBY |
| K113209 |
11/21/2011 |
CHIBA SONO |
PAJUNK GMBH |
CHRISTIAN QUASS |
| K111840 |
11/14/2011 |
EMERGE FRACTIONAL LASER |
PALOMAR MEDICAL PRODUCTS, INC. |
Sharon Timberlake |
| K113163 |
11/23/2011 |
PENUMBRA SYSTEM MAX |
PENUMBRA, INC. |
SETH SCHULMAN |
| K103483 |
11/23/2011 |
INGENUITY TF PET/MR |
PHILIPS HEALTHCARE (CLEVELAND) |
EDUARD TOEREK |
| K113125 |
11/17/2011 |
INTELLIVUE MX40 PATIENT MONITOR |
PHILIPS MEDICAL SYSTEMS |
THERESA POOLE |
| K112931 |
11/02/2011 |
LEUCADIA(TM) MIS PEDICLE SCREW SYSTEM |
PHYGEN, LLC |
HARTMUT LOCH |
| K111944 |
11/22/2011 |
NB3D BONE VOID FILLER |
PIONEER SURGICAL TECHNOLOGY, INC. |
FLOYD G LARSON |
| K103575 |
11/09/2011 |
SPIRO PD |
PMD HEALTHCARE |
E.J. Smith |
| K111026 |
11/16/2011 |
APOLLO |
POLLOGEN LTD |
YORAM LEVY |
| K112408 |
11/04/2011 |
POLY-CHEM 90 ISE MODULE |
POLYMEDCO, INC. |
HELEN LANDICHO |
| K111932 |
11/10/2011 |
IGLUCOSE SYSTEM |
POSITIVEID CORPORATION |
EDWARD VALDEZ |
| K112015 |
11/22/2011 |
PREMIER HB9210 HBA1C ANALYZER |
PRIMUS CORPORATION DBA TRINITY BIOTECH |
BRITT EINSPAHR |
| K111923 |
11/04/2011 |
SKIN GUARD, POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE |
PT. INTAN HEVEA INDUSTRY |
DARWIN TANDJO |
| K111764 |
11/10/2011 |
CHARTIS CONSOLE |
PULMONX, INC. |
HANS SCHULZ |
| K110246 |
11/04/2011 |
MEDISIZE RED AND MEDISIZE BLUE |
QSERVE AMERICA, INC. |
WILLIAM GREENROSE |
| K111773 |
11/16/2011 |
RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATE |
RENU MEDICAL, INC. |
L BRUCE PIERSON |
| K112393 |
11/16/2011 |
TASMAN |
RESMED LTD. |
DAVID D'CRUZ |
| K111885 |
11/04/2011 |
SIMPLYGO PORTABLE OXYGEN CONCENTRATOR |
RESPIRONICS INC. |
JOSEPH E OLSAVSKY |
| K112262 |
11/02/2011 |
REFLEX BALLON GUIDE CATHETER |
REVERSE MEDICAL CORPORATION |
JEFFREY VALKO |
| K111272 |
11/29/2011 |
RHAUSLER PLAGE ANTERIOR CERVICAL FUSION SYSTEM |
RHAUSLER, INC. |
BARBARA DEBIASE |
| K112453 |
11/15/2011 |
STERISPINEPS PEDICLE SCREW |
SAFE ORTHOPAEDICS |
PIERRE DUMOUCHEL |
| K112558 |
11/10/2011 |
DIGITAL FLAT PANEL X-RAY DETECTOR |
SAMSUNG MOBILE DISPLAY CO., LTD |
DAVE KIM |
| K112751 |
11/23/2011 |
SDX-4343CS |
SAMSUNG MOBILE DISPLAY CO., LTD |
DAVE KIM |
| K111858 |
11/04/2011 |
LIFTKAR PT |
SANO TRANSPORTGERAETE GMBH |
JEANINE A CARROCCIO |
| K111342 |
11/25/2011 |
LIGHT GUIDE CABLE |
SCHOTT NORTH AMERICA |
JEFFREY ROBERTS |
| K101863 |
11/07/2011 |
IT/IF CONTROL |
SEBIA |
KAREN ANDERSON |
| K110614 |
11/21/2011 |
PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM |
SEJU ENGINEERING CO., LTD. |
EILEEN YANG |
| K103376 |
11/18/2011 |
ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYSTEMS ELICAL 2 MODEL CALI-0580, ELITECH CL |
SEPPIM S.A.S. |
DEBRA K HUTSON |
| K111557 |
11/10/2011 |
X-FORCE |
SEVEN SEAS DISTRIBTION AND MANUFACTURING LLC |
MARK IOELE |
| K102741 |
11/08/2011 |
ENTERAL FEEDING BAG AND SETS |
SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD. |
Diana Hong |
| K112002 |
11/18/2011 |
CAROTID COIL |
SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD |
MEIJUAN CHEN |
| K111273 |
11/08/2011 |
FIR HEAT THERAPHY SYSYEMS |
SHENZHEN ANPAN TECHNOLOGY CO., LTD. |
WANG TAO |
| K112951 |
11/01/2011 |
BODY ANALYSIS SCALE |
SHENZHEN HEALTHCARE ELECTRONIC TECHNOLOGY CO. LTD |
CHARLIE MACK |
| K113153 |
11/28/2011 |
DP-20 AND DP-30 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
SUSAN D GOLDSTEIN |
| K111855 |
11/17/2011 |
HY-BOND RESIGLASS |
SHOFU DENTAL CORP. |
DAVID P MORAIS |
| K102644 |
11/23/2011 |
ADVIA 2120 WITH AUTOSLIDE SYSTEM, AND ADVIA 2120I |
SIEMENS HEALTHCARE DIAGNOSTICS |
GERARD SADRAKULA |
| K112999 |
11/22/2011 |
DIMENSION CLINICAL CHEMISTRY SYSTEM |
SIEMENS HEALTHCARE DIAGNOSTICS |
LORRAINE H PIESTRAK |
| K112142 |
11/04/2011 |
DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE |
SIEMENS HEALTHCARE DIAGNOSTICS |
ROSE T MARINELLI |
| K111242 |
11/23/2011 |
MAGNETOM AERA AND MAGNETOM SKYRA |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
MICHELLE L BYRNE |
| K103424 |
11/22/2011 |
SAFIRE |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ALICIA BUSTOS-JUERGENSEN |
| K113027 |
11/22/2011 |
SYNGO AORTIC VALVEGUIDE SOFTWARE |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PATRICIA D JONES |
| K113029 |
11/18/2011 |
SYNGO VIA MI WORKFLOWS |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ALAINE MEDIO |
| K111843 |
11/14/2011 |
ACUFEX DIRECTOR APPLICATION ANATOMIC GUIDE SYSTEM |
SMITH & NEPHEW INC., ENDOSCOPY DIV. |
JANICE HASELTON |
| K112406 |
11/14/2011 |
PERI-LOC PROXIMAL FEMUR LOCKING BONE PLATES |
SMITH & NEPHEW, INC. |
DAVID HENLY |
| K112784 |
11/22/2011 |
RENASYS AB ABOMINAL DRESSING KIT |
SMITH & NEPHEW, INC. |
LAURA D REYNOLDS |
| K112134 |
11/22/2011 |
TRUCLEAR OPERATIVE HYSTEROSCOPE |
SMITH & NEPHEW, INC. |
JANICE HASELTON |
| K111692 |
11/08/2011 |
TUMARK FLEX FOR MAMMOTOME,TUMARK FLEX FOR ATEC |
SOMATEX MEDICAL TECHNOLOGIES GMBH |
HARALD JUNG |
| K112602 |
11/07/2011 |
S6 DIAGNOSTIC ULTRASOUND SYSTEM |
SONOSCAPE COMPANY LIMITED |
Diana Hong |
| K113156 |
11/15/2011 |
SONOSITE EDGE ULTRASOUND SYSTEM |
SONOSITE,INC. |
SCOTT PAULSON |
| K112962 |
11/02/2011 |
SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930) |
SPACELABS MEDICAL INC. |
DAVVID J GERAGHTY |
| K112688 |
11/09/2011 |
ENSITE VELOCITY SYSTEM V.3.0 |
ST. JUDE MEDICAL |
DONNA R LUNAK |
| K112214 |
11/17/2011 |
OCTRODEX(TM), QUATTRODEX(TM), INTRODEX(TM), EPIDURAL NEEDLE, STYLETS |
ST. JUDE MEDICAL NEUROMODULATION |
PENNY HOUSTON |
| K112760 |
11/22/2011 |
AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM |
STERIS Corporation |
ROBERT SULLIVAN |
| K102752 |
11/09/2011 |
STINGRAY ULTRALITE DISPOSABLE IRRIGATING BIPOLAR FORCEPS |
STINGRAY SURGICAL PRODUCTS, INC |
MARK MCBRINN |
| K112280 |
11/16/2011 |
STRAUMANN CARES SCREW-RETAINED BRIDGE TITANIUM, STRAUMANN CARES DOLDER BAR TITANIUM |
STRAUMANN USA |
ELAINE ALAN |
| K113195 |
11/16/2011 |
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
SUQIAN RUIJANG MEDICAL SUPPLIES CO., LTD |
CHU XIAOAN |
| K113191 |
11/17/2011 |
POWER FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR |
SUQIAN RUIJANG MEDICAL SUPPLIES CO., LTD |
CHU XIAOAN |
| K111509 |
11/09/2011 |
SWEETSPOT DIABETES DATA MANAGEMENT SERVICE |
SWEETSPOT DIABETES CARE, INC. |
CHRIS LOGAN |
| K111891 |
11/28/2011 |
SYNTHES BRAINLAB TRAUMA COMPATIBLE INSTRUMENTS |
SYNTHES (USA) PRODUCTS LLC |
CHRISTOPHER HACK |
| K112085 |
11/17/2011 |
SYNTHES LCP PEDIATRIC PLATE SYSTEMS |
SYNTHES (USA) PRODUCTS LLC |
ANGELA F LASSANDRO |
| K111323 |
11/16/2011 |
SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTS |
SYNTHES INC |
ALAN T HALEY |
| K111358 |
11/18/2011 |
SYNTHES USS |
SYNTHES SPINE |
HEATHER GUERIN |
| K112068 |
11/07/2011 |
SYNTHES ZERO-P VARIABLE ANGLE (VA) |
SYNTHES SPINE CO.LP |
STACEY BONNELL |
| K112963 |
11/22/2011 |
TD-4257 BLOOD GLUCOSE MONITORING SYSTEMS,TD 4257 MULTI BLOOD GLUCOSE MONITORING SYSTEMS |
TaiDoc Technology Corporation |
TELING HSU |
| K110893 |
11/22/2011 |
VTRUST FINGER TYPE PULSE OXIMETER |
TaiDoc Technology Corporation |
TELING HSU |
| K111210 |
11/09/2011 |
T:SLIM (TM) INSULIN DELIVERY SYSTEM |
TANDEM DIABETES CARE, INC. |
DON CANAL |
| K110427 |
11/22/2011 |
FEMTEC LASER SYSTEM FOR CAPSULOTOMY |
TECHNOLAS PERFECT VISION GMBH |
BETTY M JOHNSON |
| K112554 |
11/18/2011 |
TRANSRADIAL ARTERY ACCESS DEVICES |
Teleflex Medical, Inc. |
CHRISTINE FORD |
| K112285 |
11/04/2011 |
MILESTONE KNEE SYSTEM, FEMORAL COMPONENT, POSTERIOR STABLIZED, UNOCATED / RLP, UNCOATED; TIBIAL INSERT / BASEPLATE... |
TGM MEDICAL, INC. |
DENNIS H CRANE |
| K111345 |
11/02/2011 |
SEE CLEAR SOFT CONTACT LENS, SEE CLEAR COLOR SOFT CONTACT LENS, FIERCE SOFT CONTACT LENS |
THE SEE CLEAR COMPANY, INC |
KEVIN RANDALL |
| K112219 |
11/18/2011 |
TAPAS CATHETER |
THERMOPEUTIX INC. |
THOMAS SCHROEDER |
| K111984 |
11/10/2011 |
SPI VARIO ANGLED ABUTMENT |
THOMMEN MEDICAL, AG |
LINDA K SCHULZ |
| K111902 |
11/03/2011 |
AEQUALIS SHOULDER SYSTEM |
TORNIER |
SEVERINE BONNETON |
| K113052 |
11/22/2011 |
INFINIX-CCI |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K112145 |
11/07/2011 |
MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS33I2 |
TOTOKU ELECTRIC CO., LTD |
TSUKASA TASHIRO |
| K111642 |
11/18/2011 |
ONCO TRAC MODEL 1, 2, 4 |
TRANSLATIONAL SCIENCES CORPORATION |
ALLEN GREEN, MD, PHD, JD |
| K111615 |
11/08/2011 |
SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES |
TREK DIAGNOSTIC SYSTEMS |
CYNTHIA C KNAPP |
| K112276 |
11/16/2011 |
VIZION |
TREK DIAGNOSTIC SYSTEMS |
CYNTHIA C KNAPP |
| K110762 |
11/18/2011 |
AVO BARRIER TOPICAL EMULSION |
TRIGEN LABORATORIES, INC. |
GEORGE MCCAULEY |
| K112509 |
11/04/2011 |
TRIMED CLAVICLE FIXATION SYSTEM |
TRIMED, INC. |
DOUG STEINBERGER |
| K113280 |
11/23/2011 |
CAROTID COIL GE 1.5T |
TURSIOP TECHNOLOGIES LLC |
RAJU VISWANTHAN |
| K100784 |
11/01/2011 |
UC-CARE NAVIGO SYTEM |
UC-CARE LTD. |
JOHN KAHAN |
| K112544 |
11/22/2011 |
UNIMED BLOOD PRESSURE CUFF |
UNIMED MEDICAL SUPPLIES INC. |
XINMEI TAN |
| K111771 |
11/30/2011 |
NON-CONTACT TEAR FILM THERMOGRAGH |
UNITED INTEGRATED SERVICES CO., LTD. |
JEN KE-MIN |
| K111028 |
11/01/2011 |
EUS BALLOON |
UNITED STATES ENDOSCOPY GROUP, INC. |
CARROLL L MARTIN |
| K111709 |
11/18/2011 |
FOUNDATION DENTAL RESIN |
UNIX-JAPAN CO., LTD. |
TOSHIKO BOYD |
| K112839 |
11/14/2011 |
VARIAN HIGH ENERGY LINEAR ACCELERATOR |
VARIAN MEDICAL SYSTEMS |
VY TRAN |
| K102378 |
11/02/2011 |
VECTRAPLEXECG SYSTEM WITH VECTRAPLEXAMI |
VECTRACOR, INC |
BRAD S SCHRECK |
| K103818 |
11/16/2011 |
CONFIRM ANTI-PROGESTORONE RECEPTOR (1E2) RABBIT MONOCLONAL PRIMARY ANTIBODY |
VENTANA MEDICAL SYTEMS, INC |
GEORGE DE LA ROSA |
| K102413 |
11/14/2011 |
FUZE: INTRAMEDULLARY INTERNAL FIXATION NAIL |
VILEX, INC. |
ABE LAVI |
| K112416 |
11/09/2011 |
CPK REAGENT |
VITAL DIAGNOSTICS (MANUFACTURING) PTYLTD |
MELITA LAMBIRIS |
| K112531 |
11/18/2011 |
VITREA CT MYOCARDIAL ANALYSIS |
VITAL IMAGES, INC. |
Daniel Biank |
| K110525 |
11/23/2011 |
VITALOGRAPH MODEL 7100 - VITALOJAK |
VITALOGRAPH(IRELAND) LTD. |
TOM J HEALY |
| K112447 |
11/08/2011 |
GRANDIO CORE DUAL CURE |
VOCO GMBH |
T. GERKENSMEIER |
| K112167 |
11/16/2011 |
SOYALA SILKGEL FULL FACE MASK |
WEINMANN GERATE FUR MEDIZIN GMBH + CO. KG |
RALF EGENOLF |
| K112687 |
11/22/2011 |
CONNEX(R) VITAL SIGNS MONITOR 6000 SERIES |
WELCH ALLYN, INC. |
KEVIN CROSSEN |
| K110596 |
11/18/2011 |
MW100 (MAMMOGRAPHY) LCD MONITOR SYSTEM |
WIDE CORPORATION |
CARL ALLETTO |
| K112647 |
11/22/2011 |
BESTSHAPE BLOOD PRESSURE MONITORING SYSTEM |
WISTRON CORPORATION |
TELING HSU |
| K110770 |
11/16/2011 |
HEALTHTRACKER |
WISTRON CORPORATION |
TELING HSU |
| K111392 |
11/04/2011 |
WOOJEON ACUPUNCTURE NEEDLE (=SERA ACUPUNCTURE NEEDLE) |
WOOJEON COMPANY |
PETER CHUNG |
| K112150 |
11/23/2011 |
PROFEMUR GLADIATOR HA HIP STEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
MATT PAUL |
| K113019 |
11/10/2011 |
PROFEMUR XM WINGLESS DISTAL CENTRALIZER, PERFECTA DISTAL CENTRALIZER |
WRIGHT MEDICAL TECHNOLOGY, INC. |
MATT PAUL |
| K112036 |
11/08/2011 |
CALIX PC SPINAL IMPLANT SYSTEM |
X-SPINE SYSTEMS, INC |
DAVID KIRSCHMAN |
| K112475 |
11/10/2011 |
XTRACT SYRINGE KEY SYSTEM |
XTRACT SOLUTIONS |
KEITH LOWREY |
| K112484 |
11/22/2011 |
ZAVATION SPINAL SYSTEM |
ZAVATION LLC |
JOHN WALKER |
| K112932 |
11/01/2011 |
TRANSTEK |
ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. |
LEO WANG |
| K111119 |
11/23/2011 |
TRABECULAR METAL (TM) FUSION DEVICE |
ZIMMER SPINE, INC |
JENNIFER TRIBBETT |
| K111983 |
11/18/2011 |
VISTA-S DEVICE MODEL 08/06-401-XXXXX, 08/06-402-XXXXXX |
ZIMMER TRABECULAR METAL TECHNOLOGY |
KATHLEEN RUTHERFORD |
