| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K110508 |
06/03/2011 |
SUGLUE-10 |
3M ESPE AG |
DESI W SOEGIARTO |
| K100716 |
06/23/2011 |
AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5 |
AALTO SCIENTIFIC LTD. |
DESSI LYAKOV |
| K103601 |
06/10/2011 |
AUDIT MICROCV IMMUNOASSAY LINEARITY SET |
AALTO SCIENTIFIC LTD. |
DESSI LYAKOV |
| K111023 |
06/10/2011 |
ABBOTT ARCHITECT LH CALIBRATORS |
ABBOTT LABORATORIES |
JOHN RIZOS |
| K103023 |
06/01/2011 |
UNIT, PHACOFRAGMENTATION |
ABBOTT MEDICAL OPTICS INC |
Evelyn De La Vega |
| K110617 |
06/02/2011 |
MINI TREK RX 1.20 MM CORONARY DILATATION CATHETER, MINI TREK OTW 1.20 MM CORONARY DILATATION CATHETER |
Abbott Vascular |
SUZANNE REDMAN |
| K111138 |
06/22/2011 |
THE PICC WAND (R) PEELABLE SAFETY INTRODUCER |
ACCESS SCIENTIFIC, INC. |
ALBERT MISAJON |
| K110636 |
06/16/2011 |
TULA IONTOPHORESIS SYSTEM |
ACCLARENT, INC. |
GURVINDER SINGH NANDA |
| K110812 |
06/21/2011 |
CT-GUIDE NEEDLE GUIDANCE SYSTEM |
ACTIVIEWS LTD |
JOHN J SMITH |
| K102573 |
06/30/2011 |
PROVU (TM) DENTAL X-RAY SYSTEM |
ADVANCED IMAGE SCIENCE, INC. |
PAUL ROCKWELL |
| K103210 |
06/06/2011 |
TYVEK SELF-SEAL POUCHES WITH STERRAD, TYVEK ROLLS WITH STERRAD, TYVEK HEAT-SEAL WITH STERRAD CHEMICAL INDICATORS |
ADVANCED STERILIZATION PRODUCTS |
NANCY CHU |
| K110864 |
06/15/2011 |
BIOSPINE VBR SYSTEM |
AESCULAP IMPLANT SYSTEMS, LLC |
Lisa Boyle |
| K110695 |
06/28/2011 |
BIPOLAR HF DEVICE |
AESCULAP, INC. |
LISA M BOYLE |
| K101641 |
06/16/2011 |
AG THERMOGRAPHIC CAMERA, MODEL ATIR-M301 |
AG DIGITAL TECHNOLOGY CORP. |
JENNIFER REICH |
| K111638 |
06/24/2011 |
IMPAX VOLUME VIEWING |
AGFA HEALTHCARE N.V. |
KOEN COBBAERT |
| K102479 |
06/02/2011 |
ALARA T210 COMPUTED RADIOGRAPHY SYSTEM |
ALARA, INC. |
CHRISTOPHER MITCHELL |
| K102811 |
06/02/2011 |
AOS ORION IR-192 SOURCE CABLE |
ALPHA-OMEGA SERVICES, INC. |
BOB A ROBNETT |
| K103205 |
06/02/2011 |
BRIDGEPOINT SPINOUS PROCESS CAMP- POSTERIOR FIXATION SYSTEM |
ALPHATEC SPINE, INC. |
OLGA LEWIS |
| K110936 |
06/10/2011 |
DURAFLOW 2 CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT |
ANGIODYNAMICS, INC. |
DAVID A GREER |
| K110859 |
06/23/2011 |
METAL OPAQUER |
APEX DENTAL MATERIALS, INC. |
CHRIS KULTON |
| K102274 |
06/15/2011 |
ARVIK LAPAROSCOPIC ASPIRATION INSTRUMENT |
ARVIK ENTERPRISES/ MINI LAP TECHNOLOGIES |
CURTIS RAYMOND |
| K111078 |
06/14/2011 |
AEU-26L ELCTRONIC ENDODONTIC SYSTEM |
ASEPTICO, INC. |
GRANT RAMALEY |
| K103495 |
06/29/2011 |
ASICO SOFTIP INJECTOR SYSTEM |
ASICO LLC |
RAVI NALLAKRISHNAN |
| K101005 |
06/21/2011 |
ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT |
ASTRA TECH AB |
LINDA SCHULZ |
| K110640 |
06/10/2011 |
ATLANTIS ABUTMENT FOR CAMLOG IMPLANT, DUPLICATE ABUTMENT, LATER ABUTMENT |
ASTRA TECH, INC. |
BETSY A BROWN |
| K110356 |
06/10/2011 |
ATLANTIS CROWN ABUTMENT, ATLANTIS GEMINI +(TM) ABUTMENT |
ASTRA TECH, INC. |
BETSY A BROWN |
| K111020 |
06/09/2011 |
ATRICURE DISSECTOR |
ATRICURE, INC. |
JAMES L LUCKY |
| K110829 |
06/03/2011 |
ACE STAPLER AND CARTRIDGE |
BAROSENSE, INC |
SHEILA STEVENS, PHD |
| K111217 |
06/14/2011 |
ADDITIVE CAP |
BAXTER HEALTHCARE CORP. |
NANETTE HEDDEN |
| K102614 |
06/03/2011 |
AVIVAFIX CONDUCTIVE GARMENT-KNEE/SHOULDER/UPPER BACK, TYPE 40 |
BIO-MEDICAL RESEARCH, LTD. |
ANNE-MARIE KEENAN |
| K103061 |
06/20/2011 |
BIOMATE STERILE ACUPUNCTURE NEEDLE |
BIOMATE MEDICAL DEVICES TECHNOLOGY CO., LTD. |
MICHAEL LEE |
| K110650 |
06/30/2011 |
ZYSTON ARC INTERBODY SPACER |
BIOMET SPINE (AKA EBI, LLC) |
MARGARET F CROWE |
| K111564 |
06/16/2011 |
MAXFIRE MARXMEN MENISCAL REPAIR DEVICE |
BIOMET SPORTS MEDICINE |
ELIZABETH WRAY |
| K102767 |
06/03/2011 |
CARDIO XP |
BIONET CO., LTD. |
MARC GOODMAN |
| K110900 |
06/24/2011 |
DISPOSABLE THYROID COLLAR |
BLOXR CORPORATION |
RAI CHOWDHARY |
| K111252 |
06/02/2011 |
ACUITY (TM) CUT-AWAY (TM) GUIDE CATHETERS 6F AND 8F |
BOSTON SCIENTIFIC CORP. |
HOLLY RAMIREZ |
| K111498 |
06/30/2011 |
FATHOM (TM) 14 STEERABLE GUIDEWIRE |
BOSTON SCIENTIFIC CORP. |
ERIC ELLIOTT |
| K111485 |
06/30/2011 |
FATHOM 16 STEERABLE GUIDEWIRE MODEL M001509XXX |
Boston Scientific Corporation |
ERIC ELLIOTT |
| K101627 |
06/03/2011 |
IPLAN |
BRAINLAB AG |
ALEXANDER SCHWIERSCH |
| K111488 |
06/30/2011 |
MANTARAY GUIDEWIRE MODEL M-6000, M-6001, M-6002, M-6003 |
BRIDGEPOINT MEDICAL |
JILL MUNSINGER |
| K110883 |
06/08/2011 |
J-STYLE BONE MARROW BIOPSY / ASPIRATION NEEDLE WITH SNARE-IT MARROW ACQUISITION CANNULA |
BUSSE HOSPITAL DISPOSABLES |
MUHAMAD ANSARI |
| K110088 |
06/10/2011 |
DEFENDO Y-OPSY IRRIGATOR |
BYRNE MEDICAL INCORPORATED |
JOHN WILLIS |
| K111100 |
06/16/2011 |
ENCOR ENSPIRE BREAST BIOPSY SYSTEM |
C.R. BARD, INC. |
JUSTIN LOVELACE |
| K102496 |
06/09/2011 |
POWERHEART AED G3 SEMI-AUTOMATIC, POWERHEART AED G3 AUTOMATIC, POWERHEART AED G3 PRO, POWERHEART AED G3 PLUS |
CARDIAC SCIENCE CORPORATION |
KATHLEEN ROBERTS |
| K110272 |
06/08/2011 |
STERILE POLYISOPRENE POWDER-FREE SURGICAL GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUG |
CARDINAL HEALTH, INC. |
TATYANA BOGDAN |
| K111131 |
06/17/2011 |
TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLES |
CAREFUSION 209, INC. |
GLEN HERMANSON |
| K103562 |
06/23/2011 |
CENTURION PRESSURE INJECTABLE EXTENSION SET |
CENTURION MEDICAL PRODUCTS CORPORATION |
MATTHEW K PRICE |
| K111233 |
06/24/2011 |
SUPRIS RETROPUBIC SLING SYSTEM |
COLOPLAST A/S |
TIM CRABTREE |
| K110297 |
06/15/2011 |
POWDER FREE NITRILE (BLACK) EXAMINATION GLOVES |
COMFORT RUBBER GLOVES INDUSTRIES SDN BHD |
TAN KENG BENG |
| K110730 |
06/24/2011 |
MONACO RTP SYSTEM |
COMPUTERIZED MEDICAL SYSTEMS, INC. |
KATHRYN STINSON |
| K110950 |
06/27/2011 |
CONSENSUS KNEE SYSTEM |
CONSENSUS ORTHOPEDICS, INC. |
MATTHEW M HULL |
| K101692 |
06/28/2011 |
PATIENT MONITOR |
CONTEC MEDICAL SYSTEM CO., LTD. |
Diana Hong |
| K110402 |
06/20/2011 |
BIODESIGN NIPPLE RECONSTRUCTION CYLINDER |
COOK BIOTECH, INC. |
PERRY W GUINN |
| K111244 |
06/14/2011 |
TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) |
COOK, INC. |
MIRONDA CARPENTER |
| K110099 |
06/29/2011 |
PROCLEAR TORIC XR SOFT (HYDROPHILIC) CONTACT LENS; PROCLEAR MULTIFOCAL XR SOFT (HYDROPHILIC) CONTACT LENS; PROCLEAR MULT |
COOPERVISION, INC. |
SARAH HARRINGTON |
| K102942 |
06/22/2011 |
CORELEADER ALGIPLASTER MODEL AP 050501 |
CORELEADER BIOTECH CO., LTD. |
IAN LI |
| K111046 |
06/29/2011 |
CORIN MINIHIP FEMORAL STEM |
CORIN USA |
LUCINDA GERBER |
| K111442 |
06/03/2011 |
V-LOC 180 ABSORBABLE RELOAD, V-LOC PBT NON-ABSORBABLE RELOAD, ENDO STITCH (TM) ENDOSCOPIC SUTURING DEVICE, SILS (TM)... |
COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H |
ROBERT ZOTT |
| K110133 |
06/10/2011 |
EMPIRA RX PTCA DILATATION CATHETER, EMPRIA NC RX PTCA DILATATION CATHETER |
CREGANNA-TACTX MEDICAL |
DENNIS WONG |
| K102954 |
06/22/2011 |
CUTERA QSWITCH LASER SYSTEM |
CUTERA, INC. |
Connie Hoy |
| K110753 |
06/06/2011 |
MIDWEST RDH FREEDOM CORDLESS PROPHY SYSTEM |
DENTSPLY INTERNATIONAL, INC. |
HELEN LEWIS |
| K111444 |
06/22/2011 |
UNIVERSAL AND TROCH ENTRY FEMORAL NAILING SYSTEMS LINE EXTENSION |
DEPUY ORTHOPAEDICS, INC. |
SUZANA OTANO |
| K110704 |
06/24/2011 |
SENSI |
DIACOUSTIC MEDICAL DEVICES (PTY) LTD. |
E.J. Smith |
| K102566 |
06/03/2011 |
OWL CANNULAE |
DIROS TECHNOLOGY, INC. |
GEORGE DARMOS |
| K103736 |
06/10/2011 |
DMC MEDICAL SINGLE-USE POLYCARBONATE SYRINGE |
DMC MEDICAL LTD. |
TRACY BEST |
| K110759 |
06/10/2011 |
TEMPOCEM |
DMG USA, INC. |
PAMELA PAPINEAU |
| K103086 |
06/07/2011 |
DYNAREX INTERMITTENT CATHETERS, MALE, FEMALE, PEDIATRIC |
DYNAREX CORPORATION |
DANIEL CONSAGA |
| K110728 |
06/08/2011 |
IMESH TACKER |
EASYLAP LTD. |
PAUL DRYDEN |
| K110597 |
06/14/2011 |
EV1000 CLINICAL PLATFORM |
EDWARDS LIFESCIENCES |
MARGUERITE THOMLINSON |
| K103520 |
06/24/2011 |
CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING |
EDWARDS LIFESCIENCES, LLC. |
DARYL RICHARDSON |
| K110223 |
06/29/2011 |
WAVEGUARD (TM) EEG CAP |
EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH |
DANIEL KAMM |
| K103724 |
06/08/2011 |
10 MP GRAYSCALE FLAT PANEL DISPLAY (GX 1030) |
EIZO GMBH |
GUENTER M VOLZ |
| K111016 |
06/09/2011 |
SAFEPORT MANIFOLD (TM) (OR STOPCOCK) |
ELCAM MEDICAL A.C.A.L. |
NATASHA EVRONYAN |
| K103738 |
06/01/2011 |
H-WAVE |
ELECTRONIC WAVEFORM LABORATORY, INC. |
RYAN P HEANEY |
| K110830 |
06/21/2011 |
ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO; ELITECH CLINICAL SYSTEMS ALBUMIN; ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH |
ELITECHGROUP |
DEBRA K HUTSON |
| K110739 |
06/14/2011 |
ENTELLUS MEDICAL SINUS GUIDEWIRE |
Entellus Medical, Inc. |
KAREN E PETERSON |
| K110158 |
06/07/2011 |
ILLUMINATING SINUS SEEKER |
Entellus Medical, Inc. |
KAREN E PETERSON |
| K102345 |
06/21/2011 |
EASYMAX T1 SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS10042 |
EPS BIO TECHNOLOGY CORP. |
Y.C. LEI |
| K103637 |
06/08/2011 |
ERKA. PERFECT-ANEROID |
ERKA KALLMEYER MEDIZINTECHNIK GMBH |
JAN WEISS |
| K110688 |
06/02/2011 |
MYLABGOLD |
ESAOTE |
Allison Scott |
| K101990 |
06/13/2011 |
ETHICON ENDO-SURGERY GENERATOR G11, MODEL GEN11 |
ETHICON ENDO-SUGERY, LLC |
DONOVAN MAY |
| K111111 |
06/08/2011 |
ENDOPATH ETS 35MM ENDOSCOPIC LINEAR CUTTER AND RELOADS, AND ETS-FLEX 35MM ENDOSCOPIC ARTICULATING LINEAR CUTTER AND RELO |
ETHICON ENDO-SURGERY, LLC |
LINDA HILL |
| K110509 |
06/20/2011 |
EVERYWAY INTERFERNTIAL STIMULATOR, MODEL IF-908 |
EVERYWAY MEDICAL INSTRUMENTS CO., LTD. |
JAY MANSOUR |
| K102917 |
06/17/2011 |
FIXTEMP C&B |
EXACTA DENTAL DIRECT, INC |
RICHARD KEEN |
| K111379 |
06/08/2011 |
EQUINOXE UHMWPE 12* POSTERIOR AUGMENT PEGGED GLENOID, SMALL / MEDIUM / LARGE / EXTRA-LARGE, LEFT / RIGHT |
EXACTECH, INC. |
GRAHAM L CUTHBERT |
| K103655 |
06/30/2011 |
OCTANE-C INTERBODY FUSION DEVICE SYSTEM |
EXACTECH, INC. |
PATRICK HUGHES |
| K102412 |
06/23/2011 |
VISTA DIGITAL OPTHALMOSCOPE |
EYEQUICK.LLC |
MARC ELLMAN MD |
| K103783 |
06/16/2011 |
EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDIATRIC |
FIAB S.P.A. |
ALBERTO CALABRO |
| K110275 |
06/03/2011 |
ORTHO EASY PIN |
FORESTADENT BERNHARD FORSTER GMBH |
TANYA O'BRIEN |
| K110518 |
06/24/2011 |
IBAG |
FUTURE PATH MEDICAL, LLC |
DANIEL KAMM |
| K110930 |
06/23/2011 |
ACTIVE WASTE GAS SCAVENGER |
G. DUNDAS CO.,INC. |
MICHELLE NORRIE |
| K110946 |
06/21/2011 |
ICEROD PLUS 17G CRYOABLATION NEEDLE, ICEROD PLUS 17G 90* CRYOABLATION NEEDLE |
GALIL MEDICAL LTD. |
LYNNE DAVIES |
| K102856 |
06/30/2011 |
SIROCCO THERMAL REGULATING SYSTEM |
GALMAZ BIOTECH S.L. |
CHRIS ZANDER |
| K110823 |
06/17/2011 |
PRISMAFLEX |
GAMBRO RENAL PRODUCTS, INC. |
KAE MILLER |
| K110871 |
06/17/2011 |
FIT CHECKER ADVANCED |
GC AMERICA, INC. |
MARK HEISS |
| K103234 |
06/30/2011 |
GC AADVA BO AC ABUTMENTS |
GC AMERICA, INC. |
CARL JENKINS |
| K111445 |
06/03/2011 |
DISCOVERY NM 630 |
GE HEALTHCARE |
TAL BRESLER-STRAMER |
| K102389 |
06/10/2011 |
NAVIGATOR APPLICATIONS SUITE |
GE HEALTHCARE FINLAND OY |
MONICA MORRISON |
| K103476 |
06/16/2011 |
BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMX |
GE MEDICAL SYSTEMS, LLC |
NIDHI CHAUDHARY |
| K110968 |
06/27/2011 |
PROFLU+ ASSAY |
GEN-PROBE PRODESSE, INC |
KAREN HARRINGTON |
| K111219 |
06/30/2011 |
GMD UNIVERSAL URINARY INCONTINENCE SLING |
GENERIC MEDICAL DEVICE, INC. |
JEFF MORGAN |
| K103417 |
06/28/2011 |
HALIFAX BIOMEDICAL TANATLUM BEAD SET |
HALIFAX BIOMEDICAL, INC. |
ROBERT A POGGIE, PHD |
| K103641 |
06/16/2011 |
GUARDACARE |
HEMCON MEDICAL TECHNOLOGIES, INC. |
KEVIN HAWKINS |
| K110143 |
06/02/2011 |
HET BIPOLAR ELECTROCAUTERY FORCEPS |
HET SYSTEMS, LLC |
HOWARD L SCHRAYER |
| K110752 |
06/28/2011 |
HIGHLAND INSTRUMENTS CES AND TUS INSTRUMENT HOLDER |
HIGHLAND INSTRUMENTS |
LEO BASTA |
| K100943 |
06/02/2011 |
INVADER FACTOR II |
HOLOGIC, INC. |
RANDALL COVILL |
| K100980 |
06/01/2011 |
INVADER FACTOR V |
HOLOGIC, INC. |
RANDALL J COVILL |
| K110889 |
06/20/2011 |
IND ONE STEP HCG URINE PREGNANCY TEST (STRIP) |
IND DIAGNOSTICS INC. |
KAI LOU |
| K111344 |
06/10/2011 |
I5 DIGITAL X-RAY IMAGING SYSTEM (WITH FLAATZ 560) |
INFIMED, INC. |
CATHERINE MULCAHY |
| K103737 |
06/02/2011 |
OMNI II PATIENT MONITOR |
INFINIUM MEDICAL |
JOHN OBRIEN |
| K110344 |
06/24/2011 |
INOMAX DSIR (DELIVERY SYSTEM) |
INO THERAPEUTICS |
LARRY LEPLEY |
| K110635 |
06/23/2011 |
INOMAX DS(IR) (DELIVERY SYSTEM) |
INO THERAPEUTICS LLC/DBA IKARIA |
LARRY LEPLEY |
| K102258 |
06/10/2011 |
CUSA NXT EXTENDED LENGTH TIP |
INTEGRA RADIONICS, INC. |
KEVIN J O'CONNELL |
| K102461 |
06/02/2011 |
FRACTORA |
INVASIX LTD. |
AMIR WALDMAN |
| K110810 |
06/21/2011 |
ANASCIENT BREATH MONITOR |
INVOY TECHNOLOGIES, LLC |
LUBNA M AHMAD |
| K102567 |
06/02/2011 |
WATCH-PAT 200S-3 (WP200S-3) |
ITAMAR MEDICAL LTD |
JONATHAN KAHN |
| K110826 |
06/23/2011 |
CUROS PORT PROTECTOR |
IVERA MEDICAL |
DON CANAL |
| K111459 |
06/16/2011 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR |
JIANGSU ALFA GLOVE CO., LTD |
CHU XIAOAN |
| K110248 |
06/10/2011 |
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WHITE COLOR |
JIANGSU DONGLING PLASTIC & RUBBER CO., LTD |
CHU XIAOAN |
| K110247 |
06/10/2011 |
POWDER FREE NUTRILE PATIENT EXAMINATION GLOVES, BLUE COLOR |
JIANGSU DONGLING PLASTIC & RUBBER CO., LTD |
CHU XIAOAN |
| K110843 |
06/22/2011 |
ALEUTIAN SPACER SYSTEM |
K2M, INC. |
NANCY GIEZEN |
| K103839 |
06/06/2011 |
BEHIND EAR GENTLE TOUCH THERMOMETER |
KAZ, INC. |
RAJ S KASBEKAR |
| K110747 |
06/14/2011 |
TEMPFLEX |
KERR CORPORATION |
Wendy Garman |
| K103019 |
06/09/2011 |
KJ MASK |
KJ MEDITECH CO., LTD |
Priscilla Chung |
| K103703 |
06/02/2011 |
REGUIS SIGMA |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
RUSSELL MUNVES |
| K101049 |
06/23/2011 |
WART FREEZE |
KONINKLIJKE UTERMOHLEN NV |
SHIRLEY FURESZ |
| K110983 |
06/20/2011 |
CENTRIMAG DRAINAGE CANNULA KIT |
LEVITRONIX LLC |
Lydia Sakakeeny |
| K110980 |
06/20/2011 |
CENTRIMAG RETURN CANNULA KIT |
LEVITRONIX LLC. |
Lydia Sakakeeny |
| K103423 |
06/01/2011 |
MIS ANTERIOR CERVICAL PLATING SYSTEM |
LIFE SPINE |
RANDY LEWIS |
| K102813 |
06/30/2011 |
EZONO 3000 |
LIFE-TECH, INC. |
SKIP RIMER |
| K110239 |
06/23/2011 |
LZI CANNABINOIDS (CTHC) HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS, CONTROL |
Lin-Zhi International, Inc. |
BERNICE LIN |
| K110500 |
06/23/2011 |
STAT-MAT MINOR |
MACPHERSON MEDICAL, INC. |
HOWARD HOLSTEIN |
| K111093 |
06/03/2011 |
BILLY BOY MALE LATEX CONDOM |
MAPA GMBH |
GERMAN FRANK |
| K110927 |
06/13/2011 |
MECTALIF |
MEDACTA INTERNATIONAL |
ADAM GROSS |
| K110243 |
06/28/2011 |
MEDART DIODE LASER SYSTEM & ACCESSORIES |
MEDART A/S |
JOANNE DAVIES |
| K110658 |
06/02/2011 |
APTUS CANNULATED COMPRESSION SCREWS |
MEDARTIS AG |
KEVIN A THOMAS |
| K110908 |
06/28/2011 |
APTUS FOOT 3.5 SYSTEM |
MEDARTIS AG |
KEVIN A THOMAS |
| K110630 |
06/24/2011 |
F10 |
MEDIANA CO., LTD. |
AMY M.H. KIM |
| K110374 |
06/13/2011 |
MAX PULSE SYSTEM |
MEDICORE CO., LTD. |
YOO BYUNG-KUK |
| K102177 |
06/30/2011 |
SENSICARE POWDER-FREE POLYMER COATED POLYSOPRENE SURGICAL GLOVES, STERILE |
MEDLINE INDUSTRIES, INC. |
MATT CLAUSEN |
| K110194 |
06/17/2011 |
MEDLINE EPIDURAL AND SPINAL NEEDLES |
MEDLINE, INDUSTRIES, INC. |
MATT CLAUSEN |
| K111471 |
06/10/2011 |
EXOSHAPE (TM) INTERFERENCE FIXATION DEVICE MODEL 1100-00-XXXX (VARIES BY SIZE) |
MEDSHAPE SOLUTIONS, INC |
JACK C GRIFFIS, III |
| K111340 |
06/28/2011 |
HEAD AND NECK IMMOBILIZATION SYSTEM, BODY IMMOBILIZATION SYSTEM |
MEDTEC, INC. |
JENNY JONES |
| K111658 |
06/28/2011 |
AFFINITY CP CENTRIFUGAL BLLOD PUMP WITH CARMEDA BIOACTIVE SURFACE |
MEDTRONIC INC. |
LISA STONE |
| K111339 |
06/08/2011 |
HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS) |
MEDTRONIC INC. |
AMRA RACIC |
| K110070 |
06/08/2011 |
TSRH SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANCK USA, INC. |
LILA JOE |
| K111657 |
06/23/2011 |
AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH BALANCE BIOSURFACE |
MEDTRONIC, INC. |
LISA STONE |
| K110693 |
06/08/2011 |
PACEART OPTIMA SYSTEM SOFTWARE |
MEDTRONIC, INC. |
RACHEL U LIBI |
| K110284 |
06/08/2011 |
NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM |
MEDYSSEY CO., LTD. |
PATRICK MOORE |
| K111091 |
06/24/2011 |
MERIT MEDICAL 20 ML SYRINGE |
MERIT MEDICAL SYSTEMS, INC. |
MICHAELA RIVKOWICH |
| K110616 |
06/29/2011 |
THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO |
MICROGENICS CORP. |
LISA CHARTER |
| K111307 |
06/15/2011 |
AZUR DETACHABLE 35 PLATINUM COIL SYSTEM |
MICROVENTION, INC. |
LARAINE PANGELINA |
| K111007 |
06/08/2011 |
MIDWEST REPROCESSING CENTER REPROCESSED LNCS SESSORS; MIDWEST REPROCESSING CENTER REPROCESSED OXIMAX SENSORS; MIDWEST RE |
MIDWEST REPROCESSING CENTER LLC |
SCOTT SENNER |
| K100313 |
06/14/2011 |
HYDROFIX SURGICAL SHEET |
MIMEDX GROUP, INC |
SALLY THORSEN |
| K110273 |
06/09/2011 |
AEROVENT PLUS CHC |
MONAGHAN MEDICAL CORPORATION |
CARI J REIL |
| K111315 |
06/08/2011 |
MULTIPURPOSE DRAINAGE CATHETER |
NAVILYST MEDICAL, INC. |
WANDA CARPINELLA |
| K111237 |
06/15/2011 |
MD301C4 29.8 DIAGNOSTIC IMAGING LCD MONITOR, L309TY |
NEC DISPLAY SOLUTIONS, LTD. |
ANGUS HSU |
| K110119 |
06/10/2011 |
PRESSURE MANOMETER |
NEOFORCE GROUP INC |
MONICA FERRANTE |
| K110967 |
06/30/2011 |
ENTERPRISE ELECTROPHYSIOLOGY SYSTEM |
NEURALYNX INC |
MIKE JOHNSON |
| K110712 |
06/28/2011 |
DRYTOUCH SUCTION STIMULATOR PROBE |
NEUROVISION MEDICAL PRODUCTS, INC. |
CHRISTINE VERGELY |
| K111581 |
06/23/2011 |
15 ESTHETIC ABUTMENT NOBELACTIVE 03.0 1.5MM, 15 ESTHETIC ABUTMENT NOBELACTIVE 03.0 3MM, 15 ESTHETIC ABUTMENT NOBELACTIVE |
NOBEL BIOCARE AB |
HERBERT CRANE |
| K110171 |
06/15/2011 |
NOBELPROCERA ZI ABUTMENT THOMMEN PLATFORMS |
NOBEL BIOCARE USA LLC |
HERBERT CRANE |
| K111107 |
06/30/2011 |
SUPER PORCELAIN EX-3 UNIVERSAL OPAQUE |
NORITAKE CO., INC. |
IVAN WASSERMAN |
| K111410 |
06/20/2011 |
NUVASIVE LONG LATERAL SPINAL SYSTEM |
NUVASIVE, INC. |
Elias Ketchum |
| K110953 |
06/15/2011 |
VISENSIA, VISENSIA WITH ALERT |
OBS MEDICAL |
CHRIS WEATHERALL |
| K110724 |
06/23/2011 |
SURGICAL PROCEDURE PACKS |
OMNIA SPA |
JAMIE AUSTIN |
| K111193 |
06/27/2011 |
APEX ARC HIP STEM |
OMNILIFE SCIENCE INC. |
RADHIKA PONDICHERRY |
| K110947 |
06/16/2011 |
APEX K1 HIP STEM |
OMNILIFE SCIENCE INC. |
RADHIKA PONDICHERRY |
| K111184 |
06/22/2011 |
APEX PS KNEE SYSTEM - PS-C INSERT |
OMNILIFE SCIENCE INC. |
RADHIKA PONDICHERRY |
| K103266 |
06/03/2011 |
ISTAND |
OPTOVUE, INC. |
JOHN J TALARICO |
| K110805 |
06/21/2011 |
GUIDED GROWTH SYSTEM EIGHT-PLATE, QUAD-PLATE (STAINLESS STEEL) |
ORTHOFIX INC. |
MARY BIGGERS |
| K111041 |
06/06/2011 |
MINI VARIABLE SYSTEM |
ORTHOHELIX SURGICAL DESIGNS, INC. |
DEREK LEWIS |
| K111086 |
06/17/2011 |
ORTHOPEDIATRICS FRACTURE AND OSTEOTOMY BONE PLATE SYSTEM |
ORTHOPEDIATRICS, CORP |
MARK FOX |
| K103594 |
06/15/2011 |
PONTO PRO POWER |
OTICON MEDICAL AB |
ULRIKA NIELSEN |
| K111672 |
06/29/2011 |
MAX ORIENT SUCTION DEVICE FOR ELECTROCAUTERIZER |
PACIFIC HOSPITAL SUPPLY CO., LTD |
IRENE LIN |
| K110907 |
06/22/2011 |
PALOMAR ICON (TM) AESTHETIC SYSTEM |
PALOMAR MEDICAL TECHNOLOGIES, INC. |
Sharon Timberlake |
| K111229 |
06/01/2011 |
JETSTREAM G3 (R) SF 1.6 SYSTEM |
PATHWAY MEDICAL TECHNOLOGIES, INC. |
CYNDY ADAMS |
| K111513 |
06/24/2011 |
CX50 DIAGNOSTIC ULTRASOUND SYSTEM |
PHILIPS ULTRASOUND, INC. |
PENNY GRECO |
| K110414 |
06/21/2011 |
QLAB 8.1 QUANTIFICATION SOFTWARE |
PHILIPS ULTRASOUND, INC. |
NANCY BURKE |
| K110969 |
06/10/2011 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
PPP MEDICAL AND SAFETY PRODUCTS COMPANY LIMITED |
CHU XIAOAN |
| K110972 |
06/06/2011 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR |
PPP MEDICAL AND SAFETY PRODUCTS COMPANY LIMITED |
CHU XIAOAN |
| K111297 |
06/16/2011 |
SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (AND MULTIPLE LABELS) |
PREMIER MEDICAL GLOVES FACTORY |
LIANG ZHAO |
| K110732 |
06/03/2011 |
EMULSION SB |
PRUGEN IP HOLDINGS, INC |
ROBERT L KNECHTEL |
| K102623 |
06/06/2011 |
BLUE POWDERFREE NITRILE EXAMINATION GLOVE |
PT. MEDISAFE TECHNOLOGIES |
ANIL TANEJA |
| K110566 |
06/24/2011 |
VIBERECT PENILE VIBRATORY STIMULATION DEVICE |
REFLEXONIC, LLC |
CAROLINE TONTINI |
| K111148 |
06/30/2011 |
S8 ASPEN WITH H4I PLUS |
RESMED CORP. |
DAVID D'CRUZ |
| K103578 |
06/02/2011 |
PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST |
RESPIRONICS NOVAMETRIX, LLC |
KEVIN MADER |
| K110398 |
06/01/2011 |
RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS |
RESPIRONICS, INC. |
JOSEPH E OLSAVSKY |
| K110405 |
06/06/2011 |
TRUBLUE NASAL MASK |
RESPIRONICS, INC. |
MICHELLE BRINKER |
| K111349 |
06/09/2011 |
ELECSYS SHBG CALCHECK 5 |
Roche Diagnostics |
KELLY FRENCH |
| K101733 |
06/06/2011 |
REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIES |
SAC, LLC DBA PINNACLE MEDICAL SURGICAL |
DAVE STRAIN |
| K110625 |
06/17/2011 |
SAFETYMATE TALKING FIRST AID |
SAFETYMATE, INC. |
SHARON COHEN, PH.D |
| K103584 |
06/10/2011 |
ENVISEN NELLCOR, BCI, NONIN, CSI, HP/PHILIPS, DATEX-OHMEDA COMPATIBLE DISPOSABLE AND REUSABLE SPO2 SENSORS |
SHENZHEN ENVISEN INDUSTRY CO. LIMITED |
STEPHEN H GORSKI |
| K103548 |
06/02/2011 |
ADVIA CENTAUR CALIBARATOR 80 MODEL 10492491 |
Siemens Healthcare Diagnostics Inc. |
Sandra D White |
| K111394 |
06/22/2011 |
MICROSCAN MICROSTEP |
Siemens Healthcare Diagnostics Inc. |
SHANNON POPSON |
| K103429 |
06/08/2011 |
BIOGRAPH MMR |
SIEMENS MEDICAL SOLUTIONS USA INC. |
ALAINE MEDIO |
| K111674 |
06/30/2011 |
ACUSON |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
SHELLY PEARCE |
| K111292 |
06/03/2011 |
LUMINOS AGILE |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PATRICIA D JONES |
| K110291 |
06/17/2011 |
NAVIAID ICVI-F DEVICE, NAVIAID ICVI-S DEVICE, NAVIAID ICVI-B DEVICE |
SMART MEDICAL SYSTEMS, LTD. |
ADVA YOSELZON |
| K110647 |
06/22/2011 |
RENASYS FOAM NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS GAUZE NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS |
SMITH & NEPHEW, INC. |
LAURA REYNOLDS |
| K110545 |
06/24/2011 |
SMITH & NEPHEW NEXT GENERATION FULLY THREADED PEEK SUTURE ANCHOR (NGFTSA PK) |
SMITH & NEPHEW, INC. |
ELIZABETH LAVELLE |
| K102458 |
06/13/2011 |
4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM |
SOLCO BIOMEDICAL CO., LTD. |
SAEYOUNG AHN |
| K102771 |
06/24/2011 |
BIOPSY HANDY, MRI BIOPSY HANDY |
SOMATEX MEDICAL TECHNOLOGIES GMBH |
SUSANNE RAAB |
| K110831 |
06/21/2011 |
SOUNDBITE HEARING SYSTEM BY SONITUS MEDICAL |
SONITUS MEDICAL INC |
ROBERT J CHIN, PH.D. |
| K110645 |
06/03/2011 |
BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR |
SONOSITE,INC. |
JESSICA R STENBERG |
| K110839 |
06/30/2011 |
SCANORA 3D |
SOREDEX PALODEX GROUP OY |
MATTI TULIKOURA |
| K110886 |
06/30/2011 |
CLIO/CLIOSOFT |
SOTA PRECISION OPTICS, INC. |
BRIAN KIM |
| K110306 |
06/23/2011 |
SOUND SURGICAL VASER 2.1 LIPO SYSTEM |
SOUND SURGICAL TECHNOLOGIES LLC. |
STEPHEN C SMITH |
| K110001 |
06/14/2011 |
SPACELABS PATHFINDER SL HOLTER ANALYZER |
SPACELABS HEALTHCARE LTD. |
THOMAS KROENKE |
| K110933 |
06/13/2011 |
SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE |
SPINEOLOGY, INC. |
BRYAN BECKER |
| K102490 |
06/02/2011 |
IGX PLEX CELIAC QUALITATIVE ASSAY |
SQI DIAGNOSTICS SYSTEMS |
Kate Smith |
| K111133 |
06/24/2011 |
NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CLAIM (50 MG OR LESS) |
SSC SURAT THANI |
WILLIAM E HARRIS , III |
| K111092 |
06/09/2011 |
ENGAGE/ENGAGE TR INTRODUCERS |
ST. JUDE MEDICAL |
VENKATA DAMARAJU |
| K110609 |
06/24/2011 |
EPIDUCER LEAD DELIVERY SYSTEM |
ST. JUDE MEDICAL |
RASHMI MOZA |
| K110769 |
06/03/2011 |
AMSCO WARMING CABINET |
STERIS Corporation |
ROBERT F SULLIVAN |
| K102949 |
06/15/2011 |
COLONOSCOPY ASSISTANT |
STI MEDICAL SYSTEMS, LLC |
ROLF WOLTERS |
| K103807 |
06/28/2011 |
IVAS 2-10MM (10 GUAGE) BALLON CATHETER |
STRYKER CORPORATION |
MELISSA KANN |
| K110459 |
06/24/2011 |
SUREFIRE INFUSION CATHETER SYSTEM |
SUREFIRE MEDICAL, INC |
CHERYL HASTINGS |
| K111073 |
06/22/2011 |
SURGIVISION INC. CLEARPOINT SYSTEM |
SURGI-VISION, INC. |
EDWARD WADDELL |
| K103713 |
06/16/2011 |
ELTA WOUND CLEANSER |
SWISS AMERICAN PRODUCTS, INC. |
ERIC LUO |
| K101509 |
06/27/2011 |
U-RIGHT TD-4279 BLOOD GLUCOSE MONITORING SYSTEM, FORA GD40/TD-4272 BLOOD GLUCOSE MONITORING SYSTEM |
TaiDoc Technology Corporation |
TELING HSU |
| DEN100017 |
06/28/2011 |
LIPFLOW THERMAL PULSATION SYSTEM (FORMERLY MANUAL MINI SYSTEM) |
TEARSCIENCE, INC. |
CHRISTY MOENY |
| K111117 |
06/30/2011 |
CANNON II PLUS CHRONIC HEMODIALYSIS CATHETER, EDGE CHRONIC HEMODIALYSIS CATHETER, NEXTSTEP(R) RETROGRADE CHRONIC... |
Teleflex Medical, Inc. |
SUZANNE SCHORLE |
| K103698 |
06/21/2011 |
TENSCARE ITOUCH SURE MODEL ITS |
TENSCARE LTD. |
ANDREW BROWN |
| K110850 |
06/09/2011 |
K-PACK II NEEDLE- 27G & 30G THIN WALL |
TERUMO EUROPE N.V. |
M.J. AERTS |
| K110527 |
06/06/2011 |
K-PACK SURSHIELD NEEDLE, HYPODERMIC NEEDLE FOR SINGLE USE |
TERUMO EUROPE N.V. |
M. J AERTS |
| K110669 |
06/02/2011 |
TAMPAX C PLASTIC TAMPONS, UNSCENTED |
THE PROCTER & GAMBLE CO. |
KATHLEEN BLIESZNER |
| K110035 |
06/28/2011 |
INDIKO |
THERMO FISHER SCIENTIFIC OY |
PAIVI SORMUNEN |
| K110599 |
06/14/2011 |
AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM |
TORNIER, INC. |
BRAHIM HADRI |
| K110773 |
06/02/2011 |
TORNIER INSITE FT SUTURE ANCHOR |
TORNIER, INC. |
BRAHIM HADRI |
| K103456 |
06/22/2011 |
THE SENSITITRE AIM |
TREK DIAGNOSTIC SYSTEMS |
CYNTHIA C KNAPP |
| K102507 |
06/13/2011 |
AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTOR |
TZ MEDICAL, INC. |
JOHN LUBISICH |
| K111017 |
06/06/2011 |
CLEARTEMP |
ULTRADENT PRODUCTS, INC. |
DIANE ROGERS |
| K110684 |
06/24/2011 |
MEDCAD ACCUSHAPE (TM) PEEK PATIENT SPECIFIC CRANIAL / CRANIOFACIAL IMPLANT |
VANDUZEN DBA MEDCAD |
DIANE RUTHERFORD |
| K111180 |
06/28/2011 |
VASOMEDICAL-BIOX 12- CHANNEL AMBULATORY ECG HOLTER RECORDER MODEL 1304, VASOMEDICAL-BIOX 3- CHANNEL MINIATURE AMBULATORY |
VASOMEDICAL, INC. |
RICHARD E GORDON |
| K111096 |
06/24/2011 |
VASOMEDICAL-BIOX COMBINED 12 CHANNEL AMBULATORY ECG AND BLOOD PRESSURE RECORDER MODEL 2302, VASOMEDICAL-BIOX AMBULATORY |
VASOMEDICAL, INC. |
RICHARD E GORDON |
| K102625 |
06/10/2011 |
VEGA CPAP SYSTEM/HEATED HUMIDIFIER, MODEL CP-03 |
VEGA TECHNOLOGIES, INC. |
JOSEPH LU |
| K110394 |
06/09/2011 |
ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON) |
VITAL DIAGNOSTICS (MANUFACTURING) PTY LTD |
MELITA LAMBIRIS |
| K111063 |
06/28/2011 |
VITAL SERUM CONTROLS |
VITAL DIAGNOSTICS (MANUFACTURING) PTY. LTD. |
MELITA LAMBIRIS |
| K110274 |
06/10/2011 |
AUTODELFIA NEONATAL IRT KIT |
WALLAC OY, A SUBSIDIARY OF PERKINELMER, INC. |
SUSAN K HAMANN |
| K110516 |
06/01/2011 |
CONNEX VITAL SIGNS MONITOR 6000 SERIES |
WELCH ALLYN, INC. |
FRED SCHWEITZER |
