| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K122569 |
09/12/2012 |
LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC LAVA ULTIMATE CAD/CAM RESTORATIVE FOR E4D LAVA ULTIMATE IMPLANT CROWN RESTOR |
3M COMPANY |
GINGER CANTOR |
| K113648 |
09/06/2012 |
LOQTEQ LARGE FRAGMENT SET LOQTEQ CORTICAL SCREW 4.5, SMALL HEAD, T25, SELF TAPPING LOQTEQ CORTICAL SCREW 4.5, T25, SELF |
AAP IMPLANTATE AG |
MARC SEEGERS |
| K120009 |
09/11/2012 |
TESTOSTERONE TEST SYSTEM; CALIBRATOR; AND QUALITY CONTROL MATERIAL (ASSAYED AND UNASSAYED) |
ABBOTT LABORATORIES |
JOHN RIZOS |
| K112892 |
09/06/2012 |
IMPELLA 2.5 PLUS CATHETER |
ABIOMED, INC. |
CAROLYN PEKAR |
| K121568 |
09/21/2012 |
DALI SPINAL FIXATION SYSTEM |
ACCEL SPINE |
DANIEL CHON |
| K121567 |
09/26/2012 |
ORACLE LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM |
ACCEL SPINE |
DANIEL CHON |
| K121078 |
09/13/2012 |
VAN GOGH ANTERIOR CERVICAL PLATE SYSTEM |
ACCEL SPINE |
DANIEL CHON |
| K120730 |
09/06/2012 |
LOUTREX TOPICAL CREAM |
ACELLA PHARMACEUTICALS, LLC |
LARA NOAH |
| K120450 |
09/19/2012 |
SLEEP PROFILER |
ADVANCED BRAIN MONITORING, INC. |
ADRIENNE LENZ |
| K122623 |
09/26/2012 |
SHORT LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT MODEL 3017-000 (LEFT) AND 3018-000 (RIGHT); 6 HOLE MEDIUM MIDSHAFT |
ADVANCED ORTHOPAEDIC SOLUTIONS, INC. |
ALLYSON PARKS |
| K111391 |
09/26/2012 |
STERRAD (R) 100NX DUO CYCLE TEST PACK |
ADVANCED STERILIZATION PRODUCTS |
NANCY CHU |
| K111375 |
09/14/2012 |
STERRAD (R) CYCLESURE (R) 24 BIOLOGICAL INDICATOR |
ADVANCED STERILIZATION PRODUCTS |
NANCY CHU |
| K111377 |
09/13/2012 |
STERRAD(R) 100NX STERILIZER DUO CYCLE |
ADVANCED STERILIZATION PRODUCTS |
NANCY CHU |
| K121309 |
09/06/2012 |
ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE |
ADVANCED SURGICAL CONCEPTS |
JONATHAN KAHAN |
| K120235 |
09/17/2012 |
MODEL FAMILY OF AEROLASE ND:YAG LASERS: FRIENDLYLIGHT ND: YAG LASERS, FRIENDLYLIGHT NEO, LIGHTPOD ND: YAG LASERS, LIGHTP |
AEROLASE MEDICAL LASERS LLC |
JENNIFER A HENDERSON |
| K121801 |
09/11/2012 |
QUINTEX CERVICAL PLATING SYSTEM |
AESCULAP IMPLANT SYSTEMS, LLC |
Lisa Boyle |
| K122119 |
09/13/2012 |
DX-D FULL LEG FULL SPINE |
AFGA HEALTHCARE N.V. |
DAVID LEDWIG |
| K120732 |
09/06/2012 |
LENSSX LASER SYSTEM |
ALCON LENSX, INC. |
Judy Gordon |
| K122047 |
09/04/2012 |
ALAMO P |
ALLIANCE PARTNERS, LLC |
JENNIFER PALINCHIK |
| K121150 |
09/21/2012 |
ALMA LASERS FAMILY OF PIXEL RF TIPS |
ALMA LASERS INC. |
KATHY MAYNOR |
| K121729 |
09/20/2012 |
E-CUBE 7 |
ALPINION MEDICAL SYSTEMS CO., LTD |
YUCHI CHU |
| K121641 |
09/07/2012 |
MINIARC PRO SINGLE-INCISION SLING SYSTEM |
AMERICAN MEDICAL SYSTEMS |
RENEE MELLUM |
| K121822 |
09/10/2012 |
DELICOT |
AMERICAN SURGICAL COMPANY, LLC |
ERIK PIASIO |
| K121022 |
09/17/2012 |
AMERIWATER ALARM PANEL - BASE MODEL AND REMOTE, BASE MODEL & REMOTE WITH CONDUCTIVITY, BASE MODEL & REMOTE WITH RESISTIV |
AMERIWATER |
BRIAN BOWMAN |
| K121372 |
09/10/2012 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR |
ANDON HEALTH CO., LTD |
LIU YI |
| K122270 |
09/28/2012 |
OVERTUBE ENDOSCOPIC ACCESS SYSTEM |
APOLLO ENDOSURGERY, INC. |
HEATHER CRAWFORD, RAC |
| K120814 |
09/06/2012 |
PADLOCK CLIP-12 |
APONOS MEDICAL CORP. |
JOHN FEE |
| K121305 |
09/25/2012 |
STERLING MEDICAL IMPULSE 3 STIMULATOR |
ARMSTRONG INDUSTRIES, INC. DHA MEDIQUIP INT. DHA S |
RALPH H ARMSTRONG |
| K121941 |
09/07/2012 |
ARROW PICC POWERED BY ARROW VPS STYLET |
ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.) |
ELIZABETH DUNCAN |
| K122545 |
09/20/2012 |
CG+ ARROW PICC POWERED BY ARROW VPS STYLET |
ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.) |
ELIZABETH DUNCAN |
| K122374 |
09/25/2012 |
ARTHREX SUTURE (UHMWPE) |
ARTHREX, INC. |
IVETTE GALMEZ |
| K120943 |
09/21/2012 |
SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT SPEEDLOCK HIP DRILL SPEEDLOCK HIP GUIDE CROWN TIP SPEEDLOCK HIP PATHFINDER |
ARTHROCARE CORPORATION |
CHERYL FREDRICK |
| K122022 |
09/26/2012 |
ATHEROEDGE |
ATHEROPOINT LLC |
JASJIT S SURI |
| K122611 |
09/26/2012 |
COOLRAIL LINEAR PEN MODEL MCRI |
ATRICURE, INC. |
JIM LUCKY, RAC |
| K113836 |
09/24/2012 |
BENEHOLD CHG TRANSPARENT FILM DRESSING (10X12CM) (8.5X12CM) (6.5X7 CM) |
AVERY DENNISON BELGIE, BVBA |
JERZY WOJCIK |
| K122260 |
09/12/2012 |
AYCAN MOBILE |
AYCAN DIGITALSYSTEME GMBH |
MATTHIAS BROENNER |
| K120875 |
09/07/2012 |
B&W DENTAL IMPLANT SYSTEM |
B&W SRL |
PRIYA BHUTANI |
| K120126 |
09/10/2012 |
BAROSENSE ENDOGASTRIC TUBE AND INTRODUCER BOUGIE |
BAROSENSE, INC |
SHELIA STEVENS, PHD |
| K113852 |
09/28/2012 |
BAUSCH & LOMB IOL INJECTOR |
BAUSCH & LOMB, INC. |
JASON SMITH |
| K120384 |
09/12/2012 |
PROTECTOR, INJECTOR, CONNECTOR |
BD MEDICAL-MEDICAL SURGICAL SYSTEMS |
JOHN ROBERTS |
| K121492 |
09/11/2012 |
UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN ALC-(HBA1C-) REAGENT |
BECKMAN COULTER, INC. |
ANNETTE HELLIE |
| K121797 |
09/07/2012 |
BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B |
Becton, Dickinson and Company |
GREGORY P PAYNE, RAC |
| K121633 |
09/18/2012 |
BD VERITOR(TM) SYSTEM FOR THE RAPID DETECTION OF RSV |
Becton, Dickinson and Company |
Gregory P Payne |
| K121983 |
09/07/2012 |
DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM CURVED LINEAR ARRAY 2-5 MHZ TRANSDUCER LINEAR ARRAY 5-11 MHZ TRANSDUCER PHASE ARRA |
BENQ MEDICAL TECHNOLOGY CORPATION |
BOB LEIKER |
| K121787 |
09/05/2012 |
BIOHORIZONS TAPERED INTERNAL PLUS IMPLANTS |
BIOHORIZONS IMPLANT SYSTEMS, INC. |
MICHAEL DAVIS |
| K121286 |
09/28/2012 |
EPIC 10 |
BIOLASE TECHNOLOGY, INC. |
ROBERT YANG |
| K121773 |
09/21/2012 |
NIMBUS ELECTROSURGICAL RADIOFREQUENCY MULTITINED EXPANDABLE ELECTRODE |
BIOMERICS |
EMILY MADSEN |
| K120776 |
09/11/2012 |
ABUTMENT FOR COMPETITIVE IMPLANT NOBEL ACTIVE CONNECTION |
BIOMET 3I |
TAMARA WEST |
| K121589 |
09/21/2012 |
BIOMET MICROFIXATION FACIAL PLATING SYSTEM |
BIOMET MICROFIXATION |
LAUREN JASPER |
| K121302 |
09/19/2012 |
BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM |
BIOMET MICROFIXATION |
SHERYL MALMBERG |
| K122378 |
09/20/2012 |
NEXTGEN ALTIUS OCT SYSTEM |
BIOMET SPINE (AKA EBI, LLC) |
VIVIAN KELLY |
| K122565 |
09/04/2012 |
ARC ENDOCUFF |
BODDINGTONS PLASTICS LTD |
JOHN BOVIS |
| K121694 |
09/14/2012 |
IMAGER II ANGIOGRAPHIC CATHETER |
BOSTON SCIENTIFIC CORP. |
HOLLY RAMIREZ |
| K121614 |
09/18/2012 |
NEPHROMAX HIGH PRESSURE NEPHROSTOMY BALOON DILATATION CATHETER |
BOSTON SCIENTIFIC CORP. |
LAUREN ANDERSON |
| K121774 |
09/13/2012 |
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH PERIPHERAL ROTALINK PLUS |
BOSTON SCIENTIFIC CORP. |
BETH TOROK |
| K122072 |
09/28/2012 |
WALLFLEXTM BILIARY RX STENT SYSTEM (UNCOVERED, PARTIALLY COVERED, AND FULLY COVERED) WALLFLEXTM BILIARY TRANSHEPATIC STE |
Boston Scientific Corporation |
LAURIE PANNELLA |
| K122451 |
09/28/2012 |
EXACTRAC VERO |
BRAINLAB AG |
ALEXANDER SCHWIERSCH |
| K121519 |
09/18/2012 |
ISIGHT |
C & E GP SPECIALISTS, INC. |
MARTIN DALSING |
| K121590 |
09/20/2012 |
VESTIBULAR ANALYSIS APPARATUS |
CAPACITY SPORTS, LLC |
PAMELA M BUCKMAN |
| K122507 |
09/26/2012 |
DURABLUE STERILIZATION WRAP, MODEL NUMBERS CH100, CH200, CH300, CH400, CH500 AND CH600, STERRAD NX STERILIZATION |
CARDINAL HEALTH 200, LLC |
LAVENIA FORD |
| K113407 |
09/07/2012 |
SNOWDEN PENCER LAPAROSCOPIC ERGONOMIC REPOSABLE SCISSORS |
CAREFUSION 2200, INC. |
KATE FULLER |
| K122427 |
09/12/2012 |
CS ORTHODONTIC IMAGING SOFTWARE CS OMS IMAGING SOFTWARE |
CARESTREAM DENTAL LLC |
DANIEL HOEFER |
| K111128 |
09/13/2012 |
LABONACHECK A1C |
CERAGEM INTERNATIONAL, INC. |
RAYMOND CHUNG |
| K121256 |
09/12/2012 |
ALCO-SCREEN 02 |
CHEMATICS, INC. |
CARL REYNOLDS |
| K121850 |
09/20/2012 |
Typhoon(TM) Facet Screw Fixation System |
CHOICE SPINE, LP |
KIM FINCH |
| K113731 |
09/10/2012 |
ESENSOR RESPIRATORY VIRAL PANEL |
CLINICAL MICRO SENSORS, INC. |
JOEL CENTENO |
| K121580 |
09/25/2012 |
SURELASE CO2 LASER SYSTEM |
CLINICON CORP. |
GERALD PALECKI |
| K121974 |
09/06/2012 |
CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM |
CONFORMIS, INC. |
AMITA S SHAH |
| K122033 |
09/27/2012 |
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM |
CONFORMIS, INC. |
AMITA S SHAH |
| K121935 |
09/10/2012 |
TAPERSET HIP SMALL STEMS |
CONSENSUS ORTHOPEDICS, INC. |
MATTHEW M HULL |
| K120501 |
09/20/2012 |
CHAMP CHAMP TRANSIT |
CONVAID PRODUCTS, INC. |
MERVYN WATKINS |
| K121665 |
09/25/2012 |
BENCOX FORET & BENCOX DELTA |
CORENTEC CO., LTD |
J.S. DANIEL |
| K120924 |
09/10/2012 |
BENCOX MIRABO CUP BENCOX MIRABO INSERT (STANDARD& ELEVATED TYES) BENCOX MIRABO CUP SCREW HOLE PLUG |
CORENTEC CO., LTD |
J.S. DANIEL |
| K121439 |
09/14/2012 |
METAFIX FEMORAL HIP STEM SIZE 1 |
CORIN U.S.A. |
LUCINDA GERBER |
| K113060 |
09/10/2012 |
UNITY TOATAL KNEE SYSTEM |
CORIN U.S.A. |
LUCINDA GERBER |
| K121806 |
09/28/2012 |
BESIDE RESPIRATORY PATIENT MONITORING SYSTEM BESIDE RESIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTWARE |
COVIDIEN |
ELIZABETH MALO |
| K113572 |
09/05/2012 |
LIGASURE CURVED, SMALL JAW, OPEN SEALER/DIVIDER |
COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO H |
JOHN VAN HOVEN |
| K121880 |
09/25/2012 |
DMRC NANOFLOW DMRC NANOCOMPOSITE EBOND SURE ETCH GEL SURE ETCH LIQUID |
DANVILLE MATERIALS, INC. |
LINDSAY TILTON |
| K122628 |
09/06/2012 |
SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHETER AND ACCESSORIES |
DATASCOPE CORP., CARDIAC ASSIST DIVISION |
CARLA S CERQUEIRA |
| K122030 |
09/05/2012 |
LOW PROFILE GASTROSTOMY FEEDING TUBE OR GASTROTOMEY BUTTON |
DEGANIA SILICONE, LTD. |
ZOYA LEE |
| K122442 |
09/06/2012 |
DEPUY CTA REVERSE SHOULDER SYSTEM |
DEPUY FRANCE |
MEGAN BURNS |
| K122397 |
09/06/2012 |
LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM |
DIASORIN, INC. |
CAROL A DEPOUW |
| K121558 |
09/21/2012 |
DIAZYME HSCRP POC TEST KIT |
DIAZYME LABORATORIES |
Abhijit Datta |
| K121915 |
09/28/2012 |
BRIGHT RESTORATIVE MATERIALS |
DMP LTD |
DIMITRIS PRANTSIDIS |
| K121656 |
09/24/2012 |
GEMINI LITHOTRIPTER |
DORNIER MEDTECH AMERICA, INC. |
JOHN HOFFER |
| K121885 |
09/10/2012 |
EARLYSENSE CENTRAL DISPLAY SYSTEM |
EARLYSENSE LTD. |
DALIA ARGAMAN |
| K111142 |
09/21/2012 |
ECHOSOFT(TM) |
ECHOMETRIX LLC |
LARRY A KROGER |
| K120288 |
09/19/2012 |
ORTHOCAD SOFTWARE OPTION |
ESAOTE, S.P.A. |
ALLISON SCOTT, RAC |
| K112223 |
09/11/2012 |
EUROIMMUN ANTI-LKM-1 ELISA(LGG) |
EUROIMMUN US |
KATHRYN KOHL |
| K112221 |
09/11/2012 |
EUROIMMUN ANTI-SLA/LP ELISA(LGG) |
EUROIMMUN US |
KATHRYN KOHL |
| K121462 |
09/28/2012 |
EZ-BLOCKER |
EZ-BLOCKER B.V. |
LEWIS WARD |
| K113761 |
09/07/2012 |
INFRARED THERMOMETER |
FAMIDOC TECHNOLOGY CO., LTD |
LEON CAO |
| K122428 |
09/25/2012 |
FAXITRON SPECIEN RADIOGRAPHY SYSTEM |
FAXITRON BIOPTICS LLC |
DOUGLAS C WIEGMAN |
| K122413 |
09/13/2012 |
PATIENT POSITIONING SYSTEM |
FORTE AUTOMATION SYSTEMS, INC. |
PHIL REECE |
| K121674 |
09/21/2012 |
ASPIRE HD PLUS, ASPIRE HD-S |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
PETER ALTMAN |
| K122515 |
09/11/2012 |
C2-9-D ULTRASOUND TRANSDUCER |
GE HEALTHCARE |
BRYAN BEHN |
| K122327 |
09/21/2012 |
VOLUSON E6/E8/E8EXPERT/E10 |
GE HEALTHCARE |
BRYAN BEHN |
| K122387 |
09/11/2012 |
VOLUSON P6, VOLUSON P8 |
GE HEALTHCARE |
BRYAN BEHN |
| K121827 |
09/13/2012 |
GSI VIEWER WITH VUE OPTION |
GE MEDICAL SYSTEMS SCS |
HELEN PENG |
| K122164 |
09/07/2012 |
MR VESSELLQ XPRESS |
GE MEDICAL SYSTEMS SCS |
HELEN PENG |
| K121676 |
09/20/2012 |
1.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANT |
GE MEDICAL SYSTEMS, LLC |
SHASHIDHAR CS |
| K122067 |
09/27/2012 |
TYPE 1077 ACCUSCREEN |
GN OTOMETRICS |
TOM RINIKER |
| K122259 |
09/24/2012 |
BLOOD PRESSURE MONITOR WITH STETHOSCOPE |
HANGZHOU RELI-ON CO., LTD |
CHARILE MACK |
| K121005 |
09/21/2012 |
ADIPREP ADIPOSE TRANSFER SYSTEM |
HARVEST TECHNOLOGIES, CORP. |
GABRIEL J MURACA, JR. |
| K122341 |
09/26/2012 |
PROSOUND F37 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL: PROSOUND F37 |
HITACHI ALOKA MEDICAL, LTD. |
|
| K120064 |
09/05/2012 |
TEST, BLOOD GLUCOSE SYSTEM |
HMD BIOMEDICAL, INC. |
JESSICA TUNG |
| K122563 |
09/19/2012 |
MYOSURE XL ROD LENS HYSTEROSCOPE, MYOSURE XL OUTLFOW CHANNEL |
HOLOGIC, INC. |
SARAH FAIRFIELD |
| K122498 |
09/10/2012 |
MYOSURE XL TISSUE REMOVAL DEVICE (1 PACK) MYOSURE XL TISSUE REMOVAL DEVICE (3 PACK) |
HOLOGIC, INC. |
SARAH FAIRFIELD |
| K121335 |
09/13/2012 |
G-DERM POWDER-FREE SYNTHETIC SURGICAL GLOVE |
HUTCHINSON SANTE S.N.C. |
RAFFI KRIKORIAN |
| K121654 |
09/05/2012 |
AUTO-CHEK BLOOD GLUCOSE MONITORING SYSTEM, METER, TEST STRIP. AUTO-CHECK CONTROL SOLUTION |
i-SENS, Inc. |
HYUN JOON OH |
| K121034 |
09/04/2012 |
IOI TOTAL HIP |
ICONACY ORTHOPEDIC IMPLANTS, LLC |
ROY Y HORI, PHD |
| K121541 |
09/13/2012 |
JAZZ SYSTEM |
IMPLANET S.A. |
JANICE M HOGAN |
| K121366 |
09/07/2012 |
HEMOCUE HBA1C 501 |
INFOPIA CO., LTD |
MARIA F GRIFFIN |
| K121479 |
09/13/2012 |
AIM |
INNEROPTIC TECHNOLOGY, INC |
CAROLINE GREEN |
| K121021 |
09/24/2012 |
INOMAX DS (DELIVERY SYSTEM) |
INO THERAPEUTICS |
DAVID TRUEBLOOD |
| K113863 |
09/20/2012 |
QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QUANTA FLASH DGP IGG CALIBRATORS |
INOVA DIAGNOSTICS, INC. |
GABRIELLA LAKOS |
| K120462 |
09/20/2012 |
AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED BREATHING DETECTION) |
INOVISE MEDICAL, INC. |
EARL ANDERSON |
| K120012 |
09/11/2012 |
INTEGRA JARIT VIDEO ASSISTED THORACIC SURGERY INSTRUMENTS |
INTEGRA LIFESCIENCES CORPORATION |
STEPHANIE SHEESLEY |
| K120052 |
09/04/2012 |
CVINSIGHT |
INTELOMED, INC |
JAN BERKOW |
| K112200 |
09/06/2012 |
FOCUS TOUCH CONCEPTION SYSTEM |
INTIMATE BRIDGE 2 CONCEPTION, INC |
NIKI C SPANIEL |
| K121573 |
09/10/2012 |
INTEGRA CAMINO ICP MONITOR |
INTRGRA LIFESCIENCES CORPORATION |
Erin Doyle |
| K121630 |
09/11/2012 |
RANGE SPINAL SYSTEM |
K2M, INC. |
NANCY GIEZEN |
| K122096 |
09/27/2012 |
KARL STORZ NAVIGATIONPANEL UNIT (NPU) SYSTEM |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
LEIGH SPOTTEN |
| K121187 |
09/17/2012 |
KATALYST LASER PROBES, KATALYST ILLUMINATED LASER PROBES |
KATALYST SURGICAL, LLC |
MICHELLE MCDONOUGH |
| K121755 |
09/25/2012 |
CUSTOM CRANIOFACIAL IMPLANT (CCI) |
KELYNIAM GLOBAL, INC. |
NICHOLAS BREAULT |
| K121316 |
09/10/2012 |
LANX SPINAL FIZATION SYSTEM |
LANX, INC. |
WILLIAM SANDUL |
| K120792 |
09/05/2012 |
TIXOS IMPLANT SYSTEM |
LEADER ITALIA S.R.L. |
STUART R GOLDMAN |
| K121415 |
09/05/2012 |
MOLLRING MULTITASC |
LEMAITRE VASCULAR, INC. |
ANDREW HODGKINSON |
| K112741 |
09/13/2012 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVE |
LIFESTYLE SAFTY PRODUCTS (HUI ZHOU) CO. LTD |
RHONDA T ALEXANDER |
| K122622 |
09/19/2012 |
ENDURAMESH |
LUCERO MEDICAL, LLC |
JENNIFER PALINCHIK |
| K120277 |
09/12/2012 |
VITAL COUGH |
LUNG ASSIST, INC. |
LEWIS WARD |
| K113843 |
09/27/2012 |
FREEDOM ND: YAG LASER SYSTEM |
LUTRONIC CORPORATION |
JHUNG WON VOJIR |
| K122612 |
09/10/2012 |
HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX; M00202166XXXXX |
MAQUET CARDIOVASCULAR, LLC |
MARYLOU INSINGA |
| K120657 |
09/19/2012 |
MASIMO SET AND MASIMO RAINBOW SET PULSE OXIMETERS AND SENSORS |
MASIMO CORPORATION |
PATRICIA MILBANK |
| K121914 |
09/07/2012 |
MASIMO SET USPO2 PULSE OXIMETRY CABLE |
MASIMO CORPORATION |
DAVID COLLETTE |
| K122042 |
09/04/2012 |
CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES |
MAUNA KEA TECHNOLOGIES |
MICHAEL DANIEL |
| K122232 |
09/28/2012 |
GMK NARROW |
MEDACTA INTERNATIONAL |
ADAM GROSS |
| K122641 |
09/28/2012 |
MPACT EXTENSION |
MEDACTA INTERNATIONAL |
ADAM GROSS |
| K121262 |
09/20/2012 |
MEDEFLUSH NORMAL SALINE I.V. FLUSH SYRINGE-STERILE FIELD READY |
MEDEFIL, INC. |
PRADEEP AGGARWAL |
| K120281 |
09/17/2012 |
DIGNITY POWER INJECTABLE TITANIUM PORT |
MEDICAL COMPONENTS INC |
ROSANNA SEVERINI |
| K121383 |
09/05/2012 |
PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL COMPONENTS) |
MEDICAL COMPONENTS INC |
JEAN CALLOW |
| K121848 |
09/21/2012 |
SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT CATH III 40CM AND 55CM |
MEDICAL COMPONENTS INC |
JEAN CALLOW |
| K120982 |
09/28/2012 |
DIGITAL EYE-FUNDUS CAMERA |
MEDIMAGING INTEGRATED SOLUTIONS, INC. (MIIS) |
CHIH-LU HSU |
| K120867 |
09/20/2012 |
VIPER AND EXPEDIUM NAVIGATED INSTRUMENTS |
MEDOS INTERNATIONAL SARL |
LAURA BLEYENDAAL |
| K100645 |
09/14/2012 |
AFFINITY PIXIE OXYGENATION SYSTEM WITH CARMEDA BIOACTIVE SURFACE OR BALANCE BIOSURFACE |
MEDTRONIC INC. |
JESSICA SIXBERRY |
| K121219 |
09/25/2012 |
ATTAIN CLARITY 6225 VENOGRAM BALLOON CATHETER |
MEDTRONIC INC. |
WENDY SAUNDERS |
| K122433 |
09/28/2012 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
CHRIS MCKEE |
| K122591 |
09/18/2012 |
CLYDESDALE SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
BECKY RONNER |
| K122019 |
09/13/2012 |
STREPTOCOCCUS APP. SEROLOGICAL REAGENTS |
MERIDIAN BIOSCIENCE, INC. |
Michelle L Smith |
| K120644 |
09/19/2012 |
MERIT HYDROPHILIC GUIDE WIRE |
MERIT MEDICAL SYSTEMS, INC. |
MARK MULLANEY |
| K122089 |
09/21/2012 |
OSTIAL PRO STENT POSITIONING SYSTEM |
MERIT MEDICAL SYSTEMS, INC. |
DAVID THOMAS |
| K120018 |
09/19/2012 |
MINDCHILD MERIDIAN FETAL HEART RATE MONITOR |
MINDCHILD MEDICAL |
LEO BASTA |
| K120306 |
09/27/2012 |
RAPICIDE OPA-28 |
MINNTECH CORP. |
BRENT GREIGER, MS, RAC |
| K122514 |
09/19/2012 |
VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST |
NANOSPHERE, INC |
MARK DEL VECCHIO |
| K120635 |
09/27/2012 |
EASYONE PRO RESPIRATORY TESTING DEVICE |
NDD MEDIZITECHNIK AG |
GERARD MASIELLO |
| K122373 |
09/20/2012 |
NEOMED ORAL/ENTERAL SYRINGE |
NEOMED, INC. |
MELINDA HARRISON |
| K113376 |
09/05/2012 |
NEOSS PROACTIVE TAPERED IMPLANT |
NEOSS LTD |
CHERITA JAMES |
| K120397 |
09/19/2012 |
MEB-2300A NEUROPACK EVOKED POTENTIAL AND EMG MEASURING SYSTEM |
NIHON KOHDEN CORP. |
STEVE GEERDES |
| K112628 |
09/28/2012 |
NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET |
NIPRO MEDICAL CORPORATION |
JESSICA OSWALD |
| K121926 |
09/20/2012 |
BLUE, LATEX POWDER FREE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH PROTEIN LABLING CLAIM (50UG/DM |
NORTHSTAR HEALTHCARE HOLDINGS |
WESLEY TOAVS |
| K121947 |
09/10/2012 |
ETS BLUE POWDER-FREE PATIENT NITRILE EXAMINATION GLOVES |
NORTHSTAR HEALTHCARE HOLDINGS |
WESLEY TOAVS |
| K122352 |
09/11/2012 |
NUVASIVE PRECEPT SPINAL SYSTEM |
NUVASIVE, INC. |
Elias Ketchum |
| K113725 |
09/13/2012 |
VIRTUOST |
O.N. DIAGNOSTICS |
DAVID KOPPERDAHL |
| K113120 |
09/25/2012 |
CHF-Y0005 |
OLYMPUS MEDICAL SYSTEMS CORP. |
SHERI MUSGNUNG |
| K122593 |
09/13/2012 |
PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE-USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2 |
OPTIM LLC |
JEFF BARRETT |
| K120136 |
09/26/2012 |
EMBRYOGEN |
ORIGIO A/S |
ERIC GRUFF |
| K121575 |
09/14/2012 |
OXFORD ANKLE FUSION NAIL(AFN) SYSTEM |
ORTHO SOLUTIONS LIMITED |
AL LIPPINCOTT |
| K120609 |
09/07/2012 |
VITROS CHEMISTRY PRODUCTS DHDL SLIDES |
Ortho-Clinical Diagnostics, Inc. |
MARLENE A HANNA |
| K122541 |
09/20/2012 |
ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP) |
ORTHOFIX SRL |
CANDACE F CEDERMAN |
| K113770 |
09/04/2012 |
ORTHOFIX GALAXY FIXATION SYSTEM |
ORTHOFIX SRL |
CANDACE F CEDERMAN |
| K122005 |
09/06/2012 |
MAXLOCK EXTREME SYSTEM |
ORTHOHELIX SURGICAL DESIGNS, INC. |
DEREK LEWIS |
| K122379 |
09/05/2012 |
FLASH PTA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH PTA BALLOON DILATATION CATHETER - 4MM X 19MM X 135CM |
OSTIAL CORPORATION |
KAITLIN VON HOFFMANN |
| K121228 |
09/07/2012 |
PONTO BONE ANCHORED HEARING SYSTEM |
OTICON MEDICAL AB |
KAROLIN ISBERG JERNBY |
| K121707 |
09/24/2012 |
LEW MDI O-BALL COLLARED IMPLANT, |
PARK DENTAL RESEARCH CORP. |
RONALD BULARD |
| K120289 |
09/28/2012 |
PEERSCOPE SYSTEM |
PEERMEDICAL |
DAN LAOR |
| K121917 |
09/19/2012 |
PENUMBRA EMBOLECTOMY ASPIRATION SYSTEM |
PENUMBRA, INC. |
MICHAELA MAHL |
| K113841 |
09/13/2012 |
IMMUNOCAP ALLERGEN COMPONENTS BUNDLE |
PHADIA US INC. |
MARTIN MANN |
| K113483 |
09/26/2012 |
ITERATIVE RECONSTRUCTION TECHNIQUE SOFTWARE APPLICATION |
PHILIPS HEALTHCARE (CLEVELAND) |
CHRISTINE ANDERSON |
| K122026 |
09/21/2012 |
PRISM ACQUIRE PRISM PROCESS PRISM VIEW |
PRISM CLINICAL IMAGING, INC. |
JAMES L REUSS |
| K120766 |
09/11/2012 |
ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM (MODIFICATION) |
PROSURG, INC. |
A. DESAI |
| K121713 |
09/27/2012 |
PMT BONE SCREWS |
PROVIDENCE MEDICAL TECHNOLOGY, INC. |
GLEN MANGSETH |
| K122638 |
09/25/2012 |
TOSHIBA 3T 32CH HEAD SPEEDER COIL, |
QUALITY ELECTRODYNAMICS |
Kathleen Aras |
| K120825 |
09/14/2012 |
SUPRA SCAN DELIVERY SYSTEM |
QUANTEL MEDICAL |
MAUREEN O'CONNELL |
| K113720 |
09/20/2012 |
RANDOX MATERNAL CONTROL, LEVELS 1, 2 AND 3 |
RANDOX LABORATORIES, LTD. |
PAULINE ARMSTRONG |
| K122216 |
09/05/2012 |
RELIANCE ANTERIOR CERVICAL PLATE SYSTEM |
Reliance Medical Systems, LLC |
Bret M Berry |
| K120087 |
09/26/2012 |
EXSPIRON |
RESPIRATORY MOTION, INC. |
CHAS BURR |
| K121724 |
09/20/2012 |
ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2 |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
RON HASELHORST |
| K113282 |
09/20/2012 |
CERASORB DENTAL,CERADORB M DENTAL, CERASORB PERIO |
RIEMSER ARZEIMITTEL AG |
James M Clinton |
| K112624 |
09/10/2012 |
ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5 |
Roche Diagnostics |
JANE PHILLIPS |
| K122021 |
09/20/2012 |
STERISPINE LC CAGE |
SAFE ORTHOPAEDICS |
P. DUMOUCHEL |
| K122558 |
09/20/2012 |
ULTRASAFE PASSIVE NEEDLE GUARD |
SAFETY SYRINGES, INC. |
SUZANNE RICHARDSON |
| K122583 |
09/05/2012 |
UGEO G60 DIAGNOSTIC ULTRASOUND SYSTEM |
SAMSUNG MEDISON CO., LTD |
|
| K113321 |
09/04/2012 |
TENS BACK PAIN RELIEF SYSTEM |
SAVIA LIMITED |
GUENTER GINSBERG |
| K120107 |
09/18/2012 |
SCKOONCUP |
SCKOON INC. |
MOHAMED ELGAYAR |
| K112693 |
09/12/2012 |
NON-STERILE, POWER FREE YELLOW LATEX EXAMINATION GLOVES |
SGMP CO., LTD. |
JANNA P TUCKER |
| K122266 |
09/27/2012 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
SHANDONG JUNFENG INDUSTRIES CO., LTD |
CHU XIAOAN |
| K112204 |
09/10/2012 |
KDL DISPOSABLE INFUSION SET |
SHANGHAI KINDLY ENT. DEVELOPMENT GROUP CO., LTD. |
Diana Hong |
| K113742 |
09/17/2012 |
KMC KYPHOPLASTY SYSTEM |
SHANGHAI KINETIC MEDICAL CO., LTD |
GREGORY MATHISON |
| K121144 |
09/26/2012 |
ELECTRONIC STETHOSCOPE |
SHARP CORPORATION |
DIANE RUTHERFORD |
| K120938 |
09/24/2012 |
THE PL-1064 LASER SYSTEM |
SHEAUMANN LASER, INC |
TIMOTHY J SHEA |
| K121528 |
09/11/2012 |
POWER-FREE NITRILE EXAMINATION GLOVES, PEPPERMINT SCENTED, BLUE COLOR |
SHEN WEI (USA), INC. |
ALBERT LI |
| K121749 |
09/07/2012 |
VERACIA |
SHOFU DENTAL CORPORATION |
DAVID P MORAIS |
| K122363 |
09/10/2012 |
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE |
SIAM SEMPERMED CORP. LTD. |
WILLIAM E HARRIS |
| K122825 |
09/28/2012 |
ACUSON |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
SHELLY PEARCE |
| K122471 |
09/11/2012 |
SOMATOM DEFINITION |
SIEMENS MEDICAL SYSTEMS, INC. |
KIMBERLY MANGUN |
| K121714 |
09/07/2012 |
SMITH & NEPHEW, INC. SHOULDER SYSTEM INSTRUMENTS |
SMITH & NEPHEW, INC. |
Bradley Heil |
| K110053 |
09/14/2012 |
CORRECTINJECT SAFETY SYSTEM, CATHETER CONNECTOR, FILTER, INFUSION ADAPTOR, SYRINGE KIT |
SMITHS MEDICAL ASD, INC. |
CINDY ENGELHARDT |
| K120328 |
09/17/2012 |
ORIGINS LIPOHARVESTING SYSTEM |
SOUND SURGICAL TECHNOLOGIES LLC. |
STEPHEN C SMITH |
| K121029 |
09/19/2012 |
METS MODULAR DISTAL FEMUR |
STANMORE IMPLANTS WORLDWIDE LTD |
NANCY C MACDONALD |
| K120992 |
09/05/2012 |
METS SMILES TOTAL KNEE REPLACEMENT |
STANMORE IMPLANTS WORLDWIDE LTD |
NANCY C MACDONALD |
| K121056 |
09/20/2012 |
METS MODULAR PROXIMAL FEMUR |
STANMORE IMPLANTS WORLDWIDE LTD. |
NANCY C MACDONALD |
| K121055 |
09/19/2012 |
METS MODULAR TOTAL FEMUR |
STANMORE IMPLANTS WORLDWIDE LTD. |
NANCY C MACDONALD |
| K121153 |
09/14/2012 |
PEEK CUSTOMIZED CRAIAL IMPLANT KIT |
Stryker |
Manish Patel |
| K121893 |
09/05/2012 |
STRYKER SDC3 HD INFORMATION MANAGEMENT SYSTEM |
Stryker Endoscopy |
LIFEI LIU |
| K121112 |
09/12/2012 |
STRYKER VIDEO URETEROSCOPE |
Stryker Endoscopy |
KEVIN POTGIETER, RAC |
| K122506 |
09/17/2012 |
SUREFIRE HIGH FLOW ANGIOGRAPHIC CATHETER, ACCESS |
SUREFIRE MEDICAL, INC |
MARIO ARBESU |
| K122263 |
09/28/2012 |
14.5-16.0 FRENCH CUFFED CATHETER REMOVAL DEVICE, SYMMETRY SURGICAL SINGEL USE |
SYMMETRY MEDICAL |
HANNAH FOLEY |
| K122579 |
09/13/2012 |
VELASHAPE |
SYNERON MEDICAL LTD. |
SAM WADE |
| K121224 |
09/19/2012 |
GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEM |
TaiDoc Technology Corporation |
LINDA KO |
| K120968 |
09/19/2012 |
POWER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED) |
TANGSHAN ZHONGHONG PULIN PLASTIC CO.,LTD |
CHU XIAOAN |
| K112958 |
09/21/2012 |
HUMID-VENT HEPA |
TELEFLEX MEDICAL |
LIZ PAUL |
| K122544 |
09/05/2012 |
TERUMO SURFLASH SAFETY I.V. CATHETER |
TERUMO Corporation |
SANDI HARTKA |
| K113393 |
09/11/2012 |
POWDER FREE BLACK NITRILE EXAMINATION GLOVES |
TG MEDICAL SDN BHD |
NOOR A SAIDIN |
| K112449 |
09/24/2012 |
QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TEST |
Tianjin New Bay Bioresearch Co., Ltd. |
HANN-PING WANG |
| K121114 |
09/17/2012 |
TIGRAN PERIBRUSH |
TIGRAN TECHNOLOGIES AB |
ULF LUNDGREN |
| K121504 |
09/27/2012 |
SUPER SHEATH INTRODUCER SHEATH AND SUPER SHEATH INTRODUCER SHEATH SETS |
TOGO MEDIKIT CO., LTD. |
HEATHER CRAWFORD |
| K121761 |
09/28/2012 |
SOMNOGUARD SP SOFT |
TOMED DR. TOUSSAINT GMBH |
SCOTT WHITCOMB |
| K122487 |
09/17/2012 |
BIOFIBER SYTURE |
TORNIER, INC. |
LAEL J PICKETT |
| K122109 |
09/21/2012 |
AQUILION ONE VISION, V4.90 |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K122491 |
09/13/2012 |
VIAMO SSA-640A V4.0 |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
CHARLEMAGNE CHUA |
| K113821 |
09/07/2012 |
TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM |
TRANSONIC SYSTEMS, INC. |
NAVEEN THURAMALLA |
| K120737 |
09/13/2012 |
TRIA LASER HAIR REMOVAL SYSTEM |
TRIA BEAUTY, INC. |
JONATHAN KAHAN |
| K122462 |
09/11/2012 |
ROTH NET RETRIEVER |
UNITED STATES ENDOSCOPY GROUP, INC. |
CARROLL MARTIN |
| K122301 |
09/07/2012 |
GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE |
VASCULAR SOLUTIONS ZERUSA LTD. |
JENNIFER RUETHER |
| K122155 |
09/04/2012 |
PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM |
VATECH CO., LTD. |
DAVE KIM |
| K121260 |
09/21/2012 |
TROOPER OXYGEN CONCENTRATOR |
VBOX, INC. |
THEODORE JAGGER |
| K121689 |
09/19/2012 |
VITASCAN LT SCANMASTER |
VITACON MEDICAL INC. |
RON EVANS |
| K122136 |
09/07/2012 |
VITREAVIEW |
VITAL IMAGES, INC. |
Ian Nemerov |
| K121273 |
09/10/2012 |
VISIONS PV .035 DITITAL IVUS CATHETER |
VOLCANO CORPORATION |
MARILYN POURAZAR |
| K120405 |
09/19/2012 |
WALK ON WHEELS HS-3500 ELECTRIC AISLE WHEELCHAIR |
WALK ON WHEELS AUSTRALIA PTY LTD |
SHEILA RAMERMAN |
| K121353 |
09/07/2012 |
MINI PATCH |
WELL-LIFE HEALTHCARE LIMITED |
CHIN-CHIN HSIEH |
| K110949 |
09/18/2012 |
BICERA (TM) RESORBABLE BONE SUBSTITUTE |
WILTROM CORPORATION LIMITED |
YUNG-CHIH WU |
| K121625 |
09/14/2012 |
LULLABY TM WARMER |
WIPRO GE HEALTHCARE PRIVATE, LTD. |
AGATA ANTHONY |
| K121971 |
09/27/2012 |
WITHINGS, SMART BODY SCALE |
ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. |
LEO WANG |
| K113296 |
09/14/2012 |
ZMR HIP SYSTEM KWZ-PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER |
ZIMMER, INC. |
DANIEL J WILLIMAN |
| K120907 |
09/25/2012 |
ZOLL R SERIES |
ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS |
CHARLES W KOLIFRATH |
| K120685 |
09/07/2012 |
ZYNO MEDICAL ADMINISTRATION SET |
ZYNO MEDICAL LLC |
CHAOYOUNG LEE |
