| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K132236 |
10/16/2013 |
.DECIMAL PROTON APERTURE |
.DECIMAL, INC. |
KIMBERLY RUPP |
| K131459 |
10/17/2013 |
AAP K-WIRE, STEINMANN PIN, CERCLAGE WIRE |
AAP IMPLANTATE AG |
CHRISTIAN ZIETSCH |
| K132554 |
10/03/2013 |
AAP LOQTEQ PROXIMAL MEDIAL TIBIA PLATE 3.5 |
AAP IMPLANTATE AG |
CHRISTIAN ZIETSCH |
| K131625 |
10/03/2013 |
ANYSCAN-S SPECT IMAGING SYSTEM |
ABSOLUTE IMAGING SOLUTIONS |
MARK SHINA |
| K131981 |
10/09/2013 |
CEZANNE II INTERBODY FUSION SYSTEM |
ACCEL SPINE |
LISA PETERSON |
| K131636 |
10/10/2013 |
POLARUS CONNECT |
ACUMED LLC |
BRITTANY CUNNINGHAM |
| K130525 |
10/03/2013 |
OCCLUSION PERFUSION CATHETER |
ADVANCED CATHETER THERAPIES, INC. |
CHRIS HENZA |
| K132059 |
10/25/2013 |
DIAGNOSTIC ULTRASOUND SYSTEM |
ADVANCED INSTRUMENTATIONS, INC. |
JORGE MILLAN |
| K122783 |
10/30/2013 |
PLASMAFIT ACETABULAR CUP AND VITELENE INSERT |
AESCULAP IMPLANT SYSTEM, INC. |
JULIE TOM WING |
| K131167 |
10/17/2013 |
UNIVATION |
AESCULAP IMPLANT SYSTEMS, LLC |
JULIE T WING |
| K131893 |
10/30/2013 |
AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS |
AJW TECHNOLOGY CONSULTANTS, INC. |
JANET DOUGLAS |
| K131645 |
10/07/2013 |
INSTANT-VIEW MULTI-DRUG OF ABUSE URINE TEST (CUP, PANEL CASSETTE) |
ALFA SCIENTIFIC DESIGNS, INC. |
NAISHU WANG |
| K131975 |
10/02/2013 |
ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENT |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
HYMAN KATZ |
| K132280 |
10/31/2013 |
ALTUS SPINE PEDICLE SCREW SYSTEM |
ALTUS PARTNERS |
CLAUDIA HILL |
| K130504 |
10/18/2013 |
ASA ORAL APPLIANCES |
AMERICAN SLEEP ASSOCIATION |
KAREN E WARDEN, PHD |
| K131222 |
10/31/2013 |
AMPCARE ESP THERAPY SYSTEM |
AMPCARE, LLC |
DIANE RUTHERFORD |
| K132461 |
10/16/2013 |
A.I.M. SUTURE ANCHOR |
ANCHOR INNOVATION MEDICAL, INC. |
HOWARD L SCHRAYER |
| K132905 |
10/04/2013 |
200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER |
ARTERIOCYTE MEDICAL SYSTEMS, INC. |
ANN CHAREST |
| K130675 |
10/30/2013 |
ARTHREX UNIVERS II CA HEADS |
ARTHREX, INC. |
COURTNEY SMITH |
| K131709 |
10/04/2013 |
SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT |
ARTHROCARE CORP. |
ASHLEY DAWSON |
| K132556 |
10/24/2013 |
SHEATHLESS EAUCATH CORONARY GUIDE CATHETER |
ASAHI INTECC CO., LTD. |
YOSHI TERAI |
| K131947 |
10/18/2013 |
PROVOX VEGA PUNCTURE SET |
ATOS MEDICAL AB |
FERENC DAHNER |
| K130857 |
10/08/2013 |
PRONTOSAN WOUND GEL X |
B. BRAUN MEDICAL, INC. |
NANCY SKOCYPEC |
| K132183 |
10/03/2013 |
DICOM VIDEO |
BAR CODE COMPUTER LTD |
DAN LAOR |
| K132734 |
10/08/2013 |
NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS |
BAXTER HEALTHCARE CORP. |
GARY CHUMBIMUNE |
| K131546 |
10/09/2013 |
AU BICARBONATE REAGENT |
BECKMAN COULTER IRELAND INC |
DAVID G DAVIS |
| K130020 |
10/01/2013 |
ACCESS TOTAL BHCG (5TH IS) |
BECKMAN COULTER, INC. |
GERALDINE L BAGLIEN |
| K132693 |
10/02/2013 |
BD VeritorÖ System Flu A+B Assay |
Becton, Dickinson and Company |
GREGORY P PAYNE, RAC |
| K130947 |
10/03/2013 |
FINGERTIP PULSE OXIMETER |
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
LEI CHEN |
| K131047 |
10/16/2013 |
FINGERTIP PULSE OXIMETER |
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
LEI CHEN |
| K131859 |
10/18/2013 |
MULTIFUNCTIONAL SERIES |
BEIJING HONKON TECHNOLOGIES CO., LTD |
Diana Hong |
| K132642 |
10/03/2013 |
LOCKING PLATE SYSTEM |
BEIJING LIBEIER BIO-ENGINEERING INSTITUTE CO., LTD |
Diana Hong |
| K130528 |
10/21/2013 |
BIOPLEX 2200 APLS IGM |
Bio-Rad Laboratories |
Juang Wang |
| K132227 |
10/25/2013 |
LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAY |
Bio-Rad Laboratories |
SUZANNE PARSONS |
| K130866 |
10/25/2013 |
BIOLIGHT BIODYNAM |
BIOLIGHT AB |
PAR OLAUSSON LIDO |
| K131640 |
10/16/2013 |
SMOOTH OR THREADED METALLIC BONE FASTENER |
BIOMEDICAL ENT., INC. |
JOE SOWARD |
| K132010 |
10/09/2013 |
VIDAS C DIFFICILE GDH |
BIOMERIEUX SA |
CAROLINE KOCH-MATHIAN |
| K131779 |
10/10/2013 |
VITEK 2 AST-ST TIGECYCLINE |
BIOMERIEUX, INC. |
NATHAN HARDESTY |
| K132704 |
10/09/2013 |
DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW |
BIOMET |
SUZANA OTANO |
| K131353 |
10/08/2013 |
COMPREHENSIVE REVERSE SHOULDER - TITANIUM GLENOSPHERE |
BIOMET MANUFACTURING CORP. |
PATRICIA S BERES |
| K130390 |
10/09/2013 |
COMPREHENSIVE CONVERTIBLE GLENOID |
BIOMET MANUFACTURING, INC. |
PATRICIA SANDBORN BERES |
| K132600 |
10/02/2013 |
FACIAL PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING |
BIOMET MICROFIXATION |
ELIZABETH WHEELER |
| K131393 |
10/24/2013 |
MAK OSS FEMORAL KNEE COMPONENTS |
BIOMET ORTHOPEDICS CORP. |
GARY BAKER |
| K122437 |
10/18/2013 |
NO-PROFILE SCREWS NO-PROFILE WASHER NO-PROFILE SCREWS WASHERLOC WASHERS |
BIOMET SPORTS MEDICINE |
ELIZABETH WRAY |
| K131867 |
10/29/2013 |
2.5MM INLINE FUSION PLATE |
BIOMET, INC. |
SUZANA OTANO |
| K131684 |
10/10/2013 |
BIOLOX(R) DELTA CERAMIC HEADS |
BIOMET, INC. |
BECKY EARL |
| K130428 |
10/25/2013 |
COVAMESH |
BIOMUP S.A. |
VALERIE CENTIS |
| K133003 |
10/24/2013 |
RIGHTEST CONTROL SOLUTION |
BIONIME CORPORATION |
JIGAR SHAH |
| K132096 |
10/18/2013 |
RAPIDFRET ORAL FLUID ASSAY FOR THC, THC CALIBRATOR SET, THC CONTROL SET, COLLECTOR |
BIOPHOR DIAGNOSTICS, INC. |
Nathaniel G Butlin |
| K132510 |
10/24/2013 |
BIOPRO - INFINITY PLATE ANCHOR SYSTEM |
BIOPRO, INC. |
AL LIPPINCOTT |
| K132482 |
10/10/2013 |
BARRICADE EMBOLIZATION COIL SYSTEM |
BLOCKADE MEDICAL |
Rebecca K Pine |
| K131058 |
10/25/2013 |
BIPOLAR FORCEPS |
BOSTON ENDO-SURGICAL TECHNOLOGIES, INC. |
JAMES ROGERS |
| K132947 |
10/18/2013 |
DIREXION AND DIREXION HI-FLO TORQUEABLE MICROCATHETERS |
BOSTON SCIENTIFIC CORP. |
MAUREEN SUNDEEN |
| K132990 |
10/22/2013 |
OCCLUSION BALLOON CATHETER |
BOSTON SCIENTIFIC CORP. |
DIANE NELSON |
| K131914 |
10/31/2013 |
OFFROAD RE-ENTRY CATHETER SYSTEM |
BOSTON SCIENTIFIC CORP. |
CAROL TIFFANY |
| K132430 |
10/17/2013 |
STERLING OVER-THE-WIRE (OTW) PTA BALLOON DILATATION CATHETER |
BOSTON SCIENTIFIC CORP. |
CHRISTOPHER DACHEL |
| K130294 |
10/16/2013 |
BRAEMAR CARDIOKEY HOLTER RECORDER |
BRAEMAR MANUFACTURING LLC |
KENT SAYLER |
| K131234 |
10/15/2013 |
LUNGPOINT TOOLS (LUNGPOINT SHEATH, LUNGPOINT DILATION BALLOON) |
BRONCUS MEDICAL INC |
MAHTAB FATEMI |
| K132942 |
10/17/2013 |
SITE-RITE VISION II ULTRASOUND SYSTEM |
C.R. BARD, INC. |
KERRIE HAMBLIN |
| K132774 |
10/03/2013 |
PICCOLO COMPOSITE NAILING SYSTEM |
CARBOFIX ORTHOPEDICS LTD. |
YAEL RUBIN |
| K131824 |
10/03/2013 |
AVAFLEX VERTEBRAL BALLOON SYSTEM |
CAREFUSION |
JOY GREIDANUS |
| K131820 |
10/04/2013 |
AVAMAX VERTEBRAL BALLOON SYSTEM, 8G, AVAMAX VERTEBRAL BALLOON SYSTEM, 10G, AVAMAX VERTEBRAL BALLOON SYSTEM, 11G |
CAREFUSION |
JOY GREIDANUS |
| K131251 |
10/01/2013 |
TRINITY ELE |
Carol Cole Company |
Rand Daoud |
| K130834 |
10/08/2013 |
R7 |
CEFLA S.C. |
Claude Berthoin |
| K132675 |
10/03/2013 |
EMBOZENE MICROSPHERES |
CELONOVA BIOSCIENCES, INC. |
NICOLE BARBER |
| K130180 |
10/03/2013 |
CLEANSER ROOT CANAL |
CERKAMED WOJCIECH PAWLOWSKI |
KINGA WIERUCKA |
| K131887 |
10/24/2013 |
TROJAN JAGUAR MALE NATURAL RUBBER LATEX CONDOM WITH WARMING AND TINGLING LUBRICANT |
CHURCH & DWIGHT CO., INC. |
EMILY PEREZ |
| K131178 |
10/10/2013 |
IDYS LIF CAGES |
CLARIANCE |
JANICE M HOGAN, ESQ. |
| K130644 |
10/16/2013 |
PEDIATRIC FOLDING WHEELCHAIR |
COLUMBIA MEDICAL MFG, LLC |
GARY WERSCHMIDT |
| K131437 |
10/11/2013 |
MODIFIED CONCENTRIC MICROCATHETER |
CONCENTRIC MEDICAL, INC. |
CHRISTINA ROWE |
| K131492 |
10/03/2013 |
MODIFIED FLOWGATE BALLOON GUIDE CATHETER |
CONCENTRIC MEDICAL, INC. |
RHODA SANTOS |
| K131015 |
10/08/2013 |
BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT |
COOK BIOTECH, INC. |
MARY A FADERAN |
| K132885 |
10/11/2013 |
TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET |
COOK INCORPORATED |
SEAN SPENCE |
| K132020 |
10/25/2013 |
ADVANCE 34LP LOW PROFILE PTA BALLOON DILATATION CATHETER |
COOK, INC. |
STEVEN LAWRIE |
| K131201 |
10/07/2013 |
ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE GASTROINTESTINAL SUTURE ANCHOR SET |
COOK, INC. |
ERUM B NASIR |
| K122295 |
10/24/2013 |
CORE 3D ABUTMENT SYSTEM FOR DIGITAL PROSTHETIC SOLUTIONS |
CORE 3D PROTECH, S.L. |
ANNA CORTINA |
| K130904 |
10/25/2013 |
TRELLIS-8 PERIPHERAL INFUSION SYSTEM |
COVIDIEN |
JENNIFER SULLIVAN |
| K132493 |
10/23/2013 |
ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY |
Covidien LLC |
KATHERINE KASSIM |
| K132337 |
10/07/2013 |
ESOFLIP BALLOON DILATION CATHETER |
CROSPON, LTD. |
PAUL DRYDEN |
| K132338 |
10/24/2013 |
DA01 BLOOD GLUCOSE MONITORING SYSTEM |
DELBIO INCORPORATION |
ERICA LI |
| K132139 |
10/10/2013 |
DELTEX MEDICAL CARDIOQ-EDM+ |
DELTEX MEDICAL LIMITED |
RONALD S WARREN |
| K131042 |
10/03/2013 |
LEDEX |
DENTMATE TECHNOLOGY CO., LTD. |
CHENG-FENG CHOU |
| K130999 |
10/25/2013 |
OSSEOSPEED PROFILE EV |
DENTSPLY IMPLANTS MANUFACTURING GMBH |
LINDA K SCHULZ |
| K132145 |
10/11/2013 |
MTM(R) CLEAR ALIGNER |
DENTSPLY INTERNATIONAL, INC. |
HELEN LEWIS |
| K132199 |
10/03/2013 |
DEROYAL ELECTROSURGICAL PENCIL, ROCKER STYLE WITHOUT HOLSTER, DEROYAL ELECTROSURGICAL PENCIL, BUTTON STYLE WITHOUT HOLST |
DEROYAL INDUSTRIES, INC. |
COURTNEY RINEHART |
| K130534 |
10/30/2013 |
DIPLOMAT |
DIPLOMAT DENTAL S.R.O. |
STUART R GOLDMAN |
| K131190 |
10/29/2013 |
MYPATCH |
DMS-SERVICE LLC |
LYNDA S COLE |
| K130274 |
10/29/2013 |
BIOLIGN ACIF SYSTEMS, BIOLIGN STACC ACIF SYSTEM, BIOLIGN TLIF SYSTEM |
ELITE SURGICAL SUPPLIES (PTY) LTD. |
JOHN O'TOOLE |
| K132468 |
10/17/2013 |
MRSA/SA ELITE MGB, ELITE MGB SOFTWARE |
ELITechGroup Epoch Biosciences |
DEBRA K HUTSON |
| K131677 |
10/11/2013 |
PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM |
ELLIPSE TECHNOLOGIES INC. |
John McIntyre |
| K130110 |
10/08/2013 |
MEDDUSA BIPOLAR SYSTEM |
ELLIQUENCE LLC |
OSCAR R PAREDES |
| K130048 |
10/29/2013 |
REVERSE SHOULDER PROSTHESIS MONOBLOCK |
ENCORE MEDICAL, L.P. |
TEFFANY HUTTO |
| K131991 |
10/15/2013 |
ENDOCHOICE HOT BIOPSY FORCEPS |
ENDOCHOICE, INC. |
DANIEL HOEFER |
| K131422 |
10/10/2013 |
PEERSCOPE SYSTEM |
ENDOCHOICE, INC. |
TAMAR FUERST |
| K123696 |
10/25/2013 |
MEDUSA VASCULAR PLUG |
ENDOSHAPE, INC. |
MICHAEL PARMENTER |
| K132440 |
10/04/2013 |
XPRESS MULTI-SINUS DILATION TOOL |
Entellus Medical, Inc. |
KAREN E PETERSON |
| K133017 |
10/07/2013 |
ESTECH COBRA(R) GENESIS BIPOLAR CLAMP |
ESTECH, INC. |
TAMER IBRAHIM |
| K131663 |
10/18/2013 |
ECHELON ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK |
ETHICON ENDO-SURGERY, LLC |
CHRISTINA CANTER |
| K131435 |
10/03/2013 |
ENSEAL G2 TISSUE SEALER, STRAIGHT JAW, ENSEAL G2 TISSUE SEALER, CURVED JAW, ENSEAL TRIO TISSUE SEALER, 3 MM CURVED JAW, |
ETHICON ENDO-SURGERY, LLC |
MARICA ARENTZ |
| K132512 |
10/24/2013 |
HARMONIC ACE CURVED SHEARS WITH SCISSOR HANDLE, HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE |
ETHICON ENDO-SURGERY, LLC |
DAVID LOCKE |
| K132612 |
10/17/2013 |
HARMONIC ACE+ SHEARS 23 CM LENGTH WITH ADVANCED HEMOSTASIS, HARMONIC ACE + LAPAROSCOPIC SHEARS 36 CM LENGTH WITH ADVANCE |
ETHICON ENDO-SURGERY, LLC |
BRIAN GODWIN |
| K130178 |
10/29/2013 |
INSPIRATION VENTILATOR SYSTEM 5I/7I |
EVENT MEDICAL LTD |
RICK WATERS |
| K132161 |
10/11/2013 |
OPTETRAK LOGIC PS 17MM & 19MM THICK INSERTS, OPTETRAK LOGIC PSC 17MM & 19MM THICK INSERTS |
EXACTECH, INC. |
PATRICK HUGHES |
| K131530 |
10/23/2013 |
DYNAMESH -CICAT |
FEG TEXTILTECHNIK FORSCHUNGS-UND ENTWICKLUNGSGESEL |
NEIL R ARMSTRONG |
| K131895 |
10/24/2013 |
AIRVO 2 HUMIDIFIER, MYAIRVO 2 HUMIDIFIER |
FISHER & PAYKEL HEALTHCARE, LTD. |
BRETT WHISTON |
| K132619 |
10/11/2013 |
CLASSIC INTERMITTENT CATHETER |
FLEXICARE MEDICAL LTD. |
CHRISTOPHER WATKINS |
| K132248 |
10/30/2013 |
FLOWER BONE SCREW SET |
FLOWER ORTHOPEDICS CORPORATION |
JANICE M HOGAN |
| K131908 |
10/11/2013 |
2008T HEMODIALYSIS MACHINE WITH OPTIONAL CRIT-LINE MONITOR (CLIC) |
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC |
DENISE OPPERMANN |
| K132188 |
10/25/2013 |
MAMMOGRAPHY VIEWER SMV658 |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
JYH-SHYAN LIN |
| K132272 |
10/17/2013 |
GLOOKO DEVICE SYSTEM FOR GLOOKO APPLICATION |
GLOOKO, INC. |
SHILPA MYDUR |
| K130908 |
10/03/2013 |
DISPOSABLE SILICONE FOLEY CATHETER |
GUANGDONG BAIHE MEDICAL TECHNOLOGY CO., LTD |
Diana Hong |
| K131774 |
10/09/2013 |
HAMILTON-G5 |
HAMILTON MEDICAL AG |
RALPH AGUILA |
| K131479 |
10/07/2013 |
V8 SP NORMAL CONTROL, ABNORMAL CONTROL |
HELENA LABORATORIES |
JUSTIN PADIA |
| K132462 |
10/28/2013 |
S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE |
HITACHI CHEMICAL DIAGNOSTICS, INC. |
ERIKA AMMIRATI |
| K132251 |
10/17/2013 |
APTIMA COMBO 2 ASSAY (PANTHER SYSTEM) |
HOLOGIC / GEN-PROBE INCORPORATED |
|
| K132316 |
10/30/2013 |
MULTIVIEW |
HOLOGIC, INC. |
EILEEN M BOYLE |
| K132627 |
10/23/2013 |
AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR |
HONSUN (NANTONG) CO., LTD. |
SELINA QIAN |
| K132796 |
10/30/2013 |
SUNTOUCH EYE SPEAR |
HUIZHOU FORYOU MEDICAL DEVICES CO, LTD |
Diana Hong |
| K123713 |
10/25/2013 |
IMMULISA ENHANCED CELIAC FUSION (TTG/DGP) IGA/IGG ANTIBODY ELISA |
IMMCO DIAGNOSTICS, INC. |
KEVIN J LAWSON |
| K132303 |
10/10/2013 |
IMPLANET SPINE SYSTEM |
IMPLANET S.A. |
JANICE M HOGAN |
| K130719 |
10/17/2013 |
TVC IMAGING SYSTEM, TVC INSIGHT CATHETER |
Infraredx, Inc. |
Steve Chartier |
| K131362 |
10/08/2013 |
INMODE WMBODY DEVICE |
INMODE MD LTD. |
AHAVA STEIN |
| K130958 |
10/17/2013 |
TRUE SPINAL FIXATION SYSTEM |
INNOVATIVE SURGICAL DESIGNS |
ED MORRIS |
| K132651 |
10/28/2013 |
ITCLAMP 50 |
INNOVATIVE TRAUMA CARE INC |
RICHARD WAITE |
| K130660 |
10/11/2013 |
AUDICOR CPAM WITH SDB (SINGLE SENSOR) |
INOVISE MEDICAL, INC. |
EARL ANDERSON |
| K131446 |
10/28/2013 |
INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLES |
INTEGRA LIFESCIENCES CORPORATION |
STEPHANIE N SHEESLEY |
| K131585 |
10/08/2013 |
INTEL-GE CARE INNOVATIONS QUIETCARE |
INTEL-GE CARE INNOVATIONS LLC |
MAUREEN GLYNN |
| K132900 |
10/25/2013 |
MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEM |
INTELLIGENT IMPLANT SYSTEMS, LLC |
MICHAEL NUTT |
| K132235 |
10/11/2013 |
IMDX C.DIFFICILE FOR ABBOTT M2000 |
Intelligent Medical Devices, Inc. |
FRAN WHITE |
| K122040 |
10/31/2013 |
INVOTEC LARYNGEAL ELECTRODE |
INVOTEC INTERNATIONAL, INC. |
JEFFREY L AULL |
| K121447 |
10/04/2013 |
ISCHEMA VIEW RAPID |
ISCHEMA VIEW, INC. |
MARC GOODMAN |
| K132209 |
10/31/2013 |
IPS E.MAX CAD ABUTMENT SOLUTIONS |
IVOCLAR VIVADENT AG |
DONNA HARTNETT |
| K131336 |
10/28/2013 |
TX WHEELCHAIR CHASSIS |
JCM SEATING SOLUTIONS LTD |
STUART R GOLDMAN |
| K130231 |
10/15/2013 |
NON-CONTACT INFRARED THERMOMETER |
JINXINBAO ELECTRONIC CO.,LTD |
HELEN NAN |
| K132361 |
10/03/2013 |
EVEREST SPINAL SYSTEM |
K2M, INC. |
NANCY GIEZEN |
| K122800 |
10/04/2013 |
INNER PEACE |
KAMABRY, INC., DBA INNER PEACE FOR WOMEN |
YOLANDA SMITH |
| K132025 |
10/30/2013 |
MESO BILAYER SURGICAL MESH |
KENSEY NASH CORPORATION DBA DSM BIOMEDICAL |
Susan Pileggi |
| K132343 |
10/23/2013 |
MARIGEN WOUND DRESSING |
KERECIS LIMITED |
GUDMUNDUR F SIGURJONSSON |
| K131534 |
10/11/2013 |
KATANA ZIRCONIA |
KURARAY NORITAKE DENTAL INC. |
IVAN WASSERMAN |
| K130940 |
10/07/2013 |
KYMCO EQ20C SCOOTER |
KWANG YANG MOTOR CO., LTD. |
JUNNATA CHANG |
| K130686 |
10/16/2013 |
NASAL COMFORT FREEDOM |
LAKEVIEW SLEEP CENTER |
ANDY BLACK |
| K130942 |
10/17/2013 |
LEGACY MEDICAL ECO-CHOICE DISPOSABLE BLOOD PRESSURE CUFF |
LEGACY MEDICAL, INC. |
DEB ROBERTSON |
| K122848 |
10/18/2013 |
LENSTEC LC INJECTION SYSTEM |
LENSTEC, INC. |
JIMMY CHACKO |
| K132589 |
10/08/2013 |
ANTERIOR LUMBAR PLATE SYSTEM (PRESIDIO) |
LIFE SPINE, INC |
RANDY LEWIS |
| K132866 |
10/28/2013 |
NAUTILUS SPINAL SYSTEM |
LIFE SPINE, INC |
RANDY LEWIS |
| K132760 |
10/03/2013 |
NAUTILUS SPINAL SYSTEM |
LIFE SPINE, INC |
RANDY LEWIS |
| K122536 |
10/03/2013 |
AMCAD-UT DETECTION MODEL 2.0 |
LIN & ASSOCIATES, LLC. |
CHIU S LIN |
| K131797 |
10/10/2013 |
3B LASER NEEDLE |
LIVETEC GMBH |
Kevin Walls |
| K130213 |
10/18/2013 |
QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICE |
LUMIQUICK DIAGNOSTICS, INC. |
Feng-Yu Lee |
| K132829 |
10/08/2013 |
QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS |
MAQUET CARDIOPULMONARY AG |
WHITNEY TORNING |
| K132166 |
10/30/2013 |
VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHT |
MAQUET CARDIOPULMONARY AG |
INGRID RICHTER |
| K131458 |
10/01/2013 |
MPACT DM LINER CONVERTER |
MEDACTA INTERNATIONAL |
ADAM GROSS |
| K130897 |
10/22/2013 |
MEDCOMP VASCU-PICC WITH VALVE |
MEDCOMP (MEDICAL COMPONENTS) |
JESSICA LEO |
| K130123 |
10/11/2013 |
BASIC AND DOMINANT FLEX SUCTION PUMPS |
MEDELA AG |
ADRIENNE LENZ |
| K131719 |
10/30/2013 |
OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS |
MEDICAL DEVICES (PVT) LTD. |
TAUSEEF AJMAL |
| K131023 |
10/11/2013 |
THERAFLOW SINGLE LUMEN AND THERAFLOW DUAL LUMEN |
MEDICAL PRODUCTS, LLC |
DAVID MCGILL |
| K132575 |
10/03/2013 |
PASS LP SPINAL SYSTEM |
MEDICREA INTERNATIONAL |
AUDREY VION |
| K122949 |
10/16/2013 |
MEDLINE SUCTION COAGULATOR |
MEDLINE INDUSTRIES, INC. |
MATT CLAUSEN |
| K132673 |
10/22/2013 |
5F & 6F LAUNCHER GUIDE CATHETER, 5F SHERPA ACTIVE NX GUIDE CATHETER, 6F Z4 GUIDING CATHETER |
MEDTRONIC INC. |
HEATHER MOROSE |
| K132995 |
10/31/2013 |
DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITHOUT PRESSURE MONITORING LINE, DLP RETROGRADE CORONARY SINUS PERFUSIO |
MEDTRONIC INC. |
CHELSEA PIOSKE |
| K132471 |
10/08/2013 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
SOWMYA SHETTY |
| K131673 |
10/03/2013 |
MAGNIFUSE BONE GRAFT, MAGIFUSE II BONE GRAFT |
MEDTRONIC SOFAMOR DANEK USA, INC. |
KELLY ANGLIN |
| K132972 |
10/28/2013 |
AFFINITY FUSION CARDIOTOMY/VENOUS RESERVOIR WITH BALANCE BIOSURFACE |
MEDTRONIC, INC. |
JULIA A NELSON |
| K132924 |
10/31/2013 |
MEDTRONIC EXTERNAL PULSE GENERATOR (EPG) |
MEDTRONIC, INC. |
ERIC KALMES |
| K132645 |
10/04/2013 |
THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES |
MEDTRONIC, INC. |
CHELSEA PIOSKE |
| K132083 |
10/28/2013 |
AZUR PURE PERIPHERAL COIL SYSTEMS, PUSHABLE 35 |
MICRO VENTION, INC. |
LARAINE PANGELINA |
| K131948 |
10/04/2013 |
MICROPLEX COIL SYSTEM (MCS) |
MICROVENTION, INC. |
LARAINE PANGELINA |
| K130784 |
10/30/2013 |
SPIROTEL |
MIR MEDICAL INTL. RESEARCH SRL |
GERDA VAN HOUTS |
| K131162 |
10/25/2013 |
MIRADRY SYSTEM |
MIRAMAR LABS, INC. |
Kathy O'Shaughnessy |
| K130628 |
10/04/2013 |
PATHFAST CK-MB-II CALIBRATORS |
MITSUBISHI CHEMICAL MEDIENCE CORPORATION |
Judi Smith |
| K132110 |
10/03/2013 |
NATUS WARMETTE BLANKET AND DUAL CABINETS |
NATUS NICOLET IRELAND LTD |
MICHAEL GALVIN |
| K123910 |
10/29/2013 |
WOUNDWASH SALINE SPRAY |
NEILMED PHARMACEUTICALS, INC. |
KETAN MEHTA |
| K130198 |
10/21/2013 |
NEO DENTA ZIRCONIA |
NEO GROUP LIMITED |
MIKE ADAMS |
| K130117 |
10/29/2013 |
NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS |
NETWORK MEDICAL PRODUCTS, LTD. |
ALISON MARCH |
| K132412 |
10/10/2013 |
INERTIA MIS PEDICLE SCREW SYSTEM |
NEXXT SPINE LLC |
JUSTIN EGGLETON |
| K131894 |
10/31/2013 |
NIDEK GREEN LASER PHOTOCOAGULTOR MODEL GYC-1000 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT |
NIDEK CO., LTD. |
YONEJI MIZUNO |
| K130254 |
10/16/2013 |
PROW FUSION |
NLT SPINE LTD |
JONATHAN KAHAN |
| K131013 |
10/17/2013 |
FOCUS BLOOD GLUCOSE MONITORING SYSTEM, FOCUS PRO BLOOD GLUCOSE MONITORING SYSTEM |
NOVA BIOMEDICAL CORPORATION |
PAUL W MACDONALD, PHD |
| K130601 |
10/17/2013 |
BIOROOT RCS |
NOVOCOL, INC. |
CORA BRACHO-TROCONIS |
| K132014 |
10/31/2013 |
GSB GLOBAL SPINAL BALANCE SYSTEM |
NUVASIVE, INC. |
OLGA LEWIS |
| K131739 |
10/10/2013 |
NXSTAGE CONNECTED HEALTH SYSTEM |
NXSTAGE MEDICAL, INC. |
MARY LOU STROUMBOS |
| K132181 |
10/21/2013 |
GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER |
OLYMPUS SURGICAL TECHNOLOGIES AMERICA |
NEIL KELLY |
| K131472 |
10/08/2013 |
APEX KNEE MODULAR TIBIA SYSTEM |
OMNI LIFE SCIENCE, INC. |
BRANDON MOLINA |
| K131749 |
10/07/2013 |
HEM-6221 |
OMRON HEALTHCARE, INC. |
PAUL DRYDEN |
| K130971 |
10/23/2013 |
OPTUM TELEHEALTH APPLICATION |
OPTUMHEALTH CARE SOLUTIONS, INC. |
ROSHANA AHMED, MA, RAC |
| K124041 |
10/17/2013 |
NBM-200MP |
ORSENSE LTD |
MARK A HELLER |
| K131337 |
10/11/2013 |
BALANCED KNEE SYSTEM HIGH FLEX VITAMIN E PS TIBIAL INSERT AND PATELLA |
ORTHO DEVELOPMENT CORP. |
TOM HAUETER |
| K131022 |
10/16/2013 |
OVATION 10/12 HIP STEM |
ORTHO DEVELOPMENT CORP. |
TOM HAUETER |
| K131748 |
10/31/2013 |
OSSEOFUSE DENTAL IMPLANT SYSTEM |
OSSEOFUSE, INC. |
APRIL LEE |
| K132586 |
10/31/2013 |
PAXERAPACS |
PAXERAMED |
CARL ALLETTO |
| K131617 |
10/03/2013 |
COLONGLIDE(R) LUBRICANT |
PEDIATRIC PHARMACEUTICALS, INC. |
ROBERT M HARRIS |
| K131253 |
10/22/2013 |
PERIFLUX 6000 |
PERIMED AB |
MARIA LILJEVRET |
| K131590 |
10/23/2013 |
INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE |
PHILIPS MEDICAL SYSTEMS |
CHRISTINE TREFETHEN |
| K130684 |
10/18/2013 |
PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR |
PHILIPS MEDICAL SYSTEMS |
NANCY BURKE |
| K131483 |
10/07/2013 |
PHILIPS PIXIUM 4343RC |
PHILIPS MEDICAL SYSTEMS DMC GMBH |
JENNIFER CARTLEDGE |
| K132305 |
10/30/2013 |
STENTBOOST REL. 4 |
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
LISELOTTE KORNMANN |
| K131872 |
10/17/2013 |
INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT MONITOR MX550 |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN |
MARKUS STACHA |
| K131368 |
10/03/2013 |
NEO KNEE SYSTEM |
PIPELINE ORTHOPEDICS |
TERRY POWELL |
| K131769 |
10/07/2013 |
CINCHLOCK KNOTLESS SUTURE ANCHOR, NANOTACK SUTURE ANCHOR 1.4MM |
PIVOT MEDICAL INC. |
Jon Cook |
| K132819 |
10/09/2013 |
PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS |
PLAYTEX MANUFACTURING INC. |
PUSHPA RAO |
| K131630 |
10/21/2013 |
PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM |
PURITAN MEDICAL PRODUCTS LLC |
MEHDI KARAMCHI |
| K123049 |
10/17/2013 |
SAPPHIRE INFUSION PUMP |
Q CORE MEDICAL LTD |
Rhona Shanker |
| K131473 |
10/24/2013 |
(QUANTA SYSTEM) SURGICAL LASER FIBERS |
QUANTA SYSTEM, S.P.A. |
Maurizio Bianchi |
| K132156 |
10/23/2013 |
RANDOX CSF CONTROLS LEVELS 2 AND 3 |
RANDOX LABORATORIES, LTD. |
PAULINE ARMSTRONG |
| K131157 |
10/22/2013 |
RANFAC BONE MARROW ASPIRATION NEEDLE |
RANFAC CORP. |
CHRISTOPHER P WHELAN |
| K130529 |
10/25/2013 |
RAUMEDIC-PTO-MONITORING-SYSTEM |
RAUMEDIC AG |
REINER THIEM |
| K132013 |
10/21/2013 |
SWIFT AIR |
RESMED LTD. |
JIM CASSI |
| K130378 |
10/17/2013 |
RESPIGUIDE DELIVERY SYSTEM |
RESPICARDIA |
BONNIE LABOSKY |
| K131982 |
10/18/2013 |
REMSTAR AUTO A-FLEX HT |
RESPIRONICS, INC. |
MICHELLE BRINKER |
| K131994 |
10/17/2013 |
SOMNOLYZER 24X7 |
RESPIRONICS, INC. |
DANIELA AIZPITARTE |
| K130858 |
10/11/2013 |
REVERSE MEDICAL MICROCATHETER |
REVERSE MEDICAL CORPORATION |
JEFFREY VALKO |
| K132560 |
10/11/2013 |
PCP-USB STETHOSCOPE |
RNK PRODUCTS, INC. |
CHARLES R ABBRUSCATO |
| K132405 |
10/11/2013 |
PPA/BT-RB STETHOSCOPE |
RNK PRODUCTS, INC. |
CHARLES R ABBRUSCATO |
| K132571 |
10/18/2013 |
ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY |
Roche Diagnostics |
KELLI TURNER |
| K131366 |
10/11/2013 |
ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM |
ROCHE DIAGNOSTICS OPERATIONS INC |
NATHAN CARRINGTON |
| K130379 |
10/09/2013 |
ROLLINS 7 OXYGEN MASK |
ROLLINS MEDICAL SOLUTIONS, INC. |
E. J SMITH |
| K132861 |
10/04/2013 |
UGEO H60 DIAGNOSTIC ULTRASOUND SYSTEM |
SAMSUNG MEDISON CO., LTD |
KYEONG-MI PARK |
| K131502 |
10/11/2013 |
SEATTLE - PAP |
SEATTLE CHILDRENS HOSPITAL |
PAUL DRYDEN |
| K122557 |
10/03/2013 |
MOTEX POWDER-FREE NITRILE SURGICAL GLOVES |
SHANGHAI MOTEX HEALTHCARE CO., LTD. |
JEN KE-MIN |
| K123711 |
10/01/2013 |
PATIENT MONITOR |
SHENZHEN CREATIVE INDUSTRY CO., LTD |
CHARLIE MACK |
| K123155 |
10/31/2013 |
LUNA DENTAL IMPLANT SYSTEM |
SHINHUNG MST CO., LTD |
SUNBYUNG LEE |
| K132141 |
10/03/2013 |
BEAUTIFIL BULK FLOWABLE |
SHOFU DENTAL CORPORATION |
DAVID P MORAIS |
| K131405 |
10/16/2013 |
IFUSE IMPLANT SYSTEM |
SI-BONE, INC. |
CINDY DOMECUS |
| K131662 |
10/10/2013 |
IMMULITE 2000 ACTH CALIBRATION VERIFICATION MATERIAL |
Siemens Healthcare Diagnostics Inc. |
Garo Mimaryan |
| K133122 |
10/30/2013 |
IMMULITE 2000; 3GALLERGY SPECIFIC IGE CONTROL VERIFICATION MATERIAL (CVM), TOTAL IGE CONTROL VERIFICATION MATERIAL (CVM) |
Siemens Healthcare Diagnostics Inc. |
SUSAN BROCCHI |
| K133128 |
10/22/2013 |
IMMULITE 2000; HCG CALIBRATION VERIFICATION MATERIAL, INSULIN CALIBRATION VERIFICATION MATERIAL, PYRILINKS-D CALIBRATION |
Siemens Healthcare Diagnostics Inc. |
Asha Gartland |
| K133124 |
10/25/2013 |
IMMULITE 2000; TOTAL T3 CALIBRATION VERIFICATION MATERIAL, TOTAL T4 CALIBRATION VERIFICATION MATERIAL, TOTAL TBG CALIBRA |
Siemens Healthcare Diagnostics Inc. |
Garo Mimaryan |
| K132664 |
10/16/2013 |
ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRATOR |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
KIRA GORDON |
| K130881 |
10/11/2013 |
ACUSON S2000 AND S3000 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
SHELLY PEARCE |
| K132804 |
10/24/2013 |
ACUSON S1000 / S2000 / S3000 |
SIEMENS MEDICAL SOLUTIONS USA, INC. ULTRASOUND GRO |
CHRISTINE DUNN |
| K132494 |
10/22/2013 |
VISCOELASTIC INJECTOR |
SIGHT SCIENCES, INC. |
JUDY F GORDON D.V.M. |
| K132636 |
10/17/2013 |
DYONICS PLAN HIP IMPINGEMENT PLANNING SYSTEM |
SMITH & NEPHEW, INC. |
KATHLEEN SOLOMON |
| K130728 |
10/10/2013 |
POLARSTEM STANDARD AND LATERAL FEMORAL STEMS WITH TI/HA |
SMITH & NEPHEW, INC. |
SAMEER MANSOUR |
| K132446 |
10/23/2013 |
RENASYS EZ MAX NEGATIVE PRESSURE WOUND THERAPY DEVICE |
SMITH & NEPHEW, INC. |
LAURA REYNOLDS |
| K132435 |
10/22/2013 |
SMITH & NEPHEW GLOBAL FEMORAL HEAD TRIALS |
SMITH & NEPHEW, INC. |
MEGAN FESSENDEN |
| K132357 |
10/30/2013 |
SMITH & NEPHEW ULTRATAPE |
SMITH & NEPHEW, INC. |
MELODY BI |
| K131187 |
10/22/2013 |
LESSER METATARSAL HEAD IMPLANT SYSTEM |
SOLANA SURGICAL, LLC |
JOE CLIFT |
| K132127 |
10/17/2013 |
TRANSCEND AUTO |
SOMNETICS INTERNATIONAL, INC. |
MELINDA SWANSON |
| K132768 |
10/04/2013 |
S8 EXP PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM |
SONOSCAPE COMPANY LIMITED |
TOKI WU |
| K130709 |
10/07/2013 |
VISI MOBILE MONITORING SYSTEM |
SOTERA WIRELESS, INC |
EBEN GORDON |
| K132126 |
10/28/2013 |
SPECTRUM SPINE FENESTRATED FACET SCREW SYSTEM |
SPECTRUM SPINE, LLC |
OTTIE PENDLETON |
| K131427 |
10/24/2013 |
LOTUS |
SPINAL ELEMENTS, INC. |
BENJAMIN A KIMBALL |
| K132719 |
10/04/2013 |
STAXX IBL SYSTEM |
SPINE WAVE, INC. |
ROAIDA RIZKALLAH |
| K131775 |
10/17/2013 |
UNIVERSAL NEURO 3 SYSTEM |
Stryker |
Manish Patel |
| K131214 |
10/18/2013 |
CRANIAL MAP NEURO |
STRYKER CORPORATE |
LILIAN ECKERT |
| K131365 |
10/10/2013 |
T2 TIBIAL NAILING SYSTEM |
Stryker Trauma AG |
ESTELA CELI |
| K132502 |
10/23/2013 |
VARIAX 2 SYSTEM |
Stryker Trauma AG |
ELIJAH N WREH |
| K132325 |
10/29/2013 |
GUIDOR BIORESORBABLE MATRIX BARRIER |
SUNSTAR AMERICAS, INC. |
DEBORAH L GRAYESKI |
| K131207 |
10/09/2013 |
FEMTO LDV(TM) Z-GENERATION FEMTOSECOND SURGICAL LASER |
SURGICAL INSTRUMENT ENGINEERING AG |
Kevin Walls |
| K132727 |
10/22/2013 |
GEM FLOW COUPLER DEVICE AND SYSTEM |
SYNOVIS LIFE TECHNOLOGIES, INC. |
TROY THOME |
| K131186 |
10/08/2013 |
SYNTHES 2.7MM AND 3.5MM VARIABLE ANGLE LCP MIDFOOT/HINDFOOT SYSTEM |
SYNTHES (USA) PRODUCTS LLC |
REBECCA G REITER |
| K123205 |
10/09/2013 |
ESOPHAGEAL TTS STENT |
TAEWOONG MEDICAL CO., LTD |
Calley Herzog |
| K131963 |
10/22/2013 |
TAUTONA INJECTOR DEVICE |
TAUTONA GROUP, LLC |
JOE RIMSA |
| K132751 |
10/22/2013 |
MULTICHEM S PLUS / S PLUS (ASSAYED) |
TECHNO-PATH MANUFACTURING LTD. |
STEPHANIE G GARTH |
| K131993 |
10/15/2013 |
MULTICHEM U |
TECHNO-PATH MANUFACTURING LTD. |
STEPHANIE G GARTH |
| K132362 |
10/08/2013 |
WECK EFX ENDO FASCIAL CLOSURE SYSTEM |
Teleflex Medical, Inc. |
NATALIE HICHAK |
| K131583 |
10/03/2013 |
THERMOCHEM HT-2000 |
THERMASOLUTIONS, INC. |
M.W. ANDY ANDERSON PH.D. RAC |
| K131771 |
10/07/2013 |
CAREGIVER PROFESSIONAL CLINICAL THERMOMETER, PRO-TF SERIES |
THERMOMEDICS INC. |
PAUL LIU |
| K132438 |
10/17/2013 |
IMAGENET 5 PC SOFTWARE SYSTEM |
TOPCON MEDICAL SYSTEMS, INC. |
MAUREEN O'CONNELL |
| K132667 |
10/09/2013 |
SYNERGY ODM |
TOPCON MEDICAL SYSTEMS, INC. |
MAUREEN O'CONNELL |
| K130827 |
10/31/2013 |
FIRMAP CATHETER |
TOPERA, INC. |
MELISSA WALKER |
| K131231 |
10/16/2013 |
AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROTHESIS |
Tornier SAS |
SEVERINE BONNETON |
| K132160 |
10/16/2013 |
VANTAGE TITAN 3T |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
PAUL BIGGINS |
| K130459 |
10/25/2013 |
TRIA FAN SYSTEM |
TRIA BEAUTY, INC. |
JONATHAN KAHAN |
| K131881 |
10/24/2013 |
OMBRA TABLE TOP COMPRESSOR |
TRUDELL MEDICAL INTL. |
DARRYL FISCHER |
| K132255 |
10/24/2013 |
ULTRACEM |
ULTRADENT PRODUCTS INC. / ORATECH LLC |
DIANE E ROGER |
| K132224 |
10/08/2013 |
UNIMED SURGICAL COATED ELECTROSURGICAL ELECTRODES |
UNIMED SURGICAL PRODUCTS, INC. |
LEE ALEXANDER |
| K131116 |
10/30/2013 |
U2 TOTAL KNEE SYSTEM - PSA TYPE, OFFSET STEM ADAPTER |
UNITED ORTHOPEDIC CORPORATION |
FANG-YUAN HO |
| K132142 |
10/08/2013 |
NERIA SOFT 90 INFUSION SET |
UNOMEDICAL A/S |
DEIRDRE BARROW |
| K131807 |
10/11/2013 |
HIGH ENERGY LINEAR ACCELERATOR |
VARIAN MEDICAL SYSTEMS, INC. |
PETER J CORONADO |
| K132705 |
10/31/2013 |
UNIQUE |
VARIAN MEDICAL SYSTEMS, INC. |
PETER J CORONADO |
| K132454 |
10/04/2013 |
VITAHEAT PATIENT WARMING SYSTEM |
VITAHEAT MEDICAL, LLC |
JACK SLOVICK |
| K132809 |
10/25/2013 |
INSTINCT ENDOSCOPIC HEMOCLIP |
WILSON-COOK MEDICAL INC. |
SCOTTIE FARIOLE |
| K131679 |
10/23/2013 |
EVOLUTION MP ADAPTIVE PS TIBIAL INSERT |
WRIGHT MEDICAL TECHNOLOGY, INC. |
THERESA LEISTER |
| K131143 |
10/07/2013 |
TRELLIS COLLAGEN RIBBON |
WRIGHT MEDICAL TECHNOLOGY, INC. |
SARAH HOLTGREWE |
| K132895 |
10/23/2013 |
WMT IMPLANTABLE K-WIRE |
WRIGHT MEDICAL TECHNOLOGY, INC. |
LESLIE FITCH |
| K123958 |
10/28/2013 |
JIAJIAN POINTOSELECT DIGITAL |
WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD. |
DORIS DONG |
| K131350 |
10/23/2013 |
CALIX LUMBAR SPINAL IMPLANT SYSTEM |
X-SPINE SYSTEMS, INC |
DAVID KIRSCHMAN |
| K132863 |
10/04/2013 |
SMARTSITE VIALSHIELD |
YUKON MEDICAL, LLC |
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