| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K141081 |
05/08/2014 |
FILTEK BULK FILL POSTERIOR RESTROATIVE |
3M ESPE DENTAL PRODUCTS |
SCOTT ERICKSON |
| K133776 |
05/28/2014 |
A-DEC/W&H ELECTRIC HANDPIECE MOTOR |
A-DEC, INC. |
BONNIE DUNDAS |
| K140607 |
05/08/2014 |
AAP LOQTEC(R) OLECRANON PLATE |
AAP IMPLANTATE AG |
CHRISTIAN ZIETSCH |
| K140354 |
05/09/2014 |
ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TIME CT/NG |
ABBOTT MOLECULAR, INC. |
STACY FERGUSON |
| K140483 |
05/20/2014 |
ASAP OTC WOUND DRESSING GEL |
ABL MEDICAL, LLC |
Calley Herzog |
| K140925 |
05/20/2014 |
ACUMED SUTURE ANCHOR SYSTEM |
ACUMED, LLC |
LINO TSAI |
| K140190 |
05/29/2014 |
NIGHT SHIFT |
ADVANCED BRAIN MONITORING, INC. |
ADRIENNE LENZ |
| K140343 |
05/13/2014 |
AESCULAP HISTOACRYL, HISTOACRYL BLUE AND HISTOACRYL FLEXIBLE TOPICAL SKIN, ADHESIVE WITH APPLICATOR TIP |
AESCULAP, INC. |
KATHY A RACOSKY |
| K133790 |
05/22/2014 |
IHEALTH ALIGN MINI GLUCO-MONITORING SYSTEM |
ANDON HEALTH CO., LTD |
YI LIU |
| K131531 |
05/12/2014 |
TIANKANG DISPOSABLE SYRINGES WITH RE-USE PREVENTION FEATURE WITH OR WITHOUT NEEDLE |
ANHUI TIANKANG MEDICAL PRODUCTS CO., LTD |
XIUMING CHONG |
| K141041 |
05/16/2014 |
APTUS HELI-FX ANCILLARY ENDOANCHOR CASSETTE |
APTUS ENDOSYSTEMS |
BURT GOODSON |
| K122817 |
05/01/2014 |
SILVERLON ISLAND WOUND DRESSING |
ARGENTUM MEDICAL, LLC. |
WALT BRITTLE |
| K131096 |
05/16/2014 |
AR1000 SERIES ULTRASONIC WOUND THERAPY SYSTEM |
AROBELLA MEDICAL, LLC |
MATTHEW BERSCHEID |
| K140287 |
05/16/2014 |
AXERA RX ACCESS SYSTEM |
ARSTASIS, INC. |
GRACE LI |
| K140604 |
05/14/2014 |
MULTIFIX S KNOTLESS FIXATION SYSTEM |
ARTHROCARE CORPORATION |
MITCHELL DHORITY |
| K123099 |
05/23/2014 |
Best-AV2 Pro-Sport(tm) |
AVAZZIA, INC. |
TAMMY LAHUTSKY |
| K140185 |
05/01/2014 |
OCELOT CATHETER, OCELOT PIXL CATHETER, LIGHTBOX CONSOLE |
AVINGER, INC. |
SHERRY KIM |
| K140428 |
05/30/2014 |
ULTRASOUND SCANNER SYSTEM BK2300 |
B-K MEDICAL APS |
RANDI HAUERBERG |
| K140311 |
05/07/2014 |
CARESITE LUER ACCESS DEVICE |
B. BRAUN MEDICAL, INC. |
KIMBERLY SMITH |
| K133801 |
05/07/2014 |
BAXTER SIGMA SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY |
BAXTER HEALTHCARE CORPORATION |
THOMAS SAMPOGNA |
| K140591 |
05/14/2014 |
BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - INJECTOR |
BECTON DICKINSON & CO. |
JOHN ROBERTS |
| K140446 |
05/20/2014 |
BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY |
BECTON, DICKINSON & CO. |
SHERMA WINSTON |
| K140448 |
05/20/2014 |
BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY |
BECTON, DICKINSON & CO. |
SHERMA WINSTON |
| K140111 |
05/06/2014 |
BD MAX(TM) ENTERIC BACTERIAL PANEL;BD MAX(TM) INSTRUMENT |
Becton, Dickinson and Company |
Paul Swift |
| K140447 |
05/20/2014 |
BD VIPER LT SYSTEM |
Becton, Dickinson and Company |
SHERMA WINSTON |
| K140916 |
05/06/2014 |
LIQUICHEK CARDIAC TROPONINS CONTROL, LEVELS 1,2 AND 3, TRILEVEL/MINIPAK |
Bio-Rad Laboratories |
SUZANNE PARSONS |
| K140407 |
05/02/2014 |
FILMARRAY GASTROINTESTINAL (GI) PANEL |
Biofire Diagnostics |
BETH LINGENFELTER |
| K132377 |
05/20/2014 |
OSTEOSPAN MORPHEUS |
BIOGENNIX, LLC |
ELAINE DUNCAN |
| K140509 |
05/28/2014 |
BIOMET SIDE ACCESS DISTAL FEMORAL EXPANDABLE |
BIOMET MANUFACTURING LLC |
TRACY BICKEL JOHNSON, RAC |
| K140622 |
05/13/2014 |
DVR DORSAL PLATE, DVR LATERAL PLATE, DVR ULNA PLATE |
BIOMET, INC. |
SUZANA OTANO |
| K130067 |
05/08/2014 |
MRNA APPLIANCE |
BIOMODELING SOLUTIONS, LLS |
COLETTE COZEAN, PH.D. |
| K131176 |
05/12/2014 |
ROSS RU SKIN DISCONTINUITIES |
BIOTD, S.A. |
RICHARD GILLIS |
| K130775 |
05/09/2014 |
DUET SYSTEM |
BIOVIEW LTD. |
ORLY MAOR |
| K132167 |
05/02/2014 |
I-CHROMA IFOB WITH I-CHROMA READER |
Boditech Med Inc. |
SANG YEOL PARK |
| K140329 |
05/15/2014 |
RENEGADE HI-FLO MICROCATHETER, MICROCATHETER KIT, FATHOM SYSTEM, FATHOM KIT |
BOSTON SCIENTIFIC |
MARK MURPHY |
| K140630 |
05/23/2014 |
WALLFLEX BILIARY RX STENT SYSTEM |
BOSTON SCIENTIFIC |
THOMAS HIRTE |
| K133700 |
05/14/2014 |
ADVANIX PANCREATIC STENT AND NAVIFLEX RAPID EXCHANGE PANCREATIC DELIVERY SYSTEM AND PUSHERS |
Boston Scientific Corporation |
ELENA NIEVES |
| K140151 |
05/21/2014 |
EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT |
BTG INTERNATIONAL, INC. |
JOCELYN KERSTEN |
| K133251 |
05/09/2014 |
BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM |
C.R. BARD, INC. |
MICHELE DAVIS |
| K140856 |
05/02/2014 |
BRACHYSOURCE SEED IMPLANTS WITH SOURCECAP BIOABSORBABLE CAPS |
C.R. BARD, INC. |
MICHELE DAVIS |
| K140122 |
05/09/2014 |
CANDELA GENTLEMAX FAMILY OF LASER SYSTEM |
CANDELA CORP. |
SAM WADE |
| K133148 |
05/13/2014 |
BIOMARC COAXIAL NEEDLE |
CARBON MEDICAL TECHNOLOGIES, INC. |
ANDREW J ADAMS |
| K133519 |
05/16/2014 |
CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMISTRIES GLUCOSE REAGENT, CAR |
CAROLINA LIQUID CHEMISTRIES CORP. |
Melissa F Thompson |
| K132711 |
05/08/2014 |
CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT |
CAROLINA LIQUID CHEMISTRIES CORP. |
PHILIP G SHUGART |
| K140426 |
05/22/2014 |
ANTHRACIS REAL-TIME PCR ASSAY |
CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) |
HYE-JOO KIM |
| K133200 |
05/08/2014 |
STALIF C(R) |
CENTINEL SPINE, INC. |
JOHN PARRY |
| K140139 |
05/28/2014 |
CLEARVIEWHD |
CLEARVIEW DIAGNOSTICS INC. |
CHRISTINE PODILCHUK |
| K131781 |
05/28/2014 |
CLEARVIEW TOTAL |
CLINICAL INNOVATIONS, LLC |
BRIAN MCROBERTS |
| K140163 |
05/29/2014 |
KOALA TOCO |
CLINICAL INNOVATIONS, LLC |
JOANNE BRONIKOWSKI |
| K140423 |
05/27/2014 |
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM |
CONFORMIS, INC. |
AMITA SHAH |
| K140594 |
05/30/2014 |
BODY FAT ANALYZER AND SCALE |
CONMO ELECTRONIC COMPANY LIMITED |
CHARLES MACK |
| K141043 |
05/19/2014 |
CS2 MULTI-HOLE ACETABULAR SHELL |
Consensus Orthopedics, Inc |
MATTHEW M HULL |
| K140070 |
05/07/2014 |
LUXER SHADED ZIRCONIA |
CONTINENTAL DENTAL CERAMICS, INC. |
JERRY DOVIACK |
| K140169 |
05/21/2014 |
VITAL-PORT(R) CT VASCULAR ACCESS SYSTEM |
COOK INCORPORATED |
THOMAS J KARDOS |
| K140548 |
05/23/2014 |
CORCAM HEART MONITOR |
CORCAM TECHNOLOGIA, SA |
JENNIFER A DAUDELIN |
| K132004 |
05/02/2014 |
NPWT WOUND DRESSING KIT- MEDIUM, NPWT WOUND DRESSING KIT- LARGE |
CREO QUALITY, LLC. |
JON SPEER |
| K133204 |
05/05/2014 |
AIRVIEW MINI OWIE DICK TEST PACK |
CROSSTEX INTERNATIONAL |
MICHAEL G NOLAN |
| K140038 |
05/27/2014 |
DIGIMATCH ORTHODOC ROBODOC ENCORE SURGICAL SYSTEM |
CUREXO TECHNOLOGY CORPORATION |
GLEN EMELOCK |
| K140158 |
05/29/2014 |
S.E.A.L. FRACTURE FUSION TUBE |
D.N.E., LLC |
J.D. WEBB |
| K140206 |
05/08/2014 |
SCINTILLATION GAMMA CAMERA |
DDD-DIAGNOSTIC A/S |
NEERGAARDS VEJ 5E |
| K132378 |
05/30/2014 |
X-MIND UNITY |
DE GOTZEN S.R.L. |
MAURIZIO DE GOTZEN |
| K132686 |
05/12/2014 |
AQUARIUS LOW PROFILE GASTROSTOMY FEEDING TUBE |
DEGANIA SILICONE, LTD. |
ZOYA LEE |
| DEN120016 |
05/09/2014 |
DEKA ARM SYSTEM |
DEKA INTEGRATED SOLUTIONS CORPORATION |
Roger Leroux |
| K123940 |
05/30/2014 |
DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE |
DEMETECH CORP. |
JOHN O'BRIEN |
| K140822 |
05/29/2014 |
DRIVE RAIL SYSTEM |
DEVISE ORTHO, INC. |
ALEX GREENE |
| K132225 |
05/15/2014 |
EXTRICARE |
DEVON MEDICAL INC. |
RUTH WU |
| K134055 |
05/09/2014 |
ADX4000W |
DEXCOWIN CO., LTD |
Claude Berthoin |
| DEN140004 |
05/13/2014 |
QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY |
DIAGNOSTIC HYBRIDS, INC. |
Ronald H Lollar |
| K133014 |
05/19/2014 |
DMS 300-2W HOLTER ECG RECORDER |
DIAGNOSTIC MONITORING SOFTWARE |
WILLIAM PARSONS |
| K140384 |
05/23/2014 |
FMWAND HANDPIECE SE |
DOMAIN SURGICAL, INC. |
CURTIS JENSEN |
| K131892 |
05/22/2014 |
EV1000 CLINICAL PLATFORM |
EDWARDS LIFESCIENCES, LLC. |
SALLY MAHER |
| K131588 |
05/22/2014 |
VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR; VIGILEO APCO/OXIMETRY MONITOR |
EDWARDS LIFESCIENCES, LLC. |
SALLY MAHER |
| K133565 |
05/09/2014 |
LEKSELL GAMMA KNIFE PERFEXION |
ELEKTA INSTRUMENT AB |
MATILDA FORSBERG |
| K133405 |
05/23/2014 |
MINNIE |
ELETTRONICA VALSERIANA SRL |
SERGIO GHERSINI |
| K141023 |
05/20/2014 |
PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM |
ELLIPSE TECHNOLOGIES, INC. |
REBECCA SHELBURNE |
| K140133 |
05/15/2014 |
INFUSET FLOW CONTROL EXTENSION SET |
EMED TECHNOLOGIES CORPORATION |
PETER KOLLINGS |
| K140904 |
05/06/2014 |
RSP MONOBLOCK STEM WITH P2 COATING, SIZE 6 |
ENCORE MEDICAL, L.P. |
TEFFANY HUTTO |
| K140094 |
05/21/2014 |
SPRINGTMS TOTAL MIGRAINE SYSTEM |
ENEURA THERAPEUTICS, LLC |
LARRY GETLIN |
| K133064 |
05/02/2014 |
MYSIGN S PULSE OXIMETER, MYSIGN PC SOFTWARE (OPTIONAL), SOFTTIP LARGE R-3211-31, FINGER CLIP F-3211-31 |
ENVITEC-WISMAR GMBH |
STEPHEN GORSKI |
| K133316 |
05/28/2014 |
SPIROL BLOCK (19 GA. OPEN END MODELS), (20 GA. OPEN END MODELS), (19 GA. CLOSED END MODELS), (20 GA. CLOSED END MODELS) |
EPIMED INTERNATIONAL, INC. |
PRESTON H FRASIER |
| K132899 |
05/13/2014 |
EQUASHIELD CLOSED SYSTEM DRUG TRANSFER DEVICE (CSTD) |
EQUASHIELD MEDICAL LTD |
RAYMOND J KELLY, IV |
| K133718 |
05/12/2014 |
ZERONA |
ERCHONIA CORPORATION |
Kevin Walls |
| K133722 |
05/08/2014 |
ASTHMA MONITOR AM3 |
ERESEARCH TECHNOLOGY |
RICHARD A MILLER |
| K133198 |
05/30/2014 |
ULTRAPRO COMFORT PLUG |
ETHICON, INC. |
REYNALDO LIBROJO |
| DEN140002 |
05/29/2014 |
EUROIMMUN ANTI-PLA2R IFA |
EUROIMMUN US |
MICHAEL LOCKE |
| K140568 |
05/13/2014 |
CAREFINE PEN NEEDLE WITH QUINTAPOINT AND SUPERPOINT |
FACET TECHNOLOGIES, LLC |
JENNIFER REGISTER |
| K134001 |
05/15/2014 |
FIREFLY |
FIRSTKIND LIMITED |
SHEILA HEMEON-HEYER |
| K132475 |
05/07/2014 |
FLUOBEAM 800 CLINIC LASER IMAGING DEVICE AND FLUOCASE 800 CONTROL SYSTEM |
FLUOPTICS |
MICHAEL A DANIEL |
| K140211 |
05/30/2014 |
ULTRASONIC MESH NEBULIZER |
FOSHAN GAUNYING ELECTRONICS CO., LTD. |
GUENTER GINSBERG |
| K132529 |
05/12/2014 |
GALLIEON-1 MEDICAL LASER |
FUTURE DEVICE AND TECHNOLOGY, INC |
SOUNGDON CHUNG |
| DEN130015 |
05/09/2014 |
PIXEL 3 SYSTEM |
GAUSS SURGICAL, INC. |
PEGGY MCLAUGHLIN |
| K141067 |
05/23/2014 |
VIVID T8/VIVID T8 PRO |
GE HEALTHCARE |
BRYAN BEHN |
| K133664 |
05/15/2014 |
ENCORE VERSION 16 SOFTWARE FOR GE LUNAR DXA BONE DENSITOMETERS |
GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGN |
CHRIS PAULIK |
| K140693 |
05/16/2014 |
VSCAN WITH DUAL PROBE |
GE MEDICAL SYSYEMS ULTRASOUND & PRIMARY CARE DIAGN |
TRACEY ORTIZ |
| K132027 |
05/01/2014 |
OEC 9800 PLUS |
GE OEC MEDICAL SYSTEMS, INC |
JEFF WAGNER |
| K141093 |
05/15/2014 |
6VT-D ULTRASOUND TRANSDUCER |
GE VINGMED ULTRASOUND AS |
BRYAN BEHN |
| K140875 |
05/30/2014 |
OPTOSSOL COMPRESSION DEVICE SYSTEM |
GENOSSIS, LLC |
BARRY E SANDS |
| K133482 |
05/21/2014 |
SILC FIXATION SYSTEM |
GLOBUS MEDICAL, INC. |
CHRISTINA KICHULA |
| K131468 |
05/06/2014 |
DENRACLE DENTAL ABUTMENT |
GREEN DENTECH CO LTD |
SUE RU |
| K132476 |
05/02/2014 |
SHARPS CONTAINER |
GRP & ASSOCIATES |
ROBERT SEIPLE |
| K131941 |
05/15/2014 |
FETAL MONITORS |
GUANGDONG BIOLIGHT MEDITECH CO., LTD |
Diana Hong |
| K140899 |
05/05/2014 |
HALO MEDICAL TECHNOLOGIES CATALYST MIDCRYSTL HALO ULTRASOUND SYSTEM |
HALO MEDICAL TECHNOLOGIES, LLC |
JENNIFER L KINNEY |
| K132744 |
05/27/2014 |
ACESSA GUIDANCE SYSTEM |
HALT MEDICAL INC. |
CLARISA TATE |
| K133953 |
05/28/2014 |
LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG WITH PROTEIN LABELING CLAIM OF 50 M |
HARTALEGA SDN BHD |
NURUL AISYAH KONG BT ABDULLAH |
| K133956 |
05/28/2014 |
NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - WHITE / DAWN BLUE / LEMON GREEN |
HARTALEGA SDN BHD |
NURUL AISYAH KONG |
| K132937 |
05/21/2014 |
HARVEST DENTAL POLYMER BLOCKS (ZCAD, AURORA) |
HARVEST DENTAL PRODUCTS, LLC |
ANDREW ROWE |
| K132416 |
05/28/2014 |
REHASTIM 2, ERIGOPRO (FES) |
HASOMED GMBH |
MATTHIAS WEBER |
| K140269 |
05/08/2014 |
HERMES MEDICAL IMAGING SUITE V5.4 |
HERMES MEDICAL SOLUTIONS, AB |
JOAKIM ARWIDSON |
| K131866 |
05/01/2014 |
SUSTAIN |
HOLLENDER SUSTAINABLE BRANDS LLC |
E.J. Smith |
| K140074 |
05/21/2014 |
HYGEDENT ALGINATE IMPRESSION MATERIAL |
HYGEDENT INC |
MIKE GU |
| K133620 |
05/14/2014 |
CONE BEAM 3D AND 2D PANORAMIC DENTAL IMAGING SYSTEM |
IMAGING SCIENCES INTERNATIONAL |
RUTH PUI |
| K140216 |
05/01/2014 |
ORTHOPEDIC FIXATION SYSTEMS |
IMPACT MEDICAL, LLC |
EJ DUFFY |
| K131920 |
05/01/2014 |
STABILIZATION SCREW |
IN2BONES SAS |
NORMAN F ESTRIN, PH.D. |
| K133290 |
05/01/2014 |
COLLACARE DENTAL |
INNOCOLL PHARMACEUTICALS |
AARON WYSE |
| K140238 |
05/07/2014 |
EXCELLA III-D SPINAL DEFORMITY SYSTEM |
INNOVASIS, INC. |
MASHALL MCCARTY |
| K133690 |
05/07/2014 |
TRUE SPINAL FUSSION SYSTEM |
INNOVATIVE SURGICAL DESIGNS |
ED MORRIS |
| K131304 |
05/29/2014 |
SENTIO MMG |
INNOVATIVE SURGICAL SOLUTIONS, LLC ("ISS") |
AASHISH SHAH |
| K140198 |
05/13/2014 |
IMDX HSV-1/2 FOR ABBOTT M2000 |
Intelligent Medical Devices, Inc. |
FRAN WHITE |
| K140707 |
05/28/2014 |
LIFEBORNE INFANT RESUSCITATOR |
INTERNATIONAL BIOMEDICAL |
AMY PIEPER |
| K133203 |
05/09/2014 |
SINGLE-SITE PORT |
INTUITIVE SURGICAL, INC. |
EINAV YEMINI |
| K133853 |
05/19/2014 |
VIEWFLEX XTRA ICE CATHETER |
IRVINE BIOMEDICAL, INC. A ST.JUDE MEDICAL COMPANY |
JENNIFER CORREA |
| K133859 |
05/30/2014 |
WATCH-PAT200U (WP200U) |
ITAMAR MEDICAL LTD |
JONATHAN KAHAN, ESQ |
| K130915 |
05/15/2014 |
XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK |
JAS Diagnostics, Inc. |
DAVID H JOHNSTON |
| K140529 |
05/22/2014 |
EVEREST SPINAL SYSTEM |
K2M, LLC |
NANCY GIEZEN |
| K134043 |
05/21/2014 |
NO TOUCH+FOREHEAD NTF 3000 THERMOMETER |
KAZ USA, INC (A SUBSIDIARY OF KAZ INC) |
RAJ KASBEKAR |
| K133304 |
05/15/2014 |
RXG DISTRACTION SYSTEM |
KLS-MARTIN L.P. |
JENNIFER DAMATO |
| K141138 |
05/30/2014 |
SURFLASH SAFETY I.V. CATHETER |
KOFU FACTORY OF TERUMO CORP. |
PHILLIP LESTER |
| K140412 |
05/22/2014 |
ANS1 SOFTWARE |
LD TECHNOLOGY LLC |
ALBERT MAAREK |
| K122556 |
05/19/2014 |
VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11) |
LEICA BIOSYSTEMS NEWCASTLE LTD |
BARBARA-ANN CONWAY-MAYERS |
| K140340 |
05/21/2014 |
SKINTACT |
LEONHARD LANG GMBH |
ELAINE DUNCAN |
| K133934 |
05/02/2014 |
MANUKA FOAM HC, MANUKA FOAM HC (WITH ACRYLIC ADHESIVE BORDER), MANUKA FOAM HC (WITH SILICONE ADHESIVE BORDER) |
LINKS MEDICAL PRODUCTS, INC. |
James Smith |
| K133272 |
05/13/2014 |
VERSACUT + TISSUE MORCELLATOR |
LUMENIS LTD. |
YORAM LEVY |
| K133598 |
05/21/2014 |
CARDIOHELP SYSTEM |
MAQUET CARDIOPULMONARY AG |
HELDER A SOUSA |
| K133042 |
05/12/2014 |
ENDOCEM ZR |
MARUCHI |
Priscilla Chung |
| K133054 |
05/12/2014 |
ENDOSEAL |
MARUCHI |
Priscilla Chung |
| K140027 |
05/22/2014 |
ZIMMER PATIENT SPECIFIC INSTRUMENTS/ SYSTEM/PLANNER |
MATERIALISE N.V. |
OLIVER CLEMENS |
| K133046 |
05/14/2014 |
OMNIPORE CUSTOMIZED SURGICAL IMPLANTS |
MATRIX SURGICAL HOLDINGS, LLC/MATRIX SURGICAL USA |
JULIE STEPHENS |
| K132788 |
05/23/2014 |
MYSPINE PEDICLE SCREW PLACEMENT GUIDES |
MEDACTA INTERNATIONAL |
ADAM GROSS |
| K132684 |
05/23/2014 |
MEDWS SOFTWARE (VARIANTS MEDVIEW, MEDDIAG, MEDMAMMO) |
MEDECOM SARL |
CYNTHIA COTTEREAU |
| K133763 |
05/15/2014 |
SONOTIP PRO AND PRO FLEX EBUS-TBNA NEEDLE SYSTEM |
MEDI-GLOBE CORPORATION |
SCOTT KARLER |
| K130080 |
05/13/2014 |
EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC CRP QUALITY CONTROL MATERIAL |
MEDICA CORPORATION |
Photios Makris |
| K140755 |
05/08/2014 |
ACTIVECARE DVT, ACTIVECARE+SFT, AND ACTIVECARE+DTX SYSTEMS |
MEDICAL COMPRESSION SYSTEMS (DBN) LTD. |
ADELY LEVY |
| K133428 |
05/21/2014 |
MEDIKRO NANO, MEDIKRO PRIMO AND MEDIKRO PRO |
MEDIKRO OY |
MIKKO ELORANTA |
| K132730 |
05/30/2014 |
BIO-PROBE DISPOSABLE INSERT WITH; BALANCE BIOSURFACE, CARMEDA BIOACTIVE SURFACE, TRILLIUM BIOSURFACE |
MEDTRONIC INC. |
JESSICA SIXBERRY |
| K140454 |
05/22/2014 |
NAVIGATED CD HORIZON SOLERA SCREWDRIVER/TAPS |
MEDTRONIC SOFAMOR DANEK USA, INC. |
REGINA HOLMES |
| K140192 |
05/22/2014 |
CARPENTIER BI-CAVAL FEMORAL CANNULA |
MEDTRONIC, INC. |
JACQUELINE A HAUGE |
| K140165 |
05/20/2014 |
MC2 TWO-STAGE VENOUS CANNULA, OVAL MC2 TWO-STAGE VENOUS CANNULA, THIN WALL TWO-STAGE VENOUS CANNULA, MC2X THREE-STAGE VE |
MEDTRONIC, INC. |
JACQUELINE A HAUGE |
| K132506 |
05/29/2014 |
SLEEPTIGHT MOUTHPIECE, SLEEPPRO, QUIETNITE, ALTITUDE MOUTHPIECE, SLEEP EASY |
MICHAEL D. WILLIAMS,DDS PA |
MICHAEL D WILLIAMS |
| K140676 |
05/30/2014 |
PROFEMUR TL CLASSIC LONG NECK HIP STEMS |
MICROPORT ORTHOPEDICS INC. |
BYRON LEDBETTER |
| K133779 |
05/30/2014 |
CP RELIEF WAND |
MID-AMERICA MEDICAL INNOVATIONS, LLC. |
NORM SCHROEDER |
| K132038 |
05/02/2014 |
ACCUTORR 7 VITAL SIGNS MONITOR |
MINDRAY NORTH AMERICA |
RUSSELL OLSEN |
| K132037 |
05/16/2014 |
VITAL SIGNS MONITOR |
MINDRAY NORTH AMERICA |
RUSSELL OLSEN |
| K140970 |
05/13/2014 |
ONE-PIECE PEEK FUSION IMPLANT |
MTP SOLUTIONS LLC |
ROBERT HOY |
| K132653 |
05/14/2014 |
NEOPLATE SPINE ANTERIOR FIXATION SYSTEM |
NEOORTHO PRODUCTOS ORTHOPEDICOS S/A |
TARA CONRAD |
| K132852 |
05/29/2014 |
PEEK CAGE FOR THE VERTEBRAL SPINE |
NEOORTHO PRODUTOS ORTOPEDICOS S/A |
TARA CONRAD |
| K140724 |
05/14/2014 |
MSP METATARSAL SHORTENING SYSTEM |
NEXTREMITY SOLUTIONS, INC. |
JORGE A MONTOYA |
| K133351 |
05/22/2014 |
NEXUS NIS-6P LUER ACTIVATED DEVICE |
NEXUS MEDICAL LLC |
HEATHER TURNER |
| K133731 |
05/08/2014 |
NOBELACTIVE WIDE PLATFORM (WP) |
NOBELBIOCARE AB |
PHUONG NGUYEN |
| K140252 |
05/08/2014 |
16 CH MULTIPURPOSE COIL VARIETY |
NORAS RONTGEN-UND MEDIZINTECHNIK GMBH |
ZAHED SEDIGHIANI |
| K132291 |
05/20/2014 |
NAMSA CHEMICAL PROCESS |
NORTH AMERICAN SCIENCE ASSOC., INC. |
JULIE WHEELER |
| K133738 |
05/21/2014 |
NOVOFINE PLUS 32G 4 MM |
NOVO NORDISK INC. |
RICK SPRING |
| K132838 |
05/23/2014 |
NUTRA LIGHT BLUE |
NUTRA LUXE MD, LLC |
JILL CREASY |
| K133530 |
05/02/2014 |
NUVASIVE EMG ENDOTRACHEAL TUBE |
NUVASIVE, INCORPORATED |
JEREMY MARKOVICH |
| K132694 |
05/16/2014 |
NUVASIVE NVM5 SYSTEM |
NUVASIVE, INCORPORATED |
Sheila Bruschi |
| K140571 |
05/15/2014 |
NXSTAGE PUREFLOW SL |
NXSTAGE MEDICAL, INC. |
MARY L STROUMBOS |
| K140526 |
05/19/2014 |
NXSTAGE SYSTEM ONE |
NXSTAGE MEDICAL, INC. |
MARY LOU STROUMBOS |
| K123876 |
05/22/2014 |
SYNERGY |
ODONTIT SA |
BLIX WINSTON |
| K132703 |
05/19/2014 |
THUNDERBEAT |
OLYMPUS MEDICAL SYSTEMS CORP. |
GRAHAM BAILLIE |
| K131790 |
05/09/2014 |
A9800 ANESTHESIA WORKSTATION |
ORICARE, INC. |
KURTIS MONTEGNA |
| K133912 |
05/14/2014 |
ORIGIO SEQUENTIAL FERT, ORIGIO SEQUENTIAL FERT WITH PHENOL RED, ORIGIO SEQUENTIAL CLEAV, ORIGIO SEQUENTIAL CLEAV, ORIGIO |
ORIGIO A/S |
TOVE KJAER |
| K132870 |
05/07/2014 |
Origio Gas Line Filter |
ORIGIO, INC |
JOHN CLAY |
| K140709 |
05/27/2014 |
SKYHAWK INTERBODY FUSION SYSTEM |
ORTHOFIX INC. |
TROY BROOKS |
| K133082 |
05/20/2014 |
OSTEOSYMBIONICS PATIENT-SPECIFIC CRANIAL PLATE |
OSTEOSYMBIONICS, LLC |
NICHOLAS WLKINS |
| K133514 |
05/01/2014 |
XCAGE INTERBODY FUSION SYSTEM |
OUROBOROS MEDICAL |
JOHN TO |
| K132857 |
05/01/2014 |
RESPIRATORY GAS HUMIDIFIER |
PACIFIC MEDICO CO., LTD. |
YOSHIO TOYAMA |
| K133694 |
05/23/2014 |
SHERPA PAK TRANSPORTER |
PARAGONIX TECHNOLOGIES, INC. |
LEO BASTA |
| K133317 |
05/13/2014 |
PENUMBRA SYSTEM / PENUMBRA SYSTEM MAX |
PENUMBRA, INC. |
SETH SCHULMAN |
| K132108 |
05/19/2014 |
MAXIO |
PERFINT HEALTHCARE PVT LTD |
JANICE HOGAN |
| K133793 |
05/19/2014 |
PERSYST 12 ( P12) EGG REVIEW AND ANALYSIS SOFTWARE |
PERSYST DEVELOPMENT CORPORATION |
DARI DARABBEIGI |
| K131069 |
05/14/2014 |
QUICKSCREEN AMPHETINE 500 TEST |
PHAMATECH INC. |
CARL A MONGIOVI |
| K141015 |
05/19/2014 |
INTELLIVUE PATIENT MONITOR MX400, INTELLIVUE PATIENT MONITOR MX450, INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN |
MARKUS STACHA |
| K140066 |
05/05/2014 |
INFILL CERVICAL |
PINNACLE SPINE GROUP, LLC |
Rebecca K Pine |
| K140255 |
05/14/2014 |
STOP U (PACKED BLACK USA); STOP U (PACKED WHITE USA) |
POLLOGEN LTD |
JONATHAN S KAHAN |
| K140127 |
05/28/2014 |
FERROFIBRE STAINLESS STEEL SUTURE WITH CRIMP |
PONTIS ORTHOPAEDICS, LLC |
LEONARD GORDON |
| K134017 |
05/02/2014 |
GIGALASER |
POWERMEDIC APS |
M. JOYCE HEINRICH |
| K133051 |
05/02/2014 |
PULMONE MINIBOX PFT TM |
PULMONE ADVANCED MEDICAL DEVICES, LTD |
Rhona Shanker |
| K140522 |
05/22/2014 |
RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY PREMIUM PLUS TRI-LEVEL CONTROL |
RANDOX LABORATORIES LIMITED |
PAULINE ARMSTRONG |
| K140060 |
05/13/2014 |
DIGITAL DENTAL INTRA ORAL SENSOR, HDI 2000, HDI 2000A |
RAYENCE CO., LTD |
DAVE KIM |
| K140056 |
05/13/2014 |
DIGITAL DENTAL INTRA ORAL SENSOR; HDI 1000, HDI 1000A |
RAYENCE CO., LTD |
DAVE KIM |
| K141091 |
05/28/2014 |
RAYSERT PLUS INJECTOR |
RAYNER INTRAOCULAR LENSES LTD. |
JULIETTE COOK |
| K140187 |
05/15/2014 |
RAY STATION |
RAYSEARCH LABORATORIES AB |
LADAN AMIRI |
| K140638 |
05/02/2014 |
PROPELLER SYSTEM - MODEL 2 |
RECIPROCAL LABS CORPORATION |
J. DAVID SICKLE |
| K133988 |
05/16/2014 |
TEMPUS PRO EXTENDED FEATURES |
REMOTE DIAGNOSTIC TECHNOLOGIES LTD. |
LEIGH CORNOCK |
| K133257 |
05/16/2014 |
BIOPSY PIPETTES |
RESEARCH INSTRUMENTS LTD. |
DAVID LANSDOWNE |
| K140124 |
05/12/2014 |
S9 ELOUERA |
RESMED CORP |
JIM CASSI |
| K140054 |
05/16/2014 |
RESCAN |
RESMED LTD |
JIM CASSI |
| K140606 |
05/12/2014 |
1.5T PROCURE ARRAY COIL, 3.0T PROCURE ARRAY COIL |
RESONANCE INNOVATIONS LLC |
RANDALL JONES |
| K131557 |
05/09/2014 |
RITTER IMPLANT SYSTEM |
RITTER IMPLANTS GMBH CO KG |
RAYMOND KELLY |
| K133071 |
05/28/2014 |
ELASTIC IMPRESSION MATERIAL |
RIZHAO HUGE DENTAL INDUSTRY CO., LTD |
LEON LU |
| K140404 |
05/08/2014 |
ELECSYS CK-MB STAT IMMUNOASSAY |
Roche Diagnostics |
KELLI TURNER |
| K140373 |
05/22/2014 |
ISE INDIRECT NA, K, C1 FOR GEN 2 |
Roche Diagnostics |
DAVID TRIBBETT |
| K140887 |
05/05/2014 |
COBAS CT/NG V2.0 TEST |
ROCHE MOLECULAR SYSTEMS, INC. |
WILK VON GUSTEDT |
| K140576 |
05/20/2014 |
Y WIRE 2 |
SAFEWIRE, LLC |
STEPHEN W INGLESE |
| K133121 |
05/22/2014 |
CHITO-SAM 100,4IN X4IN,CHITO-SAM, 3IN X6FT, CHITO-SAM 100,3IN X10FT, CHITO-SAM ACTIVE, 4INX4IN,CHITO-SAM ACTIVE, 3INX6FT |
SAM MEDICAL PRODUCTS |
JACK MCCUTCHEON |
| K140334 |
05/28/2014 |
XGEO GC80 |
SAMSUNG ELECTRONICS CO., LTD. |
CHULSIN KIM |
| K140326 |
05/29/2014 |
XGEO GF50 |
SAMSUNG ELECTRONICS CO., LTD. |
JEONGPO HONG |
| K140235 |
05/15/2014 |
XGEO GR40CW |
SAMSUNG ELECTRONICS CO., LTD. |
JEONGPYO HONG |
| K140332 |
05/28/2014 |
XGEO GU60A |
SAMSUNG ELECTRONICS CO., LTD. |
AEYOUNG HA |
| K132173 |
05/30/2014 |
FAMILY HEALTHWARE |
SANITAS, INC. |
ALAN DONALD |
| K140835 |
05/20/2014 |
GENERAL AND PLASTIC SURGERY |
SCION MEDICAL TECHNOLOGIES LLC |
CHRIS LEWIS |
| K133418 |
05/01/2014 |
INTEGRA EXPANDABLE INTERVEREBRAL BODY FUSION DEVICE (IBD) SYSTEM |
SEASPINE, INC. |
JEFF BRITTAN |
| K140559 |
05/30/2014 |
SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER |
SECHRIST INDUSTRIES, INC. |
VICTOR C ARELLANO |
| K122656 |
05/06/2014 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR |
SHANDONG YIFAN PLASTIC PRODUCTS CO., LTD |
LING ZHU |
| K131954 |
05/29/2014 |
MEDI PEN NEEDLE |
SHANGHAI CARELIFE INTERNATIONAL TRADING CO., LTD. |
WILLIAM CONETY |
| K132802 |
05/21/2014 |
MOTEX POWDERED NITRILE SURGICAL GLOVES |
SHANGHAI MOTEX HEALTHCARE CO., LTD. |
JEN KE-MIN |
| K140631 |
05/16/2014 |
LUMENA FH HAIR REMOVAL SYSTEM |
SHASER, INC. |
ANTHONY BURNS |
| K141010 |
05/14/2014 |
M9 DIAGNOSTIC ULTRASOUND SYSTEM, M9T DIAGNOSTIC ULTRASOUND SYSTEM, M9CV DIAGNOSTIC ULTRASOUND SYSTEM |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS., CO. LTD |
WU ZICUI |
| K132801 |
05/28/2014 |
IMMULITE 2000 SYSTEMS 3GALLERGY SPECIFIC IGE ASSAY |
Siemens Healthcare Diagnostics Inc. |
Ernest Joseph |
| K140818 |
05/01/2014 |
IMMULITE: 2000 FREE T4 CALIBRATION VERIFICATION MATERIAL, 2000 IGF-I CALIBRATION VERIFICATION MATERIAL, 2000 PROLACTIN C |
Siemens Healthcare Diagnostics Inc. |
Ernest Joseph |
| K140787 |
05/30/2014 |
PLS (POSTERIOR LUMBAR SYSTEM) |
SINTEA PLUSTEK, LLC |
RICH JANSEN |
| K131319 |
05/30/2014 |
T1/T2/T3 TURBINE FAMILY |
SIRONA DENTAL SYSTEMS GMBH |
FRITZ KOLLE |
| K140814 |
05/07/2014 |
EVOS MINI-FRAGMENT PLATING SYSTEM |
SMITH & NEPHEW, INC. |
SAMANTHA STAUBACH |
| K140555 |
05/29/2014 |
JOURNEY II BCS CONSTRAINED INSERTS |
SMITH & NEPHEW, INC. |
Shereen Bienz |
| K133662 |
05/15/2014 |
SMITH & NEPHEW CANNULATED CAPTURED SCREW |
SMITH & NEPHEW, INC. |
KATHERINE MARCACCIO |
| K140941 |
05/07/2014 |
PROGRIP SELF-GRIPPING POLYPROPYLENE MESH, PARIETENE FLAT SHEET MESH |
SOFRADIM PRODUCTION |
CLARE SANTULLI |
| K132681 |
05/22/2014 |
SOL-GUARD INSULIN AND TUBERCULIN SAFETY SYRINGE |
SOL-MILLENNIUM MEDICAL, INC. |
JIM BARLEY |
| K133752 |
05/15/2014 |
SONENDO OMNICLEAN ENDOTHERPAY SYSTEM CONSOLE, SONENDO OMNICLEAN MOLAR PROCEDURE KIT |
SONENDO, INC. |
DAN MILLER |
| K141131 |
05/23/2014 |
TIGHTRAIL MINI |
SPECTRANETICS, INC. |
CHRISTOPHER MCLELLAN |
| K140948 |
05/20/2014 |
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM |
SPINEART |
FRANCK PENNESI |
| K133153 |
05/14/2014 |
SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM |
SPINEFRONTIER, INC. |
PAUL L SPEIDEL |
| K132470 |
05/21/2014 |
SOLUM IV BONE VOID FILLER |
SPINESMITH PARTNERS, LLP |
CLIFTON NAIVAR |
| K140272 |
05/02/2014 |
SWIFT-LOCK ANCHOR |
ST. JUDE MEDICAL |
DIANA ORTEGA |
| K133481 |
05/28/2014 |
SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM) |
ST. JUDE MEDICAL, INC. |
Michael McSweeney |
| K133328 |
05/30/2014 |
AERO-AL LUMBAR CAGE SYSTEM |
STRYKER CORPORATION |
TIFFANI ROGERS |
| K140095 |
05/20/2014 |
PRIME ZOOM STRETCHER |
STRYKER CORPORATION |
MATTHEW W JORDAN |
| K133672 |
05/01/2014 |
REPROCESSED HARMONIC ACE SHEARS WITHOUT ADAPTIVE TISSUE TECHNOLOGY |
STRYKER SUSTAINABILITY SOLUTIONS |
SCOTT ENGLISH |
| K140565 |
05/29/2014 |
VARIAX 2 COMPRESSION PLATING SYSTEM |
Stryker Trauma AG |
ESTELA CELI |
| K131711 |
05/09/2014 |
YZ3 PORTABLE SLIT LAMP |
SUZHOU 66 VISION TECH CO., LTD. |
HONGLING XIA |
| K133616 |
05/02/2014 |
MATRIXRIB FIXATION SYSTEM |
SYNTHES (USA) PRODUCTS LLC |
Damon Lees |
| K131600 |
05/29/2014 |
URS-2GP (GLUCOSE PROTEIN) URINE STRIPS |
TECO DIAGNOSTICS |
STEVE PARTONO |
| K133173 |
05/23/2014 |
RUSCH TRACFLEX PLUS PEDIATRIC TRACHEOSTOMY TUBE SET |
Teleflex Medical, Inc. |
LORI PFOHL |
| K140533 |
05/21/2014 |
GALAFLEX MESH |
TEPHA, INC. |
MARY P LEGRAW |
| K140773 |
05/30/2014 |
TERASON USMART3300 ULTRASOUND SYSTEM |
TERATECH CORP. |
STEVEN R BROADSTONE |
| K130304 |
05/30/2014 |
LMA FAMILY OF AIRWAYS |
THE LARYNGEAL MASK CO.,LTD. |
PAUL DRYDEN |
| K141220 |
05/22/2014 |
APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR INSTRUMENT WITH SDS SOFTWARE |
THERMO FISHER SCIENTIFIC (LIFE TECHNOLOGIES HOLDIN |
Nikki Arora |
| K140049 |
05/29/2014 |
MOVES SLC |
THORNHILL RESEARCH INC |
CLIFF ANSEL |
| K140419 |
05/12/2014 |
SUPERCATH5 |
TOGO MEDIKIT CO., LTD. |
IZUMI MARUO |
| K140729 |
05/23/2014 |
APLIO ARTIDA, V3.2 |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K140942 |
05/16/2014 |
KLASSIC KNEE TIBIAL STEM EXTENSION |
TOTAL JOINT ORTHOPEDICS, INC. |
JEAN WHEELER |
| K140455 |
05/22/2014 |
CAPTIA MEASLES IGM |
TRINITY BIOTECH USA |
Bonnie B DeJoy |
| K130017 |
05/28/2014 |
VALENTINE STEEL WHEELCHAIR |
VALENTINE INTL. LTD. |
JEN KE-MIN |
| K141124 |
05/30/2014 |
SPIRAL FLOW VASCULAR ARTERIOVENOUS GRAFT |
VASCULAR FLOW TECHNOLOGIES LTD |
EDWIN LINDSAY |
| K140395 |
05/13/2014 |
VITREA IMAGE DENOISING SOFTWARE |
VITAL IMAGES, INC. |
PARTHIV SHAH |
| K132397 |
05/07/2014 |
GORE BIO-A WOUND MATRIX |
W. L. GORE & ASSOCIATES, INC. |
BARBARA L SMITH, RAC |
| K133057 |
05/23/2014 |
VIBRALUNG ACOUSTICAL PERCUSSOR |
Westmed, Inc. |
PAUL DRYDEN |
| K140952 |
05/15/2014 |
CHARLOTTE CAROLINA JONES FRACTURE SYSTEM SCREW |
WRIGHT MEDICAL TECHNOLOGY, INC. |
LESLIE FITCH |
| K140792 |
05/22/2014 |
SALVATION 3DI PLATING SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
LESLIE FITCH |
| K140741 |
05/15/2014 |
SALVATION BEAMS AND BOLTS SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
LESLIE FITCH |
| K140408 |
05/14/2014 |
SALVATION OSTEOPENIC SCREW |
WRIGHT MEDICAL TECHNOLOGY, INC. |
VAL MYLES |
| K131609 |
05/21/2014 |
DOUBLE ENGINE INTRAMEDDULLARY NAIL SYSTEM |
XIAMEN DOUBLE ENGINE MEDICAL MATERIAL CO., LTD |
DA ZENG |
| K131712 |
05/30/2014 |
A-TONE IPL SYSTEM |
YBK INVESTMENT INC. |
JOYCE BANG |
| K133123 |
05/30/2014 |
NON STERILE, POWEDER FREE BLUE NITRILE EXAMINATION GLOVES - 8623F |
YTY INDUSTRY (MANJUNG) SDN. BHD. |
ANDREW LOWERY |
| K132637 |
05/01/2014 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR |
ZIBO INTCO MEDICAL PRODUCTS CO., LTD. |
FRANK LIU |
| K140611 |
05/21/2014 |
TRINICA ANTERIOR LUMBAR PLATE SYSTEM |
ZIMMER SPINE, INC. |
DONNA M SEMLAK |
| K133378 |
05/12/2014 |
ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM |
ZIMMER, INC. |
DAN WILLIMAN |
| K133269 |
05/22/2014 |
ZOLL X SERIES |
ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS |
TANMAY B SHUKLA |
| K133206 |
05/13/2014 |
Z-RAY INTRA-ORAL DIGITAL RADIOGRAPHY SYSTEM |
ZUMA DENTAL, LLC |
ALBERT REGO |
