FDA 510(k) Decisions During February, 2013  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K132967 12/06/2013 3B RESMART CPAP AND AUTO CPAP, BMC RESMART CPAP AND AUTO CPAP 3B MEDICAL, INC ALEX LUCIO
K131901 12/23/2013 IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2 3B MEDICAL, INC ALEX LUCIO
K123679 02/28/2013 3M TEGADERM CHG CHLORHEXIDINE GLUCONATE I.V. PORT DRESSING 3M COMPANY JOANN HUEHN
K121069 02/11/2013 3M VFLEX HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK 3M COMPANY JIZHONG JIN
K132787 12/24/2013 LOQTEQ DISTAL DORSOLATERAL HUMERUS PLATE AAP IMPLANTATE AG CHRISTIAN ZIETSCH
K130200 02/15/2013 PICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEM ABAXIS, INC. DENNIS M BLEILE, PHD
K132511 12/24/2013 FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM ABBOTT DIABETES CARE INC. VRUSAHLI TEMBE
K121985 02/01/2013 ARCHITECT TOTAL BILIRUBIN ABBOTT LABORATORIES LINDA MORRIS
K132086 12/19/2013 ON CALL EXPRESS BLOOD GLUCOSE MONITORING SYSTEM ACON LABORATORIES, INC. QIYI XIE
K130284 12/20/2013 ON CALL SHARP BLOOD GLUCOSE MONITORING SYSTEM ACON LABORATORIES, INC. QIYI XIE
K130329 12/03/2013 SURGISEAL TOPICAL SKIN ADHESIVE Adhezion Biomedical, LLC Caridad Smith
K132243 12/20/2013 BARLE TISSUE ADHESIVE 2 ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD KAY MCGRATH
K133081 12/31/2013 TROCHANTERIC NAILS AND ES TROCHANTERIC NAILS, HUMERAL NAISL, TIBIAL NAILS, ANTEGRADE FEMORAL NAILS, RETROGRADE FEMORAL N ADVANCED ORTHOPAEDIC SOLUTIONS, INC. KAZUNORI MIYAHARA
K132082 12/05/2013 AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK AESKU.DIAGNOSTICS SASCHA PFEIFFER
K121453 02/05/2013 A-GRIX TE RESORABLE BONE VOID FILLER AG DIGITAL TECHNOLOGY CORP. JENNIFER REICH
K122162 12/20/2013 AGGREGUIDE AGGREDYNE, INC. J. HARBEY KNAUSS
K123861 12/12/2013 AIDI DENTAL IMPLANT SYSTEM AIDI BIOMEDICAL LLC CHEN TIAN
K123216 02/07/2013 AIMAGO EASYLDI MICROCIRCULATION CAMERA (STAND PLUS CAMERA ARM), AIMAGO EASY LDI STAND, INCLUDING 4-WHEELED STAND BASE AN AIMAGO SA MARC ANDRE
K123308 02/08/2013 PULSTAR LOGIX INTERMITTENT PNEUMATIC COMPRESSION SYSTEM ALBAHEALTH, L.L.C. PATRICK FRANK
K133079 12/17/2013 IO2 SPHER(MANGOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IO2 TORIC (MANGOFILCON A) SOFT (HYDROPHILIC) ALDEN OPTICAL LABS., INC. KEVIN RANDALL
K133411 12/05/2013 ALERE BINAXNOW INFLUENZA A & B CARD ALERE SCARBOROUGH, INC D/B/A BINAX, INC. Angela Drysdale
K133637 12/18/2013 ALERE INFLUENZA A & B TEST ALERE SCARBOROUGH, INC D/B/A BINAX, INC. Angela Drysdale
K110941 02/19/2013 REVOLIX JR 30, REVOLIX JR 50, REVOLIX JR 160, REVOLIX FR 200 ALLMED SYSTEMS INC. PETER ALLEN
K123623 02/14/2013 ILLICO MIS POSTERIOR FIXATION SYSTEM ALPHATEC SPINE, INC. NADINE SMITH
K123610 02/01/2013 E-CUBE 15 ALPINION MEDICAL SYSTEMS CO., LTD DONGHWAN KIM
K131229 12/05/2013 SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS AMERICAN MEDICAL SYSTEMS TODD HILDEBRANDT
K123519 02/01/2013 INVIVO DENTAL ANATOMAGE, INC MIKE MENDEZ
K133561 12/19/2013 VENACURE EVLT NEVERTOUCH PROCEDURE KIT, VENACURE EVLT TRE' SHEATH ANGIODYNAMICS, INC. Lorraine M Hanley
K133043 12/06/2013 PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE ANGIOSLIDE, LTD CLAY ANSELMO
K122477 02/19/2013 LIFESTYLES LUXE PREMIUM PERSONAL LUBRICANT ANSELL HEALTHCARE PRODUCTS LLC DONNA DIGANGI
K122720 02/22/2013 LIFESTYLES WARM LOVIN PERSONAL LUBRICANT ANSELL HEALTHCARE PRODUCTS LLC DONNA DI GANGI
K122054 02/14/2013 LIFESTYLES NATURAL PERSONAL LUBRICANT ANSELL HEALTHCARE PRODUCTS, LLC DONNA DIGANGI
K131766 12/12/2013 PLATINUM DRF IMAGING SYSTEM APELEM-DMS GROUP Sharyn Orton
K113268 02/08/2013 ALEXIS O WOUND PROTECTOR/RETRACTOR APPLIED MEDICAL RESOURCES CORP. FRANS VANDENBROEK
K122554 02/07/2013 GENASIS SCANVIEW SYSTEM APPLIED SPECTRAL IMAGING, LTD. ILAN SHARON
K132342 12/20/2013 XVWEB APTERYX, INC. KEVIN CRUCS
K123613 02/20/2013 SYNSPAR ADVANCED ARDENT INC DONNA M HARTNETT
K121942 02/08/2013 ADENOVIRUS R-GENE US ARGENE SA ERIC BRISSON
K121456 02/01/2013 AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROL ARKRAY, INC. ADAM ETTL
K133342 12/17/2013 ARTHREX IBALANCE TKA SYSTEM ARTHREX, INC. MARIELA CABARCAS
K130196 02/27/2013 SPEEDLOCK KNOTLESS FIXATION DEVICE, 3MM DRILL, 3MM+ DRILL, PATHFINDER OBTURATOR & SHARP TIPPED OBTURATOR, LOW PROFILE DR ARTHROCARE CORP. LAURA KASPEROWICZ
K123240 02/14/2013 SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT ARTHROCARE CORPORATION CHERYL FREDERICK
K121409 02/06/2013 ASAHI REXEED-SX/LX SERIES DIALYZER ASAHI KASEI MEDICAL CO., LTD. Patsy Trisler
K121826 02/13/2013 INTEGRA PROXIMAL HUMERAL PLATE SYSTEM ASCENSION ORTHOPEDICS, INC. SUSAN WALTON
K132896 12/02/2013 CJ-TYPE: METAL HANDLE WITH GUIDE TUBE, PJ-TYPE: PLASTIC HANDLE WITH GUIDE TUBE, CB-TYPE: METAL HANDLE WITHOUT GUIDE TUBE ASIA-MED GMBH AND CO KG Kevin Walls
K120701 02/07/2013 M2 WRIST MRI SYSTEM ASPECT IMAGING LTD AHAVA STEIN
K123757 02/01/2013 POWDER FREE LATEX PATIENT EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM, NATURAL COLOR ASSURGUARD SDN. BHD. LIM H GUAN
K130131 02/28/2013 EDRAIN CHEST DRAINAGE SYSTEM ATRIUM MEDICAL CORP. CHRISTINA CALDERWOOD
K121177 12/05/2013 BOND APATITE AUGMA BIOMATERIALS, LTD. KEVIN A THOMAS
K123474 12/03/2013 AVANT LASER AVANT WELLNESS SYSTEMS, LLC ANDY HEWITSON
K123248 12/10/2013 CPR RSQ ASSIST AVANTECH, INC. STEVEN B DATLOF
K121873 12/11/2013 AVINENT DENTAL IMPLANT SYSTEM AVINENT IMPLANT SYSTEM, S.L. ANNA CORTINA
K123254 02/13/2013 ULTRASOUND SCANNER FLEX FOCUS B-K MEDICAL APS RANDI HAUERBERG
K132310 12/23/2013 ASCOT BACKROADS CONSULTING, INC. KAREN E WARDEN, PHD
K130103 02/08/2013 CORONIS FUSION 6MP BARCO N.V. LIEVEN DE WANDEL
K133569 12/20/2013 TRUE DILATATION BALLOON VALVULOPLASTY CATHETER, 20MM X 4.5 CM, 22MM X 4.5CM, 24 MM X 4.5CM, 26MM X 4.5CM BARD PERIPHERAL VASCULAR, INC. TIFFINI DIAGE
K132481 12/27/2013 EASY-LOAD LENS DELIVERY SYSTEM BAUSCH & LOMB JASON SMITH
K132715 12/20/2013 BAUSCH + LOMB BIOTURE ONEDAY FOR PRESBYOPIA (NESOFILCON A) CONTACT LENS BAUSCH & LOMB INCORPORATED JENNIFER KNICLEY
K121050 02/07/2013 0.9% SODIUM CHLORIDE INJECTION USP BD POSIFLUSH FLUSH SYRINGE, SF FLUSH SYRINGE BECTON DICKINSON & CO. JOHN ROBERTS
K130197 02/27/2013 BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - P55 Becton, Dickinson and Company JOHN ROBERTS
K132674 12/27/2013 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- MEROPENEM (0.125-32 UG/ML) Becton, Dickinson and Company MONICA E GIGUERE
K122718 02/06/2013 BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF GROUP A STREP Becton, Dickinson and Company Gregory P Payne
K122046 02/04/2013 WRIST PULSE OXIMETER BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. LEI CHEN
K123435 02/11/2013 IPL THERAPY SYSTEM BEIJING SINCOHEREN S&T DEVELOPMENT CO LTD MIKE GU
K132120 12/12/2013 WTF SECURA SYRINGE AND NEEDLE BEIJING WANTEFU MEDICAL APPARATUS CO., LTD. RAYMOND SUN
K132688 12/16/2013 SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/NZ BIOCHEMICAL DIAGNOSTICS, INC. ALLEN PANETZ
K123620 02/11/2013 FILMARRAY RESPIRATORY PANEL (RP) BIOFIRE DIAGNOSTICS, INC. BETH LINGENFELTER
K132400 12/19/2013 LP(A) CALIBRATORS, AND LP(A) CONTROLS BIOKIT S.A. JOAN GUIXER
K121327 02/01/2013 DIOLASE 10S BIOLASE TECHNOLOGY, INC. ROBERT YANG
K121735 02/21/2013 FIBER DISK AND BLOCK PERMANENT, TRINIA BIOLOREN SRL RATTI ANDREA
K123549 02/25/2013 POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEM BIOMET SPINE (AKA EBI, LLC) VIVIAN KELLY, MS, RAC
K123501 02/27/2013 OSS MODULAR STEMS, OSS DIAPHYSEAL SEGMENTS BIOMET, INC. GARY BAKER
K132873 12/11/2013 VANGUARD XP KNEE SYSTEM BIOMET, INC. JULIE GANTENBERG, M.S.
K123851 02/14/2013 GLUCOSE METER-CHECK SOLUTION FOR ROCHE ACCU-CHEK BIONOSTICS, INC. RANDY BYRD
K131510 12/20/2013 POLYDIMETHYLSILOXANE IMPRESSION MATERIAL BLACKWELL DEVICE CONSULTING ANGELA BLACKWELL
K122518 02/15/2013 SYNSTER (CERVICAL,ALIF, PLIF, PTLIF AND TLIF) CAGE HERA CERVICAL CAGE RHEA PLIF CAGE TALON TIFA CAGE BM KOREA CO., LTD. Priscilla Chung
K132253 12/16/2013 REMOVABLE PATIENT LEADS ECG CABLE BOSTON SCIENTIFIC MELISSA KLAMERUS
K123424 02/20/2013 MDU5 PLUS STERILE BAG BOSTON SCIENTIFIC CORP. LORI R SMITH
K133566 12/20/2013 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH THE PERIPHERAL ROTALINK PLUS BOSTON SCIENTIFIC CORP. MAYLIN TRUESDELL
K130004 12/06/2013 ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM Boston Scientific Corporation JANIS TARANTO
K122633 02/07/2013 TOXCUP DRUG SCREEN CUP BRANAN MEDICAL CORP. Olivia Chan
K132441 12/13/2013 BARD VENTRALEX HERNIA PATCH C.R. BARD, INC. MARIYA BUHARIN
K132134 12/02/2013 OPTIFIX ABSORBABLE FIXATION SYSTEM C.R. BARD, INC. RADHIKA PONDICHERRY
K123337 02/21/2013 VERTESSA LITE 10 X 20CM, VERTESSA LITE 11 X 30CM CALDERA MEDICAL VICKI GAIL
K121928 02/19/2013 DESARA SL CALDERA MEDICAL, INC. VICKI GAIL
K133283 12/26/2013 CANDELA GENTLEMAX FAMILY OF LASER SYSTEMS CANDELA CORP. SAM WADE
K130061 02/27/2013 PICCOLO COMPOSITE PLATE SYSTEM CARBOFIX ORTHOPEDICS LTD. YAEL RUBIN
K132708 12/20/2013 BIOMARC FIDUCIAL MARKER CARBON MEDICAL TECHNOLOGIES, INC. ANDREW J ADAMS
K123217 02/05/2013 CARDEASCREEN CARDEA ASSOCIATES INC DAVID M HADLEY
K122184 02/14/2013 ECG CHECK CARDIAC DESIGNS, LLC KARIM MARROUCHE
K123289 02/28/2013 DURABLUE STERILIZATION WRAP CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES LAVENIA FORD
K132060 12/13/2013 DURABLUE STERILIZATION WRAP CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES LAVENIA FORD
K130208 12/20/2013 BERNOULLI ENTERPRISE SOFTWARE CARDIOPULMONARY CORP. UREY KANG
K132867 12/30/2013 SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 1.4MM, SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 2.2MM CAYENNE MEDICAL, INC. SHIMA HASHEMIAN
K123433 02/26/2013 CEDARS-SINAI CARDIAC SUITE NUCLEAR MEDICINE SOFTWARE CEDARS-SINAI MEDICAL CENTER GEOFF POLLARD, PROGRAM MANAGER
K123638 02/21/2013 PEKKTON IVORY CENDRES & METAUX SA T. BONGNI
K102751 02/11/2013 LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM CERAGEM MEDISYS INC. GRACE KIM
K132963 12/16/2013 FUSIONSYNC, CHIMAERA FUSIONSYNC CHIMAERA GMBH MARCUS PRUEMMER
K130439 12/12/2013 EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORING CHONGQING PSK SCI-TECH DEVELOPMENT CO., LTD FIELD FU
K120804 02/04/2013 CIANNA MEDICAL TISSUE MARKER AND DELIVERY SYSTEM CIANNA MEDICAL GARY MOCNIK
K132463 12/03/2013 CIANNA MEDICAL PERMANENT TISSUE MARKER AND DELIVERY SYSTEM CIANNA MEDICAL, INC. GARY MOCNIK
K123994 02/21/2013 DAILIES AQUACOMFORT PLUS, DAILIES AQUACOMFORT PLUS TORIC, DAILIES AQUACOMFORT PLUS MULTIFOCAL CIBA VISION CORPORATION MARTINA HEIM, PH.D., RAC
K120708 02/07/2013 ONETOUCH VERIO SYNC BLOOD GLUCOSE MONITORING SYSTEM CILAG GMBH INTERNATIONAL NADINE NASR
K122726 02/15/2013 CPI RAD VISION COMMUNICATIONS & POWER INDUSTRIES CANADA, INC. NORM MORIKAWA
K120851 02/19/2013 COMMUNIFY PACS VIEWER COMMUNIFY HEALTH, LLC CHRIS RELYEA
K123650 02/20/2013 ARIX RAD ACQUISITION CONSOLE COMPANIA MEXICANA DE RADIOLOGIA CGR, S.A. DE C.V. CARL ALLETTO
K133029 12/06/2013 ABDOMINAL AORTIC AND JUNCTIONAL TOURNIQUET (AAJT) DEVICE COMPRESSION WORKS, LLC MICHAEL FORSTADT
K132640 12/05/2013 IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM CONFORMIS, INC. AMITA SHAH
K123175 02/21/2013 DETACHATIP III PLUS INSTRUMENT TRAY MODEL 3-4343 CONMED CORPORATION ANNA D'LIMA
K131765 12/20/2013 ECOM ENDOTRACHEAL CARDIAC OUTPUT MONITOR SYSTEM CONMED CORPORATION LISA ANDERSON
K130652 12/17/2013 VITALITE E CROSS-LINKED POLYETHYLENE ACETABULAR INSERT CONSENSUS ORTHOPEDICS, INC. MATTHEW HULL
K123494 02/11/2013 SOLEA CONVERGENT DENTAL, INC Carrie Hetrick
K121360 02/27/2013 BIODESIGN ENT REPAIR GRAFT COOK BIOTECH INCORPRATED MARY A FADERAN, PH.D., RAC
K123235 02/14/2013 EQUAFLOW MULTIVALVE INFUSION CATHETER COOK INCORPORATED AMBER BROWN
K123707 02/28/2013 ALIGHT 16 SUPERSELECTIVE MICROWIRE GUIDE COOK, INC. DAVID LEHR
K133634 12/23/2013 SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET COOK, INC. SEAN SPENCE
K133627 12/23/2013 AVAIRA SPHERIC AND TORIC (ENFILCON A) SOFT CONTACT LENS COOPERVISION, INC. ANNETTE NELSON
K132994 12/05/2013 ANODYNE ANTERIOR CERVICAL PLATE SYSTEM CORELINK LLC J.D. WEBB
K131952 12/16/2013 CORIN METAFIX HIP STEM CORIN USA LUCINDA GERBER
K131986 12/16/2013 CORIN MINIHIP STEM CORIN USA LUCINDA GERBER
K123705 02/12/2013 TRINITY NON-OCCLUDED TITANIUM PLASMA SPRAYED (TPS) ACETABULAR SHELLS CORIN USA DIANA L MARTONE
K122640 02/22/2013 VPULSE COTHERA, LLC JUSTIN EGGLETON
K132604 12/04/2013 VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM COVIDIEN KELSEY LEE
K123002 02/27/2013 VITAL SYNC SYSTEM COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT, INC. KELSEY LEE
K122781 02/05/2013 RELIAMAX GASTROINTESTINAL ANASTOMOSIS AND RELOAD COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H MARY MELLOWS
K133338 12/20/2013 LIGASURE 5 MM MARYLAND JAW SEALER/DIVIDER ONE-STEP SEALING (LF 17XX) COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO H DONALD HENTON
K132242 12/06/2013 INNO SLA SUBMERGED IMPLANT SYSTEM COWELLMEDI CO., LTD SUSAN PARK
K120861 02/21/2013 FIN-S MICROIMPLANT CREEKSIDE ORTHODONTICS JOHN T KALANGE
K133372 12/06/2013 CROSSTREES PVA POD CROSSTREES MEDICAL, INC. JANICE HOGAN
K131702 12/06/2013 K SERIES CPAP SYSTEMS CURATIVE MEDICAL INC. AMY MCKINNEY
K132500 12/23/2013 CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATED CURE MEDICAL LLC. JOHN BEASLEY
K133367 12/20/2013 ORTHOVIS PREOPERATIVE PLAN CUSTOM ORTHOPAEDIC SOLUTIONS JUSTIN BAKER
K132185 12/06/2013 FAMILY OF COOLGLIDE AESTHETIC LASERS CUTERA, INC. SANDRA HANSEN
K121795 02/22/2013 CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANT CYTOPHIL INC BILL HUBBARD
K130861 12/09/2013 MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE (LINK) DAKO NORTH AMERICA, INC. JENNIFER M CHAMBERS
K120663 02/12/2013 MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI DAKO NORTH AMERICA, INC. XIAOLEI XU
K122871 02/07/2013 COMPRESSYN STAPLE DALLEN MEDICAL, INC. AL MEMMOLO
K132875 12/30/2013 COMPRESSYN STAPLE DALLEN MEDICAL, INC. AL MEMMOLO
K120592 02/27/2013 DANA REUSABLE BOWIE TEST PACK FOR DANA BOWIE DICK INDICATORS DANA PRODUCTS, INC. HARRY BALA
K133074 12/12/2013 MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIES DATASCOPE CORP. LINDA SLUTZKY
K123211 02/14/2013 A5 ANESTHESIA DELIVERY SYSTEM DATASCOPE CORP., PATIENT MONITORING DIVISION RUSSELL OLSEN
K132530 12/20/2013 GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2) DATEX-OHMEDA, INC. JAMES P RASKOB
K123125 02/06/2013 GE DATEX-OHMEDA AVANCE CS2 DATEX-OHMEDA, INC. JAMES P RASKOB
K123869 02/28/2013 POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES DEHAI (SHANDONG) MEDICAL GLOVES, CO., LTD RAY ZHOU
K123209 12/19/2013 SOFTVUE DELPHINUS MEDICAL TECHNOLOGIES, INC ANDREA N WALLEN
K123615 02/22/2013 IRIS - HIGH STRENGTH GLASS CERAMIC DENTSPLY INTL. HELEN LEWIS
K123668 02/26/2013 ORTHOCORD DEPUY MITEK INC., A JOHNSON AND JOHNSON COMPANY TATYANA KORSUNSKY
K123362 02/01/2013 MILAGRO ADVANCE INTERFERENCE SCREW DEPUY MITEK, A JOHNSON & JOHNSON COMPANY YAYOI FUJIMAKI
K121374 02/22/2013 ZI BLOWER DESHUM MEDICAL MAUREEN O'CONNELL
K123959 02/28/2013 CIRCUFLOW 5150 DEVON MEDICAL INC. RUTH WU
K123647 02/14/2013 CIRCUFLOW 5208 SEQUENTIAL COMPRESSION DEVICE DEVON MEDICAL INC. RUTH WU
K123824 02/21/2013 VITRO FIL LC DFL INDUSTRIA E COMERCIO S.A. TARA CONRAD
K123826 02/14/2013 VITRO MOLAR DFL INDUSTRIA E COMERCIO S.A. TARA CONRAD
K130090 02/12/2013 STA COMPACT MAX DIAGNOSTICA STAGO, INCORPORATED CARLO D'ALESSANDRO
K123969 02/07/2013 XIPHOS DIFUSION TECHNOLOGIES KAREN E WARDEN, PHD
K132308 12/30/2013 CLIQ DV-300 ASPIRATOR DING HWA CO., LTD. ROBERT O DEAN
K122872 02/28/2013 INTERVERTEBRAL BODY FUSION DEVICE DIO MEDICAL CO., LTD. APRIL LEE
K131823 12/09/2013 PROPRIETARY / DONGTAI/ OTHER CLIENTS PRIVATE LABELING DONG TAI CITY HUAYI GLOVES CO., LTD. CHU XIAOAN
K123030 12/19/2013 COMPRESSOR NEBULIZER MODEL MCN-S600XX DONGGUAN AIDISY MACHINERY & ELECTRONIC EQUIPMENT C LEON LU
K122159 02/01/2013 DORNIER MEDILAS H30 SOLVO DORNIER MEDTECH AMERICA, INC. JOHN HOFFER
K121999 02/28/2013 GENERAL PURPOSE TEMPERATURE PROBE, SKIN TEMPERATURE PROBE DRAEGER MEDICAL GMBH BETH ZIS
K132445 12/06/2013 PIEZON 250 E.M.S. ELECTRO MEDICAL SYSTEMS S.A. CYNTHIA NOLTE
K131379 12/18/2013 EARLYSENSE EARLYSENSE LTD. DALIA ARGAMAN
K123249 02/08/2013 DIAGNOSTIC ULTRASOUND SYSTEM EDAN INSTRUMENTS, INC. RANDY JIANG
K123187 02/22/2013 RETROGRADE CORONARY SINUS CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CANNULA EDWARDS LIFESCIENCES, LLC. KAREN JONES
K122879 02/06/2013 EEGER4 MODEL 4.3 EEG SOFTWARE LLC HOWARD LIGHTSTONE
K130070 02/08/2013 4MP COLOR LCD MONITOR, RADIFORCE RX440 EIZO NANAO CORPORATION HIROAKI HASHIMOTO
K113504 02/01/2013 DEKA SMARTXIDE AND DELIVERY ACCESSORIES EL.EN. ELECTRONIC ENGINEERING SPA PAOLO PERUZZI
K131095 12/05/2013 DEKA SYNCHRO REPLA: Y FAMILY OF LASER SYSTEMS EL.EN. ELECTRONIC ENGINEERING SPA PAOLO PERUZZI
K132794 12/19/2013 SMARTVEST AIRWAY CLEARANCE SYSTEM ELECTROMED, INC. CHET SIEVERT
K122177 02/15/2013 ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 100 MG/DL, ELITECH CLINICAL SYSTEMS URINE CONTROL BI-LEVEL ELITECHGROUP DEBRA K HUTSON
K133289 12/09/2013 PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM ELLIPSE TECHNOLOGIES, INC. John McIntyre
K122516 02/21/2013 EMBLETTA MPR EMBLA SYSTEMS Jennifer Armstrong
K132776 12/20/2013 SEAL BIOPSY VALVE - REUSABLE ENDOCHOICE, INC. DANIEL HOEFER
K132754 12/12/2013 NEOGEN PSR SYSTEM ENERGIST, LTD. DARREN THOMAS
K130556 12/13/2013 NEURALIEVE CERENA TRANSCRANIAL MAGNETIC STIMULATOR ENEURA THERAPEUTICS LARRY GETLIN
DEN130022 12/13/2013 NEURALIEVE CERENA TRANSCRANIAL MAGNETIC STIMULATOR ENEURA THERAPEUTICS LARRY GETLIN
K133425 12/05/2013 SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT ENGINEERED MEDICAL SOLUTIONS CO. LLC. RYAN SAVAGE
K133563 12/20/2013 PATHASSIST LIGHT SEEKER Entellus Medical, Inc. GARRETT P AHLBORG
K132202 12/06/2013 DC SERIES FLUID WARMING CABINET, DC SERIES FLUID WARMING CABINET ENTHERMICS MEDICAL SYSTEMS, INC. ADAM VAN ESSEN
K123740 02/22/2013 EOS EOS IMAGING JOHN J SMITH
K123538 02/01/2013 EPIEN ROOT CANAL CLEANSER EPIEN MEDICAL, INC. JEFFREY K SHAPIRO
K133180 12/11/2013 ERBE ESU MODEL VIO DV WITH ACCESSORIES ERBE USA, INC. JOHN TARTAL
K132340 12/17/2013 ERBEFLO CLEVERCAP HYBRID TUBING/CAP SET FOR PENTAX SCOPES, ERBEFLO CLEVERCAP HYBRID CO2 TUBING/CAP SET FOR OLYMPUS 160/1 ERBE USA, INC. JOHN TARTAL
K133490 12/30/2013 G-SCAN BRIO ESAOTE S.P.A. ALLISON S COTT
K132466 12/04/2013 MYLABSEVEN 6400, MYLABALPHA 7400 ESAOTE S.P.A. Allison Scott
K131996 12/13/2013 S-SCAN ESAOTE, S.P.A. ALLISON SCOTT, RAC
K124064 12/19/2013 YOUNG AGAIN ESPANSIONE MARKETING SPA GUIDO BONAPACE
K132522 12/16/2013 HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE ETHICON ENDO-SURGERY, LLC DAVID LOCKE
K133314 12/03/2013 HARMONIC FOCUS SHEARS + ADAPTIVE TISSUE TECHNOLOGY ETHICON ENDO-SURGERY, LLC BRIAN GODWIN
K123114 02/05/2013 ETHICON SECURESTRAP OPEN ABSORBABLE STRAP FIXATION DEVICE ETHICON, INC. SUSAN LIN
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K131758 12/18/2013 SURGEN U POLLOGEN LTD JONATHAN S KAHAN
K133474 12/10/2013 BIOSIGN FLU A + B, STATUS FLU A & B PRINCETON BIOMEDITECH CORP. KYUNG-AH KIM
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K123488 02/08/2013 LINSHI NITRILE DISPOSABLE EXAM GLOVES, POWDER-FREE PUYANG LINSHI HEALTH CO., LTD LAURA WENG
K133503 12/20/2013 AMPLIVUE GBS ASSAY QUIDEL CORPORATION Ronald H Lollar
K133423 12/20/2013 REST ASSURED EXTRA COMFORT NITE PROTECTOR RANIR LLC PAULA BOJSEN
K131979 12/13/2013 PROVANT THERAPY SYSTEM REGENESIS BIOMEDICAL, INC. RICHARD ISENBERG
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K120038 02/14/2013 A200 KNEE SYSTEM RENOVIS SURGICAL TECHNOLOGIES, LLC KEVIN A THOMAS
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K123979 02/27/2013 QUATTRO AIR RESMED LTD. JIM CASSI
K122035 12/13/2013 HEPAFAT SCAN RESONANCE HEALTH ANALYSIS SERVICES PTY LTD GREG HOLLAND
K123154 02/19/2013 ARTAS SYSTEM FROM RESTORATION ROBOTICS RESTORATION ROBOTICS, INC JIM TALBOT
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K133243 12/17/2013 OPTION ELITE VENA CAVA FILTER SYSTEM REX MEDICAL LP SUSAN D GOLDSTEIN-FALK
K113614 02/12/2013 ACCU-CHECK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM Roche Diagnostics MICHAEL FLIS
K132418 12/18/2013 COBAS C 501 ISE INDIRECT NA, K, CL FOR GEN. 2 Roche Diagnostics KHOA TRAN
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K132828 12/04/2013 ELECSYS CALCITONIN; IMMUNOASSAY, CALSET, CALCHECK 5; ELECSYS PRECICONTROL VARIA 3 Roche Diagnostics KELLI TURNER
K132270 12/02/2013 COBAS CT/NG V2.0 TEST ROCHE MOLECULAR SYSTEMS, INC. WILK VON GUSTEDT
K123033 02/01/2013 ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PACK AND BOTTLE SET, ROCKET IPC DRAINAGE B ROCKET MEDICAL PLC TRACY CHARLTON
K132148 12/04/2013 S HEALTH SAMSUNG ELECTRONICS CO., LTD. Priscilla Chung
K133505 12/27/2013 SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM SAMSUNG MEDISON CO., LTD PARK KYEONG-MI
K120922 02/07/2013 GUARDIAN DYSPHAGIA DUAL CHANNEL NMES UNIT SELECTIVEMED COMPONENTS INC. DANIEL KAMM
K102873 12/18/2013 SYMPHONY DEVICE SENSORY MEDICAL, INC FRED BURBANK
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K132652 12/20/2013 VIA MICROCATHETER, VIA PLUS MICROCATHETER SEQUENT MEDICAL, INC MELANIE PARRAVI
K130041 02/06/2013 SHEATHES STERILE ULTRASOUND GEL SHEATHING TECHNOLOGIES, INC. JENNIFER DOWNING
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K122710 02/15/2013 TRANSCRANIAL DOPPLER WITH ROBOTIC PROBE HEADBAND SHENZHEN DELICATE ELECTRONICS CO., LTD. Diana Hong
K131259 12/27/2013 LASER-STIM SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. JIANGPING KANG
K130325 12/24/2013 ARM AUTOMATIC BLOOD PRESSURE MONITOR SHENZHEN PUMP MEDICAL SYSTEM CO., LTD. IVY CHEN
K132748 12/04/2013 BEAUTIFIL E POSTERIOR, BEAUTIFIL BULK SHOFU DENTAL CORPORATION DAVID P MORAIS
K132532 12/09/2013 SYNGO.PLAZA VB10A SIEMENS AG HEALTHCARE VIKTORIA BENZ
K123320 02/15/2013 DIMENSION AMMONIA FLEX REAGENT CARTRIDGE SIEMENS HEALTHCARE DIAGNOSTICS ROSE T MARINELLI
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K131164 12/24/2013 ACUSON SIEMENS MEDICAL SOLUTIONS USA, INC. SHELLY PEARCE
K123529 02/26/2013 ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC. PATRICIA D JONES
K133435 12/12/2013 MAGNETOM AERA AND SKYRA WITH SOFTWARE MR D13A SIEMENS MEDICAL SOLUTIONS USA, INC. NADIA SOOKDEO
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K123420 02/01/2013 SYNGO, BREAST CARE SIEMENS MEDICAL SOLUTIONS USA, INC. PATRICIA D JONES
K133016 12/09/2013 VENT-OS SINUS DILATION SYSTEM SINUSYS CORPORATION MICHAELE A DANIEL
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K130708 12/11/2013 SMITH & NEPHEW PATIENT MATCHED CUTTING BLOCKS SMITH & NEPHEW, INC. Bradley Heil
K132079 12/05/2013 TFCC FAST-FIX KIT SMITH & NEPHEW, INC. JASON SELLS
K132015 12/13/2013 TRUCLEAR MORCELLATION SYSTEM AND TRUCLEAR MORCELLATORS SMITH & NEPHEW, INC. Bradley Heil
K123425 02/20/2013 TWINFIX TI 3.5MM SUTURE ANCHOR WITH TWO ULTRABRAID SUTURE #2 WITH NEEDLES, SL SMITH & NEPHEW, INC. CATHERINE KILSHAW
K130394 12/09/2013 CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0 SMITHS MEDICAL ASD, INC. PAULA CORDERO
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K123232 02/07/2013 SPINEOLOGY SPINOUS PROCESS PLATE SPINEOLOGY, INC. BRYAN BECKER
K122587 02/07/2013 BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208 ST. JUDE MEDICAL HARLAN JONES
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K123646 02/22/2013 EMORY CARDIAC TOOLBOX 4.0 SYNTERMED, INC. KENNETH VAN TRAIN
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K131053 12/31/2013 ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEM THE ANSPACH EFFORT, INC. ANNETTE M HILLRING
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K123751 02/28/2013 LOFRIC SENSE WELLSPECT HEALTHCARE Allison C Komiyama
K123588 02/19/2013 INTRADERMAL ADAPTER WEST PHARMACEUTICAL SERVICES, INC. DEBBIE M THOMAS
K131664 12/18/2013 COPRA TEMP PMMA-DISK WHITE PEAKS DENTAL SYSTEMS GMBH & CO. KG JOHN WATERS
K123680 02/21/2013 COPRANCOLOR WHITE PEAKS DENTAL SYSTEMS GMBH & CO. KG OLIVER PUCKERT
K123681 02/22/2013 1.5T 4CH LARGE FLEX COIL, 1.5 4CH SMALL FLEX COIL WIPRO GE HEALTHCARE PRIVATE, LTD. SHASHIDHAR C S
K123116 02/11/2013 CHLORINATED POWDER FREE NITRILE EXAMINATION GLOVES (BLACK COLOUR) WORLDMED MANUFACTURING SDN. BHD. OOI LOON SENG
K131596 12/11/2013 WOUND MEASURING & MONITORING DEVICE WOUNDVISION, LLC GRETCHEN MILLER BOWKER
K123688 02/08/2013 PROFEMUR TL CLASSIC HIP STEM WRIGHT MEDICAL TECHNOLOGY, INC. YUAN LI
K123434 02/05/2013 PROFEMUR Z CLASSIC STEMS WRIGHT MEDICAL TECHNOLOGY, INC. DAVID FITCH
K132484 12/13/2013 DERMAGRIP POWDER FREE BLACK NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE WRP ASIA PACIFIC SDN. BHD. KIRK PENNER
K133094 12/11/2013 CERTEX OCT SPINAL IMPLANT SYSTEM X-SPINE SYSTEMS, INC DAVID KIRSCHMAN, M.D.
K130611 12/19/2013 ENTUIT THRIVE BALLOON RETENTION GASTROSTOMY FEEDING TUBE XERIDIEM MEDICAL DEVICES MICHELLE LOTT
K123250 12/18/2013 AXIOS STENT AND DELIVERY SYSTEM XLUMENA, INC JANE BEGGS
DEN130007 12/18/2013 AXIOS STENT AND DELIVERY SYSTEM XLUMENA, INC JANE BEGGS
K132854 12/23/2013 EYE SECRET 38 UV ASPHERIC (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR YUNG SHENG OPTICAL CO., LTD. WEN-HAN CHEN
K132904 12/05/2013 ZIEHM VISION RFD ZIEHM IMAGING GMBH RICHARD L WESTRICH
K123459 02/22/2013 ZIMMER PERSONA TM PERSONALIZED KNEE SYSTEM ZIMMER INC. CAROL VIERLING, RAC
K132790 12/20/2013 INFIX ANTERIOR LUMBAR SYSTEM ZIMMER SPINE, INC DONNA SEMLAK
K133291 12/17/2013 ST360 DEGREES SPINAL FIXATION SYSTEM ZIMMER SPINE, INC MICHELLE LENZ
K123918 02/14/2013 MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATE SYSTEM ZIMMER, INC. STEPHEN H MCKELVEY, MA, RAC
K130143 02/22/2013 PERSONA NATURAL TIBIA BASEPLATES ZIMMER, INC. NICOLE J MEREDITH
K132386 12/23/2013 TOTALSHIELD SURGICAL HELMET SYSTEM ZIMMER, INC. ALLISON SCOTT, RAC
K133246 12/17/2013 ZIMMER DISTAL RADIUS PLATING SYSTEM ZIMMER, INC. ROMIL SHETH
K131919 12/17/2013 ZOLL EPCR IOS ZOLL MEDICAL CORPORATION SHANNON DUHAMEL
K130092 02/27/2013 SIMMETRY SACROILIAC JOINT FUSION SYSTEM Zyga Technology, Inc. Diane Brinza


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