FDA 510(k) Decisions During July, 2015  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K150477 07/02/2015 3M Comply Indicator Tape for Ethylene Oxide (EO) Sterilization 3M COMPANY MATT MORTENSEN
K151566 07/10/2015 Abbott ARCHITECT Total T4 Calibrators ABBOTT LABORATORIES Lisa Lukowski
K151317 07/06/2015 Armada 18 PTA Catheter ABBOTT VASCULAR Shu Chi Hsu
K151014 07/13/2015 Aura DR 43C-AG flat panel detector ABYZR CO., LTD JOHN LIM
K150873 07/01/2015 CyberKnife M6 FI Sytem, CyberKnife M6 FM System, CyberKnife M6 FIM System ACCURAY INCORPORATED Shweta Kaushik
K150866 07/17/2015 SURGISEAL Topical Skin Adhesvie ADHEZION BIOMEDICAL, LLC TRACY LOFGREN
K151363 07/31/2015 Zephyr Vascular Compression Device ADVANCED VASCULAR DYNAMICS MATTHEW SEMLER
K143719 07/10/2015 Aeroneb USB Contoller System Aerogen Limited Martin Crehan
K151696 07/20/2015 Caiman Seal and Cut Technology AESCULAP, INC. Denise Adams
K151858 07/21/2015 Caiman Seal and Cut Technology Aesculap, Inc. Denise Adams
K142970 07/08/2015 SterilContainer S System AESCULAP, INC. Denise R Adams
K151464 07/28/2015 Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B Control Swab Kit ALERE SCARBOROUGH, INC. ANGELA DRYSDALE
K151690 07/16/2015 Alere i Instrument, Alere i Influenza A & B, Alere i Strep A ALERE SCARBOROUGH, INC. Angela Drysdale
K142651 07/17/2015 The Moses Express appliance ALLEN J. MOSES, DDS, LTD. ALLEN J. MOSES, DDS
K150773 07/23/2015 E-CUBE 15 Diagnostic Ultrasound System ALPINION MEDICAL SYSTEMS CO., LTD DONGHWAN KIM
K150924 07/27/2015 A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (1) plus Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (2), A.I.M. Lead Loop Suturing Device plus Tension Assist/Sut ANCHOR INNOVATION MEDICAL (A.I.M.) CARY STALNECKER
K151513 07/08/2015 Arrow Endurance Extended Dwell Peripheral Catheter System Arrow Internation, Inc. (subsidiary of Teleflex Inc.) Tracy Larish
K143102 07/24/2015 Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions Arrow International, Inc. (Subsidiary of Teleflex Inc.) Debra Grodt
K143745 07/02/2015 Arthrex Corkscrew and SwiveLock Suture Anchors Arthrex, Inc. David L Rogers
K151660 07/16/2015 MultiFIX S Knotless Fixation System ArthroCare Corporation Laura Kasperowicz
K143082 07/24/2015 IV Administration Sets with 200(micro)m Blood Filter B. Braun Medical Inc. Angela J Caravella
K151505 07/17/2015 Coronis Uniti Barco N.V. Franky Dubois
K151698 07/27/2015 BD Angiocath IV Catheter, BD Insyte IV Catheter BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. HENRY BOLAND
K150953 07/16/2015 Sequential Circulator SC-2008-OC, Sequential Circulator SC-2004-OC BIO COMPRESSION SYSTEMS, INC. Barbara J Whitman
K143103 07/16/2015 PROPENCIL Smoke Pencil BIO PROTECH, INC. Terry Kim
K150296 07/02/2015 Biodenta Customized Abutment-Hybrid BIODENTA SWISS AG David Elier
K142813 07/31/2015 Biogensis Implant System-Kisses BIOGENESIS CO., LTD. Haeyong Lee
K143120 07/24/2015 OrthoPulse BIOLUX RESEARCH LTD. Kevin Strange
K151483 07/31/2015 Biomet Spine Fusion System Biomet Spine LLC. Ted Kuhn
K150850 07/16/2015 Refobacin Bone Cement R BIOMET, INC. CARMEN ALBANY
K151187 07/27/2015 QuadraSphere Microspheres BIOSPHERE MEDICAL S.A. ALIX FONLLADOSA
K142799 07/09/2015 Model BT-220L and BT-220C Bistos Co., Ltd. Young Chi
K151760 07/27/2015 Barricade Embolization Coil System BLOCKADE MEDICAL REBECCA K. PINE
K143193 07/24/2015 Symmetry and Symmetry Stiff Shaft Balloon Dilatation Catheters BOSTON SCIENTIFIC Anna Deraney
K151177 07/30/2015 XenMatrix AB Surgical Graft C.R. Bard Tony John
K150699 07/28/2015 Bard LubriGuard Foley Catheter C.R. Bard, Inc. Michele Davis
K151054 07/07/2015 Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation System C2 Therapeutics, Inc. Theresa Brandner-Allen
K151107 07/22/2015 CoSense ETCO Monitor Capnia Inc KRISTEN YEN
K151010 07/28/2015 Piccolo Composite Nailing System CARBOFIX ORTHOPEDICS LTD. YAEL RUBIN
K150990 07/02/2015 ECVUE Mapping System CardioInsight Technologies, Inc. Christina V Vacca
K143275 07/10/2015 IOLMaster700 Carl Zeiss Meditec, Inc. Christine Dunbar
K151068 07/24/2015 SureLock W Suture Anchor CAYENNE MEDICAL, INC SHIMA HASHEMIAN
K143356 07/21/2015 NovoStitch Plus Meniscal Repair System Ceterix Orthopaedics, Inc. Michael Hendricksen
K150861 07/28/2015 QBit Series Diagnostic Ultrasound System CHISON MEDICAL IMAGING CO., LTD. QIFEI LIU
K150886 07/20/2015 Trojan Riviera Personal Lubricant CHURCH & DWIGHT CO., INC. LISA BURNS
K150661 07/07/2015 ST.A.R. 90 F4 External Fixation Screws With Hydroxyapatite CITIEFFE s.r.l Stefano Pullega
K150555 07/15/2015 BA400 14mm Abutment COCHLEAR AMERICAS Tristan Manus
K150751 07/22/2015 Cordelle II Sound Processor COCHLEAR AMERICAS Laura Blair
K150935 07/02/2015 SpeediCath Compact Eve COLOPLAST A/S Meg Daniel
K151037 07/09/2015 GraftMax Button, ALB with Cradle, GraftMax Button, BTB with Cradle CONMED CORPORATION NYROBIA FREEMAN
K150590 07/10/2015 CONTAFLEX 54 (hioxifilcon D) Spherical Soft Contact Lens for Daily Wear, CONTAFLEX 49 (hioxifilcon B) Spherical Soft Contact Lens for Daily Wear, CONTAMAC LTD Rob McGregor
K150350 07/21/2015 Flexi-Seal Signal Fecal Management System ConvaTec Ltd. Clare Williamson
K142829 07/28/2015 Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo Introducer, Ansel Modification; Flexor Check-Flo Introducers, Ansel Modification with High-Flex Dilator and Hydrophilic Coating; Flexor Check-Flo Introducer Balkin Up and Over Co Cook Incorporated Sarah Reeves
K151676 07/22/2015 Retracta Detachable Embolization Coil COOK INCORPORATED DAVID LEHR
K142819 07/24/2015 Shuttle SL Flexor Tuohy-Borst Side-Arm Introducer Set COOK INCORPORATED STEVEN LAWRIE
K143650 07/21/2015 CooperSurgical Advincula Delineator Uterine Manipulator Cooper Surgical Inc. James Keller
K151204 07/31/2015 HEMO-Bandage CORELEADER BIOTECH CO., LTD. Ya-Wen Kuo
K150084 07/13/2015 Argyle? Polyvinyl Chloride (PVC) and Kangaroo? Polyurethane (PU) Neonatal and Pediatric Feeding Tubes with ENFit connector COVIDIEN SONA MANICKAM
K150844 07/14/2015 Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Reusable Inner Cannula COVIDIEN Danielle Mueller
K151548 07/02/2015 VersaOne Bladed Trocar, VersaOne Bladeless Trocar COVIDIEN Trang Huynh
K150251 07/28/2015 Barrx Anorectal RFA Wand Covidien LLC RACHEL SILVA
K151659 07/17/2015 ReliaTack Articulating Reloadable Fixation Device with Deep Purchase Reloadable Tacks Covidien LLC Mary Mellows
K150484 07/09/2015 Penguin In-Line Warmer Creche Innovations REBECCA P PINE
K151568 07/31/2015 Arthrex OrthoVis Preoperative Plan Custom Orthopaedic Solutions, Inc. Peter O'Neill
K143143 07/22/2015 PATHWAY ELIF CUSTOM SPINE, INC. Mahmoud Abdelgany
K150321 07/13/2015 EVOS Lumbar Interbody System Cutting Edge Spine, LLC John Souza
K150724 07/01/2015 SculpSure CYNOSURE, INC. KEVIN O'CONNELL
K150587 07/21/2015 Cortex Laser System Cynosure, Inc. dba Ellman Allison Sathe
K151854 07/28/2015 3MP (X213C3P0E, X213G3P0E) and 2MP (X213C2P0E, X213G2P0E) LCD Display D-VIEW DISPLAY TECHNOLOGY CO., LTD. JIANFEI SUN
K151254 07/02/2015 CARDIOSAVE Hybrid Intra-Aortic Balloon Pump DATASCOPE CORP. Helder A Sousa
K150759 07/28/2015 Hyper-C Anterior Cervical Plate System Degen Medical Craig Black
K150347 07/24/2015 Deltex Medical CardioQ-EDM, Deltex Medical CardioQ-EDM+ DELTEX MEDICAL LIMITED Paul Dwane
K143033 07/21/2015 DENTCA DENTURE BASE DENTCA, INC. Jason Lee
K150344 07/24/2015 Dentis Dental Implant System DENTIS CO., LTD. JINJU LEE
K142962 07/23/2015 PROTOCOL Incision Dressing DEROYAL INDUSTRIES Elizabeth Wheeler
K150371 07/30/2015 Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR and DTRH DIROS TECHNOLOGY, INC. GEORGE DARMOS
K151298 07/30/2015 Gemini XXP-HP Dornier MedTech America John Hoffer
K151038 07/24/2015 EPX-Series Mobile X-ray System ECOTRON CO.,LTD SANG BONG LEE
K150901 07/01/2015 Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express EDAN INSTRUMENTS, INC. Queena Chen
K150906 07/24/2015 ULTRAPRO ADVANCED Macroporous Partically Absorbable Mesh EHICON INC. SUSAN LIN
K151883 07/30/2015 5MP Monochrome LCD Monitor, RadiForce GX540 EIZO CORPORATION HIROAKI HASHIMOTO
K151113 07/22/2015 ELITech Clinical Systems CALCIUM ARSENAZO ELITechGroup Valerie Gourdon
K151552 07/08/2015 ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II ELITechGroup Valerie Gourdon
K150907 07/07/2015 Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra Ellipse A/S Ole Kofod
K151340 07/10/2015 HARMONIC Focus Long Shears + Adaptive Tissue Technology ETHICON ENDO-SURGERY, LLC MARJORIE MEDINA
K150670 07/02/2015 STRATAFIX Spiral PDS Plus Knotless Tissue Control Device ETHICON, INC. DONNA MARSHALL
K150066 07/20/2015 Exactech Alteon Monobloc Revision Stem EXACTECH, INC. Patrick Hughes
K143732 07/06/2015 FUJIFILM Endoscope Models EC-600HL and EC-600LS FUJIFILM Medical Systems U.S.A., Inc. Mary Moore
K150349 07/14/2015 Rapid Hair Removal Pads FULL POWER AED Jahn Power
K150128 07/16/2015 GC Ortho Connect, GC Ortho Etching Gel GC Orthodontics America Inc. Mark Heiss
K143676 07/31/2015 B40i Patient Monitor GE HEALTHCARE FINLAND OY JOEL KENT
K150245 07/17/2015 CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX GE HEALTHCARE FINLAND OY Mari Salmenkaita
K143345 07/10/2015 SIGNA Pioneer GE HEALTHCARE JAPAN CORPORATION Toru Shimizu
K143368 07/29/2015 GenIQ GE MEDICAL SYSTEMS, LLC. Jenny Wong
K150752 07/31/2015 GME ExSys 308 GME (GERMAN MEDICAL ENGINEERING) GMBH STEFAN SCHULZE
K142726 07/24/2015 O Glide Personal Lubricant Grafenberg Labs Manny Frankl
K143735 07/23/2015 Digital Automatic Blood Pressure Monitor MD2300 Grandway Technology (Shenzhen) Limited Patrick Chow
K151478 07/01/2015 Wondfo CR3 Keyless Split Sample Cup GUANGZHOU WONDFO BIOTECH CO., LTD. BEN CHEN
K143656 07/09/2015 StarCeram« Z-Nature, StarCeram« Z-Smile H.C. Starck Ceramics GmbH Alexandra Krausch
K143219 07/31/2015 NIRO-200NX Hamamatsu Photonics K.K. SUSUMU SUZUKI
K142764 07/09/2015 KYOLING CPR Mask with Oxygen Port and Without Oxygen Port HANGZHOU JINLIN MEDICAL APPLIANCES CO., LTD. Lydia HE
K151730 07/23/2015 Magellan Robotic System HANSEN MEDICAL, INC. TODD MILHOLLAND
K143227 07/01/2015 Magellan Robotic System, Magellan Robotic Catheter 10Fr HANSEN MEDICAL, INC. TODD MILHOLLAND
K150933 07/07/2015 iBond Universal & iBond Ceramic Primer Heraeus Kulzer LLC, Mitsui Chemicals Group Jamie Cleveland
K150756 07/20/2015 Micro well group culture dish, 9-well; Micro well group culture dish, 16-well HERTART MICHAEL TRINKLE
K151015 07/29/2015 ECHELON Oval V 5.0 MRI System HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUG THISTLETHWAITE
K143737 07/27/2015 EM25 - glute toning device HIVOX BIOTEK, INC. CLYTIE CHIOU
K151395 07/24/2015 Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets Immunalysis Corporation Joseph Ginete
K151233 07/07/2015 Monaco IMPAC MEDICAL SYSTEMS, INC. KATHRYN STINSON
K143011 07/16/2015 Implant, Endosseous, Root-Form and Endosseous dental implant abutment Implant Direct Sybron Manufacturing LLC Ines Aravena
K151146 07/24/2015 N-Force Fixation System INNOVISION, INC. KEITH RUSSELL
K143213 07/10/2015 INOmax DSIR Plus MRI INO Therapeutics/Ikaria Robert Bovy
K150365 07/21/2015 Cloud9 System inSleep Technologies, LLC Marty Kerber
K151534 07/06/2015 HemosIL D-Dimer HS INSTRUMENTATION LABORATORY CO. NIKITA MALLADI
K151616 07/15/2015 AT235 INTERACOUSTICS A/S ERIK NIELSEN
K150486 07/24/2015 Halo J & J Solutions, Inc. d/b/a/Corvida Medical Dana Schramm
K150248 07/23/2015 ORL Video NasoPharyngo-Larngoscope JEDMED INSTRUMENT COMPANY CRAIG PARKS
K143070 07/07/2015 Disposable Safety Self-destructive Syringes, 5 ML Jiangsu Yile Medical Article Co.,Ltd. Feng Xingyuan
K150367 07/13/2015 Neodent Implant System JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S Jacson Cambruzzi
K151143 07/09/2015 EndoLIF On-Cage JOIMAX GMBH Eulodie Tila
K150983 07/14/2015 Pyrenees Cervical Plate System K2M Nancy Giezen
K143271 07/01/2015 CastleLoc-P Anterior Cervical Plate System L&K BIOMED Co., Ltd Ki-Hyang Kim
K143278 07/29/2015 LnK Posterior Cervical Fixation System L&K BIOMED Co., Ltd. An Yerim
K151677 07/15/2015 LnK Cervical Interbody Fusion Cage System L&K BIOMED Co.,Ltd. Yerim An
K143152 07/22/2015 TM-ABI system LD TECHNOLOGY LLC Albert Maarek
K151196 07/14/2015 Nautilus Spinal System LIFE SPINE, INC RANDY LEWIS
K150712 07/02/2015 LTM-Perforated Surgical Mesh LifeCell Corporation Linda Scamardella
K150214 07/31/2015 OneTouch Verio Flex Blood Glucose Monitoring System LIFESCAN EUROPE Alison Wilson
K143277 07/29/2015 Cream Stretch Vinyl Patient Examination Glove (Non-Sterile),White Vinyl Patient Examination Glove (Non-Sterile), Lifestyle Safety Products (Hui Zhou) Co., Ltd. Lee Hong Chong
K150878 07/15/2015 ILUMIEN OPTIS LIGHTLAB IMAGING,INC. ERDIE DE PERALTA
K150903 07/15/2015 EACU, ZAGU, JOCU, EAKU, BALANCE, TEMPO, ACUZONE, SMART, PRIME, ACUSTAR, ACUKING, Myotech Dry, Red Coral Premium, Red Coral J-Type, Red Coral Natural MAANSHAN BOND MEDICAL INSTRUMENTS CO., LTD. Viva Gu
K142705 07/07/2015 LeadCare Plus Blood Lead Testing System Magellan Diagnostics Reba Daoust
K151199 07/30/2015 SmartDrive Wheelchair Power Assist MAX MOBILITY, LLC Ben Hemkens
K151377 07/16/2015 ActiveCare+SFT;ActiveCare+SFT HomeCare, ActiveCare+DTx;ActiveCare+DTx HomeCare MEDICAL COMPRESSION SYSTEM (DBN) LTD. EYAL SANDACH
K143688 07/01/2015 ASFORA ANTERIOR CERVICAL PLATE SYSTEM MEDICAL DESIGNS, LLC KRISTI VONDRA
K151628 07/24/2015 Medline ENFit Connectors MEDLINE INDUSTRIES, INC. STEPHANIE BLAIR
K143322 07/20/2015 Medline Natural Lubricating Liquid MEDLINE INDUSTRIES, INC. JENNIFER MASON
K150776 07/17/2015 Medrobotics Flex System MEDROBOTICS CORPORATION JOHN D BONASERA
K150611 07/15/2015 MedSource ClearSafe Safety IV Catheter MedSource International Laura Riggen
K143031 07/07/2015 mcompass Biofeedback Anorectal Manometry System MEDSPIRA, LLC JIM QUACKENBUSH
K151067 07/22/2015 Ventilation (Tympanostomy) Tubes Medtronic Xomed, Inc. Michelle Hughes
K151532 07/23/2015 KYPHON ELEMENT Inflatable Bone Tamp MEDTRONIC, INC. PAMELA EDWARDS
K151523 07/16/2015 Uncoated Tubing and Connector Components MEDTRONIC, INC. JACQUELINE A. HAUGE
K150537 07/21/2015 MiNi Internal Implant System MEGAGEN IMPLANT CO., LTD Dong Guk Ha
K151046 07/17/2015 illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control Kit, illumipro-10 MERIDIAN BIOSCIENCE, INC. STEFANIE JOHNS
K151497 07/01/2015 EN Snare Endovascular Snare System MERIT MEDICAL SYSTEMS INC MARK MULLANEY
K150107 07/29/2015 Arc Intracranial Support Catheter, Arc Mini Intracranial Support Catheter MICRO THERAPEUTICS INC DBA EV3 NEUROVASCULAR Phuong Chau
K151447 07/28/2015 Axium Detachable Coil System MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR PATRICIA CASING
K150316 07/30/2015 Polypectomy Snare MICRO- TECH (NANJING) CO., LTD. BECKY LI
K151330 07/14/2015 Microlife Wrist Watch Blood Pressure Monitor MICROLIFE INTELLECTUAL PROPERTY GmbH, SWITZERLAND GERHARD FRICK
K151543 07/07/2015 Graft Delivery Device with Integrated Stylet Micromedics Inc. (d/b/a Nordson Medical) Amy L Peterson
K151536 07/08/2015 SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm MRI INTERVENTIONS, INC. E F WADDELL
K151557 07/16/2015 EGENS Urine Test Cup Morphine - Methamphetamine, EGENS Urine DipCard Morphine - Methamphetamine NANTONG EGENS BIOTECH CO., LTD. BEN CHEN
K150912 07/10/2015 Houva-NET Control System National Biological Corporation Lynn Keller
K143607 07/08/2015 I-Portal NOTC, VNG and VOG NEURO KINETICS, INC. J. Howison Schroeder
K150313 07/09/2015 Ablation Confirmation NEUWAVE MEDICAL INC. DAN KOSEDNAR
K150742 07/23/2015 Muscle Stimulation System 110 NIVEUS MEDICAL, INC. Brian Fahey
K151654 07/17/2015 PROW FUSION NLT SPINE LTD Eti Zinger
K150874 07/31/2015 NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) NOVO NORDISK INC. Poonam Tuliani
K150370 07/22/2015 Nutra Light Advanced NUTRA LUXE MD, LLC GLORIA AVENDANO
K142855 07/28/2015 Omega Laboratories Hair Drug Screening Assay Methamphetamine (Meth) and -3, 4-methylenedioxymethamphetamine (MDMA) Omega Laboratories, Inc. William Corl
K151207 07/28/2015 Proton Immobilization Solution ORFIT INDUSTRIES NV EDDY MARIVOET
K150272 07/17/2015 Capnostream 35 Portable Respiratory Monitor ORIDION MEDICAL 1987 LTD. Dalia Givony
K151488 07/07/2015 Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System Orthofix, Inc. Jacki Geren
K151147 07/01/2015 STARband, STARlight ORTHOMERICA PRODUCTS, INC. DAVID C. KERR
K150655 07/09/2015 OIC Intramedullary Nail System ORTHOPAEDIC IMPLANT COMPANY Douglas Fulton
K151021 07/15/2015 OsteoMed Cannulated Screw System OSTEOMED CORP. Blesson Abraham
K151150 07/28/2015 Elements PAC-DENT INTERNATIONAL, INC. WENYING ZHU
K151418 07/15/2015 Monster Screw System PARAGON 28 FRANK S. BONO
K143355 07/10/2015 The Simple Locking IntraMedullary (SLIM) System PEGA MEDICAL INC. Ariel R Dujovne
K143202 07/07/2015 ANGIO-PRESS DVT Compression Device Model Name: IPCS Pegasus Medical Supply, Inc. PAO-MING SHIH
K151572 07/10/2015 Penumbra Smart Coil PENUMBRA, INC. CHARLES DENAULT
K151033 07/28/2015 Philips Self-Adhesive Electrodes PHILIPS CONSUMER LIFESTYLE MARTA WALKER
K151035 07/21/2015 PulseRelief PHILIPS CONSUMER LIFESTYLE Marta Walker
K151681 07/17/2015 IntelliVue Patient Monitor PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH JOHANNES SCHMID
K150088 07/20/2015 Evacore Fully Disposable Vacuum Assist Biopsy Device Pin-Point Care Corp. Jeff M Hathaway
K151184 07/14/2015 InFill Interbody Fusion Devices PINNACLE SPINE GROUP, LLC REBECCA K PINE
K151314 07/23/2015 CinchLock Flex Knotless Suture Anchor Pivot Medical Kelly Kucharczyk
K151530 07/07/2015 CardioChek Plus Test System POLYMER TECHNOLOGY SYSTEMS, INC. Megan Burns
K150856 07/07/2015 Reform Pedicle Screw System PRECISION SPINE, INC. Michael Dawson
K150380 07/17/2015 ProMIS Fixation System Premia Spine Ltd. Ron Sacher
K150601 07/22/2015 Zeramic Adhesive Resin Cement Premier Dental Company Products VINCENT D'ALESSANDRO
K143383 07/23/2015 Q6 Edge EM Pride Mobility Product Corporation Kimberly Elmes
K150872 07/02/2015 BruxZir Anterior Milling Blanks PRISMATIK DENTALCRAFT, INC. ARMIN ZEHTABCHI
K150423 07/08/2015 EXPAZEN PRODUITS DENTAIRES PIERRE ROLLAND (ACTEON GROUP) GENEVIEVE DE VILLEDON
K151709 07/17/2015 Hi-Light Diagnostic Ultrasound Systems Qingdao Hisense Medical Equipment Co., Ltd. Wang Wei
K151829 07/29/2015 Atlas SPEEDER Header/Neck Quality Electrodynamics, LLC KATHLEEN ARAS
K151707 07/19/2015 EzSensor Soft, EzSensor Soft i, EzSensor Bio, and EzSensor Bio i RAYENCE CO., LTD KEVIN KIM
K151438 07/07/2015 Dentrix Ascend Imaging REALCLOUD IMAGING INC. DOUGLAS A. GOLAY
K143532 07/31/2015 Durex Silicone Reckitt Benckiser LLC Elizabeth Torre
K143418 07/31/2015 STRONG Dental Handpieces Saeshin Precision Co., Ltd. Choi Sae Kwan
K151685 07/17/2015 GUA60A, GU60A-65 SAMSUNG ELECTRONICS CO., LTD. Chulsin Kim
K151808 07/29/2015 3D/5D Viewer SAMSUNG MEDISON CO., LTD KIM JIYOUNG
K150014 07/27/2015 Serenity SANUTHERA, INC. JEFFERY DIGIOVANNI
K143268 07/21/2015 TENS AND POWERED MUSCLE STIMULATOR SHENZHEN AS-TEC TECHNOLOGY CO., LTD CONNIE LI
K150995 07/06/2015 Electronic Pulse Stimulator SHENZHEN JINGKEHUI ELECTRONIC CO., LTD PU JIANG
K150632 07/06/2015 Hypervisor IX Monitoring System SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD YANHONG BAI
K150875 07/22/2015 iFuse Implant System SI-BONE, Inc. Roxanne Dubois
K150039 07/02/2015 MicroScan Dried Gram Positive MIC/Combo Panels with vancomycin (0.25-64 mcg/mL) Siemens Healthcare Diagnostics Inc. Shanon Popson
K143687 07/17/2015 ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material SIEMENS HEALTHCARE DIAGNOSTICS, INC. Fatima Pacheco
K151486 07/17/2015 Biograph mCT and mCT Flow PET/CT Scanners Siemens Medical Solutions USA, Inc. ALAINE MEDIO
K150750 07/02/2015 Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray Sirona Dental Systems GMBH Thomas Diesch
K150909 07/17/2015 INTEGO Family and Accesories Sirona Dental Systems GMBH Thomas Diesch
K151045 07/24/2015 TENEO Dental Treatment Unit and Accessories SIRONA DENTAL SYSTEMS GMBH THOMAS DIESCH
K151118 07/28/2015 Smith and Nephew Legion Hinge Knee System SMITH & NEPHEW ALLISON CHAN
K143133 07/23/2015 RENASYS? EZ MAX Negative Pressure Wound Therapy Device, RENASYS? AB Abdominal Dressing Kit with Soft Port Device SMITH & NEPHEW, INC. LAURA REYNOLDS
K151326 07/16/2015 RENASYS? EZ PLUS Negative Pressure Wound Therapy Device Smith & Nephew, Inc. Laura Reynolds
K151105 07/28/2015 Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew Suture Anchors - TAG Bioraptor Suture Anchor 7209317, 7209318, Smith and Nephew Suture Anchors - Bioraptor 2.3 PK Suture Anchor, Smith and Nephew Suture Anchors - Osteorap Smith & Nephew, Inc. Katherine Marcaccio
K143115 07/15/2015 The VersaJet II Hydrosurgery System SMITH & NEPHEW, INC. Laura Reynolds
K150377 07/29/2015 Sony LMD-X310S LCD Monitor, Sony LMD-X310MD LCD Monitor, Sony LMD-X310NB LCD Monitor, Sony LMD-X550S LCD Monitor, Sony LMD-X550MD LCD, Sony LMD-X550NB LCD Monitor SONY ELECTRONICS, INC. Amarjit Andy Singh Jowandha
K151053 07/31/2015 PSPIX 2 scanner, Imaging Plate Size 0 for PSPIX2 scanner, Imaging Plate Size 1 for PSPIX2 scanner, Imaging Plate Size 2 for PSPIX2 scanner, Imaging Plate Size 3 for PSPIX2 scanner SOPRO - ACTEON GROUP PHILIPPE BOYER
K142827 07/20/2015 Visi Mobile Monitoring System, Visi Mobile Chest Sensor Sotera Wireless, Inc. Eben Gordon
K151581 07/09/2015 Leva Spacer System SPINE WAVE, INC. GAIL YAEKER-DAUNIS
K151813 07/31/2015 Sniper Spine System SPINE WAVE, INC. Ronald K Smith
K151198 07/17/2015 A-CIFT SoloFuse SPINEFRONTIER, INC. MANTHAN J DAMANI
K151020 07/22/2015 Rampart-T Interbody Fusion System Spineology, Inc. Tim Crabtree
K151101 07/17/2015 Lotus Series 4 Ultrasonic Surgical System & Accessories SRA DEVELOPMENTS, LTD. Alan Chivers
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K150968 07/24/2015 TRU Dental Implant System Sterngold Dental, LLC Maria Rao
K150938 07/24/2015 Straumann« Dental Implant System ? Roxolid« SLA Implants STRAUMANN USA, LLC CHRISTOPHER KLACZYK
K150700 07/15/2015 ACP 1 Anterior Cervical Plating System STRYKER CORPORATION Tina Mornak
K151755 07/09/2015 OASYS(r) System Stryker Corporation Garry T Hayeck
K150301 07/08/2015 NavSuite3 Kit Stryker Leibinger GmbH & Co. KG - Navigation Robin L Rowe
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K150641 07/31/2015 MagVita TMS Therapy System TONICA ELEKTRONIK A/S Lise Terkelsen
K150715 07/28/2015 2.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture Anchors TORNIER, INC. Kaitlyn Rainbow
K151170 07/02/2015 Tosama 100% Organic Cotton Menstrual Tampon TOSAMA D.O.O. MARJETKA KRALJ KUNCIC
K151451 07/09/2015 Aplio 500/400/300 Diagnostic Ultrasound System V6.0 TOSHIBA MEDICAL SYSTEMS CORPORATION PAUL BIGGINS
K151091 07/13/2015 Vitrea Software Toshiba Package, VSTP-001A Toshiba Medical Systems Corporation Paul Biggins
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K150613 07/22/2015 LaserCap LC Pro and LC Elite TRANSDERMAL CAP, INC. MICHAEL RABIN
K150394 07/28/2015 Tyber Medical Wedge System TYBER MEDICAL LLC JEFF TYBER
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K142845 07/01/2015 SILKPRO laser hair removal system Wuhan Lotuxs Technology Co., Ltd Wu Na
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K143346 07/22/2015 Powder-Free White Vinyl Patient Examination Gloves Zibo Changda Plastic Products Company, Limited Coco Kou
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