FDA 510(k) Applications Received During April, 2016

FDA 510(k) Number Submission Date Device Name Applicant Contact
K161144 04/22/2016 iDMS Data Management System ACCURAY INCORPORATED Elizabeth Osuna
K161136 04/22/2016 Precision Treatment Planning System ACCURAY INCORPORATED Shweta Kaushik
K161146 04/22/2016 Radixact Treatment Delivery System ACCURAY INCORPORATED Keith Picker
K161011 04/11/2016 SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISEAL Twist Topical Skin Adhesive Adhezion Biomedical, LLC Richard Jones
K160903 04/01/2016 STERRAD 100NX Sterilizer with ALLClearTM Technology ADVANCED STERILIZATION PRODUCTS JAMIE BYUN
K161061 04/15/2016 IMPAX Volume Viewing 4.0 AGFA HEALTHCARE N.V. Koen Cobbaert
K161179 04/26/2016 Intelli-Ox AIR LIQUIDE HEALTHCARE AMERICA CORPORATION Steve Miller
K160952 04/05/2016 Alma Diode Tabletop Laser ALMA LTD Ariela Albalak
K160958 04/05/2016 Battalion Universal Spacer System ALPHATEC SPINE MARY FUNK
K160976 04/07/2016 Altus Spine Interbody Fusion System ALTUS PARTNERS, LLC Claudia Hill
K160924 04/04/2016 Amendia Interbody Fusion Devices AMENDIA, INC. Bruce Hooper
K160974 04/07/2016 Gammex Cut-Resistant Glove Liner ANSELL HEALTHCARE PRODUCTS LLC ROBERT MAHLER
K161177 04/26/2016 Axiom PX ANTHOGYR SAS THERESE CANDAU
K161077 04/18/2016 RnD TE and RnD SE Apex Dental Materials, Inc Scott Lamerand
K161066 04/15/2016 SpotLight CT Arineta Ltd. Ehud Dafni
K160925 04/04/2016 VPS Rhythm Device with TipTracker Technology ARROW INTERNATIONAL, INC. (A SUBSIDIARY OF TELEFLEX, INC.) KARL J. NITTINGER
K161060 04/15/2016 Arthrex iBalance UKA System Vitamin E Tibial Bearing Arthrex, Inc. David L Rogers
K161108 04/20/2016 Arthrex VaultLock Glenoid ARTHREX, INC. Courtney Smith
K161126 04/21/2016 ASAHI Corsair Pro ASAHI INTECC CO., LTD. CARROLL COUNCILMAN
K161044 04/13/2016 AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Phencyclidine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) ASSURE TECH (HANGZHOU) CO., LTD. SHISHENG LING
K161208 04/28/2016 CROSSER CTO Recanalization Catheter Bard Peripheral Vacular, Inc. Melanie Hadlock
K161012 04/11/2016 Easy-Load Lens Delivery System Bausch and Lomb, Inc. Joyce Zhong
K161170 04/26/2016 BD Eclipse Hypodermic Needle Becton, Dickinson and Company Priyanka Apte
K160984 04/07/2016 MultiScan G-Arm System BEIJING EAST WHALE IMAGING TECHNOLOGY CO., LTD SHARON FAN
K161050 04/14/2016 ACTABOND Topical Skin Adhesive BERGEN MEDICAL PRODUCTS, INC. Tom Stephens
K161109 04/20/2016 iSR'obot MRI-US Fusion BIOBOT SURGICAL PTE LTD Lai Chee LIEW
K161211 04/28/2016 Digital Thermometer BIOCARE ASIA CORPORATION LTD. KE-MIN JEN
K160911 04/01/2016 VIDAS B.R.A.H.M.S. PCT (PCT) bioMerieux, Inc Thi My Lan Dang
K161217 04/29/2016 VITEK 2 Gram Negative Ceftriaxone (<=0.25->=64 ug/mL) bioMerieux, Inc. Karen Russell
K161190 04/27/2016 G7 Dual Mobility System, Active Articulation System Biomet, Inc Emily Manuel
K161166 04/26/2016 StageOne Select Cement Spacer Molds for Temporary Hip Replacement BIOMET, INC. Carmen Albany
K160985 04/08/2016 Pantera Pro BIOTRONIK, INC Jon Brumbaugh
K161051 04/14/2016 All-Bond Universal w/BAC (not finalized) Bisco, Inc. Ryan Hobson
K161003 04/11/2016 EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, EndoVive Button Right Angle Feeding Set with ENFit Connector, EndoVive Button Bolus Fee BOSTON SCIENTIFIC CORPORATION VIRGINIA GARCIA
K161125 04/21/2016 OptiCross X, 40 MHz Coronary Imaging Catheter Boston Scientific Corporation Eric Elliott
K161134 04/22/2016 Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator, Bovie DERM 942 Electrosurgical Generator BOVIE MEDICAL CORPORATION BRIAN KUNST
K161068 04/15/2016 Ahead 300 BRAINSCOPE COMPANY INC Michael Singer
K161215 04/29/2016 Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy Drugs BRIGHTWAY HOLDINGS SDN BHD G. BASKARAN
K160941 04/04/2016 Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter Brosmed Medical Co., Ltd. Tina Yin
K160992 04/08/2016 HPM-6000 BTL INDUSTRIES, INC. JAN ZARSKY
K160900 04/01/2016 CapSure Fixation System - Straight 5mm x 37 cm û 30 Permanent fasteners, CapSure Fixation System - Straight 5mm x 37 cm û 15 Permanent fasteners C.R. BARD INC. Andrew Harrell
K161183 04/27/2016 Halo One Thin-Walled Guiding Sheath C.R. BARD, INC FIONA NI MHULLAIN
K161202 04/28/2016 C2 Cryoballoon Ablation System C2 THERAPEUTICS, INC. Theresa Brandner-Allen
K160994 04/08/2016 C2 CryoBalloon Focal Pear Catheter C2 THERAPEUTICS, INC. Theresa Brandner-Allen
K161027 04/12/2016 Cadwell AmpliScan Cadwell Industries, Inc. John Cadwell
K161130 04/21/2016 ResolutionMD CALGARY SCIENTIFIC, INC. Kyle Peterson
K161024 04/12/2016 Canadian Technical Tape, LTd. LF Process Indicator Steam Sterilization Tape Canadian Technical Tape, Ltd. Howard Cohen
K161151 04/25/2016 Spinal fixation system CANWELL MEDICAL CO., LTD. CHEN HUI
K161137 04/22/2016 Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip Reload CARDICA, INC. Greg Watson
K161194 04/27/2016 PLEX Elite 9000 SS-OCT CARL ZEISS MEDITEC, INC. CHRISTINE DUNBAR
K161033 04/13/2016 AFXÖ Femoral Implant With Inserter CAYENNE MEDICAL, INC. SHIMA HASHEMIAN
K160957 04/05/2016 CDB Self Ligating Bracket 8F CDB CORPORATION YANNIRE THOMPSON
DEN160016 04/14/2016 Variola virus Real-Time PCR Assay CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) YON YU
K160901 04/01/2016 Xpert Carba-R CEPHEID SCOTT A. CAMPBELL
K160988 04/08/2016 Biopor, AOC Porous Polyethylene, Cerepor CEREMED, INC. CHELSEA MITCHELL
K161123 04/21/2016 Baha 5 Power Sound Processor Cochlear Americas Laura Blair
K161017 04/12/2016 True HD 3MOS Camera System CONMED CORPORATION Diair Cantisani
K161100 04/19/2016 Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses CONTAMAC LTD. ROB MCGREGOR
K161048 04/14/2016 Conventus Orthopaedics Ulna Fixation System CONVENTUS ORTHOPAEDICS, INC. KENT LIND
K161000 04/11/2016 Biodesign Otologic Repair Graft COOK BIOTECH INCORPORATED PERRY W. GUINN
K161221 04/29/2016 Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug Cook Biotech Incorporated Perry W. Guinn
K161002 04/11/2016 Aprima Smartesis Centesis Pump COOK INCORPORATED ERUM B. NASIR
K161218 04/29/2016 Gianturco-Roehm BirdÆs Nest Vena Cava Filter COOK INCORPORATED Jessica Swafford
K161045 04/13/2016 Monoject Covidien Sona Manickam
K161105 04/19/2016 Reprocessed Compression Garments COVIDIEN WING NG
K160921 04/04/2016 CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical TD-5 High Level Disinfectant, CS Medical TD-8 High Level Disinfectant CS Medical LLC Kendall Ashe
K160968 04/06/2016 iPulse SmoothSkin Gold Hair Removal Device CYDEN LIMITED MIKE KIERNAN
K160922 04/04/2016 FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link); FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use (Link) Dako North America, Inc. Joel Weisenberger
K160926 04/04/2016 F1 MPS Modular Pedicle Screw System Degen Medical Craig Black
K160965 04/06/2016 SuperLine DENTIUM CO., LTD. YOUNJUNG YUK
K161030 04/13/2016 ATLANTIS Abutment for CONELOG implant Dentsply Sirona Helen Lewis
K161118 04/20/2016 SIMPLANT Online Case Review and SIMPLANT Editor DENTSPLY SIRONA HELEN LEWIS
K161213 04/29/2016 XSmart iQ DENTSPLY SIRONA HELEN LEWIS
K160907 04/01/2016 DePuy Actis DuoFix Hip Prosthesis DEPUY (IRELAND) Jaime Weeks
K161021 04/12/2016 HydroMARK Breast Biopsy Site Marker DEVICOR MEDICAL PRODUCTS, INC. SHAWNA ROSE
K161209 04/28/2016 Cirona 6400 DEVON MEDICAL PRODUCTS ROCCO BRAVOCO
K161139 04/22/2016 LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set DIASORIN, INC. JOHN WALTER
K160996 04/08/2016 Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm Dunamis LLC Prithvi Raj Chavan
K161187 04/27/2016 EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs ECO MEDI GLOVE SDN BHD Suresh Kumar
K160981 04/07/2016 Patient Monitor EDAN INSTRUMENTS, INC. QUEENA CHEN
K161056 04/14/2016 Telemetry Transmitter Edan Instruments, Inc. Queena Chen
K160982 04/07/2016 SphynxÖ Eden Spine LLC Guillaume Viallaneix
K161089 04/18/2016 sensiLight Mini EL GLOBAL TRADE LTD YAEL LIEBES-PEER
K160949 04/05/2016 Go Dose System ELI LILLY AND COMPANY SUMITRA M GHATE
K161162 04/25/2016 Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra ELLIPSE A/S OLE KOFOD
K161167 04/26/2016 Seal Single-Use Biopsy Valve ENDOCHOICE, INC. Daniel Hoefer
K161147 04/22/2016 EndoCure Model EUR078A ENDOCURE TECHNOLOGIES, INC. CHARLES J. NEFF
K160960 04/05/2016 EsophyX« Z Device with SerosaFuse Fasteners and Accessories ENDOGASTRIC SOLUTIONS, INC. STEVEN J HOFFMAN
K160945 04/05/2016 Endophys Blood Pressure Monitor ENDOPHYS HOLDINGS, LLC Rebecca K. Pine
K161199 04/28/2016 EndyMed Contour Handpiece ENDYMED MEDICAL LTD. Yoram Levy
K161067 04/15/2016 Mirragen Advanced Wound Matrix, 4x4ö, Mirragen Advanced Wound Matrix, 2x2ö, Mirragen Advanced Wound Matrix, 1x6ö ENGINEERED TISSUE SOLUTIONS, LLC Mark Borden
K160914 04/01/2016 sterEOS Workstation EOS IMAGING, INC. MATHIAS BREUIL
K161168 04/26/2016 MyLabSix Ultrasound System Esaote Europe B.V. Bert Vorstenbosch
K161117 04/20/2016 EzDent-i / E2 / Prora View EWOO SOFT CO., LTD. YOUNG SEOK KIM
K161004 04/11/2016 Self-retaining Retractor FETZER MEDICAL GMBH & CO.KG Harald Jung
K160967 04/06/2016 Finapres Nova Noninvasive Hemodynamic Monitor FINAPRES MEDICAL SYSTEMS BV IR. IRIS VAN UITERT
K161131 04/21/2016 FONA Pan/Ceph FONA SRL ELISA GUSBERTI
K161055 04/14/2016 Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji û 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15 Fuji Dynamics Ltd Kam Tim Ng
K161186 04/27/2016 Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter) FUJIFILM MEDICAL SYSTEMS U.S.A., INC. SHRADDHA MORE
K161119 04/20/2016 SonoSite iViz Ultrasound System FUJIFILM SONOSITE,INC. Patricia Liau
K160933 04/04/2016 Discovery NM 750b Bopsy GE Healthcare Efrat Hartog-David
K161047 04/13/2016 LOGIQ P9 and LOGIQ P7 GE Healthcare Bryan Behn
K160937 04/04/2016 Senolris GE Healthcare Mounir Zaouali
K161224 04/29/2016 LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3 GE Medical Systems Ultrasound & Primary Care Diagnostics LLC Tracey Ortiz
K160972 04/06/2016 Gexfix External Fixation Gexfix International Corp. Maurizio Longo
K161223 04/29/2016 TransContinental« M Spacers and InterContinental« Plate-Spacers GLOBUS MEDICAL INC. KELLY J. BAKER
K161214 04/29/2016 Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC 150(Cup, Dipcard), Wondfo Methamphetamine Urine Test MET 500 (Cup, Dipcard) GUANGZHOU WONDFO BIOTECH CO., LTD. Bin Chen
K161038 04/13/2016 PK Morcellator GYRUS ACMI, INC. GRAHAM A.L. BAILLIE
K160999 04/11/2016 Infra-red forehead thermometer HANGZHOU HUA'AN MEDICAL&HEALTH INSTRUMENTS CO., LTD AHNEO YANG
K160919 04/04/2016 Hansen Medical Magellan Robotic Catheter 9Fr HANSEN MEDICAL, INC. MARYSA LOUSTALOT
K160928 04/04/2016 Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Natural), Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Green) HARTALEGA SDB. BHD. KUAN KAM HON
K161006 04/11/2016 Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove HARTALEGA SDN. BHD. KUAN KAM HON
K161008 04/11/2016 POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE SURGICAL GLOVE HARTALEGA SDN. BHD. KUAN KAM HON
K161156 04/25/2016 Full Automatic (NIBP) Blood Pressure Monitor HEALTH & LIFE CO., LTD. SARAH SU
K161188 04/27/2016 HEPATIQ 1.1 HEPATIQ LLC DIPU GHOSH
K161163 04/25/2016 PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory HITACHI, LTD. Naoya Nishimura
K161036 04/13/2016 Hospira Extension Set, Hospira Primary Set HOSPIRA, INC. CHARLES NEITZEL
K161148 04/22/2016 icobrain Icometrix Dirk Loeckx
K161216 04/29/2016 Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators IMMUNALYSIS CORPORATION Joseph Ginete
K161158 04/25/2016 IDS-iSYS Intact PTHN IMMUNODIAGNOSTIC SYSTEMS LTD CHRIS PRICE
K161082 04/18/2016 IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration Verifiers IMMUNODIAGNOSTIC SYSTEMS LTD. MICK HENDERSON
K160995 04/08/2016 NEOVIEW Plating System In2Bones SAS Morgane Grenier
K161010 04/11/2016 HICP200 Patient/Monitor Interconnect Cable InnerSpace Neuro Solutions, Inc. Gary G. Frugard
K161013 04/11/2016 InnoSEAL Hemostatic Pad InnoTherapy Inc. Moon Sue Lee
K161189 04/27/2016 Integra TITAN Reverse Shoulder System INTEGRA LIFESCIENCES CORPORATION William Garzon
K161178 04/26/2016 da Vinci Xi Surgical System Intuitive Surgical, Inc. Brandon Hansen
K160964 04/06/2016 Neodent Implant System - Titanium Base for CEREC JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS SA JACSON Cambruzzi
K161098 04/19/2016 ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/Color) JOOWON INNOVATION CO., LTD. LEE HAE-HANG
K160918 04/04/2016 JUVORA Dental Disc, Ceramill PEEK by JUVORA JUVORA SELINA SALTHOUSE
K161028 04/12/2016 K2M Growing Spine System K2M, Inc. Nancy Giezen
K161112 04/20/2016 KARL STORZ Flexible Video-Neuro-Endoscope System KARL STORZ ENDOSCOPY-AMERICA, INC. SUSIE S. CHEN
K161042 04/13/2016 CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack Kuraray Noritake Dental, Inc. Michio Takigawa
K161101 04/19/2016 PolypVac Microdebrider (3.3mm and 4.0mm) LAURIMED LLC BRIAN R DUBOIS
K160956 04/05/2016 LD-Oxi system LD TECHNOLOGY LLC Albert MAAREK
K161173 04/26/2016 Avenue« T TLIF Cage LDR SPINE USA, INC. JOHN ROSSMAN
K161037 04/13/2016 Tarsa-Link Stand-Alone Wedge Fixation System LIFE SPINE INC. RANDY LEWIS
K161127 04/21/2016 The Small PLATEAU (PLATEAU-C) Spacer System LIFE SPINE INC. RANDY LEWIS
K161120 04/21/2016 SMR TT Metal Back Glenoid, Bone Graft instruments LIMACORPORATE S.P.A. Emanuele Buttazzoni
K161175 04/26/2016 Liofilchem MIC Test Strip (MTS)- Ceftolozane/Tazobactam 0.016/4 - 256/4 mcg/mL LIOFILCHEM S.R.L. FABIO BRACCO
K161220 04/29/2016 ARIES« Flu A/B & RSV Assay LUMINEX CORPORATION WENDY RICKER
K161195 04/27/2016 Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors) M3 GLOBAL ENTERPRISES, LLC NEIL MEHTA
K161026 04/12/2016 NexSiteÖ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 cm, 36 cm, 40 cm, 55 cm) MARVAO MEDICAL DEVICES, LTD. Christopher Davey
K160940 04/04/2016 Masimo Disposable Transflectance Forehead Sensor Masimo Corporation Marguerite Thomlinson
K161219 04/29/2016 Zmaxx T Series Maxx Digm, Inc. Keith Jew
K161128 04/21/2016 Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative Pressure Wound Therapy System, Invia Motion Canister/Tubing Set 0.151, Invia Motion Carrying Case, Power Supply Medela AG Markus Butler
K161149 04/25/2016 PASS OCT Spinal System MEDICREA INTERNATIONAL S.A David Ryan
K161035 04/13/2016 Medline Singe Patient Use Blood Pressure Cuff MEDLINE INDUSTRIES, INC. Matt Clausen
K160904 04/01/2016 Expedium Spine System, VIPER and VIPER 2 Systems MEDOS INTERNATIONAL SARL Karen Sylvia
K161001 04/11/2016 MILAGRO ADVANCE PEEK Interference Screw MEDOS INTERNATIONAL SARL Kristine Christo
K160983 04/07/2016 Kyphon HV-R Bone Cement MEDTRONIC INC PAMELA EDWARDS
K161210 04/28/2016 RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) Systems Medtronic Sofamor Danek Ankit K. Shah
K161176 04/26/2016 ARTOURA Breast Tissue Expanders with Smooth Surface MENTOR WORLDWIDE LLC LAURA C. VELLUCCI
K160961 04/05/2016 Mozec NC-Rx PTCA Baloon Dilatation Catheter MERIL LIFE SCIENCES PRIVATE LIMITED Utpal Thakor
K161058 04/15/2016 Cannulated Screw MIAMI DEVICE SOLUTIONS, LLC MARKKU BIEDERMANN
K161152 04/25/2016 Navien Intracranial Support Catheter MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR Ingrid Takeuchi
K160909 04/01/2016 ATTO Mobility Scooter Moving Life Ltd Nino A. Ransenberg
K161085 04/18/2016 Nitrile Patient Examination Powder Free Glove, Textured, Black MULTISAFE SDN. BHD. THUM TECK LAM
K161174 04/26/2016 Nanova Interference Screw NANOVA BIOMATERIALS INC. ANDREW RITTS
K161057 04/14/2016 Diagnostic Imaging Color LCD Monitor NEC DISPLAY SOLUTIONS LTD. SATORU KOTANI
K160991 04/08/2016 Neo GBR System NEOBIOTECH CO., LTD. In Ho Kim
K161039 04/13/2016 NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL) NeoMed, Inc. Tony Lair
K160936 04/04/2016 Certus 140 2.45GHz Ablation System NEUWAVE MEDICAL, INC DAN KOSEDNAR
K161165 04/25/2016 Next Science Irrigation Solution NEXT SCIENCE, LLC MATTHEW MYNTTI
K161062 04/15/2016 NR Recorder Norav Medical GmbH David Seal
K160990 04/08/2016 Nova Max Uric Acid Monitoring System NOVA BIOMEDICAL CORPORATION ELIZA WANG
K160916 04/01/2016 CoRoent« Ti-C System NUVASIVE, INCORPORATED Michelle Cheung
K160989 04/08/2016 NuVasive« Reline« System NuVasive, Incorporated Olga Lewis
K161014 04/11/2016 NuVasive« Reline« System NUVASIVE, INCORPORATED Thao Huynh
K161180 04/27/2016 Oak Ridge Products Sharps Containers OAK RIDGE PRODUCTS, LLC Tibor Kovari
K161034 04/13/2016 Microcyn Plus Wound Care Solution OCULUS INNOVATIVE SCIENCES BRIAN W. MARTIN
K161080 04/18/2016 Escalade Legend Acetabular Shell ORTHO DEVELOPMENT CORPORATION Drew Weaver
K161140 04/22/2016 VITROS Chemistry Products Calibrator Kit 3 ORTHO-CLINICAL DIAGNOSTICS, INC. MARLENE HANNA
K161129 04/21/2016 PILLAR SA PTC ORTHOFIX INC. Natalia Volosen
K161138 04/22/2016 St. Louis Band ORTHOMERICA PRODUCTS, INC. DAVID C. KERR
K161090 04/18/2016 Cranial PSI OSSDSIGN AB ULRIK BIRGERSSON
K161197 04/28/2016 Orthodontic Screw OSSTEM IMPLANT CO., LTD. NA HEEKWON
K161103 04/19/2016 US SA Implant System OSSTEM IMPLANT CO.,LTD. Hee Kwon
K161041 04/13/2016 OsteoMed ExtremiLOCK Wrist Plating System OSTEOMED KATHRYN JAYNE
DEN160014 04/11/2016 remOVE System OVESCO ENDOSCOPY AG Med.Marc O. Schurr
K161052 04/14/2016 OsteoFab Patient Specific Facial Device OXFORD PERFORMANCE MATERIALS, INC. Leigh Ayres
K161106 04/19/2016 PANPAC DISPOSABLE VACUUM CURETTES PANPAC MEDICAL CORPORATION YEN-MING PAN
K161019 04/12/2016 Uroview FD PAUSCH MEDICAL GMBH Christian Stoian
K161141 04/22/2016 ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT PENTAFERTE ITALIA S.R.L. ROSA DI GIOIA
K161222 04/29/2016 PENTAX MEDICAL ED-3490TK, Video Duodenoscope PENTAX MEDICAL KANCHANA IYER
K161064 04/15/2016 Penumbra System ACE 68 Reperfusion Catheter Penumbra, Inc. Charles DeNault
K161164 04/25/2016 CareEvent inclusive of the CareEvent Mobile Application accessory PHILIPS MEDICAL SYSTEMS Theresa Poole
K160951 04/05/2016 Philips Efficia CMS200 Central Monitoring System PHILIPS MEDICAL SYSTEMS MARY KRUITWAGEN
K160977 04/07/2016 PolyDev Soft Contact Lenses Polydev Ltd. John Mulvihill
K160979 04/07/2016 Inclusive Abutments PRISMATIK DENTALCRAFT, INC. SHELLY HARRIS
K161025 04/12/2016 priti multidisc ZrO2 High Translucent PRITIDENTA GMBH MAGDALENA GEIGENBERGER
K161099 04/19/2016 Powder Free Nitrile Examination Gloves, Black PT. MAJA AGUNG LATEXINDO IMELDA SHAMROCK
K161193 04/27/2016 16ch Tx/Rx Knee SPEEDER Quality Electrodynamics, LLC Kathleen Aras
K161182 04/27/2016 Solana Trichomonas Assay QUIDEL CORPORATION RONALD H LOLLAR
K161020 04/12/2016 XSTAT-12, 3-Pack, XSTAT-12, 1-Pack REVMEDX, INC. AMY K. POINTER
K160987 04/08/2016 ReWalk(TM) REWALK ROBOTICS INC. JOHN HAMILTON
K161204 04/28/2016 ENDOCAM Flex HD Camera System 5521 RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION MIKE LOITERMAN
K160943 04/05/2016 Bite Away Riemser Pharma Ronny Raasch
K161201 04/28/2016 ClearRead CT RIVERAIN TECHNOLOGIES, LLC Jennifer Butsch
K161212 04/28/2016 Atteris Antimicrobial Skin Protectant ROCHAL INDUSTRIES LLC William J. Coulston
K160944 04/05/2016 ACCU-CHEK Guide Blood Glucose Monitoring System Roche Diabetes Care, Inc. Khone Saysana
K160915 04/01/2016 Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker ROCHE DIAGNOSTICS Adam Clark
K160910 04/01/2016 Elecsys Syphilis ROCHE DIAGNOSTICS ANGELO PEREIRA
K160997 04/11/2016 GC85A SAMSUNG ELECTRONICS CO., LTD. CHULSIN KIM
K160902 04/01/2016 Mariner Pedicle Screw System SEASPINE ORTHOPEDICS CORPORATION GINA FLORES
K161081 04/18/2016 SeaSpine Shoreline ACS - Anterior Cervical Standalone System SEASPINE ORTHOPEDICS CORPORATION Michelle Willis
K160950 04/05/2016 MINISCAV Sedation Systems LLC S. Michael Bender
K161074 04/18/2016 Powder Free Nitrile Examination Gloves Flock-Lined, Black Color SHEN WEI (USA), INC. CHERYL BAILEY-KROLL
K160932 04/04/2016 8ch Foot Ankle Coil Shenzhen RF Tech Co., Ltd. Ke Xi
K160935 04/04/2016 8ch Foot Ankle Coil Shenzhen RF Tech Co., Ltd. Ke Xi
K160969 04/06/2016 ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler SHINEMED LLC ROGELIO A. INSIGNARES
K161196 04/27/2016 SOMATOM Drive Siemens Medical Solutions USA, Inc. Kimberly Mangum
K161155 04/25/2016 Origin Coxa Vara Hip Stem SIGNATURE ORTHOPAEDICS PTY LTD. Declan Brazil
K160923 04/04/2016 REDAPT Anteverted Cemented Liner SMITH & NEPHEW, INC. KIM PHAN
K160946 04/05/2016 4.0 and 6.5 Cancellous Bone Screw and Washer SMV SCIENTIFIC Nephi Zufelt
K160942 04/05/2016 Sonablate SonaCare Medical, LLC DAVID M. HERNON
K160905 04/01/2016 Sonendo GentleWave System SONENDO, INC. DAN W. MILLER
K161122 04/21/2016 Sony IP Converter NU-IP40S SONY ELECTRONICS INC. AMARJIT 'ANDY' JOWANDHA
K160980 04/07/2016 Threshold Pedicular Fixation System, Palisade Pedicular Fixation System SPINEOLOGY INC JACQUELINE A HAUGE
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