FDA 510(k) Applications Received During August, 2014

FDA 510(k) Number Submission Date Device Name Applicant Contact
K142112 08/04/2014 4WEB SPINAL IMPLANT PRODUCTS 4WEB, INC. RICH JANSEN
K142150 08/05/2014 AIS MODULIFT VBR SYSTEM AESCULAP IMPLANT SYSTEM, INC. LISA M BOYLE
K142315 08/19/2014 MINOP Disposable Introducer 26F AESCULAP, INC. KATHY RACOSKY
K142184 08/08/2014 DX-D IMAGING PACKAGE AGFA HEALTHCARE N.V. SHAEANN CAVANAGH
K142347 08/22/2014 Amedica Valeo II Interbody Fusion Device Amedica Corp William D Jordan
K142336 08/21/2014 GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose Monitoring System ARKRAY FACTORY INC. Kazuya Yorimitsu
K142413 08/28/2014 TITAN Modular Total Shoulder System Ascension Orthopedics Jay Patel
K142120 08/04/2014 ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP ATRICURE, INC. JONATHAN MCELWEE
K142203 08/11/2014 Atricure Cryo Module System; cryoICE cryoablation probe ATRICURE, INC. Jonathan McElwee
K142147 08/05/2014 EEVA SYSTEM AUXOGYN, INC. JULIA S ANASTAS
K142261 08/14/2014 Ultraverse 035 PTA Balloon Dilatation Catheter Bard Peripheral Vascular, Inc. Mario Thomas
K142425 08/29/2014 Uroflowmeter BE TECHNOLOGIES, INC. Edward Belotserkovsky
K142346 08/22/2014 Urine/CSF Albumin, Urine/CSF Albumin Calibrator Beckman Coulter Ireland Inc. Anne-Marie Shine
K142170 08/07/2014 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTESM - TIGECYCLINE (0.313-4UG/ML) GP Becton, Dickinson and Company MONICA E GIGUERE
K142219 08/12/2014 GammaBeam 100 Best Theratronics Limited Mike de van der Schueren
K142099 08/01/2014 CUTANEOUS ELECTRODES BIO PROTECH, INC. Terry Kim
K142292 08/18/2014 Speed, Speed Shift, Speed Titan, Speed Arc BioMedical Enterprises, Inc. Joe Soward
K142097 08/01/2014 SELEC-3 I.V.ADMINISTRATION SET BIOMEDIX, INC. MYRA J BENDER
K142295 08/18/2014 Sirius Femoral Stem, Size 30A Biomet, Inc. Jason Dugger
K142259 08/14/2014 Direxion Torqueable Microcatheter BOSTON SCIENTIFIC CORP. Mark Lanz
DEN140025 08/20/2014 BrainScope Ahead 100 BRAINSCOPE COMPANY, INC Michael E. Singer
K142267 08/15/2014 Sherlock 3CG Tip Positioning System Stylet C.R.Bard, Inc. Bryan Stone
K142372 08/25/2014 Pico Way Laser System CANDELA CORPATION Ruthie Amir
K142225 08/13/2014 Pilot Elite Diode Laser CAO Group, Inc. Robert K Larsen
K142223 08/13/2014 Pilot Pro Diode Laser CAO GROUP, INC. ROBERT K. LARSEN
K142226 08/13/2014 Pilot Ultra Diode Laser CAO GROUP, INC. ROBERT K. LARSEN
K142399 08/27/2014 DualCap IV Pole Strips(Disinfectant Caps for Male Luers) CATHETER CONNECTIONS, INC. Donald d Soloman
K142396 08/27/2014 Chemtrue BUP/TCA Single/Multi-Panel Drug Screen Dip Card/Cup/Cassette Tests Chemtron Biotech, Inc. Jane Zhang
K142193 08/11/2014 COGENT MED-LIF XL COGENT SPINE LLC JUDE PAGANELLI
K142325 08/20/2014 Veenstra Instruments VDC-506 Dose Calibrator Comecer Netherlands b.v. Gert Jan Klok
K142161 08/06/2014 ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM, ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM CONFORMIS, INC. AMITA SHAH
K142134 08/04/2014 C-WIRE DOUBLE ENDED ORTHOPEDIC WIRES CONMED CORPORATION, LARGO JOY LOVETT
K142301 08/18/2014 Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator Sheath Set, SteadySheath Evolution Tissue Stabilization Sheath, SteadySheath Evolution Shortie Tissue Stabilization Sheath COOK VASCULAR, INC. Thomas J. Kardos
K142364 08/25/2014 Barrx RFA Self Sizing Balloon Catheter Covidien llc Rachel Silva
K142198 08/11/2014 BNX Fine Needle Aspiration System Covidien LLC Saket Bhatt
K142428 08/29/2014 Shock Pulse-SE Lithotripsy System CYBERWAND II CYBERSONICS, INC. Jeff Vaitekunas
K142376 08/26/2014 Palomar Icon Aesthetic System CYNOSURE, INC. Allyson Connor
K142185 08/08/2014 EXPEDIUM VERSE SPINE SYSTEM DEPUY SPINE, INC. CATHERINE KILSHAW
K142199 08/11/2014 Ascendra Balloon Aortic Valvaloplasty Catheter EDWARDS LIFESCIENCES Susan Reynolds
K142113 08/04/2014 ESOPHYX2 HD ENDOGASTRIC SOLUTIONS, INC. MICHAEL A DANIEL
K142252 08/14/2014 XprESS Multi-Sinus Dilation Tool ENTELLUS MEDICAL, INC. Karen E. Peterson
K142245 08/13/2014 EpiAccess System EpieP, Inc. Pamela Bunes
K142306 08/19/2014 Flower Upper Extremity Plating Set Flower Orthopedics Corporation Gary Barnett
K142160 08/06/2014 LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM GE HEALTHCARE BRYAN BEHN
K142323 08/20/2014 Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System GE MEDICAL SYSTEMS ISRAEL LTD. Bryan Behn
K142383 08/26/2014 Optima XR200amx, Optima XR220amx GE Medical Systems, LLC Chris Paulik
K142098 08/01/2014 SIGNA PET/MR GE MEDICAL SYSTEMS, LLC ROBIN MARTIN
K142088 08/01/2014 DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR SWBPM22 SERIES GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED PATRICK CHOW
K142423 08/28/2014 EyeSuite Imaging HAAG-STREIT AG Oscar Banz
K142270 08/15/2014 LATEX POWDERED EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM OF 200 MICROGRAM OR LESS PER GRAM OF GLOVE HARTALEGA SDB. BHD. KUAN KAM HON
K142280 08/15/2014 Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen Morphine Test (Strip, Cassette, Cup, Dip Card) HEALGEN SCIENTIFIC LLC Jianqiu Fang
K142157 08/06/2014 PALACOS R+G PRO HERAEUS MEDICAL GMBH ASTRID MARX
K142367 08/25/2014 Hospira Primary Sets HOSPIRA, INC. CATHERINE KANG
K142300 08/18/2014 Arrow GPSCath Balloon Dialation Catheter (150 cm) HOTSPUR TECHNOLOGIES, INC., ERICK ANKERUD
K142418 08/28/2014 I.T.S. Hand Locking Plates System - HLS I.T.S. GmbH Al Lippincott
K142135 08/04/2014 REDUCE FRACTURE PLATING SYSTEM LINE EXTENSION ICON ORTHOPEDIC CONCEPTS, LLC DBA EDGE ORTHOPAEDIC JAN TRIANI
K142238 08/13/2014 MAYFIELD Skull Clamp INTEGRA LIFESCIENCES CORPORATION Brian Hoy
K142414 08/28/2014 Miltex N-Tralig Intraligamentary Syringe INTEGRA LIFESCIENCES CORPORATION Judith E. O'Grady
K142389 08/27/2014 Variolink Esthetic IVOCLAR VIVADENT AG SANDRA CAKEBREAD
K142179 08/08/2014 D-KAT Z-YPE KEELER LTD. EUGENE R VAN ARSDALE
K142197 08/11/2014 ULTRASOUND SYSTEM SONIMAGE HS1, LINEAR PROBE L18-4, CONVEX PROBE C5-2 KONICA MINOLTA INC. SHIGEYUKI KOJIMA
K142393 08/27/2014 PREDICATE III GUIDEWIRE LAKE REGION MEDICAL MATHEW PEXA
K142397 08/27/2014 Predicate III Guidewire Lake Region Medical Mathew Pexa
K142359 08/25/2014 Vasc Band hemostat Lepu Medical Technology (Beijing) Co., LTD Kim Xiangdan
K142139 08/05/2014 SMR 40MM GLENOSPHERE LIMACORPORATE S.P.A. STEPHEN PEOPLES
K142386 08/27/2014 Operating Room Light Handle Adapter Litex Manufacturing, Inc. Noel Gharibian
K142215 08/12/2014 Power Twin21-50/Power Twin21-100 LIVETEC GMBH Klaus Reichebach
K142394 08/27/2014 Masimo Root Monitoring System and Accesories MASIMO CORPORATION MARGUERITE THOMLINSON
K142258 08/14/2014 PolyCatch Retrieval Device Medi-Globe Corporation Scott Karler
K142303 08/18/2014 NeumoFilt Ergo/Neumo Filt BiteOn Medical Respiratory Devices S.L. Jose Alberto Hernandez
K142096 08/01/2014 T-PIECE RESUSCITATOR MERCURY MEDICAL PAUL DRYDEN
K142265 08/15/2014 ONE Snare Endovascular Microsnare System MERIT MEDICAL SYSTEMS, INC. Mark Mullaney
K142105 08/01/2014 ELI 380 ELECTROCARDIOGRAPH MORTARA INSTRUMENT, INC AMY YANG
K142275 08/15/2014 Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact Lens NEO VISION CO., LTD. Kyung Hwa Kim
K142286 08/18/2014 NS3000 Holmium Laser System New Star Lasers, Inc. Natalie Vollrath
K142424 08/29/2014 DR300 HOLTER MONITOR NORTH EAST MONITORING INC. SHERRY STEELE
K142220 08/12/2014 Stat Profile Prime ABG Analyzer System (incl. Controls, Calibrators) NOVA BIOMEDICAL CORPORATION Paul W. MacDonald
K142299 08/18/2014 CoRoent Small Interlock System NUVASIVE, INCORPORATED Cynthia Adams
K142339 08/21/2014 HEMASORB Resorbable Hemostatic Bone Putty ORTHOCON, LLC Howard L Schrayer
K142148 08/05/2014 ORTHOHELIX STAPLE SYSTEM ORTHOHELIX SURGICAL DESIGNS, INC. BRIAN HOCKETT
K142090 08/01/2014 REBOSSIS ORTHOREBIRTH CO., LTD. KEVIN A.THOMAS
K142408 08/28/2014 FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), FaStep Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) POLYMED THERAPEUTICS, INC FRANK LUO
K142302 08/18/2014 BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS Lipid Panel Test System, PTS PANELS HDL Cholesterol Test System, PTS PANELS CHOL+HDL Test System, PTS PANELS CHOL+HDL+GLU Panel Test System, PTS PANELS Metabolic Chemis Polymer Technology Systems, Inc. Jack Rogers
K142118 08/04/2014 INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: STRAUMANN BONE LEVEL, NOBEL BIOCARE BRANAE PRISMATIK DENTALCRAFT, INC. BRANDON SHEPARD
K142115 08/04/2014 INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: ZIMMER, BIOMET 3I, AND NOBEL BIOCARE IMPLANT PRISMATIK DENTALCRAFT, INC. BRANDON SHEPARD
K142181 08/08/2014 RANDOX ALDOLASE CALIBRATION SERUM RANDOX LABORATORIES LIMITED PAULINE ARMSTRONG
K142123 08/04/2014 REACH ACCESS TELEMEDICINE DOSE CALCULATOR REACH HEALTH, INC. BETH DESTASIO
K142304 08/18/2014 Viberect Penile Vibratory Stimulation Device REFLEXONIC, LLC Kambiz Tajkarimi
K142095 08/01/2014 RENOVIS S134 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM Renovis Surgical Technologies, Inc. Sharyn Orton
K142127 08/04/2014 ELECSYS ESTRADIOL III CALCHECK 5 Roche Diagnostics KELLI TURNER
K142133 08/04/2014 ELECYS CMV IGM IMMUNOASSAY; ELECYS PRECICONTROL CMV IGM Roche Diagnostics Sarah Baumann
K142243 08/13/2014 LessRay with Tracking SAFERAY SPINE, LLC Michael Alrutz
K142241 08/13/2014 LARIAT sulture Delivery Device SENTREHEART INC. Kit Cariquitan
K142434 08/29/2014 ARTISTE SOLUTION, SYS_VC10C, PHASE 2 UPDATE WITH THE SYNGO RT THERAPIST & RT ONCOLOGIST WORKSPACES, V4.3.1_MR1 SIEMENS MEDICAL SOLUTIONS USA, INC. CHRISTINE DUNBAR
K142395 08/27/2014 SC2000 and ACUSON X300 Diagnostic Ultrasound Systems SIEMENS MEDICAL SOLUTIONS USA, INC. Shelly Pearce
K142091 08/01/2014 PARIETENE MACROPOROUS MESH SOFRADIM PRODUCTION JENNIFER BRENNAN
K142221 08/12/2014 MEMO 3D ReChord SORIN GROUP ITALIA S.R.L MAURO ERCOLANI
K142116 08/04/2014 LLD EZ SPECTRANETICS, INC. PHAROAH GARMA
K142101 08/01/2014 ABACUS (TM) SPACER SYSTEM SPINE WAVE, INC. ROAIDA JOHNSON
K142277 08/15/2014 JULIET PO SPINEART Franck Pennesi
K142213 08/12/2014 VIA SPINOUS PROCESS FIXATION SYSTEM SPINEOLOGY, INC. TIM CRABTREE
K142272 08/15/2014 SNaP Wound Care System SPIRACUR, INC. Lawrence Hu
K142254 08/14/2014 CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque clip, CPS Excel MediGuide Guidewire Connector St. Jude Medical Geena George
K142381 08/26/2014 Xia 3 Spinal System STRYKER CORP. GARRY T HAYECK
K142251 08/14/2014 AVS AS PEEK Spacer Stryker Corporation Garry T Hayeck
K142114 08/04/2014 XIA 4.5 SPINAL SYSTEM STRYKER CORPORATION GARRY T HAYECK, PH.D.
K142100 08/01/2014 AIXPLORER SUPERSONIC IMAGINE AURELIE GRUENER
K142290 08/18/2014 KangLi pedical screw spinal system SUZHOU KANGLI ORTHOPAEDICS INSTRUMENT CO., LTD Jin Hua Huang
K142309 08/19/2014 GEM Flow COUPLER Device and System Synovis Life Technologies, Inc. Troy Thome
K142138 08/05/2014 ISO-GARD MASK Teleflex Medical, Inc. BRIAN GALL
K142183 08/08/2014 GLIDESHEATH SLENDER Terumo Medical Corporation Erin Doyle
K142182 08/08/2014 FRIMAP ADAPTER CONNECTOR (MAC) TOPERA, INC. DENNIS POZZO
K142230 08/13/2014 Apollo Suture Anchor System and Titan Screws Valeris Medical Daniel Lanois
K142268 08/15/2014 Varian Verification System (VVS) VARIAN MEDICAL SYSTEMS, INC. Peter J. Coronado
K142093 08/01/2014 V20 SYSTEM VIORA LTD. OMRI KESLER
K142353 08/21/2014 First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup Test W.H.P.M., Inc. John Wan
K142187 08/08/2014 LINK MP RECONSTRUCTION PROSTHESIS WALDEMAR LINK GMBH & CO. KG THOMAS MEHLER
K142121 08/04/2014 VALOR HINDFOOT FUSION NAIL SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. JEANINE REDDEN
K142403 08/27/2014 Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder Fracture System ZIMMER GMBH Roberto Tommasini
K142281 08/15/2014 ZIMMER M/DN INTRAMEDULLARY FIXATION SYSTEM ZIMMER, INC. PATRICK MCCULLAGH


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