| 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 |
