| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K151933 |
12/10/2015 |
BRX PRO Bruxism Guard |
12TH MAN TECHNOLOGIES, INC. |
ALEX STENZLER |
| K152060 |
12/01/2015 |
3M Attest Rapid Readout Biological Indicator 1295 |
3M COMPANY |
MATT MORTENSEN |
| K152078 |
12/04/2015 |
Implant Studio 2015 |
3Shape Medical A/S |
Hanne Nielsen |
| K152155 |
12/17/2015 |
ARCHITECT 2nd Generation Testosterone |
Abbott Laboratories |
Regina Xavier Kumar |
| K152442 |
12/17/2015 |
Freestyle Freedom Blood Glucose Monitoring Sytem |
ABBOTT LABORATORIES |
Sai Sriharshada Tatavarty |
| K152721 |
12/08/2015 |
Cytal Wound Matrix |
ACELL, INC |
THOMAS GILBERT |
| K152417 |
12/01/2015 |
Adler MicroMed Laser Surgery Fibers |
ADLER MICROMED INC. |
BRIAN CHANDLER |
| K152639 |
12/11/2015 |
DR 600 |
AGFA HEALTHCARE N.V. |
Koren Vervoort |
| K150930 |
12/18/2015 |
Deployable Oxygen Generation System-Smaill (DOGS-S) |
AirSep Corporation |
Peter Weisenborn |
| K152968 |
12/30/2015 |
Arsenal Spinal Fixation System |
ALPHATEC SPINE, INC |
RENEE MURPHY |
| K152460 |
12/22/2015 |
Rectangular Corpectomy Cage |
Amendia, Inc. |
Bruce Hooper |
| K152291 |
12/17/2015 |
Sterisheet Sterilization Wrap |
ANDERSEN STERILIZERS, INC. |
WILLIAM K ANDERSEN |
| K150833 |
12/04/2015 |
iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring System |
ANDON HEALTH CO.,LTD |
Yi Liu |
| K151168 |
12/22/2015 |
Nexodyn AOS Wound Care Solution |
APR Applied Pharma Research SA |
Giorgio Reiner |
| K153313 |
12/11/2015 |
SpeedLock Knotless Fixation System |
ARTHROCARE CORPORATION |
LAURA KASPEROWICZ |
| K153344 |
12/17/2015 |
Asahi REXEED-S Series Dialyzer |
Asahi Kasei Medical Co., Ltd. |
Hidenobu Nakazawa |
| K152047 |
12/23/2015 |
INTEGRA TITAN Modular Total Shoulder System Fin-Lock Glenoid |
ASCENSION ORTHOPEDICS |
WILLIAM GARZON |
| K152153 |
12/11/2015 |
MicroSpot Handpiece |
ASCLEPION LASER TECHNOLOGIES GMBH |
ANTJE KATZER |
| K152732 |
12/10/2015 |
AOS Small Fragment Plating System |
AVANCED ORTHOPAEDIC SOLUTIONS, INC. (AOS) |
Mark Steinhauer |
| K150787 |
12/02/2015 |
Universal Spike |
B. Braun Medical Inc. |
Tracy Maddock |
| K153158 |
12/28/2015 |
Solution Administration Sets with 0.2 Micron Filter |
BAXTER HEALTHCARE CORPORATION |
GARY CHUMBIMUNE |
| K152852 |
12/22/2015 |
ALEVE Direct Therapy (ALEVE Direct Therapy TENS device) |
BAYER HEALTHCARE, LLC |
William R Walsh |
| K153210 |
12/21/2015 |
Defibrillator Analyzer Variable Load |
BC GROUP INTERNATIONAL, INC |
Mel Roche |
| K150815 |
12/17/2015 |
BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb Cartridge Kit |
Becton, Dickinson and Company |
Catherine(Katie) Bessette |
| K153257 |
12/11/2015 |
BD FlowSmart Set, MiniMed Pro-Set |
BECTON, DICKINSON AND COMPANY |
MATTHEW TRACHTENBERG |
| K150300 |
12/11/2015 |
Liquichek Cardiac Markers Plus Control LT |
Bio-Rad Laboratories |
Elizabeth Platt |
| K151321 |
12/09/2015 |
D-100 HbA1c, D-100 HbA1c Calibrator Pack |
Bio-Rad Laboratories, Inc. |
Jackie Buckley |
| K151876 |
12/30/2015 |
Bio2 Fusion Implant System |
Bio2 Technologies, Inc |
Janet Krevolin |
| K152157 |
12/11/2015 |
LC Bead LUMI |
BIOCOMPATIBLES UK LTD |
April Kent |
| K151295 |
12/01/2015 |
Biodenta Customized Abutment - Titanium |
BIODENTA SWISS AG |
DAVID ELIER |
| K152326 |
12/10/2015 |
Biomet Microfixation OmniMax MMF System |
BIOMET MICROFIXATION |
LAUREN JASPER |
| K150722 |
12/02/2015 |
EnFocus 2300, EnFocus 4400 |
BIOPTIGEN, INC. |
Tammy B Carrea |
| K152889 |
12/30/2015 |
SONILASE BLUE, SONILASE BLUE-CLEAN, SONILASE BLUE-UV CLEAN PLUS |
BIORENEW LABS, LLC |
JON DAVID |
| K150997 |
12/22/2015 |
RUBY STAR |
BISON MEDICAL CO., LTD |
SUN-WOO LEE |
| K153088 |
12/11/2015 |
AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery System |
BOSTON SCIENTIFIC CORPORATION |
ASHLEY SANTOS |
| K151840 |
12/16/2015 |
Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire, Stretch Extension Wire |
Boston Scientific Corporation |
Nikki M Wahlberg |
| K152401 |
12/04/2015 |
Stingray LP Catheter |
BOSTON SCIENTIFIC CORPORATION |
KURTIS HUNSBERGER |
| K153298 |
12/10/2015 |
AccuCath Intravascular Catheter |
C.R. Bard, Inc. |
Casey Coombs |
| K152554 |
12/14/2015 |
Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT Technology |
C.R. Bard, Inc. |
Kerrie Hamblin |
| K150585 |
12/31/2015 |
Ascent 3D |
CAO GROUP, INC. |
Robert K Larsen |
| K150769 |
12/14/2015 |
Cardinal Health Trochanteric IM Nail System |
Cardinal Health |
Tatyana Bogdan |
| K151445 |
12/21/2015 |
Cardinal Health Sterilization Wrap |
CARDINAL HEALTH 200, LLC |
MEGAN MIDDAUGH |
| K153492 |
12/24/2015 |
CareView 1800L |
CARERAY DIGITAL MEDICAL SYSTEM CO., LTD. |
Leilei Li |
| K152467 |
12/09/2015 |
Touch Ultrasound |
CARESTREAM HEALTH, INC. |
CAROLYN L. WAGNER |
| K151255 |
12/30/2015 |
Navigator Aesthetic Delivery System |
CARTICEPT MEDICAL INC |
CARRIBETH RAMEY |
| K152162 |
12/24/2015 |
Myray- HYPERION X5 |
CEFLA S.C. |
Silvia Sansavini |
| K153148 |
12/01/2015 |
CDC Human Influenza Virus Real- time RT-PCR Diagnostic Panel, Influenza A/H5 Subtyping |
CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) |
YON YU |
| K152211 |
12/01/2015 |
PCT System |
CENTINEL SPINE, INC. |
JESSICA STAUB |
| K151226 |
12/03/2015 |
Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress System (GX-I) |
CEPHEID |
Kerry J Flom |
| K151672 |
12/21/2015 |
Cerner CareAware Event Management |
CERNER CORPORATION |
SHELLEY S. LOOBY |
| K143013 |
12/11/2015 |
Spinal Inner Fixation System |
Changzhou Dingjian Medical Appliance Co., Ltd |
Li Quinsong |
| K151062 |
12/17/2015 |
WASTON Metallic Intramedullary Nail System |
CHANGZHOU WASTON MEDICAL APPLIANCE CO., LTD |
Jack Lu |
| K153085 |
12/21/2015 |
Q Series Diagnostic Ultrasound System |
CHISON MEDICAL IMAGING CO., LTD. |
Qifei Liu |
| K152515 |
12/18/2015 |
TOMCAT Cervical Spinal System |
CHOICE SPINE, LP |
Kim Finch |
| K152146 |
12/08/2015 |
High Speed Handpieces and Accessories |
CODENT TECHNICAL INDUSTRY CO., LTD. |
Chin-Ting Wen |
| K151126 |
12/18/2015 |
Foresight Intracardiac Echocardiography (ICE) System |
Colibri Technologies Inc. |
SAM MOSTAFAVI |
| K152243 |
12/09/2015 |
One Coat 7 Universal |
Coltene/Whaledent AG |
Silke Wallaschek |
| K153499 |
12/18/2015 |
EDGE Arthroscopic Energy System, Arthroscopic Energy System Probes, Arthroscopic Energy System Wireless Footswitch, Arthroscopic Energy System Corded Footswitch, Arthroscopic Energy System Foot Control, Extension |
ConMed Corporation |
Dionne Sanders |
| K152860 |
12/29/2015 |
HELIXAR ELECTROSURGICAL GENERATOR WITH ARGON BEAM COAGULATION, HELIXAR MOBILE PEDESTAL |
CONMED CORPORATION |
LISA ANDERSON |
| K150668 |
12/09/2015 |
Biodesign Enterocutaneous Fistula Plug |
COOK BIOTECH INCORPRATED |
Perry W Guinn |
| K150748 |
12/18/2015 |
Flexipet Denuding Pipette, Flexipet Manipulation Pipette |
COOK INCORPORATED |
NAOMI FUNKHOUSER |
| K150931 |
12/18/2015 |
MReye Embolization Coils |
Cook Incorporated |
Nozomi Yagi |
| K150964 |
12/18/2015 |
MReye Flipper Detachable Embolization Coil and Delivery System |
Cook Incorporated |
Nozomi Yagi |
| K153092 |
12/21/2015 |
Ally Uterine Positioning System |
CooperSurgical, Inc. |
Roaida Johnson |
| K152284 |
12/04/2015 |
COHITECH NON APPLICATOR ORGANIC COTTON TAMPONS;COHITECH COMPACT APPLICATOR ORGANIC COTTON TAMPONS |
COTTON HIGH TECH S.L. |
Anna Garcia |
| K151279 |
12/16/2015 |
Counter OTC TENS Device, Model CSD-737Z |
COUNTER SCIENTIFIC DEVELOPMENT (GZ) LTD |
Jiang Eagle |
| K151381 |
12/11/2015 |
Mallinckrodt Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy Eye |
Covidien |
Danielle Mueller |
| K152586 |
12/30/2015 |
Beacon Fine Needle Fiducial System |
Covidien LLC |
RACHEL SILVA |
| K152306 |
12/11/2015 |
MotoBand┐ CP Implant System |
CROSSROADS EXTREMITY SYSTEMS, LLC |
VERNON HARTDEGEN |
| K151896 |
12/07/2015 |
Houdini Catheter |
Cruzar Medsystems, Inc. |
Tom Kramer |
| K151158 |
12/10/2015 |
ALP VasQcare Take Home System |
Currie Medical Specialties, Inc. |
Owen J Bry |
| K151496 |
12/15/2015 |
Latitude-C Cervical Interbody Spacer System |
Degen Medical |
Craig Black |
| K152767 |
12/14/2015 |
OTC12D AUTO RADIOGRAPHIC SYSTEM |
DEL MEDICAL, INC. |
JOHN HARTZELL |
| K152322 |
12/16/2015 |
Resolve 2.0 |
DENALI CORPORATION |
Jan G Stannard |
| K151926 |
12/14/2015 |
QuickRay HD Intraoral Sensor |
DENTERPRISE INTERNATIONAL, INC. |
CLAUDE BERTHOIN |
| K142313 |
12/10/2015 |
OneQ-SL Implant System |
DENTIS CO. LTD. |
Jeong Seop Keun |
| K152859 |
12/03/2015 |
Portable X-ray System (Model: MINIX-V / MINIX-S) |
DIGIMED CO., LTD. (DIGIMED CORPORATION UNTIL 31/12/2012) |
YOUNGBAE KWON |
| DEN150010 |
12/08/2015 |
Dignitana AB DigniCap System |
DIGNITANA AB |
JAN RICHARDSSON |
| K152508 |
12/31/2015 |
Ageless Health Medical Digital Thermometer |
DONGGUAN AGELESS HEALTH INDUSTRIAL CO., LTD |
VICTOR WAN |
| K152172 |
12/14/2015 |
Econsole1 |
DRTECH CORPORATION |
CHOUL-WOO SHIN |
| K151878 |
12/01/2015 |
Video Colposcope |
EDAN INSTRUMENTS, INC. |
Queena Chen |
| K153011 |
12/11/2015 |
iViewDose R1.0 |
Elekta Limited |
Maurice Paine |
| K151686 |
12/30/2015 |
HumanPen Ergo II |
ELI LILLY AND COMPANY, INC. |
CHRISTINE A. PHILLIPS |
| K152370 |
12/22/2015 |
PRECICE Trauma Nail System |
Ellipse Technologies Incorporated |
John McIntyre |
| K152182 |
12/10/2015 |
Fuse Gastroscopy System |
ENDOCHOICE INC. |
DANIEL HOEFER |
| K151567 |
12/23/2015 |
ENDOPLUS hand-held laparoscopic instruments |
ENDOPLUS |
Matthew Gudeman |
| DEN150005 |
12/18/2015 |
Newa Skin Therapy System |
EndyMed Medical Ltd. |
Yoram Levy |
| K152406 |
12/23/2015 |
SalivaMAX |
FORWARD SCIENCE LLC |
Brian Pikkula |
| K150708 |
12/10/2015 |
2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis Machine |
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC |
DENISE OPPERMANN |
| K153483 |
12/15/2015 |
Balloon controller PB-30 |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. |
Aaron Ge |
| K152722 |
12/08/2015 |
neoV980 & neoV1470 Diode Lasers |
G.N.S NEO LASER LTD. |
GIL SHAPIRA |
| K150408 |
12/14/2015 |
V-STEADY, V-FAST |
G21 S.R.L. |
MAURIZIO FORONI |
| K152528 |
12/02/2015 |
Attachable Cath Lab Hemostasis Valve |
GALT MEDICAL CORP. |
DAVID DERRICK |
| K151063 |
12/15/2015 |
Monitor B40 |
GE MEDICAL SYSTEMS CHINA CO., LTD. |
Sun YanLi |
| K150354 |
12/10/2015 |
PAPAYA 3D Plus |
GENORAY CO., LTD. |
Kyoung-hwa Kim |
| K150782 |
12/14/2015 |
AbStats Gateway |
GI Logic Inc |
James Beeton |
| K152219 |
12/17/2015 |
PK AIM |
GYRUS ACMI INC |
NEIL KELLY |
| K150966 |
12/04/2015 |
HMB32 |
HAEMOPHARM BIOFLUIDS SRL |
GIUSEPPE TOMASINI |
| K151127 |
12/08/2015 |
higi Station |
higi SH LLC |
Colin Hill |
| K153223 |
12/09/2015 |
ProParaFlu+ Assay |
HOLOGIC, INC. |
RON DOMINGO |
| K151133 |
12/09/2015 |
PENTRA XLR |
HORIBA ABX SAS |
Caroline Ferrer |
| K151025 |
12/29/2015 |
iHearTest |
IHEAR MEDICAL, INC. |
ANGELA LEE FOREMAN |
| K152491 |
12/17/2015 |
MoMe Software Platform |
INFOBIONIC, INC. |
MATTHEW KING |
| K152996 |
12/17/2015 |
Molteno3 Glaucoma Implant |
INNOVATIVE OPHTHALMIC PRODUCTS, INC. (IOP) |
BRYAN WEINMANN |
| K152875 |
12/21/2015 |
QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar Anti-B2GPI Domain 1 Controls |
INOVA DIAGNOSTICS, INC. |
GABRIELLA LAKOS |
| K150877 |
12/13/2015 |
ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS |
Instrumentation Laboratory Co. |
Carol Marble |
| K150682 |
12/18/2015 |
CUSA Excel+ |
INTEGRA LIFESCIENCES CORP. |
JENNIFER SIEGEL |
| K151364 |
12/28/2015 |
Intellijoint HIP(tm) System |
INTELLIJOINT SURGICAL INC. |
BRANDON GINGRICH |
| K152112 |
12/29/2015 |
VisualEyes |
INTERACOUSTICS A/S |
ERIK NIELSEN |
| K152436 |
12/07/2015 |
Suntanning Lamps |
Interlectric Corporation |
Ken C. Frazier |
| K152150 |
12/18/2015 |
V8 Balloon Aortic Valvuloplasty Catheter |
InterValve, Inc. |
Mark Ungs |
| K153126 |
12/09/2015 |
da Vinci Xi Hasson Cone |
INTUITIVE SURGICAL INC. |
VISHAL KANANI |
| K152330 |
12/23/2015 |
Expression MR400 MRI Patient Monitoring System |
INVIVO CORPORATION |
Rusty Kelly |
| K151074 |
12/22/2015 |
Magnetic Reasonance Imaging System |
JIANGSU MAGSPIN INSTRUMENT CO.,LTD |
LEO LI |
| K152323 |
12/14/2015 |
Disposable Infusion Needle, Safelock Disposable Infusion Needle |
JIANGYIN CAINA TECHNOLOGY CO., LTD |
JUN LU |
| K151991 |
12/11/2015 |
Safelock Disposable Blood Collection Set, Disposable Blood Collection Set |
JIANGYIN CAINA TECHNOLOGY CO., LTD. |
JUN LU |
| K151481 |
12/21/2015 |
Sahara Stabilization System |
K2M, INC |
NANCY GIEZEN |
| K152644 |
12/31/2015 |
KEELER DISPOSABLE TONOMATE, KEELER DISPOSABLE TONOMATE, BOX OF 100 |
KEELER LIMITED |
IRINA PROUTSKI |
| K152441 |
12/04/2015 |
KIRO Set |
KIRO ROBOTICS S.L. |
Naiara Telleria |
| K150817 |
12/21/2015 |
Dario Blood Glucose Monitoring System |
LabStyle Innovations Ltd. |
TRACEY WIELINSKI |
| K150841 |
12/29/2015 |
Luvena Enhanced Personal Moisturizer, Luvena Enhanced Personal Lubricant |
LACLEDE, INC. |
Michael Pellico |
| K151934 |
12/07/2015 |
ROI-C Titanium-Coated Implant System |
LDR SPINE USA |
JAMES WILSON |
| K152175 |
12/04/2015 |
Upcera Dental Zirconia Blank for Aesthetic Restoration |
LIAONING UPCERA CO.,LTD |
Charles Shen |
| K151611 |
12/14/2015 |
OneTouch Ultra Plus Flex Blood Glucose Monitoring System |
LIFESCAN EUROPE |
NIKI SKELLY |
| K151370 |
12/17/2015 |
UV Lamps for Indoor Tanning Devices |
LIGHT SOURCES, INC. |
EUGENE CZAKO |
| K150934 |
12/21/2015 |
Powder Free Vinyl Patient Examination Glove (Non?-Sterile) |
LPL (HUI ZHOU) GLOVE |
LEE HONG CHONG |
| K152386 |
12/17/2015 |
NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software |
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
TINA IP |
| K153461 |
12/11/2015 |
Guide wire for Edi Catheter 6 Fr, Guide wire for Edi Catheter 8 Fr, 100 cm, Guide wire for Edi Catheter 8 Fr, 125 cm |
MAQUET CRITICAL CARE AB |
Mirva Boothe |
| K151814 |
12/21/2015 |
SERVO-U Ventilator System, SERVO-n Ventilator System |
MAQUET CRITICAL CARE AB |
MARIA VON BAHR |
| K150831 |
12/22/2015 |
Cellvizio 100 Series System with Confocal Miniprobes |
MAUNA KEA TECHNOLOGIES |
Sophie Rehault |
| K152201 |
12/30/2015 |
MedActive Oral Gel and Spray |
MedActive Oral Pharmaceuticals, LLC. |
Brian Walker |
| K142125 |
12/22/2015 |
New Medax Biopsy Systems |
MEDAX SRL UNIPERSONALE |
Stefano Cavalieri |
| K143711 |
12/02/2015 |
Reaxon Plus |
MEDOVENT GMBH |
THOMAS FREIER |
| K151359 |
12/18/2015 |
ROSA Brain |
MEDTECH S.A. |
MICHAEL CHRIST |
| K153463 |
12/30/2015 |
CD HORIZON Spinal System, IPC POWEREASE System |
MEDTRONIC SOFAMOR DANEK USA, INC. |
Becky Ronner |
| K152121 |
12/01/2015 |
NuVent EM Sinus Dilation System |
MEDTRONIC XOMED, INC. |
Gabriela Anchondo |
| K151762 |
12/28/2015 |
PediatrOS RigidTack/FlexTack |
MERETE MEDICAL GMBH |
EMMANUEL ANAPLIOTIS |
| K152783 |
12/07/2015 |
Merit 20 mL Syringe |
Merit Medical Systems, Inc. |
CORY MARSH |
| K153071 |
12/23/2015 |
Solitaire Platinum Revascularization Device |
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
Phuong Chau |
| K152001 |
12/10/2015 |
Sterile Repositionable Hemostasis Clipping Device |
Micro-Tech (Nanjing) CO.,Ltd. |
Becky Li |
| K153450 |
12/16/2015 |
Microlife Upper Arm Automatic Digital Blood Pressure Monitor |
MICROLIFE INTELLECTUAL PROPERTY GMBH |
GERHARD FRICK |
| K150870 |
12/21/2015 |
HydroPearl Microspheres, HydroPearl Microspheres |
MICROVENTION, INC. |
NAOMI GONG |
| K153053 |
12/29/2015 |
Traxcess Pro 14 Guidewire |
MICROVENTION, INC. |
SAPNA SINGH |
| K143222 |
12/11/2015 |
FIREFLY Pedicle Screw Navigation Guide |
Mighty Oak Medical Inc |
Heidi Frey |
| K151396 |
12/09/2015 |
MIVI Mi-AXUS Guide Catheter |
MIVI NEUROSCIENCE, INC |
Matthew Ogle |
| K150898 |
12/18/2015 |
LiquoGuard 7, LiquoGuard 7 Drainage Set, Lenght 2000mm |
MOLLER MEDICAL GMBH |
JULIANE DRAGON |
| K153228 |
12/04/2015 |
NMI Port, NMI Port II |
NAVILYST MEDICAL, INC. |
Robin Fuller |
| K152857 |
12/17/2015 |
NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip Caps |
NEOMED, INC. |
TONY LAIR |
| K150729 |
12/29/2015 |
SpectraShield 9500 Surgical N95 Respirator |
Nexera Medical Inc. |
Paul Sallarulo |
| K150792 |
12/17/2015 |
Next Science Wound Gel |
NEXT SCIENCE, LLC |
MATTHEW MYNTTI |
| K152548 |
12/21/2015 |
AXI+LINE Proximal Bunion Correction System |
NEXTREMITY SOLUTIONS, Inc. |
Ryan Schlotterback |
| K150079 |
12/10/2015 |
Regenomer« Syringe, Regenomer« Plug, Regenomer« Block |
NIBEC CO, LTD |
YOON-JEONG PARK |
| K152943 |
12/01/2015 |
NuVasive Foundation-LL System |
NUVASIVE INCORPORATED |
CYNTHIA ADAMS |
| K150828 |
12/18/2015 |
O-RING Condom |
O-RING Products LLC |
William Mistler |
| K152945 |
12/15/2015 |
Alevicyn SG Antipruritic Gel |
OCULUS INNOVATIVE SCIENCES |
BRIAN W. MARTIN |
| K152809 |
12/31/2015 |
Giraffe Incubator Carestation CS1 |
OHMEDA MEDICAL, A DIVISION OF DATEX-OHMEDA, INC. |
KENNY BELLO |
| K142785 |
12/17/2015 |
PRODIGY iConnect Blood Glucose Monitoring System |
OK BIOTECH CO., LTD. |
Jen Ke-Min |
| K153437 |
12/21/2015 |
Apex Revision Knee System |
OMNILIFE SCIENCE |
CHRISTINA ROVALDI |
| K141157 |
12/22/2015 |
BONDEASE TOPICAL SKIN ADHESIVE |
OPTMED, INC. |
STEPHANIE RAIS |
| K153306 |
12/18/2015 |
Imbibe Needle |
ORTHOVITA, INC. |
LYNN LUNDY |
| K152145 |
12/21/2015 |
OsteoMed ExtremiLOCK Wrist Plating System |
OSTEOMED |
Piedad Pena |
| K152267 |
12/15/2015 |
Remedy« Shoulder Spacer |
Osteoremedies LLC |
Chris Hughes |
| K153378 |
12/21/2015 |
Monster BITE Screw System |
PARAGON 28 |
Frank S. Bono |
| K152951 |
12/28/2015 |
Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, Camera Sterilization Tray |
PARAGON MEDICAL, INC. |
MIKE GOSMEYER |
| K152636 |
12/17/2015 |
Laser Dock |
PATIENT POCKET, LLC |
ALLEN D SEFTEL |
| K152840 |
12/02/2015 |
Lantern Delivery Microcatheter |
PENUMBRA, INC. |
CHARLES DENAULT |
| K150854 |
12/14/2015 |
ImmunoCAP Specific IgE; ImmunoCAP Allergen f439, Hazelnut; ImmunoCAP Allergen f440, Hazelnut; ImmunoCAP Allergen f441, Walnut; ImmunoCAP Allergen f442, Walnut; ImmunoCAP Allergen f443, Cashew nut |
PHADIA AB |
Carina Magnusson |
| K153480 |
12/16/2015 |
ClearVue850 Diagnostic Ultrasound System |
PHILIPS HEALTHCARE |
Saraswathi Deora |
| K153318 |
12/22/2015 |
Philips Eleva Workspot with SkyFlow |
Philips Medical Systems DMC GmbH |
MING XIAO |
| K151658 |
12/01/2015 |
Gmate Origin Blood Glucose Monitoring System |
Philosys Inc. |
LINDA CHAN |
| K142879 |
12/23/2015 |
BTM Wound Dressing |
POLYNOVO BIOMATERIALS PTY LTD |
Philip Powell |
| K151050 |
12/22/2015 |
Pacifier Activated Lullaby (PAL«) |
Power Medical Devices, LLC |
Patricia Palmer |
| K151413 |
12/18/2015 |
Always/Tampax bladder supports |
PROCTER & GAMBLE |
LENORE FAULHABER |
| K143514 |
12/11/2015 |
Panther StereoSeed |
PROWESS, INC. |
Rachel Scarano |
| K150806 |
12/16/2015 |
PulseFlowDF |
PulseFlow Technologies |
Les Lindsay |
| K152321 |
12/04/2015 |
kVue Encompass SRS Insert (Encompass Insert), Encompass SRS Standalone (Encompass Device), Encompass SRS MRI Immobilization device (Encompass MRI Device, Encompass Intracranial Fibreplast Variable Perf Head Only Open View System, Encompass Intracranial Fi |
QFIX |
NADIA SOOKDEO HARHEN |
| K152012 |
12/08/2015 |
EVO platform |
Quanta System SpA |
Francesco Dell'Antonio |
| K152714 |
12/21/2015 |
Quanta Forte |
QUANTA SYSTEM SPA |
FRANCESCO DELL'ANTONIO |
| K152292 |
12/07/2015 |
Respire Blue Series-EF |
Respire Medical Holding |
David Walton |
| K152624 |
12/07/2015 |
XSTAT 30, 3-PACK, XSTAT 30, 1-PACK |
REVMEDX, INC. |
AMY K. POINTER |
| K152542 |
12/24/2015 |
Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for Use with Chemotherapy Drugs |
RIVERSTONE RESOURCES SDN BHD |
SURESH KUMAR |
| K153401 |
12/21/2015 |
GR40CW |
SAMSUNG ELECTRONICS CO., LTD. |
CHULSIN KIM |
| K153408 |
12/21/2015 |
HM70A Diagnostic Ultrasound System |
SAMSUNG MEDISON CO., LTD |
Jiyoung Kim |
| K152513 |
12/15/2015 |
8X-10-XXXX Camera System |
Santa Barbara Imaging Systems |
James Candy |
| K153189 |
12/17/2015 |
Beacon Tissue Marker (SE) |
SCION MEDICAL TECHNOLOGIES, LLC |
LOUIS LI |
| K151639 |
12/07/2015 |
ABL80 FLEX and ABL80 FLEX CO-OX |
SENDX MEDICAL INC |
VIBEKE AGERLIN |
| K151329 |
12/17/2015 |
SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet |
SENTEC AG |
ANKE WEISBRICH |
| K150664 |
12/22/2015 |
NeoLas |
SHEAUMANN LASER, INC |
Katina Sousa |
| K152384 |
12/18/2015 |
Digital Electrocardiograph |
SHENZHEN BIOCARE BIO-MEDICAL EQUIPMENT CO., LTD. |
Hongbo Zhong |
| K151810 |
12/17/2015 |
Bpump Blood Pressure Cuff |
SHENZHEN PUMP MEDICAL SYSTEM CO., LTD. |
XIE QIONGYU |
| K151699 |
12/10/2015 |
BEAUTIFIL II Enamel |
SHOFU DENTAL CORPORATION |
Mauro Malyzyner |
| K152451 |
12/11/2015 |
VINTAGE Art LF |
SHOFU DENTAL CORPORATION |
MAURO MALZYNER |
| K142826 |
12/22/2015 |
ADVIA Centaur Toxoplasma M (Toxo M) |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
Matthew Gee |
| K153365 |
12/18/2015 |
ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
KIRA GORDON |
| K151767 |
12/11/2015 |
Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Bridge, Trinidad CH Albumin BCP reagent (Alb_P), Trinidad CH Albumin BCP Calibrator |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
Laura J. Duggan |
| K152283 |
12/24/2015 |
MAGNETOM Amira |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
CORDELL L FIELDS |
| K153208 |
12/31/2015 |
Internal Joint Stabilizer - Elbow |
SKELETAL DYNAMICS, LLC |
Ana M Escagedo |
| K150908 |
12/16/2015 |
XM-01 Electronic Automatic Blood Pressure Monitor |
Sky Innovation Technology ( Shanghai) Limited |
Charles Shen |
| K152566 |
12/02/2015 |
PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to Twinfix Ti Quick-T, Twinfix FT PK, Twinfix Ultra Ti, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors, FOOTPRINT Ultra OK Suture Anchors, BIORAPTOR 2.9 Suture Anchor |
SMITH & NEPHEW, INC. |
KATHERINE MARCACCIO |
| DEN140024 |
12/23/2015 |
cNEP Airway |
Sommetrics |
Richard Rose |
| K152341 |
12/14/2015 |
ViSi Mobile Monitoring System |
SOTERA WIRELESS, INC |
Carson Krupp |
| K152355 |
12/10/2015 |
Twin Peaks Lumbar Interbody Fusion System |
SPINEWAY |
Julien Thao my |
| K152958 |
12/04/2015 |
INEX Absorbable Nasal Implant |
SPIROX, INC. |
MIKE ROSENTHAL |
| K151114 |
12/11/2015 |
Medismart ( Latex Surgeon┐s Gloves powdered ) and Medismart + (Latex Surgeon┐s Gloves Powder Free, Polymer coated with protein |
ST.MARYS RUBBERS PVT. LTD. |
Srinivasan. S |
| K152115 |
12/17/2015 |
Renew NCP-5 External Counterpulsation System |
Stage 2 Innovations |
Richard Kotz |
| K152651 |
12/15/2015 |
AccuLIF TL and PL Cage |
STRYKER CORPORATION |
AAKASH JAIN |
| K152632 |
12/02/2015 |
XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument Accessory |
STRYKER CORPORATION |
SORAYA KING |
| K152532 |
12/18/2015 |
AERO -C Cervical Cage System |
STRYKER SPINE |
SORAYA KING |
| K153154 |
12/28/2015 |
Asnis JFX System |
Stryker Trauma AG |
Garry T. Hayeck |
| K152692 |
12/21/2015 |
Powder Free Vinyl Patient Examination Gloves (Green) |
Supermax Plastic Products Co., Ltd |
Wu Zhigang |
| K150524 |
12/16/2015 |
Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Technology |
Surgical Instrument Services and Savings, Inc |
Richard D Wynkoop |
| K151936 |
12/04/2015 |
Steerable Intracardiac Catheter Introducer Kit and Transseptal Needle |
SYNAPTIC MEDICAL LIMITED |
Yang Tiecheng |
| K152239 |
12/02/2015 |
Zero-P Natural Plate System |
Synthes (USA), LLC |
Beth Becotte |
| K153140 |
12/02/2015 |
Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir with Xcoating, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir with Xcoating |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
JOSHUA P. EWING |
| K153376 |
12/16/2015 |
Advanced Perfusion System 1 |
Terumo Cardiovascular Systems Corporation |
Bryan Hann |
| K153143 |
12/02/2015 |
Capiox Advance Hardshell Reservoir |
Terumo Cardiovascular Systems Corporation |
Tierra A. Brown |
| K153213 |
12/03/2015 |
Capiox RX Hollow Fiber Oxygenator with/without Hardshell Reservoir |
Terumo Cardiovascular Systems Corporation |
Tierra A Brown |
| K152173 |
12/01/2015 |
Glidesheath |
TERUMO MEDICAL CORPORATION |
ERIN DOYLE |
| K152389 |
12/18/2015 |
Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda Kit |
THE BINDING SITE GROUP LTD |
STEPHANIE THOULESS |
| K150676 |
12/23/2015 |
L-Mesitran Dressing Family II- Soft and Tulle |
Theo Manufacturing BV |
Monique Gottgens |
| K152774 |
12/21/2015 |
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftazidime/Avibactam in the dilutions range of 0.015/4 - 32/4 ug/mL |
THERMO FISHER SCIENTIFIC |
CYNTHIA KNAPP |
| K153122 |
12/14/2015 |
Endoskeleton(r) TCS System |
TITAN SPINE, LLC |
Jane Rodd |
| K152202 |
12/14/2015 |
Intermediate Catheter, 105 cm, Intermediate Catheter, 115cm, Intermediate Catheter , 125cm |
TNI Manufacturing, Inc. |
Daniel Sablyak |
| K152128 |
12/23/2015 |
2-in-1 Abdominal Muscle Training & Back Pain Relief System |
Tohkai Precision Electrical Manufactory (Shenzhen) Limited |
Yuk Wing Li |
| K153417 |
12/18/2015 |
ST AIA-PACK PROG III Calibrator Set |
TOSOH BIOSCIENCE, INC. |
ROBERT L. WICK |
| K153310 |
12/17/2015 |
Klassic Knee System |
TOTAL JOINT ORTHOPEDICS, INC. |
CHRIS WEABER |
| K151916 |
12/18/2015 |
TRI Dental Implant System |
TRI DENTAL IMPLANTS INT. AG |
SANDRO VENANZONI |
| K153362 |
12/16/2015 |
AquaShield system CO2, AquaShield system-PENTAX |
UNITED STATES ENDOSCOPY GROUP, INC. |
CARROLL MARTIN |
| K150716 |
12/08/2015 |
Varaya Sport |
VARAYA PHOTOCEUTICALS, LLC |
Myk Lum |
| K151022 |
12/17/2015 |
Intraluminal Applicator Set |
VARIAN MEDICAL SYSTEMS, INC. |
PETER J. CORONADO |
| K152387 |
12/18/2015 |
Fluent Inflation Device |
VASCULAR SOLUTIONS, INC. |
BEKA VITE |
| K150869 |
12/10/2015 |
Checkme Pro Health Monitor |
Viatom Technology Co., Ltd. |
Zhou Saixin |
| K150992 |
12/16/2015 |
Vios Monitoring System |
VIOS MEDICAL, INC. |
MEGAN GRAHAM |
| K152373 |
12/30/2015 |
VITA VM LC Flow |
VITA ZAHNFABRIK H. RAUTER GMBH & CO. |
Bernd Walker |
| K152139 |
12/06/2015 |
Vital Connect Platform, HealthPatch MD, VitalPatch |
VITAL CONNECT, INC. |
BONNIE WU |
| K150961 |
12/04/2015 |
EmbryoSlide Culture Dish |
VITROLIFE A/S |
BELINDA DUEHOLM |
| K150950 |
12/21/2015 |
FreezeKit Cleave , ThawKit Cleave |
VITROLIFE SWEDEN AB |
Brett Sonet Glazar |
| K152582 |
12/03/2015 |
CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box |
VOLCANO CORPORATION |
NATHAN DA SILVA |
| K153369 |
12/22/2015 |
SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install Kit, s5iz |
VOLCANO CORPORATION |
Brian Park |
| K153094 |
12/31/2015 |
Visions PV .035 Digital IVUS Catheter |
Volcano Corporation |
Neeta Sharma |
| K152609 |
12/11/2015 |
GORE SYNECOR Biomaterial |
W.L GORE & ASSOCIATES, INC. |
BARBARA L. SMITH |
| K151900 |
12/11/2015 |
VariLift-L Interbody Fusion Device |
WENZEL SPINE, INC. |
BECKINAM NOWATZKE |
| K152851 |
12/24/2015 |
BrainPort V100 |
WICAB, INC. |
ROBERT BECKMAN |
| K152118 |
12/16/2015 |
Zenostar MT, Zenostar Color Liquids |
WIELAND DENTAL + TECHNIK GMBH & CO. KG |
BETINA KISTNER |
| K152782 |
12/21/2015 |
SYDNEY IVF SPERM MEDIUM, SYDNEY IVF SPERM GRADIENT KIT, SYDNEY IVF SPERMIENT |
WILLIAM A. COOK AUSTRALIA PTY LTD |
GORDANA POZVEK |
| K152904 |
12/03/2015 |
SYDNEY IVF EMBRYO BIOPSY MEDIUM |
WILLIAM A. COOK AUSTRALIA PTY, LTD. |
GORDANA POZVEK |
| K151714 |
12/03/2015 |
Disposable Endoscope Valves Set A |
WILSON INSTRUMENTS (SHANGHAI) COMPANY LIMITED |
LIJUAN ZHANG |
| K152038 |
12/22/2015 |
MammoGRIP |
Women's Imaging Solutions Enterprises LLC |
Nancy DeRobertis |
| K152974 |
12/11/2015 |
ORTHOLOC« 3Di Foot Plating Reconstruction System |
Wright Medical Technology, Inc. |
Val Myles |
| K150640 |
12/01/2015 |
RX-FIX Mini Rail External Fixator |
WRIGHT MEDICAL TECHNOLOGY, INC. |
LESLIE FITCH |
| K151890 |
12/23/2015 |
Medical Diode Laser Systems |
Wuhan Gigaa Optronics Technology Co., Ltd |
Nie Xinxing |
| K151284 |
12/21/2015 |
Electric Double Breast Pumps |
Wuxi Xinzhongrui Baby Supplies Co.,Ltd |
Shaozhong Chen |
| K152987 |
12/11/2015 |
Xenco Medical Cervical Interbody System, Xenco Medical Lumbar Interbody System |
XENCO MEDICAL, LLC |
GUSTAVO PRADO |
| K151498 |
12/18/2015 |
Breathing circuit bacterial/viral filter |
ZHEJIANG HAISHENG MEDICAL DEVICE CO., LTD. |
HU JUBIN |
| K151907 |
12/30/2015 |
Cable-Ready« Cable Grip System: Cable-Ready« GTR System, Cable-Ready« 1.8mm Cerclage Cables |
ZIMMER, INC. |
PATRICK MCCULLAGH |
| K152484 |
12/04/2015 |
FastFrame External Fixation System - Distal Radius |
ZIMMER, INC. |
DOROTHY SNYDER |
| K152755 |
12/21/2015 |
FastFrame External Fixation System-Ankle Spanning |
Zimmer, Inc. |
Dorothy Snyder |
