| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K171908 |
06/26/2017 |
3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing |
3M Company |
Melissa Forth |
| K171634 |
06/02/2017 |
Ortho System |
3Shape A/S |
Antje Marquardsen |
| K171941 |
06/28/2017 |
FreeStyle Precision Neo Blood Glucose Test Strips |
Abbott Diabetes Care Inc. |
Danielle Tayor |
| K171650 |
06/05/2017 |
Alere Afinion HbA1c and ACR on Afinion 2 analyzer |
Abbott Rapid Diagnostics |
Monica Vallestad |
| K171761 |
06/14/2017 |
ACCLARENT AERA Eustachian Tube Balloon Dilation System |
Acclarent, Inc. |
James Patrick Garvey II |
| K171687 |
06/07/2017 |
Relieva SpinPlus Nav Balloon Sinuplasty System |
Acclarent, Inc. |
James Patrick Garvey II |
| K171837 |
06/20/2017 |
TomoTherapy Treatment Delivery System with iDMS |
Accuray Incorporated |
Keith Picker |
| K171646 |
06/05/2017 |
ACISTCVi« Contrast Delivery System |
ACIST Medical Systems, Inc. |
Melissa Sommerfeld |
| K171629 |
06/02/2017 |
ABCcolla Bone Graft |
ACRO Biomedical Co., Ltd. |
Dar-Jen Hsieh |
| K171606 |
06/01/2017 |
AOS Anterolateral Proximal Humeral Plate |
Advanced Orthopaedic Solutions, Inc. (AOS) |
Alex Bhaskarla |
| K171720 |
06/12/2017 |
encevis |
AIT Austrian Institute of Technology GmbH |
Tilmann Kluge |
| K171947 |
06/29/2017 |
SOLOASSIST II |
AKTORmed GmbH |
Andreas Mohr |
| K171792 |
06/16/2017 |
Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit |
Alere Scarborough, Inc. |
Angela Drysdale |
| K171816 |
06/19/2017 |
Kardia Band System |
AliveCor, Inc |
Prabhu Raghavan |
| K171876 |
06/23/2017 |
Ceramill Zolid HT+ white |
Amann Girrbach AG |
Debora Engel |
| K171857 |
06/21/2017 |
AMSure« Enteral Feeding Syringe with ENFit Tip |
Amsino International, Inc. |
Cathy Hong |
| K171921 |
06/27/2017 |
VenaCure EVLT NeverTouch Procedure Kit |
AngioDynamics, Inc. |
Hans Kjolhede |
| K171863 |
06/22/2017 |
Anjon Bremer Halo System |
Anjon Holdings, LLC |
Tommy Mitchell |
| K171737 |
06/12/2017 |
Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves |
Ansell Healthcare Products LLC |
Robert Mahler |
| K171886 |
06/26/2017 |
OverStitch SX Endoscopic Suturing System (ESS) |
Apollo Endosurgery Inc |
Maritza Ward |
| K171701 |
06/08/2017 |
GelPOINT Path Transanal Access Platform |
Applied Medical Resources Corp. |
Corinne Weisheit |
| K171684 |
06/07/2017 |
Epix Electrosurgical Probe with Smoke Evacuation |
Applied Medical Resources Corporation |
Aditi Iyengar |
| K171841 |
06/20/2017 |
Arthrex Shoulder System |
Arthrex Inc. |
David L. Rogers |
| K171613 |
06/01/2017 |
ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tip |
Asahi Intecc Co., Ltd. |
Yasuyuki Kawahara |
| K171933 |
06/28/2017 |
ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro Microcatheter |
Asahi Intecc Co., Ltd. |
Yasuyuki Kawahara |
| K171812 |
06/19/2017 |
Nio Color 2MP (MDNC-2123) |
Barco NV |
Helena Soenen |
| K171953 |
06/29/2017 |
Bard Mission Disposable Core Biopsy Instrument |
Bard Peripheral Vascular, Inc. |
Susan Sheffield |
| K171671 |
06/06/2017 |
Prismaflex System 8.10 |
Baxter Healthcare Corporation |
Rick Lukacovic |
| K171802 |
06/19/2017 |
ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device) |
Bayer HealthCare LLC |
Cindy R. Abraham |
| K171898 |
06/26/2017 |
Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs |
Better Care Plastic Technology Co., Ltd |
Zhu Chunyan |
| K171793 |
06/16/2017 |
Sequential Circulator SC-2004FC-OC |
Bio Compression Systems, Inc. |
Barbara J. Whitman |
| K171664 |
06/05/2017 |
Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software |
Bio-Rad Laboratories, Inc. |
Sweta Patel |
| K171822 |
06/19/2017 |
NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352) |
Biotest Medical Corporation |
Fred Lee |
| K171785 |
06/15/2017 |
WowGoHealth Blood Glucose Monitoring System |
Biotest Medical Corporation |
Fred Lee |
| K171851 |
06/21/2017 |
SOFTXIL |
BISTOOL |
Eunhyun Bae |
| K171782 |
06/15/2017 |
Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy drugs |
Blue Sail Medical Co.,Ltd |
Robin Liu |
| K171648 |
06/05/2017 |
BM.IRIS |
Bluecore Co.,Ltd. |
Bill Choi |
| K171893 |
06/26/2017 |
Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone Synergy Cervical Interbody Fusion System (Slate) |
Bluestone Synergy |
Lisa Peterson |
| K171612 |
06/01/2017 |
ACUITY Pro Lead Delivery System |
Boston Scientific Corporation |
Lori Berends |
| K171809 |
06/19/2017 |
Epic Biliary Endoscopic Stent System |
Boston Scientific Corporation |
Thomas Hirte |
| K171913 |
06/26/2017 |
Rubicon 14, 18 and 35 Support Catheters |
Boston Scientific Corporation |
Ka Zoua Xiong |
| K171922 |
06/27/2017 |
Anatotemp Anatomic Dental Implant Healing Abutment |
Buckeye Medical Technologies LLC |
Terry B. Philibin |
| K171735 |
06/12/2017 |
PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle Set |
C.R. Bard, Inc. |
Jeremy Tidwell |
| K171751 |
06/13/2017 |
SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot Monitoring Mode, SmartLinx Vitals Plus Alarm Hub, SmartLinx Vitals Plus License for Advanced Monitoring Mode, Covidien FILAC 3000 - Temperature Module |
Capsule Technologie, SAS |
James Hodge |
| K171957 |
06/29/2017 |
MaxZero Extension Sets with Needless Connector |
Carefusion 303 Inc. |
Viviana Lai |
| K171956 |
06/29/2017 |
Sterile Endoscope Biopsy Sampling Needle |
Changzhou Detain Medical Devices Co., Ltd. |
Zhengrong Ding |
| K171686 |
06/07/2017 |
Choice Spine HawkeyeÖ Vertebral Body Replacement (VBR) System |
Choice Spine |
Kim Finch |
| K171877 |
06/23/2017 |
SLM-1ER, SLM-2ER, SLM-3ER |
Chongqing Kanghua Ruiming S&T Co., Ltd. |
Xi You |
| K171835 |
06/20/2017 |
Irradiation Aesthetic Device |
Chongqing Peninsula Medical Technology Co., Ltd. |
Zhang Sudi |
| K171639 |
06/02/2017 |
Trojan Supra Lubricated Polyurethane Male Condom |
Church & Dwight Co., Inc. |
Lisa Burns |
| K171767 |
06/14/2017 |
Cianna Medical SAVI Scout Reflector and SAVI Scout System |
Cianna Medical, Inc. |
Gary Mocnik |
| K171637 |
06/02/2017 |
OpClear System |
Cipher Surgical Ltd |
Justin Buch |
| K171702 |
06/08/2017 |
Exciplex308nm |
Clarteis |
Laurent Meilhac |
| K171677 |
06/06/2017 |
Clear Guide SCENERGY |
Clear Guide Medical |
Jack Kent |
| K171954 |
06/29/2017 |
ClearLine IV |
ClearLine MD |
Rick Romeo |
| K171862 |
06/22/2017 |
GALAXY G3 Mini Microcoil Delivery System |
Codman & Shurtleff, Inc |
Yoon Hee Beatty |
| K171747 |
06/13/2017 |
MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch Resistant Microcoil Delivery System, DELTAFILL 18 Stretch Resistant Microcoil Delivery System, DELTAXSFT 10 Stretch Resistant Microcoil Delivery System, GALAXY G3 FILL and |
Codman & Shurtleff, Inc. |
Vivian Perez |
| K171653 |
06/05/2017 |
YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back Up |
Codman & Shurtleff, Inc. |
Yoon Hee Beatty |
| K171855 |
06/21/2017 |
External Moisturizing Gel |
Combe Incorporated |
Richard Grabarz |
| K171805 |
06/19/2017 |
Luer-Jack Slip 3 ml, Luer-Jack Slip 5 ml, Luer-Jack Slip 20 ml, Luer-Jack Lock 10 ml |
ConceptoMed AS |
Marit Martinsen |
| K171725 |
06/12/2017 |
CuffLink Implant System |
CONMED Corporation |
Dionne Sanders |
| K171817 |
06/19/2017 |
Biodesign Diaphragmatic Hernia Graft |
Cook Biotech Incorporated |
Perry W. Guinn |
| K171897 |
06/26/2017 |
Approach CTO Microwire Guide |
Cook Incorporated |
Jennifer Allman |
| K171609 |
06/01/2017 |
Check-Flo Performer Introducer Micropuncture Radial Artery Access Set |
Cook Incorporated |
Jennifer Allman |
| K171810 |
06/19/2017 |
Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter |
Cook Incorporated |
Yan Li |
| K171603 |
06/01/2017 |
Cope Nephroureterostomy Stent and Amplatz Ureteral Stent Set |
Cook Incorporated |
Erum B. Nasir |
| K171912 |
06/26/2017 |
Double Flexible Tip Wire Guides |
Cook Incorporated |
Jennifer Allman |
| K171764 |
06/14/2017 |
Fixed Core Wire Guides |
Cook Incorporated |
Jennifer Allman |
| K171917 |
06/27/2017 |
Frova Intubating Introducer |
Cook Incorporated |
Kotei Aoki |
| K171853 |
06/21/2017 |
Liver Access and Biopsy Sets |
Cook Incorporated |
David Lehr |
| K171915 |
06/26/2017 |
Nathanson Transcystic Bile Duct Stone Exploration Pack |
Cook Incorporated |
Colin Jacob |
| K171662 |
06/05/2017 |
Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-End Ureteral Catheter, Open-End Flexi-Tip Ureteral Catheter, Flexi-Tip Ureteral Catheter (Closed End), Whistle Tip Ureteral Catheter, Round Tip Ureteral Catheter, Spiral Tip Ure |
Cook Incorporated |
Carly Powell |
| K171604 |
06/01/2017 |
R÷sch Thurmond Fallopian Tube Catheterization Set, Fallopian Tube Catheterization Set, and Fallopian Tube Catheterization Wire Guide with Platinum Tip |
Cook Incorporated |
Ian Herrman |
| K171600 |
06/01/2017 |
Renal Access Cobra Catheter, Kumpe Access Catheter |
Cook Incorporated |
Samuel Engelman |
| K171948 |
06/29/2017 |
Roadrunner Extra Support Wire Guide |
Cook Incorporated |
Jennifer Allman |
| K171820 |
06/19/2017 |
Transjugular Liver Access Sets |
Cook Incorporated |
David Lehr |
| K171601 |
06/01/2017 |
Ultraxx Nephrostomy Balloon Catheter |
Cook Incorporated |
Minjin Choi |
| K171602 |
06/01/2017 |
Williams Cystoscopic Injection Needle |
Cook Incorporated |
Rebecca Odulio (Li-chun Liu) |
| K171619 |
06/02/2017 |
14Fr Colon Decompression Set, Macon Colon Decompression Set |
Cook Ireland Ltd |
Laura Graham |
| K171623 |
06/02/2017 |
Nasal Pancreatic Drainage Set |
Cook Ireland Ltd |
Orla Gunning |
| K171685 |
06/07/2017 |
Med4 Elite |
Cool Systems, Inc. (dba Game Ready) |
Natalie Kennel |
| K171847 |
06/21/2017 |
Corin Optimized Positioning System (OPSÖ) Plan |
Corin USA Limited |
Kathy Trier |
| K171819 |
06/19/2017 |
Attain Assist CS Access Catheter |
Creganna Medical also doing business as Ceganna Tactx Medica |
Olivia Odhiambo |
| K171983 |
06/30/2017 |
Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory |
Creo Medical Ltd |
Keith Penny |
| K171626 |
06/02/2017 |
truFreeze System |
CSA Medical, Inc. |
Sherrie Coval-Goldsmith |
| K171909 |
06/26/2017 |
HAL for Medical Use (Lower Limb Type) |
CYBERDYNE Inc. |
Yohei Suzuki |
| K171694 |
06/07/2017 |
s-Clean TiN Coating Abutments |
Dentis Co., Ltd. |
Sun Chul Shin |
| K171622 |
06/02/2017 |
Dentium Ti-Base |
Dentium Co., Ltd. |
Sangpil Yoon |
| K171750 |
06/13/2017 |
Citric Complete Dry Citric Acid (45X) |
Dimesol USA, LLC |
Marlene Van Dyke |
| K171952 |
06/29/2017 |
Dimesol Tubing Sets for Hemodialysis |
Dimesol, Inc. |
Stephen P. Callaghan |
| K171772 |
06/14/2017 |
Ecosite Bulk Fill |
DMG USA Inc. |
Gordon Craig |
| K171729 |
06/12/2017 |
Fixtemp C&B |
Dreve Dentamid GmbH |
Reiner Altmann |
| K171836 |
06/20/2017 |
EarlySense Bed Sensing Unit |
EarlySense Ltd. |
Dalia Argaman |
| K171824 |
06/19/2017 |
Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound System |
Edan Instruments Inc |
Alice Yang |
| K171900 |
06/26/2017 |
Acclarix AX4 Diagnostic Ultrasound System |
Edan Instruments, Inc |
Crystal Cai |
| K171943 |
06/28/2017 |
Electrocardiograph |
Edan Instruments, Inc. |
Alice Yang |
| K171942 |
06/28/2017 |
Electrocardiograph |
Edan Instruments, Inc. |
Alice Yang |
| K171799 |
06/16/2017 |
Elos Accurate Customized Abutment, Elos Prosthetic Screw |
Elos Medtech Pinol A/S |
Tina Friis Poulsen |
| K171845 |
06/20/2017 |
EMBA Hourglass Peripheral Embolization Device |
EMBA Medical Limited |
Veronica Reott |
| K171860 |
06/22/2017 |
Sureclear aligners |
Emergo Global Consulting, LLC |
Stuart R. Goldman |
| K171781 |
06/15/2017 |
eVox System |
Evoke Neuroscience, Inc. |
David Hagedorn |
| K171865 |
06/22/2017 |
F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring |
Farus, LLC |
Rahul Singh |
| K171879 |
06/23/2017 |
HylaGuard Moisturizing Cream |
Founders Science Group, LLC |
Ronald M. Gurge |
| K171789 |
06/15/2017 |
ARROW Reverse Porous Glenoid |
Fournitures Hospitalieres Industrie |
Patricia Donnard |
| K171652 |
06/05/2017 |
Fresenius Liberty Select Cycler |
Fresenius Medical Care Renal Therapies Group, LLC |
Denise Oppermann |
| K171834 |
06/20/2017 |
G Surgical OCT Spinal System |
G Surgical LLC |
Donald Grafton |
| K171669 |
06/05/2017 |
g.Nautilus PRO |
g.tec medical engineering GmbH |
Christoph Guger |
| K171673 |
06/06/2017 |
Focus Cap |
GCE Medical Corporation |
Stanley Chang |
| K171800 |
06/16/2017 |
OEC Elite MiniView |
GE Hualun Medical Systems Co.Ltd. |
Lifeng Wang |
| K171643 |
06/02/2017 |
Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed |
Geistlich Pharma AG |
Marco Steiner |
| K171842 |
06/20/2017 |
Geistlich Wound Matrix |
Geistlich Pharma AG |
Jan van der Ploeg |
| K171736 |
06/12/2017 |
Geri Embryo Incubator and Geri Dish |
Genea Biomedx Pty Ltd |
Kea Dent |
| K171656 |
06/05/2017 |
Genesys Spine Apache Interbody Fusion System |
Genesys Spine |
Brian J. Bergeron |
| K171838 |
06/20/2017 |
TiLock2 Spinal System |
Genesys Spine |
William W. Sowers |
| K171752 |
06/13/2017 |
X-SURGE |
Genicon, Inc |
Katlyn Kachman |
| K171651 |
06/05/2017 |
EXCELSIUS GPS |
Globus Medical Inc. |
Kelly J. Baker |
| K171848 |
06/21/2017 |
FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO Corpectomy Spacers, SUSTAIN Spacers, COALITION Spacers, PATRIOT Lumbar Spacers, PATRIOT Cervical Spacers, ALTERA Spacers, RISE Spacers, CALIBER Spacers, ELSA Spacers, LATIS |
Globus Medical Inc. |
Lori Burns |
| K171939 |
06/28/2017 |
ALVUE Balloon Dilation System |
Globus Medical, Inc. |
Lori Burns |
| K171885 |
06/26/2017 |
Radiance V4 |
GMV Soluciones Globales Internet S.A.U. |
Carlos Illana |
| K171867 |
06/22/2017 |
DrÆs Finder NEO |
Good Doctors Co.,Ltd. |
Sungro Joo |
| K171707 |
06/08/2017 |
GA-B, GA-C, GA-E, GA-I, GA-S, GA-W3A, GA-F3A, GA-IL, GA-SL, GA-W3B, GA-F1A |
Gowoonsesang Cosmetics Co., Ltd |
Kyeong Tai Ko |
| K171926 |
06/27/2017 |
C5 Diagnostic Ultrasound System |
Guangzhou Sonostar Technologies Co., Ltd. |
Weizhong Cai |
| K171975 |
06/30/2017 |
HardyDisk AST Delafloxacin 5 ╡g (DLX5) |
Hardy Diagnostics |
Rianna Malherbe |
| K171874 |
06/23/2017 |
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant and Tested for Use With Chemotherapy Drugs (Dawn Blue) |
HARTALEGA SDN. BHD. |
KUAN KAM HON |
| K171821 |
06/19/2017 |
2 Face / Face Evolution |
Heat In A Click |
Guy Levi |
| K171681 |
06/06/2017 |
Hermes Medical Imaging Suite v5.7 |
Hermes Medical Solutions AB |
Joakim Arwidson |
| K171719 |
06/09/2017 |
Hybrid3D |
Hermes Medical Solutions AB |
Joakim Arwidson |
| K171888 |
06/26/2017 |
Non-contact infrared body thermometer |
Hetaida Technology Co., Ltd |
ZhenGuang Chen |
| K171977 |
06/30/2017 |
miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer |
Hinacom Software and Technology, Ltd |
Yi Isabelle Sun |
| K171708 |
06/08/2017 |
ALOKA ARIETTA 850 |
Hitachi Healthcare Americas Corporation |
Doug Thistlethwaite |
| K171738 |
06/12/2017 |
Supria True64 |
Hitachi Healthcare Americas Corporation |
Doug Thistlethwaite |
| K171803 |
06/19/2017 |
HIVOX OTC Electrical Stimulator |
Hivox Biotek Inc. |
Linda Lin |
| K171599 |
06/01/2017 |
WiTouch Pro, WiTouch, Neubac |
Hollywog LLC |
Michael Treas |
| K171963 |
06/30/2017 |
Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther Fusion Assay Fluids I-S Kit, Panther Fusion Specimen Lysis Tubes |
Hologic, Inc. |
Ron Domingo |
| K171768 |
06/14/2017 |
Trident« II Acetabular System |
Howmedica Osteonics Corp. aka Stryker Orthopaedics |
Valerie Giambanco |
| K171982 |
06/30/2017 |
DROPLET PEN NEEDLE |
HTL-STREFA S.A. |
Aleksandra Prazmowska-Wilanowska |
| K171825 |
06/19/2017 |
Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrument |
Hunan Handlike Minimally Invasive Surgery Co., Ltd |
Hu hanhan |
| K171881 |
06/23/2017 |
JAZZ Passer Band |
Implanet, S.A. |
Fabienne Larquey Cadiere |
| K171647 |
06/05/2017 |
BeneLife Premium Facial Treatment Pack, Model: QZ0701A |
Infinitus (China) Company Ltd. |
Judy Zhou |
| K171672 |
06/06/2017 |
065 Zenith, 074 Zenith |
InNeuroCo, Inc |
Marc Litzenberg |
| K171788 |
06/15/2017 |
Reprocessed Halo XP Diagnostic Electrophysiology Catheter |
Innovative Health, LLC. |
Amy Stoklas-Oakes |
| K171649 |
06/05/2017 |
Straumann CARES M-Series CAD/CAM System |
Institut Straumann AG |
Andreas Petermann |
| K171773 |
06/14/2017 |
Straumann n!ce Glass Ceramic A14 Blocks |
Institut Straumann AG |
Shokoufeh Khodabandeh |
| K171831 |
06/20/2017 |
Intra-Lock Bone Fixation System |
Intra-Lock International, Inc. |
Mary L. Jean |
| K171632 |
06/02/2017 |
da Vinci Xi Surgical System |
Intuitive Surgical, Inc |
Brandon Hansen |
| K171699 |
06/08/2017 |
da Vinci Xi Surgical System, da Vinci Si Surgical System, da Vinci X Surgical System |
Intuitive Surgical, Inc |
Brandon Hansen |
| K171880 |
06/23/2017 |
IRRAflow CNS System |
IRRAS Inc. |
Dessi Lyakov |
| K171778 |
06/15/2017 |
MR Wireless Gating System, Model WGS-100 |
Ivy Biomedical Systems, Inc |
Nicole Bush |
| K171713 |
06/09/2017 |
Neodent Instrument Kits |
JJGC Industria e Comercio de Materiais Dentarios S.A. |
Julianne de Oliveira Capucho Lechechem |
| K171704 |
06/08/2017 |
CAPRI Corpectomy Cage System |
K2M |
Nancy Giezen |
| K171832 |
06/20/2017 |
Range/Denali/Mesa Spinal System |
K2M, Inc. |
Nancy Giezen |
| K171717 |
06/09/2017 |
AUTOCON III 400 |
KARL STORZ Endoscopy-America, Inc. |
AnnaLisa Smullin |
| K171748 |
06/13/2017 |
Vitrification Kit and Thawing Kit |
Kitazato Corporation |
Futoshi Inoue |
| K171716 |
06/09/2017 |
SKR 3000 |
Konica Minolta, Inc. |
Tsutomu Fukui |
| K171731 |
06/12/2017 |
KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit |
Kronus, Inc. |
Brian Deis |
| K171813 |
06/19/2017 |
OpenLoc-L Spinal Fixation System, LnK Spinal Fixation System |
L&K BIOMED Co., Ltd. |
Yerim An |
| K171895 |
06/26/2017 |
Grivamax Hair Growth System |
Leana Orders, Inc. |
Leonid Krits |
| K171753 |
06/12/2017 |
BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 |
Leica Biosystems Newcastle Limited |
Bert Peerboom |
| K171906 |
06/26/2017 |
Liofilchem MIC Test Strip (MTS)- Delafloxacin 0.002 - 32 ╡g/mL |
Liofilchem s. r. l. |
Fabio Brocco |
| K171971 |
06/30/2017 |
Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer |
Lite-On Technology Corp. H.S.P.B. |
John Lo |
| K171610 |
06/01/2017 |
MC3 QuickFlow Dual Lumen Catheter |
MC3 Incorporated |
Martha Rumford |
| K171958 |
06/29/2017 |
PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE |
Mectron SPA |
Franco Zunino |
| K171928 |
06/27/2017 |
Med-Hot Thermal Imaging Systems |
Med-Hot Thermal Imaging Inc. |
Carol Chandler |
| K171640 |
06/02/2017 |
M-ARS ACL: Anatomic Ribbon Surgery System |
Medacta International SA |
Stefano Baj |
| K171758 |
06/14/2017 |
M.U.S.T. Combined Set Screws |
Medacta International SA |
Stefano Baj |
| K171966 |
06/30/2017 |
Mpact« 3D MetalÖ Implants and Augments 3D MetalÖ |
Medacta International SA |
Stefano Baj |
| K171618 |
06/02/2017 |
Symetrex Long Term Hemodialysis Catheter |
Medcomp (DBA Medical Components, Inc.) |
Courtney Nix |
| K171931 |
06/28/2017 |
Celerity ECG Cable Accessory Pack |
Medcomp (Medical Components, Inc.) |
Colton Muraira |
| K171798 |
06/16/2017 |
Silverwear Silver Pro Garment Device |
Media Plus, LLC |
Rita Vacco |
| K171890 |
06/26/2017 |
BEXCORE Breast Biopsy System, Biopsy Needle |
Medical Park CO., LTD |
Hye-Yeon Park |
| K171796 |
06/16/2017 |
Vial Adapter 15mm |
Medimop Medical Project Ltd. |
Jeffrey Ravel |
| K171938 |
06/28/2017 |
KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set |
Medtronic |
Lee Grant |
| K171689 |
06/07/2017 |
ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology |
Medtronic Sofamor Danek USA, Inc. |
Kelly Anglin |
| K171866 |
06/22/2017 |
Sentrant Introducer Sheath with Hydrophilic Coating |
Medtronic Vascular, Inc. |
Wee Wen Leow |
| K171979 |
06/30/2017 |
Tubing Pack |
Medtronic, Inc. |
Renee Cveykus |
| K171641 |
06/02/2017 |
Accula Flu A/Flu B Test |
Mesa Biotech, Inc. |
Barbara E. Stevens |
| K171937 |
06/28/2017 |
Microlife Upper Arm Automatic Digital Blood Pressure Monitor |
Microlife Intellectual Property GmbH |
Gerhard Frick |
| K171904 |
06/26/2017 |
Tandry Locking Plate System |
Microware Precision Co., Ltd. |
Harrison Du |
| K171964 |
06/30/2017 |
LigaMetrics Suture Anchors |
Mortise Medical LLC |
Robert Hoy |
| K171884 |
06/23/2017 |
I-Portal Portable Assessment System - Nystagmograph (I-PAS) |
Neuro Kinetics, Inc |
Brian Sullivan |
| K171914 |
06/26/2017 |
CortinaÖ Lumbar Cage System |
NeuroStructures, Inc. |
Kathleen Wong |
| K171902 |
06/26/2017 |
Nexstim Navigated Brain Therapy (NBT) System 2 |
Nexstim Plc |
Rainer Harjunpaa |
| K171765 |
06/14/2017 |
Nihon Kohden CO2 Monitor |
Nihon Kohden Corporation |
Thomas Bento |
| K171730 |
06/12/2017 |
FuckWater |
Non-Friction Products Inc. |
Marc Barrette |
| K171754 |
06/13/2017 |
NovaPACS |
Novarad Corporation |
Doug Merrill |
| K171791 |
06/16/2017 |
MAGEC« System |
NuVasive Specialized Orthopedics, Incorporated |
Manthan J. Damani |
| K171633 |
06/02/2017 |
NuVasive TLX Interbody System |
NuVasive, Incorporated |
Cynthia Adams |
| K171894 |
06/26/2017 |
NuVasive« PreceptÖ Spinal System |
NuVasive, Incorporated |
Marysa Loustalot |
| K171916 |
06/26/2017 |
Single Use Hot Biopsy Forceps FD-231 |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K171692 |
06/07/2017 |
Instrument basket, for EndoEYE |
Olympus Winter & Ibe GmbH |
Jan-Oliver Upmeier |
| K171965 |
06/30/2017 |
Resection Electrodes with HF cable |
Olympus Winter & Ibe GmbH |
Jan-Oliver Upmeier |
| K171755 |
06/13/2017 |
CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System |
Omega Medical Imaging, LLC |
John Newman |
| K171828 |
06/20/2017 |
ETCO2 Sensor |
Orantech Inc. |
Yunxi Xiong |
| K171734 |
06/12/2017 |
HP PRO Positioning Device |
Orfit Industries NV |
Eddy Marivoet |
| K171844 |
06/20/2017 |
Inspire ICE aka Inspire ICE Clear Brackets |
Ormco Corporation |
Tara Bonny |
| K171780 |
06/15/2017 |
OrthAlign Plus System |
OrthAlign, Inc. |
David Vancelette |
| K171617 |
06/01/2017 |
OKI Surgical Planning Software |
Ortho Kinematics, Inc. |
Adam Deitz |
| K171698 |
06/08/2017 |
Smart Syringe |
Osprey Medical, Inc. |
Melanie Hess |
| K171774 |
06/14/2017 |
RPM Reinforced PTFE Mesh |
Osteogenics Biomedical, Inc. |
Shane Shuttlesworth |
| K171899 |
06/26/2017 |
Revitalair 430F |
Oxavita S.R.L. |
Eduardo Northing |
| K171703 |
06/08/2017 |
PUMA System |
Panther Orthopedics, Inc. |
Kathryn Stecco |
| K171715 |
06/09/2017 |
HammerTube System |
Paragon 28 |
Frank S. Bono |
| K171936 |
06/28/2017 |
Peerbridge Cor(TM) System |
Peerbridge Health INc. |
Arthur A. Bertolero |
| K171872 |
06/23/2017 |
P50 Series Dental Operative Unit and Accessories |
Pelton & Crane |
Frank Ray |
| K171850 |
06/21/2017 |
Philips CT Big Bore |
Philips Medical Systems (Cleveland) Inc. |
Michael Chilbert |
| K171801 |
06/16/2017 |
IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic Extension, Capnography Extension, Microstream Extension;Transpac IV Dual IBP Cable |
Philips Medizin Systeme Boeblingen GmbH |
Markus Stacha |
| K171696 |
06/07/2017 |
NOxBOXi Nitric Oxide Delivery System |
Praxair Distribution, Inc |
Michael E. Skrjanc |
| K171630 |
06/02/2017 |
LumFuse-TP |
Precifit Medical Ltd |
ZhenYu (Eric) Wu |
| K171657 |
06/05/2017 |
ShurFit 2C Lumbar Interbody Fusion System |
Precision Spine, Inc. |
Michael C. Dawson |
| K171667 |
06/05/2017 |
Powder Free Nitrile Examination Glove |
Professional Latex Sdn Bhd |
Yoon Lim Kok |
| K171868 |
06/22/2017 |
A1AT Genotyping Test |
Progenika Biopharma S.A., a Grifols Company |
Diego Tejedor |
| K171620 |
06/02/2017 |
PiCCO Catheter |
PULSION Medical Systems SE |
Ingrid Rohm |
| K171945 |
06/28/2017 |
Discovery Pico, Discovery Pico Plus |
Quanta System S.p.A. |
Francesco Dell'Antonio |
| K171711 |
06/09/2017 |
Thunder, Thunder VT, Thunder HR |
Quanta System S.p.A. |
Francesco Dell'Antonio |
| K171976 |
06/30/2017 |
Sofia Strep A+ FIA, Sofia 2 Analyzer |
Quidel Corporation |
Edward C. Brehm |
| K171974 |
06/30/2017 |
Solana RSV+hMPV Assay |
Quidel Corporation |
Ronald H. Lollar |
| K171896 |
06/26/2017 |
Feminine Personal Trainer (FPT) |
Ralston Group |
Russell Ralston |
| K171666 |
06/05/2017 |
MPR2 logO DATALOGGER |
Raumedic AG |
Reiner Thiem |
| K171605 |
06/01/2017 |
Elecsys CA 15-3 II |
Roche Diagnostics |
Adennis Cora |
| K171655 |
06/05/2017 |
cobas m 511 integrated hematology analyzer |
Roche Diagnostics Hematology, Inc. |
Dan Bracco |
| K171770 |
06/14/2017 |
cobas Cdiff Nucleic acid test for use on the cobas Liat System |
Roche Molecular Systems, Inc. |
Clare Santulli |
| K171661 |
06/05/2017 |
Scopis Extended Instrument Set EM |
Scopis GmbH |
Christopher ╓zbek |
| K171861 |
06/22/2017 |
CAPILLARYS Hb A1c |
Sebia |
Karen Anderson |
| K171726 |
06/12/2017 |
LapBag |
Sejong Medical Co., Ltd. |
Yoojung Choi |
| K171741 |
06/12/2017 |
Laport |
Sejong Medical Co., Ltd. |
Yoojung Choi |
| K171615 |
06/01/2017 |
Xingyu Nitrile Powder Free Patient Examination Gloves, White color |
Shandong Xingyu Gloves Co., Ltd |
Xu Qiang |
| K171616 |
06/01/2017 |
Xingyu Powder Free Nitrile Patient Examination Gloves, Blue color |
Shandong Xingyu Gloves Co., Ltd |
Xu Qiang |
| K171833 |
06/19/2017 |
Digital Blood Pressure Monitor-Wrist Style |
Shenzhen Combei Technology CO., LTD |
Huaguang Meng |
| K171978 |
06/30/2017 |
Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10 |
Shenzhen Dongdixin Technology Co., Ltd. |
Siping Yuan |
| K171721 |
06/12/2017 |
Electrodes with silver conductive |
Shenzhen Konmed Technology Co., Ltd |
Tony Tony |
| K171722 |
06/12/2017 |
Electrodes with snap / Electrodes with pigtail |
Shenzhen Konmed Technology Co., Ltd |
Tony Tony |
| K171901 |
06/26/2017 |
uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S) |
Shenzhen Mindray Bio-Medical Electronics Co., Ltd |
Yanhong Bai |
| K171891 |
06/26/2017 |
ZS3 Ultrasound System, z.one pro Ultrasound System |
Shenzhen Mindray Bio-Medical Electronics Co., Ltd |
Zhai Pei |
| K171771 |
06/14/2017 |
ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay |
Siemens Healthcare Diagnostics Inc. |
Alan Haley |
| K171642 |
06/02/2017 |
Atellica IM Ferritin Assay |
Siemens Healthcare Diagnostics Inc. |
Kira Gordon |
| K171742 |
06/12/2017 |
N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2 |
Siemens Healthcare Diagnostics Products GmbH |
Christine Perkins |
| K171766 |
06/14/2017 |
Acuson SC2000 Diagnostic Ultrasound System |
Siemens Medical Solutions Inc. |
Kevin Kong |
| K171905 |
06/26/2017 |
VISCO 360 Viscosurgical System |
Sight Sciences, Inc. |
Anne-Marie Ripley |
| K171743 |
06/12/2017 |
Powder Free Pink Polychloroprene Copolymer Examination Gloves, Powder Free Black Polychloroprene Copolymer Examination Gloves |
Smart Glove Corporation Sdn.Bhd |
Khon Pu Foo |
| K171827 |
06/20/2017 |
ReddyPort NIV Access Elbow |
SMD Manufacturing, LLC |
Rian Wendling |
| K171674 |
06/06/2017 |
Angel Align System |
Smile Development Corp |
Ian Kitching |
| K171934 |
06/28/2017 |
Birmingham Hip (BH) Dual Mobility Insert |
Smith & Nephew, Inc. |
Mike Scott |
| K171794 |
06/16/2017 |
Smith & Nephew 25 Fluid Management System |
Smith & Nephew, Inc. |
Kathleen Solomon |
| K171968 |
06/30/2017 |
EchoGlo Needle |
Smiths Medical ASD, Inc. |
Michael R. Johnson |
| K171727 |
06/12/2017 |
Hydrocleanse Antimicrobial Skin and Wound Care Solution |
Sonoma Pharmaceuticals |
Brian W. Martin |
| K171935 |
06/28/2017 |
Alevicyn SG Antimicrobial Gel |
Sonoma Pharmaceuticals, Inc. |
Brian W. Martin |
| K171797 |
06/16/2017 |
TRYPTIK2 C-Plate Anterior Cervical Plate System |
Spineart |
Franck Pennesi |
| K171660 |
06/05/2017 |
Duo Lumbar Interbody Fusion Device |
Spineology Inc. |
Jacqueline A. Hauge |
| K171724 |
06/12/2017 |
Rampart L Lumbar Interbody Fusion Device |
Spineology Inc. |
Jacqueline A. Hauge |
| K171728 |
06/12/2017 |
MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm |
Sterngold Dental, LLC |
Maria Rao |
| K171784 |
06/15/2017 |
Straumann Dental Implant System |
Straumann USA, LLC |
Jennifer M. Jackson |
| K171769 |
06/14/2017 |
Straumann PURE Ceramic Implants |
Straumann USA, LLC (on behalf of Institut Straumann AG) |
Chanrasmey White |
| K171757 |
06/14/2017 |
Straumann Screw Retained Abutments |
Straumann USA, LLC (on behalf of Institut Straumann AG) |
Chanrasmey White |
| K171645 |
06/05/2017 |
CoMatryx Collagen Wound Dressing 1 gram pouch, CoMatryx Collagen Wound Dressing 1 gram vial, CoMatryx Collagen Wound Dressing 10 gram bottle |
Strukmyer Medical |
Pamela Liberto |
| K171807 |
06/19/2017 |
ES2 Neuromonitoring Accessory Instruments |
Stryker Corporation |
Nikin Desai |
| K171840 |
06/20/2017 |
Stryker Consolidated Operating Room Equipment (CORE) 2 Console |
Stryker Corporation |
Nicholas Werner |
| K171628 |
06/02/2017 |
HBS2 Headless Bone Screw |
Stuckenbrock Medizintechnik GmbH |
Fabian Stuckenbrock |
| K171624 |
06/02/2017 |
IXOS Radius Plate System |
Stuckenbrock Medizintechnik GmbH |
Fabian Stuckenbrock |
| K171911 |
06/26/2017 |
Medline ReNewal Reprocessed Synthes External Fixation Systems |
Surgical Instrument Service and Savings Inc |
Stephanie Boyle Mays |
| K171869 |
06/22/2017 |
Sutter CURIS RF Generator |
Sutter Medizintechnik GmbH |
Ulrike Zeissler |
| K171665 |
06/05/2017 |
Microcatheter and guide-wire system |
Suzhou Hengrui Disheng Medical Co.,Ltd. |
Jingwen Li |
| K171889 |
06/26/2017 |
Reusable Blood Pressure Cuff |
Suzhou Minhua Medical Apparatus Supplies Co., LTD |
Yang Qidong |
| K171883 |
06/23/2017 |
Sysmex UF-5000 Fully Automated Urine Particle Analyzer |
Sysmex America, Inc. |
Sharita Brooks |
| K171709 |
06/08/2017 |
BR-FHUS Viewer 1.0 |
TaiHao Medical Inc. |
Hsin Hung (Simon) Lai |
| K171808 |
06/19/2017 |
TDM Plate and Screw System |
TDM Co. Ltd. |
Babu Periasamy |
| K171775 |
06/14/2017 |
Theradome LH80 PRO |
Theradome Inc. |
Tamim Hamid |
| K171829 |
06/20/2017 |
EndoNaut |
Therenva SAS |
Matthis HAMY |
| K171870 |
06/22/2017 |
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.0005 û 8 ug/mL |
Thermo Fisher Scientific |
Cynthia Knapp |
| K171795 |
06/16/2017 |
Thommen Implant System |
Thommen Medical AG |
Daniel Snetivy |
| K171967 |
06/30/2017 |
MagVita TMS Therapy System |
Tonica Elektronik A/S |
Lise Terkelsen |
| K171962 |
06/30/2017 |
Klassic HD« Hip System |
Total Joint Othopedics, Inc. |
Chris Weaber |
| K171690 |
06/07/2017 |
Trident Extremity Fixation System |
Trident Orthopedics |
Al Austin |
| K171749 |
06/13/2017 |
Velofix(tm) Interbody Fusion System |
U&i Corporation |
Jee Ae Bang |
| K171823 |
06/19/2017 |
U&U Indicator tape and strip |
U&U Medical Technology Co., Ltd |
Xuebo Wang |
| K171631 |
06/02/2017 |
Standard Catheter Set |
Varian Medical Systems, Inc. |
Peter J. Coronado |
| K171733 |
06/12/2017 |
TrueBeam, TrueBeam STx, Edge |
Varian Medical Systems, Inc. |
Sara Muddell |
| K171946 |
06/29/2017 |
Gel-Bead |
Vascular Solutions, Inc. |
Lisa Gallatin |
| K171668 |
06/05/2017 |
Bluetooth blood pressure monitor |
Visiomed Group SA |
Eric Sebban |
| K171950 |
06/29/2017 |
Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B) |
Visionary Optics LLC |
Donald R. Sanders |
| K171815 |
06/19/2017 |
Registrado Scan |
VOCO GmbH |
M. Th. Plaumann |
| K171678 |
06/06/2017 |
Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 2.5m/8ft, 10/pkg, Disposable, Gas Sampling Line, Coextruded, 3m/10ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 6m |
Vyaire Medical, Inc. |
Leo Sohlberg |
| K171695 |
06/07/2017 |
First Sign Multi-Drug Dip Card Test, First Sign Multi-Drug Cup Test, First Sign Drug of Abuse Dip Card Test Marijuana, First Sign Drug of Abuse Cup Test Marijuana |
W.H.P.M., Inc. |
John Wan |
| K171621 |
06/02/2017 |
Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor |
Welch Allyn, Inc. |
Mark Alsberge |
| K171611 |
06/01/2017 |
Double Lumen Ovum Aspiration Needles |
William A. Cook Australia Pty Ltd |
Gordana Pozvek |
| K171712 |
06/09/2017 |
Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Jugular Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach |
William Cook Europe ApS |
Henriette Stordal Christiansen |
| K171625 |
06/02/2017 |
Single Lumen Ovum Aspiration Needles |
Willian A. Cook Australia Pty Ltd |
Gordana Pozvek |
| K171973 |
06/30/2017 |
Captura« Disposable Hot Biopsy Forceps |
Wilson-Cook Medical, Inc. |
Ashley Howard |
| K171969 |
06/30/2017 |
Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket, Memory 5 Fr. Soft Wire Baskets or Memory Helical Stone Extractor, Memory Eight Wire Baskets or Memory Hard Wire Baskets, Fusion Wire Guided Extraction Basket, Non-Lithotripsy Ext |
Wilson-Cook Medical, Inc. |
Ashley Howard |
| K171607 |
06/01/2017 |
Bronchi and Gastrointestinal Cytology Brush |
Wilson-Cook Medical, Inc. / Cook Endoscopy |
Doris A. Hawks |
| K171852 |
06/21/2017 |
DARCO Locking Bone Plate System |
Wright Medical Technology, Inc. |
Val Myles |
| K171961 |
06/30/2017 |
Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm) |
Xiamen Compower Medical Tech. Co. Ltd. |
Lifen Chen |
| K171680 |
06/06/2017 |
Infinity-Lock 3, Infinity-Lock 5 |
Xiros Ltd |
Stephen Seed |
| K171984 |
06/30/2017 |
Clickfine Pen Needle, Penfine Classic Pen Needle |
Ypsomed AG |
Stephan Affolter |
| K171804 |
06/19/2017 |
Zap-X Radiosurgery System |
Zap Surgical Systems |
Radhika Mohan Bodduluri |
| K171873 |
06/23/2017 |
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs |
Zhonghong Pulin Medical Products Co., Ltd. |
Jinge Li |
| K171907 |
06/26/2017 |
Vitality« Spinal Fixation System |
Zimmer Biomet Spine, Inc. |
Kelly Stratton |
| K171858 |
06/21/2017 |
Sidus Stem-Free Shoulder |
Zimmer GmbH |
Roberto Tommasini |
