| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| DEN180028 |
10/31/2018 |
23andMe Personal Genome Service (PGS) Pharmacogenetic Reports |
23andMe, Inc. |
Adam Odeh |
| K180941 |
10/17/2018 |
Ortho System |
3Shape A/S |
Kristian Worziger Nielsen |
| K181607 |
10/12/2018 |
Thorecon Rigid Fixation System |
A&E Medical Corporation |
Dana Rodriguez |
| K182644 |
10/19/2018 |
EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 |
Abbott |
Cody Johnson |
| K181527 |
10/03/2018 |
On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring System |
ACON Laboratories, Inc. |
Qiyi Xie |
| K182466 |
10/30/2018 |
AOS Calcaneal Plating System |
Advanced Orthopaedic Solutions |
Elaine Nguyen |
| K172709 |
10/17/2018 |
ELAN 4 Electro Motor System Tools |
Aesculap, Inc. |
Kathy A. Racosky |
| K181739 |
10/26/2018 |
Invisalign System with Mandibular Advancement Feature |
Align Technology, Inc. |
Somi Ekwealor |
| K181617 |
10/11/2018 |
E-CUBE 8 |
Alpinion Medical Systems Co., Ltd. |
Boyeon CHO |
| K181910 |
10/15/2018 |
BracePaste MTP Light Cure Primer |
American Orthodontics |
Trang Adams |
| K181445 |
10/01/2018 |
AMSure Hydrophilic Intermittent Catheter |
Amsino International Inc. |
Zoe Wu |
| DEN180004 |
10/24/2018 |
picoAMH ELISA |
Ansh Labs LLC |
Ajay Kumar |
| K182244 |
10/11/2018 |
Voyant Electrosurgical Generator |
Applied Medical Resources Corp. |
Andrew Nguyen |
| K182034 |
10/17/2018 |
Arterys MICA |
Arterys Inc. |
Sharon Cholowsky |
| K182239 |
10/18/2018 |
OLYMPIC Posterior Spinal Fixation System |
Astura Medical, LLC |
Parker Kelch |
| K181725 |
10/05/2018 |
Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005) |
Avenu Medical, Inc. |
Rebecca K. Pine |
| K180446 |
10/12/2018 |
b-ONE Total Knee System |
b-One Ortho Corp. |
Allison Gecik |
| K182392 |
10/30/2018 |
Frozen C |
B.M. Tech. Worldwide Co., Ltd. |
Jenny Cho |
| K182337 |
10/04/2018 |
HYBRID Guidewire |
Balt USA, LLC |
Nancy Xu |
| K181718 |
10/18/2018 |
BD FlowSmart Set/MiniMed Pro-Set |
Becton, Dickinson and Company |
Meriam Youssef |
| K172670 |
10/23/2018 |
BD Single Use, Hypodermic Syringe |
Becton, Dickinson and Company |
Victoria Morrow |
| K181503 |
10/11/2018 |
Fingertip Pulse Oximeter |
Beijing Choice Electronic Technology Co., Ltd. |
Haiying Zhao |
| K180688 |
10/25/2018 |
SLENDERTONE CoreFit Abs 8, Type 734 |
Bio-Medical Research Ltd |
Eoin Keating |
| K182070 |
10/10/2018 |
BioHorizons Tapered IM Implants |
BioHorizons Implant Systems, Inc. |
Michael Davis |
| K170732 |
10/26/2018 |
Biomate Dental Implant System |
Biomate Medical Devices Technology Co., Ltd. |
Leslie Su |
| K180605 |
10/24/2018 |
GastroFlush |
Bionix Development Corporation |
James Huttner |
| K182283 |
10/23/2018 |
FUSE Pedicle Screw System |
Black Box Medical |
Todd Stanaford |
| DEN180026 |
10/05/2018 |
Bose Hearing Aid |
Bose Corporation |
James Yeagle |
| K180487 |
10/26/2018 |
Peak.me |
Breathe me LTD |
Yoram Levy |
| K182106 |
10/23/2018 |
BTL 799-2T |
BTL Industries, Inc. |
David Chmel |
| K182281 |
10/24/2018 |
Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech |
C.R. Bard |
Sari Stevens |
| K182706 |
10/25/2018 |
External upper limb tremor stimulator |
Cala Health, Inc. |
Scott A. Wilson |
| K180980 |
10/27/2018 |
ORTHROSÖ Posterior Stabilization System; ORTHROSÖ MIS Posterior Stabilization System |
Camber Spine Technologies LLC |
Tom Zamorski |
| K182546 |
10/17/2018 |
Alphenix, INFX-8000H/B, V8.0 |
Canon Medical Systems Corporation |
Paul Biggins |
| K182679 |
10/31/2018 |
Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1 |
Canon Medical Systems Corporation |
Paul Biggins |
| K182282 |
10/19/2018 |
Vantage Orian 1.5T, MRT-1550, V4.5 |
Canon Medical Systems Corporation |
Paul Biggins |
| K182015 |
10/11/2018 |
Piccolo Composite« Plate System |
CarboFix Orthopedics Ltd. |
Yael Rubin |
| K181196 |
10/03/2018 |
Caretaker Remote Display App and Caretaker Software Library |
Caretaker Medical, LLC |
Jeff Pompeo |
| K181116 |
10/25/2018 |
CONVIVO |
Carl Zeiss Meditec AG |
Christian Muenster |
| K182318 |
10/24/2018 |
Retina Workplace |
Carl Zeiss Meditec, Inc |
Maria Golovina |
| K181008 |
10/11/2018 |
NuFACE Trinity |
Carol Cole Company dba NuFACE |
Donald Ellis |
| K181863 |
10/10/2018 |
Elvie Pump |
Chiaro Technology Limited |
Jonathan O'Toole |
| K180258 |
10/25/2018 |
SpeediCath Standard |
Coloplast |
Ngoc Linh Pham Latchman |
| K182122 |
10/04/2018 |
Ureteric Catheters |
Coloplast Corp |
Cori Ragan |
| K181248 |
10/22/2018 |
Comarch e-Care Platform |
Comarch Healthcare SA |
Irmina Serafin |
| K181566 |
10/22/2018 |
Nutrifill |
Contamac Ltd. |
Rob McGregor |
| K180205 |
10/19/2018 |
AVELLE Negative Pressure Wound Therapy System |
ConvaTec Limited |
Justin Lovelace |
| K180291 |
10/26/2018 |
Cook Silicone Balloon HSG Catheter |
Cook Incorporated |
Yan Li |
| K180302 |
10/24/2018 |
GuardiaÖ Access Malleable Obturator, GuardiaÖ Obturator, Soft-PassÖ Obturator, Soft-Trans Malleable Obturator, GuardiaÖ ETS Embryo-Tested Syringe, Flushing Catheter |
Cook Incorporated |
Naomi Funkhouser |
| K180300 |
10/26/2018 |
Margolin HSG Cannula, Goldstein Sonohysterography Catheter |
Cook Incorporated |
Naomi Funkhouser |
| K182066 |
10/30/2018 |
O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set |
Cook Incorporated |
Carly Powell |
| K180286 |
10/26/2018 |
Polyethylene Catheter |
Cook Incorporated |
Jessica Swafford |
| K180054 |
10/05/2018 |
Royal Flush Plus High-Flow Catheter |
Cook Incorporated |
Jessica Swafford |
| K171199 |
10/31/2018 |
AVIEW |
Coreline Soft Co., Ltd. |
Hye Yi Park |
| K181038 |
10/10/2018 |
CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 cm x 10 cm)(single pack) |
CorMatrix Cardiovascular, Inc. |
Wendy Perreault |
| K180622 |
10/23/2018 |
Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port |
Covidien |
Alexis Erazo |
| K182151 |
10/11/2018 |
MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate |
CTL Medical Corporation |
Andrea Wilcox |
| K182365 |
10/24/2018 |
TempSure System |
Cynosure, Inc |
Amy Tannenbaum |
| K182215 |
10/29/2018 |
ClearLink Controlled Phototherapy Equipment |
Daavlin Distributing Company |
Michele Thiel |
| K181578 |
10/11/2018 |
DemeTECH PTFE Nonabsorbable Surgical Suture |
Demetech Corporation |
Linda Hernandez |
| K171585 |
10/31/2018 |
LUXEN Zr, LUXEN Smile |
Dentalmax Co., Ltd |
Jindong Kim |
| K181520 |
10/11/2018 |
Sirona Dental CAD/CAM System |
Dentsply Sirona |
Karl J. Nittinger |
| K182041 |
10/26/2018 |
Dexcom G6 Glucose Program Continuous Glucose Monitoring System |
Dexcom, Inc. |
Luke Olson |
| K180209 |
10/04/2018 |
Diazyme 1,5-AG Assay |
Diazyme Laboratories Inc. |
Abhijit Datta |
| K170723 |
10/25/2018 |
Swaive Thermometer SWT1A |
E-Care Technology Co., Ltd. |
K.Y. Ko |
| K180568 |
10/16/2018 |
KidCap |
Eastern Cranial Affiliates, LLC |
Joseph Terpenning |
| K180516 |
10/19/2018 |
EchoS |
Echolight Spa |
Sergio Casciaro |
| K180275 |
10/24/2018 |
VAMP Optima closed blood sampling system |
Edwards Lifesciences LLC |
Jennifer Wilbur |
| K181644 |
10/12/2018 |
EIT Cellular Titanium« Lumbar Cage LLIF |
EIT Emerging Implant Technologies GmbH |
Barbara Wirth |
| K182591 |
10/18/2018 |
RadiForce RX360, RX360-AR |
EIZO Corporation |
Hiroaki Hashimoto |
| K181867 |
10/02/2018 |
Deka Smartxide2 Trio |
El.En Electronic Engineering Spa |
Paolo Peruzzi |
| K180559 |
10/29/2018 |
HSV 1 & 2 ELITe MGB Kit; ELITe InGenius |
ELITechGroup |
Terry Trimingham |
| K181941 |
10/18/2018 |
Swift System |
Emblation Ltd |
Mairi MacFadyen |
| K182490 |
10/09/2018 |
Swiss LithoClast Trilogy |
EMS Electro Medical Systems SA |
Sonia Callegaro |
| K180620 |
10/12/2018 |
Endophys Pressure Sensing Sheath Kit |
Endophys Holdings, LLC |
Phillip Purdy |
| K181488 |
10/30/2018 |
LIGACLIP 12mm L Endoscopic Rotating Multiple Clip Applier |
Ethicon Endo-Surgery, LLC |
Sigfrido Delgado |
| K182753 |
10/26/2018 |
A6 OTC Pain Relief TENS |
Everyway Medical Instruments Co., Ltd. |
Paul Hung |
| K182767 |
10/26/2018 |
V2 OTC Pain Relief TENS |
Everyway Medical Instruments Co., Ltd. |
Paul Hung |
| K182536 |
10/12/2018 |
Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse Shoulder Humeral Liners , Exactech Equinoxe Small Reverse Shoulder Glenoid Plates , Exactech Equinoxe Reverse Shoulder Locking Cap |
Exactech, Inc. |
Zach Sharrah |
| K181642 |
10/05/2018 |
B-Laser Atherectomy System |
Eximo Medical Ltd. |
Yossi Muncher |
| K182087 |
10/31/2018 |
DynaMesh-POSTERIOR |
FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft |
Stefan Schneemelcher |
| K173076 |
10/04/2018 |
CURA 16; ScintCare CT16 |
FMI Medical Systems Inc. |
Scott LeMaster |
| K182088 |
10/31/2018 |
XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro |
Fotona d.o.o. |
Marko Berdajs |
| K182051 |
10/02/2018 |
FUJIFILM Duodenoscope Model |
FUJIFILM Corporation |
Randy Vader |
| K181815 |
10/15/2018 |
DynaBridge |
Fusion Orthopedics, LLC |
Adam Cundiff |
| K182059 |
10/04/2018 |
Prase MIS Spinal System |
GBS Commonwealth Co., Ltd. |
Jimmy Kim |
| K182590 |
10/19/2018 |
1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, 1.5T 30ch AIR AA |
GE Healthcare |
Veronica Meridith |
| K182504 |
10/12/2018 |
3.0T Air MP M, 3.0T Air MP L |
GE Healthcare Coils (USA Instruments, Inc.) |
Veronica A. Meridith |
| K181685 |
10/25/2018 |
Vivid E80, Vivid E90, Vivid E95 |
GE Medical Systems Ultrasound and Primary Care Diagnostics, |
Tracey Ortiz |
| K182450 |
10/19/2018 |
Vivid S60N, Vivid S70N |
GE Medical Systems Ultrasound and Primary Care Diagnostics, |
Tracey Ortiz |
| K180554 |
10/22/2018 |
ANTHEM Fracture System |
Globus Medical Inc. |
Kelly J. Baker |
| K182880 |
10/31/2018 |
Halifax Imaging Kit |
Halifax Biomedical, Inc. |
Crystal Jones |
| K181192 |
10/22/2018 |
PIP Fix |
Hand Biomechanics Lab, Inc. |
Dustin Dequine |
| K180240 |
10/17/2018 |
Full Automatic(NIBP) Blood Pressure Monitor |
Health & Life Co. Ltd. |
J. S. Hsu |
| K182569 |
10/18/2018 |
Spectralis HRA+OCT and variants with High Magnification Module |
Heidelberg Engineering GmbH |
Arianna Schoess |
| K181468 |
10/25/2018 |
Hybrid3D |
Hermes Medical Solutions AB |
Joakim Arwidson |
| K173603 |
10/24/2018 |
Monarch Airway Clearance System |
Hill-Rom Holdings, Inc. |
Joseph Braido |
| K180991 |
10/12/2018 |
AG 100s |
Hospitech Respiration Ltd. |
Yoram Levy |
| K182264 |
10/19/2018 |
ICONN Revolution Knotless Suture Anchor |
ICONN Orthopedics, LLC |
Whitt Israel |
| K181868 |
10/05/2018 |
SHINY RPL System |
IDS, Ltd. |
C.J. Park |
| K181553 |
10/31/2018 |
Immunalysis Ethyl Alcohol Enzyme Assay |
Immunalysis Corporation |
Weying (Jessica) Zhu |
| K180202 |
10/19/2018 |
Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts |
Immuno Concepts, NA, Ltd. |
Eric S Hoy |
| K181223 |
10/20/2018 |
ImPACT |
ImPACT Applications, Inc. |
Michael Zagorski |
| K182531 |
10/10/2018 |
ClotTriever Thrombectomy System |
Inari Medical |
Eben Gordon |
| K182233 |
10/15/2018 |
FlowTriever Retrieval/Aspiration System |
Inari Medical |
Eben Gordon |
| K182112 |
10/05/2018 |
Sense System with IBT Electrodes |
Infinite Biomedical Technologies, LLC |
Rahul Kaliki |
| K181354 |
10/25/2018 |
074 Zenith Flex System |
InNeuroCo Inc. |
Marc Litzenberg |
| K181458 |
10/27/2018 |
Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter |
Innovative Health, LLC. |
Amanda Babcock |
| K181618 |
10/18/2018 |
Reprocessed Torqr Diagnostic EP Catheter |
Innovative Health, LLC. |
Amanda Babcock |
| K180971 |
10/16/2018 |
QUANTA Flash Calprotectin and Fecal Extraction Device |
Inova Diagnostics, Inc. |
Roger Albesa |
| K173594 |
10/19/2018 |
Straumann cerabone |
Institut Straumann AG |
Christelle Gerspach-Gasser |
| K173945 |
10/05/2018 |
Straumann SC Variobase Abutments |
Institut Straumann AG |
Christopher Klaczyk |
| K181902 |
10/25/2018 |
Codman Certas Plus Electronic Tool Kit |
Integra LifeSciences Corp. |
Nancy MacDonald |
| K181999 |
10/12/2018 |
Integra TITAN Reverse Shoulder System |
Integra Lifesciences Corporation |
Blesson Abraham |
| K173965 |
10/26/2018 |
Implant Planning Software |
Inteware Co. Ltd. |
Wayne Tsai |
| K182140 |
10/24/2018 |
da Vinci Xi Surgical System, da Vinci X Surgical System |
Intuitive Surgical, Inc |
Brandon Hansen |
| K182561 |
10/19/2018 |
UroNav (Version 3.0) |
Invivo Corporation |
Kenneth M. Revennaugh |
| K182550 |
10/17/2018 |
Wireless Digital Flat Panel Detector |
iRay Technology Taicang Ltd. |
Meng Li |
| K182551 |
10/17/2018 |
Wireless Digital Flat Panel Detector |
iRay Technology Taicang Ltd. |
Meng Li |
| K173920 |
10/11/2018 |
LS OIL |
J. Morita USA, Inc. |
Keith A. Barritt |
| K180972 |
10/03/2018 |
ARIX Clavicle System |
Jeil Medical Corporation |
Seungyong Lee |
| K181426 |
10/11/2018 |
Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL) |
Jiangsu Micsafe Medical Technology Co., Ltd |
Tony Yang |
| K172826 |
10/10/2018 |
Cellent Spinal Systems |
Jiangsu Trauhui Medical Instrument Co.,Ltd. |
Zhou Yu |
| K182117 |
10/06/2018 |
Vinyl Patient Examination Gloves |
Jiangxi Zhonghong Pulin Medical Products Co., Ltd |
Joe Zhang |
| K180555 |
10/11/2018 |
Ergoline Prestige 1600 Hybrid Performance |
JK Holding GmbH |
Juergen Gerstenmeier |
| K181081 |
10/02/2018 |
Infrared Ear Thermometer |
Joytech Healthcare Co., Ltd. |
Ren Yunhua |
| K181239 |
10/29/2018 |
Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer |
Joytech Healthcare Co.,Ltd |
Ren Yunhua |
| K182539 |
10/03/2018 |
2MP Color LCD Monitor CL-R211 |
JVC Kenwood Corporation |
Masafumi Yugami |
| K181603 |
10/05/2018 |
EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT Spinal System |
K2M Inc. |
Nancy Giezen |
| K180735 |
10/31/2018 |
Endomat Select |
Karl Storz SE & Co. KG |
Serkan Sezer |
| K182002 |
10/23/2018 |
Cumulus Remover |
Kitazato Corporation |
Futoshi Inoue |
| K181373 |
10/18/2018 |
Extended Lipid Panel Assay |
Laboratory Corporation of America Holdings |
Suzette Warner |
| K180680 |
10/11/2018 |
Salivea Dry Mouth Mouthwash, Salivea Dry Mouth Mouthspray |
Laclede, Inc. |
Michael Pellico |
| K182348 |
10/18/2018 |
14HK701G-W |
LG Electronics Inc. |
Jinhwan Jun |
| K181717 |
10/12/2018 |
Life Spine Laminoplasty System |
Life Spine Inc. |
Angela Batker |
| K182540 |
10/30/2018 |
DiLumen Endolumenal Interventional Platform |
Lumendi, LLC |
Dennis Daniels |
| K180046 |
10/23/2018 |
Masimo Rad-97 and Accessories |
Masimo Corporation |
Sindura Penubarthi |
| K180249 |
10/11/2018 |
OmniPore DUROMAX Surgical Implants |
Matrix Surgical Holdings, LLC/Matrix Surgical USA |
John O'Shaughnessy |
| K182177 |
10/26/2018 |
Accipiolx |
MaxQ-Al Ltd. |
Joshua Schulman |
| K182914 |
10/29/2018 |
MC3 Vascular Access Kit 21030 |
MC3 Incorporated |
Adam Viitala |
| K181254 |
10/22/2018 |
Quadra P |
Medacta International SA |
Stefano Baj |
| K181803 |
10/18/2018 |
Medax Biopsy Systems III |
Medax Srl Unipersonale |
Stefano Cavalieri |
| K181937 |
10/16/2018 |
Pump In Style Advanced, Advanced Personal Double Breastpump |
Medela LLC |
PJ Pasia |
| K182240 |
10/17/2018 |
PASS LP Spinal System |
Medicrea International S.A. |
David Ryan |
| K181949 |
10/04/2018 |
SYMPHONYÖ OCT System |
Medos International SARL |
Sheree Geller |
| K181622 |
10/01/2018 |
StrataMR guider tool |
Medtronic Neurosurgery |
Xiaojian Sun |
| K182436 |
10/04/2018 |
POWEREASE System |
Medtronic Sofamor Danek USA, Inc. |
Ankit K. Shah |
| K182586 |
10/19/2018 |
DLP Aortic Root Cannula, DLP Aortic Root Cannula with Vent Line, DLP Pressure Monitoring Extension Line Adapter, DLP Cardioplegia Adapter with Pressure Port |
Medtronic, Inc. |
Linda L. Julia Davila |
| K181026 |
10/17/2018 |
OsteoBridgeÖ IDSF System |
Merete GmbH |
Paul Munch |
| K181186 |
10/25/2018 |
Solitare Platinum Revascularization Device |
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
Ryan Kenney |
| K180418 |
10/15/2018 |
Reliant(TM) Multistage Dilatation Balloon Catheter |
Micro-Tech (Nanjing) CO., Ltd. |
Becky Li |
| K181883 |
10/03/2018 |
FIREFLY« Midline Navigation Guide |
Mighty Oak Medical Inc. |
Mark A. Wylie |
| K182036 |
10/15/2018 |
NeuroBlate System |
Monteris Medical |
David H. Mueller |
| K181138 |
10/03/2018 |
IS-III active System |
Neobiotech Co., Ltd. |
Young-Ku Heo |
| K173756 |
10/24/2018 |
Certus 140 2.45GHz Ablation System |
NeuWave Medical, Inc. |
Dan Kosednar |
| K181330 |
10/11/2018 |
NeoMatriX Wound Matrix |
NeXtGen Biologics, Inc. |
Jonelle L. Toothman |
| K181621 |
10/19/2018 |
Stable-C Interbody System |
Nexus Spine, LLC |
Jared Crocker |
| K182261 |
10/16/2018 |
NvisionVLE Imaging System, NvisionVLE Optical Probe |
NinePoint Medical, Inc. |
Eman Namati |
| K180899 |
10/31/2018 |
Universal Base Abutment |
Nobel Biocare AB |
Charlemagne Chua |
| K181860 |
10/05/2018 |
NuVasive Cohere Thoracolumbar Interbody System |
NuVasive, Incorporated |
Olga Lewis |
| K181240 |
10/04/2018 |
Rhino-Laryngo Fiberscope Olympus ENF-GP2 |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K181994 |
10/31/2018 |
Single Use Aspiration Needle NA-U201H |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K181460 |
10/11/2018 |
OnePacs System |
OnePacs, LLC |
Justin Falk |
| K173194 |
10/10/2018 |
Temperature Probe |
Orantech Inc. |
Hsin Xiong |
| K182085 |
10/31/2018 |
Balanced Knee Revision System Trabecular Tibial Cone Augments |
Ortho Development Corporation |
Adrienne von Foller |
| K181569 |
10/12/2018 |
BKS Revision Sleeves System |
Ortho Development Corporation |
Dan Petersen |
| K182072 |
10/30/2018 |
VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides |
Ortho-Clinical Diagnostics, Inc. |
Marlene Hanna |
| K182063 |
10/30/2018 |
VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System |
Ortho-Clinical Diagnostics, Inc. |
Marlene Hanna |
| K181936 |
10/25/2018 |
DyeVert PLUS EZ Contrast Reduction System |
Osprey Medical, Inc. |
Vic Fabano |
| K181539 |
10/12/2018 |
OSSDSIGN Cranioplug |
OssDsign AB |
Ulrik Birgersson |
| K173351 |
10/31/2018 |
Panpac Flexi Shelf Pessary |
Panpac Medical Corporation |
Yen-Ming Pan |
| K182735 |
10/19/2018 |
Paragonix SherpaPak Cardiac Transport System |
Paragonix Technologies |
Lisa M. Anderson |
| K181220 |
10/12/2018 |
Juell 3D Volo Base |
Park Dental Research Corporation |
Ronald A Bulard |
| K182464 |
10/25/2018 |
PeekMed |
Peek Health, S.A. |
Sara Silva |
| K180285 |
10/26/2018 |
PENTAX Medical Video Colonoscope EC34-i10T Series |
PENTAX Medical of America, Inc |
James W. Monroe |
| K180292 |
10/12/2018 |
PENTAX Video Upper G.I. Scope EG34-i10 |
PENTAX Medical of America, Inc |
James W. Monroe |
| K182522 |
10/12/2018 |
Penumbra System (Modified 110 Aspiration Tubing) |
Penumbra, Inc. |
Micaela Victoria |
| K173944 |
10/25/2018 |
Endocular Viewing Lenses and Silicone Ring |
Phakos |
J. D. Webb |
| K181945 |
10/18/2018 |
QuickScreen Pro Multi Drug Screening Test, Model 9395Z |
Phamatech Inc. |
Robert Merlock |
| K180940 |
10/24/2018 |
KODEX EPD System |
Philips Medical Systems Nederland B.V. |
Gina Crossetta |
| K182529 |
10/23/2018 |
Xperius Ultrasound System |
Philips Ultrasound, Inc. |
Deep Pal |
| K182115 |
10/03/2018 |
Vinyl Patient Examination Gloves |
Ping An Medical Products Co., Ltd. |
Fu Dong Zhang |
| K180020 |
10/29/2018 |
HemoScreen Hematology Analyzer |
PixCell Medical Technologies, Ltd. |
Yaaya Ben-Yosef |
| K182533 |
10/04/2018 |
PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels |
Pixxgen Corporation |
John Ross |
| K171696 |
10/02/2018 |
NOxBOXi Nitric Oxide Delivery System |
Praxair Distribution, Inc |
Michael E. Skrjanc |
| K181031 |
10/26/2018 |
TSI Transseptal Introducer |
Pressure Products Medical Device Manufacturing LLC |
Andrew Armour |
| K182501 |
10/26/2018 |
Hair Laser Headband |
Pulsaderm LLC |
Gloria Avendano |
| K182189 |
10/04/2018 |
Encompass SRS Headframe ; Encompass MR SRS Headframe |
Qfix |
Alexandra Low Smythe |
| K182669 |
10/17/2018 |
Youlaser CO2 |
Quanta System SpA |
Francesco Dell'Antonio |
| K173716 |
10/01/2018 |
MPS2 Myocardial Protection System Console |
Quest Medical, Inc. |
Jan Hodges |
| K181651 |
10/12/2018 |
Radial Medical Compression System |
Radial Medical, Inc. |
Eric Johnson |
| K182042 |
10/23/2018 |
Randox Calcium (Ca) |
Randox Laboratories Ltd. |
Pauline Armstrong |
| K182614 |
10/16/2018 |
RCT700 |
RAY Co.,Ltd |
Changhwan Lee |
| K182647 |
10/24/2018 |
GC70 |
Samsung Electronics Co., Ltd. |
Jaesang Noh |
| K182622 |
10/23/2018 |
GU60A, GU60A-65 |
SAMSUNG ELECTRONICS CO., LTD. |
Jaesang NOH |
| K182237 |
10/12/2018 |
uMI 550 PET/CT System |
Shanghai United Imaging Healthcare Co., Ltd. |
Shumei Wang |
| K181370 |
10/03/2018 |
uMR 780 |
Shanghai United Imaging Healthcare Co., Ltd. |
Xin GAO |
| K181371 |
10/03/2018 |
uMR 790 |
Shanghai United Imaging Healthcare Co.,Ltd. |
Xin GAO |
| K182289 |
10/10/2018 |
Sterile High-pressure Angiographic Syringes for Single-use |
Shenzhen Baoan Medical Supplies Co., Ltd |
Mingan Mu |
| K181728 |
10/17/2018 |
Muscle Trainer |
Shenzhen Kentro Medical Electronics Co., Ltd |
Zewu Zhang |
| K182018 |
10/06/2018 |
Bluetooth blood pressure monitor |
Shenzhen Kingyield Technology Co., Ltd. |
Dacheng Gong |
| K180788 |
10/24/2018 |
Gas Module 3 |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
Yanhong Bai |
| K182423 |
10/04/2018 |
MAGLUMI 2000 FT4 |
Shenzhen New Industries Biomedical Engineering Co., Ltd |
Jie Rao |
| K173824 |
10/23/2018 |
Humeral Short Stem System |
Shoulder Innovations Inc |
Don Running |
| K180467 |
10/10/2018 |
SBG Blue Nitrile Powder Free Medical Examination Glove |
Showa Best Glove, Inc |
Jeffrey Richardson |
| K180468 |
10/10/2018 |
SBG Black Nitrile Powder Free Medical Examination Glove |
Showa Best Glove, Inc. |
Jeffrey Richardson |
| K182299 |
10/26/2018 |
MAGNETOM Aera |
Siemens Medical Solutions USA Inc. |
Martin Rajchel |
| K181550 |
10/30/2018 |
Cios Spin |
Siemens Medical Solutions USA, Inc. |
Patricia D. Jones |
| K182050 |
10/03/2018 |
Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy Therapist v4.3.1_MR3 Patch, syngo Radiation Therapy Oncologist v4.3.1_MR3 Patch |
Siemens Medical Solutions USA, Inc. |
Martin Rajchel |
| K181322 |
10/05/2018 |
MAGNETOM Sola |
Siemens Medical Solutions USA, Inc. |
Cordell L. Fields |
| K182129 |
10/12/2018 |
MAGNETOM Sola |
Siemens Medical Solutions USA, Inc. |
Cordell L. Fields |
| K181433 |
10/19/2018 |
MAGNETOM Vida |
Siemens Medical Solutions USA, Inc. |
Martin Rajchel |
| K181560 |
10/24/2018 |
Cios Alpha |
Siemens Medical Systems USA, Inc. |
Patricia D. Jones |
| K181530 |
10/24/2018 |
World Total Knee System |
Signature Orthopaedics Pty Ltd. |
Declan Brazil |
| K181881 |
10/03/2018 |
Outlet Sacroiliac Joint Fusion System |
SIJ Surgical |
Daniel Hoehn |
| K182492 |
10/10/2018 |
Geminus Volar Distal Radius Plate System |
Skeletal Dynamics, LLC |
Ana M. Escagedo |
| K173642 |
10/02/2018 |
KLOCKNER SURGICAL BOX |
Soadco, S.L. |
Maria Mitjaneta |
| K182082 |
10/31/2018 |
Tumark for Eviva, Tumark for Brevera |
Somatex Medical Technologies GmbH |
Burkhard Jakob |
| K181922 |
10/22/2018 |
Sonendo Material A |
Sonendo, Inc. |
Eric Simon |
| K181942 |
10/18/2018 |
Quantum Ventilation Module |
Spectrum Medical Ltd |
Mark Drain |
| K181596 |
10/24/2018 |
Spine Wave Navigated Instruments |
Spine Wave, Inc. |
Amy Noccioli |
| K181818 |
10/09/2018 |
Scarlet AL-T |
Spineart |
Franck Pennesi |
| K181531 |
10/05/2018 |
SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices |
SpineEX Inc. |
Andrew Rogers |
| K182322 |
10/24/2018 |
Duo Lumbar Interbody Fusion Device |
Spineology Inc |
Karen Roche |
| K181848 |
10/12/2018 |
ADAPT for Gamma3, Gamma3 |
Stryker GMBH |
Tina Mornak |
| K181091 |
10/11/2018 |
AxSOS 3 Ti |
Stryker GmbH |
Saad Attiyah |
| K182171 |
10/25/2018 |
SMV Scientific K-Wire and Pins |
Summit MedVentures |
Nephi Zufelt |
| K182588 |
10/31/2018 |
Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider |
Surgical Instrument Service and Savings Inc (dba Medline ReN |
Stephanie Boyle Mays |
| K182826 |
10/11/2018 |
Ormco Spark Aligner System |
Sybron Dental Specialties |
Mey Saied |
| K182154 |
10/16/2018 |
Depuy Synthes Femoral Neck System |
Synthes (USA) Products, LLC |
Stephan Jepards |
| K180213 |
10/19/2018 |
Titanium TomoFix Medial High Tibia Plate Anatomical |
Synthes (USA) Products, LLC |
Stephan Jepards |
| K182062 |
10/30/2018 |
Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device |
Sysmex America, Inc. |
Jessica Rivera-Montejo |
| K172733 |
10/22/2018 |
TD-1035 Thermometer |
TaiDoc Technology Corporation |
Sheena Song |
| K181774 |
10/10/2018 |
Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force Fiber OrthoTape suture; Bondek suture and Bondek Plus suture; Monodek suture; Polyglytone*6211 suture |
Teleflex Medical Incorporated |
Andrea Curria |
| K181852 |
10/12/2018 |
Percuvance Percutaneous Surgical System |
Teleflex Medical, Inc. |
Kim Campbell |
| K180099 |
10/12/2018 |
Optilite High Sensitivity C-Reactive Protein Kit |
The Binding Site Group Ltd |
Kirsty Samuels |
| K180474 |
10/18/2018 |
TNI softFlow 50 |
TNI Medical AG |
Joseph P. McMenamin |
| K180718 |
10/30/2018 |
ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES |
TOMY, Inc. |
Jinichi Watanabe |
| K181587 |
10/05/2018 |
ORTHOLOC SPS Shoulder Plating System |
Tornier Inc. |
Renee Stoffel |
| K181517 |
10/09/2018 |
Senhance Surgical System |
TransEnterix, Inc. |
Kaitlyn Alexander |
| K181898 |
10/26/2018 |
Two-Step Implant System |
Trilliant Surgical |
Jon Olson |
| K180354 |
10/30/2018 |
UroGen Ureteral Catheter |
UroGen Pharma Ltd. |
James G. Ottinger |
| K180345 |
10/17/2018 |
Uroject12 Syringe Lever |
UroGen Pharma Ltd. |
Liz Schindel |
| K181903 |
10/03/2018 |
BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes, and Length Assessment Device |
Varian Medical Systems, Inc. |
Peter J. Coronado |
| K172533 |
10/22/2018 |
GM Implant Tubes, Length Cutting Gauge |
Varian Medical Systems, Inc. |
Peter J. Coronado |
| K180872 |
10/11/2018 |
SCARLET SRF |
Viol Co., Ltd. |
Chai Kyoung Woo |
| K181885 |
10/02/2018 |
Voyant System |
Viseon, Inc. |
Cora Sim |
| K181964 |
10/23/2018 |
JiveX |
Visus Health IT GmbH |
Axel Schreiber |
| K182247 |
10/12/2018 |
ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) |
VizionFocus, Inc. |
Angus Shih |
| K180919 |
10/05/2018 |
GORE Tri-Lumen Catheter |
W.L. Gore and Associates Inc. |
Michael Ivey |
| K182381 |
10/30/2018 |
Wilson-Cook Mini Basket |
Wilson-Cook Medical, Inc |
Tiffanny A. Thomas |
| K180758 |
10/24/2018 |
Osteocera Resorbable Bone Substitute |
Wiltrom Corporation Limited |
Yi-Chun Su |
| K180736 |
10/04/2018 |
WishBone Medical Plate and Screw System |
WishBone Medical, Inc. |
Gary Barnett |
| K181640 |
10/12/2018 |
X-BOLT Hip Fracture Fixation System |
X-Bolt Orthopaedics |
Brian Thornes |
| K180708 |
10/18/2018 |
Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube with ENFit Connection, Entuit LP Patient Care Kit, Entuit LP Patient Care Kit with ENFit Connection, PromaX Low Profi |
Xeridiem Medical Devices, A Spectrum Plastics Group Company |
Steve Murray |
| K181947 |
10/25/2018 |
Persona Revision Knee System |
Zimmer Inc. |
Nicole Meredith |
| K181892 |
10/09/2018 |
Ziostation2 |
Ziosoft, Inc. |
Tsuyoshi Nagata |
