| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K172556 |
06/29/2018 |
TubeClear System |
Actuated Medical, Inc. |
Michael T. Britton |
| K180988 |
06/08/2018 |
Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens, Acuity 58 (enflufocon B) Rigid Gas Permeable Contact Lens, Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens, Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens |
Acuity Polymers, Inc. |
James A. Bonafini |
| K172895 |
06/18/2018 |
AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816, BA-818 and BA-819 |
Ageless Health Industrial Co., Ltd |
Victor Wan |
| K172770 |
06/22/2018 |
AIROS 6 Sequential Compression Device |
AIROS Medical, Inc. |
Darren Behuniak |
| K172779 |
06/22/2018 |
AIROS 8 Sequential Compression Device |
AIROS Medical, Inc. |
Darren Behuniak |
| K173225 |
06/15/2018 |
Interlude and private label Unscented 3-piece compact applicator tampon |
ALBAAD fem |
Shlomo Helvits |
| K181298 |
06/13/2018 |
Harmony XL Multi-Application Platform |
Alma Lasers Inc. |
Rekha Anand |
| K181281 |
06/11/2018 |
Altus Spine Pedicle Screw System |
Altus Partners, LLC |
Mark Melton |
| K172981 |
06/08/2018 |
Reusable SpO2 Sensors, Disposable SpO2 Sensors |
APK Technology Co., Ltd. |
Caifang Wang |
| K181141 |
06/27/2018 |
OverStitch Endoscopic Suturing System and Accessories |
Apollo Endosurgery |
Maritza Ward |
| K180026 |
06/01/2018 |
Bowel Management Device, Bowel Management Irrigation Set |
Applied Medical Technology, Inc. |
Michelle Scott |
| K181301 |
06/14/2018 |
Smart External Drain (SED) System |
Aqueduct Critical Care, Inc. |
Thomas Clement |
| K180191 |
06/05/2018 |
SuperBall Meniscal Repair System |
Arcuro Medical Ltd. |
Lee Ranon |
| K180427 |
06/06/2018 |
ARK Fentanyl Assay |
ARK Diagnostics, Inc. |
Cherry Mun |
| K173376 |
06/14/2018 |
ASI Evolution |
Arlington Scientific, Inc. (ASI) |
David Binks |
| K180594 |
06/22/2018 |
Knotless SutureTak Anchors |
Arthrex, Inc. |
Ivette Galmez |
| K181280 |
06/14/2018 |
Patello-Femoral Wave (Kahuna) Arthroplasty System |
Arthrosurface, Inc. |
Dawn J. Wilson |
| K180675 |
06/13/2018 |
Atlas Spine Expandable Cervical Interbody System |
Atlas Spine, Inc. |
Thomas Smith |
| K181474 |
06/28/2018 |
ArtiClip LAA Exclusion System |
AtriCure, Inc. |
Jonathan McElwee |
| K181465 |
06/25/2018 |
SpaceOAR System |
Augmenix, Inc. |
Marcus Garcia |
| DEN170004 |
06/22/2018 |
Ellipsys Vascular Access System |
Avenu Medical, Inc |
Rebecca K. Pine |
| K173803 |
06/11/2018 |
Omnican fine |
B. Braun Medical Inc. |
Kimberly Smith |
| K172831 |
06/12/2018 |
Perfusor« Space Syringe Infusion Pump System |
B.Braun Medical Inc |
Tracy Maddock |
| K173361 |
06/26/2018 |
IV Administration Set |
B.Braun Medical Inc. |
Nancy Skocypec |
| K173780 |
06/14/2018 |
EchoMD Automated Ejection Fraction Software |
Bay Labs, Inc. |
Charles Cadieu |
| K172783 |
06/12/2018 |
Access hs Tnl |
Beckman Coulter, Inc. |
Kerrie Sue Oetter |
| K172787 |
06/14/2018 |
Access hsTnl |
Beckman Coulter, Inc. |
Jennifer Lee Bennett |
| K180493 |
06/22/2018 |
A3 Total Knee System |
Beijing AK Medical Co., Ltd. |
Aiguo Liu |
| K172846 |
06/26/2018 |
Uterine Manipulator |
Beijing HangTian KaDi Technology R&D Institute |
Liying Zhang |
| K173066 |
06/22/2018 |
OSSEODUO Shaver and Drill System |
Bien-Air Surgery SA |
Adil Slimani |
| K180577 |
06/22/2018 |
BioPlex 2200 25-OH Vitamin D Kit |
Bio-Rad Laboratories |
Arlene Carillo |
| K181368 |
06/20/2018 |
VITEK 2 AST-YS Micafungin (<=0.06 - =>8 ╡g/mL) |
bioMerieux, Inc. |
Jolyn Tenllado |
| K173139 |
06/19/2018 |
Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring System Wiz Plus |
Bionime Corporation |
Kay Wu |
| K173977 |
06/14/2018 |
CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module |
Biosense Webster, Inc. |
Phuong Chau |
| K180238 |
06/01/2018 |
CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT |
Biosense Webster, Inc. |
Phuong Chau |
| K180785 |
06/22/2018 |
iSLEEVE Introducer Set |
Boston Scientific Corporation |
Toni Guidarelli |
| K180726 |
06/18/2018 |
Savion DLVR Guidewire, Savion FLX Guidewire |
Boston Scientific Inc. |
Jake Baldauf |
| K181343 |
06/12/2018 |
HeartSee Cardiac P.E.T. Processing Software |
Bracco Diagnostics Inc. |
Patrice Marchildon |
| K180813 |
06/14/2018 |
BTL 799-2 |
BTL Industries, Inc. |
David Chmel |
| K181012 |
06/04/2018 |
BUHLMANN fCAL ELISA |
BUHLMANN Laboratories AG |
Alicja Ritz |
| K180560 |
06/18/2018 |
Sherlock 3CG+ T ip Confirmation System |
C.R. Bard, Inc. |
Christopher M. Phillips |
| K180724 |
06/25/2018 |
SPIRA Open Matrix LLIF |
Camber Spine Technologies LLC |
Sean S. Bishop |
| K180809 |
06/21/2018 |
Eclipse II |
Carestream Health, Inc |
Diane Koetter |
| K172725 |
06/08/2018 |
VT Dressing Kits |
Carilex Medical, Inc. |
Henry Kao |
| K180839 |
06/07/2018 |
AT 030 |
Carl Zeiss Meditec AG |
Christian Muenster |
| K180858 |
06/27/2018 |
CALLISTO eye |
Carl Zeiss Meditec AG |
Christian Muenster |
| K181348 |
06/20/2018 |
Cartiva SCI Disposable Instrumentation Set |
Cartiva, Inc. |
Tanya Eberle |
| K173259 |
06/13/2018 |
Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories |
Case Medical, Inc |
Tania Lupu |
| K180959 |
06/11/2018 |
Phenom 27 Catheter |
Cathera, Inc. |
Victor Ham |
| K172807 |
06/04/2018 |
Silicone Foley Catheter for single use |
Changzhou Rongxin Medicine Minimal Invasion Technology |
Ping Liu |
| K180800 |
06/01/2018 |
Colonic Plus Regular, Small, and Straight Shape Hydrokit |
Colonic Plus |
Rosa Alvarez |
| K180738 |
06/14/2018 |
COMPACTCATH Lubricated Intermittent UrinaryCatheter and OneCath Intermittent Urinary Catheter |
Compactcath, Inc. |
Naama S. Breckler |
| K173414 |
06/22/2018 |
Advance Biliary Balloon Catheter |
Cook Incorporated |
Colin Jacob |
| K181144 |
06/28/2018 |
Angled Tip Ureteral Catheter |
Cook Incorporated |
Chelsea Woods |
| K171609 |
06/04/2018 |
Check-Flo Performer Introducer Micropuncture Radial Artery Access Set |
Cook Incorporated |
Jennifer Allman |
| K181351 |
06/14/2018 |
Double Flexible Tipped Wire Guides |
Cook Incorporated |
Jennifer Allman |
| K173155 |
06/07/2018 |
Pakter Curved Needle Set |
Cook Incorporated |
Johnathan Liu |
| K172551 |
06/15/2018 |
Trinity PLUS Acetabular Shell |
Corin USA Limited |
Rachel King |
| K181085 |
06/21/2018 |
LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coated |
Covidien |
James R. Davis |
| K181389 |
06/19/2018 |
Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform |
Covidien |
Celso Duran |
| K181410 |
06/29/2018 |
MotoCLIP/HiMAX Implant System |
CrossRoads Extremity Systems, LLC |
Chad Hollis |
| K172788 |
06/25/2018 |
MONETÖ Anterior Cervical Interbody Fusion Cage System |
CTL Medical Corporation |
Tosan Onosode |
| K180709 |
06/06/2018 |
truSculpt RF Device; truSculpt; truSculpt 3D |
Cutera, Inc. |
Brad Renton |
| K180674 |
06/25/2018 |
EVOL« ha-C Cervical Interbody Fusion System |
Cutting Edge Spine, LLC |
Kyle Kuntz |
| K172457 |
06/28/2018 |
Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM |
Deltex Medical Limited |
Mark Baylis |
| K181438 |
06/26/2018 |
Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay |
Diazyme Laboratories Inc. |
Abhijit Datta |
| K173975 |
06/01/2018 |
UF(II) Wide Fixture |
DIO Corporation |
Jiae Park |
| DEN170043 |
06/12/2018 |
DreaMed Advisor Pro |
DreaMed Diabetes, Ltd. |
Eran Atlas |
| K173164 |
06/29/2018 |
Ecolab POU Water Filter |
Ecolab Inc. |
Jennifer Willner |
| K172780 |
06/06/2018 |
SD1 Ultrasonic Pocket Doppler |
Edan Instruments Inc |
Alice Yang |
| K172721 |
06/07/2018 |
FOCAL ONE |
EDAP Technomed, Inc. |
Hugo Embert |
| K180766 |
06/11/2018 |
Endiscope, Endiscope Cervical |
Elliquence, LLC |
Paul D. Buhrke |
| K180640 |
06/04/2018 |
SmartClip Soft Tissue Marker |
Elucent Medical, Inc. |
Debra Kridner |
| K180904 |
06/08/2018 |
Sniper Infusion Catheter with Balloon Occlusion |
Embolx, Inc |
Greg Haistead |
| K181364 |
06/20/2018 |
Swiss LithoClast Trilogy |
EMS Electro Medical Systems SA |
Sonia Callegaro |
| K172346 |
06/19/2018 |
sterEOS Workstation |
EOS imaging |
Mathias Breuil |
| K173162 |
06/28/2018 |
GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide |
Ethicon, Inc |
Julie Tom Wing |
| K180829 |
06/28/2018 |
PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE (Polypropylene) Hernia System, Non-absorbable Synthetic Surgical Mesh |
Ethicon, Inc |
Stephanie Saati |
| K171422 |
06/11/2018 |
Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color |
Ever Global (Vietnam) Enterprise Corp |
Jerry Lin |
| K181207 |
06/06/2018 |
Balego TENS Digital Edition with Accessories for Pain Relief (OTC) |
Everyway Medical Instruments CO., LDT. |
Paul Hung |
| K180581 |
06/22/2018 |
UV Lamps for Sunlamp Products |
Feilo Sylvania Germany GmbH |
Achim Tonat |
| K181290 |
06/15/2018 |
Fusion Bx 2.0 |
Focal Healthcare Inc. |
Karen Zhou |
| DEN170089 |
06/05/2018 |
Curve Positive Airway Pressure System |
FRESCA Medical |
Mary Lou Mooney |
| K172121 |
06/07/2018 |
Digital Thermometer |
Fudakang Industrial Co., Ltd |
Bob Yu |
| K180995 |
06/25/2018 |
Vscan Extend |
GE Medical Systems Ultrasound and Primary Care Diagnostics |
Tracey Ortiz |
| K180152 |
06/22/2018 |
gel-e Flex |
gel-e, Inc. |
Elsa Abruzzo |
| K180188 |
06/07/2018 |
Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish |
Genea Biomedx Pty Ltd |
Kea Dent |
| K172842 |
06/18/2018 |
GCE704 Breast Pump |
Globalcare |
Chiara Cavagnolo |
| K181068 |
06/29/2018 |
CREO« Stabilization System, REVERE« Stabilization System |
Globus Medical Inc. |
Kelly J. Baker |
| K180690 |
06/25/2018 |
Navigation Instruments |
Globus Medical Inc. |
Lori Burns |
| K180136 |
06/01/2018 |
BioNude Lubricant |
Good Clean Love, Inc. |
Wendy Strgar |
| K172765 |
06/01/2018 |
Smart Moves Complete |
Great Lakes Orthodontics Ltd |
David Graver |
| K172835 |
06/11/2018 |
GRI-Alleset Veress Needle |
GRI Medical and Electronic Technology Co., Ltd. |
Martin Paugh |
| K180646 |
06/27/2018 |
Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs |
Halyard Health |
Christine L. Macauley |
| K180505 |
06/14/2018 |
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low-Dermatitis Potential Claim and Tested For Use with Chemotherapy Drugs (White) |
Hartalega Sdn. Bhd. |
Kuan Kam Hon |
| K180364 |
06/27/2018 |
HD LifeSciences Cervical IBFD System |
HD LifeSciences LLC |
John Sullivan |
| K173028 |
06/21/2018 |
BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software |
HealthSTATS International Pte Ltd |
Ngak Hwee Chua |
| K173070 |
06/08/2018 |
HSW Resection Instruments |
Henke-Sass, Wolf GmbH |
Anna Reifschneider |
| K170835 |
06/15/2018 |
Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE |
Hightech Development |
Martin Boros |
| K172011 |
06/14/2018 |
LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System) |
HMicro, Inc. |
Kim Tompkins |
| K180824 |
06/22/2018 |
VaPro 2 Intermittent Catheter |
Hollister Incorporated |
Michelle Schiltz-Taing |
| K180681 |
06/13/2018 |
Aptima Combo 2 Assay (Panther System) |
Hologic, Inc. |
Jeffrey Hergesheimer |
| K181121 |
06/28/2018 |
Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin Pro |
Home Well Trading LTD |
Martin Gurovich |
| K180612 |
06/07/2018 |
Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts |
Howmedica Osteonics Corp aka Stryker Orthopaedics |
Emily DiMambro |
| K181363 |
06/13/2018 |
EcoVue Sterile and Non-Sterile Ultrasound Gels |
HR Pharmaceuticals, Inc. |
Colby Wiesman |
| K180849 |
06/11/2018 |
Vinyl Examination Glove (Clear, Non-Colored) |
Huifu Trading Co., Ltd |
Kangkang Wang |
| K172821 |
06/11/2018 |
Ti-one 101 TS Dental Implant System |
Hung Chun Bio-S Co.,Ltd. |
Jethro Liou |
| K180729 |
06/28/2018 |
FaSet Fixation System |
Huvexel Co., Ltd |
Sung Hee-Lee |
| K172745 |
06/05/2018 |
ImmuGlo HEp-2 Elite IFA |
IMMCO Diagnostics, Inc. |
Kevin Lawson |
| K181113 |
06/15/2018 |
CoLinkÖ Afx Plating System |
In2Bones USA, LLC |
Rebecca Wahl |
| K180377 |
06/20/2018 |
Fracture and Correction System |
In2Bones USA, LLC |
Rebecca Wahl |
| K181325 |
06/17/2018 |
FlowTriever Retrieval/Aspiration System |
Inari Medical, Inc. |
Eben Gordon |
| K180719 |
06/14/2018 |
InMode Diolaze System |
InMode MD Ltd. |
Amit Goren |
| K180189 |
06/01/2018 |
InMode System with Fractora3D/3D-90 Applicators |
Inmode MD Ltd. |
Amit Goren |
| K180710 |
06/19/2018 |
Reprocessed DecaNav Diagnostic Electrophysiology Catheter |
Innovative Health, LLC. |
Amanda Babcock |
| K180975 |
06/25/2018 |
QUANTA Flash HMGCR Reagents |
Inova Diagnostics, Inc. |
Roger Albesa |
| K173961 |
06/05/2018 |
Straumann BLX Implant System |
Institut Straumann AG |
Viviana Horhoiu |
| K180791 |
06/21/2018 |
Straumann BLX Surgical Cassette |
Institut Straumann AG |
Anna Vianna |
| K180045 |
06/01/2018 |
Omnipod DASH Insulin Management System |
Insulet Corporation |
Matthew King |
| K173717 |
06/21/2018 |
Integra TITAN Reverse Shoulder System |
Integra LifeSciences Corporation |
Kathleen McGuire |
| K173577 |
06/07/2018 |
Guarded Luer Connector |
International Medical Industries Inc. |
Brandon Hunt |
| K180769 |
06/26/2018 |
SecurAcath |
Interrad Medical Inc |
Denise Lenz |
| K181316 |
06/14/2018 |
POGO Automatic Blood Glucose Monitoring System |
Intuity Medical, Inc. |
Robb Hesley |
| K173573 |
06/07/2018 |
Tetric CAD |
Ivoclar Vivadent AG |
Sandra Cakebread |
| K172938 |
06/14/2018 |
Disposable Sterile Needle |
Jiangsu Caina Medical Co., Ltd. |
Jun Lu |
| K172499 |
06/01/2018 |
NEOSHIELD |
JMS North America Corporation |
Sho Hosoki |
| K180847 |
06/19/2018 |
Neutrogena Light Therapy Acne Mask+ |
Johnson & Johnson Consumer Inc. |
Timothy Kline |
| K180856 |
06/19/2018 |
Neutrogena Light Therapy Aging Mask+ |
Johnson & Johnson Consumer, Inc. |
Cindy R. Abraham |
| K181119 |
06/26/2018 |
Range (Denali and Mesa) Spinal Systems |
K2M, Inc. |
Nancy Giezen |
| K180401 |
06/14/2018 |
TiWAVE-CÖ Porous Titanium Cervical Cage |
Kalitec Direct, LLC |
Scott Winn |
| K180855 |
06/01/2018 |
Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System |
KCI USA, Inc. |
Kimberly McCoy |
| K151721 |
06/22/2018 |
FIJI SUN FLUORESCENT TANNING UNIT |
KDB INC. (DBA) SPERTI SUNLAMP |
JAMES SHEPERD |
| K173116 |
06/28/2018 |
KJ ZIRCONIA Implant System |
KJ Meditech Co., Ltd |
Hyukki Moon |
| K180722 |
06/11/2018 |
CAPERE Thrombectomy System |
KP Medcure, Inc. |
Samuel Shaolian |
| K181230 |
06/25/2018 |
Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lensfor ASTIGMATISM, Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens for PRESBYOPIA |
Largan Medical Co. Ltd. |
Amy Tien |
| K181232 |
06/29/2018 |
Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia |
Largan Medical Co. Ltd. |
Amy Tien |
| K180447 |
06/04/2018 |
reVive Light Therapy LED Cleansing System |
LED Technologies, Inc. |
Lloyd Nelson |
| K172985 |
06/14/2018 |
Ligation Device |
Leo Medical Co., Ltd. |
Yunpeng Ma |
| K180885 |
06/20/2018 |
HairMax Laser |
Lexington International, LLC |
David Michaels |
| K180332 |
06/08/2018 |
17HK700G-W |
LG Electronics |
Jinhwan Jun |
| K180749 |
06/15/2018 |
Life Spine SIMPACT Sacroiliac Joint Fixation System |
Life Spine Inc. |
Randy Lewis |
| K180166 |
06/22/2018 |
Life Spine Lumbar Fixation System (SENTRY) |
Life Spine, Inc. |
Randy Lewis |
| K173700 |
06/19/2018 |
PICOPLUS Laser System |
Lutronic Corporation |
Jhung Won Vojir |
| K171798 |
06/01/2018 |
Silverwear Silver Pro Garment Device |
Media Plus, LLC |
Rita Vacco |
| K180720 |
06/27/2018 |
Medifine Pen Needle 3 Bevel; Medifine Pen Needle Quinta 5 Bevel |
Medibio Usa LLC. |
Jatin Rajani |
| K173348 |
06/21/2018 |
0.9% Sodium Chloride Injection, USP |
Medline Industries, Inc. |
Matt Clausen |
| K172954 |
06/15/2018 |
Medline Prevention CoolZone Gown |
Medline Industries, Inc. |
Pauline Maralit |
| K173787 |
06/11/2018 |
X-MESH« Expandable Cage System, OCELOT« Stackable Cage System, Stackable Cage System, Surgical Titanium Mesh System, BENGAL Stackable Cage System, BENGAL System, CONCORDE« System, CONCORDE« Inline Lumbar Interbody System, CONCORDE« Curve Lumbar Interbody |
Medos International SARL |
Sheree Geller |
| K180021 |
06/29/2018 |
Proton Positioing and Immobilization Devices |
MEDTEC Inc dba CIVCO Medical Solutions and CIVCO Radiotherap |
Alena Newgren |
| K180122 |
06/07/2018 |
TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro Absorbable Antibacterial Envelope (large) |
Medtronic, Inc. |
Nancy Cameron |
| K180325 |
06/01/2018 |
Single Use MultiClip Device |
Micro-Tech (Nanjing) CO., Ltd |
Becky Li |
| K180761 |
06/18/2018 |
SD LTM STIM Cortical Stimulator |
micromed S.p.A. |
Monica Camillo |
| K173330 |
06/01/2018 |
PanNAT STEC Test |
Micronics, Inc |
Karen Hedine |
| K173200 |
06/11/2018 |
SOFIA Plus Aspiration Catheter |
MicroVention, Inc. |
Naomi Gong |
| K180815 |
06/22/2018 |
MIM - SPECTRA Quant |
MIM Software Inc. |
Lynn Hanigan |
| K180282 |
06/22/2018 |
MIS Internal Hex Dental Implant System |
MIS Implants Technologies Ltd. |
Arbel Shezaf |
| K173856 |
06/26/2018 |
Express 4 Sleep appliance/CPAP Sidekick appliance |
Moses Appliances LLC |
Allen J. Moses |
| K181437 |
06/21/2018 |
Pure Vu System |
Motus GI Medical Technologies Ltd. |
Hagit Ephrath |
| K180100 |
06/14/2018 |
MRIaudio PREM System |
MRIaudio |
Joe Caruso |
| K173905 |
06/19/2018 |
Surgic Pro, Surgic Pro+ |
Nakanishi Inc. |
Kimihiko Satoh |
| K173815 |
06/29/2018 |
Allergan Botox Needle Electrode |
Natus Manufacturing Limited |
Maria Connolly |
| K180290 |
06/14/2018 |
Natus Brain Monitor Amplifier |
Natus Medical Incorporated DBA Excel-Tech Ltd. (Xltek) |
Sanjay Mehta |
| K173936 |
06/15/2018 |
Natus Photic Stimulator |
Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) |
Sanjay Mehta |
| K180565 |
06/13/2018 |
PEAK NS033CF, PEAK NS017CF |
Neosil Co., Ltd |
Woo-ryong Ryou |
| K173725 |
06/26/2018 |
NeuMoDx GBS Assay |
NeuMoDx Molecular, Inc. |
Kay Fuller |
| K180306 |
06/08/2018 |
Nexy |
Next Sight srl |
Arianna Dalla Ba |
| K180608 |
06/05/2018 |
Lunoa System |
NightBalance BV |
Sophia Lam |
| K181202 |
06/06/2018 |
Sentry IVC Filter |
Novate Medical Ltd. |
Gordon Crowley |
| K180038 |
06/29/2018 |
NuVasive Pulse System |
NuVasive, Incorporated |
Olga Lewis |
| K180895 |
06/27/2018 |
Alleye |
Oculocare Medical AG |
Lucas Bachmann |
| K180449 |
06/08/2018 |
Single Use Aspiration Needle NA-U200H |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K172909 |
06/07/2018 |
ELEVARE, PERFECTIO 4 |
Omm Imports d/b/a Zero Gravity |
Zivan Habibi |
| K180993 |
06/28/2018 |
Beacon Advanced CO2 Laser System |
OmniGuide, Inc |
Sam Wade |
| K180660 |
06/08/2018 |
Avanti |
Optovue, Inc. |
Indu Lakshman |
| K180921 |
06/28/2018 |
Sapphire II PRO Balloon Dilatation Catheter |
OrbusNeich Medical Trading Inc. |
John Pazienza |
| K180743 |
06/20/2018 |
Balanced Knee Revision System - Offset Junction Box |
Ortho Development Corporation |
Dan Petersen |
| K180459 |
06/07/2018 |
VERASENSE for Zimmer Biomet Persona |
OrthoSensor, Inc. |
Deborah Johnson |
| K180947 |
06/07/2018 |
Orthopantomograph OP 3D |
PaloDEx Group Oy |
Terho Turkumaki |
| K173032 |
06/07/2018 |
Paxman Scalp Cooler |
Paxman Coolers Limited |
Richard Paxman |
| K180008 |
06/20/2018 |
Penumbra System |
Penumbra, Inc. |
Richard Kimura |
| K181329 |
06/25/2018 |
EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay |
Phadia AB |
Carina Magnusson |
| K173507 |
06/15/2018 |
Prodiva 1.5T CX and Prodiva 1.5T CS R5.4 |
Philips Healthcare (Suzhou) Co., Ltd. |
Gordon Shu |
| K181264 |
06/07/2018 |
QLAB Advanced Quantification Software |
Philips Ultrasound Inc. |
Penny Greco |
| K173503 |
06/11/2018 |
Pollogen Legend System |
Pollogen Ltd. |
Einat Shammai |
| K172483 |
06/21/2018 |
Kopac Sterile Needle |
Poonglim Pharmatech Inc. |
Cho Hee Min |
| K173189 |
06/08/2018 |
Lumfuse TP |
Precifit Medical Ltd |
Zhen Yu (Eric) Wu |
| K173053 |
06/06/2018 |
POWDER FREE LATEX EXAMINATION GLOVE |
Professional Latex Sdn Bhd |
Yoon Lim Kok |
| K181050 |
06/13/2018 |
Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted) |
Qualimed SRL |
Tereza Uhrova |
| K180989 |
06/13/2018 |
PEDRA-17F Digital Flat Panel X-ray Detector |
Radisen Inc. |
John Lim |
| K180502 |
06/14/2018 |
S128 Anterior Lumbar Interbody Fusion (ALIF) System |
Renovis Surgical Technologies Inc. |
Anthony DeBenedictis |
| K180497 |
06/15/2018 |
Scone Mask |
ResMed Ltd |
Kim Kuan LEE |
| K173147 |
06/20/2018 |
SuperNO2VA Et Device |
Revolutionary Medical Devices, Inc. |
David M. Kane |
| K180583 |
06/28/2018 |
LOGIC 4K CAMERA CONTROLLER, LOGIC 4K CAMERA HEAD |
Richard Wolf Medical Instruments Corporation |
Michael Loiterman |
| K180452 |
06/12/2018 |
White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim |
Riverstone Resources SDN BHD |
Suresh Kumar |
| K181492 |
06/22/2018 |
Elecsys CA 15-3 II |
Roche Diagnostics |
Adennis Cora |
| K180481 |
06/29/2018 |
Servator B SALF Solution |
S.A.L.F. spa |
Carmelo Gagliano |
| K180701 |
06/25/2018 |
SafePath Suturing System |
SafePath Medical, Inc. |
Howard L. Schrayer |
| K181436 |
06/22/2018 |
OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test |
Sekisui Diagnostics, LLC |
Shelly Harris |
| K173156 |
06/08/2018 |
Integrated CardioRespiratory System |
Sensydia, Inc. |
Thomas Bruggere |
| K181413 |
06/27/2018 |
uDR 592h, uDR 596i |
Shanghai United Imaging Healthcare Co.,Ltd. |
Shumei Wang |
| K180926 |
06/06/2018 |
uMR 560 |
Shanghai United Imaging Healthcare Co.,Ltd. |
Shumei Wang |
| K180925 |
06/06/2018 |
uMR 570 |
Shanghai United Imaging Healthcare Co.,Ltd. |
Shumei Wang |
| K180260 |
06/12/2018 |
Powder Free Vinyl Patient Examination Gloves (Yellow, White) |
Shanxi Hongjin Plastic Technology Co., Ltd |
Wu Zhigang |
| K181051 |
06/22/2018 |
IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug, 10mm |
Shape Memory Medical |
Meghan Reu |
| K180331 |
06/22/2018 |
Wireless Pain Relieve Device |
Shenzhen Dongdixin Technology Co.,Ltd. |
Siping Yuan |
| K173045 |
06/05/2018 |
Oximeter |
Shenzhen Greatmade Tech limited |
Mei Mei |
| K170886 |
06/21/2018 |
HOMED Mesh Nebulizer |
Shenzhen Homed Medical Device Co,.Ltd. |
Shengming Shi |
| K180956 |
06/07/2018 |
Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator |
Shenzhen Roundwhale Technology Co., Ltd. |
Kevin Zhang |
| K180454 |
06/27/2018 |
Shockwave Medical Intravascular Lithotripsy (IVL) System |
Shockwave Medical, Inc. |
Plessy Paul |
| K180649 |
06/11/2018 |
BeautiCem Veneer Kit |
Shofu Dental Corporation |
Mauro Malzyner |
| K181279 |
06/13/2018 |
Ysio Max |
Siemens Medical Solutions, Inc. |
Denise Adams |
| K180661 |
06/05/2018 |
SIGMA Sterilization Pouch and Roll |
Sigma Medical Supplies Corp. |
Mason Huang |
| K180672 |
06/06/2018 |
Sterilization Pouch/Roll Made with Tyvek |
Sigma Medical Supplies Corporation |
Mason Huang |
| K181271 |
06/13/2018 |
Signature Orthodontic System |
Signature Orthodontics |
Alfred Charles Griffin |
| K172961 |
06/11/2018 |
LIAC HWL |
Sit Sordina Iort Technologies Spa |
Alessia Giaffreda |
| K180134 |
06/29/2018 |
Ensizor Monopolar Endoscopic Scissors |
Slater Endoscopy, LLC |
John Starkey |
| K180124 |
06/12/2018 |
ZQuiet |
Sleeping Well,LLC |
Daniel Webster |
| K172823 |
06/12/2018 |
Portex NRFit Epidural Needles |
Smiths Medical ASD, Inc. |
Sunita Teekasingh |
| K172410 |
06/01/2018 |
Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of Resistance (L.O.R.) Syringes., Portex EpiFuse Catheter Connector, Portex Regional Anaesthesia Portfolio Filters |
Smiths Medical ASD, Inc. |
Michael R. Johnson |
| K172800 |
06/14/2018 |
Portex« Lancet Point Spinal Needles with NRFitÖ connectors, Portex« Pencil Point Spinal Needles with NRFitÖ connectors |
Smiths Medical ASD, Inc. |
Michael R. Johnson |
| K180621 |
06/06/2018 |
EchoMark, EchoMark LP |
Sonavex, Inc. |
David Narrow |
| K180472 |
06/19/2018 |
ViSi Mobile Monitoring System |
Sotera Wireless, Inc. |
Lan Herrington |
| K173706 |
06/08/2018 |
Piccolo Implants and Accessories |
Southern Implants (Pty) Ltd. |
Lauranda Breytenbach |
| K172536 |
06/20/2018 |
Atlas Percussion Adjusting Instrument |
Spinalight, Inc |
Stanford Pierce |
| K181203 |
06/28/2018 |
Juliet Ti |
Spineart |
Frank Pennesi |
| K173574 |
06/26/2018 |
DenSeeMammo |
Statlife |
Stephane Ragusa |
| K181429 |
06/13/2018 |
CELERITY 20 HP Biological Indicator |
STERIS Corporation |
Anthony Piotrkowski |
| K181442 |
06/13/2018 |
VERIFY Assert Self-Contained Biological Indicator |
STERIS Corporation |
Anthony Piotrkowski |
| K180500 |
06/04/2018 |
VariAx 2 System |
Stryker GmbH |
Paul Nelson |
| K180436 |
06/06/2018 |
T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System |
Stryker Trauma GmbH |
Heike Gustke |
| K180985 |
06/08/2018 |
Aveo (omafilcon A) Soft (Hydrophilic) Contact Lenses |
Supervision Optimax SDN BHD |
Yap Peak Geeh |
| K173455 |
06/14/2018 |
SurgTech Bipolar Head System |
SurgTech, Inc., |
Xuegong Yu |
| K180389 |
06/29/2018 |
Venera 508 Deep Vein Thrombosis (DVT) Prevention System |
Suzhou Minhua Medical Apparatus Supplies Co. Ltd. |
Michael Ying |
| K172068 |
06/01/2018 |
Kenz Cardico1211 |
Suzuken Co.,Ltd. |
Eiji Yamaguchi |
| K180593 |
06/05/2018 |
Vbeam Prima Laser System |
Syneron-Candela |
Sharon Timberlake |
| K172975 |
06/21/2018 |
DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins û MR Conditional, DePuy Synthes Variable Angle Positioning Pins û MR Conditional, DePuy Synthes Wire Mount û MR Conditional, DePuy Synthes Cerclage Positioning Pin û MR Conditional |
Synthes (USA) Products LLC/DePuy Orthopaedics Inc |
Suchitra Basu |
| K181093 |
06/12/2018 |
SyMRI |
SyntheticMR AB |
Maria Almesaker |
| K172234 |
06/01/2018 |
Oxygen Concentrator |
SysMed (China) Co., Ltd |
Jian Yue |
| K172221 |
06/06/2018 |
VTRUST Vital Signs Monitor, Model: TD-2300; FORA Vital Signs Monitor, Model: VSM100 |
TaiDoc Technology Corporation |
Anne Kuo |
| K173093 |
06/05/2018 |
TAMA BEMS device |
TAMA Research Corporation |
Ali Shambayati |
| K181358 |
06/20/2018 |
Televere Digital Dental Imaging System |
Televere Systems, Inc. |
Randell Quaal |
| K180818 |
06/13/2018 |
Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) |
Tenon Medical, Inc. |
Kal Mentak |
| K173908 |
06/15/2018 |
DESS Dental Smart Solutions |
Terrats Medical SL |
Roger Terrats |
| K180950 |
06/22/2018 |
Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox NX19 Oxygenator with Reservoir (west Orientation), Terumo Capiox NX19 Oxygenator (east Orientation), Terumo Capiox NX19 Oxygenator (west Orientation) |
Terumo Cardiovascular Systems Corporation |
Adam Pickholtz |
| K173821 |
06/05/2018 |
LungQ Software |
Thirona Corporation |
Eva van Rikxoort |
| K173316 |
06/19/2018 |
SpeedBird Model SB38 Soft Tissue Biopsy Device; SpeedBird Model SBU Soft Tissue Biopsy Device; SpeedBird Model SBU99 Soft Tissue Biopsy Device |
TransMed7, LLC |
James Vetter |
| DEN160006 |
06/22/2018 |
everlinQ endoAVF System |
TVA Medical, Inc. |
Noah Bartsch |
| K180712 |
06/06/2018 |
Coconut Infused Hybrid Personal Lubricant |
United Consortium |
Stephanie Morris |
| K172833 |
06/12/2018 |
E-XPE Acetabular Components and U-Motion II Acetabular Cup |
United Orthopedic Corporation |
Gimpel Chien |
| K181404 |
06/28/2018 |
Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf Collimator |
Varian Medical Systems, Inc. |
Peter J. Coronado |
| K172586 |
06/22/2018 |
Vios Monitoring SystemÖ Model 2050 |
Vios Medical, Inc. |
Amit Patel |
| K180911 |
06/20/2018 |
Visura Technologies TEECAD System |
Visura Technologies, LLC |
Eric Sandberg |
| K172345 |
06/18/2018 |
IU Implant System |
Warantec Co.,Ltd. |
Dong-Hwa Jang |
| K180832 |
06/06/2018 |
SALVATION External Fixation System |
Wright Medical Technology, Inc. |
Rachel Roberts |
| K173595 |
06/22/2018 |
Shear Wave Quantificational Ultrasound Diagnostic System |
Wuxi Hisky Medical Technologies Co., Ltd. |
Jinhua Shao |
| K170826 |
06/22/2018 |
Perfadex Plus |
XVIVO Perfusion AB |
Kathleen Johnson |
| K180617 |
06/01/2018 |
Hair Up |
Y&J BIO Co, Ltd., |
Kwang Sic Kim |
| K172983 |
06/13/2018 |
HealthCCS |
Zebra Medical Vision Ltd. |
Matan Neeman |
| K172763 |
06/04/2018 |
Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with |
Zhejiang Kindly Medical Devices Co.,Ltd |
Yong Zhang |
| K180861 |
06/13/2018 |
Vinyl Examination Glove (Clear, Non-Colored) |
Zhicheng Trading Co., Ltd. |
Chong Zhao |
| K180562 |
06/28/2018 |
TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE, THERAPON, TRY-IN, BURNOUT, TRY-IN & BURNOUT |
Zirkonzahn Gmbh |
Julian Steger |
| K181484 |
06/18/2018 |
Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral Tissue |
Zirkonzahn Srl |
Sandra Leitner |
| K180865 |
06/28/2018 |
ZMI Self-Adhesive Electrodes |
ZMI Electronics, Ltd. |
Wayne Chen |
| K171197 |
06/30/2018 |
Zuga Dental Implant System |
Zuga Medical, Inc. |
Chan Wang |
