| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K191122 |
05/29/2019 |
3M RelyX Pediatric Resin Modified Glass Ionomer Cement |
3M ESPE Dental Products |
Lin Ma |
| K190167 |
05/29/2019 |
MitraClip G4 Steerable Guide Catheter |
Abbott |
Ekta Lad |
| K190525 |
05/03/2019 |
RELIEVA ULTIRRA Sinus Balloon Catheter |
Acclarent, Inc. |
Leena Sorathia |
| K190532 |
05/03/2019 |
TruDi NAV Wire |
Acclarent, Inc. |
Leena Sorathia |
| K183645 |
05/29/2019 |
Silver High Performance Dressing |
Advanced Medical Solutions Ltd. |
Amy Turner |
| K190896 |
05/31/2019 |
BriefCase |
Aidoc Medical, Ltd. |
Nimrod Epstein |
| K183530 |
05/24/2019 |
TruDiagnosis System |
Akonni Biosystems Inc. |
Charles Daitch |
| K183319 |
05/10/2019 |
Triangle System |
AliveCor, Inc. |
Prabhu Raghavan |
| K182617 |
05/09/2019 |
ATEC IOM Accessory Instruments |
Alphatec Spine, Inc |
Jeremy Markovich |
| K183084 |
05/29/2019 |
Fuji Cervical Plate System |
Altus Partners, LLC |
Mark Melton |
| K191080 |
05/22/2019 |
Ambu aScope 4 RhinoLaryngo Slim |
Ambu A/S |
Gurpreet Kaur Rehal |
| K183534 |
05/16/2019 |
Fully Automatic Electronic Blood Pressure Monitor |
Andon Health Co., Ltd. |
Liu Yi |
| K190018 |
05/23/2019 |
Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs |
Ansell Healthcare Products, LLC. |
Don Cronk |
| K182394 |
05/17/2019 |
WiZARD 310/320 Series CPAP Mask |
Apex Medical Corp. |
Frank Lin |
| K190599 |
05/03/2019 |
Aptis Medical Distal Radio Ulnar Joint Implant |
Aptis Medical, LLC |
Bryan Babb |
| K190069 |
05/14/2019 |
SixFixÖ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) |
Arrowhead DE, LLC |
Thomas J. Twardzik |
| K190287 |
05/03/2019 |
Arthrex DynaNite« PIP (Hammertoe) Implant |
Arthrex Inc. |
Rebecca R. Homan |
| K182877 |
05/03/2019 |
HALF DOME Posterior Lumbar Interbody System |
Astura Medical, LLC |
Parker Kelch |
| K190278 |
05/03/2019 |
AuraGen 123 Suction Lipoplasty System (A123) |
AuraGen Aesthetics LLC |
Yiannis Monovoukas |
| K182350 |
05/22/2019 |
Dental Ceramic |
Baot Biological Technology Co., LTD |
Liqun Zhu |
| K191000 |
05/16/2019 |
Carnation Ambulatory Monitor |
Bardy Diagnostics, Inc |
Brit Baird |
| K190985 |
05/14/2019 |
BAROnova Insufflation System, BAROnova Accessory Kit |
BAROnova, Inc. |
Lian Cunningham |
| K180739 |
05/28/2019 |
Clearlink System Solution Set |
Baxter Healthcare Corporation |
Jeanette Licata |
| K183655 |
05/20/2019 |
VersaCross Transseptal Sheath |
Baylis Medical Company Inc. |
Meghal Khakhar |
| K190567 |
05/08/2019 |
KeYi Spinal Fixation System |
Beijing KeYi Medical Device Technology Co., Ltd. |
Jenny Jiang |
| K183560 |
05/23/2019 |
Luna 3D GEN2 Interbody Fusion System |
Benvenue Medical, Inc. |
Laurent Schaller |
| K190941 |
05/06/2019 |
BioCardia 8.5 F Avance Steerable lntroducer |
BioCardia, Inc. |
Kevin DeMartini |
| K190154 |
05/01/2019 |
ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL) |
bioMerieux SA |
Marine Taravant |
| K190405 |
05/15/2019 |
BACT/ALERT MP Reagent System |
bioMerieux, Inc. |
Esther Hernandez |
| K190378 |
05/24/2019 |
Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14 Gauge, Spirotome Endo 14 Gauge with 10 mm Helix |
Bioncise NV |
Jaak Janssens |
| K182474 |
05/02/2019 |
alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL |
BioSystems S.A. |
Noelia Gil |
| K182235 |
05/20/2019 |
OnSite Waste Sharps Container |
Bluestone Medical, Inc. |
Jon Bricken |
| K191067 |
05/30/2019 |
Arc Endocuff Glide AEG110 & AEG120 |
Boddingtons Plastics Ltd |
Shimaa Elsawy |
| K182975 |
05/21/2019 |
MAKO 7 |
Boston Scientific Corporation |
Ibhina Sherchan |
| K190603 |
05/24/2019 |
Tria Firm Ureteral Stent |
Boston Scientific Corporation |
Justin Kapitan |
| K182180 |
05/11/2019 |
SPEAC System |
Brain Sentinel, Inc. |
Richard Waite |
| K182302 |
05/17/2019 |
CardioGard Emboli Protection Cannula |
CardioGard Medical Ltd |
Orit Ronan |
| K181671 |
05/02/2019 |
Cocoon Convective Warming System |
Care Essentials Pty Ltd |
Abhay Sinha |
| K191025 |
05/17/2019 |
DRX-Revolution Mobile X-ray System |
Carestream Health Inc. |
Gina Maiolo |
| K181419 |
05/14/2019 |
FLIX-EMS |
Casgarum Investment, S.L. |
Rafael Castillo |
| DEN180032 |
05/23/2019 |
Synovasure Alpha Defensin Lateral Flow Test Kit, Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (30 Test), Synovasure Alpha Defensin Cont |
CD Diagnostics Inc. |
Sujith Kallur |
| K190441 |
05/23/2019 |
Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems, GeneXpert Infinity-48 System, Xpert Vaginal/Endocervical Specimen Collection, Xpert Urine Specimen Collection Kit, Xpert Swab Specimen Collection Kit |
Cepheid |
Yi-Ping Lin |
| K190227 |
05/01/2019 |
BoomerangÖ Anterior Cervical Plate System |
ChoiceSpine, LP |
Kim Finch |
| K190802 |
05/24/2019 |
Envision ultrasound pad and cover |
CIVCO Medical Solutions |
Jim Leong |
| K183648 |
05/15/2019 |
APAS Independence with Urine Analysis Module |
Clever Culture Systems AG |
Julie Winson |
| K191083 |
05/24/2019 |
COMPLETE CONTROL System Gen2 |
Coapt, LLC |
Blair A Lock |
| K183109 |
05/13/2019 |
ControlRad Trace Model 8 |
ControlRad, Inc. |
Guillaume Bailliard |
| K182231 |
05/01/2019 |
Brush Biopsy Set ; Deflectable Brush Biopsy Set |
Cook Incorporated |
Thomas Palmer |
| K182252 |
05/17/2019 |
Cook Unimpregnated Central Venous Catheter |
Cook Incorporated |
Johnathan Liu |
| K182403 |
05/29/2019 |
Peel-Away Introducer |
Cook Incorporated |
Johnathan Liu |
| K183035 |
05/17/2019 |
Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle |
Cook Incorporated |
Yan Li |
| K191015 |
05/17/2019 |
Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Catheter Set and Soft-Pass Embryo Mock Transfer Catheter Set with Echogenic Tip) |
Cook Incorporated |
Ian Herrman |
| K182959 |
05/10/2019 |
Wallace Dual Lumen Oocyte Recovery System |
CooperSurgical Inc. |
Roaida Johnson |
| K190639 |
05/15/2019 |
Endosee System |
CooperSurgical, Inc. |
Christine Kupchick |
| K190182 |
05/06/2019 |
Unity Subcutaneous Delivery System for Remodulin |
DEKA Research & Development |
Brian Carney |
| K183077 |
05/17/2019 |
Delta Xtend Reverse Shoulder System |
DePuy (Ireland) |
Yayoi Fujimaki |
| K190409 |
05/03/2019 |
MatrixRIB Fixation System |
DePuy Synthes |
Francoise Cettour-Delbart |
| K183054 |
05/23/2019 |
SYNMESH System |
DePuy Synthes Spine |
Michelle Hughes |
| K190219 |
05/13/2019 |
Simplexa VZV Direct, Simplexa VZV Positive Control Pack |
DiaSorin Molecular LLC |
Sharon Young |
| K183337 |
05/29/2019 |
LuxaCrown, Shade A1, A2, A3, A3.5; LuxaCrown B1, B3, C2, D2 |
DMG Chemisch-Pharmazeutische Fabrik GmbH |
Sonja Toeppen |
| K182576 |
05/21/2019 |
Solax Powered Wheelchair |
Dongguan Prestige Sporting Goods Co., Ltd |
Zhang Zhao |
| K183292 |
05/15/2019 |
Topaz Mobile DR System |
DRGEM Corporation |
Ki-Nam Yang |
| K183646 |
05/21/2019 |
Acumen Hypotension Prediction Index û EV1000 Clinical Platform, Acumen Hypotension Prediction Index û HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index û HemoSphere Advanced Monitoring Platform - Pressure |
Edwards Lifeciences, LLC |
Lisa Gilman |
| K183413 |
05/01/2019 |
TruWave Disposable Pressure Transducer |
Edwards Lifeciences, LLC |
Ye Seul Kim |
| K190565 |
05/31/2019 |
Cervical Plate |
EiserTech, LLC |
Lukas Eisermann |
| K183205 |
05/30/2019 |
PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System |
EmCyte Corporation |
Patrick Pennie |
| K191124 |
05/29/2019 |
Swiss LithoClast Trilogy |
EMS Electro Medical Systems SA |
Timothee Deblock |
| K190823 |
05/22/2019 |
Erbe ESU Model VIO 3 with Accessories |
Erbe Elektromedizin GmbH |
Julia Weller |
| K190469 |
05/23/2019 |
ERBEFLO 2 Disposable Tubing System |
Erbe USA, Inc. |
John Tartal |
| K190989 |
05/10/2019 |
6400 Ultrasound System (MyLabX6, MyLabX7) |
Esaote, S.p.A. |
Piet de Jong |
| K190995 |
05/10/2019 |
ExactVu High Resolution Micro-Ultrasound System |
Exact Imaging, Inc. |
Randy AuCoin |
| K190034 |
05/15/2019 |
REMY Medical Therapy Laser System |
Footdocprenur, LLC |
David Zuckerman |
| K183417 |
05/17/2019 |
iRestore Professional 282 |
Freedom Laser Therapy, Inc. |
Craig Nabat |
| K190628 |
05/30/2019 |
FlexSeal Introducer Sheath with Hydrophilic Coating |
Freudenberg Medical MIS, Inc |
Larry Bender |
| K190649 |
05/07/2019 |
FUJIFILM Endoscope Model EC-760S-V/L |
FUJIFILM Corporation |
Randy Vader |
| K182342 |
05/21/2019 |
IntraLock Lapidus System |
Fusion Orthopedics, LLC |
Eli Jacobson |
| K182660 |
05/30/2019 |
GaltTWS |
Galt Medical Corp. |
David Derrick |
| K183394 |
05/01/2019 |
CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO |
GE Healthcare Finland Oy |
Joel Kent |
| K190161 |
05/07/2019 |
Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chloride Mist, Ethyl Chloride Accustream 360* Medium Spray, Ethyl Chloride Accustream 360* Fine Spray |
Gebauer Company |
Brittney Cooper |
| K190275 |
05/10/2019 |
GenePOC Carba |
GenePOC Inc. |
Dany Leblanc |
| K190147 |
05/08/2019 |
COLOSSEUM Mesh |
Globus Medical Inc. |
Kelly J. Baker |
| K190170 |
05/13/2019 |
MVP Cervical Plate System |
GS Medical Co., Ltd. |
Barry Sands |
| K183160 |
05/09/2019 |
TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge |
Haemonetics Corporation |
Nancy Bengtson |
| K190134 |
05/20/2019 |
Full Automatic (NIBP) Blood Pressure Monitor-HL158TB |
Health & Life Co., Ltd. |
JS Hsu |
| K190766 |
05/31/2019 |
PALACOS fast R+G |
Heraeus Medical GmbH |
Ute Greiner |
| K183242 |
05/21/2019 |
ET IV SA Dental Implants |
Hiossen, Inc. |
Peter Lee |
| K182428 |
05/08/2019 |
GlucoLeader Enhance Blood Glucose Monitoring System |
HMD BioMedical Inc. |
Jen Ke-Min |
| K190452 |
05/23/2019 |
Aptima BV Assay |
Hologic, Inc. |
Jeffrey Hergesheimer |
| K190515 |
05/23/2019 |
Aptima Combo 2 Assay (Panther System) |
Hologic, Inc. |
Jeffrey Hergesheimer |
| K190472 |
05/16/2019 |
Aptima CV/TV Assay |
Hologic, Inc. |
Jeffrey Hergesheimer |
| K173895 |
05/16/2019 |
Tel-O-Graph |
I.E.M. Industrielle Entwicklung and Medizintechnik |
Hella Witt |
| K183618 |
05/17/2019 |
Revolution Radial Head |
Ignite Orthopedics, Inc. |
Russ Parrott |
| K190187 |
05/08/2019 |
Gynescope System |
Illumigyn Ltd. |
Lior Greenstein |
| DEN180069 |
05/23/2019 |
ZIKV Detect 2.0 IgM Capture ELISA |
InBios International, Inc. |
Estela Raychaudhuri |
| K180510 |
05/01/2019 |
NS 120P-TRS Airway Pressure Gauge |
Instrumentation Industries, Inc. |
Doris Walter |
| K190240 |
05/31/2019 |
Tiger Sharps Containers |
International Marketing Specialists Inc. |
Rod Calderon |
| K190534 |
05/29/2019 |
Manual Wheelchair SIVFH2A102 |
Jiangsu Horizon Medical Science & Technology Co., Ltd. |
Cheng Gong |
| K180309 |
05/03/2019 |
Manual Wheelchair W54 |
Jiangsu Jumao Medical Equipment Co., Ltd. |
Qian Gao |
| K182575 |
05/24/2019 |
Jaysun Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) |
Jiangxi Jaysun Medcare Co., Ltd. |
Zong Run |
| K182865 |
05/07/2019 |
Neodent Instruments Kits |
JJGC Industria e Comercio de Materiais Dentarios S.A. |
Julianne de Oliveira Capucho Lechechem |
| K190173 |
05/10/2019 |
Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid Technology / AC / Sound, Ergoline Planet Fitness 42/4 Hybrid Light Technology / Sound |
JK-Holding GmbH |
Juergen Gerstenmeier |
| K190584 |
05/15/2019 |
CAYMAN LP Plate System |
K2m, Inc. |
Casey Hinckley |
| K190233 |
05/02/2019 |
K-Shield Advantage Port Access Infusion Set (PAIS) |
Kawasumi Laboratories, Inc. |
Katsu Furuya |
| K182711 |
05/21/2019 |
Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) |
Kelyniam Global Inc. |
Eric Boyea |
| K190606 |
05/28/2019 |
Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile |
Kossan International Sdn. Bhd. |
Cho Sow Fong |
| K182430 |
05/03/2019 |
CLEARFIL MAJESTY IC |
Kuraray Noritake Dental Inc. |
Yasujiro Ohara |
| K190436 |
05/23/2019 |
KATANA Zirconia Block |
Kuraray Noritake Dental Inc. |
Yasujiro Ohara |
| K182544 |
05/28/2019 |
AccelFix Spinal Fixation System |
L&K BioMed Co., Ltd. |
Jihyeon Seo |
| K190332 |
05/20/2019 |
Aperio AT2 DX System |
Leica Biosystems Imaging, Inc. |
Christine Kishi |
| K191188 |
05/30/2019 |
ASHK100G |
LG Electronics |
Jinhwan Jun |
| K190448 |
05/24/2019 |
LightLas Pattern Scanning System - TruScan Pro |
Light-Med(USA), INC. |
Hedy Chiang |
| K181491 |
05/09/2019 |
Delta Dual Mobility System |
Limacorporate S.p.A. |
Roberto Gabetta |
| K190914 |
05/29/2019 |
MTS Doxycycline 0.016 - 256 ╡g/mL |
Liofilchem s. r. l. |
Fabio Brocco |
| K190222 |
05/03/2019 |
FilmArray Pneumonia/Pneumoniaplus Control |
Maine Molecular Quality Controls, Inc. |
Joan Gordon |
| K183697 |
05/15/2019 |
Masimo Rad-97 and Accessories |
Masimo Corporation |
Sindura Penubarthi |
| K182118 |
05/03/2019 |
armor LC |
Mavrik Dental Systems Ltd |
Sherwyn Davidson |
| K173158 |
05/30/2019 |
Air Relax |
Maxstar Industrial Co., Ltd |
Lee BungHyun |
| K182362 |
05/23/2019 |
MaxCap Ped and MaxCap Neo |
Maxtec, LLC |
Tammy Lavery |
| K182460 |
05/06/2019 |
MD-6000P Bladder Scanner |
Meda Co., LTD |
Linda Zhang |
| K191145 |
05/30/2019 |
MasterLoc Extension |
Medacta International SA |
Stefano Baj |
| K190474 |
05/28/2019 |
MectaLock PEEK Suture Anchor |
Medacta International SA |
Stefano Baj |
| K190376 |
05/02/2019 |
PASS LP Spinal System |
Medicrea International S.A. |
David Ryan |
| K190092 |
05/08/2019 |
UNiD Patient specific 3D printed TLIF cage |
Medicrea International S.A. |
David Ryan |
| K182611 |
05/30/2019 |
Qangio XA 3D |
Medis Medical Imaging Systems bv |
B. Goedhart |
| K191011 |
05/07/2019 |
Scope ProTech |
Meditech Endoscopy Ltd |
Peter Ramsey |
| K190372 |
05/16/2019 |
Aveta System |
Meditrina, Inc. |
Csaba Truckai |
| K190764 |
05/13/2019 |
SurgicalAR |
MEDIVIS, Inc. |
Amy Lynn |
| K190643 |
05/06/2019 |
Medline Electrocautery Pencil |
Medline Industries, Inc. |
Matt Clausen |
| K183577 |
05/04/2019 |
Medline Quick-Clear Wand |
Medline Industries, Inc. |
Dinah Rincones |
| K190623 |
05/30/2019 |
Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device |
Medtronic |
Rahul Shah |
| K183515 |
05/12/2019 |
MR8 Drill System, Midas Rex MR8 ClearView Tools |
Medtronic Powered Surgical Solutions |
Jenna Groves |
| K183644 |
05/22/2019 |
Stealth-Midas MR8 System |
Medtronic Powered Surgical Solutions |
Jenna Groves |
| K190165 |
05/06/2019 |
Capstone ControlÖ Spinal System |
Medtronic Sofamor Danek USA, INC. |
Justin O'Connor |
| K191029 |
05/17/2019 |
Affinity NTTM Oxygenator (Model 511), Affinity« NT Hollow Fiber Oxygenator with Plasma Resistant Fiber (PRF) with TrilliumTM Biosurface (Model 511T), Affinity« NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541), Affinity« NT Int |
Medtronic, Inc. |
Sammie C Joseph-Fredericks |
| K190493 |
05/15/2019 |
Recovery Pump, 737R (RPX) |
Mego Afek AC Ltd. |
Reuven Yunger |
| K190510 |
05/29/2019 |
GuttaSil |
Meta Biomed Co., Ltd. |
Suk Song Oh |
| K182602 |
05/15/2019 |
SOFIA EX Intracranial Support Catheter |
Micro Vention Inc. |
Tina Ariaee |
| K182910 |
05/29/2019 |
Segmented Esophageal Stent System |
Micro-Tech (Nanjing) Co., Ltd. |
Becky Li |
| K190223 |
05/08/2019 |
Cepheid Xpert CT/NG Control Panel |
Microbiologics, Inc. |
Tina Sobania |
| K182251 |
05/16/2019 |
EVOLUTION NitrX Medial-Pivot Knee |
MircoPort Orthopedics, Inc. |
Byron Ledbetter |
| K190666 |
05/09/2019 |
CYGNUSÖ Anterior Cervical Plate System |
MiRus, LLC |
Jordan Bauman |
| K190160 |
05/30/2019 |
neXus Ultrasonic Surgical Aspirator System |
Misonix, Inc. |
John Salerno |
| K190077 |
05/24/2019 |
Biogel« PI UltraTouch S Surgical Glove, Biogel« Pl Ultra Touch S Indicator Underglove |
Molnlycke Health Care, US LLC |
Leonard Stewart |
| K190246 |
05/31/2019 |
NeuroShield |
Monarch Bioimplants GmbH |
Rivelino Montenegro |
| K190831 |
05/31/2019 |
E240AG LCD Monitor, E240A LCD Monitor, JUSHA-E240AG LCD Monitor, JUJSHA-E240A LCD Monitor, C230A LCD Monitor, JUSHA-C230A LCD Monitor, C230M LCD Monitor, JUSHA-C230M LCD Monitor |
Nanjing Jusha Display Technology Co., Ltd |
Zilong Liang |
| K190848 |
05/14/2019 |
JUSHA-M550G/ JUSHA-M550/M550G/M550 LCD Monitor |
Nanjing Jusha Display Technology Co., Ltd |
Zilong Liang |
| K182532 |
05/15/2019 |
Liba3 System |
National Cardiac, Inc. |
Scott Mallett |
| K183126 |
05/08/2019 |
Electrosurgical accessory |
New Deantronics Taiwan Ltd |
Jane Liu |
| K181630 |
05/29/2019 |
Revolution External Plating System |
New Standard Device DBA Metalogix |
Bryant Phamvu |
| K190231 |
05/24/2019 |
InCore« Lapidus Sterile Kits |
Nextremity Solutions, Inc. |
Greg Denham |
| K190546 |
05/31/2019 |
NEXXT MATRIXX Stand Alone Cervical System |
Nexxt Spine LLC |
Andy Elsbury |
| K190468 |
05/28/2019 |
Nihon Kohden SVM-7200 Series Vital Signs Monitor |
Nihon Kohden Corporation |
Thomas Bento |
| K190560 |
05/02/2019 |
SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface |
Nonin Medical, Inc. |
Nancy DeAngelo |
| K190083 |
05/03/2019 |
Leaf Photocoagulator |
Norlase ApS |
Jan Forstberg |
| K190974 |
05/14/2019 |
D'Vill Introducer |
NuMED, Inc. |
Nichelle LaFlesh |
| K183016 |
05/07/2019 |
SteriCap Mini Needle |
OcuJet, LLC |
Rebecca K Pine |
| K182408 |
05/15/2019 |
Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645 |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K183199 |
05/02/2019 |
TRIO Handpiece |
OmniGuide, Inc. |
Samuel Wade |
| K190751 |
05/22/2019 |
Connector System |
Orthofix Inc. |
Jacki Koch |
| K181157 |
05/24/2019 |
Conical Plus Implant System |
OsseoFuse International, Inc. |
Jennifer Cha |
| K181854 |
05/07/2019 |
OssBuilder System |
Osstem Implant Co., Ltd.. |
Jungmin Yoo |
| K190540 |
05/02/2019 |
Ponto 4 |
Oticon Medical AB |
Lise Terkelsen |
| K190345 |
05/16/2019 |
VPC |
Pajunk GmbH Medizintechnologie |
Christian G.H Quass |
| K183701 |
05/07/2019 |
Stryker ChestShield Sterilization Tray System |
Paragon Medical |
Rebecca Walker |
| K190194 |
05/31/2019 |
C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge |
PENTAX Medical, A Division of PENTAX of America, Inc. |
Gurvinder Singh Nanda |
| K183654 |
05/23/2019 |
PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI VISION Preirus |
PENTAX of America, Inc. |
William Goeller |
| K190266 |
05/03/2019 |
NeoLSD MSMS Kit |
PerkinElmer Inc. |
Brian Ciccariello |
| K190315 |
05/14/2019 |
ImmunoCAP Allergen e229, Allergen Component rCan f 4 Dog, ImmunoCAP Allergen e230, Allergen Component rCan f 6 Dog, ImmunoCAP Allergen e231, Allergen Component rFel d 7 Cat |
Phadia AB |
Ulf Karlberg |
| K182716 |
05/29/2019 |
Brain Perfusion (BP) application |
Philips Medical Systems Nederland B.V. |
Yoram Levy |
| K190355 |
05/16/2019 |
Precision Casting Solutions Total Knee System |
Precision Casting Solutions, Inc. |
Jim Moore |
| K182443 |
05/31/2019 |
Pristine Hemodialysis Catheter |
Pristine Access Technologies Ltd. |
Ron Livne |
| K183597 |
05/18/2019 |
QIAstat-Dx Respiratory Panel |
QIAGEN GmbH |
Lindsey Howard |
| K190218 |
05/09/2019 |
Unscented Menstrual Tampon |
Qingdao Youjia Hygiene Technology Co., Ltd |
Huiying Zhao |
| K183505 |
05/17/2019 |
KY Banksy Moisture |
RB Health (US) LLC |
Elizabeth Viguerie |
| K190393 |
05/09/2019 |
Wingman 14C Crossing Catheter |
ReFlow Medical, Inc. |
Rebecca K Pine |
| K190504 |
05/03/2019 |
Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator |
Relievant Medsystems |
Alex DiNello |
| K183512 |
05/07/2019 |
Moore Park Mask |
ResMed Ltd |
Nerida Hunt |
| K181894 |
05/09/2019 |
TOF-Cuff monitor |
RGB Medical Devices SA |
Ricardo Ruiz |
| K183188 |
05/03/2019 |
Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF |
Richard Wolf Medical Instruments Corporation |
Mike Loiterman |
| K190817 |
05/01/2019 |
HS Fiber |
Riverpoint Medical |
Edwin Anderson |
| K183432 |
05/07/2019 |
cobas u 601 urinalysis test system |
Roche Diagnostics |
Angela Clements |
| K190433 |
05/22/2019 |
cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas Buffer Negative Control Kit |
Roche Molecular Systems, Inc. |
Nobuko Nakajima |
| K190699 |
05/09/2019 |
Rowheels Revolution 1.0 |
Rowheels Inc. |
Matthew Doeppers |
| K190444 |
05/22/2019 |
HERA I10 Diagnostic Ultrasound System |
Samsung Medison Co., Ltd. |
Ji Yea Lee |
| K191051 |
05/16/2019 |
ARGOS |
SANTEC CORPORATION |
Changho Chong |
| K183639 |
05/23/2019 |
Mariner Outrigger Revision System |
SeaSpine Orthopedics Corporation |
Gina Flores |
| K190851 |
05/02/2019 |
HYDRASHIFT 2/4 daratumumab |
Sebia |
Karen Anderson |
| K181545 |
05/10/2019 |
Hysteroscope System |
Shanghai AnQing Medical Instrument CO., Ltd. |
Lina FEI |
| K191157 |
05/29/2019 |
uMR 780, uMR 790 |
Shanghai United Imaging Healthcare Co., Ltd. |
Xin Gao |
| K182390 |
05/23/2019 |
IMPEDE-FX Embolization Plug |
Shape Memory Medical |
Meghan Reu |
| K182437 |
05/05/2019 |
Wireless Intelligent Thermometer |
Shenzhen Jumper Medical Equipment Co.,Ltd. |
Tom Tom |
| K183277 |
05/15/2019 |
SpO2 Sensor |
Shenzhen Upnmed Equipment Co., Ltd. |
Fu Jian |
| K190159 |
05/06/2019 |
Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove |
Showa Best Glove, Inc. |
Jefferey Richardson |
| K190879 |
05/03/2019 |
N Latex FLC kappa, N Latex FLC lambda |
Siemens Healthcare Diagnostics Products GmbH |
Christine Perkins |
| K190675 |
05/17/2019 |
Dimension EXL High-Sensitivity Troponin I (TNIH) Assay |
Siemens Healthcare Diagnostics, Inc. |
Laura J. Duggan |
| K191040 |
05/16/2019 |
syngo.via (Version VB40A) |
Siemens Healthcare GmbH |
Elango Alampalayam Rangappan |
| K190757 |
05/31/2019 |
MAGNETOM Avanto Fit |
Siemens Medical Solution USA, Inc. |
Cordell L. Fields |
| K190900 |
05/06/2019 |
Biograph Vision |
Siemens Medical Solutions USA, Inc. |
Alaine Medio |
| K183310 |
05/09/2019 |
Encore System |
Siesta Medical, Inc |
Michael Kolber |
| K182374 |
05/22/2019 |
LIAC S |
Sit Sordina Iort Technologies Spa |
Alessia Giaffreda |
| K190367 |
05/21/2019 |
Smith & Nephew Tablet Application |
Smith & Nephew |
Janice Haselton |
| K190542 |
05/24/2019 |
Soliton Acoustic Wave Device |
Soliton Inc. |
Leslie Honda |
| K190555 |
05/01/2019 |
PowerX Lipo System |
Solta Medical |
Manal Morcos |
| K190551 |
05/01/2019 |
VASERlipo System |
Solta Medical |
Manal Morcos |
| K183443 |
05/08/2019 |
SomnoDent Avant |
SomnoMed Inc. |
Dorene Markwiese |
| K183611 |
05/22/2019 |
Soniquence RF Generator and Soniquence Electrodes |
Soniquence, LLC |
Suzanne Lucas |
| K190282 |
05/24/2019 |
Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand) |
Spectrum Medical Ltd |
Colleen Powell |
| K190877 |
05/29/2019 |
Juliet« Ti LL Lumbar Interbody Device |
SPINEART |
Franck Pennesi |
| K191091 |
05/23/2019 |
Rampart One Lumbar Interbody Fusion System |
Spineology, Inc. |
Andrew Adams |
| K182308 |
05/30/2019 |
Non-Sterile, Powder-Free Nitrile Examination Glove Pink Tested for use with Chemotherapy Drugs |
Sri Trang Gloves (Thailand) Co., LTD. |
Anan Pruksanusak |
| K190297 |
05/14/2019 |
Celerity HP Incubator |
Steris Corporation |
Anthony Piotrkowski |
| K190917 |
05/09/2019 |
V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature Sterilization Systems |
STERIS Corporation |
Anthony Piotrkowski |
| K191046 |
05/10/2019 |
L10 LED Light Source with AIM, L11 LED Light Source with AIM |
Stryker |
Agatha Szeliga |
| K183381 |
05/17/2019 |
Navigation Enabled Instruments |
STRYKER |
Megan Callanan |
| K190843 |
05/01/2019 |
Synchro2 Support Guidewire |
Stryker |
Lorraine Mazzeo |
| K182238 |
05/08/2019 |
Reprocessed ViewFlex Xtra ICE Catheter |
Stryker Sustainability Solutions |
Ramona Kulik |
| K182520 |
05/15/2019 |
Flexible Overtube |
Sumitomo Bakelite Co., Ltd |
Shiro Agehama |
| K173570 |
05/17/2019 |
SD Abutment |
Surgident Co., Ltd. |
Ju Youn Choi |
| K190769 |
05/22/2019 |
Bladder Scanner (Models: M2, M2-W, M1, M1-W) |
Suzhou Lischka Medtech Co., Ltd. |
Shi Jing |
| K182725 |
05/31/2019 |
Apis |
SweetBio, Inc |
Kayla Graff |
| K181933 |
05/09/2019 |
DePuy Synthes Sterilization Container System |
Synthes (USA) Products LLC / DePuy Orthopaedics Inc. |
Thomas Shea |
| K190125 |
05/19/2019 |
FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire |
T.A.G. Medical Products Corporation, Ltd |
Shlomi Dines |
| K183461 |
05/08/2019 |
Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter |
Teleflex Medical, Inc |
Lori Pfohl |
| K181979 |
05/24/2019 |
Rusch FloCath Quick 18 Fr. CoudΘ Hydrophilic Intermittent Catheter |
Teleflex Medical, Inc. |
Sirisha Kommana |
| K190686 |
05/28/2019 |
Optilite IgM CSF Kit |
The Binding Site Group Ltd. |
Kanika Darbar |
| DEN180059 |
05/20/2019 |
Nerivio Migra |
Theranica Bioelectronics ltd |
Alon Ironi Ironi |
| K190027 |
05/10/2019 |
SteriStay |
Toul Meditech AB |
Tomas Hansson |
| K182328 |
05/15/2019 |
VeriClear Digital Early Result Pregnancy Test |
True Diagnostics, Inc. |
Jerry Lee |
| K190310 |
05/31/2019 |
U Deliver Bolink ENFit Enteral Feeding Sets |
U Deliver Medical, LLC |
Brian Johnson |
| K182734 |
05/16/2019 |
Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contac |
UNICON Optical CO., LTD |
HSIAO-WEI SHEN |
| K182937 |
05/23/2019 |
Upstream GoBack Crossing Catheter |
Upstream Peripheral Technologies, Ltd. |
Dan Rottenberg |
| K182526 |
05/29/2019 |
Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D) |
Vcomin Technology Limited |
Han JieLin |
| K190604 |
05/13/2019 |
PIVO |
Velano Vascular |
Tiffini Wittwer |
| K191023 |
05/16/2019 |
Dolphin/IQ, Dolphin/4D and Dolphin/MAX |
Viasonix Ltd. |
Shlomi Deler |
| K190543 |
05/31/2019 |
Cannulated Hemi Implant |
Vilex in Tennessee, Inc. |
Sylvia Southard |
| K182646 |
05/01/2019 |
Vitreq disposable laser probes, light fibers and Chandelier |
Vitreq B.V. |
JanKees Wouts |
| K190948 |
05/09/2019 |
Magic Clear Aligners |
Voodoo Manufacturing, Inc. |
Max Friefeld |
| K182321 |
05/24/2019 |
MobileLink Acetabular Cup System |
Waldemar Link GmbH & Co. KG |
Karen Sonnenberger |
| K190902 |
05/22/2019 |
RH non-Automated Blood Pressure Meter RH non-Automated Blood Pressure Meter with Stethoscope |
Wenzhou Renhua Instruments Co., Ltd |
Wang Saijie |
| K183336 |
05/29/2019 |
Entuit PEG, Entuit PEGJ |
Wilson-Cook Medical, Inc |
Tiffany A. Thomas |
| K190482 |
05/28/2019 |
IGNITE Bone Void Filler |
Wright Medical Technology, Inc. |
Alayne Melancon |
| K190670 |
05/14/2019 |
ORTHOLOCÖ 2 Lapidus with Rotation System |
Wright Medical Technology, Inc. |
Alayne Melancon |
| K182515 |
05/27/2019 |
Surgical Face Mask |
Wuhan Dymex Healthcare Co., Ltd |
Ada Liu |
| K190362 |
05/06/2019 |
HealthPNX |
Zebra Medical Vision Ltd. |
Flair Bar |
| K190854 |
05/10/2019 |
Therm-X |
Zenith Technical Innovations |
Greg Binversie |
| K182458 |
05/23/2019 |
Longterm NPWT Foam Dressing Kit |
Zhejiang Longterm Medical Technology Co., LTD |
Claudia Zsang |
| K182612 |
05/10/2019 |
Powder Free Nitrile Examination Gloves (Cobalt Blue, Black, Blue and Violet Blue) |
Zibo Yahao Supplies Co., LTD |
Fiona Xin |
| K183583 |
05/10/2019 |
Vanguard Complete Knee System |
Zimmer Inc. |
Charles Neitzel |
| K182678 |
05/31/2019 |
Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR Labeling |
Zimmer, Inc |
Caleb Barylski |
