| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K191774 |
07/02/2019 |
SmileAlign Orthodontic Aligner System |
3D Global Biotech Inc. |
Keng-Liang Ou |
| K191911 |
07/17/2019 |
3Shape Splint Design |
3Shape A/S |
Shreyosi Chakraborty |
| K191771 |
07/02/2019 |
SECURE Screw |
A.M. Surgical, Inc. |
Vincent Pascale |
| K192037 |
07/30/2019 |
Advisor VL Circular Mapping Catheter, Sensor Enabled |
Abbott Medical |
Tamara L. Stanczak |
| K192019 |
07/29/2019 |
Dragonfly OpStarÖ Imaging Catheter, AptiVueÖ Software version E.5.1 |
Abbott Medical |
Richard DeMello |
| K191912 |
07/17/2019 |
BiWaze Cough |
ABMRC LLC |
Chad M Boerst |
| K191817 |
07/05/2019 |
ActivOrtho Continuous Compression Screw System |
ActivOrtho, Inc. |
Paul Hindrichs |
| K191812 |
07/05/2019 |
ADI Cervical Interbody Fusion Device |
Additive Device, Inc. (ADI) d/b/a restor3d |
Nathan Evans |
| K191847 |
07/10/2019 |
Adeor Medical nxt Non-stick Bipolar Forceps, Adeor Medical nxt Single-Use Non-stick Bipolar Forceps |
Adeor Medical AG |
Florian Gehrmann |
| K192025 |
07/29/2019 |
STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader |
Advanced Sterilization Products (ASP) |
Elsie Kim |
| K191884 |
07/15/2019 |
DR 100s |
Agfa N.V. |
Wim Govaerts |
| K192032 |
07/30/2019 |
Fixone Biocomposite Small Anchor |
AJU Pharm Co., Ltd. |
Lee Gun Tak |
| K192016 |
07/29/2019 |
SMOOV O10 |
Alber GmbH |
Michael Vent |
| K191795 |
07/03/2019 |
AOCup Lens Case with AODisc |
Alcon Laboratories, Inc. |
Katryna Warren |
| K191807 |
07/05/2019 |
ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device |
ALPCO |
Jeffrey Freedman |
| K191836 |
07/09/2019 |
Ceramill A-Splint |
Amann Girrbach AG |
Debora Engel |
| K191843 |
07/09/2019 |
Ceramill A-Temp |
Amann Girrbach AG |
Debora Engel |
| K192048 |
07/31/2019 |
Single Use Endoscope Valves Set |
Anrei Medical (Hangzhou) Co., Ltd. |
Yang HuiBing |
| K191866 |
07/12/2019 |
GelPOINT Mini Advanced Access Platform |
Applied Medical |
Frans VandenBroek |
| K191758 |
07/01/2019 |
Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit |
Argon Medical Devices, Inc. |
Jo Huang |
| K191960 |
07/23/2019 |
Arthrex Univers Revers Modular Glenoid System |
Arthrex Inc. |
Ivette Galmez |
| K192027 |
07/29/2019 |
WEREWOLF COBLATION System, COBLATION HALO Wand |
Arthrocare Corporation |
Shruthi Bhat |
| K192006 |
07/29/2019 |
SIRION Lateral Lumbar Interbody System |
Astura Medical, LLC |
Parker Kelch |
| K191989 |
07/25/2019 |
WVSM (Wireless Vital Signs Monitor) RWC + miniCap |
Athena GTX |
Sean Mahoney |
| K192003 |
07/26/2019 |
Auxein Nailing System |
Auxein Medical Private Limited |
Rahul Luthra |
| K191910 |
07/17/2019 |
SpaceStation MRI |
B. Braun Melsugen AG |
Ullrich Trottier |
| K191845 |
07/10/2019 |
Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools (IWT) |
Barco NV |
Julie Vandecandelaere |
| K192005 |
07/29/2019 |
Bausch + Lomb PreVue Inserter for enVista Preloaded |
Bausch & Lomb, Inc |
Rekha Janarthanan |
| K191826 |
07/08/2019 |
KeYi Total Hip System |
Beijing KeYi Medical Device Technology Co., Ltd. |
Jenny Jiang |
| K191970 |
07/24/2019 |
Diode Laser Hair Removal System |
Beijing Sano Laser S&T Development Co., Ltd |
Hongbo Zhang |
| K191896 |
07/15/2019 |
Belimed Steam Sterilizer MST-H TOP 5000 |
Belimed AG |
Marc Luthi |
| K192033 |
07/30/2019 |
Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad Tip |
Bennett Jacoby, DDS, MS, Inc. |
Bennett Jacoby |
| K192035 |
07/30/2019 |
EvaQMax Smoke Evacuation System |
Bio Protech, Inc. |
Namhyun Cho |
| K192050 |
07/31/2019 |
ETEST Eravacycline (ERV) (0.002 û 32 ?g/mL) |
bioMerieux SA |
Marine Taravant |
| K191953 |
07/22/2019 |
ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL) |
BioMerieux SA |
Marine Taravant |
| K191766 |
07/01/2019 |
VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4?g/mL) |
bioMerieux, Inc. |
Esther Hernandez |
| K192007 |
07/29/2019 |
TheraBase, TheraBase Ca |
Bisco, Inc. |
Diana Vu |
| K191996 |
07/26/2019 |
BC Reflex Uni Knee System |
Bodycad Laboratories, Inc. |
Guy Sevigny |
| K191871 |
07/12/2019 |
15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set |
Boston Scientific Corporation |
Kripa Pandya |
| K192043 |
07/31/2019 |
AXIOS Stent and Electrocautery Enhanced Delivery System |
Boston Scientific Corporation |
Kayla Mackey |
| K191789 |
07/03/2019 |
Stonetome Stone Removal Device |
Boston Scientific Corporation |
Laura Kuroski |
| K191966 |
07/23/2019 |
NewPrim System |
BRM Extremities |
Andrea De Maglio |
| K192012 |
07/29/2019 |
Capillus 112, Capillus 244 |
Capillus |
Patricia Schnoor |
| K191797 |
07/03/2019 |
BiomarC Fiducial Marker |
Carbon Medical Technologies |
Eric Furlich |
| K191879 |
07/15/2019 |
DRX-Evolution with Carestream Digital Tomosynthesis |
Carestream Health, Inc. |
Duane Gutowski |
| K191811 |
07/05/2019 |
Catalyst OrthoScience CSR Shoulder System |
Catalyst OrthoScience, Inc. |
Dale Davison |
| K191823 |
07/08/2019 |
Clear-Aligners |
CDB Corporation |
Leah M. Lehman |
| K191921 |
07/18/2019 |
Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments |
Cochlear Americas |
Chinda Hemmavanh |
| K191876 |
07/15/2019 |
PulmoScan |
Cognita Labs, LLC |
Rajoshi Biswas |
| K191785 |
07/03/2019 |
Orion LifeSpan MEG |
Compumedics Limited |
William Alam |
| K191763 |
07/01/2019 |
MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A) MULTIFOCAL, MyDay (Stenfilcon A) MULTIFOCAL TORIC |
CooperVision, Inc. |
Marie Dutton |
| K192040 |
07/31/2019 |
AVIEW Modeler |
Coreline Soft Co., Ltd |
Hyeyi Park |
| K191831 |
07/09/2019 |
MobiliT Cup |
Corin USA Limited |
Severine Siracusa |
| K192038 |
07/30/2019 |
Emprint Visualization Application |
Covidien LLC. |
Janna Babson |
| K191967 |
07/23/2019 |
Unyvero LRT BAL Application |
Curetis GmbH |
Karsten Mueller |
| K191810 |
07/05/2019 |
Curiteva Pedicle Screw System |
Curiteva, Inc. |
Eric Linder |
| K192010 |
07/29/2019 |
SmoothSkin BARE+ |
CyDen Limited |
Adam Stephens |
| K192000 |
07/26/2019 |
D R Burton OxyPAP |
D R Burton Healthcare, LLC |
Dennis Cook |
| K191786 |
07/03/2019 |
CyclopsÖ Anterior Cervical Plate System |
DeGen Medical INC |
Craig Black |
| K191806 |
07/05/2019 |
Propex IQ Apex Locator |
Dentsply Sirona |
Karl Nittinger |
| K191865 |
07/12/2019 |
SmartLite Pro Modular LED Curing Light |
Dentsply Sirona |
Karl Nittinger |
| K191779 |
07/02/2019 |
Attune Revision LPS Inserts |
Depuy (Ireland) |
Kathy Harris |
| K191833 |
07/09/2019 |
Dexcom G6 Pro Continuous Glucose Monitoring System |
Dexcom, Inc. |
Jacob Nardone |
| K192022 |
07/29/2019 |
DiaTemp Flow |
Diadent Group International |
Kab Sun Lee |
| K192046 |
07/31/2019 |
LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set |
DiaSorin Inc. |
John C. Walter |
| K191944 |
07/22/2019 |
MU2net |
DOSIsoft |
Marc Usynski |
| K191937 |
07/19/2019 |
Ezvena IPC, Ezvena SQS |
Eezcare Medical Corp |
Michelle C Mitchell |
| K192004 |
07/26/2019 |
Eko Analysis Software |
Eko Devices Inc |
Connor Landgraf |
| K191830 |
07/09/2019 |
gammaCore Sapphire |
Electrocore, Inc. |
Mike Romaniw |
| K191890 |
07/15/2019 |
Elos Accurate Customized Abutment |
Elos Medtech Pinol A/S |
Tina Friis Poulsen |
| K191919 |
07/18/2019 |
Elos Accurate Hybrid Base |
Elos Medtech Pinol A/S |
Tina Friis Poulsen |
| K192009 |
07/29/2019 |
LED Curing Light |
EZGO Group Inc. |
Hong Chen |
| K191997 |
07/26/2019 |
FAICO CMF System |
FAICO Medical LLC |
Heman Dario Fernandez |
| K192015 |
07/29/2019 |
Faico Dental Implant System |
FAICO Medical LLC |
Hernan Dario Fernandez |
| K191844 |
07/09/2019 |
Fidmi Low Profile Enteral Feeding Device |
Fidmi Medical Ltd |
Shahar Millis |
| K191818 |
07/05/2019 |
F&P Optiflow 3S Nasal Cannula (Small, Medium, Large) |
Fisher & Paykel Healthcare Ltd |
Reena Daken |
| K191909 |
07/17/2019 |
HepaShield Bacterial Viral Breathing System Filter |
Flexicare Medical Limited |
Joel Biddle |
| K191987 |
07/25/2019 |
Orapeutic |
Forward Science |
Brian Pikkula |
| K192017 |
07/29/2019 |
Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate |
Fresenius Medical Care Renal Therapies Group, LLC |
Denise Oppermann |
| K191747 |
07/01/2019 |
FUJIFILM Duodenoscope Model ED-580XT |
FUJIFILM Corporation |
Randy Vader |
| K191973 |
07/24/2019 |
Lumpipulse G CA19-9-N |
Fujirebio Dianostics, Inc. |
Kristin Maddaloni |
| K192041 |
07/31/2019 |
G21 SpaceFlex Hip |
G21 S.r.l |
Filippo Foroni |
| K192026 |
07/29/2019 |
Peridot Intervertebral body fusion System |
GBS Commonwealth Co., Ltd. |
Jimmy Kim |
| K191798 |
07/03/2019 |
Versana Active |
GE Medical Systems Ultrasound and Primary Care Diagnostics |
Tracey Ortiz |
| K191792 |
07/03/2019 |
Versana Balance |
GE Medical Systems Ultrasound and Primary Care Diagnostics |
Tracey Ortiz |
| K191777 |
07/02/2019 |
Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition |
GE Medical Systems, LLC |
Laura Turner |
| K192042 |
07/31/2019 |
Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen, Geistlich Perio-System Combi-Pack, Geistlich Mucograft and Geistlich Mucograft Seal |
Geistlich Pharma AG |
Marco Steiner |
| K191957 |
07/23/2019 |
BD MAX Vaginal Panel |
GeneOhm Sciences Canada, Inc. (BD Diagnostics) |
Katie Edwards |
| K191748 |
07/01/2019 |
Genesys Spine Sacroiliac Joint Fusion System |
Genesys Spine |
William W. Sowers |
| K191923 |
07/18/2019 |
EverLift Submucosal Lifting Agent |
GI Supply |
Erika Parry |
| K191835 |
07/09/2019 |
CREO Stabilization System, Navigation Instruments, ExcelsiusGPS Instruments |
Globus Medical, Inc. |
Kelly J. Baker |
| K191875 |
07/12/2019 |
Owgels Oxygen Concentrator |
Guangzhou Life Light Electronic Technology Co., Ltd. |
Erika Meng |
| K191856 |
07/11/2019 |
Compression Therapy Device |
Guangzhou Longest Science & Technology Co., Ltd. |
Xiaobing Luo |
| K191862 |
07/11/2019 |
Compression Therapy Device Model LGT-2200SP |
Guangzhou Longest Science & Technology Co., Ltd. |
Xiaobing Luo |
| K191992 |
07/25/2019 |
PELNAC Bilayer Wound Matrix |
Gunze Limited |
Hidenori Nishioka |
| K191931 |
07/19/2019 |
HardyDisk AST Imipenem/relebactam 10/25?g (IMR10/25) |
Hardy Diagnostics |
Anna Klavins |
| K191841 |
07/09/2019 |
Accurate Multi Panel Drug Urine Test Cup |
Healstone Biotech Inc |
Bryan Fang |
| K191938 |
07/19/2019 |
FitRelief TENS&EMS Wireless Device |
Heat In A Click LLC. |
Guy Levi |
| K191751 |
07/01/2019 |
EM Provisional |
Hiossen, Inc. |
Peter Lee |
| K191801 |
07/03/2019 |
PROBEAT-CR |
Hitachi Ltd. |
Tomoyuki Seino |
| K191993 |
07/25/2019 |
Yumizen C1200 CRP |
Horiba ABX SAS |
Caroline Ferrer |
| K192028 |
07/26/2019 |
Yumizen C1200 CRP |
Horiba ABX SAS |
Caroline Ferrer |
| K191828 |
07/08/2019 |
Vathin Video Bronchoscope System |
Hunan Vathin Medical Instrument Co., Ltd. |
Yun Feng |
| K192002 |
07/26/2019 |
Lucy Point-of-Care Magnetic Resonance Imaging Device |
Hyperfine Research, Inc. |
Brian Sawin |
| K191821 |
07/08/2019 |
Blue Phantom PT |
IBA Dosimetry GmbH |
Andreas Suchi |
| K191994 |
07/26/2019 |
ProFound AI Software V2.1 |
iCAD Inc. |
Heather Reed |
| K191868 |
07/12/2019 |
iCEWav Neuromonitoring Platform |
iCE Neurosystems, Inc. |
Allen Waziri |
| K192036 |
07/30/2019 |
ClotTriever Thrombectomy System |
Inari Medical |
Eben Gordon |
| K191764 |
07/01/2019 |
Inion BioRestore |
Inion Oy |
Tiina Tyni |
| K191855 |
07/10/2019 |
EmFace Device |
InMode MD Ltd. |
Amit Goren |
| K191939 |
07/19/2019 |
Yushan X-Ray Flat Panel Detector |
InnoCare Optoelectronics Corp. |
Yumei Cheng |
| K192049 |
07/31/2019 |
Oryx Cervical Plate System |
Innovasis, Inc. |
Marshall McCarty |
| K191880 |
07/15/2019 |
Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter |
Innovative Health, LLC. |
Amanda Babcock |
| K191895 |
07/15/2019 |
Straumann Mini Implants |
Institut Straumann AG |
Viviana Horhoiu |
| K192029 |
07/30/2019 |
Straumann PUREloc abutments |
Institut Straumann AG |
Giulia Oran |
| K191741 |
07/01/2019 |
Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape |
Intertape Polymer Inc. |
Michael Bryant |
| K191972 |
07/24/2019 |
ARIX Wrist System |
Jeil Medical Corporation |
Ahhyeon Woo |
| K192039 |
07/30/2019 |
Torc Body |
Johari Digital Healthcare Limited |
Pooja Johari |
| K191933 |
07/19/2019 |
COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal |
Johnson & Johnson Surgical Vision, Inc. |
Larry Boucher |
| K191949 |
07/22/2019 |
UNFOLDER Vitan Inserter |
Johnson & Johnson Surgical Vision, Inc. |
Silvia Jiang-Hughes |
| K191858 |
07/11/2019 |
Pylant Monitor |
Kal-Med LLC |
Sandra Greenwood |
| K191881 |
07/15/2019 |
KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun |
KBL GmbH |
Ralf de Andreis |
| K191800 |
07/03/2019 |
Sterile Powder Free Nitrile Examination Glove, Blue Colored, with Non-Pyrogenic Labeling Claim, Sterile Powder Free Nitrile Examination Glove, White Colored, with Non-Pyrogenic Labeling Claim |
Kossan International Sdn. Bhd. |
Cho Sow Fong |
| K191945 |
07/22/2019 |
KOWA nonmyd 8 |
Kowa Company, Ltd. |
Nariaki Morita |
| K191754 |
07/01/2019 |
Hair Growth System |
Kunshan Bella Optical technology Co., Ltd. |
Wu Xuefeng |
| K191980 |
07/24/2019 |
CLEARFIL MAJESTY ES Flow |
Kuraray Noritake Dental Inc. |
Yasujiro Ohara |
| K191832 |
07/09/2019 |
Kurin Blood Culture Collection Set with Kurin Lock Technology, Push-Button Needle (Product models M-21221, M-21223, D-21221, D-21223, T-21221, T-21223) |
Kurin, Inc |
Neal Hartman |
| K191762 |
07/01/2019 |
Magnetic Surgical System |
Levita Magnetics International Corp. |
Alberto Rodrigues-Navarro |
| K191780 |
07/02/2019 |
AP50/30 Insufflator with Insuflow Port |
Lexion Medical LLC |
Bernard Horwath |
| K191864 |
07/12/2019 |
21HK512D |
LG Electronics Inc. |
Jinhwan Jun |
| K191834 |
07/09/2019 |
Stand-Alone ALIF Titanium System |
Life Spine Inc. |
Angela Batker |
| K191927 |
07/19/2019 |
Hinged Laminoplasty System |
Life Spine, Inc. |
Angela Batker |
| K191963 |
07/23/2019 |
SMR Finned Short Stems |
LimaCorporate S.p.A |
Giuseppe Valenti |
| K191746 |
07/01/2019 |
SMR TT Augmented Glenoid System |
Limacorporate S.p.A |
Michela Zanotto |
| K191809 |
07/05/2019 |
MTS Imipenem-relebactam 0.002/4-32/4 ?g/mL |
Liofilchem s. r. l. |
Fabio Brocco |
| K191908 |
07/16/2019 |
MTS Imipenem 0.016-256 ?g/mL |
Liofilchem s.r.l. |
Fabio Brocco |
| K191742 |
07/01/2019 |
ARIES MRSA Assay |
Luminex Corporation |
Kate Linak |
| K191942 |
07/22/2019 |
MT One Diamond |
M&T Srl |
Firorenzo Rossi |
| K191998 |
07/26/2019 |
Mako Total Hip Application, Mako Total Knee Application |
MAKO Surgical Corp. |
Shikha Khandelwal |
| K191930 |
07/19/2019 |
7 mm Extended Length Endoscope |
Maquet Cardiovascular, LLC |
Mark Dinger |
| K191947 |
07/22/2019 |
VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension Cable, Fixed Distance, Active Return Cord |
Maquet Cardiovascular, LLC. |
Mark Dinger |
| K191882 |
07/15/2019 |
Masimo Centroid System |
Masimo Corporation |
Linus Park |
| K191935 |
07/19/2019 |
Nautilus Smart ECMO Module |
MC3 Incorporated |
Adam Viitala |
| K191816 |
07/05/2019 |
M-Vizion Femoral Revision System Extension |
Medacta International SA |
Stefano Baj |
| K191848 |
07/10/2019 |
APTUS Wrist Spanning Plates 2.5 |
Medartis AG |
Andrea Schweizer |
| K191958 |
07/23/2019 |
Aveta System |
Meditrina, Inc. |
Csaba Truckai |
| K191915 |
07/17/2019 |
SensiCare Sterile Power-Free Polymer Coated Polyisoprene Sugical Glove, Coated with Aloe V |
Medline Industries, Inc |
Jennifer Mason |
| K191759 |
07/01/2019 |
Medline Quick Switch Valve with ENFit Connector |
Medline Industries, Inc. |
Dinah Rincones |
| K191753 |
07/01/2019 |
Medline Sterile Powder-Free Nitrile Examination Gloves - Green (Tested For Use with Chemotherapy Drugs) |
Medline Industries, Inc. |
Claire Pigman |
| K192014 |
07/29/2019 |
SYPMHONYÖ OCT System |
Medos International SARL |
Sheree Geller |
| K191943 |
07/22/2019 |
SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor Set |
Medos International, SARL |
Daria Bochenek |
| K191851 |
07/10/2019 |
VS3-IR |
Medtronic |
Alex Chanin |
| K191745 |
07/01/2019 |
Medtronic Commander Flex |
Medtronic Care Management Services |
Gordon Nelson |
| K191788 |
07/03/2019 |
CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium, DIVERGENCE-L Anterior/Oblique Lumbar Fusion System |
Medtronic Sofamor Danek, USA Inc. |
Mia Wiggins |
| K191872 |
07/12/2019 |
Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution |
Menicon Co., Ltd. |
Tetsuji Kawai |
| K191991 |
07/25/2019 |
Ezfil |
Meta Biomed Co., Ltd. |
Suk Song Oh |
| K191829 |
07/09/2019 |
Microlife Non-Contact Infrared Forehead Thermometer |
Microlife Intellectual Property GmbH |
Gerhard Frick |
| K191867 |
07/12/2019 |
ATLAS Plating System |
MiRus, LLC |
Jordan Bauman |
| K191757 |
07/01/2019 |
EUROPA Pedicle Screw System |
MiRus, LLC |
Jordan Bauman |
| K191906 |
07/16/2019 |
MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed PLIF, HYPERION 3D Printed TLIF, CALYPSO 3D Printed LLIF, and ANTARES 3D Printed ALIF |
MiRus, LLC |
Jordan Bauman |
| K191898 |
07/16/2019 |
Sterile Latex Powder-Free Surgical Gloves |
Modern Healthcare Corp. |
Ke-Min Jen |
| K191869 |
07/12/2019 |
Biogel(R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel(R) PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim |
Molnlycke Health Care, US LLC |
Leonard Stewart |
| K191838 |
07/09/2019 |
Clearform Aligners |
Motor City Lab Works |
Christina Groth |
| K191822 |
07/08/2019 |
Nano FortiCore, FortiCore |
Nanovis LLC |
Matthew Hedrick |
| K191793 |
07/03/2019 |
Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand of DHS Plating System |
Nebula Surgical Private Limited |
Rajat Kumar Khant |
| K191796 |
07/03/2019 |
Neo Cage System |
Neo Medical S.A. |
Jonas Larsson |
| K191889 |
07/15/2019 |
NG-Test CARBA 5 |
NG Biotech |
Milovan Stankov-Puges |
| K192045 |
07/31/2019 |
Ophthalmic Yag Laser System YC-200 |
Nidek Co., Ltd. |
Tsutomu Sunada |
| K191975 |
07/24/2019 |
Elefix V Paste for EEG & EMG |
Nihon Kohden Corporation |
Sandra Gadeyne |
| K191802 |
07/03/2019 |
Electric Breast Pump |
Ningbo Huiyoo Baby Products Co. Ltd. |
Xiaoping Liu |
| K191749 |
07/01/2019 |
TIGR Matrix Surgical Mesh, TIGR Surgical Mesh |
Novus Scientific AB |
Thomas Engstrom |
| K191974 |
07/24/2019 |
NuVasive AttraX Putty |
NuVasive, Incorporated |
Jessica LeBlanc |
| K191955 |
07/22/2019 |
Enhanced External Counter Pulsation Device Plus Omay-A |
Omay(Guangzhou)Med Technologies Co., Ltd. |
Peixian Su |
| K191765 |
07/01/2019 |
OMNI TiN Coated Apex KneeÖ System |
OMNI life science, Inc. |
Christina Rovaldi |
| K191778 |
07/02/2019 |
Omnia Medical VBR |
Omnia Medical, LLC |
Troy Schifano |
| K191907 |
07/16/2019 |
OptoWire III |
Opsens Inc. |
Marc Chaunet |
| K191981 |
07/24/2019 |
REMEDY Acetabular Cup |
OsteoRemedies, LLC |
Eric Stookey |
| K191990 |
07/25/2019 |
OSW Aligner System |
OSW Manufacturing, LLC |
Ian Kitching |
| K191782 |
07/02/2019 |
TTC Phantom Intramedullary Nail System |
Paragon 28, Inc. |
Eric Lintula |
| K191783 |
07/03/2019 |
Parcus Synd-EZ Ti |
Parcus Medical, LLC |
Paul Vagts |
| K192034 |
07/30/2019 |
HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way Foley Catheter, 16Fr/5cc, HDX 100% Silicone 2-way Foley Catheter, 18Fr/10cc |
Pathway, LLC |
David Stroup |
| K191946 |
07/22/2019 |
Penumbra System Penumbra JET 7X |
Penumbra, Inc. |
Micaela Victoria |
| K191874 |
07/12/2019 |
F5 Corpus VS |
Permobil AB |
Ivan Fernandez |
| K191804 |
07/05/2019 |
TOMi Scope |
PhotoniCare, Inc. |
Ryan Shelton |
| K191976 |
07/24/2019 |
Piper GO-IO Intraosseous Infusion System |
Piper Access, LLC |
Jacob Lee |
| K191854 |
07/10/2019 |
Premia Spine XL Instruments |
Premia Spine, Ltd. |
Ron Sacher |
| K191903 |
07/16/2019 |
BruxZir GT (Gum Tissue) Color |
Prismatik Dentalcraft, Inc. |
Mythili Reguraman |
| K191740 |
07/01/2019 |
DORO LUCENT« iXI and iMRI Headrest System |
Pro Med Instruments GmbH |
Sandra Untenberger |
| K191979 |
07/24/2019 |
DORO QR3 XTom Headholder System |
Pro Med Instruments GmbH |
Sandra Untenberger |
| K191853 |
07/10/2019 |
Dual-Safety Pen Needle |
Promisemed Hangzhou Meditech Co., Ltd. |
Zearou Yang |
| K191959 |
07/23/2019 |
QuantX Breast MRI Biopsy Guidance Plugin |
Qlarity Imaging |
Robert Tomek |
| K191842 |
07/09/2019 |
Discovery Pico, Discovery Pico Plus, Discovery Pico Derm |
Quanta System, S.p.A. |
Francesco DellÆAntonio |
| K191962 |
07/23/2019 |
Vitra 2 |
Quantel Medical |
Bruno Pages |
| K191861 |
07/11/2019 |
Aurora Surgiscope System |
Rebound Therapeutics |
Naomi Gong |
| K191899 |
07/16/2019 |
Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions |
Roche Diagnostics |
Khoa Tran |
| K191924 |
07/18/2019 |
SAFECARE« THC Urine Strip Test |
Safecare Biotech (Hangzhou) Co., Ltd. |
Alex Qiu |
| K192030 |
07/30/2019 |
RS80 EVO Diagnostic Ultrasound System |
Samsung Medison Co., Ltd. |
Ji Yea Lee |
| K191813 |
07/05/2019 |
MobileDiagnost wDR 2.2 |
Sedecal SA |
Maria Luisa Gomez De Aguero |
| K192011 |
07/29/2019 |
PhoeniX |
Sedecal, SA. |
M¬ Luisa Gomez de Aguero |
| K191860 |
07/11/2019 |
Sterile Powder-Free Synthetic Rubber SurgeonÆs Glove with Low Dermatitis Potential |
Semperit Technische Produkte Gesellchaft m.b.H. |
Andreas Woess |
| K191769 |
07/01/2019 |
ePM Series Patient monitors |
Shenzhen Mindray Bio-medical Electronics Co., LTD. |
Yanhong Bai |
| K191894 |
07/15/2019 |
Upper Arm Blood Pressure Monitor |
ShenZhen ZhengKang Technology Co., Ltd. |
Huayong Yang |
| K191877 |
07/15/2019 |
FLUOROspeed |
Shimadzu Corporation |
Toshio Kadowaki |
| K191840 |
07/09/2019 |
Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement) |
Shockwave Medical, Inc. |
Cindy Morrow |
| K191794 |
07/03/2019 |
Vintage Art Universal |
Shofu Dental Corporation |
Mauro Malzyner |
| K191922 |
07/18/2019 |
ACUSON P200 Diagnostic Ultrasound System |
Siemens Medical Solutions USA, Inc. |
HyunJung Lee |
| K191891 |
07/15/2019 |
SOMATOM X.cite |
Siemens Medical Solutions USA, Inc. |
Tabitha Estes |
| K192024 |
07/29/2019 |
Cemented TSI Hip Stem |
Signature Orthopaedics Pty Ltd. |
Declan Brazil |
| K192013 |
07/29/2019 |
VERTICALE« Cervical System |
Silony Medical GmbH |
Melanie Lubjuhn |
| K191760 |
07/01/2019 |
PICO 14 Single Use Negative Pressure Wound Therapy System |
Smith & Nephew Medical Limited |
Sam Greenhalgh |
| K192044 |
07/31/2019 |
4CIS Marlin PEEK ACIF Cage |
Solco Biomedical Co., Ltd. |
Hwi-geun Yu |
| K192047 |
07/31/2019 |
RampartÖ One Lumbar Interbody Fusion System |
Spineology, Inc. |
Andrew Adams |
| K191885 |
07/15/2019 |
Standard Bougie |
Standard Bariatrics |
Alison Sathe |
| K192001 |
07/26/2019 |
Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device |
Sterilucent, Inc. |
Peter Kalkbrenner |
| K191999 |
07/26/2019 |
Sterilucent VH2O2 Chemical Indicators |
Sterilucent, Inc. |
Peter Kalkbrenner |
| K192020 |
07/29/2019 |
Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process Indicator Adhesive Label, VERIFY V24 Self-Contained Biological Indicator Vial Label |
STERIS Corporation |
Gregory Land |
| K191916 |
07/17/2019 |
Stryker CMF MEDPOR Priority Customized Implant Kit |
Stryker Leibinger GmbH & Co. KG |
Gregory Gohl |
| K191768 |
07/01/2019 |
AXS Vecta Aspiration System |
Stryker Neurovascular |
Shazia Hakim |
| K191995 |
07/26/2019 |
S4 Screw System |
Subchondral Solutions, Inc. |
Sheryl McCoy |
| K191827 |
07/08/2019 |
Sunmed Disposable Angio-Closure Pads |
Sunny Medical Device (Shenzhen) Co.,Ltd. |
James Qi Zhang |
| K191784 |
07/03/2019 |
Gabriel Feeding Tube with Balloon, and EnFit Connector |
Syncro Medical Innovations, Inc. |
Sabry Gabriel |
| DEN190034 |
07/15/2019 |
Control-IQ Technology |
Tandem Diabetes Care, Inc. |
Michael Sarrasin |
| K192053 |
07/31/2019 |
W Zirconia Implants |
TAV Medical Ltd. |
Revital Shabtai |
| K191986 |
07/25/2019 |
DESS Dental Smart Solutions |
Terrats Medical SL |
Roger Terrats |
| K191985 |
07/25/2019 |
Optilite IgA Kit |
The Binding Site Group Ltd. |
Natasha Verhaak |
| K191936 |
07/19/2019 |
iNSitu Total Hip System |
Thecken Companies, LLC |
Garrett Spurgeon |
| K191914 |
07/17/2019 |
Thermo Scientific Sensititre ARIS HiQ System |
Thermo Fisher Scientific |
Cynthia Knapp |
| K191918 |
07/18/2019 |
Thermo Scientific Sensititre ARIS HiQ System |
Thermo Fisher Scientific |
Cynthia Knapp |
| K191803 |
07/03/2019 |
Orthopedic Fixation Pin |
Tinavi (Anhui) Medical Technologies Co., Ltd. |
Jianhua Jiang |
| K191961 |
07/23/2019 |
OrthoGold |
Tissue Regeneration Technologies |
John Warlick |
| K192018 |
07/29/2019 |
Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic Interbody Fusion Device, Endoskeleton TO Interbody Fusion Device, Endoskeleton TT Interbody Fusion Device, Endoskeleton TC Interbody Fusion Device, Endoskeleton TCS Interbody |
Titan Spine, Inc |
Jane Rodd |
| K192054 |
07/31/2019 |
Endoskeleton TAS Plate |
Titan Spine, Inc |
Kelly McDonnell |
| K191791 |
07/03/2019 |
TranS1 Interbody Fusion System |
TranS1 |
Kristen Allen |
| K191913 |
07/17/2019 |
TruAbutment DS |
TruAbutment Inc. |
Kiyoon Nam |
| K192023 |
07/29/2019 |
Arm Blood Pressure Monitor |
Truly Instrument Limited |
Su HaiSen |
| K191902 |
07/16/2019 |
Razor, Everest, U&C Liquid |
U&C International Co., Ltd. |
Jong-min Kim |
| K191932 |
07/19/2019 |
MomentumÖ Posterior Spinal Fixation System |
Ulrich Medical USA |
Hans Stover |
| K191929 |
07/19/2019 |
UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens |
UNICON Optical CO., LTD |
Hsiao-Wei Shen |
| K191761 |
07/01/2019 |
Mobius3D |
Varian Medical Systems, Inc |
Peter J. Coronado |
| K191948 |
07/22/2019 |
GlideScope BFlex 5.8 Single-Use Bronchoscope |
Verathon Medical (Canada) ULC |
Haleh Ghassemi |
| K191926 |
07/18/2019 |
VITA VIONIC Bond |
VITA Zanhnfabrik H. Rauter GmbH Co. |
Bernd Walker |
| K191837 |
07/09/2019 |
UniSmile Clear Aligner System |
Vitang Technology, LLC |
Xiangxu Chen |
| K192008 |
07/29/2019 |
LaserShot M, NaviLase |
Vitrolife GmbH |
Susanne Schweitzer |
| K191870 |
07/12/2019 |
VV330 Continuous ECG Platform, VivaLNK Adhesive Patch |
VivaLNK, Inc. |
Quoi V. Huynh |
| K191846 |
07/10/2019 |
MAXReach Laser Probe |
Vortex Surgical Inc. |
Bob Neu |
| K191773 |
07/02/2019 |
GORE BIO-A Tissue Reinforcement |
W.L. Gore & Associates, Inc. |
Barbara L. Smith |
| K191755 |
07/01/2019 |
SPAR-K Instruments (for use with Gemini SL Total Knee System) |
Waldemar Link GmbH & Co. KG |
Stefanie Fuchs |
| K191819 |
07/05/2019 |
Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Border |
Winner Medical Co., Ltd. |
Dan Wang |
| K191928 |
07/19/2019 |
AccuContour |
Xiamen Manteia Technology LTD. |
Lu Xie |
| K191925 |
07/18/2019 |
MATRx Plus |
Zephyr Sleep Technologies |
Sabina Bruehlmann |
| K191900 |
07/16/2019 |
Single Use Grasping Forceps |
Zhejiang Chuangxiang Medical Technology Co., LTD. |
Lucius Long |
| K192021 |
07/29/2019 |
NCB Polyaxial Locking Plate System |
Zimmer GmbH |
Annemie Rehor Kausch |
| K191781 |
07/02/2019 |
Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis System |
Zimmer GmbH |
Roberto Tommasini |
| K191814 |
07/05/2019 |
Alliance Glenoid |
Zimmer Inc. |
Patricia Sandborn Beres |
