| 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 |
| 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 |
| K191817 |
07/05/2019 |
ActivOrtho Continuous Compression Screw System |
ActivOrtho, Inc. |
Paul Hindrichs |
| K191884 |
07/15/2019 |
DR 100s |
Agfa N.V. |
Wim Govaerts |
| K191795 |
07/03/2019 |
AOCup Lens Case with AODisc |
Alcon Laboratories, Inc. |
Katryna Warren |
| K191843 |
07/09/2019 |
Ceramill A-Temp |
Amann Girrbach AG |
Debora Engel |
| 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 |
| 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 |
| 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 |
| K192012 |
07/29/2019 |
Capillus 112, Capillus 244 |
Capillus |
Patricia Schnoor |
| K191797 |
07/03/2019 |
BiomarC Fiducial Marker |
Carbon Medical Technologies |
Eric Furlich |
| K191811 |
07/05/2019 |
Catalyst OrthoScience CSR Shoulder System |
Catalyst OrthoScience, Inc. |
Dale Davison |
| K191810 |
07/05/2019 |
Curiteva Pedicle Screw System |
Curiteva, Inc. |
Eric Linder |
| K192010 |
07/29/2019 |
SmoothSkin BARE+ |
CyDen Limited |
Adam Stephens |
| 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 |
| 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 |
| K191844 |
07/09/2019 |
Fidmi Low Profile Enteral Feeding Device |
Fidmi Medical Ltd |
Shahar Millis |
| K191747 |
07/01/2019 |
FUJIFILM Duodenoscope Model ED-580XT |
FUJIFILM Corporation |
Randy Vader |
| 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 |
| K191748 |
07/01/2019 |
Genesys Spine Sacroiliac Joint Fusion System |
Genesys Spine |
William W. Sowers |
| K191835 |
07/09/2019 |
CREO Stabilization System, Navigation Instruments, ExcelsiusGPS Instruments |
Globus Medical, Inc. |
Kelly J. Baker |
| 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 |
| K191801 |
07/03/2019 |
PROBEAT-CR |
Hitachi Ltd. |
Tomoyuki Seino |
| K191993 |
07/25/2019 |
Yumizen C1200 CRP |
Horiba ABX SAS |
Caroline Ferrer |
| K191994 |
07/26/2019 |
ProFound AI Software V2.1 |
iCAD Inc. |
Heather Reed |
| K192036 |
07/30/2019 |
ClotTriever Thrombectomy System |
Inari Medical |
Eben Gordon |
| K191764 |
07/01/2019 |
Inion BioRestore |
Inion Oy |
Tiina Tyni |
| K191939 |
07/19/2019 |
Yushan X-Ray Flat Panel Detector |
InnoCare Optoelectronics Corp. |
Yumei Cheng |
| K191741 |
07/01/2019 |
Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape |
Intertape Polymer Inc. |
Michael Bryant |
| 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 |
| 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 |
| K191780 |
07/02/2019 |
AP50/30 Insufflator with Insuflow Port |
Lexion Medical LLC |
Bernard Horwath |
| 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 |
| 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 |
| 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 |
| K191848 |
07/10/2019 |
APTUS Wrist Spanning Plates 2.5 |
Medartis AG |
Andrea Schweizer |
| K191958 |
07/23/2019 |
Aveta System |
Meditrina, Inc. |
Csaba Truckai |
| K191943 |
07/22/2019 |
SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor Set |
Medos International, SARL |
Daria Bochenek |
| K191757 |
07/01/2019 |
EUROPA Pedicle Screw System |
MiRus, LLC |
Jordan Bauman |
| K191822 |
07/08/2019 |
Nano FortiCore, FortiCore |
Nanovis LLC |
Matthew Hedrick |
| K191889 |
07/15/2019 |
NG-Test CARBA 5 |
NG Biotech |
Milovan Stankov-Puges |
| 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 |
| 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 |
| K191854 |
07/10/2019 |
Premia Spine XL Instruments |
Premia Spine, Ltd. |
Ron Sacher |
| K191853 |
07/10/2019 |
Dual-Safety Pen Needle |
Promisemed Hangzhou Meditech Co., Ltd. |
Zearou Yang |
| K191842 |
07/09/2019 |
Discovery Pico, Discovery Pico Plus, Discovery Pico Derm |
Quanta System, S.p.A. |
Francesco DellÆAntonio |
| 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 |
| 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 |
| K192047 |
07/31/2019 |
RampartÖ One Lumbar Interbody Fusion System |
Spineology, Inc. |
Andrew Adams |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
