| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K183489 |
08/29/2019 |
D2P |
3D Systems, Inc. |
Kim Torluemke |
| K190044 |
08/21/2019 |
VSP Orthopedics System |
3D Systems, Inc. |
Kim Torluemke |
| K190870 |
08/12/2019 |
Cervical Spinal Truss System-Stand Alone (CSTS-SA) |
4Web, Inc. |
Jessee Hunt |
| K183276 |
08/07/2019 |
7D Surgical System |
7D Surgical Inc. |
Daniel Ziskind |
| K182086 |
08/20/2019 |
ARCO FP |
A.T.S. Applicazione Tecnologie Speciali s.r.l. |
Duilio Finazzi |
| K182818 |
08/01/2019 |
LOQTEQ VA Calcaneus Plate 3.5 |
aap Implantate AG |
Annesha Lahiri |
| K182950 |
08/23/2019 |
Acare Suction Unit |
Acare Technology Co., Ltd. |
Kevin Tsai |
| K183203 |
08/09/2019 |
ELAN 4 Tools |
Aesculap, Inc. |
Kathy A. Racosky |
| K191884 |
08/09/2019 |
DR 100s |
Agfa N.V. |
Wim Govaerts |
| K191623 |
08/21/2019 |
ScanX Touch/ScanX Duo Touch |
Air Techniques, Inc. |
Samir Ghevariya |
| K190674 |
08/08/2019 |
REFRESH RELIEVA For CONTACTS |
Allergan, Inc |
Emily Huang |
| K191107 |
08/27/2019 |
Plexus |
Alleva Medical (D.G.) Ltd |
Max Choi |
| K191311 |
08/12/2019 |
ATEC Lateral Interbody System |
Alphatec Spine, Inc. |
Cynthia Adams |
| K182401 |
08/28/2019 |
B.O.L.T Base Unit, B.O.L.T Non-Invasive Blood Pressure (NIBP) Cuff, B.O.L.T Infared Radiation Energy Technology(IRT) Thermometer probe, B.O.L.T Pulse Oximeter(SPO2) probe, B.O.L.T Gluchobin Blood Glucose, Total Cholesterol and Hemoglobin meter |
AmZetta Technologies Private Limited |
Sridharan Mani |
| K191439 |
08/29/2019 |
OverStitch 2-0 Polypropylene Suture |
Apollo Endosurgery |
Maritza Ward |
| K190261 |
08/14/2019 |
BOSS Toe Fixation System |
Arthrosurface, Inc. |
Dawn J. Wilson |
| K190176 |
08/01/2019 |
MINAMO |
Asahi Intecc Co., Ltd. |
Yasuyuki Kawahara |
| K191413 |
08/21/2019 |
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-Clip |
AtriCure, Inc |
Jim Taufen |
| K191114 |
08/09/2019 |
Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle |
Avenu Medical |
Dave Campbell |
| K183088 |
08/02/2019 |
ADVIA Centaur Erythropoietin (EPO) assay |
Axis-Shield Diagnostics Limited |
Claire Dora |
| K191471 |
08/30/2019 |
Carnation Ambulatory Monitor |
Bardy Diagnostics, Inc |
Brit Baird |
| K191494 |
08/12/2019 |
FacilisÖ Spinal System |
Baui Biotech Co., Ltd. |
Herman Jhan |
| K191546 |
08/02/2019 |
Epicardial Access System |
Baylis Medical Company Inc. |
May Tsai |
| K190126 |
08/22/2019 |
Bendit2.7 Steerable Microcatheter |
Bend It Technologies Ltd |
Nitza Shoham |
| K191352 |
08/08/2019 |
binx health io CT/NG Assay |
binx health, Inc. |
Sarah Kalil |
| K192035 |
08/29/2019 |
EvaQMax Smoke Evacuation System |
Bio Protech, Inc. |
Namhyun Cho |
| K190792 |
08/22/2019 |
BB-613WP |
BioBeat Technologies Ltd. |
Johanan May |
| K183282 |
08/15/2019 |
Biovitals Analytics Engine |
Biofourmis Singapore Pte. Ltd |
Kuldeep Singh Rajput |
| K190371 |
08/09/2019 |
Morpheus-C |
Biogennix, LLC. |
Timothy Bumbalough |
| K191953 |
08/22/2019 |
ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL) |
BioMerieux SA |
Marine Taravant |
| K191766 |
08/05/2019 |
VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4╡g/mL) |
bioMerieux, Inc. |
Esther Hernandez |
| K183120 |
08/06/2019 |
EmboCube Embolization Gelatin |
Biosphere Medical, S.A. |
Alix Fonlladosa |
| K191469 |
08/01/2019 |
Biotronik Stylets |
Biotronik, Inc |
Jon Brumbaugh |
| K190491 |
08/12/2019 |
Blue Sky Bio Zygomatic Implant System |
Blue Sky Bio, LLC. |
Michele Kupcso |
| K191274 |
08/07/2019 |
BonAlive Granules |
BonAlive Biomaterials Ltd. |
Jimmy Lucchesi |
| K191871 |
08/07/2019 |
15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set |
Boston Scientific Corporation |
Kripa Pandya |
| K192043 |
08/26/2019 |
AXIOS Stent and Electrocautery Enhanced Delivery System |
Boston Scientific Corporation |
Kayla Mackey |
| K191609 |
08/16/2019 |
Tria Soft Ureteral Stent |
Boston Scientific Corporation |
Justin Kapitan |
| K183605 |
08/29/2019 |
Spine & Trauma Navigation |
Brainlab AG |
Alexander Schweirsch |
| K191119 |
08/23/2019 |
EkoSonic Endovascular Device |
BTG International, Inc. |
Joshua Kim |
| K191143 |
08/02/2019 |
PowerFlow Implantable Apheresis IV Port |
C.R. Bard, Inc. |
Kristen Soodak |
| K191582 |
08/13/2019 |
Cartesion Prime |
Canon Medical Systems Corporation |
Paul Biggins |
| K191024 |
08/13/2019 |
xPORT Lens Fragmentation System |
Carl Zeiss Meditec Cataract Technology Inc. |
Gary Mocnik |
| K190613 |
08/29/2019 |
BD MAX Check-Points CPO |
Check-Points Health B.V. |
Pieter Vos |
| K191621 |
08/15/2019 |
ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer System Ascendant PC, ChoiceSpine Cervical Interbody Spacer System Ascendant, ChoiceSpine Cervical Spacer System Blackhawk, ChoiceSpine Intervertebral Fusion Device Octan |
ChoiceSpine, LLC |
Kim Finch |
| K192107 |
08/29/2019 |
Clarius Ultrasound Scanner |
Clarius Mobile Health Corp. |
Brendan Seward |
| K190904 |
08/28/2019 |
Conformis BeneFIT Hip System |
ConforMIS, Inc. |
Emmanuel Nyakako |
| K190562 |
08/08/2019 |
iTotal Identity Cruciate Retaining Knee Replacement System |
Conformis, Inc. |
Paul Smolenski |
| K183323 |
08/05/2019 |
UPJ Occlusion Balloon Catheter |
COOK Incorporated |
Johnathan Liu |
| K191394 |
08/07/2019 |
ILLUMISITE Platform |
Covidien llc |
Kristi Fox |
| K190813 |
08/23/2019 |
CrossBay Cervical Dilator Catheter System |
CrossBay Medical |
Piush Vidyarthi |
| K191342 |
08/19/2019 |
CrossRoads Screw System |
CrossRoads Extemity Systems, LLC |
Chad Hollis |
| K190722 |
08/16/2019 |
TriMAX Implant System |
CrossRoads Extemity Systems, LLC |
Chad Hollis |
| K183485 |
08/28/2019 |
CryoVizion System |
Cryos Technologies Inc. |
John A. Stimpson |
| K191810 |
08/28/2019 |
Curiteva Pedicle Screw System |
Curiteva, Inc. |
Eric Linder |
| K190025 |
08/12/2019 |
EVOL« -SI Joint Fusion System |
Cutting Edge Spine, LLC |
Kyle Kuntz |
| K191786 |
08/30/2019 |
CyclopsÖ Anterior Cervical Plate System |
DeGen Medical INC |
Craig Black |
| K183315 |
08/23/2019 |
CustMBite Dental Guard |
Dental Choice Holdings, LLC |
Ron Story |
| K191427 |
08/26/2019 |
Halley resin system |
Dentsply Sirona |
Karl Nittinger |
| K183390 |
08/21/2019 |
QNext and DG-PT |
Diagnostic Grifols, S.A. |
Joaquin Alberto Tamparillas |
| K183316 |
08/12/2019 |
Dr J Spinal and Epidural Needles |
Dr. Japan Co., Ltd. |
Mitsuko Uchida |
| K183230 |
08/15/2019 |
OneDraw A1C Test System |
Drawbridge Health, Inc. |
Annie Wright |
| K191319 |
08/29/2019 |
Dunamis Fixation Button System |
Dunamis LLC |
Prithviraj Chavan |
| K190090 |
08/02/2019 |
DynoSense Vital Sign Measuring System |
DynoSense Corp. |
Saeed Azimi |
| K191079 |
08/16/2019 |
Piezon Built-in Kit, Piezon Built-in Kit LED |
E.M.S Electro Medical Systems S.A |
Suzanne Fassio-Hardy |
| K192058 |
08/30/2019 |
EV1000 Clinical Platform NI, EV1000 Clinical Platform |
Edwards Lifesciences, LLC |
Christine Chun |
| K190205 |
08/29/2019 |
HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module |
Edwards Lifesciences, LLC |
Chirag Shah |
| K190887 |
08/01/2019 |
Leksell Vantage Stereotactic System |
Elekta Instrument AB |
Helena Skar |
| K190885 |
08/07/2019 |
Elevation Spine Saber-C System |
Elevation Spine |
Charlie Gilbride |
| K191257 |
08/08/2019 |
Erchonia EVRL |
Erchonia Corporation |
Steven Shanks |
| K191561 |
08/20/2019 |
Exactech Equinoxe Humeral Augmented Trays |
Exactech, Inc |
Shing Jen Tai |
| K191262 |
08/05/2019 |
aBSI |
EXINI Diagnostics AB |
Aseem Anand |
| K183458 |
08/06/2019 |
exoplan 2.3 |
exocad GmbH |
Stefan Walter |
| K191554 |
08/30/2019 |
LightWalker Laser System Family |
Fotona d.o.o. |
Lina Rupnik |
| K190459 |
08/23/2019 |
Hemoflow F3 and F4 Dialyzers |
Fresenius Medical Care Renal Therapies Group, LLC |
Denise Oppermann |
| K191190 |
08/01/2019 |
Steerable Introducer |
Freudenberg Medical LLC |
Mary Prunty |
| K183607 |
08/23/2019 |
FUJIFILM Bronchoscope |
FUJIFILM Corporation |
Randy Vader |
| K190702 |
08/30/2019 |
Lumipulse G whole PTH |
Fujirebio Diagnostics, Inc. |
Stacey Dolan |
| K192159 |
08/29/2019 |
Voluson E6, Voluson E8, Voluson E10 |
GE Healthcare |
Bryan Behn |
| K191798 |
08/09/2019 |
Versana Active |
GE Medical Systems Ultrasound and Primary Care Diagnostics |
Tracey Ortiz |
| K191792 |
08/09/2019 |
Versana Balance |
GE Medical Systems Ultrasound and Primary Care Diagnostics |
Tracey Ortiz |
| K183182 |
08/12/2019 |
Critical Care Suite |
GE Medical Systems, LLC. |
Camille Vidal |
| K192042 |
08/29/2019 |
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 |
| K182811 |
08/29/2019 |
gel-e Flex+ |
gel-e, Inc. |
Elsa Abruzzo |
| K190988 |
08/16/2019 |
GIM-STIM OTC TENS/EMS System |
Gemore Technology Co Ltd |
Boden S.P. Lai |
| K192076 |
08/29/2019 |
Binary« Anterior Cervical Plate System |
Genesys Spine |
Andrew C. Davison C. Davison |
| K191835 |
08/06/2019 |
CREO Stabilization System, Navigation Instruments, ExcelsiusGPS Instruments |
Globus Medical, Inc. |
Kelly J. Baker |
| K182382 |
08/29/2019 |
Nitrile Examination Powder Free Glove, Aloe Vera, Blue, Nitrile Examination Powder Free Glove, Aloe Vera, Pink |
GMP Medicare SDN BHD (F25) |
Noraini bt Raus |
| K181216 |
08/02/2019 |
HAMILTON-T1, HAMILTON-C1 |
Hamilton Medical AG |
Katrin Vogt |
| K190399 |
08/05/2019 |
Beddr 200 System |
Hancock Medical, Inc. |
Tom Goff |
| K183536 |
08/16/2019 |
Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove |
Hartalega Ngc Sdn. Bhd. |
Kuan Mun Leong |
| K191841 |
08/07/2019 |
Accurate Multi Panel Drug Urine Test Cup |
Healstone Biotech Inc |
Bryan Fang |
| K190328 |
08/15/2019 |
HCT Empty EVA Container Pack |
Health Care Technologies |
Adam T. Benson |
| K190925 |
08/15/2019 |
HeartFlow FFRct Analysis |
HeartFlow, Inc. |
Windi Hary |
| K191321 |
08/02/2019 |
Primelase Excellence |
High Technology Products SLU |
Sergi Lozano |
| K190735 |
08/16/2019 |
EQ Balance |
Highmark Innovations Inc. DBA Highmark Interactive |
Dave Crane |
| K191233 |
08/09/2019 |
ARIETTA 750 |
Hitachi Healthcare Americas |
Aaron Pierce |
| K191281 |
08/29/2019 |
Omni Hysteroscope, Omni Lok cervical seal |
Hologic, Inc. |
Rachelle D. Fitzgerald |
| K191245 |
08/30/2019 |
Yumizen C1200 ALP, Yumizen C1200 Albumin |
HORIBA ABX SAS |
Caroline Ferrer |
| K190991 |
08/15/2019 |
Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment |
Howmedica Osteonics Corp. (aka Stryker Orthopaedics) |
Dipan Lad |
| K191217 |
08/02/2019 |
JAZZ PF |
Implanet, S.A. |
Fabienne Larquey Cadiere |
| K191569 |
08/28/2019 |
Implantcast ic-Bipolar Head System |
Implantcast, GmbH |
Juliiane Hoppner |
| K191130 |
08/23/2019 |
Customized Contour Implant |
Implantech Associates Inc. |
Craig Arthur |
| K190385 |
08/08/2019 |
CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System |
In2Bones USA, LLC |
Christine Scifert |
| K192036 |
08/29/2019 |
ClotTriever Thrombectomy System |
Inari Medical |
Eben Gordon |
| K190338 |
08/02/2019 |
046 Zenith Flex |
InNeuroCo, Inc |
Marc Litzenberg |
| K191939 |
08/29/2019 |
Yushan X-Ray Flat Panel Detector |
InnoCare Optoelectronics Corp. |
Yumei Cheng |
| K190127 |
08/23/2019 |
Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheter |
Innovative Health, LLC. |
Amanda Babcock |
| K191731 |
08/13/2019 |
Instylla Microcatheter |
Instylla, Inc. |
Amita Shah |
| K191741 |
08/02/2019 |
Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape |
Intertape Polymer Inc. |
Michael Bryant |
| K191159 |
08/29/2019 |
Concentrator with Single battery pack, carry bag with shoulder strap, back pack shoulder straps, A, POC1 USB Bluetooth Dongle, POC1 Invacare Mobile Medical Application Accessory for use on iOS and Android Devices, Invacare Platinum Mobile Oxygen Concentra |
Invacare Corporation |
Elijah Wreh |
| K190593 |
08/23/2019 |
Zio XT ECG Monitoring System, Zio AT ECG Monitoring System |
iRhythm Technologies, Inc. |
Gabrielle Logan |
| K191382 |
08/26/2019 |
IPS e.max CAD Abutment Solutions- extra systems |
Ivoclar Vivadent, AG |
Sandra Cakebread |
| K191012 |
08/07/2019 |
Navigated Pedicle Access Kit |
IZI Medical Products LLC |
Qiang Cao |
| K190502 |
08/06/2019 |
ENFit Oral / Enteral Syringe |
Jiangsu Caina Medical Co., Ltd. |
Xinyan Ruan |
| K182142 |
08/28/2019 |
FEMME Applicator Tampon |
Jiangsu YOAI Technology co., Ltd. |
Huan Wang |
| K191933 |
08/16/2019 |
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 |
| K191645 |
08/16/2019 |
SKR 4000 |
Konica Minolta, Inc. |
Tsutomu Fukui |
| K191780 |
08/28/2019 |
AP50/30 Insufflator with Insuflow Port |
Lexion Medical LLC |
Bernard Horwath |
| K191575 |
08/08/2019 |
ARx Spinal System |
Life Spine Inc. |
Angela Batker |
| K191809 |
08/23/2019 |
MTS Imipenem-relebactam 0.002/4-32/4 ╡g/mL |
Liofilchem s. r. l. |
Fabio Brocco |
| K183112 |
08/02/2019 |
DiLumen Endolumenal Interventional Knife (ôDiLumen IKÖö) |
Lumendi, LLC |
Dennis Daniels |
| K183684 |
08/23/2019 |
Libertas û Taper Uncemented Femoral Stem |
Maxx Orthopedics Inc. |
Priscilla Herpai |
| K191033 |
08/05/2019 |
LunaGuard Nighttime Dental Protector |
McKeon Products |
Devin Benner |
| K191636 |
08/16/2019 |
APTUS Foot System |
Medartis AG |
Andrea Schweizer |
| K181760 |
08/08/2019 |
Transit-Pellets |
Medifactia AB |
Diana Nystrom |
| K190264 |
08/15/2019 |
Viola |
MEDITIME Co., Ltd |
Yong Baik Kim |
| K191242 |
08/22/2019 |
HEALIX ADVANCE SP BIOCOMPOSITE Anchor |
Medos International SARL |
Elizabeth Messana |
| K191267 |
08/01/2019 |
ImagingRing System on Rails |
MedPhoton GmbH |
Daniel Schaffarzick |
| K190716 |
08/08/2019 |
Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Atrial Pacing Lead, Streamline 6494 Unipolar Temporary Myocardial Pacing Wire, Streamline 6495 Unipolar Temporary Myocardial Pacing Lead |
Medtronic |
Joven Almazan |
| K191077 |
08/27/2019 |
Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortive BioActive Surface, Medtronic External Drive Motor |
Medtronic Inc |
Harsh Dharamshi |
| K191039 |
08/26/2019 |
Navigated T2 STRATOSPHERE Inserters and Navigated Templates |
Medtronic Sofamor Danek, USA Inc |
Elizabeth Hamilton |
| K183407 |
08/30/2019 |
Triton Cage |
Medyssey USA, Inc. |
Shawn Kim |
| K191496 |
08/05/2019 |
TDS Standard Solution |
Mesa Laboratories, Inc. |
Jamie Louie |
| K191376 |
08/13/2019 |
Modular Power Standing System |
Motion Concepts |
Dona Bhamra |
| K182618 |
08/14/2019 |
SleepImage System |
MyCardio, LLC dba SleepImage. |
Robert Schueppert |
| K190849 |
08/14/2019 |
IS-III active System_S-narrow Type |
Neobiotech Co., Ltd. |
Young-Ku Heo |
| K191424 |
08/28/2019 |
Interphalangeal Joint Fusion Device Range |
Neosteo |
Anne-Cecile Grandremy |
| K191415 |
08/30/2019 |
Pathfinder Endoscope Overtube |
Neptune Medical, Inc. |
Alex Tilson |
| K190437 |
08/28/2019 |
Delta 3300 |
Netech Corporation |
Mohan Das |
| K191475 |
08/29/2019 |
Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic PureSet Plate |
Nobel Biocare AB |
Charlemagne Chua |
| K191626 |
08/16/2019 |
Stat Profile Prime ES Comp Plus Analyzer System |
Nova Biomedical Corporation |
Cesidio Tempesta |
| K191553 |
08/14/2019 |
NuVaisve« Reline« Cervical System |
NuVasive, Incorporated |
Michelle Cheung |
| K183158 |
08/09/2019 |
NxStage Cartridge Express with Speedswap |
NxStage Medical, Inc. |
Christina Marabella |
| K191505 |
08/02/2019 |
Rezum System |
NxThera (A Boston Scientific Company) |
Justin Kapitan |
| K190293 |
08/02/2019 |
Single Use Cytology Brush BC-205D |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K183590 |
08/01/2019 |
Single Use Reloadable Clip Applicator, Clip, Long Clip, Short Clip, Super Short Clip |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K190449 |
08/30/2019 |
Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Head |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K183647 |
08/09/2019 |
SOLTIVEÖ Laser System(SOLTIVEÖ Pro SuperPulsed Laser, SOLTIVEÖ Premium SuperPulsed Laser, SOLTIVEÖLaser Fibers, and Accessories) |
Olympus Surgical Technologies America |
Jon Gilbert |
| K190744 |
08/29/2019 |
ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A) |
Olympus Winter & Ibe GmbH |
Jan-Oliver Upmeier |
| K191778 |
08/28/2019 |
Omnia Medical VBR |
Omnia Medical, LLC |
Troy Schifano |
| K191158 |
08/06/2019 |
The AIO Solution |
Orfit Industries NV |
Eddy Marivoet |
| K190992 |
08/06/2019 |
OrthoPediatrics PediFoot Deformity Corrections System |
OrthoPediatrics, Corp |
Jen Gregory |
| K183544 |
08/23/2019 |
Efficient Care 3D Planning |
Orthosoft, Inc. (d/b/a Zimmer CAS) |
Paul Hardy |
| K192074 |
08/30/2019 |
Signature ONE System |
Orthosoft, Inc. (d/b/a Zimmer CAS) |
Paul Hardy |
| K191241 |
08/14/2019 |
AutoStrut |
OrthoSpin |
Oren Cohen |
| K181888 |
08/22/2019 |
Osstell Beacon |
Osstell AB |
Stefan Horn |
| K182881 |
08/09/2019 |
Bone Screw, Bone Tack |
Osstem Implant Co., Ltd. |
Jungmin Yoo |
| K183475 |
08/30/2019 |
T1-CS, T1-C |
Osstem Implant Co., Ltd. |
Jiyoon Ha |
| K191981 |
08/23/2019 |
REMEDY Acetabular Cup |
OsteoRemedies, LLC |
Eric Stookey |
| K191990 |
08/23/2019 |
OSW Aligner System |
OSW Manufacturing, LLC |
Ian Kitching |
| K190236 |
08/29/2019 |
O2Vent Optima |
Oventus Manufacturing PTY LTD |
Robyn Woidtke |
| K190719 |
08/30/2019 |
Artemis Eye System |
Penumbra, Inc. |
Aditi Kolla |
| K183387 |
08/06/2019 |
M3290B Patient Information Center iX |
Philips Medical Systems |
Peng Cui |
| K191222 |
08/05/2019 |
Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV |
Prismatik Dentalcraft, Inc. |
Herbert Schoenhoefer |
| K191200 |
08/15/2019 |
TULSA-PRO System |
PROFOUND MEDICAL INC. |
Goldy Singh |
| K191295 |
08/06/2019 |
Percutaneous Introducer Needle |
Progressive Medical, Inc. |
Roland D. Sullivan |
| K191664 |
08/30/2019 |
SelectFlex 072 Neurovascular Access System |
Q'Apel Medical |
Ken Peartree |
| K191504 |
08/16/2019 |
PowerDR |
Radiology Information Systems, Inc. |
Chen-Tai Ma |
| K191547 |
08/30/2019 |
ReliefBand |
ReliefBand Technologies LLC |
Barbara Whitman |
| K191606 |
08/07/2019 |
RenovoCath |
RenovoRx, Inc. |
Kamran Najmabadi |
| K183193 |
08/01/2019 |
MREplus+ Software |
Resoundant Inc |
Bernard Horwath |
| K191225 |
08/05/2019 |
EEG Electrode Template |
Rhythmlink International, LLC |
Gabriel Orsinger |
| K190428 |
08/13/2019 |
Elecsys Anti-HAV II |
Roche Diagnostics |
Jamie Ferguson |
| K191899 |
08/16/2019 |
Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions |
Roche Diagnostics |
Khoa Tran |
| K190063 |
08/14/2019 |
Servator C SALF Solution |
S.A.L.F. Spa |
Carmelo Gagliano |
| K191924 |
08/16/2019 |
SAFECARE« THC Urine Strip Test |
Safecare Biotech (Hangzhou) Co., Ltd. |
Alex Qiu |
| K191813 |
08/02/2019 |
MobileDiagnost wDR 2.2 |
Sedecal SA |
Maria Luisa Gomez De Aguero |
| K182219 |
08/29/2019 |
SGS Dental Implants System |
SGS International Ltd |
Michaeli Shabtai |
| K191349 |
08/16/2019 |
980nm Diode Laser Therapy Device |
Shanghai Apolo Medical Technology Co., Ltd. |
Felix Li |
| K183122 |
08/25/2019 |
810nm Diode Laser System |
Shanghai Wonderful Opto-Electrics Tech. Co., Ltd |
Yvonne Xue |
| K191180 |
08/23/2019 |
Electronic Blood Pressure Monitor |
Shenzhen AOJ Medical Technology Co., Ltd. |
Qihuan Zhao |
| K182871 |
08/01/2019 |
Mini TENS Therapy Device |
Shenzhen Jumper Medical Equipment Co., Ltd. |
Tom Tom |
| K181154 |
08/02/2019 |
Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood Pressure Monitor |
Shenzhen Med-link Electronics Tech Co, Ltd. |
Baihan Feng |
| K191499 |
08/01/2019 |
MAGLUMI 2000 25-OH Vitamin D |
Shenzhen New Industries Biomedical Engineering Co., Ltd |
Jie Rao |
| K190207 |
08/19/2019 |
Blood Pressure Monitor |
Shenzhen Viatom Technology Co., Ltd. |
Zhou Saixin |
| K191063 |
08/23/2019 |
1-Step Culture Medium |
Shenzhen VitaVitro Biotech Co., Ltd. |
Donghai Pan |
| K191877 |
08/05/2019 |
FLUOROspeed |
Shimadzu Corporation |
Toshio Kadowaki |
| K191840 |
08/07/2019 |
Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement) |
Shockwave Medical, Inc. |
Cindy Morrow |
| K191533 |
08/28/2019 |
ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG |
Siemens Healthcare Diagnostics Inc. |
Paul DaSilva |
| K191922 |
08/15/2019 |
ACUSON P200 Diagnostic Ultrasound System |
Siemens Medical Solutions USA, Inc. |
HyunJung Lee |
| K190704 |
08/28/2019 |
Signature Ceramic Femoral Head |
Signature Orthopaedics Pty Ltd. |
Declan Brazil |
| K191177 |
08/23/2019 |
LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K Camera Head |
Smith and Nephew, Inc. |
Kathleen Solomon |
| K190650 |
08/07/2019 |
Revolution Centrifugal Blood Pump |
SORIN GROUP ITALIA S.R.L. |
Luigi Vecchi |
| K183208 |
08/15/2019 |
Suprasorb A + Ag ôRö |
Speciality Fibres and Materials Ltd. |
Lindie Turvey |
| K192047 |
08/23/2019 |
RampartÖ One Lumbar Interbody Fusion System |
Spineology, Inc. |
Andrew Adams |
| K183091 |
08/02/2019 |
Elaris Pedicle Screw System |
SpineWelding AG |
Joerg Mayer |
| K190610 |
08/15/2019 |
Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology |
Sterilmed, Inc. |
Jan Flegeau |
| K190081 |
08/21/2019 |
RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector |
STERIS Corporation |
Marcia L Benedict |
| K191412 |
08/23/2019 |
VariAx 2 System, VariAx 2 Mini Fragment System |
Stryker GmbH |
Sanja Jahr |
| K191916 |
08/15/2019 |
Stryker CMF MEDPOR Priority Customized Implant Kit |
Stryker Leibinger GmbH & Co. KG |
Gregory Gohl |
| K191414 |
08/28/2019 |
EXETER Centralizer, EXETER 2.5mm Plug |
Stryker Orthopaedics |
Denise Daugert |
| K190402 |
08/22/2019 |
Triathlon Total Knee System-Additional Components |
Stryker Orthopaedics (aka Howmedica Osteonics Corp.) |
Margaret Crowe Klippel |
| K191192 |
08/01/2019 |
SurgTech GENOLL Total Knee System |
SurgTech, Inc. |
Xuegong Yu |
| K191732 |
08/30/2019 |
Sutter RaVoR Bipolar Electrodes |
Sutter Medizintechnik GmbH |
Ulrike Zeissler |
| K190026 |
08/21/2019 |
Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit) |
Teleflex Medical |
Lakshmi Kanuri |
| K191985 |
08/19/2019 |
Optilite IgA Kit |
The Binding Site Group Ltd. |
Natasha Verhaak |
| K191936 |
08/20/2019 |
iNSitu Total Hip System |
Thecken Companies, LLC |
Garrett Spurgeon |
| K192071 |
08/30/2019 |
iNSitu Total Hip System |
Theken Companies, LLC |
Garrett Spurgeon |
| K192018 |
08/16/2019 |
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 |
08/29/2019 |
Endoskeleton TAS Plate |
Titan Spine, Inc |
Kelly McDonnell |
| K191565 |
08/06/2019 |
Endoskeleton TCS Interbody Fusion Device |
Titan Spine, Inc |
Kelly McDonnell |
| K191399 |
08/28/2019 |
BIOLOX CONTOURA Ceramic Femoral Head |
Total Joint Othopedics, Inc. |
Chris Weaber |
| K183305 |
08/05/2019 |
Crossing Support Catheter |
Tractus Vascular LLC |
Janet Burpee |
| K191009 |
08/12/2019 |
Arsenal Plating System |
Trilliant Surgical |
Christopher Radzicki |
| K183108 |
08/16/2019 |
Combined Aerobika OPEP and VersaPAP device |
Trudell Medical International |
Marianne Tanton |
| K190810 |
08/30/2019 |
OPERA, OPERA eco |
Unimom Co. |
Sang-Hyun Hong |
| K191214 |
08/01/2019 |
JO Premium Jelly Original Personal Lubricant |
United Consortium |
Stephanie Morris |
| K183312 |
08/08/2019 |
Conformity Stem |
United Orthopedic Corporation |
Lois Ho |
| K191559 |
08/01/2019 |
AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM |
United States Endoscopy Group, Inc |
Carroll Martin |
| K191560 |
08/09/2019 |
Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP Catheter |
Vascular Solutions LLC |
Beka Vite |
| K191602 |
08/02/2019 |
APA Oxy Blade |
Venner Medical (Singapore) Pte Ltd |
Adrian P. Waterton |
| K191948 |
08/21/2019 |
GlideScope BFlex 5.8 Single-Use Bronchoscope |
Verathon Medical (Canada) ULC |
Haleh Ghassemi |
| K190689 |
08/14/2019 |
SignalMark Breast Marker |
View Point Medical, Inc. |
Thomas Kane |
| K190893 |
08/07/2019 |
Non-invasive Hemodynamic Blood Pressure Monitor |
Vita-Course Technologies Co., Ltd. |
Kezheng Ma |
| K183567 |
08/23/2019 |
Vyntus/SentrySuite Product Line |
Vyaire Medical |
Elmar Niedermeyer |
| K190853 |
08/16/2019 |
Vyntus BODY |
Vyaire Medical Inc. |
Colleen Watson |
| K190535 |
08/06/2019 |
BiMobile Dual Mobility System - E-Dur Inserts |
Waldemar Link GmbH & Co. KG |
Stefanie Fuchs |
| K183356 |
08/19/2019 |
Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch |
Weihai Xingtai Packaging Products Co.,Ltd. |
Miao Qifen |
| K191393 |
08/22/2019 |
INFINITY Total Ankle System, INBONE Total Ankle System |
Wright Medical Technology, Inc. |
Rachel Roberts |
| K190970 |
08/13/2019 |
PROSTEPÖ TBIÖ (Tailors Bunion Implant) System |
Wright Medical Technology, Inc. |
Michael Mullins |
| K190269 |
08/28/2019 |
PureLift |
Xtreem Pulse, LLC |
Andrew Berile |
| K191423 |
08/06/2019 |
Normandy VBR System |
Zavation Medical Products LLC |
Frankie Cummins |
| K191339 |
08/19/2019 |
Zavation eZspand Interbody System |
Zavation Medical Products, LLC |
Matt Jones |
| K192021 |
08/22/2019 |
NCB Polyaxial Locking Plate System |
Zimmer GmbH |
Annemie Rehor Kausch |
| K191781 |
08/06/2019 |
Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis System |
Zimmer GmbH |
Roberto Tommasini |
| K190852 |
08/14/2019 |
Zurich Pressure Guidewire System Model 100 |
Zurich Medical Inc. |
Kin-Joe Sham |
