| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K193599 |
12/23/2019 |
BOUNDER 300 Power Wheelchair, BOUNDER Plus 300 Power Wheelchair, BOUNDER 450 Power Wheelchair, BIG BOUNDER 600 Power Wheelchair, BIG BOUNDER 1000 Power Wheelchair |
21st Century Scientific, Inc. |
RD Davidson |
| K193492 |
12/17/2019 |
23andMe Personal Genome Service (PGS) Pharmacogenetic Reports |
23andMe, Inc. |
Lisa Charter |
| K193479 |
12/16/2019 |
Sternal Cable System |
A&E Medical Corporation |
Peter Browne |
| K193371 |
12/05/2019 |
FreeStyle Libre 2 Flash Glucose Monitoring System |
Abbott Diabetes Care Inc. |
Naveen Thuramalla |
| K193453 |
12/13/2019 |
TruDi Probe |
Acclarent, Inc. |
Leena Sorathia |
| K193318 |
12/02/2019 |
Distinct« Early Detection Pregnancy Test |
Acon Laboratories Inc. |
Qiyi Xie |
| K193509 |
12/18/2019 |
AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX |
Acutus Medical, Inc. |
Greg Geissinger |
| K193359 |
12/04/2019 |
SureMAX Family of Cervical Spacers |
Additive Implants, Inc |
Jeff Horn |
| K193582 |
12/23/2019 |
SterilContainer S2 System |
Aesculap, Inc. |
Sierra Mertz |
| K193659 |
12/30/2019 |
iTero Element 5D |
Align Technology, Inc. |
Angela M. Frederickson |
| K193589 |
12/23/2019 |
TrueTear Intranasal Tear Neurostimulator |
Allergan |
Barbara Simon |
| K193612 |
12/26/2019 |
AMT Suture Delivery System |
Applied Medical Technology, Inc. |
Joy Tubero |
| K193345 |
12/03/2019 |
Arthrex DynaNite Compression Plate |
Arthrex Inc. |
Rebecca R. Homan |
| K193575 |
12/23/2019 |
Arthrex SutureTape |
Arthrex Inc. |
Ivette Galmez |
| K193503 |
12/18/2019 |
Arthrex SwiveLock Suture Anchor |
Arthrex Inc. |
Jessica L. Singelais |
| K193523 |
12/19/2019 |
ArthrexVIP Web Portal |
Arthrex Inc. |
Heli F Chambi Infantas |
| K193372 |
12/05/2019 |
Univers Revers Modular Glenoid System (Augemented baseplates) |
Arthrex Inc. |
Ivette Galmez |
| K193425 |
12/10/2019 |
Pre-Milled Blank |
Arum Dentistry Co. Ltd |
Hwang-Heung Yeon |
| K193534 |
12/20/2019 |
Monarch Platform |
Auris Health, Inc. |
Anna Libman |
| K193482 |
12/17/2019 |
PrisMax System Version 3 |
Baxter Healthcare Corporation |
Christopher Scavotto |
| K193536 |
12/20/2019 |
MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8?g/mL) |
Beckman Coulter, Inc |
Elaine Duncan |
| K193358 |
12/04/2019 |
MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx) (0.008-16ug/mL) |
Beckman Coulter, Inc. |
Elaine Duncan |
| K193553 |
12/20/2019 |
VarseoSmile Temp |
BEGO Bremer Goldschlagerei Wilh. Herbst GmbH & Co. KG |
Tanja Gotz |
| K193328 |
12/02/2019 |
IPL + Diode Laser Machine |
Beijing Globalipl Development Co., Ltd. |
Li Ye |
| K193477 |
12/16/2019 |
Nd: YAG Laser Therapy Systems |
Beijing Kes Biology Technology Co., Ltd. |
Wei Meng Meng |
| K193609 |
12/26/2019 |
Q Switched Nd: YAG Laser machine |
Beijing Lead Beauty S & T Co., Ltd |
Jiao Zhang |
| K193464 |
12/16/2019 |
ND:YAG Laser |
Beijing Superlaser Technology Co., Ltd. |
Shi Shuang |
| K193519 |
12/19/2019 |
BioFire Blood Culture Identification 2 (BCID2) Panel |
BioFire Diagnostics, LLC |
Kristen Kanack |
| K193487 |
12/17/2019 |
Agilon Strip |
Biogennix, LLC |
Timothy Bumbalough |
| K193486 |
12/17/2019 |
Epic 980 |
Biolase, Inc |
Alicia Mszyca |
| K193567 |
12/23/2019 |
VITEK 2 AST- Gram Negative Polymyxin B (<=0.25 û >=16 ug/mL) |
BioMerieux, Inc. |
Esther Hernandez |
| K193572 |
12/23/2019 |
VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 ?g/mL) |
BioMerieux, Inc. |
Jolyn Tenllado |
| K193402 |
12/06/2019 |
ALLthread PEEK Suture Anchor |
Biomet Inc. |
Haley Pioch |
| K193373 |
12/05/2019 |
Comprehensive« Reverse Shoulder |
Biomet Inc. |
Kari Hovorka |
| K193451 |
12/13/2019 |
Titanium Interference Screws |
Biomet Inc. |
Saveetha Raghupathi |
| K193533 |
12/20/2019 |
WIN Flexible Nail System |
Biomet Inc. |
Dominique Dompor |
| K193632 |
12/27/2019 |
LassoStar Circular Mapping Catheter |
Biosense Webster, Inc. |
Michelle Wheeler |
| K193513 |
12/19/2019 |
SIGNAFUSE Bioactive Bone Graft |
Bioventus |
Kim Patterson Kelly |
| K193618 |
12/26/2019 |
ExactechGPS System |
Blue Ortho |
Matthieu Coic |
| K193614 |
12/26/2019 |
FINE Osteotomy around the knee |
Bodycad Laboratories, Inc. |
Guy Sevigny |
| K193473 |
12/16/2019 |
LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - US |
Boston Scientific Corporation |
Melissa Klamerus |
| K193424 |
12/10/2019 |
Resolution 360Ö ULTRA Clip |
Boston Scientific Corporation |
Elena Hennessey |
| K193591 |
12/23/2019 |
ARC 400 |
BOWA-electronics GmbH & Co. KG |
Wolf-Ruediger Fritz |
| K193619 |
12/26/2019 |
Cry-Ac«, Cry-Ac-3«, Cry-Baby |
Brymill Cryogenic Systems |
Paul Sideleau |
| K193603 |
12/23/2019 |
Benesta Medical Sterilization Tray |
Caldera Medical, Inc |
Vicki Gail |
| K193378 |
12/05/2019 |
CarboClear Lumbar Cage System |
CarboFix Orthopedics Ltd. |
Hila Wachsler-Avrahami |
| K193327 |
12/02/2019 |
Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve |
Cardinal Health 200, LLC |
Caroline Miceli |
| K193574 |
12/23/2019 |
Q-Rad System |
Carestream Health, Inc. |
Carolyn L Wagner |
| K193376 |
12/05/2019 |
Visalis V500, Visalis S500 |
Carl Zeiss Meditec AG |
Katrin Faber |
| K193441 |
12/11/2019 |
Aqua Naina Sterile Saline Solution |
Chemtex USA, Inc. |
Haribabu Talasila |
| K193450 |
12/13/2019 |
Pre-SeedÖ Fertility Lubricant |
Church & Dwight Co., Inc. |
Joelle Reinson |
| K193380 |
12/05/2019 |
CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set |
Codman & Shurtleff, Inc. |
Kirsten Franco |
| K193637 |
12/27/2019 |
MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic System |
Compania Mexicana De Radiologia CGR, S.A. DE C.V. |
Tonatiuh Monroy Soberon |
| K193606 |
12/23/2019 |
Y-Knot OneStep Anchor |
ConMed Corporation |
Carrie Engleman |
| K193667 |
12/31/2019 |
Shapiro MD model laser 272 |
Conversion Labs, PR, LLC |
Stefan Galluppi |
| K193545 |
12/20/2019 |
Corin Optimized Positioning System (OPS) Femoral |
Corin USA |
Lucinda Gerber |
| K193356 |
12/04/2019 |
BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider |
Covidien, LLC |
Juma Hoshino |
| K193452 |
12/13/2019 |
MotoBAND CP Implant System |
CrossRoads Extemity Systems, LLC |
Kim Strohkirch |
| K193426 |
12/10/2019 |
Elite iQ |
Cynosure LLC |
Michael King |
| K193588 |
12/23/2019 |
DD Contrast |
Dental Direkt GmbH |
Uwe Greitens |
| K193341 |
12/03/2019 |
iCTmotor (WL-1) |
Dentium Co., Ltd |
Sangwoo Lee |
| K193496 |
12/17/2019 |
CharmFil |
Dentkist, Inc. |
Shin Haeng Lee |
| K193529 |
12/20/2019 |
ATLANTIS Abutment for MIS Conical Connection Implants |
Dentsply Sirona |
Karl Nittinger |
| K193405 |
12/09/2019 |
Simplant Digital Guide |
Dentsply Sirona |
Karl Nittinger |
| K193408 |
12/09/2019 |
Sirona Dental CAD/CAM System with CEREC Chairside Software |
Dentsply Sirona |
Karl Nittinger |
| K193549 |
12/20/2019 |
SIGMA High Performance (HP) Partial Knee System |
DePuy Ireland UC |
Erin Combs |
| K193398 |
12/06/2019 |
Summit DuoFix HA Coating |
DePuy Orthopaedics, Inc. |
Erin Combs |
| K193540 |
12/20/2019 |
TRUMATCH Personalized Solutions |
DePuy Orthopaedics, Inc. |
Erin Combs |
| K193642 |
12/30/2019 |
Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System |
Dexcom, Inc. |
Linda Wang |
| K193532 |
12/20/2019 |
LIAISON Anti-HAV Assay |
DiaSorin Inc. |
John C. Walter |
| K193404 |
12/06/2019 |
UF(II) Bar holder abutment |
DIO Corporation |
JiAe Park |
| K193628 |
12/26/2019 |
AGE Automatic Wrist Blood Pressure Monitor |
Dongguan E-Test Technology Co., Ltd |
Victor Wan |
| K193624 |
12/26/2019 |
Automatic Upper Arm Blood Pressure Monitor |
Dongguan E-Test Technology Co., Ltd |
Victor Wan |
| K193627 |
12/26/2019 |
Automatic Upper Arm Blood Pressure Monitor |
Dongguan E-Test Technology Co., LTD |
Victor Wan |
| K193518 |
12/19/2019 |
KOSMOS |
EchoNous, Inc. |
Trish Liau |
| K193379 |
12/05/2019 |
Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe |
Edwards Lifesciences, LLC |
Wendy Vera Gonzalez |
| K193466 |
12/16/2019 |
Swan-Ganz Catheters |
Edwards Lifesciences, LLC |
Anne Lo |
| K193600 |
12/23/2019 |
EndoGI Biliary Stent System |
EndoGI Medical, Ltd. |
Omri Naveh |
| K193555 |
12/20/2019 |
Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate |
Ever Global (Vietnam) Enterprise Corp |
Jerry Lin |
| K193610 |
12/26/2019 |
BreathID Smart System |
Exalenz Bioscience Ltd. |
Raffi Werner |
| K193547 |
12/20/2019 |
CustomizedBone Service |
Fin-Ceramica Faenza Spa |
Marina Monticelli |
| K193661 |
12/30/2019 |
LightWalker Laser System Family |
Fotona d.o.o. |
Marko Berdajs |
| K193656 |
12/30/2019 |
SkyPulse |
Fotona d.o.o. |
Marko Berdajs |
| K193394 |
12/06/2019 |
Humeral Cup Stability & Humeral Cup 135/145o Stability |
FX Shoulder USA, Inc. |
Kathy Trier |
| K193484 |
12/17/2019 |
GC Fuji Triage EP |
GC America Inc. |
Mark Heiss |
| K193334 |
12/02/2019 |
Pristina Serena Bright |
GE Healthcare |
Barthelemy Arman |
| K193578 |
12/23/2019 |
Non-spermicidal Lubricated Male Latex Condom |
Global Protection Corp. |
Christina Cataldo |
| K193448 |
12/13/2019 |
BioNourish Lubricant |
Good Clean Love, Inc. |
Weny Strgar |
| K193449 |
12/13/2019 |
Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01) |
Guangdong Horigen Mother & Baby Products Co., Ltd |
Jun Deng |
| K193339 |
12/02/2019 |
GTK Veress Needles |
Guangzhou T.K Medical Instrument Co., Ltd. |
Tracy Weng |
| K193516 |
12/19/2019 |
Sonata« Sonography-Guided Transcervical Fibroid Ablation System 2.1 |
Gynesonics, Inc |
Diane King |
| K193528 |
12/19/2019 |
Empty EVA Bag |
Haemotronic, Spa |
Paola Franciosi |
| K193504 |
12/18/2019 |
HardyDisk AST Cefiderocol 30ug (FDC30) |
Hardy Diagnostics |
Rianna Malherbe |
| K193367 |
12/04/2019 |
elysion-pro |
High Technology Products SLU |
Sergi Lozano |
| K193664 |
12/31/2019 |
SubQKath Catheter and Needle Set |
HK Surgical |
Gary Mocnik |
| K193525 |
12/19/2019 |
Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M |
Horiba ABX SAS |
Caroline Ferrer |
| K193429 |
12/10/2019 |
Exeter V40 Femoral Stem, Exeter X3 RimFit Cup |
Howmedica Osteonics Corp |
Alexandra Kirby |
| K193590 |
12/23/2019 |
CareSens S Fit BT Blood Glucose Monitoring System |
i-SENS, Inc. |
Joon Ho Jung |
| K193423 |
12/09/2019 |
VADER«one Pedicle System MIS and LightMore« Pedicle System 6.0 |
Icotec AG |
Marina Hess |
| K193417 |
12/09/2019 |
FractureDetect (FX) |
Imagen Technologies, Inc. |
Robert Lindsey |
| K193543 |
12/20/2019 |
CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System, CoLink View Plating System, CoLink Afx Plating System |
In2Bones USA, LLC |
Christine Scifert |
| K193462 |
12/16/2019 |
ClotTriever Thrombectomy System |
Inari Medical |
Eben Gordon |
| K193498 |
12/17/2019 |
Infinitt RT PACS |
Infinitt Healthcare Co.,Ltd. |
Sang Wook Cho |
| K193369 |
12/05/2019 |
Xelis Dental 2.0 |
Infinitt Healthcare Co.,Ltd. |
Sang Wook Cho |
| K193389 |
12/06/2019 |
Vista Clear |
Inter-Med / Vista Dental Products |
Alex Johnson |
| K193447 |
12/13/2019 |
Vista Dyes |
Inter-Med / Vista Dental Products |
Alex Johnson |
| K193409 |
12/09/2019 |
Vista Rinse, Vista Rinse Plus |
Inter-Med/Vista Dental Products |
Alex Johnson |
| K193481 |
12/17/2019 |
AeroNOx 2.0 Nitric Oxide Titration & Monitoring System |
International Biomedical |
Amy Pieper |
| K193403 |
12/06/2019 |
UroNav System |
Invivo Corporation |
Kym Rupp |
| K193616 |
12/26/2019 |
ARIX Ankle System |
Jeil Medical Corporation |
Jonghwan Kim |
| K193526 |
12/19/2019 |
Syringe with safety needle, Safety needle |
Jiangsu Caina Medical Co., Ltd |
Jianwei Pan |
| K193592 |
12/23/2019 |
Neodent Implant System - Change in the Shelf Life of Neodent Acqua Implants |
JJGC Industria e Comercio de Materiais Dentarios S.A. |
Mariana Soares Hartmann |
| K193324 |
12/02/2019 |
Motion Correction System |
KinetiCor, Inc. |
Doug Donzelli |
| K193522 |
12/19/2019 |
iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA |
Kitazato Corporation |
Futoshi Inoue |
| K193320 |
12/02/2019 |
KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System |
Kyocera Medical Technologies, Inc. |
Anthony DeBenedictis |
| K193350 |
12/03/2019 |
Leadtek Fingertip Pulse Oximeter |
Leadtek Research Inc. |
K. S. Lu |
| K193393 |
12/06/2019 |
BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format). |
Leica Biosystems Newcastle Ltd. |
Matthew West |
| K193521 |
12/19/2019 |
Steerable Plateau Ti |
Life Spine, Inc. |
Angela Batker |
| K193539 |
12/20/2019 |
REVOLVE ENVI 600 Advanced Adipose System |
LifeCell Corporation |
Bozhana Hegarty |
| K193381 |
12/05/2019 |
RadCalc Software |
LifeLine Software, Inc. |
Craig Laughton |
| K193475 |
12/16/2019 |
OneTouch Verio Reflect Blood Glucose Monitoring System |
LifeScan Europe GmbH |
Niki Skelly |
| K193535 |
12/20/2019 |
EZER, Portable X-ray System |
Livermoretech Inc. |
Jae Hong Kim |
| K193644 |
12/30/2019 |
E-COM DR-2000 DR |
LiverMoreTech, Inc. |
Jay Kim |
| K193500 |
12/17/2019 |
Stellar M22 for Intense Pulsed Light (IPL) and Laser System |
Lumenis Ltd. |
Shlomit Segman |
| K193446 |
12/12/2019 |
Bare: 808 |
LUVO Medical Technologies, Inc |
Gregory Berzak |
| K193602 |
12/23/2019 |
LV Liberty Vision Model 1 90Yttrium Brachytherapy Source |
LV Liberty Vision Corporation |
Paul T. Finger |
| K193515 |
12/19/2019 |
Mako Total Knee Application |
Mako Surgical Corp. |
Shikha Khandelwal |
| K193626 |
12/26/2019 |
Masimo Rad-97 Pulse CO-Oximeter and Accessories |
Masimo Corporation |
Linus Park |
| K193560 |
12/23/2019 |
Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase Planner |
Materialise NV |
Veerle Vanderheyden |
| K193416 |
12/09/2019 |
Cellvizio I.V.E. with Confocal Miniprobes |
Mauna Kea Technologies |
Veronique Dentan |
| K193439 |
12/11/2019 |
MEBO Wound Dressing |
MEBO Life Science Inc. |
Sidney Hong |
| K193559 |
12/23/2019 |
NextAR TKA Platform |
Medacta Inernational SA |
Stefano Baj |
| K193433 |
12/10/2019 |
AMIStem-C |
Medacta International SA |
Stefano Baj |
| K193365 |
12/04/2019 |
M.U.S.T. Pedicle Screw System |
Medacta International SA |
Stefano Baj |
| K193461 |
12/16/2019 |
MectaLock All-Suture Anchors |
Medacta International SA |
Stefano Baj |
| K193633 |
12/27/2019 |
APTUS« Ankle Trauma System 2.8/3.5 |
Medartis AG |
Andrea Kiefer-Schweizer |
| K193639 |
12/27/2019 |
APTUS« Foot 2.8-3.5 System |
Medartis AG |
Andrea Kiefer-Schweizer |
| K193554 |
12/20/2019 |
APTUS« Forearm Shaft Plates and APTUS« Wrist 2.5 System |
Medartis AG |
Andrea Kiefer-Schweizer |
| K193652 |
12/30/2019 |
AbClose - Port Site Closure Device |
Medeon Biodesign, Inc. |
Tsung-Yu Hsieh |
| K193666 |
12/31/2019 |
Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy and Fentanyl) û Regular Cuff; Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) - Extended Cuff |
Medline Industries, Inc. |
Leontyne Banks |
| K193579 |
12/23/2019 |
PlasmaBlade X 3.0S LIGHT |
Medtronic Navigation |
Gina Cunsolo |
| K193399 |
12/06/2019 |
Miru 1day UpSide (midafilcon A) |
Menicon Co., Ltd. |
Li Haosheng |
| K193571 |
12/23/2019 |
Go2Wire Guide Wire |
Merit Medical System, Inc. |
Mark Mullaney |
| K193507 |
12/18/2019 |
Merit ONE Snare System |
Merit Medical Systems, Inc. |
Mark Mullaney |
| K193457 |
12/16/2019 |
AUDERE Lumbar Spacer System |
Met One Technologies |
Kyle Atwood |
| K193392 |
12/06/2019 |
BioSiCar Silicone Implant |
Metalware Technology Corp. |
Megan Chang |
| K193548 |
12/20/2019 |
Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire |
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
Ryan Kenney |
| K193601 |
12/23/2019 |
Single Use Electrosurgical Knife |
Micro-Tech (Nanjing) Co., Ltd. |
Sally He |
| K193340 |
12/02/2019 |
GoChek Blood Glucose Monitoring System, GoChek Connect Blood Glucose Monitoring System |
MicroTech Medical, Inc. |
Dore Mark |
| K193607 |
12/26/2019 |
BOBBY Balloon Guide Catheter |
MicroVention, Inc. |
Stephanie Onstot |
| K193573 |
12/23/2019 |
Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro |
Molnlycke Health Care US LLC. |
Calen Souther |
| K193375 |
12/05/2019 |
NeuroBlate System |
Monteris Medical |
David H. Mueller |
| K193374 |
12/05/2019 |
TumEase Acupressure Bracelets |
MumEase |
Catherine Varley |
| K193321 |
12/02/2019 |
MY01 Continuous Compartmental Pressure Monitor |
MY01, Inc. |
Charles Allan |
| K193370 |
12/05/2019 |
Nexxt Matrixx System |
Nexxt Spine LLC |
Andy Elsbury |
| K193412 |
12/09/2019 |
NEXXT MATRIXX System |
Nexxt Spine LLC |
Andy Elsbury |
| K193351 |
12/03/2019 |
NinesAI |
Nines, Inc. |
Russell Stewart |
| K193456 |
12/13/2019 |
Arm Blood Pressure Monitor |
Ningbo Ranor Medical Science & Technology Co., Ltd. |
Emma Hu |
| K193322 |
12/02/2019 |
NovaCross CTO Microcatheter |
Nitiloop Ltd. |
Amir Pansky |
| K193506 |
12/18/2019 |
NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR System |
NuVasive Incorporated |
Aditya Sharma |
| K193617 |
12/26/2019 |
Precice« Screws |
NuVasive Specialized Orthopedics, Inc. |
Madison Heffron |
| K193593 |
12/23/2019 |
NuVasive 3DP Interfixated ALIF System |
NuVasive, Incorporated |
Jessica LeBlanc |
| K193541 |
12/20/2019 |
NuVasive Cohere Thoracolumbar Interbody System |
NuVasive, Incorporated |
Michelle Cheung |
| K193414 |
12/09/2019 |
Trigon HA Stand-Alone Wedge Fixation System |
Nvision Biomedical Technologies, Inc |
Diana Langham |
| K193645 |
12/30/2019 |
nva, nvp, and nvt |
Nvision Biomedical Technologies, Inc. |
Diana Langham |
| K193517 |
12/19/2019 |
ViziShot 2 FLEX |
Olympus Surgical Technologies America |
Mary Anne Patella |
| K193335 |
12/02/2019 |
Sherlock |
Open Implants, LLC |
Tamara Nazzal |
| K193620 |
12/26/2019 |
OptoMonitor 3 |
Opsens Inc. |
Marc Chaunet |
| K193472 |
12/16/2019 |
OrthoCircle Spine Pedicle Screw System |
OrthoCircle Spine |
Jack Mathews |
| K193494 |
12/17/2019 |
OriginÖ Anterior Cervical Plate System |
Orthopaedic & Spine Development |
Nicolas Palillon |
| K193660 |
12/30/2019 |
OSSIOfiberÖ Compression Screws |
Ossio Ltd. |
Taly Lindner |
| K193520 |
12/19/2019 |
EVA 15 Insufflator |
Palliare Ltd. |
John O'Dea |
| K193595 |
12/23/2019 |
Indigo Aspiration System - Aspiration Catheter 7 and Separator 7 |
Penumbra, Inc. |
Teri Nguyen |
| K193454 |
12/13/2019 |
IQon Spectral CT |
Philips Medical Systems, Nederland B.V. |
Nimit Shah |
| K193415 |
12/09/2019 |
physIQ Heart Rhythm and Respiration Module |
physIQ, Inc |
George Allen Hides |
| K193468 |
12/16/2019 |
Tritium Sternal Cable Plate System |
Pioneer Surgical Technology, Inc. (dba RTI Surgical, Inc.) |
Linda Busklein |
| K193364 |
12/04/2019 |
Intimate Rose Kegel Exercise System |
Plus EV Holdings dba Intimate Rose |
Aaron Wilt |
| K193329 |
12/02/2019 |
PreXion3D Explorer EX |
PreXion Corporation |
Hiroaki Takahashi |
| K193438 |
12/11/2019 |
DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium) |
Pro Med Instruments GmbH |
Muhammad Zubair |
| K193361 |
12/04/2019 |
ProCell Surgical Sponge-Blood Recovery Unit |
ProCell Surgical, Inc. |
Robert Krensky |
| K193325 |
12/02/2019 |
Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches |
ProSys International Ltd |
Graham Steer |
| K193459 |
12/16/2019 |
Panther Stereotactic |
Prowess Inc. |
Rachel Scarano |
| K193440 |
12/11/2019 |
ER-REBOA PLUS Catheter |
Prytime Medical Devices, Inc |
Brian Young |
| K193363 |
12/04/2019 |
Dermapose Refresh |
Puregraft LLC |
Olivia Kim |
| K193640 |
12/27/2019 |
ClearCalc |
Radformation, Inc. |
Kurt Sysock |
| K193360 |
12/04/2019 |
Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard |
Radmedix LLC |
Gabriel Issa |
| K193596 |
12/23/2019 |
Wingman 14, Wingman 14C, Wingman 18, Wingman 35 |
Reflow Medical |
Krystal Santiago |
| K193388 |
12/06/2019 |
GlassLok Kits, GlassLok Powder, GlassLok Liquid |
Reliance Orthodontic Products Inc. |
Paula Wendland |
| K193491 |
12/17/2019 |
restor3d Metallic Interference Screw |
restor3D |
Nathan Evans |
| K193355 |
12/04/2019 |
Electrodes Handpieces for Mygen V-1000 RF System |
RF Medical Co., Ltd |
Kwang S Choi |
| K193615 |
12/26/2019 |
NorthStarÖ OCT Spinal System |
SeaSpine Orthopedics Corporation |
Alicia McArthur |
| K193636 |
12/27/2019 |
SeaSpine Reef TH System |
SeaSpine Orthopedics Corporation |
Aly Alvarez |
| K193418 |
12/09/2019 |
SeaSpine Skipjack System |
SeaSpine Orthopedics Corporation |
Aly Alvarez |
| K193655 |
12/30/2019 |
MSLS6QF TENS/PMS Device |
Self Doctor Care, LLC |
Wei Wei |
| K193480 |
12/16/2019 |
BIOEASY Multi-Drug Test Cup |
Shenzhen Bioeasy Biotechnology Co.,Ltd. |
Wenhau Yan |
| K193629 |
12/26/2019 |
Disposable NIBP Cuff |
Shenzhen Changke Connect Electronics Co., Ltd. |
Yahui Zhou |
| K193625 |
12/26/2019 |
Disposable Temperature Probe |
Shenzhen Changke Connect Electronics Co., Ltd. |
Yahui Zhou |
| K193354 |
12/04/2019 |
Air Compression Therapy Device |
Shenzhen Dongjilian Electronics Co.,Ltd. |
Zhang Hong |
| K193338 |
12/02/2019 |
Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes |
Shenzhen Med-link Electronics Tech Co., Ltd. |
Fei Liu |
| K193391 |
12/06/2019 |
BeneVision Central Monitoring System |
Shenzhen Mindray Bio-medical Electronics Co., LTD. |
Yanhong Bai |
| K193348 |
12/03/2019 |
Blood Pressure Monitor |
Shenzhen Viatom Technology Co., Ltd. |
Zhou Saixin |
| K193657 |
12/30/2019 |
Disposable Enteral Feeding Syringe with Enfit Connector |
Shinva Ande Healthcare Apparatus Co., Ltd. |
Xiaolei Tian |
| K193524 |
12/19/2019 |
SI-BONE iFuse Implant System« |
Si-Bone, Inc |
Susan Noriega |
| K193489 |
12/17/2019 |
ADVIA Centaur BR |
Siemens Healthcare Diagnostics Inc. |
Ian Thompson |
| K193493 |
12/17/2019 |
ADVIA Centaur Total IgE (tIgE) |
Siemens Healthcare Diagnostics Inc. |
Ian Thompson |
| K193326 |
12/02/2019 |
ARTIS Icono |
Siemens Medical Solutions USA, Inc. |
Patricia D. Jones |
| K193476 |
12/16/2019 |
VariLymph 12 pro |
SLK Medical GmbH |
Matthew Reid |
| K193558 |
12/23/2019 |
HEALICOIL Knotless Suture Anchors |
Smith & Nephew, Inc. |
Camille Black |
| K193460 |
12/16/2019 |
The iNAP One Sleep Therapy System |
Somnice, Inc. |
Sujith Shetty |
| K193465 |
12/16/2019 |
CorticaLINK Spinal Fusion Platform |
Spine Smith Holdings, LLC |
Nickolas G. Kriska |
| K193396 |
12/06/2019 |
PERLA« TL posterior osteosynthesis system |
Spineart |
Franck Pennesi |
| K193577 |
12/23/2019 |
SleepRight ProRx Custom Dental Guard |
Splintek, Inc. |
Thomas W Brown |
| K193478 |
12/16/2019 |
XTRAC Momentum Excimer Laser System |
Strata Skin Sciences, Inc. |
Chuck Mierkiewicz |
| K193502 |
12/18/2019 |
TGS Universal Headrest with Mounting Arm |
Stryker ENT |
Denise Thompson |
| K193366 |
12/04/2019 |
T2 ICF |
Stryker GmbH |
Cindy Leon |
| K193563 |
12/23/2019 |
Medline ReNewal Reprocessed Harmonic ACE+7 Shears |
Surgical Instrument Service and Savings Inc (dba Medline ReN |
Gail Gassner |
| K193587 |
12/23/2019 |
Sutter Swyng non-stick bipolar forceps, single-use |
Sutter Medizintechnik GmbH |
Ulrike Zeissler |
| K193653 |
12/30/2019 |
Hydrophilic Coating Guide Wire |
Suzhou Hengrui Disheng Medical Co.,Ltd. |
Ling Li |
| K193647 |
12/30/2019 |
Superpipe Angiographic Catheter |
Suzhou Hengrui Disheng Medical Co.,Ltd. |
Li Ling |
| K193570 |
12/23/2019 |
Dental Pain Eraser |
Synapse Dental |
Cosmo Haralambidis |
| K193336 |
12/02/2019 |
Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse |
Synedgen, Inc. |
Shenda Baker |
| K193483 |
12/17/2019 |
Basal-IQ Technology |
Tandem Diabetes Care, Inc. |
Trevor J Dendo |
| K193530 |
12/20/2019 |
Deklene MAXX |
Teleflex Medical |
Robin Haden |
| K193510 |
12/18/2019 |
Terason uSmart3200T Ultrasound System |
Teratech Corporation |
Steven R. Broadstone |
| K193512 |
12/18/2019 |
THD Procto Software System |
THD SpA |
Filippo Bastia |
| K193538 |
12/20/2019 |
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 ?g/ml |
Thermo Fisher Scientific |
Cynthia Knapp |
| K193537 |
12/20/2019 |
Omnichroma Flow |
Tokuyama Dental Corporation |
Keith A. Barritt |
| K193420 |
12/09/2019 |
XO Cross Support Catheter |
Transit Scientific |
Jenifer Arnold |
| K193495 |
12/17/2019 |
XO Score Percutaneous Transluminal Angioplasty Scoring Catheter |
Transit Scientific |
Jennifer Arnold |
| K193390 |
12/06/2019 |
CS Model+ |
Trophy |
Marie-Pierre Labat-Camy |
| K193349 |
12/03/2019 |
Vapocoolshot Mist |
Vapocoolshot, Inc. |
Jacob Leibovici |
| K193319 |
12/02/2019 |
XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System |
Vasoptic Medical Inc. |
Abhishek Rege |
| K193569 |
12/23/2019 |
PIVO(TM) |
Velano Vascular |
Tiffini Wittwer |
| K193488 |
12/17/2019 |
GlideScope BFlex 3.8 Single-Use Bronchoscope |
Verathon Medical (Canada) ULC |
Teresa Davidson |
| K193431 |
12/10/2019 |
AlignRT Plus |
Vision RT Ltd |
Arun Mahendran |
| K193436 |
12/11/2019 |
VITA Ambria |
VITA Zahnfabrik GmbH H Rauter & Co |
Bernd Walker |
| K193434 |
12/11/2019 |
VITA LUMEX AC |
VITA Zahnfabrik GmbH H Rauter & Co |
Bernd Walker |
| K193343 |
12/03/2019 |
Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed) |
VitalConnect, Inc. |
Cynthia Merrell |
| K193611 |
12/26/2019 |
Viveve 2.0 System |
Viveve Medical, Inc. |
Kevin Robison |
| K193658 |
12/30/2019 |
Viz ICH |
Viz.ai, Inc. |
Gregory Ramina |
| K193561 |
12/23/2019 |
Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch |
Weihai Xingtai Packaging Products Co.,Ltd. |
Miao Qifen |
| K193654 |
12/30/2019 |
BlueStar Rx |
WellDoc, Inc |
Sabyasachi Roy |
| K193344 |
12/03/2019 |
Tri-Ex Extraction Balloon with Multiple Sizing |
Wilson-Cook Medical Inc. |
Theresa de Prat |
| K193368 |
12/05/2019 |
Smart Correction System |
WishBone Medical, Inc. |
Mary Wentorf |
| K193665 |
12/31/2019 |
Frozen N |
Yozma BmTech Co., Ltd. |
Jenny Cho |
| K193566 |
12/23/2019 |
ZELTIQ CoolSculpting System |
ZELTIQ Aesthetics, Inc. |
Tammy Wharton |
| K193550 |
12/20/2019 |
Therm-X |
Zenith Technical Innovations |
Greg Binversie |
