| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K192673 |
10/28/2019 |
3MÖ ComplyÖ Hydrogen Peroxide Indicator Tape 1228 |
3M Company |
Mary Fretland |
| K192961 |
10/31/2019 |
ADH19 |
3M Deutschland GmbH |
Ruediger Franke |
| K191771 |
10/16/2019 |
SECURE Screw |
A.M. Surgical, Inc. |
Vincent Pascale |
| K192593 |
10/18/2019 |
Confirm Rx Insertable Cardiac Monitor |
Abbott |
Laura Sparks |
| K192725 |
10/25/2019 |
Cytal Wound Matrix 3-Layer |
ACell, Inc. |
Michelle Huettner |
| K192175 |
10/17/2019 |
On Call Express II Blood Glucose Monitoring System |
ACON Laboratories, Inc. |
Qiyi Xie |
| K191812 |
10/24/2019 |
ADI Cervical Interbody Fusion Device |
Additive Device, Inc. (ADI) d/b/a restor3d |
Nathan Evans |
| K192728 |
10/24/2019 |
Agnes |
Agnes Medical Co., Ltd |
SeungHwan Seo |
| K191431 |
10/07/2019 |
Interlude Rolled Tampons in Plastic Applicator |
ALBAAD fem |
Shlomo Helvits |
| K182143 |
10/03/2019 |
ALFA GATE Dental Implants System |
Alfa Gate Mazen Ltd |
Mohamad Zahalka |
| K192541 |
10/16/2019 |
DigiX FDX |
Allengers Medical Systems Limited |
Sanjeev K. Marjara |
| K191807 |
10/25/2019 |
ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device |
ALPCO |
Jeffrey Freedman |
| K190210 |
10/24/2019 |
Tear Pool Dissolvable Punctum Plugs |
AlphaMed Inc |
James Gubachy |
| K191723 |
10/18/2019 |
ATEC IOM Accessory Instruments |
Alphatec Spine, Inc. |
Ruby Zheng |
| K191843 |
10/04/2019 |
Ceramill A-Temp |
Amann Girrbach AG |
Debora Engel |
| K192434 |
10/15/2019 |
DualX Lumbar Intervertebral Body Fusion Device |
Amplify Surgical Inc |
Andy Choi |
| K190183 |
10/04/2019 |
Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe |
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. |
Gang Yu |
| K191563 |
10/25/2019 |
FILTRAY 2G Disposable Water Filters |
aqua-tools |
Virginie S. Grondin |
| K190921 |
10/30/2019 |
Arthrex Low Profile Screws |
Arthrex Inc. |
Heli F. Chambi Infantas |
| K191326 |
10/15/2019 |
Arthrex Mini Comprehensive Fixation System û 1.4mm & 1.6mm Module |
Arthrex Inc. |
Rebecca R. Homan |
| K191344 |
10/03/2019 |
Arthrex Mini Comprehensive Fixation System û 2.0mm & 2.4mm Module |
Arthrex Inc. |
Rebecca R. Homan R. Homan |
| K192532 |
10/19/2019 |
Arthrex SwiveLock Anchor |
Arthrex Inc. |
Ivette Galmez |
| K192441 |
10/17/2019 |
Arthrex SwiveLock Anchors |
Arthrex Inc. |
Jessica L. Singelais |
| K190953 |
10/16/2019 |
Arthrex Minimally Invasive Ankle Fusion Plate |
Arthrex, Inc. |
Caroline Bloemker |
| K192690 |
10/24/2019 |
Upgrade Kit MR GUI PRO, MrJ 3300 Plus |
ASG Superconductors S.p.A. |
De Benedetti Luisella |
| K190426 |
10/24/2019 |
ALTA Anterior Cervical Corpectomy System |
Astura Medical, LLC |
Parker Kelch |
| K191099 |
10/03/2019 |
Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel |
Atlas Medical |
Amani AL-Habahbeh |
| K190149 |
10/15/2019 |
Vial Adapter ╪20 mm |
Avenir Performance Europeenne Medical (APEM) |
Fatoumata Dao |
| K183710 |
10/04/2019 |
Vivio System |
Avicena LLC |
Sean Brady |
| K192616 |
10/21/2019 |
CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Envelope (extra extra large) (SubQ) |
Aziyo Biologics, Inc. |
Wendy Perreault |
| K192318 |
10/03/2019 |
Ultraverse 014 and 018 PTA Balloon Dilatation Catheters |
Bard Peripheral Vascular, Inc. |
Andrew Quach |
| K192556 |
10/17/2019 |
Carnation Ambulatory Monitor |
Bardy Diagnostics, Inc |
Jocelyn Kersten |
| K192005 |
10/04/2019 |
Bausch + Lomb PreVue Inserter for enVista Preloaded |
Bausch & Lomb, Inc |
Rekha Janarthanan |
| K190342 |
10/18/2019 |
BIAFINE Topical Cream |
Bausch Health Americas Incorporated |
Marci Halevi |
| K192705 |
10/25/2019 |
MiniCap Extended Life PD Transfer Sets |
Baxter Healthcare |
Kimberly Garcia |
| K191513 |
10/19/2019 |
Altapore Shape |
Baxter Healthcare Corporation |
Phillip Romei |
| K190298 |
10/04/2019 |
DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12 |
Beckman Coulter Biomedical GmbH |
Amanda Brown |
| K190054 |
10/21/2019 |
BD Insulin Syringe |
Becton Dickinson and Company |
Meriam Youssef |
| K191896 |
10/31/2019 |
Belimed Steam Sterilizer MST-H TOP 5000 |
Belimed AG |
Marc Luthi |
| K191417 |
10/10/2019 |
Belun Ring |
Belun Technology Company Limited |
Leung Lap Wai Lydia |
| K190319 |
10/10/2019 |
Waterlase Laser System Family |
Biolase, Inc. |
Alicia Mszyca |
| K192110 |
10/31/2019 |
Vitek Densichek |
bioMerieux, Inc |
Jennifer Jines |
| K190047 |
10/31/2019 |
StimRouter Neuromodulation System |
Bioness Inc. |
Sageev George |
| K191150 |
10/08/2019 |
Bodycad Unicompartmental Knee System |
Bodycad Laboratories, Inc. |
Guy Sevigny |
| K192360 |
10/25/2019 |
IntellaMap Orion High Resolution Mapping Catheter |
Boston Scientific Corporation |
Nicole Lyden |
| K192867 |
10/31/2019 |
Apyx Helium Plasma Generator (APYX-200H/P, APYX-JS3/RS3) |
Bovie Medical Corporation dba Apyx Medical Corporation |
Topaz Kirlew |
| K191542 |
10/11/2019 |
Apyx Plasma/RF Handpiece |
Bovie Medical Corporation dba Apyx Medical Corporation |
Topaz Kirlew |
| K182073 |
10/17/2019 |
BcSs-PICNI-2000 Sensor |
Braincare desenvolvimento e Inovacao Tecnologica S.A. |
Arnaldo Betta |
| K192239 |
10/17/2019 |
WavelinQ Plus EndoAVF System |
C.R. Bard, Inc. |
Kulveen Dhatt |
| K191584 |
10/22/2019 |
FORTICO Anterior Cervical Fixation System |
Camber Spine Technologies LLC |
Rami Hamzey |
| K192214 |
10/11/2019 |
CarboClear VBR System |
CarboFix Orthopedics Ltd. |
Yael Rubin |
| K191672 |
10/15/2019 |
NuFACE Mini Device |
Carol Cole Company dba NuFACE |
Nadia Vazirzadeh Miller |
| K190270 |
10/21/2019 |
FORE-SIGHT ELITE Tissue Oximeter Module |
CAS Medical Systems, Inc. |
Ron Jeffrey |
| K192428 |
10/05/2019 |
AFX Femoral Implant with Inserter |
Cayenne Medical |
Shima Hashemian |
| K191174 |
10/10/2019 |
Mercy babyTAPE |
Children's Mercy Hospital |
Susan Abdel-Rahman |
| K191470 |
10/25/2019 |
C-CAT Anaesthesia Catheter kit |
Cimpax ApS |
Patrick Busch-Madsen |
| K190349 |
10/24/2019 |
MediExpand TL Expandable VBR System |
CMF Medicon Surgical Inc. |
Therese Davey |
| K191385 |
10/29/2019 |
BRILLIANT COMPONEER |
Coltene/Whaledent AG |
Wolfgang Dorner |
| K191668 |
10/18/2019 |
Infrared Forehead Thermometer (Model IR-FT) |
Comper Chuangxiang (Beijing) Technology Co., Ltd. |
Han Du |
| K190084 |
10/11/2019 |
McLean-Ring Enteral Feeding Tube Set |
Cook Incorporated |
Paul Meyer |
| K192114 |
10/29/2019 |
Game Ready GRPro 2.1 System |
Cool Systems, Inc. (dba Game Ready) |
Natalie Kennel |
| K191806 |
10/03/2019 |
Propex IQ Apex Locator |
Dentsply Sirona |
Karl Nittinger |
| K191779 |
10/08/2019 |
Attune Revision LPS Inserts |
Depuy (Ireland) |
Kathy Harris |
| K192448 |
10/04/2019 |
Delta Xtend Revers Shoulder System |
DePuy(Ireland) |
Ashley Goncalo |
| K192787 |
10/25/2019 |
Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) System |
Dexcom, Inc. |
Bryan Osborne |
| K191833 |
10/07/2019 |
Dexcom G6 Pro Continuous Glucose Monitoring System |
Dexcom, Inc. |
Jacob Nardone |
| K190747 |
10/31/2019 |
Claritag |
DGI Technologies |
Jeremy Josephson |
| K192064 |
10/02/2019 |
LIAISON Vitamin B12 |
DiaSorin Inc. |
John C. Walter |
| K192046 |
10/28/2019 |
LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set |
DiaSorin Inc. |
John C. Walter |
| K190208 |
10/03/2019 |
Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe |
Diversatek Healthcare |
Laura L. Boll |
| K191944 |
10/24/2019 |
MU2net |
DOSIsoft |
Marc Usynski |
| K192453 |
10/01/2019 |
DIAMOND-5A/6A/8A |
DRGEM Corporation |
Ki-Nam Yang |
| K192400 |
10/03/2019 |
EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AG |
DRTECH Corporation |
Choul-Woo Shin |
| K192743 |
10/31/2019 |
VisionX 2.4 |
Durr Dental SE |
Oliver Lange |
| K190124 |
10/20/2019 |
EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One |
E.M.S Electro Medical Systems S.A. |
Gaelle Pacaud |
| K191258 |
10/23/2019 |
Intraosseous infusion device |
Einstein Works, L.L.C. |
Linda Taylor |
| K183562 |
10/23/2019 |
Powder-Free Nitrile Examination Glove (White Colored, Blue Colored, and Black Colored) Tested for Use with Chemotherapy Drugs |
Encompass Industries Sdn. Bhd. |
Eunice Yee |
| K183479 |
10/03/2019 |
Asthma Monitor AM3 |
eResearchTechnology |
Kristin Feld |
| K190937 |
10/14/2019 |
Echelon Endopath Staple Line Reinforcement |
Ethicon Endo-Surgery LLC |
Emily Nesbitt |
| K191373 |
10/22/2019 |
VICRYL Mesh |
Ethicon, Inc. |
Melina Escobar |
| K192303 |
10/01/2019 |
ExactVu High Resolution Micro-Ultrasound System |
Exact Imaging Inc. |
Sam Rajkumar |
| K190890 |
10/22/2019 |
Exactech Alteon Modular Dual Mobility (MDM) System |
Exactech, Inc. |
Liz Howell |
| K182773 |
10/08/2019 |
Single-Use Non-Stick Bipolar forceps Bayonet, Single-Use Non-Stick Bipolar Irrigating forceps, Single Use Non-Stick Bipolar Suction forceps |
Faulhaber Pinzetten OHG |
Dorothea Faulhaber |
| K192210 |
10/10/2019 |
ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System |
Fiab SpA |
Francesco Batistini |
| K180347 |
10/28/2019 |
3d Cage |
Fims Co., Ltd. |
Younggwang Choi |
| K190713 |
10/11/2019 |
F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face Sleep Lab Model (Small, Medium, Large) |
Fisher & Paykel Healthcare Ltd. |
Masar Mohammad |
| K192422 |
10/04/2019 |
Steerable Introducer 12F |
Freudenberg Medical LLC |
Mary Prunty |
| K191544 |
10/18/2019 |
Synapse 3D Blood Flow Analysis |
Fujifilm Corporation |
Randy Vader |
| K191973 |
10/22/2019 |
Lumpipulse G CA19-9-N |
Fujirebio Dianostics, Inc. |
Kristin Maddaloni |
| K190136 |
10/21/2019 |
Fusion Silastic System |
Fusion Orthopedics, LLC |
Eli Jacobson |
| K192206 |
10/08/2019 |
32mm Glenosphere and Humeral Cup |
FX Shoulder USA, Inc. |
Kathy Trier |
| K192041 |
10/29/2019 |
G21 SpaceFlex Hip |
G21 S.r.l |
Filippo Foroni |
| K192686 |
10/24/2019 |
Revolution Maxima, Revolution Ace |
GE Hangwei Medical Systems Co.,Ltd. |
Haibo He |
| K192426 |
10/01/2019 |
Signa Voyager, Signa Voyager Quantum |
GE Healthcare(Tianjin) Company Limited |
Yuan Ma |
| K192667 |
10/25/2019 |
gel-e Flex+ gel OTC |
gel-e, Inc. |
Elsa Abruzzo |
| K191085 |
10/25/2019 |
Maverick RNP Assay and Maverick Diagnostic System |
Genalyte, Inc. |
Rick Hockett |
| K191957 |
10/21/2019 |
BD MAX Vaginal Panel |
GeneOhm Sciences Canada, Inc. (BD Diagnostics) |
Katie Edwards |
| K192678 |
10/24/2019 |
Genesys Spine Binary« Lumbar Plate System |
Genesys Spine |
Chloe Lance |
| K183171 |
10/08/2019 |
ScopeSeal Duodenoscope Protective Device |
GI Scientific LLC |
Scott Miller |
| K183681 |
10/11/2019 |
Protego Antimicrobial Wound Dressing |
Global Health Solutions (DBA Turn Therapeutics) |
Bradley Burnam |
| K192314 |
10/23/2019 |
RESONATE Anterior Cervical Plate System |
Globus Medical Inc. |
Kelly J Baker |
| K191862 |
10/29/2019 |
Compression Therapy Device Model LGT-2200SP |
Guangzhou Longest Science & Technology Co., Ltd. |
Xiaobing Luo |
| K183274 |
10/18/2019 |
RTHawk, HeartVista Cardiac Package |
HeartVista, Inc. |
James J. Rogers |
| K191216 |
10/17/2019 |
Voxel DosimetryÖ v1.0 |
Hermes Medical Solutions AB |
Joakim Arwidson |
| K191993 |
10/03/2019 |
Yumizen C1200 CRP |
Horiba ABX SAS |
Caroline Ferrer |
| K191358 |
10/24/2019 |
Trident II Acetabular System |
Howmedica Osteonics Corp. aka Stryker Orthopaedics |
Valerie Giambanco |
| K182605 |
10/28/2019 |
HS AMICA devices family |
HS Hospital Service SPA |
Laura Lenzi |
| K190465 |
10/18/2019 |
Evolve Breast Pump |
Hygeia II Medical Group, Inc. |
Brett Nakfoor |
| K191994 |
10/04/2019 |
ProFound AI Software V2.1 |
iCAD Inc. |
Heather Reed |
| K190157 |
10/23/2019 |
Diana ChemoClave Transfer Set |
ICU Medical |
Jason Ma |
| K192084 |
10/22/2019 |
Madison Total Knee System |
Implanet, S.A. |
Regis Le Couedic |
| K191458 |
10/10/2019 |
Legacy SMARTBase Abutments |
Implant Direct Sybron Manufacturing LLC |
Reina Choi |
| K191855 |
10/29/2019 |
EmFace Device |
InMode MD Ltd. |
Amit Goren |
| K191170 |
10/30/2019 |
Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Catheter |
Innovative Health, LLC. |
Amanda Babcock |
| K183503 |
10/17/2019 |
EasyMark Tissue Marker |
INRAD Inc. |
Steve Field |
| K192029 |
10/28/2019 |
Straumann PUREloc abutments |
Institut Straumann AG |
Giulia Oran |
| K191659 |
10/10/2019 |
Instylla Delivery Kit |
Instylla, Inc. |
Amita Smith |
| K192659 |
10/21/2019 |
Omnipod Insulin Management System, Omnipod DASH Insulin Management System |
Insulet Corporation |
Julie Perkins |
| K191684 |
10/11/2019 |
MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System |
Integra Lifesciences Corporation |
Omayra Ramirez |
| K191507 |
10/01/2019 |
Intellijoint« Navigation System |
Intellijoint Surgical Inc. |
Breanne Cuddington |
| K192200 |
10/09/2019 |
DynaCAD |
Invivo Corporation |
Kym Rupp |
| K190221 |
10/25/2019 |
IOB Warming Blankets |
IOB Medical Inc |
Jiulin Xia |
| K192512 |
10/16/2019 |
Focus 35C Detector, Trimax 35C Detector |
iRay Technology Taicang Ltd. |
Meng Li |
| K191448 |
10/08/2019 |
Barrier Sleeves |
Ivoclar Vivadent, AG |
Sandra Cakebread |
| K192369 |
10/29/2019 |
PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit |
iXensor Co. Ltd. |
Evita Chen |
| K181896 |
10/18/2019 |
LIPOcel |
Jeisys Medical, Inc. |
Sugun Lee |
| K191490 |
10/03/2019 |
Retractable Safety Syringe, Retractable Safety Insulin Syringe, Retractable Safety Tuberculin Syringe, Retractable Safety Allergy Syringe |
Jiangsu Caina Medical Co., Ltd. |
Xinyan Ruan |
| K190179 |
10/03/2019 |
SAHARA Stabilization System |
K2M, Inc. |
Oonagh Lahiff |
| K190820 |
10/02/2019 |
Aimanfun Lumea Comfort |
Kam Yuen Plastic Products Ltd |
Anna Dan |
| K191881 |
10/28/2019 |
KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun |
KBL GmbH |
Ralf de Andreis |
| K191548 |
10/11/2019 |
Nexus Universal Self-Cure |
Kerr Corporation |
Ardrena Jackson |
| K191523 |
10/09/2019 |
Visalys Restorative Primer |
Kettenbach GmbH & Co. KG |
Katja Simon |
| K191133 |
10/08/2019 |
KATANA Cleaner, KATANA Cleaner (Trial) |
Kuraray Noritake Dental Inc. |
Yasujiro Ohara |
| K192208 |
10/09/2019 |
CORNICE Cervical Spacer System |
Legend Spine Technologies |
Steve Marinelli |
| K190267 |
10/30/2019 |
EZE SIT Valvulotome |
LeMaitre Vascular |
John N. Bradsher |
| K190632 |
10/24/2019 |
Latex SurgeonÆs Gloves Powder Free with protein content labeling claim of 50╡g/dm2 or less per glove of extractable protein |
Lenora Glove PVT LTD. |
Antony Kurian |
| K192235 |
10/11/2019 |
AEON Laparoscopic Instruments |
Lexington Medical, Inc. |
Douglas MacBride |
| K192325 |
10/18/2019 |
Quantum Blood and Fluid Warming System |
Life Warmer, Inc. |
John Pettini |
| K191963 |
10/10/2019 |
SMR Finned Short Stems |
LimaCorporate S.p.A |
Giuseppe Valenti |
| K192433 |
10/04/2019 |
LZI Methadone II Enzyme Immunoassay |
Lin-Zhi International, Inc |
Bernice Lin |
| K190181 |
10/25/2019 |
Instruments for LINK MEGASYSTEM-C Family |
Link Bio Corp. |
Terry Powell |
| K192345 |
10/31/2019 |
MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 ╡g/mL |
Liofilchem s. r. l. |
Fabio Brocco |
| K191942 |
10/17/2019 |
MT One Diamond |
M&T Srl |
Firorenzo Rossi |
| K182862 |
10/21/2019 |
Servo Guard |
Maquet Critical Care AB |
Elise Brun |
| K192398 |
10/03/2019 |
Millenium HX |
Mar Cor Purification, Inc. |
Mike Halliday |
| K182184 |
10/10/2019 |
Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted) |
MDK (ShangHai) Medical Packing Co., Ltd. |
Gong Yaoren |
| K191653 |
10/17/2019 |
Freestyle Flex |
Medela AG |
Judith Bernardo |
| K183412 |
10/31/2019 |
mediCAD Web |
mediCAD Hectec GmbH |
Claas-Fabian Lueers |
| K191134 |
10/30/2019 |
IB3D ALIF |
Medicrea International S.A. |
David Ryan |
| K190281 |
10/31/2019 |
Ultrasonic Surgical System |
MediSonic Technology Co |
Reginald Bart-Williams |
| K191958 |
10/01/2019 |
Aveta System |
Meditrina, Inc. |
Csaba Truckai |
| K190314 |
10/09/2019 |
Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000 |
MedNovel Technology Ltd |
Jia Yu |
| K191943 |
10/18/2019 |
SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor Set |
Medos International, SARL |
Daria Bochenek |
| K192173 |
10/29/2019 |
ROSA ONE Spine application |
MEDTECH S.A. |
Serge Tabet |
| K190840 |
10/15/2019 |
Medtronic Transportation / Sterilization Cassettes |
Medtronic Sofamor Danek USA, INC. |
Elizabeth Hamilton |
| K191066 |
10/03/2019 |
CD HorizonÖ AstuteÖ Spinal System |
Medtronic Sofamor Danek, USA Inc. |
Bhavya Vendra |
| K191526 |
10/01/2019 |
Cardioblate CryoFlex Surgical Ablation System |
Medtronic, Inc. |
Choua Thao |
| K191127 |
10/08/2019 |
Advanced Intermezzo Implant System |
MegaGen Implant Co., Ltd. |
JiYoung Son |
| K182448 |
10/09/2019 |
AnyRidge Octa 1 Implant System |
MegaGen Implant Co., Ltd. |
HyeJin Jung |
| K192455 |
10/17/2019 |
Merge PACS |
Merge Healthcare Incorporated |
Amy Tannenbaum |
| K191596 |
10/09/2019 |
Arcadia Balloon Catheter |
Merit Medical Systems, Inc. |
Shamsa Karimi |
| K190086 |
10/07/2019 |
Cepheid Xpert Respiratory Control Panel |
Microbiologics, Inc. |
Tina Sobania |
| K191632 |
10/07/2019 |
PROFEMUR TL2 Stems |
MicroPort Orthopedics Inc. |
Sneh Pingle |
| K192268 |
10/22/2019 |
Europa Pedicle Screw System |
MiRus, LLC |
Jordan Bauman |
| K190539 |
10/22/2019 |
TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile |
MonuMedical, LLC |
John Knapik |
| K183462 |
10/01/2019 |
Applied Biosystems Bacillus anthracis Detection Kit |
MRIGlobal |
Fran White |
| K191822 |
10/11/2019 |
Nano FortiCore, FortiCore |
Nanovis LLC |
Matthew Hedrick |
| K191363 |
10/02/2019 |
Neocis Planning Software Application (NPSA) for 3rd Party PCs |
Neocis Inc. |
Thomas ("Ted") E. Claiborne |
| K192427 |
10/03/2019 |
Ablation Confirmation |
NeuWave Medical, Inc. |
Neda Chini |
| K191181 |
10/11/2019 |
NXPRO Neuromuscular Electrical Stimulation Device |
NeuX Technologies, Inc. |
Scot Minniear |
| K182743 |
10/23/2019 |
Patient-Specific Airway Stent |
New Cos Inc. |
Keith Grafmeyer |
| K191889 |
10/02/2019 |
NG-Test CARBA 5 |
NG Biotech |
Milovan Stankov-Puges |
| K190037 |
10/24/2019 |
Cronus HP PTA Balloon Catheter |
Nipro Medical Corporation |
Jessica Oswald-McLeon |
| K191359 |
10/09/2019 |
Nipro Syringe |
Nipro Medical Corporation |
Jessica Oswald-McLeod |
| K192760 |
10/18/2019 |
NuVasive Modulus XLIF Interbody System |
NuVasive, Incorporated |
Jessica LeBlanc |
| K190636 |
10/19/2019 |
NuVasive« Reline« 4.5-5.0 System |
NuVasive, Incorporated |
Ivanna Lopez |
| K192083 |
10/30/2019 |
Okami Medical LOBO Vascular Occlusion System |
Okami Medical |
Rebecca K Pine |
| K190772 |
10/10/2019 |
SURGICAL MICROSCOPE SYSTEM ORBEYE with IR |
OLYMPUS MEDICAL SYSTEMS CORP. |
Toshiyuki Nakajima |
| K191713 |
10/04/2019 |
CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShieldÖ (ROI Assembly) |
Omega Medical Imaging, LLC |
John Newman |
| DEN190025 |
10/10/2019 |
OraQuick Ebola Rapid Antigen Test |
OraSure Technologies, Inc. |
Tiffany Miller |
| K190162 |
10/17/2019 |
SmartCeph |
Ortho2, LLC |
Amy Schmidt |
| K190321 |
10/09/2019 |
Pediatric Nailing PlatformFemur |
OrthoPediatrics, Corp. |
Jen Gregory |
| K190102 |
10/17/2019 |
DyeVertÖ Plus Contrast Reduction System, DyeTectÖ Contrast Monitoring System, DyeVertÖ Plus EZ Contrast Reduction System |
Osprey Medical Inc. |
Melanie Hess |
| K190523 |
10/10/2019 |
Cranial PSI Accessory û Anatomical Model Original, Cranial PSI Accessory û Anatomical Model Modified, Cranial PSI Accessory û Plastic Drawing Guide, Cranial PSI Accessory û Cranial Implant Trial |
OssDsign AB |
Ulrik Birgersson |
| K192121 |
10/29/2019 |
Black Diamond Pedicle Screw System |
Osseus Fusion Systems |
Robert Pace |
| K183309 |
10/22/2019 |
stentfix OTSC System Set |
Ovesco Endoscopy AG |
Marc O. Schurr |
| K192147 |
10/10/2019 |
Halyard ONE-STEP* Sterilization Wrap |
Owens & Minor (O&M) Halyard, Inc |
Steven Dowdley |
| K191783 |
10/09/2019 |
Parcus Synd-EZ Ti |
Parcus Medical, LLC |
Paul Vagts |
| K192280 |
10/21/2019 |
PENTAX Medical ED-3490TK Video Duodenoscope |
Pentax Medical |
William Goeller |
| K191874 |
10/25/2019 |
F5 Corpus VS |
Permobil AB |
Ivan Fernandez |
| K192802 |
10/28/2019 |
primeMidline Catheters |
PFM Medical, Inc. |
Mina Jiang |
| K191687 |
10/09/2019 |
pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire |
phenox Limited |
Gary Brogan |
| K190624 |
10/27/2019 |
EarlyVue VS30 |
Philips Medizin Systeme Boeblingen GmbH |
Greg Li |
| K192494 |
10/29/2019 |
NexGen Anterior Cervical Plate System |
Precision Spine |
Michael C. Dawson |
| K191854 |
10/08/2019 |
Premia Spine XL Instruments |
Premia Spine, Ltd. |
Ron Sacher |
| K191979 |
10/22/2019 |
DORO QR3 XTom Headholder System |
Pro Med Instruments GmbH |
Sandra Untenberger |
| K183589 |
10/11/2019 |
PMT Facet Screw |
Providence Medical Technology, Inc. |
Edward Liou |
| K192525 |
10/31/2019 |
087 Balloon Guide Catheter System |
Q'Apel Medical LLC |
Ken Peartree |
| K190646 |
10/18/2019 |
QT Scanner 2000 Model A |
QT Ultrasound, LLC |
Rajni Natesan |
| K183661 |
10/22/2019 |
ClearEdge Balance System |
Quadrant Biosciences |
Bryan Greene |
| K192737 |
10/22/2019 |
RCT800 |
RAY CO., Ltd |
Changhwan Lee |
| K192566 |
10/17/2019 |
Reach and CQ'ENCE Circular Staplers |
Reach Surgical, Inc. |
Mark Goldin |
| K192474 |
10/10/2019 |
VERA |
Reflexion Health, Inc. |
Walter Cordiglia |
| K183226 |
10/18/2019 |
Care Orchestrator Essence |
Respironics Inc. |
Michelle Brinker |
| K183625 |
10/18/2019 |
SomnaPatch |
Respironics, Inc. |
Amy Panzik |
| K190486 |
10/16/2019 |
Pitkar External Fixation System |
S H Pitkar Orthotools Pvt Ltd. |
Vivek Mangalwedhekar |
| K191436 |
10/18/2019 |
Saalio |
Saalmann medical GmbH & Co. KG |
Rolf Eilers |
| K190591 |
10/04/2019 |
Safergel Sterile Ultrasound Gel |
Safersonic US, Inc. |
David L. Seitelman |
| K192316 |
10/17/2019 |
Matrix HA PEEK Cervical Implant System |
Sapphire Medical Group |
Anthony Ruggiero |
| K192783 |
10/30/2019 |
Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard Profile ; Aristotle 24 Guidewire, 200cm, Support Profile |
Scientia Vascular LLC |
Amy McManus |
| K190630 |
10/09/2019 |
SolidAIRity III Airway Stabilization System |
Securisyn Medical, LLC |
Arthur Kanowitz |
| K191610 |
10/01/2019 |
RTapp |
SegAna, LLC |
Rodney Bosley |
| K183441 |
10/04/2019 |
Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs |
Semperit Investments Asia PTE LTD. |
Andreas Woess |
| K190795 |
10/18/2019 |
Tetragraph Neuromuscular Transmission Monitor |
Senzime AB |
Johanna Faris |
| K192515 |
10/11/2019 |
BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20 |
Shenzhen Bioeasy Biotechnology Co.,Ltd. |
Wenhau Yan |
| K191251 |
10/15/2019 |
Infared Thermometer |
Shenzhen Calibeur Industries Co., Ltd. |
Weibin He |
| K191420 |
10/11/2019 |
Reusable SpO2 Sensor |
Shenzhen Changke Connect Electronics Co., Ltd. |
Yahui Zhou |
| K183674 |
10/11/2019 |
Electronic Pulse Stimulator |
Shenzhen Leading Perfection Technology Co., Ltd |
Simon Hou |
| K191769 |
10/31/2019 |
ePM Series Patient monitors |
Shenzhen Mindray Bio-medical Electronics Co., LTD. |
Yanhong Bai |
| K182136 |
10/10/2019 |
Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303) |
Shenzhen OSTO Technology Co., Ltd. |
Li Yang |
| K191430 |
10/18/2019 |
Pulse Oximeter |
Shenzhen Yimi Life-Technology Co.,Ltd. |
Shande Peng |
| K191794 |
10/03/2019 |
Vintage Art Universal |
Shofu Dental Corporation |
Mauro Malzyner |
| K192790 |
10/30/2019 |
Atellica IM Total hCG (ThCG) |
Siemens Healthcare Diagnostics Inc. |
Mey Lyn Vasquez |
| K192835 |
10/22/2019 |
ACUSON NX3 Diagnostic Ultrasound System / ACUSON NX3 Elite Diagnostic Ultrasound System |
Siemens Medical Solutions, USA, Inc. |
Hyunjung Lee |
| K191002 |
10/31/2019 |
OR3O Dual Mobility System |
Smith & Nephew, Inc. |
Mike Scott |
| K190847 |
10/25/2019 |
REDAPT Blade Augments |
Smith & Nephew, Inc. |
Konrad Wolfmeyer |
| K181660 |
10/24/2019 |
Acapella Choice Blue Vibratory PEP Device |
Smiths Medical |
Donna Semlak |
| K192526 |
10/10/2019 |
Spine Wave Navigated Instruments |
Spine Wave, Inc. |
Amy Noccioli |
| K190386 |
10/10/2019 |
KTA Adipose Treatment Kit |
Stemics S.A.S |
Stephane Giraud |
| K192775 |
10/30/2019 |
Niobe« Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri |
Stereotaxis, Inc. |
Kenneth H. Lock |
| K192001 |
10/22/2019 |
Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device |
Sterilucent, Inc. |
Peter Kalkbrenner |
| K191999 |
10/21/2019 |
Sterilucent VH2O2 Chemical Indicators |
Sterilucent, Inc. |
Peter Kalkbrenner |
| K192722 |
10/24/2019 |
Padlock Clip defect closure system, Padlock Pro-Select defect closure device |
STERIS Corporation |
Tony Piotrkowski |
| K191007 |
10/25/2019 |
Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems |
Supersonic Imagine |
Jacques Souquet |
| K192128 |
10/04/2019 |
Sutter Arrowtip Monopolar Electrodes |
Sutter Medizintechnik GmbH |
Ulrike Zeissler |
| K191283 |
10/18/2019 |
Infrared Thermometer, Breeze model |
Suzhou Melodicare Medical Technology Co.,Ltd. |
Xiaoqian Zou |
| K192053 |
10/29/2019 |
W Zirconia Implants |
TAV Medical Ltd. |
Revital Shabtai |
| K192623 |
10/22/2019 |
LipiFlow Thermal Pulsation System |
TearScience Inc. |
Michelle Ricafort |
| K192057 |
10/11/2019 |
K-Pack II Needle - 27G x 1/2ö Extra Thin Wall, K-Pack II Needle - 27G x 1/2ö Ultra Thin Wall, K-Pack II Needle - 30G x 1/2ö Extra Thin Wall, K-Pack II Needle - 30G x 1/2ö Ultra Thin Wall |
Terumo Europe N.V. |
M. J. Aerts |
| K192250 |
10/16/2019 |
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Imipenem-Relebactam in the dilution range of 0.03/4-256/4 ug/mL |
Thermo Fisher Scientific |
Cynthia Knapp |
| K191369 |
10/08/2019 |
TSolution One Total Knee Application |
THINK Surgical, Inc. |
Meliha Mulalic |
| K192598 |
10/18/2019 |
Bashir S-B Endovascular Catheter, Ref. No. 7101 |
Thrombolex, Inc. |
Amy Katsikis |
| K190940 |
10/04/2019 |
Tokuyama Rebase III |
Tokuyama Dental Corporation |
Keith A. Barritt |
| K192504 |
10/30/2019 |
Treace Medical Concepts (TMC) Plating System |
Treace Medical Concepts, Inc. |
Rachel Osbeck |
| K191480 |
10/11/2019 |
Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-Based Hybrid) |
Trigg Laboratories, Inc. D/B/A Wet International |
Louie Goryoka |
| K191902 |
10/11/2019 |
Razor, Everest, U&C Liquid |
U&C International Co., Ltd. |
Jong-min Kim |
| K191264 |
10/30/2019 |
Every Second Matters-Uterine Balloon Tamponade (ôESM-UBTö) |
Ujenzi Charitable Trust |
Thomas Burke |
| K191932 |
10/02/2019 |
MomentumÖ Posterior Spinal Fixation System |
Ulrich Medical USA |
Hans Stover |
| K192185 |
10/09/2019 |
The Cellfina System |
Ulthera, Inc |
Lisa Pray |
| K190060 |
10/04/2019 |
Urethrotech UCD |
Urethrotech |
Daniela Andrich |
| K192518 |
10/25/2019 |
Reusable Monopolar Active Cord |
US Endoscopy |
Gregory Land |
| K191208 |
10/11/2019 |
Spectra Cashmere |
Uzinmedicare Co. |
Nathan Ahn |
| K191010 |
10/10/2019 |
Palladium High Flow Therapy System |
Vapotherm, Inc. |
Richelle Helman |
| K192424 |
10/03/2019 |
Mobius3D |
Varian Medical Systems, Inc |
Peter J. Coronado |
| K191073 |
10/22/2019 |
Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter |
Vein360, LLC |
Suzanne Meyer |
| K191493 |
10/16/2019 |
Ventripoint Medical System Plus (VMS+) 3.0 |
Ventripoint Diagnostics, Ltd. |
Desmond Hirson |
| K192465 |
10/10/2019 |
DigiFix Sterile Kit |
Virak Orthopedics, LLC |
Virak Tan |
| K191397 |
10/02/2019 |
OxySoft (olifilcon C) silicone hydrogel soft contact lens |
Visco Vision Inc. |
Evan Huang |
| K190538 |
10/07/2019 |
NIO-I |
WaisMed Ltd |
Maya Shuvi |
| K191332 |
10/03/2019 |
XACT Robotic System |
XACT Robotics Ltd. |
Chen Levin |
| K191925 |
10/29/2019 |
MATRx Plus |
Zephyr Sleep Technologies |
Sabina Bruehlmann |
| K190556 |
10/24/2019 |
Zimmer Biomet Universal Navigation System |
Zimmer Biomet Spine, Inc. |
Kelly Stratton |
| K192133 |
10/29/2019 |
Zimmer Biomet Universal Navigation System |
Zimmer Biomet Spine, Inc. |
Alex Pawlowski |
| K192416 |
10/01/2019 |
BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System |
Zimmer GmbH |
Roberto Tommasini |
| K192312 |
10/11/2019 |
Zimmer Natural Nail System Cephalomedullary Nails |
Zimmer GmbH |
Annemie Rehor Kausch |
| K191814 |
10/23/2019 |
Alliance Glenoid |
Zimmer Inc. |
Patricia Sandborn Beres |
| K192194 |
10/15/2019 |
TotalShield II Surgical Helmet System |
Zimmer Surgical, Inc |
Abigail Miller |
