| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K181041 |
08/08/2018 |
7D Surgical System Cranial Application |
7D Surgical Inc. |
Daniel Ziskind |
| K180040 |
08/24/2018 |
NC TREKÖ RX Coronary Dilatation Catheter; NC TREKÖ OTW Coronary Dilatation Catheter; TREKÖ RX Coronary Dilatation Catheter; TREKÖ OTW Coronary Dilatation Catheter; MINI TREKÖ RX Coronary Dilatation Catheter; MINI TREKÖ OTW Coronary Dilatation Catheter; MI |
Abbott Vascular |
Emily Zhao |
| K181471 |
08/29/2018 |
ACCUFUSE Cervical System |
Absolute Advantage Medical, LLC |
J.D. Webb |
| K181544 |
08/09/2018 |
Anchor Bolt (as an accessory to Depth Electrodes) |
Ad-Tech Medical Instrument Corporation |
Lisa Theama |
| K181197 |
08/03/2018 |
PHMB Foam Wound Dressing |
Advanced Medical Solutions Ltd. |
Rose Guang |
| K180634 |
08/07/2018 |
Surgical Silver Post Operative Dressing |
Advanced Medical Solutions Ltd. |
Rose Guang |
| K181035 |
08/24/2018 |
AOS Small Fragment Plating System Lite |
Advanced Orthopaedic Solutions, Inc. (AOS) |
Alex Bhaskarla |
| K172508 |
08/08/2018 |
Ageless Health Medical Digital Thermometer |
Ageless Health Industrial Co., Ltd |
Victor Wan |
| K180647 |
08/01/2018 |
BriefCase |
Aidoc Medical, Ltd. |
Nimrod Epstein |
| K181482 |
08/31/2018 |
myTAP2 |
Airway Management, Inc. |
Eric Jarrett |
| K181796 |
08/03/2018 |
FreshLook Handling Tint, FreshLook Colors, FreshLook ColorBlends, FreshLook Dimensions |
Alcon Laboratories, Inc. |
Sherri Lakota |
| K181853 |
08/08/2018 |
Alere BinaxNOW Influenza A & B Card 2, Alere Reader |
Alere Scarborough, Inc. |
Angela Drysdale |
| K182054 |
08/29/2018 |
Natrelle 133S Tissue Expander |
Allergan |
Melissa Pathmajeyan |
| K181435 |
08/21/2018 |
ATEC Cervical Spacer System |
Alphatec Spine, Inc. |
Cynthia Adams |
| K181677 |
08/09/2018 |
Kodiak Spinal Fixation System |
Alphatec Spine, Inc. |
Cynthia Adams |
| K180006 |
08/31/2018 |
AmCAD-UT Detection 2.2 |
AmCad BioMed Corporation |
Jack Yang |
| K180185 |
08/31/2018 |
BIO-C REPAIR |
Angelus Industria de Produtos Odontologicos S/A |
Paulo Sergio Calixto de Oliveria |
| K173658 |
08/21/2018 |
Confidence Blood Glucose Monitoring System |
Applied Biomedical LLC |
Zakir Murtaza |
| K182024 |
08/30/2018 |
Dissecting Balloon System |
Applied Medical Resources Corp. |
Corinne Yestrepsky |
| K180539 |
08/13/2018 |
Deformity Analysis and Correction Software (DACS) and Instrumentation |
Arrowhead Medical Device Technologies, LLC |
Thomas J. Twardzik |
| K181513 |
08/30/2018 |
Arthrex PushLock Tenodesis Anchor |
Arthrex Inc. |
Ivette Galmez |
| K173845 |
08/06/2018 |
Arthrex SwiveLock |
Arthrex Inc. |
David L Rogers |
| K181768 |
08/20/2018 |
AssureTech Panel Dip Tests, AssureTech Quick Cup Tests |
Assure Tech (Hangzhou) Co., Ltd. |
Shisheng Ling |
| K180155 |
08/03/2018 |
Arm Type Blood Pressure Monitor |
Avita Corporation |
Steven Jhou |
| K173380 |
08/30/2018 |
b-ONE« Total Hip System |
b-One Ortho Corp. |
Clark Hutton |
| K173531 |
08/02/2018 |
Lockbox for Perfusor Space PCA Infusion Pump |
B. Braun Medical Inc. |
Tracy Maddock |
| K173257 |
08/17/2018 |
BTI Dental Implant System UnicCa |
B.T.I. Biotechnology Institute, S.L. |
Fernanda O Ros |
| K181627 |
08/10/2018 |
Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner |
Bausch & Lomb Incorporated |
Melissa Thomas |
| K181306 |
08/17/2018 |
Actifuse Flow |
Baxter Healthcare Corporation |
Daniel Davis |
| K181225 |
08/31/2018 |
ALTAPORE |
Baxter Healthcare Corporation |
Caitlin Ziebell |
| K173773 |
08/17/2018 |
MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T |
Bayer Medical Care Inc. |
Lisa A Ewing |
| K170824 |
08/20/2018 |
BD Vacutainer Eclipse Signal Blood Collection Needle |
Becton, Dickinson and Company |
Eileen Hiller |
| K180417 |
08/09/2018 |
Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single Use; Sterile Hypodermic Needles for Single Use; Sterile Safety Hypodermic Needles for Single Use |
BERPU MEDICAL TECHNOLOGY CO., LTD |
Jundong Tan |
| K172280 |
08/03/2018 |
BH Sterilization Pouch |
BH Medical Products Co., Ltd. |
Edward Tao |
| K180248 |
08/07/2018 |
VascuEase IC-1200-WH |
Bio Compression Systems, Inc. |
Barbara Whitman |
| K181333 |
08/23/2018 |
ADVIA Centaur Herpes-1 IgG |
Biokit, S.A. |
Joan Guixer |
| K181334 |
08/23/2018 |
ADVIA Centaur Herpes-2 IgG |
Biokit, S.A. |
Joan Guixe |
| K173623 |
08/30/2018 |
Anchor plate |
BioMaterials Korea, Inc |
Jiyea Kim |
| K173638 |
08/17/2018 |
Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System Max Plus, GE Blood Glucose Monitoring System Max, GE Blood Glucose Monitoring System Max Plus |
Bionime Corporation |
Kay Wu |
| K173978 |
08/24/2018 |
CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER Module |
Biosense Webster, Inc. |
Phuong Chau |
| K173248 |
08/11/2018 |
CARDIOSKIN |
Bioserenity SAS |
Quang Tran |
| K180805 |
08/08/2018 |
Pure EP |
BioSig Technologies |
Tiffini Wittwer |
| K180943 |
08/17/2018 |
BioWaveGO |
Biowave Corporation |
Bradford Siff |
| K180737 |
08/01/2018 |
Ultrasound Scanner System bk2300 |
BK Medical ApS |
Susana Mogensen |
| K180542 |
08/22/2018 |
NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe |
Boston Endo Surgical Tech, |
James Rogers |
| K181439 |
08/23/2018 |
SpyGlass DS and DS II Direct Visualization System |
Boston Scientific Corporation |
Carter Navarro |
| DEN170078 |
08/17/2018 |
Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System |
Brainways Ltd. |
Ahava Stein |
| K181323 |
08/03/2018 |
Atlas Gold PTA Dilatation Catheter |
C. R. Bard, Inc. |
Aaron Conovaloff |
| K181804 |
08/02/2018 |
Alphenix, INFX-8000C/B, V8.0 |
Canon Medical Systems Corporation |
Paul Biggins |
| K181593 |
08/13/2018 |
Vantage Galan 3T, MRT-3020/A7, V5.0 |
Canon Medical Systems Corporation |
Paul Biggins |
| K180734 |
08/08/2018 |
SmartLinx Vitals Plus Patient Monitoring System |
Capsule Technologie |
Maylin Truesdell |
| K180990 |
08/13/2018 |
TirboLOX-L Lumbar IBFD |
Captiva Spine, Inc. |
Jackie Ferro |
| K181217 |
08/05/2018 |
VesoFlow Lite DVT Compression Device |
Caremed Supply, Inc. |
Tsung-Hsuan Liu |
| K173407 |
08/09/2018 |
VT - 100, VT - 200 |
Carilex Medical, Inc. |
Henry Kao |
| K173771 |
08/24/2018 |
IOLMaster 700 |
Carl Zeiss Meditec AG |
Christian Muenster |
| K181289 |
08/15/2018 |
Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48S System and GeneXpert Infinity-80 System |
Cepheid |
Yi-Ping Lin |
| K181772 |
08/01/2018 |
NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0) |
Ceterix Orthopaedics, Inc. |
Tarhan Kayihan |
| K181185 |
08/29/2018 |
Change Healthcare Enterprise Viewer |
Change Healthcare Canada Company |
Nadia Marchant |
| K180974 |
08/17/2018 |
CBit Series Digital Color Doppler Ultrasound System |
CHISON Medical Technologies Co., Ltd. |
Qifei Liu |
| K171245 |
08/09/2018 |
Presygen/si-1 |
Christie Medical Holdings, Inc. |
Salwa Rezk |
| K180764 |
08/01/2018 |
TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) |
Church & Dwight Co., Inc |
Joelle Reinson |
| K181007 |
08/02/2018 |
Cianna Medical SAVI Scout Reflector and SAVI Scout System |
Cianna Medical, Inc. |
Gary Mocnik |
| K180150 |
08/02/2018 |
PL8 Wrist Reconstruction Plate |
CITIEFFE S.r.l. |
Stefano Pullega |
| K182067 |
08/14/2018 |
PleuraFlow System with FlowGlide Extra Drainage Length |
ClearFlow, Inc. |
Dov Gal |
| K173848 |
08/07/2018 |
Model WP-3840 and WP-3040 |
CNMC Co., Inc. |
Thomas Kraus |
| K181500 |
08/15/2018 |
BRILLIANT Crios |
Coltene/Whaledent AG |
Daniel Meier |
| K181206 |
08/16/2018 |
GentleCath Glide Intermittent Urinary Catheter |
ConvaTec Limited |
Elinor Jones |
| K173657 |
08/23/2018 |
Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter |
Cook Incorporated |
Samuel Engelman |
| K181713 |
08/17/2018 |
Ultraxx Nephrostomy Balloon Catheter Set |
Cook Incorporated |
Minjin Choi |
| K181592 |
08/15/2018 |
RAIN Sheath Transradial |
Cordis Corporation |
Ankita Phophalia |
| K181836 |
08/08/2018 |
4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo Angiography Catheters |
Cordis, a Cardinal Health Company |
Vidya Venkataeaghavan |
| K180814 |
08/10/2018 |
CoreLink« M3Ö Stand-Alone Anterior Lumbar System |
CoreLink, LLC |
Steve Mounts |
| K181799 |
08/29/2018 |
ResCUBEÖ Ligament Fixation System |
Cousin Biotech S.A.S. |
Mathilde Collet |
| K180496 |
08/29/2018 |
TruClear Elite Hysteroscope |
Covidien |
Gail Yaeker-Daunis |
| K181020 |
08/16/2018 |
Cytosponge Cell Collection Device |
Covidien llc |
Rachel Silva |
| K181219 |
08/03/2018 |
OptiPillows EPAP Mask |
Cpapnea Medical Supply |
Sal T. Hakim |
| K181866 |
08/09/2018 |
MotoCLIP/HiMAX Step Staple Implant System |
CrossRoads Extremity Systems, LLC |
Chad Hollis |
| K181562 |
08/02/2018 |
Curiteva Anterior Cervical Plate System |
Curiteva, LLC |
Eric Linder |
| K181549 |
08/03/2018 |
Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate System) |
Curiteva, LLC |
Eric Linder |
| K181962 |
08/07/2018 |
CubeVue |
CurveBeam, LLC |
Stuti Singh |
| K181582 |
08/27/2018 |
DemeTECH DemeDIOX absorbable surgical suture |
Demetech Corporation |
Linda Hernandez |
| K181464 |
08/31/2018 |
LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set |
DiaSorin Inc. |
John C. Walter |
| K173498 |
08/13/2018 |
Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack |
DiaSorin Molecular LLC |
Sharon Young |
| K181891 |
08/10/2018 |
Portable X-ray System (Model: MiniX-V, Mini X-S) |
Digimed Co., LTD. |
Youngbae Kwon |
| K181318 |
08/13/2018 |
ONIS-PACS |
DigitalCore Co., Ltd |
Lemoigne Cedric |
| K181234 |
08/07/2018 |
Self-adhesive Electrode |
Dong Guan Ou Kang Electronics CO., LTD |
Nianjun Liu |
| K172830 |
08/24/2018 |
Double Medical Femoral Nail System |
Double Medical Technology Inc. |
Yan Zuo |
| K181432 |
08/02/2018 |
ProVectra 3D Prime with VistaSoft |
Durr Dental SE |
Oliver Lange |
| K173042 |
08/30/2018 |
Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3 |
Edan Instruments, Inc |
Alice Yang |
| K181609 |
08/24/2018 |
RadiForce GX560, GX560-AR |
EIZO Corporation |
Hiroaki Hashimoto |
| K181486 |
08/30/2018 |
DEKA Motus AY |
Elen Electronic Engineering Spa |
Paolo Peruzzi |
| K180853 |
08/06/2018 |
EP GranulesÖ BVF |
Elute, Inc. |
Kirk Andriano |
| K181346 |
08/06/2018 |
CystoSure Plus Catheter |
Emmy Medical, LLC. |
Ronald Adams |
| K181997 |
08/30/2018 |
Swiss LithoClast Trilogy |
EMS Electro Medical Systems SA |
Sonia Callegaro |
| K182057 |
08/24/2018 |
EasyMax BT Self-Monitoring Blood Glucose System |
EPS Bio Technology Corp. |
Cynthia Hung |
| K182107 |
08/31/2018 |
CarriGen PF |
ETEX Corporation |
Stacy Hutchens |
| K181151 |
08/10/2018 |
GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System |
Ethicon Inc |
Debbie Fazen |
| K173923 |
08/02/2018 |
Temporary Cardiac Pacing Wire |
Ethicon, Inc. |
Joice Pappan |
| K181849 |
08/10/2018 |
iStim S2 OTC Pain Relief TENS |
Everyway Medical Instruments CO., LDT. |
Paul Hung |
| K173193 |
08/08/2018 |
F&P SleepStyle |
Fisher & Paykel Healthcare Ltd |
Jayanti Karandikar |
| K173505 |
08/09/2018 |
FORA GTel Blood Glucose Monitoring System |
ForaCare Inc. |
Anne Kuo |
| K173608 |
08/17/2018 |
Forest Dental Unit |
Forest Dental Products, Inc. |
Erin-Kate Barton |
| K180341 |
08/03/2018 |
FUJIFILM 600 Series Endoscope EG-600WR v2 |
FUJIFILM Corporation |
Randy Vader |
| K180610 |
08/29/2018 |
Geister retractor for neuro - and spine surgery |
Geister Medizintechnik GmbH |
Christian Grotzinger |
| K181295 |
08/29/2018 |
Genesys Spine AIS-C Cervical Stand-Alone System |
Genesys Spine |
Benjamin V. Keller |
| K181791 |
08/21/2018 |
SIMPLYSTRONG, SIMPLYEZEE |
Genicon, Inc |
Katlyn Kachman |
| K181943 |
08/17/2018 |
OSCAR (OSCAR Prime, OSCAR Classic) |
Genoray Co., Ltd. |
Jeff Hwang |
| K173703 |
08/15/2018 |
Sonata Sonography-Guided Transcervical Fibroid Ablation System |
Gynesonics, Inc. |
Diane King |
| K173819 |
08/09/2018 |
MyPlant II Implant System |
Hager & Meisinger GmbH |
Adam Tomczak |
| K180644 |
08/10/2018 |
Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green |
Hartalega Sdn Bhd |
Mr. Kuan Kam Hon |
| K173509 |
08/17/2018 |
Biodegradable Nitrile Powder Free Examination Glove (Blue) |
Hartalega Sdn. Bhd. |
Kuan Kam Hon |
| K181130 |
08/10/2018 |
Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs |
Hebei Titans Hongsen Medical Technology Co., LTD. |
Shaozhang Nan |
| K173648 |
08/30/2018 |
Spectralis HRA + OCT and variants |
Heidelberg Engineering GmbH |
Christoph Schoess |
| K171977 |
08/02/2018 |
miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer |
Hinacom Software and Technology, Ltd |
Yi Isabelle Sun |
| K172492 |
08/17/2018 |
Optical Topography System ETG-4100 |
Hitachi Healthcare Americas |
Doug Thistlethwaite |
| K181676 |
08/15/2018 |
Mini Ridge Filter and auxiliary functions for PROBEAT-V |
Hitachi Ltd. Healthcare Hitachi Works |
Tomoyuki Seino |
| K181974 |
08/23/2018 |
MyoSure XL Tissue Removal Device for Fluent |
Hologic, Inc |
Rachelle D. Fitzgerald |
| K180825 |
08/03/2018 |
Fluent Fluid Management System |
Hologic, Inc. |
Christine Cameron |
| K180866 |
08/31/2018 |
CareSens S Fit Blood Glucose Monitoring System |
i-SENS, Inc. |
Joon Ho Jung |
| K181680 |
08/09/2018 |
ICONN Answer II Suture Anchor |
ICONN Orthopedics, LLC |
Whitt Israel |
| K170110 |
08/10/2018 |
Diana Medication Transfer Set |
ICU MEDICAL INC |
Jason Ma |
| K173477 |
08/31/2018 |
ChemoCLAVE Cytotoxic Medication Preparation and Delivery System |
ICU Medical, Inc. |
Catherine E. Kang |
| K180522 |
08/16/2018 |
IGTFusion |
IGI Technologies |
Will Plishker |
| K181228 |
08/31/2018 |
IlluminOss Bone Stabilization System |
IlluminOss Medical, Inc. |
Robert Rabiner |
| K173541 |
08/24/2018 |
EPINAUT |
Imedicom Co., Ltd. |
Priscilla Chung |
| K173663 |
08/17/2018 |
Electronic Stethoscope DS3011A |
IMEDIPLUS INC. |
Shirley Lai |
| K180169 |
08/08/2018 |
EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay Access Catheter, 0.071 ID, 137cm Length, EagleRay Access Catheter, 0.055 ID, 137cm Length, EagleRay Access Catheter, 0.045 ID, 144cm Length, EagleRay Access Catheter, 0.035 ID, |
Imperative Care Inc. |
Jake Wolenberg |
| K181359 |
08/15/2018 |
InterActive SMARTBase Abutments |
Implant Direct Sybron Manufacturing LLC |
Reina Choi |
| K181473 |
08/27/2018 |
DENV Detect NS1 ELISA |
InBios International, Inc. |
Estela Raychaudhuri |
| K180619 |
08/16/2018 |
Bongo |
InnoMed Healthscience, Inc. |
Javier Collazo |
| K181584 |
08/10/2018 |
Redi-Spine |
Innovative Surgical Designs, Inc. |
Jon Rinehart |
| K173516 |
08/17/2018 |
NuBorne Infant Warmer |
International Biomedical |
Amy Pieper |
| K181982 |
08/21/2018 |
MIDAScope and Introducer Kit, and MIDASystem |
IntraVu, Inc. |
Plamena Entcheva-Dimitrov |
| K180351 |
08/07/2018 |
EndoWrist Mercury Bipolar Grasper |
Intuitive Surgical, Inc. |
Vishal Kanani |
| K181502 |
08/29/2018 |
Zio AT ECG Monitoring System, ZEUS System |
iRhythm Technologies, Inc. |
Rich Laguna |
| K180775 |
08/17/2018 |
Watch-PAT300 |
Itamar Medical, Ltd. |
Koby Sheffy |
| K180574 |
08/17/2018 |
Halo Closed Vial Adaptor (Multiple Models based on 13, 20 or 28mm Vial Neck Size), Halo Closed Syringe Adaptor, Halo Closed Line Adaptor, Closed Vial Adaptor |
J & J Solutions, Inc. d/b/a/ Corvida Medical |
Dana Schramm |
| K180536 |
08/30/2018 |
Neodent Implant System û GM Line |
JJGC Industria e Comercio de Materiais Dentarios S.A. |
Julianne de Oliveira Capucho Lechechem |
| K173024 |
08/22/2018 |
Non-invasive blood pressure measurement systems |
Joytech Healthcare Co.,Ltd |
Ren Yunhua |
| K180777 |
08/03/2018 |
K2M Expandable Interbody System |
K2M, Inc. |
Nancy Giezen |
| K180131 |
08/14/2018 |
Vicks RapidRead Digital Thermometer |
Kaz USA, Inc., A Helen of Troy Company |
Matt J. Baun |
| K181749 |
08/01/2018 |
SuperCable« Iso-ElasticÖ Cerclage System |
Kinamed, Incorporated |
Heather Neely |
| K180962 |
08/13/2018 |
KLS Martin Individual Patient Solutions |
KLS-Martin L.P. |
Jennifer Damato |
| K181146 |
08/03/2018 |
ASK System |
L and K Biomed Corporation Limited |
Semi Jang |
| K181430 |
08/09/2018 |
LENSAR Laser System - fs 3D (LLS-fs 3D) |
LENSAR, Inc. |
Keith Peck |
| K181094 |
08/02/2018 |
Polydioxanone Surgical Scaffold |
lntegra LifeSciences |
Kendall L. Ciriaco |
| K180907 |
08/03/2018 |
HORIZON TMS Therapy System |
Magstim Company Ltd. |
Tom Campbell |
| K173890 |
08/23/2018 |
GMK Sphere - Kinematic Alignment |
Medacta International SA |
Stefano Baj |
| K181635 |
08/23/2018 |
GMK Sphere CR Tibial Inserts |
Medacta International SA |
Stefano Baj |
| K181009 |
08/24/2018 |
APTUS CMC-I Fusion Plate System |
Medartis AG |
Andrea Schweizer |
| K181425 |
08/05/2018 |
APTUS« Proximal Humerus System |
Medartis AG |
Andrea Schweizer |
| K171890 |
08/20/2018 |
BEXCORE Breast Biopsy System, Biopsy Needle |
Medical Park CO., LTD |
Hye-Yeon Park |
| K181543 |
08/31/2018 |
CureÖ OPEL-C Plate System |
Meditech Spine, LLC |
Bruce Dunaway |
| K181182 |
08/02/2018 |
DYNACORD Suture |
Medos International SARL |
Tatyana Korsunsky |
| K181809 |
08/03/2018 |
GRYPHON« Anchors with DYNACORDÖ Suture |
Medos International SARL |
Tatyana Korsunsky |
| K181257 |
08/02/2018 |
PlasmaBlade X 3.0S, PlasmaBlade X 4.0 |
Medtronic Advanced Energy |
Heather Valley |
| K181060 |
08/24/2018 |
Solitaire 2 and Solitaire Platinum Revascularization Device |
Medtronic Neurovascular |
Amnon Talmor |
| K181954 |
08/22/2018 |
autoLog IQ Autotransfusion System |
MEDTRONIC PERFUSION SYSTEMS |
Sue Fidler |
| K182119 |
08/29/2018 |
CD HORIZONÖ Spinal System |
Medtronic Sofamor Danek USA, Inc. |
Ankit K. Shah |
| K181973 |
08/21/2018 |
Medtronic Model 5392 External Pulse Generator (EPG) |
Medtronic, Inc. |
Brenna Loufek |
| K181978 |
08/13/2018 |
ZeniusÖ, IliadÖ and KoraÖ Spinal Fixation Systems |
Medyssey USA, Inc. |
Shawn Kim |
| K180802 |
08/29/2018 |
Meta P&Bond |
META BIOMED, CO., LTD. |
Suk Song Oh |
| K170050 |
08/23/2018 |
Z-CAD smile |
Metoxit AG |
Dipl.-Ing Stefan Leyen |
| K163578 |
08/03/2018 |
EasyTouch Safety Pen Needle |
MHC Medical Products, LLC. |
John Edmiston |
| K181683 |
08/28/2018 |
BD MAX CT/GC/TV 20-Day QC Panel |
Microbiologics, Inc. |
Tina Sobania |
| K181711 |
08/15/2018 |
BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel |
Microbiologics, Inc. |
Tina Sobania |
| K181666 |
08/01/2018 |
Smart One |
MIR Medical International Research |
Gerda Van Houts |
| DEN170052 |
08/10/2018 |
Natural Cycles |
Natural Cycles Nordic AB |
Raoul Scherwitzl |
| K181483 |
08/27/2018 |
Tranquil Interbody System |
Nexus Spine, LLC |
Jared Crocker |
| K180428 |
08/15/2018 |
Stat Profile Prime Plus Analyzer System |
Nova Biomedical Corporation |
Adam Heroux |
| K180186 |
08/23/2018 |
Stat Profile Prime Plus Analyzer System |
Nova Biomedical Corporation |
Adam Heroux |
| K181386 |
08/24/2018 |
NuVasive Brigade Lateral System |
NuVasive, Incorporated |
Jessica Silverman |
| K173205 |
08/29/2018 |
Equinox Advantage |
O-Two Medical Technologies Inc. |
David Zhang |
| K171435 |
08/03/2018 |
VirtuOst Vertebral Fracture Assessment |
O.N. Diagnostics, LLC. |
David Kopperdahl |
| K173197 |
08/21/2018 |
Reusable NIBP Cuff |
Orantech Inc. |
Yunxi Xiong |
| K180179 |
08/24/2018 |
Firebird« Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird« NXG Spinal Fixation System; Phoenix« Minimally Invasive Spinal Fixation System; Phoenix« CDXÖ Minimally Invasive Spinal Fixation System; JANUS« Midline Fixation Screw |
Orthofix Inc. |
Jacki Koch |
| K181347 |
08/15/2018 |
Aries« Lumbar Interbodies |
Osseus Fusion Systems, LLC |
Robert Pace |
| K173575 |
08/17/2018 |
OsteoReady Dental Implant System |
OsteoReady LLC |
Robert Gottlander |
| K172906 |
08/29/2018 |
REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement |
OsteoRemedies, LLC |
Eric Stookey |
| K181977 |
08/14/2018 |
WiScope Digital Endoscope System |
OTU Medical Inc. |
Doris Dong |
| K180173 |
08/23/2018 |
Freespira |
Palo Alto Health Sciences, Inc. |
Simon Thomas |
| K180957 |
08/21/2018 |
exGraft, exGraft Carbon ePTFE Vascular Grafts |
PECA Labs |
Doug Bernstein |
| K182004 |
08/21/2018 |
PENTAX Medical Endoscopic Ultrasound System |
PENTAX of America, Inc. |
William Goeller |
| K173761 |
08/17/2018 |
Penumbra System Reperfusion Catheter JET 7 |
Penumbra, Inc. |
Michaela Mahl |
| K181479 |
08/03/2018 |
Ingenia Ambition S and Ingenia Ambition X |
Philips Medical Systems Nederland B.V. |
Jan Van de Kerkhof |
| K181830 |
08/02/2018 |
Azurion R2.0 |
Philips Medical Systems Nederland BV |
Owen Callaghan |
| K181966 |
08/17/2018 |
SmartPerfusion |
Philips Medical Systems Nederlands B.V. |
Chandrika Srinivasan |
| K181797 |
08/03/2018 |
Philips CT Big Bore Sliding Gantry Configuration |
Phillips Medical Systems (Cleveland) Inc. |
Michael Chilbert |
| K180234 |
08/10/2018 |
physiQ Heart Rhythm Module |
physiQ Inc. |
George Allen Hides |
| K181253 |
08/10/2018 |
Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser Cup |
PJM Worldwide, LLC d/b/a Phoenix Medical Technology, LLC |
Ira Nusbaum |
| K181983 |
08/17/2018 |
PreXion 3D Excelsior |
PreXion Corporation |
Katsumi Hayashi |
| K171549 |
08/31/2018 |
Intelligent Mesh Nebulizer |
Qingdao Future Medical Technology Co., Ltd. |
Wang WeiLai |
| K181313 |
08/27/2018 |
BenQ Diagnostic Ultrasound System |
Qisda Corporation |
Johnson Sheu |
| K171547 |
08/02/2018 |
Qualisys Clinical System |
Qualisys AB |
Henrik Wiberg |
| K173496 |
08/30/2018 |
Sofia 2 Lyme FIA, Sofia Lyme Control Set |
Quidel Corporation |
Jennifer S. Rial |
| K180770 |
08/01/2018 |
Propeller Sensor for Neohaler |
Reciprocal Labs Corporation |
David Hubanks |
| K181968 |
08/20/2018 |
SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card |
Safecare Biotech(Hangzhou)Co.,Ltd. |
Alex Qiu |
| K181828 |
08/07/2018 |
Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard Profile |
Scientia Vascular LLC |
David Sabodski |
| K181414 |
08/14/2018 |
uCT 530, uCT 550 |
Shanghai United Imaging Healthcare Co., Ltd. |
Shumei Wang |
| K181104 |
08/29/2018 |
Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style |
Shenzhen Combei Technology CO., LTD |
Kevin Fong |
| K173454 |
08/16/2018 |
Multi-parameter Patient Monitor, models C30 |
Shenzhen Comen Medical Instruments Co.,Ltd. |
Hongbo Yan |
| K173368 |
08/31/2018 |
Reusable & Disposable SpO2 Sensors |
Shenzhen Coreray Technology, Ltd. |
Simon Fan |
| K173123 |
08/13/2018 |
Pulse Oximeter |
Shenzhen IMDK Medical Technology Co., Ltd. |
Xia Yuan |
| K173869 |
08/02/2018 |
Med-link Reusable Blood Pressure Cuff |
Shenzhen Med-link Electronics Tech Co., Ltd |
Baihan Feng |
| K180073 |
08/29/2018 |
Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set |
Shenzhen Vitavitro Bio-tech Co., Ltd |
Jenny Lin |
| K181407 |
08/15/2018 |
Artis zee/zeego & Artis Q/Q.zen |
Siemens Medical Solution USA, Inc. |
Patricia D. Jones |
| K181767 |
08/17/2018 |
Cios Select |
Siemens Medical Solutions USA, Inc. |
Patricia D. Jones |
| K181074 |
08/17/2018 |
Simple Science Antimicrobial Facial and Eyelid Cleanser |
Simple Science LLC |
Eoin Croke |
| K180221 |
08/08/2018 |
Powder Free White, Green Sterilized Polychloroprene Copolymer Surgical Gloves - Tested for Use with Chemotherapy Drugs |
Smart Glove Corporation Sdn.Bhd |
Foo Khon Pu |
| K173461 |
08/03/2018 |
ECG recorder and Arrhythmia Detector |
Smart Solutions Technologies SL |
Daniel Llorca |
| K180698 |
08/21/2018 |
PICO 7 Single Use Negative Pressure Wound Therapy System |
Smith & Nephew Medical Limited |
Lavinia Tompkins |
| K181533 |
08/09/2018 |
EVOS Wrist Fracture Plating System |
Smith & Nephew, Inc. |
Bryan Cowell |
| K173784 |
08/23/2018 |
Smylic Invisible Clear Aligners |
Smylio, Inc |
Ken Menon |
| K173844 |
08/09/2018 |
Titan Ag 200 |
Specialty Fibres and Materials Ltd |
Lindie Marx |
| K181923 |
08/17/2018 |
Quantum Workstation 12.1 |
Spectrum Medical Ltd |
Colleen Powell |
| K181792 |
08/14/2018 |
DuoÖ Lumbar Interbody Fusion Device |
Spineology Inc. |
Karen Roche |
| K181480 |
08/01/2018 |
MMD Tip |
Strata Skin Sciences, Inc. |
Shmuel Gov |
| K180834 |
08/10/2018 |
Altrix Precision Temperature Management System |
Stryker Medical |
Brian Orwat |
| K181308 |
08/15/2018 |
SuperGrow 272, Ultimate 272 |
Super Grow Lasers |
Jeffrey Stanifer |
| K180077 |
08/16/2018 |
NeuroQ 3.8 |
Syntermed |
Kenneth Van Train |
| K181400 |
08/21/2018 |
H. PYLORI CHEKÖ |
TECHLAB, Inc. |
Donna T. Link |
| K181379 |
08/21/2018 |
H. PYLORI QUIK CHEK |
TECHLAB, Inc. |
Donna T. Link |
| K173280 |
08/02/2018 |
Neonatal ConchaSmart Breathing Circuits |
Teleflex Medical, Inc |
Brian Gall |
| K181367 |
08/28/2018 |
Tenex Health TX System with the TXP MicroTip |
Tenex Health, Inc. |
David Vancelette |
| K181237 |
08/03/2018 |
Glidesheath Slender Tibial Pedal Kit |
Terumo Medical Corporation |
Liang Lu |
| K173732 |
08/23/2018 |
Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit |
The Binding Site Group Ltd |
Christopher Bradshaw |
| K181946 |
08/08/2018 |
Sensititre 18-24 hour MIC Breakpoint Susceptibility System with Plazomicin in the dilution range of 0.06-128 ug/mL |
Thermo Fisher Scientific |
Cynthia Knapp |
| K180850 |
08/20/2018 |
re.t.a Reuseable Tampon Applicator |
Thinx, Inc. |
Kerrie Timmons |
| K173620 |
08/14/2018 |
Mag Vita TMS Therapy System w/Theta Burst Stimulation |
Tonica Elektronik A/S |
Sanne Barsballe Jessen |
| K173918 |
08/17/2018 |
VersaPAP Positive Airway Pressure (PAP) Device |
Trudell Medical International |
Marianne Tanton |
| K180759 |
08/09/2018 |
SECULOKÖ Suture Anchor |
U & I Corporation |
Bo-Ram Kang |
| K180075 |
08/06/2018 |
MINUET LCD, MINUET LCD eco |
Unimom Co. |
Hong Sang-Hyun |
| K180598 |
08/08/2018 |
UNIQA Dental Implants System |
UNIQA DENTAL LTD |
Dima Goberman |
| K181408 |
08/27/2018 |
JO Classic Hybrid Personal Lubricant |
United Consortium |
Stephanie Morris |
| K180888 |
08/30/2018 |
LYFT |
Uplevity, Inc. |
Thomas Kraft |
| K181909 |
08/16/2018 |
Luminelle DTx Hysteroscopy System |
UVision360 Inc. |
Allison London Brown |
| K173549 |
08/13/2018 |
BIAFINE |
Valeant Pharmaceuticals |
Melissa Thomas |
| K173952 |
08/28/2018 |
Universal SmartECG |
VectraCor, Inc. |
Andrew Schreck |
| K181262 |
08/30/2018 |
SpineJack Expansion Kit |
Vexim SA |
Vincent Gardes |
| K181218 |
08/07/2018 |
AlignRT Plus |
Vision RT Ltd |
Chris Hannan |
| K180703 |
08/01/2018 |
VITA YZ ST and VITA YZ XT |
VITA Zahnfabrik H.Rauter GmbH Co. |
Bernd Walker |
| K181013 |
08/21/2018 |
Fever Scout |
VivaLnk Inc. |
Christine Kuo |
| K181312 |
08/22/2018 |
GrandioSO x-tra |
VOCO GmbH |
M. Th. Plaumann |
| K181940 |
08/17/2018 |
GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement |
W. L. Gore & Associates, Inc. |
Michael J. Titus |
| K173673 |
08/24/2018 |
AcuSnare Polypectomy Snare |
Wilson-Cook Medical, Inc |
Theresa de Prat |
| K181557 |
08/09/2018 |
INFINITY Total Ankle System |
Wright Medical Technology, Inc. |
Tara Conrad |
| K180373 |
08/24/2018 |
CancelleX Porous Titanium Lumbar Interbody Device |
Xenco Medical, LLC. |
Gustavo R. Prado |
| K171377 |
08/20/2018 |
Young INFINITY Cordless Handpiece System |
Young Dental Manufacturing Co 1, LLC |
Brian Prange |
| K181740 |
08/29/2018 |
ZELTIQ CoolSculpting System |
ZELTIQ Aesthetics, Inc. |
Ewald Riechert |
| K181149 |
08/03/2018 |
Therm-X Pro, Therm-X AT, Therm-X Pro Athlete |
Zenith Technical Innovations |
Greg Binversie |
| DEN170090 |
08/23/2018 |
MATRx plus |
Zephyr Sleep Technologies |
Sabrina Bruehlmann |
| K181069 |
08/28/2018 |
Disposable Insulin Pen Needle |
Zhejiang Kindly Medical Devices Co. Ltd |
Yong Zhang |
