| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| DEN170046 |
09/05/2017 |
23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) |
23andMe, Inc. |
Lisa Charter |
| K173041 |
09/28/2017 |
3DIEMME RealGUIDE |
3DIEMME Ltd. |
Alessandro Montroni |
| K173159 |
09/29/2017 |
Cervical Spinal Truss System (CSTS) Interbody Fusion Device |
4Web, Inc. |
Jessee Hunt |
| K173065 |
09/29/2017 |
A&D Medical Blood Pressure Monitors |
A&D Company, Ltd |
Jerry Wang |
| K173122 |
09/29/2017 |
Abbott Architect Free T4 |
Abbott Laboratories |
Linda Sohn |
| K172885 |
09/21/2017 |
HydroPICC |
Access Vascular, Inc |
Elizabeth Kinnal |
| K172630 |
09/01/2017 |
Kisses Plus Implant System |
ACHIMHAI Medical Corporation |
Ji Ho Jung |
| K173063 |
09/29/2017 |
ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System |
ACIST Medical Systems, Inc. |
Amber R. Luker |
| DEN170080 |
09/29/2017 |
Adaptive Biotechnologies clonoSEQ Assay |
Adaptive Biotechnologies Corporation |
B. Melina Cimler |
| K172799 |
09/18/2017 |
Positional Sleep Assessment System (PoSAS) software |
Advanced Brain Monitoring |
Daniela Soll |
| K172931 |
09/25/2017 |
DUS-6000 Digital Ultrasonic Diagnostic Imaging System |
Advanced Instrumentations, Inc. |
Jorge Millan |
| K172966 |
09/26/2017 |
CMS-2000 Central Monitoring System |
Advanced Instumentations, Inc. |
Jorge Millan |
| DEN170075 |
09/29/2017 |
ContainOR |
Advanced Surgical Concepts Ltd. |
Edward Hyland |
| K172907 |
09/25/2017 |
ELAN 4 Air Motor System |
Aesculap, Inc. |
Jessica Stigliano |
| K172709 |
09/08/2017 |
ELAN 4 Electro Motor System Tools |
Aesculap, Inc. |
Kathy A. Racosky |
| K172850 |
09/20/2017 |
SterilContainer with PrimeLine Pro Lid |
Aesculap, Inc. |
Lisa Boyle |
| K172895 |
09/22/2017 |
AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816, BA-818 and BA-819 |
Ageless Health Industrial Co., Ltd |
Victor Wan |
| K172784 |
09/15/2017 |
DX-D Imaging Package |
Agfa HealthCare N.V. |
Wim Govaerts |
| DEN170056 |
09/25/2017 |
Parathyroid Detection (Model PTeye) System |
AiBiomed, Corp. |
Al Memmolo |
| K172770 |
09/14/2017 |
AIROS 6 Sequential Compression Device |
AIROS Medical, Inc. |
Darren Behuniak |
| K172779 |
09/14/2017 |
AIROS 8 Sequential Compression Device |
AIROS Medical, Inc. |
Darren Behuniak |
| K173128 |
09/29/2017 |
Alamo« C |
Alliance Partners, LLC |
Kristiina Gilkey |
| K172732 |
09/11/2017 |
E-CUBE 8 |
ALPINION MEDICAL SYSTEMS Co., Ltd. |
Boyeon CHO |
| K172953 |
09/26/2017 |
Acid Etchant |
American Orthodontics |
Trang Adams |
| K172908 |
09/25/2017 |
Q-Switched Nd:YAG Laser System |
AMI Inc. |
Hae Youn Lee |
| K172862 |
09/20/2017 |
Portable ECG Monitor (ECG3) |
Andon Health Co., Ltd. |
Liu Yi |
| K172701 |
09/07/2017 |
BIO-C SEALER |
Angelus Industria de Produtos Odontologicos S/A |
Paulo Sergio Calixto de Oliveira |
| K173017 |
09/27/2017 |
Kindguard Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) |
Anhui Kindguard Medical Supplies Technology Co.,Ltd |
Chen Wei |
| K173016 |
09/27/2017 |
Kindguard Powder Free Vinyl Patient Examination Gloves, Light Yellow Color |
Anhui Kindguard Medical Supplies Technology Co.,Ltd |
Chen Wei |
| K173008 |
09/27/2017 |
SCS 17-01 |
Anika Therapeutics, Inc. |
Steven Chartier |
| K172981 |
09/27/2017 |
Reusable SpO2 Sensors, Disposable SpO2 Sensors |
APK Technology Co., Ltd. |
Caifang Wang |
| K172624 |
09/01/2017 |
Voyant 5mm Fusion Device |
Applied Medical Resources Corporation |
Andrew Nguyen |
| K172759 |
09/13/2017 |
Smart External Drain (SED) System |
Aqueduct Critical Care, Inc. |
Thomas Clement |
| K172947 |
09/26/2017 |
HALF DOME Posterior Lumbar Interbody System |
Astura Medical |
Thomas Purcell |
| K172742 |
09/12/2017 |
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2) |
AtriCure, Inc. |
Melissa Smallwood |
| K173031 |
09/28/2017 |
AtriClip LAA Exclusion System with Preloaded PRO╖V Clip |
AtriCure, Inc. |
Melissa Smallwood |
| K173064 |
09/29/2017 |
ZAPnea Oral Appliance |
B. Fareid, DDS, PC |
Behzad Fareid |
| K172831 |
09/18/2017 |
Perfusor« Space Syringe Infusion Pump System |
B.Braun Medical Inc |
Tracy Maddock |
| K172922 |
09/25/2017 |
MMPC-4127F1 |
Barco N.V. |
Lieven De Wandel |
| K173089 |
09/29/2017 |
Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original Conditioning Solutions |
Bausch & Lomb Incorporated |
Melissa Thomas |
| K173084 |
09/29/2017 |
Spectrum IQ Infusion System, Dose IQ Safety Software |
Baxter Healthcare Corporation |
Dhiraj Bizzul |
| K172912 |
09/25/2017 |
MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 û 8 ╡g/mL) |
Beckman Coulter Inc. |
Shannon Popson |
| K172783 |
09/15/2017 |
Access hs Tnl |
Beckman Coulter, Inc. |
Kerrie Sue Oetter |
| K172787 |
09/15/2017 |
Access hsTnl |
Beckman Coulter, Inc. |
Jennifer Lee Bennett |
| K172670 |
09/05/2017 |
BD Single Use, Hypodermic Syringe |
Becton, Dickinson and Company |
Victoria Morrow |
| K172789 |
09/15/2017 |
Specimen Retrieval Bag |
Beijing HangTian KaDi Technology R&D Institute |
Liying Zhang |
| K172846 |
09/19/2017 |
Uterine Manipulator |
Beijing HangTian KaDi Technology R&D Institute |
Liying Zhang |
| K172804 |
09/18/2017 |
Besmed Peak Flow Meter |
Besmed Health Business Corp. |
Lawrence Wu |
| K172942 |
09/26/2017 |
Pristeen (Latex SurgeonÆs Gloves Powder Free, Polymer coated with protein content labeling claim of 50 ug/dm2 or less per glove of extractable protein |
Beta Healthcare Products Pvt.Ltd. |
Boney Moolayil |
| K173066 |
09/29/2017 |
OSSEODUO Shaver and Drill System |
Bien-Air Surgery SA |
Adil Slimani |
| K173138 |
09/29/2017 |
Biim Diagnostic Ultrasound System |
Biim Ultrasound AS |
Rune Nystad |
| DEN170049 |
09/18/2017 |
Innovo |
Bio-Medical Research Ltd. |
Anne-Marie Keenan |
| K172771 |
09/14/2017 |
Epic Pro 940 |
Biolase, Inc |
Alicia Mszyca |
| K172971 |
09/26/2017 |
BMLS16-1 |
BioMedical Life Systems, Inc. |
Gary Bussett |
| K172731 |
09/11/2017 |
VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL) |
bioMerieux, Inc. |
Esther Hernandez |
| K172944 |
09/26/2017 |
VITEK 2 AST-GN Ceftazidime/Avibactam <=0.12 û >=16 ╡g/mL |
bioMerieux, Inc. |
Cherece L. Jones |
| K173139 |
09/29/2017 |
Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring System Wiz Plus |
Bionime Corporation |
Kay Wu |
| K173180 |
09/29/2017 |
Mega Plus Spine System |
BK MEDITECH Co., Ltd. |
Byoungjun Park |
| K172843 |
09/19/2017 |
TwitchView System |
Blink Device Corporation |
Justin Hulvershorn |
| K172955 |
09/26/2017 |
LungVision Tool |
Body Vision Medical Ltd. |
Dorian Averbuch |
| K173184 |
09/29/2017 |
Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle |
Boston Scientific |
Jennifer Edouard |
| K172929 |
09/25/2017 |
Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath |
Boston Scientific Corporation |
Daniel FitzDaniel |
| K172820 |
09/18/2017 |
Microscope Navigation Software |
Brainlab AG |
Alexander Schwiersch |
| DEN170078 |
09/29/2017 |
Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System |
Brainways Ltd. |
Ahava Stein |
| DEN170081 |
09/29/2017 |
MALDI Biotyper CA System |
Bruker Daltonik GmbH |
Markus Kostrzewa |
| K172717 |
09/08/2017 |
Automatic Tissue Processing Unit |
BSL Co. |
Jun Suk Lee |
| K173143 |
09/29/2017 |
Phasix ST Mesh |
C. R. Bard Inc |
Tony John |
| K172932 |
09/26/2017 |
True Flow Valvuloplasty Perfusion Catheter |
C. R. Bard, Inc. |
Aaron Conovaloff |
| K172801 |
09/18/2017 |
ECG SENTINEL System |
Cardiomedix, Inc. |
Zipora David |
| K172725 |
09/11/2017 |
VT Dressing Kits |
Carilex Medical, Inc. |
Henry Kao |
| K173006 |
09/27/2017 |
Cefaly Dual |
CEFALY Technology |
Jean-Yves Mignolet |
| K172642 |
09/01/2017 |
Orange Non Sterile Powder Free Nitrile Examination Gloves |
Central Medicare Sdn. Bhd. |
Arivalagan Subramaniam |
| K173145 |
09/29/2017 |
CereMetrix Silver |
CereMetrix Corp |
John A Kelley |
| K172807 |
09/18/2017 |
Silicone Foley Catheter for single use |
Changzhou Rongxin Medicine Minimal Invasion Technology |
Ping Liu |
| K172816 |
09/18/2017 |
TiGer SharkÖ System |
Choice Spine, LP. |
Kim Finch |
| K173148 |
09/29/2017 |
ACIF |
coLigne, AG |
Robert Lange |
| K172937 |
09/26/2017 |
Colorado Therapeutics Xenograft Implant |
Colorado Therapeutics LLC |
William Jackson |
| K172791 |
09/15/2017 |
Lumilisse IPL Hair Remover |
Conair Corporation |
Mike Cantrell |
| K172940 |
09/26/2017 |
ANCHOR Tissue Retrieval System |
Conmed Corporation |
Rachelle D. Fitzgerald |
| K172671 |
09/05/2017 |
HelixAR Electrosurgical Generator with Argon Beam Coagulation, HelixAR Mobile Pedestal |
Conmed Corporation |
Lisa Anderson |
| K172986 |
09/27/2017 |
Zmachine Synergy |
Consolidated Research of Richmond, Inc. dba General Sleep Co |
Richard Kaplan |
| K172924 |
09/25/2017 |
GentleCath Intermittent Urinary Catheter |
ConvaTec Limited |
Hannah Sharp |
| K173105 |
09/29/2017 |
Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst Adapter |
Cook Incorporated |
Samuel Engelman |
| K173035 |
09/28/2017 |
Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter, Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set, Multipurpose Drainage Catheters and Sets |
Cook Incorporated |
Erum B. Nasir |
| K172635 |
09/01/2017 |
High-Flo Silver Polyethylene Catheter |
Cook Incorporated |
Jessica Swafford |
| K172980 |
09/27/2017 |
Micropuncture Pedal Access Set |
Cook Incorporated |
Daniel J Corbin |
| K173009 |
09/27/2017 |
NCompass Nitinol Stone Extractors |
Cook Incorporated |
Colin Jacob |
| K173155 |
09/29/2017 |
Pakter Curved Needle Set |
Cook Incorporated |
Johnathan Liu |
| K173068 |
09/29/2017 |
Performer Introducer |
COOK Incorporated |
Reuben G. Lidster |
| K173103 |
09/29/2017 |
Pivet and Soft-Pass Embryo Transfer Catheter Sets |
Cook Incorporated |
Naomi Funkhouser |
| DEN170055 |
09/25/2017 |
Retrograde Intubation Set |
Cook Incorporated |
Hui Ouyang |
| K172806 |
09/18/2017 |
Bencox Mirabo Cup System |
Corentec Co., Ltd |
J. S. Daniel |
| K172707 |
09/08/2017 |
Renamel Microfill |
Cosmedent, Inc |
Mary Nowak |
| K172757 |
09/13/2017 |
Valleylab FX8 Electrosurgical Platform |
Covidien llc |
Sharon McDermott |
| K172769 |
09/13/2017 |
CryOmega Flexx |
CryoConcepts LP |
R Sam Niedbala |
| K173141 |
09/29/2017 |
CSM Submerged3-L Implant System |
CSM Implant |
Sung Am Cho |
| K172788 |
09/15/2017 |
MONETÖ Anterior Cervical Interbody Fusion Cage System |
CTL Medical Corporation |
Tosan Onosode |
| K173185 |
09/29/2017 |
SEURATÖ Universal Pedicle Screw System |
CTL Medical Corporation |
Tosan Onosode |
| DEN170047 |
09/11/2017 |
Curetis Unyvero LRT Application |
Curetis GmbH |
Gail E. Radcliffe |
| K173101 |
09/29/2017 |
Curve Image 2.0 PACS |
Curve Dental LTD |
Raul Nemes |
| DEN170070 |
09/29/2017 |
MLL (KMT2A) Breakapart FISH Probe Kit; AML1 (RUNX1) Breakapart FISH Probe Kit, P53 (TP53) Deletion FISH Probe Kit; EVI1 (MECOM) Breakapart FISH Probe Kit, Del(20q) Deletion FISH Probe Kit; AML1/ETO (RUNX1/RUNXIT1)) Translocation, Dual Fusi, CBFB (CBFB) /M |
Cytocell Ltd |
Xavier Baker |
| K172778 |
09/14/2017 |
CheckMyHeart Plus |
DailyCare Biomedical, Inc |
Ming Da Lee |
| K172772 |
09/14/2017 |
Freemie Independence, Freemie Liberty |
DAO Health |
Dave Paul |
| K172991 |
09/27/2017 |
Advanced Dental Applicance |
DaSoft Partners |
Dante Togliatti |
| K172702 |
09/07/2017 |
Tec 820, Tec 850 |
Datex-Ohmeda, Inc. |
Trishia Mercier |
| K173018 |
09/28/2017 |
MDR17 Mobile Direct Radiographic System |
Del Medical, Inc. |
Tony Bavuso |
| K172640 |
09/01/2017 |
Dentium Implantium & SuperLine Prosthetics |
Dentium Co., Ltd. |
Sangpil Yoon |
| K172872 |
09/21/2017 |
DePuy Synthes Femoral Neck System |
DePuy Synthes |
Ana Sala Roca |
| K173072 |
09/29/2017 |
Algidex Ag Silver Alginate Wound Dressing |
DeRoyal Industries, Inc. |
Sarah Bennett |
| K172648 |
09/01/2017 |
Drive DeVilbiss iGo 2 Portable Oxygen Concentrator |
DeVilbiss Healthcare, LLC |
Betty Miller |
| K173046 |
09/28/2017 |
Cocoon Portable Handheld X-Ray System |
Dexcowin Co., Ltd. |
Ryu Seung-Bum |
| K172992 |
09/27/2017 |
Diazyme EZ Vitamin D Assay |
Diazyme Laboratories |
Abhijit Datta |
| K173048 |
09/28/2017 |
No-contact Forehead Thermometer |
Dongguan SIMZO Electronic Technology Co.Ltd. |
Mei Mei |
| K172828 |
09/18/2017 |
Double Medical Cage System |
Double Medical Technology Inc |
Yan Zuo |
| K172830 |
09/18/2017 |
Double Medical Femoral Nail System |
Double Medical Technology Inc. |
Yan Zuo |
| K172656 |
09/05/2017 |
BiliLux |
Draeger Medical Systems, Inc. |
Gale Winarsky |
| K173075 |
09/29/2017 |
ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850╡l, 3ml) |
DxNow, Inc. |
William T. Sharp |
| K173034 |
09/28/2017 |
FibroScan« Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) |
Echosens |
Karine Bonenfant |
| K173164 |
09/29/2017 |
Ecolab POU Water Filter |
Ecolab Inc. |
Jennifer Willner |
| K172780 |
09/14/2017 |
SD1 Ultrasonic Pocket Doppler |
Edan Instruments Inc |
Alice Yang |
| K173042 |
09/28/2017 |
Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3 |
Edan Instruments, Inc |
Alice Yang |
| K173003 |
09/27/2017 |
U50 Diagnostic Ultrasound System |
Edan Instruments, Inc. |
Alice Yang |
| K172721 |
09/08/2017 |
FOCAL ONE |
EDAP Technomed, Inc. |
Hugo Embert |
| K172660 |
09/05/2017 |
Duravess bovine pericardial vascular patch |
Edwards Lifesciences, LLC |
Christine Chun |
| K172888 |
09/21/2017 |
EIT Cellular Titanium« Cervical Cages, EIT Cellular Titanium« PLIF Cages, EIT Cellular Titanium« TLIF Cages, EIT Cellular Titanium« ALIF Cages |
EIT Emerging Implant Technologies GmbH |
Barbara Wirth |
| K172738 |
09/12/2017 |
RadiForce RX560, RX560-AR |
EIZO Corporation |
Hiroaki Hashimoto |
| K172703 |
09/07/2017 |
Disposable Snap Electrode |
Embla Systems |
Sanjay Mehta |
| K172935 |
09/26/2017 |
Embrace |
Empatica Srl |
Simone Tognetti |
| K173073 |
09/29/2017 |
AltiVate Anatomic to Reverse Conversion Module |
Encore Medical, L.P. |
Teffany Hutto |
| K172651 |
09/05/2017 |
FMP Extended Liners |
Encore Medical, L.P. |
Teffany Hutto |
| K172811 |
09/18/2017 |
EsophyX Z, EsophyX2 HD |
EndoGastric Solutions, Inc. |
Steve Hoffman |
| K172858 |
09/20/2017 |
PreOp |
Epilog |
Gregor Strobbe |
| K173019 |
09/28/2017 |
GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar |
Ethicon Inc. |
Melina Escobar |
| K173162 |
09/29/2017 |
GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide |
Ethicon, Inc |
Julie Tom Wing |
| K172722 |
09/11/2017 |
Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) |
EUROIMMUN US, Inc. |
Michael A. Locke |
| K172919 |
09/25/2017 |
EV-804 OTC Pain Relief TENS |
Everyway Medical Instruments Co., Ltd. |
Paul Hung |
| K173094 |
09/29/2017 |
OrthoVision |
Ewoo Soft Co., Ltd. |
Young Seok Kim |
| K172960 |
09/26/2017 |
easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use |
Ezisurg Medical Co., Ltd. |
Sheng Tian |
| K172661 |
09/05/2017 |
Fetzer Medical Gynecological Forceps |
Fetzer Medical GmbH & Co. KG |
Harald Jung |
| K172952 |
09/26/2017 |
Figaro Crowns Anterior Crown Kit, Figaro Crowns Posterior Crown Kit |
Figaro Crowns, Inc. |
Kyle Rose |
| K173060 |
09/28/2017 |
F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version |
Fisher and Paykel Healthcare Limited |
Ashley Nguyen |
| K173076 |
09/29/2017 |
CURA 16; ScintCare CT16 |
FMI Medical Systems Inc. |
Scott LeMaster |
| K172819 |
09/18/2017 |
LightWalker Laser System Family |
Fotona d.o.o. |
Marko Berdajs |
| K172916 |
09/25/2017 |
FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM Water Tank Model WT-603 |
Fujifilm Corporation |
Randy Vader |
| K173132 |
09/29/2017 |
ASPIRE Cristalle |
Fujifilm Medical Systems U.S.A., Inc. |
Jyh-Shyan Lin |
| K172713 |
09/08/2017 |
Lumipulse G BòRòAòHòMòS PCT Immunoreaction Cartridges, Lumipulse G BòRòAòHòMòS PCT Calibrators set |
Fujirebio Diagnostics, Inc. |
Stacey Dolan |
| K173037 |
09/28/2017 |
Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection Panel |
Galil Medical Inc. |
Lynne Davies |
| K172695 |
09/07/2017 |
AIR Anterior Array, AIR Posterior Array |
GE Healthcare Coils (USA Instruments, Inc.) |
Mary A. Mayka |
| K172700 |
09/07/2017 |
OEC One |
GE HUALUN MEDICAL SYSTEMS CO., LTD. |
Lifeng Wang |
| K172869 |
09/20/2017 |
Discovery XR656 HD |
GE Hualun Medical Systems Co.Ltd. |
Kenny Ma |
| K172714 |
09/08/2017 |
LipiVage |
Genesis Biosystems, Inc. |
Jim Lafferty |
| K172810 |
09/18/2017 |
PORT-X IV |
GENORAY Co., Ltd. |
Ji-Yeon Choi |
| K172842 |
09/19/2017 |
GCE704 Breast Pump |
Globalcare |
Chiara Cavagnolo |
| K173166 |
09/29/2017 |
ANTHEM Fracture System |
Globus Medical Inc. |
Kelly J. Baker |
| K173115 |
09/29/2017 |
COALITION« and COALITION« TPS, COALITION MIS« and COALITION MIS« TPS, COALITION AGX« and COALITION AGX« TPS |
Globus Medical Inc. |
Kelly J. Baker |
| K172987 |
09/27/2017 |
Surgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001, AG2001, AG3001) |
GMAX Industries, Inc. |
Julia Huang |
| K172867 |
09/20/2017 |
Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free Glove, Orange |
GMP MEDICARE SDN BHD (F25) |
Noraini Raus |
| K173157 |
09/29/2017 |
Dr's Light2 |
Good Doctors Co.,Ltd. |
Sungro Joo |
| K172765 |
09/13/2017 |
Smart Moves Complete |
Great Lakes Orthodontics Ltd |
David Graver |
| K172712 |
09/08/2017 |
gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler |
GRI Medical & Electronic Technology Co, Ltd |
Marty D. Paugh |
| K172835 |
09/19/2017 |
GRI-Alleset Veress Needle |
GRI Medical and Electronic Technology Co., Ltd. |
Martin Paugh |
| K172750 |
09/12/2017 |
Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe) |
Guangzhou Sonostar Technologies Co., Ltd. |
Weizhong Cai |
| K172887 |
09/21/2017 |
XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro - III, Neck Therapy Pro - IV) |
Guangzhou Xinbo Electronic Co., Ltd. |
Sammy Li |
| K172871 |
09/21/2017 |
SpineKure Kyphoplasty System |
Hanchang Co., Ltd. |
An Kwon Ho |
| K172727 |
09/11/2017 |
Hemoclip |
Hangzhou AGS MedTech CO., Ltd |
Chunqi Han |
| K172729 |
09/11/2017 |
Polypectomy Snare |
Hangzhou AGS MedTech CO., Ltd |
Chunqi Han |
| K172861 |
09/20/2017 |
Digital thermometer(with disposable thermometer cover) |
Hangzhou Hua'an medical&health instruments Co.,Ltd |
Ahneo Yang |
| K172870 |
09/20/2017 |
Infra-red ear thermometer model: ET-100A, ET-100B, ET-100D, ET-100E, ET-100G, ET-100I, ET-100J |
Hangzhou Hua'an medical&health instruments Co.,Ltd |
Ahneo Yang |
| K173137 |
09/29/2017 |
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink) |
Hartalega Sdn. Bhd. |
Kuan Kam Hon |
| K172892 |
09/22/2017 |
Neuro Assessment System NAS-1000 |
HeadSense Medical Inc. |
Richard A. Lotti |
| K172719 |
09/08/2017 |
HealthBeacon HB2 Sharps Bin |
HealthBeacon Ltd |
Joyce Power |
| K173028 |
09/28/2017 |
BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software |
HealthSTATS International Pte Ltd |
Ngak Hwee Chua |
| K172649 |
09/05/2017 |
Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with Multicolor |
Heidelberg Engineering GmbH |
Gerhard Zinser |
| K173070 |
09/29/2017 |
HSW Resection Instruments |
Henke-Sass, Wolf GmbH |
Anna Reifschneider |
| K173052 |
09/28/2017 |
Heraeus TMW Guidewire |
Heraeus Medical Components, LLC |
Margaret Batchelder |
| K172739 |
09/12/2017 |
higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station ( with Body Composition and Fixed cuff housing) |
higi SH LLC |
Colin Hill |
| K172629 |
09/01/2017 |
Panther Fusion AdV/hMPV/RV Assay |
Hologic, Inc. |
Anila K Tarte |
| K172634 |
09/01/2017 |
Triathlon« X3« UHMWPE Tibial Inserts and Patellar Components |
Howmedica Osteonics Corp aka Stryker Orthopaedics |
Shahrir Alam |
| K172821 |
09/18/2017 |
Ti-one 101 TS Dental Implant System |
Hung Chun Bio-S Co.,Ltd. |
Jethro Liou |
| K173099 |
09/29/2017 |
Fortis and Hana Anterior Cervical Plate System |
Huvexel Co., Ltd |
Sung Hee-Lee |
| K173080 |
09/29/2017 |
IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF) |
Huvexel Co., Ltd |
Sung Hee-Lee |
| K173131 |
09/29/2017 |
Rexious Spinal Fixation System |
Huvexel Co., Ltd |
Sung Hee-Lee |
| K172690 |
09/06/2017 |
ToFscan |
Idmed |
FrΘdΘric BERNERT |
| K173038 |
09/28/2017 |
CuRAS Nd:YAG Laser |
Ilooda Co., Ltd. |
Yun-Jung HA |
| K172745 |
09/12/2017 |
ImmuGlo HEp-2 Elite IFA |
IMMCO Diagnostics, Inc. |
Kevin Lawson |
| K173083 |
09/29/2017 |
IMPLANTER DENTAL PLANNING SOFTWARE |
Implanter LLC |
Jorge Millan |
| K173121 |
09/29/2017 |
Ankle Fusion Plating System |
In2Bones SAS |
Morgane Grenier |
| K172803 |
09/18/2017 |
Infinitt PACS 7.0 |
Infinitt Healthcare Co.,Ltd. |
Sang Wook Cho |
| K173126 |
09/29/2017 |
ArisstosÖ Spinal System |
Ingenium Spine |
David Brumfield |
| K173120 |
09/29/2017 |
CCM Abutment System |
InnoBioSurg Co., Ltd. |
Bo-reum Yoo |
| K172760 |
09/13/2017 |
REST EAZY Appliance |
Insert Molding Solutions, Inc. |
Paul Hendrixson |
| K172798 |
09/18/2017 |
Straumann CARES Abutments CoCr |
Institut Straumann AG |
Shokoufeh Khodabandeh |
| K172903 |
09/22/2017 |
HemosIL D-Dimer HS 500 |
Instrumentation Laboratory Co. |
Shajunath Nirupama |
| K172849 |
09/20/2017 |
Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP Instrument Tray |
Intellijoint Surgical Inc. |
Brandon Gingrich |
| K172943 |
09/26/2017 |
Flex-Thread Fibula Pin System |
IntraFuse LLC |
Robert Hoy |
| K172643 |
09/01/2017 |
da Vinci Xi Surgical System; da Vinci X Surgical System |
Intuitive Surgical, Inc. |
Brandon Hansen |
| K173085 |
09/29/2017 |
invendoscopy E210 System |
invendo medical GmbH |
Oliver v. Ruepprecht |
| K172938 |
09/26/2017 |
Disposable Sterile Needle |
Jiangsu Caina Medical Co., Ltd. |
Jun Lu |
| K173005 |
09/27/2017 |
SURECELL Gelling Fiber Wound Dressing |
Jiangsu Newvalue Medical Producst Co.,Ltd |
Julie Chen |
| K172826 |
09/18/2017 |
Cellent Spinal Systems |
Jiangsu Trauhui Medical Instrument Co.,Ltd. |
Zhou Yu |
| K172989 |
09/27/2017 |
Electric Breast Pump |
Joytech Healthcare Co., Ltd. |
Ren Yunhua |
| K173024 |
09/28/2017 |
Non-invasive blood pressure measurement systems |
Joytech Healthcare Co.,Ltd |
Ren Yunhua |
| K172941 |
09/26/2017 |
CASCADIA Interbody System |
K2M |
Nancy Giezen |
| K172808 |
09/18/2017 |
CosmoLock Pedicle Screw System |
Kalitec Direct, LLC |
Scott Winn |
| K172918 |
09/25/2017 |
DEXIS Titanium, KaVo IXS HD (Size 1, Size 2) |
KaVo Dental Technologies, LLC |
Frank Ray |
| K172957 |
09/26/2017 |
Kawasumi Laboratories Blood Drawing Kit (BDK) System |
Kawasumi Laboratories, Inc. |
Takayuki Nakajima |
| K173116 |
09/29/2017 |
KJ ZIRCONIA Implant System |
KJ Meditech Co., Ltd |
Hyukki Moon |
| K172793 |
09/15/2017 |
SKR 3000 |
KONICA MINOLTA, INC. |
Tsutomu Fukui |
| K172723 |
09/11/2017 |
Dario LC Blood Glucose Monitoring System |
LabStyle Innovation, Ltd. |
Erez Raphael |
| K172818 |
09/18/2017 |
LMT-3000 |
Lameditech Co., Ltd. |
Jong Seuk Choi |
| K172639 |
09/01/2017 |
PALLAS 308/311 Solid-State UV Laser System |
Laseroptek Co.Ltd |
Hong Chu |
| K172662 |
09/05/2017 |
reVive Perioral |
LED Technologies, Inc. |
Lloyd Nelson |
| K172985 |
09/27/2017 |
Ligation Device |
Leo Medical Co., Ltd. |
Yunpeng Ma |
| K172973 |
09/26/2017 |
Life Spine Foot and Ankle Plating System |
Life Spine Inc. |
Randy Lewis |
| K173182 |
09/29/2017 |
ProLift« Expandable System |
Life Spine Inc. |
Randy Lewis |
| K173047 |
09/28/2017 |
The Solstice OCT System |
Life Spine, Inc. |
Randy Lewis |
| K173067 |
09/29/2017 |
LightForce LTS Model 1000, 1500, 2500, and 4000 |
LiteCure, LLC |
Eric Rock |
| K172659 |
09/05/2017 |
MEGASORB - Natural absorbable Polyglycolic Acid Surgical Suture, MITSU - Absorbable Polyglactin 910 Surgical Sutures, MITSU FST - Absorbable Polyglactin 910 Surgical Suture, FILAXYN - Absorbable Polydioxanone Surgical (PDS), FILAPRON - Absorbable poly(gly |
M/s. Meril Endo Surgery Private Limited |
Umesh Sharma |
| K172737 |
09/11/2017 |
MESIRE - Balloon Sinus Dilatation System |
M/s. Meril Life Sciences Private Limited |
Umesh Sharma |
| K173171 |
09/29/2017 |
FilmArray RP2/RP2plus Control Panel |
Maine Molecular Quality Controls, Inc. |
Joan Gordon |
| K172890 |
09/22/2017 |
SedLine Sedation Monitor |
Masimo Corporation |
Matthew Tiacharoen |
| K172963 |
09/26/2017 |
Master-Frank N95 Particulate Respirator |
Master & Frank Enterprise Co., Ltd |
Shuge Zhao |
| K172650 |
09/05/2017 |
Materialise PKA Guide System |
Materialise NV |
Oliver Clemens |
| K173039 |
09/28/2017 |
TruMatch CMF Titanium 3D Printed Implant |
Materialise NV |
Lina Ramirez |
| K172844 |
09/19/2017 |
Cellvizio 100 Series System with Confocal Miniprobes |
Mauna Kea Technologies |
Veronique Dentan |
| K173158 |
09/29/2017 |
Air Relax |
Maxstar Industrial Co., Ltd |
Lee BungHyun |
| K172864 |
09/20/2017 |
Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs |
Maxter Glove Manufacturing Sdn Bhd |
Yap Peak Geeh |
| K172956 |
09/26/2017 |
Medicant Mucosal Atomizer |
Medica Holdings, LLC |
George Reed |
| K173170 |
09/29/2017 |
Epicardia Anywhere |
Medicomp, Inc. |
Sean Marcus |
| K172677 |
09/05/2017 |
Advantage Plus Pass-Thru |
Medivators Inc. |
Megan Skaar |
| K173113 |
09/29/2017 |
Medline Disposable Electronic Thermometer Probe Cover |
Medline Industries, Inc. |
Dinah Rincones |
| K172954 |
09/26/2017 |
Medline Prevention CoolZone Gown |
Medline Industries, Inc. |
Pauline Maralit |
| K173134 |
09/29/2017 |
SENTIO MMG Pedicle Access Needles |
Medos International SARL |
Sheree Geller |
| K173095 |
09/29/2017 |
VIPER PRIMEÖ Screws, VIPER PRIMEÖ Screws with Fenestrations, EXPEDIUM« Verse Screws with Fenestrations |
Medos International SARL |
Thao Le |
| K172796 |
09/15/2017 |
Flex Robotic System and Flex Transabdominal Drive |
MEDROBOTICS CORPORATION |
Linda J Varroso |
| K173125 |
09/29/2017 |
T2 STRATOSPHEREÖ Expandable Corpectomy System |
Medtronic Sofamor Danek |
Kanesha Hines |
| K172626 |
09/01/2017 |
Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Fusion Oxygenator with Cortiva Biosurface, Affinity Fusion Oxygenator with Cortiva BioActive Surface & Cardiot |
Medtronic, Inc. |
Lisa Stone |
| K172984 |
09/27/2017 |
Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Pixie Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and |
Medtronic, Inc. |
Lisa Stone |
| K172756 |
09/13/2017 |
Varian cage |
Medyssey USA, Inc. |
Shawn Kim |
| DEN170058 |
09/25/2017 |
MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a Hybridization-Capture Based Next Generation Sequencing Assay |
Memorial Sloan-Kettering Cancer Center |
Christine England |
| K172866 |
09/20/2017 |
NeuroCap |
Memory MD INC |
Abdus-Salaam Muwwakkil |
| K173136 |
09/29/2017 |
Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses |
Menicon Co., Ltd. |
Kenichi Tanaka |
| K172930 |
09/25/2017 |
mCare Powder-free Blue Nitrile Examination Gloves |
Mercator Medical (Thailand) LTD. |
Dariusz Jan Krezymon |
| K172936 |
09/26/2017 |
DestikneeÖ Total Knee System |
Meril Healthcare Pvt. Ltd. |
Bhavik Gondaliya |
| K172857 |
09/20/2017 |
Latitud Hip Replacement System |
Meril Healthcare Pvt. Ltd. |
Bhavik Gondaliya |
| K172637 |
09/01/2017 |
HeRO Graft |
Merit Medical Systems, Inc. |
Susan Christensen |
| K173124 |
09/29/2017 |
PEEK Biosolution |
Merz Dental GmbH |
Claudia Bobrowski |
| K172689 |
09/06/2017 |
DESCRIBE PFD Patch |
Merz North America, Inc. |
Misty DÆOttavio |
| K172655 |
09/05/2017 |
Automated ankle brachial pressure index measuring device |
Mesi D.O.O.; Mesi, Development of medical devices, Ltd. |
Jakob Susteric |
| K172848 |
09/19/2017 |
MEVION S250i Proton Beam Radiation Therapy Device |
Mevion Medical Systems |
Thomas H. Faris |
| K172786 |
09/15/2017 |
MDS Plating System |
Miami Device Solutions, LLC |
Michelle Montesino |
| K172663 |
09/05/2017 |
Cytology Brush |
Micro-Tech (Nanjing) CO., Ltd. |
Becky Li |
| K172813 |
09/18/2017 |
Esophageal Stent System |
Micro-Tech (Nanjing) Co.,Ltd. |
Becky Li |
| K172880 |
09/21/2017 |
Microlife Upper Arm Automatic Digital Blood Pressure Monitor |
Microlife Intellectual Property GmbH |
Gerhard Frick |
| K172672 |
09/05/2017 |
Endoscopic Applicator, 41 cm |
Micromedics Inc. (d/b/a Nordson Medical) |
Kristi Brezinka |
| K172881 |
09/21/2017 |
NeuroBlate System |
Monteris Medical |
David H. Mueller |
| K172994 |
09/27/2017 |
EPI K Console |
Moria SA |
Jean-Paul Mercereau |
| K172764 |
09/13/2017 |
Keymill |
Mycone Dental Supply Company, Inc. (aka Keystone Industries) |
Priscilla Herpai |
| K172977 |
09/27/2017 |
Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel |
Nanova Biomaterials Inc |
Andrew C. Ritts |
| K173043 |
09/28/2017 |
Holycon Synthetic Absorbable Sutures |
Nantong Holycon Medical Devices Co., Ltd. |
Feng Lu |
| DEN170052 |
09/20/2017 |
Natural Cycles |
Natural Cycles Nordic AB |
Raoul Scherwitzl |
| K172711 |
09/08/2017 |
Comet-PLUS |
Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) |
Sanjay Mehta |
| K172743 |
09/12/2017 |
Natus VikingQuest |
Natus Neurology Incorporated |
Shane T. Sawall |
| K172962 |
09/26/2017 |
Nurture Rest |
Neonatal Loving Kare, Inc. |
Nicole Sawyers |
| K173087 |
09/29/2017 |
UroLift System (UL400 and UL500) |
NeoTract, Inc. |
Louis-Pierre Marcoux |
| K173082 |
09/29/2017 |
ArcoÖ-SA Lumbar Cage System |
NeuroStructures, Inc. |
Kathleen Wong |
| K173077 |
09/29/2017 |
Cavetto-SA Cervical Cage System |
NeuroStructures, Inc. |
Kathleen Wong |
| K173044 |
09/28/2017 |
Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff |
Ningbo Albert Novosino Co.,Ltd. |
Ningbo Albert Novosino |
| K173029 |
09/28/2017 |
Nipro Syringe |
Nipro Medical Corporation |
Jessica Oswald-McLeod |
| K172854 |
09/20/2017 |
NobelPerfect Abutments |
Nobel Biocare AB |
Charlemagne Chua |
| K172625 |
09/01/2017 |
Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor |
Nonin Medical Inc. |
Kim E. Aves |
| K173036 |
09/28/2017 |
North-vision Multi-parameter Patient Monitor |
North-vision Tech. Inc. |
Albert Huang |
| K173129 |
09/29/2017 |
PRECICE System |
NuVasive Specialized Orthopedics, Inc. |
Lance Justice |
| K172628 |
09/01/2017 |
PRECICE System |
NuVasive Specialized Orthopedics, Inc. |
Cora Sim |
| K173117 |
09/29/2017 |
NuVasive« VersaTieÖ System |
NuVasive, Inc. |
Marysa Loustalot |
| K172623 |
09/01/2017 |
NuVasive Navigation Instruments |
NuVasive, Incorporated |
Manthan J. Damani |
| K172979 |
09/27/2017 |
NuVasive« Growth Rod Conversion Set |
NuVasive, Incorporated |
Olga Lewis |
| K173025 |
09/28/2017 |
NuVasive« MLX« û Medial Lateral Expandable Lumbar Interbody System; NuVasive« AP Expandable XLIF System |
NuVasive, Incorporated |
Cynthia Adams |
| K172676 |
09/05/2017 |
NuVasive« Modulus-C Interbody System |
NuVasive, Incorporated |
Marysa E. Loustalot |
| K173030 |
09/28/2017 |
Vertera Spine Cohere Cervical Interbody Fusion Device |
NuVasive, Incorporated |
Michelle Cheung |
| K173153 |
09/29/2017 |
Vertera SpineÖ CoalesceÖ Thoracolumbar Interbody Fusion System |
NuVasive, Incorporated |
Michelle Cheung |
| K173091 |
09/29/2017 |
Boundary Anterior Lumbar Buttress Plate |
Nvision Biomedical Technologies, LLC |
Diana L. Langham |
| K172817 |
09/18/2017 |
4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB, 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EA |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K172726 |
09/11/2017 |
EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy Forceps FB-433D |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K172734 |
09/11/2017 |
Single Use Electrosurgical Snare SD-400 |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K172691 |
09/06/2017 |
Ultrasonic Generator |
OLYMPUS MEDICAL SYSTEMS CORP. |
Toshiyuki Nakajima |
| K172909 |
09/25/2017 |
ELEVARE, PERFECTIO 4 |
Omm Imports d/b/a Zero Gravity |
Zivan Habibi |
| K172845 |
09/19/2017 |
Symetri Clear |
Ormco Corporation |
Tara Bonny |
| K172696 |
09/07/2017 |
FORZA« XP Expandable Spacer System |
Orthofix Inc. |
Natalia Volosen |
| K172699 |
09/07/2017 |
Agile Nail |
Orthofix Srl |
Gianluca Ricadona |
| K172698 |
09/07/2017 |
G-Beam Fusion Beaming System |
Orthofix Srl |
Gianluca Ricadona |
| K173051 |
09/28/2017 |
Orthofix MJ-FLEX THE NEW METAIZEAU NAIL |
Orthofix Srl |
Gianluca Ricadona |
| K172681 |
09/06/2017 |
Edge Air Digital Flat Panel X-ray Detector |
OSKO, INC. |
Richard Jeon |
| K172682 |
09/06/2017 |
Edge Digital Flat Panel X-ray Detector |
Osko, Inc. |
Richard Jeon |
| K172906 |
09/22/2017 |
REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement |
OsteoRemedies, LLC |
Eric Stookey |
| K172925 |
09/25/2017 |
Contact Lens Case, Model: A-1, B-1 |
P L Overseas Limited |
Maggie Li |
| K172777 |
09/14/2017 |
Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter NRFit 80369-7 |
PAJUNK GmbH Medizintechnologie |
Christian G. H. Quass |
| K172886 |
09/21/2017 |
Breakaway Screw System |
Paragon 28 |
Eric Lintula |
| K173032 |
09/28/2017 |
Paxman Scalp Cooler |
Paxman Coolers Limited |
Richard Paxman |
| K173012 |
09/27/2017 |
ANGIO-PRESS LITE DVT Compression Device |
Pegasus Medical Supply, Inc. |
Pao-Ming Shih |
| K172959 |
09/26/2017 |
PeraServer and PeraTrend |
PeraHealth, Inc. |
Joseph Beals |
| K172685 |
09/06/2017 |
LiverMultiScan |
Perspectum Diagnostics Ltd |
Jaco Jacobs |
| K173114 |
09/29/2017 |
primeMidline Catheters |
PFM Medical, Inc. |
Jessica Jho |
| K172920 |
09/25/2017 |
3D APT |
Philips Medical Systems Nederland B.V. |
Jan van de Kerkhof |
| K173079 |
09/29/2017 |
Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4 |
Philips Medical Systems Nederland B.V. |
Jan van de Kerkhot |
| K172822 |
09/18/2017 |
Azurion series R1.2 |
Philips Medical Systems Nederland BV |
Jeanette Becker |
| K172904 |
09/22/2017 |
IntelliVue Capnography Extension, IntelliVue Microstream Extension |
Philips Medizin Systeme Boeblingen GmbH |
Markus Stacha |
| K173130 |
09/29/2017 |
Reform« Midline Cortical Screw System |
Precision Spine, Inc. |
Michael C. Dawson |
| K172934 |
09/25/2017 |
Needle Free Transseptal Cannula |
Pressure Products Medical Device Manufacturing LLC |
Andrew Armour |
| K172893 |
09/22/2017 |
SafeSept Needle Free Transseptal Guidewire |
Pressure Products Medical Device Manufacturing LLC |
Andrew Armour |
| K172950 |
09/26/2017 |
TSN Transseptal Needle |
Pressure Products Medical Device Manufacturing LLC |
Andrew Armour |
| K173053 |
09/28/2017 |
POWDER FREE LATEX EXAMINATION GLOVE |
Professional Latex Sdn Bhd |
Yoon Lim Kok |
| K172859 |
09/20/2017 |
Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder |
Prosomnous Sleep Technologies |
David Kuhns |
| K172636 |
09/01/2017 |
VitaMESH Macroporous PP Surgical Mesh |
Proxy Biomedical Ltd. |
Adrienne Tierney |
| K172790 |
09/15/2017 |
ER-REBOA Catheter |
Prytime Medical Devices, Inc. |
Brian Young |
| K173020 |
09/28/2017 |
OBA-MCP, Orthodontic Bracket Adhesive with MCP |
Pulpdent Corporation |
Kenneth J. Berk |
| K173002 |
09/27/2017 |
2940 nm Er:Yag Laser Handpiece |
Quanta System S.p.A. |
Francesco DellÆAntonio |
| DEN170064 |
09/28/2017 |
Comaneci, Comaneci Petit, Comaneci 17 |
Rapid-Medical Ltd. |
Orit Yaniv |
| K173102 |
09/29/2017 |
Reliance Cervical IBF System |
Reliance Medical Systems, LLC |
Bret M. Berry |
| K172647 |
09/01/2017 |
Reprocessed ArthroCare ENT Coblator |
ReNovo, Inc. |
Mark K. Wells |
| K172751 |
09/12/2017 |
iVitri Straw |
Reprobitech Corp. |
Huai L. Feng |
| K172875 |
09/21/2017 |
Astral 100/150 |
ResMed Ltd |
Peter Jennings |
| K173181 |
09/29/2017 |
ExSpiron 1Xi |
Respiratory Motion Inc. |
Susan Hamann |
| K173147 |
09/29/2017 |
SuperNO2VA Et Device |
Revolutionary Medical Devices, Inc. |
David M. Kane |
| K172913 |
09/25/2017 |
cobas Factor II and Factor V Test |
Roche Molecular Systems, Inc. |
Pooja Shah |
| K172928 |
09/25/2017 |
Portable X-ray System |
Rolence Enterprise Inc. |
Sterling Cheng |
| K172627 |
09/01/2017 |
David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette |
Runbio BioTech Co.,Ltd |
Chandler Chen |
| K172674 |
09/05/2017 |
Sapphire Cervical Implant System |
Sapphire Medical Group |
Anthony Ruggiero |
| K173022 |
09/28/2017 |
SeaSpine Ventura NanoMetalene System |
SeaSpine Orthopedics Corporation |
Gina Flores |
| K172926 |
09/25/2017 |
SeaSpine Vu cPOD, Zuma-C, Complete Cervical |
SeaSpine Orthopedics Corporation |
Gina Flores |
| K173112 |
09/29/2017 |
LAP-iX |
Sejong Medical Co., Ltd. |
Yoojung Choi |
| K173111 |
09/29/2017 |
LAP-iX Suction Irrigation |
Sejong Medical Co., Ltd. |
Yoojung Choi |
| K173108 |
09/29/2017 |
Smoklean |
Sejong Medical Co., Ltd. |
Yoojung Choi |
| K173156 |
09/29/2017 |
Integrated CardioRespiratory System |
Sensydia, Inc. |
Thomas Bruggere |
| K172839 |
09/19/2017 |
ENDOSOLV |
Septodont |
Jaimie Woodruff |
| K172761 |
09/13/2017 |
New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded) |
Shanghai New Century Dental Materials Co., Ltd. |
Charles Shen |
| K173001 |
09/27/2017 |
uWS-CT |
Shanghai United Imaging Healthcare Co.,Ltd. |
Shumei Wang |
| K172998 |
09/27/2017 |
uWS-MI |
Shanghai United Imaging Healthcare Co.,Ltd. |
Shumei Wang |
| K172999 |
09/27/2017 |
uWS-MR |
Shanghai United Imaging Healthcare Co.,Ltd. |
Shumei Wang |
| K173000 |
09/27/2017 |
Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color Doppler Ultrasound Imaging System |
Shantou Institute of Ultrasonic Instruments Co., Ltd. (SIUI) |
Flower Cai |
| K173169 |
09/29/2017 |
Rapid Family |
SharpLight Technologies Ltd. |
Ilan Sharon |
| K172678 |
09/05/2017 |
THERMOPLASTIC ELASTOMER EXAMINATION (TPE) GLOVE |
Shen Wei USA Inc. |
Cheryl Reep |
| K172694 |
09/07/2017 |
Sterile Disposable Syringes |
Shenyang MasTech Medical Device Co., Ltd. |
Liu Han |
| K172969 |
09/26/2017 |
Essence 55S Large Monitor System |
Shenyang Torch-Bigtide Digital Technology Co., Ltd. |
Fu Ailing |
| K172815 |
09/18/2017 |
2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+) |
Shenzhen Beacon Display Technology Co., Ltd. |
Fu Ailing |
| K172797 |
09/15/2017 |
ECG Cable/Leadwires |
Shenzhen Coreray Technology., Ltd |
Simon Fan |
| K172792 |
09/15/2017 |
Handheld Pulse Oximeter, Model SP-20 |
Shenzhen Creative Industry Co., Ltd. |
Jia Wang |
| K173045 |
09/28/2017 |
Oximeter |
Shenzhen Greatmade Tech limited |
Mei Mei |
| K173123 |
09/29/2017 |
Pulse Oximeter |
Shenzhen IMDK Medical Technology Co., Ltd. |
Xia Yuan |
| K172896 |
09/22/2017 |
Arm Type Automatic Blood Pressure Monitor BP310A, BP313A, BP351A, BP362A, BP366A, BP369A, BP380A, BP389A, BP-JC312 |
Shenzhen Jiacom Technology Co ., Ltd |
Luo Tianfeng |
| K172894 |
09/22/2017 |
Infrared Thermometer |
Shenzhen Jiacom Technology Co ., Ltd |
Luo Tianfeng |
| K172874 |
09/21/2017 |
Infrared Thermometer |
Shenzhen Jiacom Technology Co., Ltd |
Luo Tianfeng |
| K172972 |
09/26/2017 |
Wrist Type Automatic Blood Pressure Monitor |
Shenzhen Jiacom Technology Co., Ltd |
Luo Tianfeng |
| K172795 |
09/15/2017 |
Infrared Thermometer |
Shenzhen Jumper Medical Equipment Co., Ltd. |
Rambo Yang |
| K172883 |
09/21/2017 |
Home Use Hair Removal Device/T1, T2, T3 |
Shenzhen Mareal Tech Co., Ltd |
Libin Liu |
| K172970 |
09/26/2017 |
M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound |
ShenZhen Mindray Bio-Medical Electronics Co., Ltd |
Yang Zhaohui |
| K172860 |
09/20/2017 |
Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite Diagnostic Ultrasound System/Resona 6S/Resona 6PRO/Resona 6OB Diagnostic Ultrasound System /Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System |
ShenZhen Mindray Bio-Medical Electronics Co., Ltd |
Ma Chao |
| K172834 |
09/19/2017 |
Dual output digital therapy massager |
Shenzhen OSTO Technology Co., Ltd. |
Li Yang |
| K172837 |
09/19/2017 |
Low-frequency Multi-function physiotherapy instrument |
Shenzhen OSTO Technology Co., Ltd. |
Li Yang |
| K172897 |
09/22/2017 |
Neck Care Therapy, Model: SYK 509B |
Shenzhen OSTO Technology Co., Ltd. |
Li Yang |
| K172889 |
09/21/2017 |
Infrared Thermometer |
Shenzhen Pacom Medical Instruments Co., Ltd. |
Liangzhou Zhong |
| K172910 |
09/25/2017 |
Emit II Plus Oxycodone Assay |
Siemens Healthcare Diagnostics Inc. |
Alan Haley |
| K173023 |
09/28/2017 |
Symbia T16, Symbia Intevo 16 and Symbia Intevo Bold |
Siemens Medical Solutions USA, Inc. |
Tabitha Estes |
| K172832 |
09/19/2017 |
Insight BD |
Siemens Medical Solutions, Inc |
Denise Adams |
| K172961 |
09/26/2017 |
LIAC HWL |
Sit Sordina Iort Technologies Spa |
Alessia Giaffreda |
| K172688 |
09/06/2017 |
Align Radial Head System |
Skeletal Dynamics, LLC |
Ana M. Escagedo |
| K173127 |
09/29/2017 |
skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit) |
Skyla Corporation H.S.P.B. |
Cindy Lu |
| K172876 |
09/21/2017 |
PowerDot PD-01M |
Smartmissimo Technologies Pte Ltd |
Alexey Pisarev |
| K172785 |
09/15/2017 |
CONQUEST FN |
Smith & Nephew |
Allison Chan |
| K172684 |
09/06/2017 |
Smith & Nephew, Inc. ANTHOLOGYÖ AFIT Hip Stem |
Smith & Nephew, Inc. |
Jonathan DiMotta |
| K172823 |
09/18/2017 |
Portex NRFit Epidural Needles |
Smiths Medical ASD, Inc. |
Sunita Teekasingh |
| K172800 |
09/18/2017 |
Portex« Lancet Point Spinal Needles with NRFitÖ connectors, Portex« Pencil Point Spinal Needles with NRFitÖ connectors |
Smiths Medical ASD, Inc. |
Michael R. Johnson |
| K172622 |
09/01/2017 |
Microcyn Antimicrobial Skin and Wound Cleanser |
Sonoma Pharmaceuticals |
Brian W. Martin |
| K172851 |
09/20/2017 |
Microcyn Plus Antimicrobial Wound Care Solution |
Sonoma Pharmaceuticals, Inc. |
Brian Martin |
| K173058 |
09/28/2017 |
P10 Series Digital Color Doppler Ultrasound System |
Sonoscape Medical Corp. |
Toki Wu |
| K172993 |
09/27/2017 |
P20 Series Digital Color Doppler Ultrasound System |
Sonoscape Medical Corp. |
Toki Wu |
| K172687 |
09/06/2017 |
Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters |
Spectranetics, Inc. |
Stephanie Byrum |
| K172967 |
09/26/2017 |
Mercury« Spinal System |
Spinal Elements Inc. |
Julie Lamothe |
| K173175 |
09/29/2017 |
Paramount Anterior Cervical Cage System |
Spine Wave, Inc. |
Yvonne Riley-Poku |
| K172752 |
09/12/2017 |
CELERITY 20 HP Biological Indicator |
Steris Corporation |
Jennifer Nalepka |
| K172755 |
09/12/2017 |
PRO-LITE Sterilization Trays |
Steris Corporation |
Tricia Cregger |
| K172754 |
09/12/2017 |
V-PRO maX 2 Low Temperature Sterilization System |
Steris Corporation |
Bill Brodbeck |
| K172753 |
09/12/2017 |
VERIFY VH2O2 Indicator Tape |
Steris Corporation |
Bill Brodbeck |
| K172746 |
09/12/2017 |
VERIFY« HPU Chemical Indicator and VERIFY« Vaporized VH2O2 Process Indicator Adhesive Label |
STERIS Corporation |
Bill Brodbeck |
| K172749 |
09/12/2017 |
Vis-U-All Low Temperature Sterilization Pouch/Tubing |
Steris Corporation |
Tricia Cregger |
| K172748 |
09/12/2017 |
VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack |
STERIS Corporations |
Jennifer Nalepka |
| K172644 |
09/01/2017 |
Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base |
Stimwave Technologies Incorporated |
Elizabeth Greene |
| K173074 |
09/29/2017 |
ICONIX XBraid TT with Needles, NanoTack TT Suture Anchor |
Stryker |
Jacob Scheenstra |
| K172921 |
09/25/2017 |
Stryker Self-Punching ICONIX |
Stryker |
Katie Farraro |
| K172724 |
09/11/2017 |
XIA« 4.5 Spinal System, Power Adaptor Instrument Accessory |
Stryker Corporation |
Priyanka Patel |
| K173135 |
09/29/2017 |
VariAx 2 System |
Stryker GmbH |
Paul Nelson |
| K172856 |
09/20/2017 |
Reprocessed LigaSure Blunt Tip Laparoscopic Sealer/Divider |
Stryker Sustainability Solutions |
Scott English |
| K172774 |
09/14/2017 |
T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System |
Stryker Trauma Gmbh |
Heike Gustke |
| K173004 |
09/27/2017 |
SB Soft Hood - Straight type, SB Soft Hood - Undercut type |
Sumitomo Bakelite Co., Ltd |
Shiro Agehama |
| K173110 |
09/29/2017 |
GRAFTSITE |
Summit Medical Ltd. |
Robyn Cochrane |
| K172982 |
09/27/2017 |
SuperGrow 272, Ultimate 272 |
Super Grow Lasers |
Jeff Stanifer |
| K173021 |
09/28/2017 |
Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems |
Supersonic Imagine |
Laurence Hermitte |
| K172978 |
09/27/2017 |
SurgeoBite |
Surgovations LLC |
Chris Menard |
| K172666 |
09/05/2017 |
CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor |
SutureEase, Inc. |
Scott Heneveld |
| K172975 |
09/27/2017 |
DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins û MR Conditional, DePuy Synthes Variable Angle Positioning Pins û MR Conditional, DePuy Synthes Wire Mount û MR Conditional, DePuy Synthes Cerclage Positioning Pin û MR Conditional |
Synthes (USA) Products LLC/DePuy Orthopaedics Inc |
Suchitra Basu |
| K172708 |
09/08/2017 |
T2Bacteria Panel |
T2 Biosystems, Inc. |
Tom Lowery |
| K172733 |
09/11/2017 |
TD-1035 Thermometer |
TaiDoc Technology Corporation |
Sheena Song |
| K172728 |
09/11/2017 |
Applanation tonometer AT-1 |
TAKAGI SEIKO CO., LTD. |
Shinya Kitamura |
| K173093 |
09/29/2017 |
TAMA BEMS device |
TAMA Research Corporation |
Ali Shambayati |
| K172692 |
09/06/2017 |
Tangible Hydrogel with Tangible Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens |
Tangible Science LLC |
Vic McCray |
| K172668 |
09/05/2017 |
W Zirconia Implants |
TAV Medical Ltd. |
Revital Shabtai |
| K172645 |
09/01/2017 |
iLux Instrument, iLux Disposable |
Tear Film Innovations, Inc. |
John Slate |
| K172775 |
09/14/2017 |
MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle |
Teleflex Medical, Inc. |
Holly Hallock |
| K172995 |
09/27/2017 |
Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath |
Terumo Medical Corporation |
Liang Lu |
| K172868 |
09/20/2017 |
Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls |
The Binding Site Group Ltd. |
Kirsty Samuels |
| DEN170072 |
09/29/2017 |
Enlight 1810 |
Timpel Inc. |
Rafael Holzhacker |
| K172667 |
09/05/2017 |
MagVita TMS Therapy w/MagPro R20 |
Tonica Elektronik A/S |
Lise Terkelsen |
| K172923 |
09/25/2017 |
Nitrile Examination Powder Free Glove, White, Black, Orange, Nitrile Examination Powder Free Gloves Tested For Use With Chemotherapy Drugs, Blue |
Top Glove Sdn. Bhd. |
Noor Akilah Binti Saidin |
| K173119 |
09/29/2017 |
DRI OCT Triton |
Topcon Corporation |
Charles Reisman |
| K173090 |
09/29/2017 |
Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4 |
Toshiba Medical Systems Corporation |
Paul Biggins |
| K172863 |
09/20/2017 |
Infinix-i, INFX-8000V, V7.0 |
Toshiba Medical Systems Corporation |
Paul Biggins |
| K173088 |
09/29/2017 |
Vitrea Software Toshiba Package VSTP-001A |
Toshiba Medical Systems Corporation |
Paul Biggins |
| K172646 |
09/01/2017 |
XIDF-AWS801, Angio Workstation, V7.0 |
Toshiba Medical Systems Corporation |
Paul Biggins |
| K172878 |
09/21/2017 |
Vantage Titan 3T, MRT-3010/A7, M-Power GX |
Toshiba Medical Systems Corporation, Japan |
Paul Biggins |
| K173104 |
09/29/2017 |
Klassic HD« Hooded Acetabular Insert with E-Link« Poly, Klassic HD« Low Profile Acetabular Insert with E-Link« Poly |
Total Joint Orthopedics, Inc. |
Chris Weaber |
| K172720 |
09/08/2017 |
TRACOE silcosoft Tracheostomy Tube |
TRACOE medical GmbH |
Eva Schaeffer |
| K173054 |
09/28/2017 |
Navigo Workstation Version 2.0 |
UC-Care Ltd. |
Hadas Sheynise |
| K172882 |
09/21/2017 |
UINCARE HOME |
UINCARE Corp. |
Youngbean You |
| K173163 |
09/29/2017 |
ChlorCid, ChlorCid V, ChlorCid Surf |
Ultradent Products, Inc. |
Corey Jaseph |
| K172833 |
09/19/2017 |
E-XPE Acetabular Components and U-Motion II Acetabular Cup |
United Orthopedic Corporation |
Gimpel Chien |
| K172805 |
09/18/2017 |
gi-4000 Electrosurgical Generator |
United States Endoscopy Group, Inc. |
Carroll L. Martin |
| K173062 |
09/28/2017 |
Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties)) |
V&Q Manufacturing Corporation |
Jacky Jin |
| K172716 |
09/08/2017 |
V2K Rinspiration System |
V2K Medical Inc. |
Jake Wolenberg |
| K172951 |
09/26/2017 |
Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3) |
Varex Imaging Corporation |
Catherine Mulcahy |
| K172675 |
09/05/2017 |
Varian Cervical Sleeves |
Varian Medical Systems, Inc. |
Peter J. Coronado |
| K173107 |
09/29/2017 |
Vios Central Station Monitor Software, Vios Central Server Software |
Vios Medical, Inc. |
Amit Patel |
| K172747 |
09/12/2017 |
HYALURONIC ACID TOPICAL WOUND CREAM |
VIRCHOW BIOTECH PVT LTD |
Bruce Gibbins |
| K172965 |
09/26/2017 |
Handheld VitalSigns Monitoring System |
Visiomed Technology Co.,Ltd |
Chen XiaoFeng |
| K173086 |
09/29/2017 |
NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses |
Visioneering Technologies, Inc. |
Stephen Snowdy |
| K172855 |
09/20/2017 |
Vitrea Advanced Visualization, Version 7.6 |
Vital Images, Inc. |
Katie Ryan |
| K173140 |
09/29/2017 |
VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino Sync Blood Glucose Monitoring System, VivaChek Ino Sound Blood Glucose Monitoring System, VivaChek Ino Plus Blood Glucose Monitoring System, VivaChek Ino Sound Simple Blood Glucose Monitorin |
VivaChek Laboratories, Inc. |
Julie Zhou |
| DEN170073 |
09/29/2017 |
ContaCT |
Viz.Al, Inc. |
Gregory Ramina |
| K172899 |
09/22/2017 |
Vygon PICCs |
Vygon USA |
Jillian Mikovich |
| K172825 |
09/18/2017 |
MN-111 |
W&H Sterilization s.r.l. |
Marco Parolini |
| K172809 |
09/18/2017 |
OTC Combo TENS/EMS System |
Well-Life Healthcare Limited |
Chin-Chih Hsieh |
| K172794 |
09/15/2017 |
Suction Irrigation Set |
WickiMed (Huizhou) Medical Equipment Manufacturing Co., Ltd. |
Haobin Li |
| K172665 |
09/05/2017 |
Classic Cotton Cannulatome«, CannulaTome II« Double Lumen Sphincterotome, Cotton CannulaTome II« PC, UTS« Ultra Taper Sphincterotome, Tri-Tome pc« Triple Lumen Sphincterotome, Howell D.A.S.H.« Sphincterotome with DomeTip«, Billroth II Sphincterotome, Soeh |
Wilson-Cook Medical, Inc. / Cook Endoscopy |
Theresa de Prat |
| K173013 |
09/27/2017 |
WishBone K-Wire System |
WishBone Medical, Inc. |
Gary Barnett |
| K172633 |
09/01/2017 |
INFINITY Total Ankle System |
Wright Medical Technology, Inc. |
Tara Conrad |
| K172706 |
09/07/2017 |
GammaPod - Model A |
Xcision Medical Systems, LLC |
Daniel R. Plonski |
| K172968 |
09/26/2017 |
Hair Up |
Y&J BIO Co., Ltd. |
Kwang Sic Kim |
| K172683 |
09/06/2017 |
Yamahachi Pink CAD/CAM Disk |
Yamahachi Dental Mfg., Co. |
Shogo Muramatsu |
| K173078 |
09/29/2017 |
Powder-free Clear Vinyl Patient Examination Gloves |
Yongsheng Medical Products Co., Ltd |
Jason Wei |
| K172884 |
09/21/2017 |
Arisure Closed Vial Adapter |
Yukon Medical |
Todd Korogi |
| K172631 |
09/01/2017 |
Arisure Dry Spike |
Yukon Medical |
Todd Korogi |
| K172983 |
09/27/2017 |
HealthCCS |
Zebra Medical Vision Ltd. |
Matan Neeman |
| K172735 |
09/11/2017 |
WR19 System |
Zeto, Inc. |
Aswin Gunasekar |
| K172768 |
09/13/2017 |
ZOOM |
Zetta Medical Technologies, LLC. |
Main M. Ghazal |
| K172758 |
09/13/2017 |
Rotatable Snares, Non-Rotatable Snares |
Zhejiang Chuangxiang Medical Technology Co., LTD. |
Lucius Long |
| K172762 |
09/13/2017 |
Single Use Hemoclip |
Zhejiang Chuangxiang Medical Technology Co., LTD. |
Lucius Long |
| K172763 |
09/13/2017 |
Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with |
Zhejiang Kindly Medical Devices Co.,Ltd |
Yong Zhang |
| K173057 |
09/28/2017 |
Zimmer Knee Joint Replacement Prostheses MR Labeling |
Zimmer, Inc. |
Jason Heckaman |
| K172767 |
09/13/2017 |
Zimmer Trabecular Metal Reverse Shoulder System, Mini Glenoid |
Zimmer, Inc. |
Ehab Esmail |
| K172653 |
09/05/2017 |
Power Infuser |
ZOLL Medical Corporation |
Pooja Dalvi |
