| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K202465 |
11/25/2020 |
Night Guard |
3D Diagnostix Inc. |
Ehab Amin |
| K193432 |
11/09/2020 |
Vantage PSI System |
3D Systems |
Kim Torluemke |
| K202888 |
11/23/2020 |
Confirm Rx Insertable Cardiac Monitor |
Abbott (St. Jude Medical) |
Laura Sparks |
| K202066 |
11/25/2020 |
EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL Circular Mapping Catheter, Sensor Enabled, Advisor HD Grid High Density Mapping Catheter, Senor Enabled |
Abbott Medical |
Alyssa Timmers |
| DEN190047 |
11/24/2020 |
CADScor System |
Acarix A/S |
Mette Munch |
| K193287 |
11/20/2020 |
CorInsights MRI |
ADM Diagnostics, Inc. |
Dawn C. Mathews |
| K201902 |
11/05/2020 |
MammaPrint |
Agendia Inc. |
Marcelo Trevino |
| K192618 |
11/02/2020 |
e-Motion M25 |
Alber GmbH |
Michael Vent |
| K201985 |
11/12/2020 |
KardiaAI |
AliveCor, Inc. |
Saket Bhatt |
| K200886 |
11/10/2020 |
StimSite |
Allotrope Medical Inc |
Albert Huang |
| K202587 |
11/06/2020 |
ATEC Lateral Interbody System |
Alphatec Spine, Inc. |
Sandy Gill |
| K203056 |
11/23/2020 |
InvictusÖ Spinal Fixation System |
Alphatec Spine, Inc. |
Cynthia Dorne |
| K200334 |
11/12/2020 |
AN1036 Dosimeter |
Andersen Sterilizers, Inc. |
William K Andersen |
| K192980 |
11/12/2020 |
EOGas 4 Endo-SteriTest |
Andersen Sterilizers, Inc. |
William K. Andersen |
| K192978 |
11/12/2020 |
EOGas 4 Ethylene Oxide Gas Sterilizer |
Andersen Sterilizers, Inc. |
William K. Andersen |
| K200335 |
11/12/2020 |
Sterisheet Sterilization Wrap |
Andersen Sterilizers, Inc. |
William K Andersen |
| K200336 |
11/12/2020 |
Tyvek Sterilization Pouches with Chevron Seal |
Andersen Sterilizers, Inc. |
William K Andersen |
| K202777 |
11/17/2020 |
VeriFixxÖ Small Bone Implant |
Armis Biopharma, Inc. |
Franklin Okumu |
| K203100 |
11/20/2020 |
Arthrex Eclipse Titanium Humeral Head |
Arthrex Inc. |
David L Rogers |
| K202535 |
11/18/2020 |
Arthrex FastThread Interference Screw |
Arthrex Inc. |
Jessica L. Singelais |
| K203268 |
11/27/2020 |
Arthrex FiberTak Suture Anchor |
Arthrex Inc. |
Jessica L Singelais |
| K202581 |
11/04/2020 |
Arthrex TightRope II |
Arthrex Inc. |
Kelsey N. Roberts |
| K202444 |
11/17/2020 |
Knotless TensionTight Button Implant System |
Arthrex Inc. |
Jessica Singelais |
| K201687 |
11/30/2020 |
Avenda Health Treatment System |
Avenda Health, Inc. |
Brittany Berry-Pusey |
| K203106 |
11/10/2020 |
Nio Fusion 12MP (MDNC-12130) |
Barco NV |
Julie Vandecandelaere |
| K201867 |
11/19/2020 |
Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System |
Baxter Healthcare Corporation |
Brad Roynon |
| K201404 |
11/20/2020 |
Passio Pump Drainage System |
Bearpac Medical |
Jay Zimmerman |
| K202343 |
11/16/2020 |
MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 ╡g/mL ) |
Beckman Coulter, Inc. |
Elaine Duncan |
| K193190 |
11/09/2020 |
BD PureHub Disinfecting Cap |
Becton, Dickinson and Company |
Samhitha Mohan |
| K200239 |
11/13/2020 |
Astroglide Organix Gel |
BioFilm Inc. |
Richard Hines |
| DEN200043 |
11/20/2020 |
FilmArray Global Fever Panel |
BioFire Defense, LLC |
Cynthia Phillips |
| K202382 |
11/20/2020 |
FilmArray Global Fever Panel External Control Kit |
BioFire Defense, LLC |
Cynthia Phillips |
| K193214 |
11/10/2020 |
WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System, Biomet Headless Compression and Twist-Off Screws |
Biomet Inc. |
Janine Kem |
| K200484 |
11/25/2020 |
CARTO« 3 EP Navigation System with Signal Processing Unit |
Biosense Webster, Inc. |
Khaled Hamad |
| K203173 |
11/12/2020 |
ExacTrac Dynamic |
Brainlab AG |
Chiara Cunico |
| K200761 |
11/25/2020 |
Tenax Laser Resistant Endotracheal Tube |
Bryan Medical, Inc. |
Andrew J. Georgilis |
| K202150 |
11/18/2020 |
GlidePath 7.5F Long-Term Dialysis Catheter |
C.R. Bard, Inc. |
Joan Bergstrom |
| K201568 |
11/12/2020 |
Calvary Spine Pedicle Screw System |
Calvary Spine, LLC |
James Edwards |
| K201904 |
11/24/2020 |
Monet Curing Laser |
CAO Group, Inc. |
Robert K. Larsen |
| K203317 |
11/25/2020 |
CarboClear X Pedicle Screw System |
CarboFix Orthopedics Ltd. |
Hila Wachsler-Avrahami |
| K203008 |
11/19/2020 |
DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System |
Cardiovascular Systems Inc. |
Nikita Basabdra |
| K202442 |
11/19/2020 |
Carewear Firefly Wrinkle Reduction |
Carewear Corp. |
Patrick Parker |
| K201742 |
11/24/2020 |
eKuore One Wireless Electronic Interface for stethoscope |
Chip Ideas Electronics S.L |
Bernardo Plaza Trillo |
| K201308 |
11/27/2020 |
Axonpen, Axonmonitor, Axonbox, Tablet |
ClearMind Biomedical |
Sheng-Chi Lin |
| K192904 |
11/02/2020 |
SpeediCath Compact Set |
Coloplast |
Michael Bumgarner |
| K200820 |
11/13/2020 |
SpeediCath Compact Set |
Coloplast |
Michael Bumgarner |
| K202713 |
11/18/2020 |
TrueView 100 Pro |
CompAI Healthcare (Shenzhen) Co.,ltd |
Wang Yan |
| K202074 |
11/12/2020 |
Apache Ultrasound System (Model C62) |
Compal Electronics, Inc. |
DK Lee |
| K203179 |
11/20/2020 |
Fortress Introducer Sheath System |
Contract Medical International GmbH |
Marketa Shanelova |
| K201060 |
11/16/2020 |
Cordiana Dx16 |
Cordiana Medical Informatics AG |
Johan Sandberg |
| K202805 |
11/20/2020 |
Optimized Positioning System (OPS) Insight |
Corin USA |
Lucinda Gerber |
| K201881 |
11/13/2020 |
CoroFlow Cardiovascular System |
Coroventis Research AB |
Johan Svanerud |
| K193056 |
11/20/2020 |
Puritan Bennett 980 Series Ventilator System |
Covidien, LLC |
Zheng Liu |
| K203187 |
11/18/2020 |
HiRise |
CurveBeam, LLC |
Ryan Conlon |
| K201382 |
11/18/2020 |
X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology) |
de Gotzen S.r.l. |
Dario Bandiera |
| K202194 |
11/25/2020 |
ATTUNE« Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUMÖ 3DP Technology |
DePuy Ireland UC |
Erin Combs |
| K202098 |
11/25/2020 |
GLOBAL UNITEÖ Platform Shoulder System |
DePuy Ireland UC |
Karen Mahoney |
| K203167 |
11/19/2020 |
DePuy Corail AMT Hip Prosthesis |
DePuy Orthopaedics Inc. |
Erin Combs |
| K200461 |
11/16/2020 |
Freeprint denture |
Detax GmbH & Co. KG |
Markus Stratmann |
| K201653 |
11/27/2020 |
Compex Sport Elite 3.0 |
DJO, LLC |
Michael Davis |
| K203287 |
11/18/2020 |
DBSWIN, VISTAEASY |
Dⁿrr Dental SE |
Oliver Lange |
| K193621 |
11/23/2020 |
Digital Thermometer-(Model BT-301, BT-302, BT-303, BT-305, BT-306, BT-308, BT-311, BT-318) |
Dongguan E-Test Technology Co., Ltd |
Victor Wan |
| K201815 |
11/20/2020 |
Dornier MAGELLAN Ureteral Access Sheath |
Dornier MedTech America Inc |
John Hoffer |
| K201937 |
11/13/2020 |
Ceramir Restore QuikCap |
Doxa Dental AB |
Anna-Lisa Tiensuu |
| K200077 |
11/06/2020 |
BioMin Restore Plus |
Dr. Collins, Inc. |
Jiahe Li |
| K200005 |
11/09/2020 |
Concinnity Aligners |
Drake Precision Dental Laboratory Inc |
Robert Savage |
| K200580 |
11/19/2020 |
FotoDent denture |
Dreve Dentamid GmbH |
Reiner Altmann |
| K200017 |
11/05/2020 |
Eclipse DermaFlex Cannula |
Eclipse MedCorp, LLC |
John Tepper |
| DEN190029 |
11/13/2020 |
Acumen Assisted Fluid Management (AFM) Software Feature |
Edwards Lifesciences |
Lisa Gilman |
| K202079 |
11/25/2020 |
Physiq |
El. En. Electronic Engineering SPA |
Paolo Peruzzi |
| K202558 |
11/02/2020 |
Ellusa Bipolar Wands |
Ellusa, LLC |
Suzanne Lucas |
| K202562 |
11/02/2020 |
Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and Tips, Ellusa Tip Set |
Ellusa, LLC |
Suzanne Lucas |
| K203085 |
11/12/2020 |
NOVA Patient Warming System |
Encompass Group, LLC |
Eric Howard |
| K201173 |
11/27/2020 |
E-Guard |
EnvisionTEC GmbH |
Ruediger van Bernum |
| K202306 |
11/25/2020 |
T3 Platform software |
Etiometry, Inc. |
Tim Hanson |
| K202470 |
11/25/2020 |
Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300 |
Everyway Medical Instruments Co., Ltd. |
Paul Hung |
| K202317 |
11/13/2020 |
Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806 |
Everyway Medical Instruments Co., Ltd. |
Paul Hung |
| K192285 |
11/25/2020 |
CPR Face Shield |
Firstar Healthcare Company Limited (Guangzhou) |
Alice Zhao |
| K201666 |
11/13/2020 |
SINGLE USE MANOMETER |
Flexicare Medical Limited |
Joel Biddle |
| K202172 |
11/19/2020 |
StarWalker |
Fotona d.o.o. |
Anja Pucer |
| K200931 |
11/24/2020 |
RF Surgical Generator |
Fulwell LLC |
Perla Melisa Mcliberty |
| K202959 |
11/24/2020 |
PolyLock Plating System |
Fusion Orthopedics, LLC |
Eli Jacobson |
| K193377 |
11/25/2020 |
TopLock Anchor System |
Fusion Orthopedics, LLC |
Kolby Black |
| K203032 |
11/02/2020 |
IcePearl 2.1 CX 90░ Needle, IcePearl 2.1 CX L 90░ Needle, IcePearl 2.1 CX Needle, IceFORCE 2.1 CX 90░ Needle, IceFORCE 2.1 CX L 90░ Needle, IceFORCE 2.1 CX Needle |
Galil Medical Inc. |
Amy McKinney |
| K200798 |
11/24/2020 |
G-CEM ONE |
GC America Inc. |
Mark Heiss |
| K202966 |
11/13/2020 |
SIGNA Architect |
GE Healthcare (GE Medical Systems, LLC) |
Andrew Menden |
| K203169 |
11/20/2020 |
Revolution Ascend |
GE Healthcare Japan Corporation |
Tomohiro Ito |
| K201941 |
11/04/2020 |
Monitor B125, Monitor B105 |
GE Medical Systems Information Technologies, Inc. |
Joel Kent |
| K193289 |
11/12/2020 |
FastStroke, CT Perfusion 4D |
GE Medical Systems SCS |
Elizabeth Mathew |
| K193306 |
11/17/2020 |
PROView |
GE Medical Systems SCS |
Hong Cui |
| K202132 |
11/13/2020 |
Venue |
GE Medical Systems Ultrasound and Primary Care Diagnostics, |
Tracey Ortiz |
| K202233 |
11/18/2020 |
Venue Go |
GE Medical Systems Ultrasound and Primary Care Diagnostics, |
Tracey Ortiz |
| K202035 |
11/20/2020 |
Vscan Air |
GE Medical Systems Ultrasound and Primary Care Diagnostics, |
Tracey Ortiz |
| K200155 |
11/30/2020 |
Bright High Flow |
GENOSS Co., Ltd. |
Hong Jun Jeon |
| K193158 |
11/24/2020 |
ACENTÖ Central Venous Catheter |
Global Medikit Limited |
Mahendra Singh |
| K201431 |
11/09/2020 |
OGYILI TENS/NMES Stimulator |
Gongguan Tutamen Metalwork Co., LTD |
Charles Shen |
| K202427 |
11/06/2020 |
Aqueduct 100 Plus Cervical Dilation Balloon Catheter |
GTIMD LLC |
Eran Levit |
| K202139 |
11/20/2020 |
Medical surgical mask |
Guangdong Kingfa SCI.&Tech.Co., Ltd. |
Yu Xiaoge |
| K201622 |
11/24/2020 |
Medical surgical mask |
Guangdong KINGFA Sci.&Tech.Co.,Ltd. |
Yu Xiaoge |
| K201294 |
11/27/2020 |
Pulse Oximeter |
Guangdong Long Yao Electronic Technology Co., Ltd. |
Lei Wang |
| K200402 |
11/25/2020 |
DR-HO'S Electro Therapy Conductive Gel |
Guangzhou Xinbo Electronic Co., Ltd. |
Sammy Li |
| K192503 |
11/19/2020 |
GM501 Wash with Phenol Red and Gentamicin |
Hamilton Thorne Incorporated |
Donald Fournier |
| K191940 |
11/03/2020 |
Palm NRG cellulite and muscle toning body device |
Heat In A Click |
Guy Levi |
| K202475 |
11/23/2020 |
PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G |
Heraeus Medical GmbH |
Yannick Nils Hermanns |
| K202422 |
11/04/2020 |
Arietta 65 |
Hitachi Healthcare Americas |
Aaron Pierce |
| K201019 |
11/18/2020 |
Genius AI Detection |
Hologic, Inc. |
Deborah Thomas |
| K201683 |
11/03/2020 |
PMMA Block |
Huge Dental Material Co., Ltd. |
Maggie Zheng |
| K200693 |
11/19/2020 |
K2 MOBILE |
HULASER, Inc. |
InBae Park |
| K191433 |
11/12/2020 |
AGILON« XO Shoulder Replacement System |
Implantcast GmbH |
Juliane Hoppner |
| K200401 |
11/14/2020 |
Apogee |
Incoba Ltd. d/b/a Dynaris |
Lon Aylsworth |
| K202042 |
11/20/2020 |
Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter |
Innovative Health, LLC. |
Rick Ferreira |
| K193346 |
11/20/2020 |
Codman Surgical Patties & Strips |
Integra LifeSciences Corporation |
Alyssa Woodcock |
| K202198 |
11/03/2020 |
FlareHawk Interbody Fusion System |
Integrity Implants Inc. |
Lauren Kamer |
| K202571 |
11/12/2020 |
da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and Accessories |
Intuitive Surgical, Inc. |
Elaine Lee |
| K202370 |
11/16/2020 |
Ion Endoluminal System |
Intuitive Surgical, Inc. |
Jyoti Singh |
| K193193 |
11/16/2020 |
Telio CAD Abutment Solutions- extra systems |
Ivoclar Vivadent, AG |
Sandra Cakebread |
| K183044 |
11/10/2020 |
JTK Dental Implant System |
Jiangyin Jintech Biotech Co., Ltd. |
Jie Zhang |
| K202515 |
11/24/2020 |
NUVO Implant System û NUVO Instrument Kit Cases |
JJGC Industria e Comercio de Materiais Dentarios S.A. |
Mariana Soares Hartmann |
| K202851 |
11/27/2020 |
Spo2 Sensor |
JKH USA, LLC |
Bill Quanqin Dai |
| K203154 |
11/05/2020 |
KASILOF Cervical Plate System |
Kahtnu Surgical, Inc |
Craig Wilcox |
| K201526 |
11/20/2020 |
TIPCAM1 Rubina Video Endoscope System |
Karl Storz Endoscopy America |
Mario Trujillo |
| K201976 |
11/10/2020 |
SnapshotNIR |
Kent Imaging |
Liz Newell |
| K192612 |
11/13/2020 |
Kerecis Gingiva Graft |
Kerecis Limited |
Gudmundur Fertram Sigurjonsson |
| K202416 |
11/30/2020 |
Kimtech Prizm Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid, Kimtech Prizm Xtra Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioi |
Kimberly Clark Corporation |
Juan Marquez |
| K201484 |
11/23/2020 |
Somnos Anti-Snoring Mouth Guard |
Koncept Innovators, LLC. |
Sylvan Newby |
| K193010 |
11/18/2020 |
Liebel-Flarsheim IBP Transfer Set |
Liebel-Flarsheim Company LLC |
Alice Lorenzo |
| K200171 |
11/19/2020 |
SMR TT Augmented Glenoid System |
LimaCorporate S.p.A |
Michela Zanotto |
| K203081 |
11/24/2020 |
RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture |
LSI Solutions |
Christopher B Miller |
| K203120 |
11/24/2020 |
RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK LOAD SUTURE, 2-0 Polypropylene |
LSI Solutions, Inc. |
Christopher B Miller |
| K200166 |
11/23/2020 |
Mirus Ligating Clip, Mirus Ligating Clip Applier |
M/s. Meril Endo Surgery Private Limited |
Umesh Sharma |
| DEN200029 |
11/25/2020 |
Parallel |
Mahana Therapeutics, Inc. |
Jean-Noel Courvoisier |
| K200912 |
11/18/2020 |
Freedom(R) - TiNbN Coated Knee |
Maxx Orthopedics, Inc. |
Priscilla Herpai |
| K203149 |
11/16/2020 |
M.U.S.T. MINI Posterior Cervical Screws System |
Medacta International SA |
Stefano Baj |
| K203076 |
11/06/2020 |
Mecta-C Stand Alone Extension |
Medacta International SA |
Stefano Baj |
| K200350 |
11/04/2020 |
MyHip Planner & Verifier |
Medacta International SA |
Stefano Baj |
| K202589 |
11/06/2020 |
APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire System |
Medartis AG |
Andrea Kiefer-Schweizer |
| K202449 |
11/18/2020 |
Signature Latex LT, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50╡g/dm▓ per glove of Extractable Protein |
Medline Industries, Inc. |
Jennifer Mason |
| K202620 |
11/13/2020 |
FlexCath Advance Steerable Sheath and Dilator |
Medtronic CryoCath LP |
Matthew Lobeck |
| K202552 |
11/02/2020 |
Midas Rex Attachments and Dissecting Tools |
Medtronic Powered Surgical Solutions (MPSS) |
Jainam Shah |
| K202800 |
11/18/2020 |
Pacific Plus PTA Catheter |
Medtronic Vascular,Inc(formerly d.b.a ev3 Inc.,Covidien llc) |
Rupali Gupta |
| K192406 |
11/25/2020 |
AveCure BT Microwave Ablation System |
MedWaves, Inc. |
Theodore Ormsby |
| K201269 |
11/09/2020 |
Accula Strep A Test |
Mesa Biotech, Inc. |
Barbara Stevens |
| K193576 |
11/20/2020 |
Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire Revascularization Device) |
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
Helen Chow |
| K200071 |
11/03/2020 |
Blue Beacon Submucosal Injectable Solution |
Micro-Tech (Nanjing) Co., Ltd. |
Sally He |
| K202269 |
11/25/2020 |
PRE-MILLED Abutment |
MIT Global Co., Ltd. |
Lim Rok Won |
| K200372 |
11/30/2020 |
Smoke Evacuation Fingerswitch, Smoke evacuation system with electrosurgical pencil |
Modern Medical Equipment Manufacturing, Ltd. |
Jerry Cheung |
| K202090 |
11/22/2020 |
Biogel Eclipse / Biogel Eclipse Indicator Underglove, Biogel Surgeons / Biogel Indicator Underglove, Biogel PI Micro Indicator Underglove, Biogel PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel PI UltraTouch S Indicator Underg |
Molnlycke Health Care, US LLC |
Leonard Stewart |
| K202274 |
11/09/2020 |
Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 em: Single 8/Dual8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 ern Kil, 40 cm/ 60 cm/60 em TrialJExtension Lead Kits, Patient Kits and miscell |
Nalu Medical, Inc. |
Michele Chin-Purcell |
| K201669 |
11/06/2020 |
SimpleSENSE |
Nanowear Inc. |
Venkatesh Varadan |
| K201158 |
11/20/2020 |
NeuroStar Advanced Therapy |
Neuronetics, Inc. |
Gary Johnson |
| K200081 |
11/13/2020 |
NEUWAVE Microwave Ablation System and Accessories |
NeuWave Medical, Inc. |
Dan Kosednar |
| K202962 |
11/20/2020 |
Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D1, Smoke Evacuation Button Switch Pencil, Non-Ext., 15ft, D1, Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D2, Smoke Evacuation Button Switch Pencil, Non-Ext., 15ft, D2, Telescopic Smoke Ev |
New Deantronics Taiwan Ltd |
Jane Liu |
| K202307 |
11/17/2020 |
Activ Fuse |
Newclip Technics |
Gaelle Lussori |
| K200873 |
11/20/2020 |
HALO |
NICo-Lab B.V. |
Merel Boers |
| DEN200033 |
11/06/2020 |
NightWare Kit, Apple iPhone, Apple Watch, Apple iPhone Charging Cable, Apple Watch Charging Cable |
NightWare, Inc |
Grady Hannah |
| K193155 |
11/25/2020 |
Nipro Dry Complete Dry Acid Concentrate for Hemodialysis |
Nipro Renal Solutions USA, Corp. |
Vincent DeGrandchamp |
| K203156 |
11/20/2020 |
DTX Studio Clinic |
Nobel Biocare AB |
Wim Vrydag |
| K202344 |
11/16/2020 |
TiUltra Implants and Xeal Abutments |
Nobel Biocare AB |
Bernice Jim |
| K202244 |
11/05/2020 |
SPY-PHI System with SPY-PHI Fluorescence Assessment Software |
Novadaq Technologies ULC (now a part of Stryker) |
Agatha Szeliga |
| K202972 |
11/24/2020 |
Anterior Cervical Plate System |
Nutech Spine and Biologics |
Grant Horton |
| K200428 |
11/10/2020 |
Multi-Drive Interference Screw System |
Nvision Biomedical Technologies, Inc |
Diana Langham |
| K203025 |
11/05/2020 |
LOBO Vascular Occlusion System (model LOBO-5) |
Okami Medical |
Jill Delsman |
| K203128 |
11/09/2020 |
EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2/EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2 PREMIER PLUS |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K202943 |
11/24/2020 |
OptoMonitor 3 |
Opsens Inc. |
Marc Chaunet |
| K201325 |
11/20/2020 |
Optomed Smartscope M5 with Optomed Smartscope FA |
Optomed Oyj |
Jyri LeskelΣ |
| K202764 |
11/20/2020 |
Ortho Solutions Plating System |
Ortho Solutions UK Ltd |
Andy Leither |
| K203138 |
11/18/2020 |
FIREBIRD SI Fusion System |
Orthofix Inc. |
Jacki Koch |
| K202883 |
11/25/2020 |
Sterile bone screw (PEEK ACL screw) |
Osteonic Co., Ltd. |
Sungmoo Hwang |
| K202373 |
11/13/2020 |
APEX 3D Total Ankle Replacement System |
Paragon 28, Inc. |
Haylie Hertz |
| K203011 |
11/13/2020 |
Monster Screw System |
Paragon 28, Inc. |
Haylie Hertz |
| K203024 |
11/24/2020 |
C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge |
PENTAX of America, Inc. |
Gurvinder Singh Nanda |
| K202821 |
11/18/2020 |
Indigo Aspiration System - Aspiration Catheter 12 and Separator 12 |
Penumbra, Inc. |
Michaela Mahl |
| K200098 |
11/10/2020 |
VagiVital Aktivgel |
Peptonic Medical AB |
Dan Markusson |
| K193411 |
11/12/2020 |
O2asis Personal Oxygen Humidifier |
Perma Pure LLC |
Sidra Hankins |
| K203216 |
11/25/2020 |
The Multimodality Advanced Vessel Analysis |
Philips Medical Systems Nederland B.V. |
Vered Nitzan |
| K201827 |
11/05/2020 |
GR-17 Resin System |
Pro3dure Medical GmbH |
Martin Klare |
| K202682 |
11/24/2020 |
Promisemed Triple Safety Pen Needle |
Promisemed Hangzhou Meditech Co., Ltd. |
Zearou Yang |
| K202529 |
11/20/2020 |
ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring |
ProSomnus Sleep Technologies, Inc. |
Divya Mavalli |
| K193499 |
11/04/2020 |
DigiGuide System |
ProtoMED, Inc. |
James Jimenez |
| K192860 |
11/19/2020 |
Sapphire Infusion Pump, Sapphire administration sets |
Q Core Medical Ltd. |
Guy Mlechkovich |
| K202503 |
11/18/2020 |
Chrome |
Quanta System Spa |
Francesco Dell'Antonio |
| K201984 |
11/20/2020 |
MPS 3 ND Myocardial Protection System |
Quest Medical, Inc. |
Tosan Eweka |
| K200672 |
11/06/2020 |
Durex Penck Standard, Durex Penck XL |
RB Health (US) LLC |
Kyle Prince |
| K201840 |
11/04/2020 |
Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box) |
Rebound Therapeutics |
Naomi Gong |
| K200811 |
11/06/2020 |
cobas u 701 microscopy analyzer |
Roche Diagnostics |
Teresa Carrow |
| K203043 |
11/11/2020 |
Route 92 Medical 070 Access System |
Route 92 Medical, Inc. |
Kathy Tansey |
| K200992 |
11/17/2020 |
S.I.N. Dental Implant System |
S.I.N.-Sistema de Implante Nacional S.A. |
Denise Domiciano |
| K202413 |
11/20/2020 |
LC ResinCal PC |
S&C Polymer Silicon- und Composite Spezialitaten GmbH |
Christian Bottcher |
| K202000 |
11/20/2020 |
Silatrix Oral Gel |
SA3, LLC |
Farbod Melamed |
| K201877 |
11/05/2020 |
OtoSet- Ear Cleaning System |
SafKan, Inc. |
Sahil Diwan |
| K201193 |
11/25/2020 |
SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu aòPOD-L NanoMetalene; SeaSpine Vu eòPOD System; and SeaSpine Reef TH System, SeaSpine Vu aòPOD Prime NanoMetalene IBD; and SeaSpine Shoreline ACS, SeaSpine Cambria System |
SeaSpine Orthopedics Corporation |
Alicia McArthur |
| K202758 |
11/16/2020 |
Nd: YAG Laser Therapy Systems HM-YL900 |
Shangdong Huamei Technology Co., Ltd. |
Xu QingHua |
| K201601 |
11/10/2020 |
Medical Face Mask |
Shanghai Kindly Medical Instruments Co., Ltd. |
Xu Jianhai |
| K201694 |
11/19/2020 |
Air Compression Therapy Device |
Shenzhen Dongjilian Electronics Co.,Ltd. |
Zhang Hong |
| K201991 |
11/23/2020 |
Medical surgical mask |
Shenzhen Everwin Precision Technology Co., Ltd. |
Guoshun Shi |
| K202980 |
11/19/2020 |
Laser Therapy Device |
Shenzhen Leaflife Technology Co., Ltd |
Cheng Qiang |
| K201990 |
11/09/2020 |
DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp Diagnostic Ultrasound System |
Shenzhen Mindray Bio-medical Electronics Co., Ltd |
Jiang Haosen |
| K203110 |
11/09/2020 |
iFuse Implant System - iFuse Navigation |
SI-BONE, Inc. |
Nancy Kaiser |
| K193562 |
11/06/2020 |
AI-Rad Companion Organs RT |
Siemens Medical Solutions USA, Inc. |
Lauren Bentley |
| K201195 |
11/18/2020 |
syngo.via MI Workflows, syngo MBF |
Siemens Medical Solutions USA, Inc. |
Clayton Ginn |
| K200706 |
11/16/2020 |
Sientra OPUS Silicone Gel Breast Implant Sizer |
Sientra, Inc |
JoAnn Kuhne |
| K202762 |
11/16/2020 |
Circular Fixation with Balanced Cable Transport |
Smith & Nephew, Inc. |
Crystal Higgenbottom-Shaffer |
| K201918 |
11/16/2020 |
EVOS Large Fragment Plating System |
Smith & Nephew, Inc. |
Thomas Fearnley |
| K200612 |
11/17/2020 |
R501 aortic root cannula without vent line, R502 aortic root cannula with vent line |
Sorin Group Italia S.r.l. |
Luigi Vecchi |
| K202664 |
11/06/2020 |
Clio Prime and Clio Pedo |
Sota Precision Optics, Inc. dba SOTA Imaging |
Bumsuk Kim |
| K202476 |
11/05/2020 |
Salvo« Spine System |
Spine Wave, Inc. |
Amy Noccioli |
| K203061 |
11/06/2020 |
Amsco Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200),Evolution Automated Loading and Unloading System (ALUS); Amsco EvolutionMedium Steam Sterilizer (Models HC-600 and HC-1500),Evolution Automated Loading and Unloading System (ALUS); Amsco |
STERIS Corporation |
Anthony Piotrkowski |
| K202583 |
11/06/2020 |
BioShield biopsy valve EUS - Linear |
Steris Corporation |
Jacqueline Oliver |
| K202355 |
11/13/2020 |
Stryker Omega PEEK Knotless Anchor System |
Stryker |
Katie Farraro |
| K182084 |
11/04/2020 |
Sweden & Martina Surgical Tray (Model ZSHORTY-INT) |
Sweden & Martina S.p.A. |
Alessia Pezzato |
| K201741 |
11/05/2020 |
Gabriel 3 Way EnFit Valve |
Syncro Medical Innovations, Inc. |
Sabry Gabriel |
| K192177 |
11/25/2020 |
SysMed S/T |
SysMed (China) Co., Ltd |
Yue Jian |
| K202178 |
11/13/2020 |
VersaLoop Anchor System |
T.A.G. Medical Products Corporation, Ltd |
Shlomi Dines |
| K200750 |
11/06/2020 |
Neuro.Al Algorithm |
TeraRecon, Inc. |
Megha Jain |
| K203040 |
11/13/2020 |
TSolution One Total Knee Application |
THINK Surgical, Inc. |
Meliha Mulalic |
| K193385 |
11/12/2020 |
TP Orthodontics Clear Aligner System |
TP Orthodontics Inc. |
Stephanie Thyen |
| K192621 |
11/06/2020 |
Medical RF |
Triworks Group SRL |
Elio Piero Berchicci |
| K203082 |
11/12/2020 |
Insight Infrared Video Goggles |
Vestibular First |
Helena Esmonde |
| K202490 |
11/16/2020 |
Avid CT2 |
Vision Quest Industries Inc./dba VQ OrthoCare |
Mohamed Ouerghi |
| K193285 |
11/20/2020 |
V-ONESTEP |
Vitromed GmbH |
Deepesh Changat |
| K200472 |
11/18/2020 |
Viveve System |
Viveve Medical, Inc. |
Kevin Robison |
| K201091 |
11/06/2020 |
V-Print splint |
VOCO GmbH |
M. Th. Plaumann |
| K201998 |
11/17/2020 |
JETi AIO Peripheral Thrombectomy System |
Walk Vascular, LLC |
David Look |
| K193191 |
11/20/2020 |
MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag |
Weinmann Emergency Medical Technology GmbH + Co. KG |
Kristin Ratschiller |
| K202931 |
11/17/2020 |
Disposable Trocar |
Wuxi Shukang Medical Appliance Co., Ltd. |
Xiaoqing Yuan |
| K201825 |
11/20/2020 |
MiniCAT 2D |
Xoran Technologies LLC |
Mark McGarrow |
| K202624 |
11/04/2020 |
Z-Span Plate System |
Zavation Medical Products LLC |
Frankie Cummins |
| K201523 |
11/12/2020 |
Sharps container |
Zhejiang Gongdong Medical Technology Co., Ltd |
Weifeng Zhong |
| K202250 |
11/25/2020 |
Dermatological Carbon Dioxide Laser Systems |
Zhuolu Jontelaser Manufacturing Technology Co., Ltd |
Karen Liu |
