| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K200633 |
10/11/2020 |
Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove |
0 & M Halyard, Inc |
Steven Dowdley |
| K200299 |
10/29/2020 |
Curos Jet Disinfecting Cap |
3M Company |
Cory J Hitzman |
| K200100 |
10/07/2020 |
Abutment Design |
3Shape A/S |
Jenny Axel |
| K201610 |
10/21/2020 |
IonicRF Generator |
Abbott Medical |
Jim Chapman |
| K200109 |
10/23/2020 |
OXY-1 System |
Abiomed Inc. |
Steve Orwig |
| K202797 |
10/23/2020 |
Drakon and Sequre Microcatheters |
Accurate Medical Therapeutics Ltd. |
Osnat Harbater |
| K201816 |
10/16/2020 |
ARTHROTAP |
Accuro Technologies Inc. |
Michael Dolphin |
| K200725 |
10/07/2020 |
Citregen Tendon Interference Screw and Citrelock |
Acuitive Technologies |
Jaclyn Docs |
| K202489 |
10/26/2020 |
AOS Fibonacci Lower Extremity Plating System û AOS Proximal Tibia Plating System |
Advanced Orthopaedic Solutions, Inc. |
Jolie Krance |
| K202938 |
10/30/2020 |
Aesculap Caiman 5 Seal and Cut Technology System |
Aesculap Inc. |
Omunique (Nikki) Luke |
| K202327 |
10/15/2020 |
InvictusÖ OsseoScrew« System |
Alphatec Spine, Inc. |
Sandy Gill |
| K200710 |
10/01/2020 |
Infrared PT2L Digital No-Touch Thermometer |
Andon Health Co., Ltd. |
Liu Yi |
| K201380 |
10/07/2020 |
Livocare Surgical Mask |
Andon Health Co., Ltd. |
Liu Yi |
| K201771 |
10/19/2020 |
Single Use Rotatable and Repositionable Hemoclip |
Anrei Medical (Hangzhou) Co., Ltd. |
Huibing Yang |
| K193206 |
10/29/2020 |
WiZARD 510 Nasal Mask |
Apex Medical Corp. |
Chieh Yang |
| K201525 |
10/08/2020 |
ECG App |
Apple Inc. |
Luke Olson |
| K202539 |
10/29/2020 |
Nutriglide(TM) Nasal Feeding Tube |
Applied Medical Technology, Inc. |
Joy Tubero |
| K201438 |
10/21/2020 |
ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer |
Arlington Scientific, Inc. (ASI) |
David Binks |
| K190707 |
10/02/2020 |
Arthrex SoftStitch |
Arthrex Inc. |
David L Rogers |
| K200718 |
10/15/2020 |
Arthrosurface WristMotion Total Wrist Arthroplasty System |
Arthrosurface, Inc. |
Dawn J. Wilson |
| K202065 |
10/26/2020 |
DOLOMITE Anterior Cervical Stabilization System |
Astura Medical, LLC |
Parker Kelch |
| K202302 |
10/30/2020 |
Atlas Spine Rebar (Ti) Spacer System |
Atlas Spine, Inc. |
Thomas Smith |
| K200031 |
10/05/2020 |
Neonatal Phototherapy System |
Avalon Biomedical (Shenzhen) Limited |
Eva Zhu |
| K202180 |
10/22/2020 |
Broncoflex Agile; Product Reference: 20030001 , Broncoflex Vortex; Product Reference: 10030001, Screeni; Product Reference: 30030001 |
Axess Vision Technology |
Marie-HΘlΦne Bacheley |
| K202429 |
10/23/2020 |
Mobio Total Knee System |
b-One Ortho, Corp. |
Allison Gecik |
| K193542 |
10/08/2020 |
Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22 |
Bellco Srl |
Rekha Roveri |
| K201427 |
10/21/2020 |
Trivergent Spinal Fixation System |
Benvenue Medical, Inc. |
Laurent Schaller |
| K202010 |
10/16/2020 |
Disposable Vinyl Glove |
Better Health Medical Products Co., Ltd. |
Xiaomeng Li |
| K200114 |
10/13/2020 |
Astroglide Organix Liquid |
BioFilm Inc |
Richard Hines |
| K201161 |
10/02/2020 |
Infrared Thermometer Model E127 |
Bioland Technology Ltd. |
Yiqing Feng |
| K193038 |
10/28/2020 |
Comprehensive Shoulder System |
Biomet Manufacturing Corp. |
Patricia Sandborn Beres |
| K200103 |
10/09/2020 |
BIOTEQ Drainage Catheter Set (One Step Type) |
Bioteque Corporation |
Stella Hsu |
| K193474 |
10/16/2020 |
Selectra 3D Outer Guiding Catheters |
BIOTRONIK, Inc |
Jon Brumbaugh |
| K202114 |
10/06/2020 |
CoolSeal Generator/CSL-200-50, CoolSeal Trinity (30 cm shaft)/CSL-TR105-30, CoolSeal Trinity (37 cm shaft)/CSL-TR105-37, CoolSeal Trinity (44 cm shaft)/CSL-TR105-44, CoolSeal Mini (20cm shaft)/CSL-MN103-20 |
Bolder Surgical, LLC |
Nicholas Wong |
| K201535 |
10/16/2020 |
Cerament Bone Void Filler |
BoneSupport AB |
Blerta Shuka |
| K202089 |
10/28/2020 |
LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer |
Bonraybio Co., Ltd. |
Brown Hsu |
| K202478 |
10/08/2020 |
Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares |
Boston Scientific Corporation |
Stephanie Gorman |
| K202584 |
10/06/2020 |
iSleeve Introducer Set |
Boston Scientific Corporation |
Kripa Pandya |
| K202218 |
10/02/2020 |
ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device |
Boston Scientific Corporation |
Vanessa Fowler |
| K193421 |
10/30/2020 |
Smart Alarm Interface |
BoxView, LLC |
Cody Guest |
| K192703 |
10/08/2020 |
Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (BK), Intraoperative Structure Update |
Brainlab AG |
Chiara Cunico |
| K192771 |
10/21/2020 |
C4 Fiducial Marker |
C4 Imaging LLC |
Andrew Bright |
| K192811 |
10/23/2020 |
BenestaTM Tissue Removal Device |
Caldera Medical, Inc. |
Vicki Gail |
| K202364 |
10/15/2020 |
Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1 |
Canon Medical Systems Corporation |
Paul Biggins |
| K201972 |
10/08/2020 |
Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1 |
Canon Medical Systems Corporation |
Paul Biggins |
| K202737 |
10/16/2020 |
Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Xario200G and Xario100G, Diagnostic Ultrasound System |
Canon Medical Systems Corporation |
Paul Biggins |
| K202349 |
10/15/2020 |
Cartesion Prime, PCD-1000A, V10.7 |
Canon Medical Systems Corporation |
Paul Biggins |
| K201475 |
10/28/2020 |
Ultimate Contour, Ultimate Contour Mini |
CAO Group, Inc. |
Robert K. Larsen |
| K201917 |
10/08/2020 |
Piccolo Composite Proximal Tibia Plate System |
CarboFix Orthopedics, Ltd. |
Yael Rubin |
| K201155 |
10/21/2020 |
PleurX Peritoneal Catheter System |
CareFusion |
Nazeer Khan |
| K193088 |
10/23/2020 |
MaxZero Extension Sets with Needle-Free Connector(s) |
Carefusion, Inc. |
Viviana Lai |
| K200207 |
10/15/2020 |
xPORT S Lens Fragmentation System |
Carl Zeiss Meditec Cataract Technology Inc. |
Gary Mocnik |
| K200595 |
10/16/2020 |
CellaVision DC-1, CellaVision DC-1 PPA |
CellaVision AB |
Magnus Johnsson |
| K200764 |
10/15/2020 |
STATSTIX |
Centrix Incorporated |
Greg Moreau |
| K203007 |
10/30/2020 |
eKuore Pro Series |
Chip Ideas Electronics S.L. |
Bernardo Plaza Trillo |
| K202280 |
10/02/2020 |
Cleerly Labs v2.0 |
Cleerly, Inc. |
James K. Min |
| K202756 |
10/20/2020 |
Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 Day Multifocal (somofilcon A), Clariti 1 Day Multifocal Toric (somofilcon A) |
CooperVision, Inc. |
Marie Dutton |
| K201377 |
10/09/2020 |
SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter |
Cordis Corporation |
Luis Davila |
| K201710 |
10/16/2020 |
A View LCS |
Coreline Soft Co., Ltd. |
Hye Yi Park |
| K202864 |
10/28/2020 |
Tri-Staple 2.0 Reloads |
Covidien |
Carolina Cabezas |
| K200003 |
10/28/2020 |
NP1 Instrument, Creo Electrosurgical System |
Creo Medical Ltd. |
Shaun Preston |
| K201559 |
10/02/2020 |
HAL for Medical Use(Lower Limb type) |
Cyberdyne Inc. |
Yohei Suzuki |
| K202472 |
10/21/2020 |
ACTIS Duofix Hip Prosthesis |
DePuy Orthopaedics Inc. |
Karen Mahoney |
| K200757 |
10/15/2020 |
Foley Catheter with Temperature Sensor |
DeRoyal Industries, Inc. |
Sarah Bennett |
| K200273 |
10/27/2020 |
FREEPRINT temp |
DETAX GmbH & Co.KG |
Markus Stratmann |
| K200544 |
10/01/2020 |
SmartLyte« Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+ |
Diamond Diagnostics Inc. |
Kathy Fisher |
| K201908 |
10/15/2020 |
LIAISON Testosterone xt |
DiaSorin Inc. |
John Walter |
| K193623 |
10/22/2020 |
DIOnavi-Denture |
DIO Corporation |
Jiae Park |
| K202633 |
10/07/2020 |
ScanX Edge |
Dⁿrr Dental SE |
Oliver Lange |
| K202292 |
10/05/2020 |
UDE |
EBM Technologies Inc. |
John Su |
| K193296 |
10/30/2020 |
eCordum Cardiac Monitor (eCordum CM) |
eCordum, Inc. |
Vladislav Bukhman |
| K201446 |
10/01/2020 |
HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module |
Edwards Lifesiences, LLC |
Varad Raghuwanshi |
| K201572 |
10/19/2020 |
TAPESTRY Biointegrative Implant |
Embody, Inc. |
Scott Bruder |
| K200767 |
10/08/2020 |
SilverStream Gel |
EnzySurge Ltd. |
Moshe Landsberg |
| K200125 |
10/28/2020 |
Thermoforming Sheet Materials |
Erkodent Erich Kopp GmbH |
Hans-Peter Kopp |
| K202665 |
10/15/2020 |
Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Flex 60mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Endopath Endoscopic Linear Cutter Reloads, 45mm, Echelon Endopath Endoscopic Linear Cutter Reloads, 60mm |
Ethicon Endo-Surgery, LLC |
Nathan Anderson |
| K201335 |
10/24/2020 |
Li-Battery powered OTC TENS/EMS Combination Stimulator |
Everyway Medical Instruments Co., Ltd |
Paul Hung |
| K202948 |
10/22/2020 |
EzOrtho |
Ewoo Soft Co., Ltd. |
Young Seok Kim |
| K200127 |
10/01/2020 |
TELEGRAPH« EVOLUTION Humeral Nailing System |
FH Industrie |
Patricia Donnard |
| K200217 |
10/05/2020 |
ClearEndoclip |
Finemedix Co., Ltd. |
H. S. Lee |
| K192949 |
10/07/2020 |
Flower Suture Anchor Set |
Flower Orthopedics Corporation |
Jessica Huang |
| K201139 |
10/20/2020 |
WEGO-PDO Barbed Suture |
Foosin Medical Supplies Inc., Ltd. |
Zhipeng Yang |
| K203028 |
10/30/2020 |
FUJIFILM Distal End Cap |
Fujifilm Corporation |
Randy Vader |
| K200088 |
10/29/2020 |
g.Estim FES |
g.tec medical engineering GmbH |
Christoph Guger |
| K200682 |
10/02/2020 |
BZF-29 |
GC America Inc. |
Mark Heiss |
| K201768 |
10/22/2020 |
Voluson E10 |
GE Healthcare |
Bryan Behn |
| K201828 |
10/11/2020 |
Voluson SWIFT, Voluson SWIFT+ |
GE Medical Systems Ultrasound and Primary Care Diagnostics |
Bryan Behn |
| K201615 |
10/15/2020 |
SIGNA 7.0T |
GE Medical Systems, LLC |
Brian R. Zielski |
| K202253 |
10/06/2020 |
TruForm Sievers Annuloplasty Ring |
Genesee BioMedical, Inc |
Woodrow Mathison |
| K200153 |
10/28/2020 |
Bright Bond Universal |
GENOSS Co., Ltd. |
Hong Jun Jeon |
| K200156 |
10/27/2020 |
Bright Low Flow |
Genoss co.,Ltd. |
Hong Jun Jeon |
| K202496 |
10/29/2020 |
ANTHEM Fracture System |
Globus Medical Inc. |
Jennifer Antonacci |
| K200332 |
10/29/2020 |
EXPERT - Joint Fixation System |
GM dos Reis Industria e Comercio Ltda |
Paula Oliveira |
| K202817 |
10/22/2020 |
GEO Bone Screw System |
Gramercy Extremity Orthopedics, LLC |
Michael Simpson |
| K201845 |
10/08/2020 |
Portable Electro-Stimulation Therapy Device, Model: LGT-232(US) |
Guangzhou Longest Science & Technology Co., LTD. |
Xiaobing Luo |
| K181477 |
10/20/2020 |
MS Lide Implant Systems |
Hangzhou Minsheng Lide Medical Science & Technology Co., Ltd |
Charles Shen |
| K202044 |
10/21/2020 |
Powerpress Recovery Unit |
Hanuri Distribution, Inc |
Jung Hyun Moon |
| K201748 |
10/02/2020 |
Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for use with Chemotherapy Drugs |
Hartalega SDN BHD |
Kuan Kam Hon |
| K192921 |
10/09/2020 |
Zeos Aqua Vision Pump and tube |
Hemodia SAS |
Adeline Theron |
| K202030 |
10/21/2020 |
OASIS MRI System |
Hitachi Healthcare Americas |
Aaron Pierce |
| K193090 |
10/29/2020 |
HCG Zirconia Ceramic Block |
Hocheng Corporation |
Chieh-Ju Huang |
| K202294 |
10/05/2020 |
Affirm Contrast Biopsy |
Hologic, Inc |
Kate Brown |
| K203099 |
10/27/2020 |
Triathlon PKR System |
Howmedica Osteonics Corp aka Stryker Orthopaedics |
Allison Byrne |
| K202016 |
10/16/2020 |
Dall-Miles« Cable System |
Howmedica Osteonics Corp., dba Stryker Orthopaedics |
Margaret Klippel |
| K202340 |
10/15/2020 |
Droplet Pen Needle 30G & 33G |
HTL-Strefa S.A. |
Aleksandra Prazmowska-Wilanowska |
| K200596 |
10/13/2020 |
G21 Cement, VADER« Pedicle System |
Icotec AG |
Marina Hess |
| K201587 |
10/15/2020 |
icotec Anterior Cervical Plate System |
Icotec AG |
Marina Hess |
| K202887 |
10/27/2020 |
IlluminOss Bone Stabilization System |
IlluminOss Medical, Inc. |
Robert Rabiner |
| K201092 |
10/29/2020 |
LSN |
Imaging Biometrics, LLC |
Timothy Dondlinger |
| K193410 |
10/02/2020 |
SOZO Body Fluid Analyzer |
ImpediMed Limited |
Catherine Kingsford |
| K200045 |
10/16/2020 |
MUTARS Cemented Femoral Stems |
implantcast, GmbH |
Juliane Hoppner |
| K200937 |
10/26/2020 |
ACURA Stabilization System |
Indius Medical Technologies Pvt. Ltd. |
Aditya Ingalhalikar, |
| K201528 |
10/11/2020 |
Yushan X-Ray Flat Panel Detector with DROC |
InnoCare Optoelectronics Corp. |
Yumei Cheng |
| K193357 |
10/23/2020 |
V-Mix |
Inter-Med/ Vista Dental Products |
Katherine Barry |
| K203058 |
10/29/2020 |
CloudVue |
International Medical Solutions Inc. |
Vernon Colaco |
| K202760 |
10/21/2020 |
Iridex 810 Laser |
Iridex Corporation |
Bill Hyatt |
| K202912 |
10/29/2020 |
ARIX Ankle Distal Tibia System |
Jeil Medical Corporation |
Ahhyeon Woo |
| K202528 |
10/26/2020 |
Cannulated Power Driver Attachment |
K2M Inc. |
Megan Callanan |
| K202957 |
10/29/2020 |
Flexible Video Cysto-Urethroscope (C-view) |
KARL STORZ Endoscopy-America, Inc |
Winkie Wong |
| K200318 |
10/22/2020 |
UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece |
Karl Storz Endoscopy-America, Inc. |
Alita McElroy |
| K200249 |
10/23/2020 |
Sequential Culture Media (Fertilization Medium [without HSA/rHA, with HSA, with rHA], Cleavage Medium [without HSA/rHA, with HSA, with rHA], Blastocyst Medium [without HSA/rHA, with HSA, with rHA]) |
Kitazato Corporation |
Futoshi Inoue |
| K200794 |
10/20/2020 |
AccelFix Spinal Fixation System |
L&K BIOMED Co., Ltd. |
KiHyang Kim |
| K200793 |
10/08/2020 |
LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation System |
L&K BIOMED Co., Ltd. |
KiHyang Kim |
| K200790 |
10/28/2020 |
LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System |
L&K BIOMED Co., Ltd. |
KiHyang Kim |
| K201882 |
10/09/2020 |
AEON Endoscopic Stapler |
Lexington Medical Inc. |
Rainer Maas |
| K201777 |
10/08/2020 |
31HN713D |
LG Electronics Inc. |
Jinhwan Jun |
| K202901 |
10/30/2020 |
Longeviti ClearFit Cranial Implant |
Longeviti Neuro Solutions, LLC |
Heather Hourihan |
| K201038 |
10/09/2020 |
Luce Ceramic Bracket |
Luce Castle Co., Ltd. |
Kyung Joo Kim |
| K202428 |
10/22/2020 |
AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories |
Lumenis Ltd. |
Shlomit Segman |
| K193631 |
10/09/2020 |
Stethee Pro 1, Stethee Pro Software System |
M3DICINE Pty Ltd. |
Nayyar Hussain |
| K200661 |
10/08/2020 |
Steripath Micro Blood Collection System |
Magnolia Medical Technologies Inc. |
Gregory J. Bullington |
| K202207 |
10/02/2020 |
Materialise PKA Guide System |
Materialise NV |
Veerle Vanderheyden |
| K192989 |
10/29/2020 |
Libertas E-XLPE Modular Liner |
Maxx Orthopedics, Inc. |
Priscilla Herpai |
| K203005 |
10/27/2020 |
Mazor X |
Mazor Robotics Ltd. |
Shiran Conforti |
| K201983 |
10/09/2020 |
BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm) |
Med-El Elektromedizinische Geraete GmbH |
Stephanie Haselwanter |
| K200792 |
10/05/2020 |
MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides |
Medacta Inernational SA |
Stefano Baj |
| K200067 |
10/01/2020 |
MectaScope System |
Medacta International SA |
Stefano Baj |
| K202152 |
10/27/2020 |
NextAR TKA Platform |
Medacta International SA |
Stefano Baj |
| K192282 |
10/29/2020 |
MedCAD« AccuPlan« System |
MedCAD |
Brian Buss |
| K200906 |
10/16/2020 |
MINICONE Implant |
Medentika GmbH |
Alexandra Schulz |
| K200434 |
10/09/2020 |
V20, V20a, AVSM3 SNF |
Mediana Co., Ltd. |
Dana Mun |
| K201695 |
10/30/2020 |
Patent Hemostasis Band (PH Band) |
Medical Ingenuities |
Richard "Chip" Corrigan |
| K200316 |
10/30/2020 |
UNiD IB3D ALIF |
Medicrea International S.A. |
David Ryan |
| K201129 |
10/16/2020 |
Medline Smoke Evacuation Pencil |
Medline Industires, Inc. |
Matt Clausen |
| K200150 |
10/26/2020 |
Medline Powder-Free Orange Nitrile Patient Examination Glove (Tested for use with Fentanyl) |
Medline Industries Inc |
Leontyne Banks |
| K202285 |
10/09/2020 |
Medline ENfit OTC Feeding Syringe |
Medline Industries, Inc. |
Dinah Rincones |
| K202179 |
10/26/2020 |
Medline Glide-On 3G Vinyl Examination Gloves (Tested for use with Chemotherapy Drugs) |
Medline Industries, Inc. |
Adam Ostrower |
| K200425 |
10/29/2020 |
Female Luer Lock Cap |
MedSafety Solutions LLC |
Rich Weiskopf |
| K202771 |
10/19/2020 |
CD Horizon Spinal System |
Medtronic |
Raphael McInnis |
| K200759 |
10/28/2020 |
NIM Vital, Nerve Integrity Monitor |
Medtronic Xomed, Inc. |
Marek Pawlowski |
| K201595 |
10/14/2020 |
Merit Hydrophilic Guide Wire |
Merit Medical Systems, Inc. |
Mark Mullaney |
| K201884 |
10/21/2020 |
ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted ReNew XR Handpiece 34cm |
Microline Surgical, Inc. |
Scott Marchand Davis |
| K202960 |
10/27/2020 |
General Cutting Contra Handpiece |
Nakanishi Inc. |
Masaaki Kikuchi |
| K193169 |
10/29/2020 |
Nelson Sentinel Series Basic Chlorine Sentinel |
Nelson Environmental Technologies, Inc. |
QuocHuy (Huy) Nquyen |
| K202100 |
10/19/2020 |
Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS) |
Neocis Inc. |
Thomas E Claiborne |
| K201561 |
10/05/2020 |
Membrane Screws and Membrane Tacks |
Neoss Limited |
Stellan Sundstrom |
| K202190 |
10/02/2020 |
Oculus-SA Lumbar Cage System |
Neurostructures |
Moti Altarac |
| K200810 |
10/08/2020 |
IPS CaseDesigner |
Nobel Biocare AB |
Elena Cavallini |
| K201692 |
10/29/2020 |
NuVasive Modulus XLIF Interbody System |
NuVasive, Incorporated |
Jessica LeBlanc |
| K200953 |
10/06/2020 |
NuVasive« Cohere« Thoracolumbar Interbody System |
NuVasive, Incorporated |
Michelle Cheung |
| K201724 |
10/21/2020 |
Pentacam AXL Wave |
OCULUS Optikgerate GmbH |
Eckhard Loh |
| K202646 |
10/29/2020 |
Visera Elite II Video System Center |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K202949 |
10/29/2020 |
CONSTRUX Mini PEEK Spacer System |
Orthofix Inc. |
Natalia Volosen |
| K202666 |
10/14/2020 |
CONSTRUX Mini PTC Spacer System |
Orthofix Inc. |
Natalia Volosen |
| K202519 |
10/27/2020 |
OrthoNext Platform System |
Orthofix Srl |
Gianluca Ricadona |
| K202071 |
10/23/2020 |
SURGIPHOR Wound Irrigation System |
Orthophor, LLC |
Alan Miller |
| K201396 |
10/16/2020 |
Finetest Lite Smart Blood Glucose Monitoring System |
OSANG Healthcare Co., Ltd. |
Ik-Hyeon Kim |
| K201803 |
10/16/2020 |
OSSIOfiberÖ Hammertoe Fixation System/OSSIOfiberÖ Hammertoe Fixation Implant |
Ossio Ltd. |
Taly Lindner |
| K202680 |
10/15/2020 |
OsteoMed ExtremiFix Mini & Small Cannulated Screw System |
OsteoMed LLC |
Andrew "Drew" Johnson |
| K202105 |
10/29/2020 |
OsteoMed ExtremiFix Mini & Small System Tray |
OsteoMed LLC |
Andrew Johnson |
| K202799 |
10/21/2020 |
EVA15 |
Palliare Ltd. |
John O'Dea |
| K201453 |
10/07/2020 |
Fortilink Cages with TiPlus Technology |
Paradigm Spine, GmbH |
Alberto Jurado |
| K202259 |
10/28/2020 |
Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti, Actiflip Naked, Actiflip Cinch, Actiflip Whip, and GFS Ultimate Hip |
Parcus Medical, LLC |
Paul Vagts |
| K200296 |
10/15/2020 |
Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses, Pegavision (Etafilcon A) Color Soft (Hydrophilic) Contact Lenses |
Pegavision Corporation |
Estela Lin |
| K200223 |
10/23/2020 |
PocketDocÖ Micro Wound Therapy System |
Pensar Medical, LLC |
David Buchicchio |
| K202170 |
10/02/2020 |
LiverMultiScan |
Perspectum LTD |
Jaco Jacobs |
| K201381 |
10/01/2020 |
Philips Avent Single/Double electric breast pump Advanced |
Philips Consumer Lifestyle - Innovation Site Eindhoven |
Aurore Millet |
| K201497 |
10/28/2020 |
EVOS Cabling System |
Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.) |
Sarah Pleaugh |
| K200821 |
10/19/2020 |
anti-bacterial bandage |
Planet (Suzhou) Medical Products Co., Ltd |
Frank Zhou |
| K192317 |
10/23/2020 |
Planmed Clarity 2D and Clarity S |
Planmed Oy |
Lars Moring |
| K201268 |
10/21/2020 |
Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) |
Plexus Optix, Inc. |
Dave Delle Donne |
| K193556 |
10/23/2020 |
Cryocheck Hex LA |
Precision BioLogic |
Karen Black |
| K201939 |
10/08/2020 |
GAIA Lumbar Interbody Fusion Device (LIFD) Family |
PrinterPrezz |
Kishore Karkera |
| K202041 |
10/15/2020 |
Opera Evo |
Quanta System SpA |
Francesco Dell'Antonio |
| K202501 |
10/11/2020 |
Quantib Prostate |
Quantib BV |
Floor van Leeuwen |
| K200323 |
10/30/2020 |
AutoContour |
Radformation, Inc. |
Kurt Sysock |
| K202722 |
10/26/2020 |
1212FCA |
Rayence Co., Ltd |
Kee Dock Kim |
| K201811 |
10/26/2020 |
coraForce and coraFlex Support Catheters |
Reflow Medical, Inc. |
Krystal Santiago |
| K202142 |
10/29/2020 |
Sleepware G3 |
Respironics, Inc. |
Jonquil Mau |
| K201546 |
10/02/2020 |
OsOpia Synthetic Bone Void Filler |
RevisiOs BV |
Hen Baron |
| K200728 |
10/06/2020 |
Pitkar DeftFix System |
S H Pitkar Orthotools Pvt Ltd. |
Vivek Mangalwedhekar |
| K202193 |
10/16/2020 |
PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP Adjustable Fixation System for Ligament Reconstruction, PULLUP TEX CLIP Adjustable Fixation System for Ligament Reconstruction, BT LOOP Adjustable Fixation System for Ligament |
S.B.M. SAS (Science & Bio Materials) |
Anne Cospin-Latapie |
| K201688 |
10/21/2020 |
S.I.N. Instrument Kits |
S.I.N. - Sistema de Implante Nacional S.A. |
Denise Domiciano |
| K201659 |
10/05/2020 |
KHEIRON« Spinal Fixation System |
S.M.A.I.O |
Stephanie Escoffier |
| K202556 |
10/30/2020 |
HS30 Diagnostic Ultrasound System |
Samsung Medison Co., LTD |
Ji Yea Lee |
| K201970 |
10/08/2020 |
Schoelly Cystoscopes/Hysteroscopes and Accessories |
Schoelly Fiberoptic GmbH |
Sandra Baumann |
| K201301 |
10/02/2020 |
X100 with Full Field Peripheral Blood Smear (PBS) Application |
Scopio Labs LTD. |
Shahar Karny |
| K202293 |
10/07/2020 |
Radiographic System Challenge X |
Sedecal, SA. |
M¬ Luisa G≤mez de Agⁿero |
| K202374 |
10/19/2020 |
4MP/8MP Color LCD Monitors C44W+/C82W+, C83W+, C85W+ |
Shenzhen Beacon Display Technology Co., Ltd. |
Fu Ailing |
| K200237 |
10/19/2020 |
Transcutaneous Electronic Nerve Stimulator |
Shenzhen Kentro Medical Electronics Co., Ltd |
Zewu Zhang |
| K200802 |
10/07/2020 |
Infrared Thermometer |
Shenzhen Urion Technology Co., Ltd |
Autumn Liu |
| K200408 |
10/16/2020 |
VitaVitro« Fertilization Medium, VitaVitro« Gamete Buffer Medium, VitaVitro« Flushing Buffer Medium |
Shenzhen VitaVitro Biotech Co.,Ltd. |
Donghai Pan |
| K202213 |
10/11/2020 |
syngo.CT Neuro Perfusion |
Siemens Medical Solutions USA, Inc. |
Veronica Padharia |
| K201670 |
10/21/2020 |
YSIO X.pree |
Siemens Medical Solutions USA, Inc. |
Andrew Turner |
| K202683 |
10/15/2020 |
ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System, ACUSON Freestyle Diagnostic Ultrasound System,ACUSON S1000, S2000, S3000 Diagnostic Ultrasound Systems, ACUSON P200 Diagnostic Ultrasound System, ACUSON P500 Diagnos |
Siemens Medical Solutions, USA, Inc. |
Christine Dunbar |
| K201238 |
10/02/2020 |
Encore System |
Siesta Medical, Inc. |
Michael Kolber |
| K202392 |
10/23/2020 |
SIR-Spheres Microspheres Activity Calculator (SMAC) |
Sirtex Medical US Holdings Inc. |
Michael P. Hanley |
| K200623 |
10/02/2020 |
OssGuide |
Sk bioland Co., Ltd. |
Yeonjeong Chae |
| K201962 |
10/13/2020 |
Skeletal Dynamics Ulnar Shortening Plating System |
Skeletal Dynamics, Inc. |
Diana Taylor |
| K191320 |
10/02/2020 |
Slow Wave DS8 |
Slow Wave, Inc. |
Wayne R. Wagner |
| K202469 |
10/26/2020 |
G-EYE System |
SMART Medical Systems Ltd. |
Adva Yoselzon |
| K202157 |
10/30/2020 |
PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Pack |
Smith & Nephew Medical Limited |
Steeve Lamvohee |
| K201701 |
10/06/2020 |
R3 HA Coated Acetabular Shells |
Smith & Nephew, Inc. |
John Reabe |
| K201988 |
10/30/2020 |
T-Lite |
Sonoscanner |
Bruno Richard |
| K193084 |
10/27/2020 |
TIB Abutment System |
Southern Implants (Pty) Ltd |
Lauranda G Breytenbach |
| K202733 |
10/16/2020 |
Quantum Ventilation Module |
Spectrum Medical Ltd |
Colleen Powell |
| K202557 |
10/02/2020 |
Quantum Workstation 12 Elite |
Spectrum Medical Ltd |
Colleen Powell |
| K193000 |
10/20/2020 |
Hexanium« ACIF |
SpineVision SAS |
Anaelle Gallego |
| K202592 |
10/08/2020 |
Adavanced Imaging Modality System (1688 4K Camera System With Advanced Imaging Modality, L11 LED Light Source with Adavanced Imaging Modality) |
Stryker |
Divya Sekar |
| K202609 |
10/09/2020 |
Instrument Clamps Electromagnetic |
Stryker Corporation |
Maya Schiel |
| K202393 |
10/20/2020 |
SpineJack Expansion Kit |
Stryker Corporation |
Kristi Ashton |
| K201398 |
10/15/2020 |
SINUSPRIME Dilation System |
Stryker ENT |
Bruce Backlund |
| K202935 |
10/28/2020 |
Syntec Femoral Nail Extended System |
Syntec Scientific Corporation |
Nicole Tseng |
| K202497 |
10/30/2020 |
Aulisa Multiple Patient Digital Vital Sign Monitoring System |
Taiwan Aulisa Medical Devices Technologies, Inc. |
Paul Liu |
| K201824 |
10/23/2020 |
Nerivio |
Theranica Bio-Electronics LTD. |
Alon Ironi |
| K202357 |
10/01/2020 |
Nutricare Clear-ISOSAF Nasogastric Feeding Tube |
Three Circles Consulting Limited |
Matthew Theobald |
| K202740 |
10/09/2020 |
Klassic Knee System Tibial Inserts, PS-Max |
Total Joint Orthopedics, Inc. |
Chris Weaber |
| K193552 |
10/21/2020 |
InnovaMatrix |
Triad Life Sciences, Inc. |
Russell I Olsen |
| K200817 |
10/07/2020 |
URIS OMNI Narrow System & Prosthetic |
TruAbutment Inc. |
Eunjin Jang |
| K201627 |
10/27/2020 |
Dental Computed Tomography X-Ray System, Green X |
Vatech Co., Ltd |
Daniel Kim |
| K200190 |
10/30/2020 |
ScalpelCric |
VBM Medizintechnik GmbH |
Jannika Jaeger |
| K201562 |
10/14/2020 |
Spirotrac |
Vitalograph Ireland Ltd. |
Tony O'Hanlon |
| K200510 |
10/09/2020 |
Multi-LinkTM X2 ECG Adapter and Leadwires |
Vyaire Medical, Inc. |
Suzanne Moreno |
| K202119 |
10/07/2020 |
AcuSee AS-P1000 System |
Weipeng (Suzhou) Medical Devices Co., Ltd. |
Bin Yang |
| K201843 |
10/23/2020 |
Infrared ear and forehead thermometer, model YI-100 |
Wenzhou Yosun Medical Technology Co., Ltd. |
Lihao Yang |
| K201415 |
10/21/2020 |
Vial2Bag Advanced 20mm Admixture Device |
West Pharmaceutical Services AZ, Inc. |
Elena Mack |
| K202013 |
10/30/2020 |
WRDensity by Whiterabbit.ai |
Whiterabbit.ai Inc. |
Jason Su |
| K202894 |
10/23/2020 |
Wiltrom Spinal Fixation System |
Wiltrom Corporation Limited |
Freda Lin |
| K200507 |
10/21/2020 |
PRO-DENSE LoVisc Bone Graft Substitute |
Wright Medical Technology, Inc. |
Rachel Roberts |
| K201359 |
10/01/2020 |
ECG Cables and Leadwires |
Xinkang Medical Instrument Co., Ltd |
Xu Changsheng |
| K201395 |
10/28/2020 |
Sterile High-pressure Angiographic Syringes for single-use |
Youwo (Guangzhou) Medical Device Co., Ltd. |
Meijin Song |
| K200386 |
10/14/2020 |
Z5-BL |
Z-Systems AG |
Rubino DiGirolamo |
| K200084 |
10/19/2020 |
Zavation IBF System |
Zavation Medical Products LLC |
Colby Williams |
| K202305 |
10/13/2020 |
Zavation IBF System |
Zavation Medical Products, LLC |
Colby Williams |
| K201483 |
10/08/2020 |
Impression Material |
Zhengzhou Huaer Electro Optics Technology Co., Ltd |
Li XiaoJun |
| K202309 |
10/08/2020 |
Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero Facet Screw System, Alpine XC Adjustable Fusion System, Aspen MIS Fusion System, L-Plate MIS Fusion System |
Zimmer Biomet Spine, Inc. |
David Pollard |
