| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K222859 |
09/22/2022 |
3M V.A.C. Peel and Place Dressing Kit, Small (EZ10SML), 3M V.A.C. Peel and Place Dressing Kit, Medium (EZ10MED), 3M V.A.C. Peel and Place Dressing Kit, Large (EZ10LRG) |
3M |
Melanie Avila |
| K222850 |
09/21/2022 |
HAVAb IgG II |
ABBOTT LABORATORIES |
Dominic Tunzi |
| K223094 |
09/30/2022 |
EnSiteÖ X EP System TactiFlexÖ Ablation Catheter, Sensor EnabledÖ, Software Upgrade; EnSiteÖ X EP System TactiFlexÖ Ablation Catheter, Sensor EnabledÖ, Software License |
Abbott Medical |
Alyssa Timmers |
| K222658 |
09/02/2022 |
Accurate 24 Non-invasive blood pressure monitor |
Accurate Meditech Inc. |
Wang Kuan Jen |
| K223013 |
09/29/2022 |
AccurECG Analysis System |
AccurKardia, Inc. |
Juan C. Jimenez |
| K222998 |
09/28/2022 |
F3 |
Acrew Imaging, Inc. |
Craig Hughes |
| K222950 |
09/27/2022 |
AcuPebble OX100 |
Acurable Limited |
Esther Rodriguez-Villegas |
| K223065 |
09/30/2022 |
Adcura« Sagittae« Lateral Lumbar Interbody Fusion Devices |
Adcura, Inc. |
Andrew Rogers |
| K222909 |
09/26/2022 |
Axiostat Gauze |
Advamedica Inc. |
Leo Mavely |
| K222975 |
09/28/2022 |
Advantis Platform |
Advantis Medical Imaging Single Member P.C. |
Paris Ziogkas |
| K222692 |
09/06/2022 |
BriefCase |
Aidoc Medical, Ltd. |
Amalia Schreier |
| K222987 |
09/28/2022 |
Akunah REFLECT |
Akunah PTY LTD |
Shanthan Pather |
| K222894 |
09/23/2022 |
Invisalign System, Pre-Formed Attachment System |
Align Technology, Inc. |
Manjunath Bisalehalli |
| K223073 |
09/30/2022 |
Alio |
Alio, Inc. |
Kimberly Snyder |
| K223060 |
09/30/2022 |
DigiX FDX |
Allengers Medical Systems Limited |
Sanjeev K Marjara |
| K223009 |
09/29/2022 |
Wireless/Wired X-Ray Flat Panel Detectors |
Allengers Medical Systems Limited |
Sanjeev K. Marjara |
| K222973 |
09/28/2022 |
IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System, IdentiTi NanoTec Cervical Interbody System, Transcend Cervical PEEK Interbody System, Transcend NanoTec Cervical Interbody System, IdentiTi Cervical Standalone Interb |
Alphatec Spine Inc. |
Andrew Zhang |
| K222681 |
09/06/2022 |
Altaviz Needle Kit |
Altaviz, LLC |
James Lescoulie |
| K222749 |
09/12/2022 |
High Fluid-Resistant Surgical and Procedure Mask |
AmericaÆs Supply Chains |
Paul Park |
| K222867 |
09/22/2022 |
AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS) |
Andon Health Co., Ltd. |
Liu Yi |
| K222869 |
09/22/2022 |
Arm Blood Pressure Monitor |
Andon Health Co., Ltd. |
Liu Yi |
| K222773 |
09/14/2022 |
Feeding Tube |
Anhui Tiankang Medical Technology Co., Ltd. |
Zhang Yong |
| K222772 |
09/14/2022 |
Oral/Enteral Syringe with ENFit connector |
Anhui Tiankang Medical Technology Co., Ltd. |
Zhang Yong |
| K222809 |
09/16/2022 |
Medical Disposable Face Masks |
Anqing Mayfield Medical Limited |
Minghan Zhou |
| K222846 |
09/21/2022 |
AMT G-Tube Balloon Gastrostomy Feeding Device |
Applied Medical Technology, Inc. |
Jennifer Hazou |
| K222690 |
09/06/2022 |
SmartGUIDE deflectable hydrophilic guidewire |
Artiria Medical SA |
Guillaume Petit-Pierre |
| K223095 |
09/30/2022 |
Senhance Surgical System |
Asensus Surgical, Inc. |
Casey Hinckley |
| K222889 |
09/23/2022 |
FlowArt« Needle-Free Split Septum Valve |
Asset Medikal Tasarim San Tic As. |
Ebru Sirali |
| K222967 |
09/27/2022 |
Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Screws |
Avanti Orthopaedics, Inc. |
J. Doug Patterson |
| K222745 |
09/12/2022 |
Axial3D Insight |
Axial Medical Printing Limited |
Jenna McGarry |
| K222794 |
09/16/2022 |
FlowStar Touch Digital Mixer Flowmeter |
Baldus Sedation GmbH & Co. KG |
Lisa Baldus |
| K223016 |
09/29/2022 |
BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit |
BD |
Dung Nguyen |
| K222881 |
09/22/2022 |
Access hsTnI |
Beckman Coulter Inc |
Kate Oelberg |
| K223038 |
09/29/2022 |
Access Cortisol |
Beckman Coulter, Inc |
Kuljeet Kaur |
| K222996 |
09/28/2022 |
Access PCT |
Beckman Coulter, Inc |
Neha Desai |
| K222916 |
09/26/2022 |
US 450 Diode Laser Equipment |
Beijing Globalipl Development Co., Ltd. |
Liu Jun |
| K222903 |
09/23/2022 |
Tailored-H Cervical Stand Alone System |
BeSpoke Technologies, LLC |
Daniel Hoehn |
| DEN220058 |
09/21/2022 |
BT-001 |
Better Therapeutics |
Heather Hill |
| K222984 |
09/28/2022 |
BioClean Implant Restorative System |
BioClean Dental, LLC |
Russ Bonafede |
| K222689 |
09/06/2022 |
Mallya Injection Pen Adapter (Mallya« for Solostar«) |
Biocorp Production |
Alexia Garin |
| K222760 |
09/13/2022 |
StageOneÖ Select Hip Cement Spacer Molds |
Biomet, Inc. |
Meredith Reed |
| K222964 |
09/27/2022 |
BioPoly Lesser Toe Hemiarthroplasty Implant |
BioPoly, LLC |
Herb Schwartz |
| K222972 |
09/27/2022 |
BioProtect Balloon ImplantÖ System |
BioProtect, Ltd. |
Itay Barnea |
| K222695 |
09/06/2022 |
troCarWashÖ System |
Biotex Inc. |
Wade Munsch |
| K223106 |
09/30/2022 |
Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0) |
Brainlab AG |
Marc Bergenthal |
| K222966 |
09/27/2022 |
Cirq Arm System (2.0);Alignment System Spine |
Brainlab AG |
Sadwini Suresh |
| K222820 |
09/19/2022 |
BRM TOOL Screws, BIOPLAN Subtalar Implant |
BRM Extremities |
Lisa Fazzini |
| K222793 |
09/16/2022 |
WavelinQÖ Generator |
C.R. Bard, Inc. |
Jakob Wells |
| K222673 |
09/06/2022 |
Alexandrite and Nd:YAG Laser models CANLASE and TORLASE |
Canadian Pioneer Medical Technology Corporation (CPMT LASER) |
Rashid Reza Mir Sayah |
| K222915 |
09/26/2022 |
Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE PLUS |
Canadian Pioneer Medical Technology Corporation (CPMT LASER) |
Rashid Reza Mir Sayah |
| K222661 |
09/02/2022 |
Digital Radiography CXDI-CS01 |
Canon Inc. |
Akira Hirai |
| K222687 |
09/06/2022 |
Digital Radiography CXDI-Elite, Digital Radiography E1 |
Canon Inc. |
Mr. Akira Hirai |
| K222662 |
09/02/2022 |
Vitrea CT Cardiac Analysis |
Canon Medical Informatics, Inc. |
Jay Vaishnav |
| K223017 |
09/29/2022 |
Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 |
Canon Medical Systems Corporation |
Paul Biggins |
| K222819 |
09/19/2022 |
Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i |
Canon Medical Systems Corporation |
Paul Biggins |
| K222968 |
09/27/2022 |
Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR |
Canon Medical Systems Corporation |
Janine F Reyes |
| K222855 |
09/21/2022 |
Digital Radiography CXDI-Pro, Digital Radiography D1 |
Canon, Inc. |
Mr. Akira Hirai |
| K222865 |
09/22/2022 |
M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic Disposable Biopsy Needle, M Biopsy /SureAim Coaxial Biopsy Needle |
Canyon Medical Inc. |
Huiqi Jiang |
| DEN220063 |
09/28/2022 |
Caption Interpretation Automated Ejection Fraction Software |
Caption Health, Inc |
Tahir Rizvi |
| K222874 |
09/22/2022 |
CarboClear Cervical Cage System, CarboClear Cervical VBR System |
CarboFix Orthpedics Ltd. |
Yael Rubin |
| K222652 |
09/01/2022 |
Aneroid Sphygmomanometer; Single Patient Use Aneroid Sphygmomanometer |
Cardicare Company, Ltd. |
Ying Hao |
| K222854 |
09/21/2022 |
iTFlow |
Cardio Flow Design Inc. |
Teruyasu Nishino |
| K223101 |
09/30/2022 |
BD Secondary Infusion Set |
CareFusion |
Paulina Davis |
| K223088 |
09/30/2022 |
BD SmartSiteÖ Needle-Free Connector |
CareFusion |
Jacob Lee |
| K223076 |
09/30/2022 |
BD TexiumÖ Closed Male Luer |
CareFusion |
Elgin Oktay |
| K222676 |
09/06/2022 |
Ceevra Reveal 3 |
Ceevra, Inc. |
Ken Koster |
| K223097 |
09/30/2022 |
RenaNav Ureteroscope System |
CenterPoint Systems LLC |
Marybeth Gamber |
| K222638 |
09/01/2022 |
Xpert« Xpress GBS, GeneXpert« Dx System, GeneXpert« Infinity Systems |
Cepheid |
Suzette Chance |
| K223046 |
09/29/2022 |
Xpert« FII & FV |
Cepheid« |
Suzette Chance |
| K223086 |
09/30/2022 |
Ceribell Instant EEG Headcap |
Ceribell, Inc. |
Raymond Woo |
| K222669 |
09/06/2022 |
Cryopush Cold Compression Device |
Chengdu Cryo-Push Medical Technology Co., Ltd |
Zhang Peiyong |
| K222787 |
09/15/2022 |
Sunkingdom Ophthalmic Ultrasound Examination Instrument SK-3000A, SK-3000B, SK-3000C, SK-2000AP, SK-2000A, SK-2000P |
Chongqing Sunkingdom Medical Instrument Co., Ltd |
Shulin Guo |
| K222709 |
09/08/2022 |
Retraction, CWM-910T, APOLEX Tite |
Chungwoo CO., LTD. |
Il Kwon Lee |
| K222757 |
09/12/2022 |
Clarus Viewer |
Clarus Viewer Corporation |
Steve Thomas |
| K223098 |
09/30/2022 |
Bakri Essential Postpartum Balloon |
Cook Incorporated |
Ian Herman |
| K223064 |
09/30/2022 |
ALLY II Uterine Positioning SystemÖ (UPS) |
CooperSurgical, Inc. |
Yin Huang |
| K223074 |
09/30/2022 |
CorNeat EverPatch |
CorNeat Vision Ltd. |
Gerry Tal |
| K222641 |
09/01/2022 |
SigniaÖ Small Diameter Reloads Including Regular (Round) Tip Version |
Covidien |
Robert Zott |
| K222723 |
09/08/2022 |
AMBARINO High-Class |
Creamed GmbH & Co. Produktions- und Handels KG |
Robert Lemmer |
| K222698 |
09/07/2022 |
CUVIS-spine |
Curexo, Inc. |
Jungeun Park |
| DEN220066 |
09/29/2022 |
BrainSee |
Darmiyan, Inc. |
Kaveh Vejdani |
| K222781 |
09/15/2022 |
Augmento |
Deeptek Medical Imaging Private Limited |
Kallol Sen |
| K222918 |
09/26/2022 |
DentCare Aligners |
DentCare Dental Lab Pvt Ltd. |
Abin Johns Raju |
| K222976 |
09/28/2022 |
MU System |
Dentis Co., Ltd |
Gyu Ri Kim |
| K222913 |
09/26/2022 |
s-Clean Link Abutment |
Dentis Co., Ltd. |
Gyu Ri Kim |
| K222685 |
09/06/2022 |
NIRA Model 2 |
Dermal Photonics Corp |
Felix Feldchtein |
| K222877 |
09/22/2022 |
FREEPRINT crown |
DETAX GmbH |
Markus Stratmann |
| K222970 |
09/27/2022 |
LVivo IQS |
DiA Imaging Analysis Ltd |
Michal Yaacobi |
| K222734 |
09/09/2022 |
Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing |
Diversatek Healthcare |
Alyssa Roelli |
| K222663 |
09/02/2022 |
MultiStage Balloon Dilatation Catheter |
Dongguan TT Medical, Inc. |
Yuying Bi |
| K222822 |
09/19/2022 |
VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608) |
Draegerwerk AG & Co. KGaA |
Jan Upmeier |
| K223249 |
09/12/2022 |
Pro-Tx Endorectal Balloon (PROT-25) |
DxTx Medical, Inc. |
Paul Lawson |
| K222813 |
09/19/2022 |
Nitrile Examination Gloves |
Ecoglove Medical Manufacturing Company Limited |
Nguyen Anh Tu |
| K222902 |
09/23/2022 |
Electrocardiograph: SE-1200 Pro and SE-1201 Pro |
Edan Instruments, Inc. |
Milin Wu |
| K222880 |
09/22/2022 |
Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie) |
Endolumik Inc. |
Mara McFadden |
| K222832 |
09/20/2022 |
Sentimag System |
Endomagnetics Ltd |
Mehryar Behizad |
| DEN220065 |
09/29/2022 |
Pill Sense System |
EnteraSense Ltd. |
David Collins |
| K222929 |
09/26/2022 |
ToxiSeal Vial Adapter with External Balloon |
Epic Medical Pte Ltd |
Freddie Lee |
| K222797 |
09/16/2022 |
X-Pac Expandable Lumbar Cage System |
Expanding Innovations, inc |
Robert Jaramillo |
| K223099 |
09/30/2022 |
Facet Manatee Reusable Lancing Base |
Facet Technologies LLC |
James Bonds |
| K222887 |
09/23/2022 |
Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor |
Famidoc Technology Company Limited |
Amos Zou |
| K222693 |
09/06/2022 |
Single-use medical latex examination gloves (LG100) |
Fitone Latex Products Co., Ltd. Guangdong |
Christine Ou |
| K222712 |
09/08/2022 |
Fogg System Patient Monitoring Cables |
Fogg System Company, Inc. |
Ken Neef |
| K222952 |
09/27/2022 |
2008T BlueStar Hemodailysis Machine |
Fresenius Medical Care Renal Therapies Group, LLC |
Denise M Oppermann |
| K222845 |
09/21/2022 |
Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece |
Frey Oral Technologies LLC |
David Frey |
| K223070 |
09/30/2022 |
Remi Robotic Navigation System |
Fusion Robotics, LLC |
Sarah Braun |
| K222936 |
09/26/2022 |
Humeris« 135 Shoulder System |
FX Shoulder USA, Inc. |
Cory Trier |
| K222895 |
09/23/2022 |
DynamicIQ |
GE Medical Systems SCS |
Tong Zhao |
| K222702 |
09/07/2022 |
RGS; RGS Mini |
Genesis Air, Inc. |
Dan Briggs |
| K222688 |
09/06/2022 |
The Trust |
Genoss Co., Ltd |
Myeong Yujin |
| K222810 |
09/16/2022 |
TD-7301 Peak Flow meter |
GOSTAR Co., Ltd. |
Pei-Fen Yang |
| K222892 |
09/23/2022 |
Powder Free Polyurethane Examination Gloves, Blue color, Tested for use with Chemotherapy Drugs |
Grand Work Plastic Products Co., Ltd |
Wu Yuli |
| K222714 |
09/08/2022 |
Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs |
Guang Dong Kingfa Sci. & Tech.Co., Ltd. |
Xiaoge Yu |
| K223068 |
09/30/2022 |
Medical Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E) |
Guangdong Golden Leaves Technology Development Co., LTD |
Wenhong Zhou |
| K222891 |
09/23/2022 |
Dental Desensitizer |
Guangzhou Beogene Biotech Co., Ltd |
Duan Qiangqiang |
| K222771 |
09/14/2022 |
Sample Preservative Fluid |
Hangzhou Bioer Technology Co., LTD |
Zoey . |
| K222677 |
09/06/2022 |
Intermittent nelaton catheter for single use |
Hangzhou Jimushi Meditech Co., Ltd. |
Fenlong Wu |
| K222718 |
09/08/2022 |
Vial Adapter |
Hangzhou Qiantang Longyue Biotechnology Co., LTD |
Zhengxu Xiang |
| K222739 |
09/09/2022 |
Disposable Insulin Pen Needle |
Hantech Medical Device Co., Ltd. |
Rachel Jin |
| K222672 |
09/06/2022 |
Disposable Insulin Syringe |
Hantech Medical Device Co., Ltd. |
Rachel Jin |
| K222961 |
09/27/2022 |
Harvest Conceal ZR Block Out |
Harvest Dental Products, LLC |
Colleen Boswell |
| K222741 |
09/09/2022 |
DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast) |
HDI, Inc. |
Taekyou Kim |
| K222921 |
09/26/2022 |
Minuteful-kidney test |
Healthy.io Ltd. |
Ron Zohar |
| K222735 |
09/09/2022 |
HJY VisualNext Endoscopic Vision System |
HJY Smart Medical Device Co., Ltd. |
John Jiannyuh Chen |
| K222736 |
09/09/2022 |
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay |
Hologic, Inc. |
Vlada Rudenko |
| K223069 |
09/30/2022 |
Modular Rotating Hinge Knee Systems and Compatible Components |
Howmedica Osteonics Corp. dba Stryker Orthopaedics |
Margaret Klippel |
| K222988 |
09/28/2022 |
neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical |
HT Medical d.b.a. Xenix Medical |
Ryan Phillips |
| K223003 |
09/29/2022 |
Banded Face Mask |
Hubei Medlink Healthcare Co., Ltd |
Niki Wang |
| K222999 |
09/28/2022 |
Surgical Gown |
Hubei Woozon Healthcare Co.,Ltd. |
Li Chunlin |
| K222656 |
09/02/2022 |
LDE4 Lancing Device |
i-SENS, Inc. |
H.S. Yoo |
| K222727 |
09/08/2022 |
i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S) |
i3 Membrane GmbH |
Stephan Brinke-Seiferth |
| K222706 |
09/07/2022 |
iCE-SG2 Subcutaneous Electrode Kit |
iCE Neurosystems, Inc. |
Emir Kapetanovic |
| K223049 |
09/29/2022 |
CardioSTAT« ECG Test Solution |
Icentia Inc. |
DaniΦle Grondines |
| K222789 |
09/15/2022 |
VADER« Pedicle System, G21 Cement |
icotec ag |
Marina Hess |
| K222838 |
09/20/2022 |
iSyncBrain⌐-C |
iMediSync Inc. |
Young-Geun Kim |
| K223103 |
09/30/2022 |
BethaLoc« stem cementless HA |
implantcast Gmbh |
Juliane Hoppner |
| K223000 |
09/28/2022 |
Artix BG |
Inari Medical |
Ellen Nguyen |
| K222733 |
09/09/2022 |
Disposable Nitrile Examination Glove (Tested for use with Chemotherapy Drug) |
Inner Mongolia Boming Medical Supplies Co., Ltd. |
Guo Hua |
| K222642 |
09/01/2022 |
Disposable Nitrile Examination Glove(Tested for use with Chemotherapy Drug) |
Inner Mongolia Cureguard Medical Technology Co.,Ltd. |
Guo Hua |
| K222954 |
09/27/2022 |
Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens |
Innova Vision Inc. |
Kari Huang |
| K222992 |
09/28/2022 |
iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root Repair Material |
Innovative BioCeramix Inc. |
Quanzu Yang |
| K223093 |
09/30/2022 |
Aptiva APS IgG Reagent; Aptiva APS IgM Reagent |
INOVA Diagnostics, Inc. |
Andrea Seaman |
| K223083 |
09/30/2022 |
Straumann SLActive labeling changes |
Institut Straumann AG |
Ana Vianna |
| K222836 |
09/20/2022 |
Straumann« Variobase« Abutments and Straumann« n!ce« Zirconia discs |
Institut Straumann AG |
Dr. Renate Reiss |
| K223090 |
09/30/2022 |
GEM Premier ChemSTAT |
Instrumentation Laboratory Co |
Gabriella Erdosy |
| K223043 |
09/22/2022 |
The Integrity Spine Core System |
Integrity Spine |
Timothy Leak |
| K223051 |
09/29/2022 |
Pre-Formed Silicone Block |
International Medical Devices, Inc. |
Dr. James Elist |
| K223039 |
09/29/2022 |
da Vinci E-200 Electrosurgical Generator |
Intuitive Surgical |
Shamsa Karimi |
| K222839 |
09/20/2022 |
EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 System |
Intuitive Surgical Inc |
Amrit Jaggi |
| K222827 |
09/19/2022 |
da Vinci Firefly Imaging System |
Intuitive Surgical Inc. |
Melissa Gonzalez |
| K223080 |
09/30/2022 |
da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000) |
Intuitive Surgical, Inc |
Connor McCarty |
| K222932 |
09/26/2022 |
INVOcell Intravaginal Culture System |
INVO Bioscience |
Steve Shum |
| K222886 |
09/23/2022 |
Mercu 1717V |
iRay Technology Taicang Ltd. |
Junjie Qian |
| K223010 |
09/29/2022 |
Portable X-ray System |
iRay Technology Taicang Ltd. |
Wei Pan |
| K222804 |
09/16/2022 |
Irrisept Antimicrobial Wound Lavage |
Irrimax Corporation |
Tanya Eberle |
| K223077 |
09/30/2022 |
ViewFlex Xtra ICE Catheter |
Irvine Biomedical, a St. Jude Medical Company |
Suzanne Pekarna |
| K222884 |
09/22/2022 |
Rapid NCCT Stroke |
iSchemaView, Inc. |
James Rosa |
| K222834 |
09/20/2022 |
Safety Push Button Blood Collection Set |
Jiangsu Caina Medical Co.,Ltd |
Jianwei Pan |
| K222937 |
09/26/2022 |
Disposable Nitrile Examination Glove |
Jiangsu Cureguard Glove Co., Ltd. |
Guo Hua |
| K223004 |
09/29/2022 |
Disposable Nitrile Examination Gloves |
Jiangxi Handspro Products Solutions CO., LTD. |
Jun Yin |
| K223008 |
09/29/2022 |
Disposable Vinyl Examination Gloves |
Jiangxi Handspro Products Solutions CO., LTD. |
Jun Yin |
| K222864 |
09/22/2022 |
8MP Color LCD Monitor CL-R813 |
JVCKENWOOD Corporation |
Hideki Tengeiji |
| K222830 |
09/19/2022 |
Rainbow 360 |
Kerr Corporation |
Viviana Lai |
| K223105 |
09/30/2022 |
Tesera-K SC System |
Kyocera Medical Technologies, Inc. |
Scott Rucker |
| K222726 |
09/08/2022 |
Smartpump 3.0 Double Electric Breast Pump |
Lansinoh Laboratories |
Lindsay Ewers |
| K222925 |
09/26/2022 |
Hypodermic Syringes & Needle |
Lifelong Meditech Private Limited |
Mr. Hamendra Nath Srivastava |
| K222764 |
09/13/2022 |
LightForce Orthodontic System |
LightForce Orthodontics |
Kelsey Fafara |
| K222780 |
09/14/2022 |
LILY Extension Tube and Needleless Connector |
LILY Medical Corporation |
Steven Shen |
| K222807 |
09/16/2022 |
TEMA Elbow system - Line extension |
LimaCorporate S.p.A. |
Marco Tallerico |
| K222791 |
09/15/2022 |
SafeBreak Vascular |
Lineus Medical, LLC |
Vance Clement |
| K222862 |
09/22/2022 |
SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWC |
Lotuxs Medtech (Suzhou) Co., Ltd. |
Na Wu |
| K222783 |
09/15/2022 |
MD Mattress Suture Placement Device |
LSI Solutions, Inc. |
Christopher B Miller |
| K222790 |
09/15/2022 |
F65 Laser System |
Lumenis Be, Ltd. |
Shlomit Segman |
| K223102 |
09/30/2022 |
Tegamen Nitrile Examination Gloves |
M/S Tegamen Safety Products Private Limited |
Manmohan Gulati |
| K222977 |
09/28/2022 |
DSPS-ProminentÖ Masks; DSPS-ProminentÖ Baseplate, MR; CouchStrip |
MacroMedics BV |
Elizabeth Hajos |
| K222930 |
09/26/2022 |
Evolve Nitric Oxide Delivery System |
Mallinckrodt Manufacturing LLC |
David Trueblood |
| K222657 |
09/02/2022 |
MEBO Wound Dressing |
MEBO Life Science Inc. |
Sidney Hong |
| K223024 |
09/29/2022 |
MedCAD AccuPlan System |
MedCAD |
Brian Buss |
| K223048 |
09/29/2022 |
Medisystem Pacs |
Medilab Manutencao E Sitemas Ltda |
Jorge Millan |
| K223040 |
09/29/2022 |
Endo SmartCap |
Medivators Inc |
Disha Kabrawala |
| K223100 |
09/30/2022 |
Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14) |
Medline Industries, Inc |
Nichole Schaffer |
| K222665 |
09/06/2022 |
Medline UNITE« Ankle Fusion Plating System |
Medline Industries, Inc. |
Jennifer Mason |
| K223108 |
09/30/2022 |
TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear) |
Medos International, SARL |
Karin McDonough |
| K222873 |
09/22/2022 |
Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery system |
Medtronic |
Sarah Meyer |
| K222829 |
09/19/2022 |
Curian« Shiga Toxin |
Meridian Bioscience Inc. |
Heather Planck |
| K222779 |
09/14/2022 |
Revogene |
Meridian Bioscience, Inc |
Jack Rogers |
| K222816 |
09/19/2022 |
Opulent TiNbN Coated Knee |
Meril Healthcare Pvt. Ltd. |
Neelam Desai |
| K222806 |
09/16/2022 |
Kodiak C Spinal Implant System |
Met One Technologies, LLC |
Adrian Carbonell |
| K222979 |
09/28/2022 |
Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5W |
Microlife Intellectual Property GmbH |
Ariel Wang |
| K223050 |
09/29/2022 |
AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060) |
MicroVention Inc. |
Riddhi Pandya |
| K222694 |
09/06/2022 |
EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190) |
MicroVention, Inc. |
Ganesh Balachandar |
| K223084 |
09/30/2022 |
MilkMate Breast Pump |
MilkMate Products, Inc. |
Patrice Meagher |
| K223085 |
09/30/2022 |
Miris Human Milk Analyzer (HMA) |
Miris AB |
Elin Hallen |
| K222948 |
09/27/2022 |
Q Distal Access Catheter |
MIVI Neuroscience, Inc |
Srija Reddy Bandari |
| K223107 |
09/30/2022 |
MOLLI 2 |
MOLLI Surgical, Inc |
Joseph De Croos |
| K222983 |
09/28/2022 |
NeuroBlate Fusion-S Software V3.17 |
Monteris Medical, |
David H Mueller |
| K222703 |
09/07/2022 |
ATTO Mobility Scooter (ATTO);ATTO Mobility Scooter (ATTO SPORT);ATTO Mobility Scooter (ATTO SPORT MAX) |
Moving Life Ltd |
Igor Naroditsky |
| K222875 |
09/22/2022 |
Powered Muscle Stimulator (Model name:MagGraver F200) |
Nanjing Vishee Medical Technology Co., Ltd. |
Kai QIU |
| K222934 |
09/26/2022 |
Nanox.ARC |
Nano-X Imaging Ltd. |
Erez Meltzer |
| K222890 |
09/23/2022 |
RADIANCE ULTRA 32 4K ZEROWIRE DUO |
NDS Surgical Imaging, LLC. |
Jim Leng |
| K222750 |
09/12/2022 |
Yomi Robotic System |
Neocis Inc. |
Joshua Davis |
| K222683 |
09/06/2022 |
Fibroid Mapping Reviewer Application (FMRA) |
Nesa Medtech Private Limited |
Sreekar Kothamachu |
| K223047 |
09/29/2022 |
NeuroSwift Pro |
Neurobit Technologies Co., Ltd. |
Chun-Chen Yang |
| K223027 |
09/29/2022 |
NeuroTrigger Basic (NTB) |
NeuroTrigger |
Nikolai Kuincher |
| K222644 |
09/01/2022 |
Nihon Kohden NKV-440 Ventilator System |
Nihon Kohden OrangeMed, Inc. |
Sheryl Higgins |
| K222906 |
09/23/2022 |
Maxcon Reusable Sharps Container, 17 Gallon Sharps Container MA1421 |
Ningbo Maxcon Medical Technology Co., Ltd. |
Puhai Ma |
| K222905 |
09/23/2022 |
Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (5.4 QT Sharps Container, MA1212), Maxcon Sharps Container (5.4 QT Sharps Container, MA1213), Maxcon Sharps Container (7 Liter Sharps Container, MA1324) |
Ningbo Maxcon Medical Technology Co., Ltd. |
Puhai Ma |
| K222852 |
09/21/2022 |
Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle |
Nipro Medical Corporation |
Jessica Oswald-McLeod |
| DEN220059 |
09/21/2022 |
NTX100 Tonic Motor Activation (NTX100 ToMAc) System |
Noctrix Health, Inc. |
Shriram Raghunathan |
| K223026 |
09/29/2022 |
NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter |
Northeast Scientific, Inc. |
Matt Farley |
| K223033 |
09/29/2022 |
Tixel« 2 System |
Novoxel Ltd. |
Omri Findler |
| K223091 |
09/30/2022 |
CT Perfusion V1.0 |
Olea Medical |
Nathalie Palumbo |
| K222861 |
09/22/2022 |
EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100, Bronchovideoscope Olympus BF-1TH1100 |
Olympus Medical Systems Corporation |
Shinichiro Kawachi |
| K222803 |
09/16/2022 |
Oncospace |
Oncospace, Inc. |
Sigrid Schoepel |
| K222946 |
09/27/2022 |
Oneday Mini Implant System |
Oneday Biotech Co., Ltd. |
Jae Hyun Song |
| K222799 |
09/16/2022 |
Haymaker« Screw System |
OrthoCircle Spine d.b.a. OC Medical Devices |
Jack Matthews |
| K222847 |
09/21/2022 |
Ceramic Brackets Orthometric |
Orthometric - Industria e Comercio de Produtos Medicos |
Silvio Zilio |
| K222778 |
09/14/2022 |
Osstem Implant System |
Osstem Implant CO., LTD. |
Seungju Kang |
| K222746 |
09/12/2022 |
Overjet Caries Assist |
Overjet, Inc. |
Adam Odeh |
| K222901 |
09/23/2022 |
EVA15 insufflator |
Palliare Ltd. |
John O'Dea |
| K222762 |
09/13/2022 |
SIDDHARTH-II;IMPACT |
Panacea Medical Technologies Pvt Ltd |
Valli G. |
| K223056 |
09/30/2022 |
JAWS Nitinol Staple System |
Paragon 28, Inc. |
Haylie Hertz |
| K222767 |
09/13/2022 |
PeekMed web (v1) |
Peek Health, S.A. |
Sara Silva |
| K222885 |
09/23/2022 |
Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) |
Pegavision Corporation |
Estela Lin |
| K223072 |
09/30/2022 |
PENTAX Medical Video Esophagoscope EE17-J10 |
PENTAX of America, Inc. |
William Goeller |
| K222808 |
09/16/2022 |
Penumbra System (Reperfusion Catheter RED 43) |
Penumbra, Inc. |
Micaela Victoria |
| K222848 |
09/21/2022 |
pRESET Thrombectomy Device |
phenox Limited |
Catriona Lynch |
| K222648 |
09/01/2022 |
5000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500 P, Ultrasound System 5500 W, Ultrasound System 5500 CV, Ultrasound System 5300 G, Ultrasound System 5300 P, Ultrasound System 5300 W) |
Philips Ultrasound LLC |
Shilpa Rapaka |
| K222655 |
09/02/2022 |
OtoSight Middle Ear Scope |
PhotoniCare, Inc |
Ryan Shelton |
| K223023 |
09/29/2022 |
Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) |
Plasmapp Co,.Ltd. |
Byeong Geon Song |
| K223015 |
09/29/2022 |
STERLINKÖ FPS-15s Plus sterilizer with STERPACKÖ plus cassette |
Plasmapp Co., Ltd. |
Byeong Geon Song |
| K223025 |
09/29/2022 |
Tyvek Roll with CI for STERLINK Sterilizer |
Plasmapp Co., Ltd. |
Byeong Geon Song |
| K222738 |
09/09/2022 |
Point implant system |
PointNix Co., Ltd |
Chang Nam Lee |
| K223071 |
09/30/2022 |
Xenoview VDP |
Polarean, Inc. |
Neil Wadehra |
| K222896 |
09/23/2022 |
AirRay |
POSKOM Co.,Ltd. |
Jeong Hyun Seong |
| K222831 |
09/19/2022 |
CRYOcheck Factor VIII Deficient Plasma with VWF |
Precision BioLogic Inc. |
Karen Black |
| K222680 |
09/06/2022 |
DeltaScan Monitor |
Prolira B.V. |
Rutger O. van Merkerk |
| K222671 |
09/06/2022 |
DeltaScan Patch |
Prolira B.V. |
Rutger O. van Merkerk |
| K222786 |
09/15/2022 |
072 Aspiration System |
Q'Apel Medical, Inc. |
Kim Ky |
| K222938 |
09/26/2022 |
Ablation-fit |
R.A.W. Srl |
Chiara Ferrari |
| K222798 |
09/16/2022 |
Rejoni Intrauterine Catheter |
Rejoni, Inc. |
Brian Bergeron |
| K223096 |
09/30/2022 |
Dark Star Deformity Pedicle Screw System |
Republic Spine, LLC |
James Doulgeris |
| K222763 |
09/13/2022 |
Responsive Arthroscopy Mustang and Mustang Knotless Suture Anchors |
Responsive Arthroscopy LLC |
Garrett Ahlborg |
| K222907 |
09/26/2022 |
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate |
RMKH Glove (Cambodia) Co., Ltd. |
Yang Clement KC |
| K222678 |
09/06/2022 |
Mobility+ Enteral Feeding System |
Rockfield Medical |
Orla Connaughton |
| K222969 |
09/27/2022 |
FERTI-LILY Conception Cup |
Rosesta Medical BV |
Stal Robert |
| K222743 |
09/09/2022 |
Route 92 Medical Full Length 070 Access System |
Route 92 Medical, Inc. |
Kirsten Valley |
| K222944 |
09/26/2022 |
SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture |
SafePath Medical, Inc. |
Joseph Lane |
| K222715 |
09/08/2022 |
Black Nitrile Powder Free Patient Examination Glove, Non Sterile |
Safeskin Retailing (HK) Limited |
Alvin Ho |
| K222720 |
09/08/2022 |
Blue Nitrile Powder Free Patient Examination Glove, Non Sterile |
Safeskin Retailing (HK) Limited |
Alvin Ho |
| K222721 |
09/08/2022 |
Violet Nitrile Powder Free Patient Examination Glove, Non Sterile |
Safeskin Retailing (HK) Limited |
Alvin Ho |
| K222713 |
09/08/2022 |
White Nitrile Powder Free Patient Examination Glove, Non Sterile |
Safeskin Retailing (HK) Limited |
Alvin Ho |
| K222898 |
09/23/2022 |
SafeSource Direct Blue Powder-Free Nitrile Exam Gloves |
SafeSource Direct, LLC |
Justin Hollingsworth |
| K222800 |
09/16/2022 |
Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A) |
Sanhe Laserconn Tech Co., Ltd. |
Xia Aijiang |
| K222801 |
09/16/2022 |
Safety Lancet |
Sarstedt AG & CO KG |
Jochen Hoffman |
| K222958 |
09/27/2022 |
mJOULE RF System and Accessories |
Sciton, Inc. |
Jay Patel |
| K222812 |
09/19/2022 |
Insufflator |
Scivita Medical Technology Co., Ltd. |
Ruqin Wu |
| K222753 |
09/12/2022 |
SeaSpine 7D Navigation Instruments |
SeaSpine Orthopedics Corporation |
Laeitia Cousin |
| K222732 |
09/09/2022 |
WaveForm A Interbody System |
SeaSpine Orthopedics Corporation |
Jesse Albright |
| K222951 |
09/27/2022 |
SM-V |
SEDECAL SA |
M¬ Luisa G≤mez de Agⁿero |
| K222993 |
09/28/2022 |
Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, Green Tested For Use with 13 Chemotherapy Drugs; Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, White Tested For Use with 32 Chemotherapy Drugs |
Sentienx Sdn Bhd |
Sahrudin Shah Bin Abu Bakar |
| K222707 |
09/07/2022 |
IH Implant System |
Sewon Medix Inc. |
Jinsoo Lee |
| K222766 |
09/13/2022 |
Disposable Extension Set |
Shandong Ande Healthcare Apparatus Co., Ltd. |
Xiaolei Tian |
| K222842 |
09/20/2022 |
V-Patch Cardiac Monitor |
Shandong CoreCare Technology Limited |
Cao Cheng |
| K222737 |
09/09/2022 |
Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US) |
Shanghai AnQing Medical Instrument Co., Ltd. |
Shuwen Fan |
| K222647 |
09/01/2022 |
INT Introducer Set |
Shanghai Kindly Medical Instruments Co., Ltd |
Xu Jianhai |
| K223028 |
09/29/2022 |
uCT ATLAS Astound with uWS-CT-Dual Energy Analysis |
Shanghai United Imaging Healthcare Co., Ltd. |
Xin Gao |
| K222755 |
09/12/2022 |
uMR 680 |
Shanghai United Imaging Intelligence Co., Ltd. |
Xin GAO |
| K222917 |
09/26/2022 |
Breathing circuit bacterial/viral filter |
Shaoxing Haitech Medical Products Co., Ltd |
Liming Zhao |
| K223044 |
09/29/2022 |
Digital Thermometer (Model QT001) |
Shen Zhen Rong Feng Technology Co., Ltd |
Hong Xiao Lan |
| K223037 |
09/29/2022 |
Infrared Thermometer, Model: IR8807 |
Shen Zhen Rong Feng Technology Co., Ltd |
Hong Xiao Lan |
| K222994 |
09/28/2022 |
Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B |
Shenzhen AOJ Medical Technology Co., Ltd. |
Jack Wang |
| K222910 |
09/26/2022 |
Bronchoscope System |
Shenzhen HugeMed Medical Technical Development Co., Ltd |
Cathy S |
| K222870 |
09/22/2022 |
Transcutaneous Electrical Nerve Stimulator, Model: KTR-4031, KTR-4032, KTR-4012, KTR-4015, KTR-4029, KTR-4027, KTR-4026, KTR-4021, KTR-4034, KTR-4036, KTR-4037, KTR-4039 |
Shenzhen Kentro Medical Electronics Co., Ltd |
Zewu Zhang |
| K222928 |
09/26/2022 |
Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa R9 Exp Diagnostic Ultrasound Sysem, Nuewa R9 Pro/ Nuewa R9S/ Resona 7/ Resona 7CV/Resona 7EXP/Resona 7S/ Resona 70B Diagnostic Ultrasound System, Resona 7PRO/Imagyn 7/ Resona Y/Resona R9 |
Shenzhen Mindray Bio-Medical Electronics Co.,LTD |
Zhang Wei |
| K222754 |
09/12/2022 |
ViewMate Multi Ultrasound System |
Shenzhen Mindray Bio-Meidcal Electronics Co., LTD |
Jin Jiahong |
| K222924 |
09/26/2022 |
Leg Massager RF-ALM070 |
Shenzhen Ruiyi Business Technology Co., Ltd. |
Jacky Li |
| K222710 |
09/08/2022 |
IPL Cooling Hair Removal Device |
Shenzhen Siken 3D Technology Development Co., Ltd. |
Jingquan Liu |
| K222926 |
09/26/2022 |
Arm Blood Pressure Monitor, Model Name:111, Arm Blood Pressure Monitor, Model Name: B1681, Arm Blood Pressure Monitor, Model Name: B1682, Arm Blood Pressure Monitor, Model Name: B1683 |
Shenzhen Yuezhongxing Technology Co., Ltd. |
Yuchao Chen |
| K222748 |
09/12/2022 |
ShiNeo Silicone Implant |
Shineo Technology Co., Ltd |
Wan-Chun Lai |
| K222774 |
09/14/2022 |
iFuse Bedrock Granite« Implant System |
SI-BONE, Inc. |
Meirav Harsat |
| K223078 |
09/30/2022 |
Atellica« CH Diazo Direct Bilirubin (D_DBil) |
Siemens Healthcare Diagnostics Inc. |
Anthony Calabro |
| K223062 |
09/30/2022 |
World Total Knee System |
Signature Orthopaedics Pty Ltd. |
Declan Brazil |
| K222664 |
09/02/2022 |
Sim&Size |
Sim&Cure |
Colette Maurin |
| K223022 |
09/29/2022 |
SC HONKYTONK PTCA Balloon Dilatation Catheter |
Sino Medical Sciences Technology Inc. |
Jianhua Sun |
| K232978 |
09/21/2022 |
DX. Bond V Dental Bonding Adhesive |
Sino-Dentex Co., Ltd. |
Pengtao Yan |
| K222643 |
09/01/2022 |
Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit |
Sirius Medical Systems B.V. |
Bram Schermers |
| K223018 |
09/29/2022 |
OSPREY PERIPHERAL IV Catheter System |
SkyDance Vascular, Inc. |
Scott Pease |
| K222971 |
09/27/2022 |
ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device; ULTRABUTTON TIB SMALL Adjustable Fixation Device; ULTRABUTTON TIB MEDIUM Adjustable Fixation Device; ULTRABUTTON TIB LARGE Adjustable Fixation Device |
Smith & Nephew Inc |
Dongeun LoPresti |
| K223041 |
09/29/2022 |
Renasys Edge (66803126) |
Smith & Nephew Medical Limited |
Zoe Smith |
| K222653 |
09/01/2022 |
JOURNEY II UKÖ and ENGAGEÖ Cementless Partial Knee System |
Smith+Nephew, Inc |
Lilian Hren |
| K222792 |
09/16/2022 |
SNUCONE Tissue Level Implant System |
Snucone Co., Ltd. |
Song Ha Eun |
| K222744 |
09/12/2022 |
Sol-M Luer Lock Syringe |
Sol-Millennium Medical Inc. |
Ying Zhao |
| K222856 |
09/21/2022 |
SOMAVAC 100 Sustained Vacuum System |
SOMAVAC Medical Solutions, Inc. |
Phil Ryan |
| K222871 |
09/22/2022 |
Stethophone v1 |
Sparrow Acoustics Inc. |
Nadezda Ivanova |
| K222740 |
09/09/2022 |
Venus Ag 120, 160, 200 2x2 inch, Venus Ag 120, 160, 200 4x4 inch, Venus Ag 120, 160, 200 4x5 inch, Venus Ag 120, 160, 200 6x6 inch,Venus Ag 120, 160, 200 1x18 inch |
Speciality Fibres and Materials Ltd. |
Nyerngoor Korda Hewitt |
| K222837 |
09/20/2022 |
Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters |
Spectranetics Inc. |
Taylor Olen |
| K222833 |
09/20/2022 |
VentanaÖ C Spinal System |
Spinal Elements, Inc. |
Julie Lamothe |
| K223079 |
09/30/2022 |
Stage |
SpinTech, Inc. |
Rana El Hachem |
| K222701 |
09/07/2022 |
MANTA Laser |
SQUALUS MED Ltd. |
Gil Shapira |
| K222997 |
09/28/2022 |
VVR Generator system |
Starmed Co., Ltd. |
Honggeun Lee |
| K222849 |
09/21/2022 |
AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Ch |
Steris |
Anthony Piotrkowski |
| K222650 |
09/01/2022 |
Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate |
Stryker Craniomaxillofacial (CMF) |
Zainab Amini |
| K222818 |
09/19/2022 |
Xpedition Ö Powered Stair Chair (625700000000) |
Stryker Medical |
Rachel Stallworth |
| K222684 |
09/06/2022 |
XIA« 4.5 Spinal System, XIA« 4.5 Cortical Trajectory, XIA« 3 Spinal System, Serrato« Spinal System, XIA« Growth Rod Conversion Set, XIA« II Spinal System, XIA« Precision System, XIA« Anterior, Diapason« Spinal System, OpusÖ Spinal System, Radius« Spinal S |
Stryker Spine |
Sierra Mertz |
| K222823 |
09/19/2022 |
AeroDVx Arm System |
Sun Scientific Inc |
Allan Alward |
| K223032 |
09/29/2022 |
SIS System (Version 5.6.0) |
Surgical Information Sciences, Inc. |
Ann Quinlan-Smith |
| K222711 |
09/08/2022 |
HS186B Scooter |
Suzhou Master Machinery Manufacturing Co.,Ltd. |
Siqi Shangguan |
| K222640 |
09/01/2022 |
Sweden & Martina Surgical Trays |
Sweden & Martina S.p.A. |
Alessia Pezzato |
| K223052 |
09/29/2022 |
Peri-Guard and Supple Peri-Guard |
Synovis Life Technologies, Inc. |
Megan Sajjad |
| K223067 |
09/23/2022 |
Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent |
Taewoong Medical Co., Ltd. |
Yongjin Kim |
| K222897 |
09/23/2022 |
Enlight 2100 |
Timpel S.A. |
Rafael Holtzhacker |
| K222863 |
09/22/2022 |
Garment Electrodes |
Tone-A-Matic International Inc. |
Manuel Chuck |
| K222770 |
09/14/2022 |
Conductive Gel |
Top-Rank Health Care Co.,Ltd. |
Gangfeng Lou |
| K222645 |
09/01/2022 |
Treace Medical Concepts (TMC) Implant Fixation System |
Treace Medical Concepts |
Brittany Grochala |
| K222666 |
09/06/2022 |
X-View 3D Pan/X-View 2D Pan |
Trident s.r.l |
Giorgio Rizzo |
| K222700 |
09/07/2022 |
Tibial baseplate, Tibial insert |
United Orthopedic Corporation |
Lois Ho |
| K222728 |
09/08/2022 |
Radiation Planning Assistant (RPA) |
University of Texas, MD Anderson Cancer Center |
Stella Tsai |
| K222775 |
09/14/2022 |
Aarhus Applicator Set |
Varian Medical Systems, Inc |
Peter J. Coronado |
| K222941 |
09/26/2022 |
Halcyon, Ethos Radiotherapy System |
Varian Medical Systems, Inc |
Peter J. Coronado |
| K222679 |
09/06/2022 |
Vericor Support Catheter |
VascuPatent Medical (Shenzhen) Co. Ltd. |
Heather Li |
| K222686 |
09/06/2022 |
Perfit FS Dental Zirconia Fully Sintered Block |
Vatech Acucera, Inc. |
Kwon Kyung Wook |
| K223058 |
09/30/2022 |
EzRay Air 2 Wall (Model: VEX-S350W) |
Vatech Co., Ltd |
Daniel Kim |
| K223029 |
09/29/2022 |
Perfit CL |
Vatech mcis Co., Ltd. |
Kim Gyeong Rok |
| K222639 |
09/01/2022 |
VHA Radiotherapy Bolus |
VHA DEAN |
Beth Ripley |
| K223031 |
09/29/2022 |
Vibrant System |
Vibrant Ltd. |
Martha Bezalel |
| K222982 |
09/28/2022 |
Virtus Metabolic Monitor |
Virtus Technology ApS |
Leif Olesen |
| K222933 |
09/26/2022 |
MYAH |
VISIA Imaging S.r.l. |
Alessia Magnanini |
| K223020 |
09/29/2022 |
VS3-Iridium System (VS3-IR) |
Visionsense Ltd. |
Guy Wroclawski |
| K222667 |
09/06/2022 |
Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx |
Vivachek Biotech (Hangzhou) Co., Ltd |
Jessica Chen |
| K222872 |
09/22/2022 |
DNA Appliance |
Vivos Therapeutics, Inc. |
Kimberly Griffith |
| K223042 |
09/29/2022 |
Viz LVO ContaCT |
Viz.ai, Inc. |
Gregory Ramina |
| K222919 |
09/26/2022 |
GORE« ENFORM Biomaterial |
W. L. Gore and Associates, Inc. |
Barbara L Smith |
| K223045 |
09/29/2022 |
3-Ply Disposable Medical Mask |
Wealth Lead Industrial Limited |
Ethel Chiu Man Mok |
| K222888 |
09/23/2022 |
BlueStar CGM insulin dose calculator |
Welldoc, Inc. |
Ian Cadieux |
| K222697 |
09/07/2022 |
Disposable Medical Face Mask (DF3-001) |
Wellmed Dental Medical Supply Co., Ltd. |
Tang Renxian |
| K222828 |
09/19/2022 |
Specimen Bag, model: WEP040306B, WEP010304B, WEP040304B, WEP010759B, WEP010709B, WEP010304A, WEP010759A, WEP010709A |
WickiMed (Huizhou) Medical Equipment Manufacturing Co., Ltd. |
Mac Lai |
| K222717 |
09/08/2022 |
CL24N |
WIDE Corporation |
YeoJin Yun |
| K222722 |
09/08/2022 |
CW60N |
WIDE Corporation |
YeoJin Yun |
| K222719 |
09/08/2022 |
CX50N |
WIDE Corporation |
YeoJin Yun |
| K222716 |
09/08/2022 |
MX50N |
WIDE Corporation |
YeoJin Yun |
| K223075 |
09/30/2022 |
Ogmend« Implant Enhancement System |
Woven Orthopedic Technologies |
Brandon Bendes |
| K222835 |
09/20/2022 |
Prophecy Preoperative Navigation Alignment System |
Wright Medical Technology, Inc. |
Paxia Her |
| K222729 |
09/08/2022 |
Electrical Scooter, WT-T4QP2 |
WuÆs Tech Co., Ltd. |
Dr.Jen Ke-Min |
| K222879 |
09/22/2022 |
Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1) |
Wuxi Jiajian Medical Instrument Co., Ltd |
Wu Zhifang |
| K223059 |
09/30/2022 |
Xenco Medical InterAlign Cervical Interbody System |
Xenco Medical, LLC |
Jason Haider |
| K222955 |
09/27/2022 |
Xenta Drug Screen Cup, Xenta Drug Screen Dipcard |
Xenta Biomedical Science Co., Ltd. |
Huang Ling |
| K222991 |
09/28/2022 |
Air Compression Leg Massager (model: EMK-701) |
Xiamen Emoka Health Science & Technology Co., Ltd. |
Iris Fung |
| K222651 |
09/01/2022 |
Surgical Face Mask |
Xiantao Sanda Industrial Co., Ltd |
Rong Min |
| K223055 |
09/29/2022 |
Disposable Medical Face Mask |
Xiantao Zhuobo Industrial Co., LTD |
Chen Xiaodong |
| K222978 |
09/28/2022 |
Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device |
Xiros Ltd |
Steve Curran |
| K222751 |
09/12/2022 |
LED Light Therapy Device, KN-7000L |
Xuzhou Kernel Medical Equipment Co., Ltd. |
Cuiling Xi |
| K222980 |
09/28/2022 |
Pentax Medical Valve Set |
Yangzhou Fartley Medical Instrument Technology Co., Ltd. |
Tina Han |
| K222705 |
09/07/2022 |
Introducer Needle |
YouCare Technology Co., Ltd. (Wuhan) |
Bing Hu |
| K223019 |
09/29/2022 |
sam 2.0 Long Ultrasound Device |
ZetrOZ Systems, LLC |
Sabrina Lewis |
| K222782 |
09/15/2022 |
Wearable Breast Pump (Model:YD-1193,YD-1195,YD-1196,YD-1198,YD-1199;YD-1193S,YD-1195S,YD-1196S,YD-1198S,YD-1199S) |
Zhejiang Carebao Co., Ltd. |
Xie Yan |
| K222949 |
09/27/2022 |
Air Compression Leg Massager (Model: LY-670D) |
Zhejiang Luyao Electronics Technology Co., Ltd |
Joyce Lin |
| K222920 |
09/26/2022 |
Oxygen concentrator |
Zhengzhou Olive Electronic Technology Co., Ltd. |
Yunping Qu |
| K222815 |
09/19/2022 |
Powder Free Nitrile Examination Gloves (Blue, White and Black), Tested For Use With Chemotherapy Drugs and Fentanyl |
Zibo Lanhua Medical Packaging Material Co., Ltd |
Lily Wang |
| K222912 |
09/26/2022 |
c1Trac |
Zimmer MedizinSysteme GmbH |
Ute Hauss |
