| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K213295 |
11/17/2022 |
C.C. LIFE 21 |
21 Equipment S.R.L. |
Dolores Moretto |
| K222508 |
11/01/2022 |
3MÖ ComplyÖ Hydrogen Peroxide Chemical Indicator 1248 |
3M Company |
Yumi Wackerfuss |
| K222109 |
11/17/2022 |
Accure Laser |
Accure Acne, Inc. |
Karl Nicholls |
| K220833 |
11/04/2022 |
Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and Citrelock ACL |
Acuitive Technologies, Inc. |
Matthew Poggie |
| K221719 |
11/03/2022 |
ABTross ALIF Expandable Cage System |
Aegis Spine, Inc. |
KiHyang Kim |
| K223328 |
11/30/2022 |
Purgo |
AeroClean Technologies, Inc. |
Richard Foster |
| K222363 |
11/28/2022 |
Aevumed PHANTOMÖ-LP Suture Anchors |
Aevumed, Inc. |
Saif Khalil |
| K221183 |
11/10/2022 |
AEYE-DS |
AEYE Health, Inc. |
Zack Dvey-Aharon |
| K221330 |
11/18/2022 |
BriefCase |
Aidoc Medical, Ltd. |
Nimrod Epstein |
| K220346 |
11/07/2022 |
Lotus Prophy Angle |
AJK Engineering, Inc. |
Ajay Kumar |
| K223009 |
11/27/2022 |
Wireless/Wired X-Ray Flat Panel Detectors |
Allengers Medical Systems Limited |
Sanjeev K. Marjara |
| K222973 |
11/17/2022 |
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 |
| K222455 |
11/18/2022 |
Calibrate LTX Interbody System |
Alphatec Spine, Inc. |
Cynthia Dorne |
| K223270 |
11/01/2022 |
POSEÖ Health Care Surgical Mask |
America's Supply Chains |
Paul Park |
| K222749 |
11/14/2022 |
High Fluid-Resistant Surgical and Procedure Mask |
AmericaÆs Supply Chains |
Paul Park |
| K220230 |
11/10/2022 |
AMSure Enteral Feeding Pump |
Amsino International Inc. |
Jane Gao |
| K222124 |
11/04/2022 |
Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle |
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd |
Bingyi Xiang |
| K221608 |
11/22/2022 |
NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam Tether, NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule and NaviCam Tether |
AnX Robotica Corp |
Tim Thomas |
| K220421 |
11/04/2022 |
BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System |
Apex BioTechnology Corp. |
Lisa Liu |
| K213215 |
11/25/2022 |
VSI HoloMedicine |
ApoQlar GmbH |
Liliana Duarte |
| K223164 |
11/04/2022 |
Aquilo Sports CCT1500 System |
Aquilo SPorts LLC |
JP Spence |
| K220663 |
11/22/2022 |
AccuCTP |
ArteryFlow Technology Co., Ltd. |
Jianping Xiang |
| K222084 |
11/02/2022 |
OneTouch Delica Safety, HemoCue Safety Lancet, Assure Lance and Assure Lance Plus, Capiject Safety Lancet, Heel Lancet Newborn, Heel Lancet Preemie |
Asahi Polyslider Co., Ltd. |
Yoshitaka Akagi |
| K223293 |
11/18/2022 |
CONTOUR« NEXT GEN Blood Glucose Monitoring System |
Ascensia Diabetes Care US Inc. |
Larnie James |
| K220905 |
11/17/2022 |
xvision Spine System |
Augmedics Ltd. |
Contact Title |
| K221499 |
11/22/2022 |
Minimally Invasive Prostate Surgery Navigation System |
Augment Intelligent Medical System (China) Co., Ltd. |
Chen Lihong |
| K213018 |
11/18/2022 |
Auxilock GFS Mini, GFS II Large, and GFS Ultimate |
Auxein Medical Private Limited |
Rahul Luthra |
| K213108 |
11/04/2022 |
Humerus & Ulna System |
Auxein Medical Private Limited |
Rahul Luthra |
| K222967 |
11/23/2022 |
Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Screws |
Avanti Orthopaedics, Inc. |
J. Doug Patterson |
| K221268 |
11/21/2022 |
SR-1 Skin Treatment System |
AVAVA, Inc |
Jay Bhawalkar |
| K221624 |
11/22/2022 |
Avenda Health AI Prostate Cancer Planning Software |
Avenda Health, Inc. |
Brittany Berry-Pusey |
| K221716 |
11/22/2022 |
CINA |
AVICENNA.AI |
Stephane Berger |
| K221815 |
11/23/2022 |
Electrosurgical Pencil (OBS-Db, OBS-Dr, OBS-Dc, OBS-Df, OBS-Di, OBS-De); Electrosurgical Pencil (OBS-Dt, OBS-Dd, OBS-Ds, OBS-Dl, OBS-Da) |
Baisheng Medical Co., Ltd. |
Xi Chen |
| K223198 |
11/10/2022 |
BD Intraosseous Vascular Access System EMS Powered Driver (D001003) |
Bard Access Systems |
Nasreen Al-Quaid |
| K220558 |
11/17/2022 |
Blood Administration Sets |
Baxter Healthcare Corporation |
James L. Vangeisen |
| K223246 |
11/18/2022 |
Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense |
Baxter Healthcare Corproration |
Jigar Shah |
| K221225 |
11/10/2022 |
Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer |
Beckman Coulter, Inc. |
Kuljeet Kaur |
| K211507 |
11/22/2022 |
Airdog X5 Recirculating Air Cleaner (model KJ300F-X5) |
Beiang Air Tech LTD. |
Yan Zhang |
| K222408 |
11/29/2022 |
Disposable Safety Lancet |
Beijing Ruicheng Medical Supplies Co., Ltd. |
Yuechao Li |
| K213217 |
11/14/2022 |
Disposable hemoclip |
Beijing ZKSK Technology Co.,Ltd |
Ma Li |
| K221045 |
11/03/2022 |
Insulin Syringes without needle |
Berpu Medical Technology Co., Ltd |
Buxin Yu |
| K222903 |
11/18/2022 |
Tailored-H Cervical Stand Alone System |
BeSpoke Technologies, LLC |
Daniel Hoehn |
| K221184 |
11/02/2022 |
ORiGO System |
Bien-Air Surgery SA |
Jonas Guerdat |
| K223199 |
11/15/2022 |
2.1 x 255mm Drill, 22mm Stop |
Biomet Microfixation |
Jay Sharma |
| K220535 |
11/15/2022 |
Cardio10 |
Bionet Co., Ltd. |
Kyungeun Park |
| K222964 |
11/22/2022 |
BioPoly Lesser Toe Hemiarthroplasty Implant |
BioPoly, LLC |
Herb Schwartz |
| K211934 |
11/10/2022 |
APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APDL Drainage Catheter System Kit with Dissolving Tip, Flexima APDL Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System, Flexima APD Drainage Cath |
Boston Scientific Corporation |
Liz Johnston |
| K211816 |
11/02/2022 |
Brightway Brand, Nitrile Examination Gloves, Powder Free (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate |
Brightway Holdings Sdn. Bhd. |
G. Baskaran |
| K222237 |
11/22/2022 |
Cala kIQ |
Cala Health, Inc. |
Danielle McDonnell Boyd |
| K222673 |
11/17/2022 |
Alexandrite and Nd:YAG Laser models CANLASE and TORLASE |
Canadian Pioneer Medical Technology Corporation (CPMT LASER) |
Rashid Reza Mir Sayah |
| K222915 |
11/15/2022 |
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 |
| K211830 |
11/15/2022 |
LifeSPARC System |
CardiacAssist, Inc. |
Megan Walsh |
| K222652 |
11/28/2022 |
Aneroid Sphygmomanometer; Single Patient Use Aneroid Sphygmomanometer |
Cardicare Company, Ltd. |
Ying Hao |
| K222009 |
11/22/2022 |
aprevo« anterior lumbar interbody fusion device with interfixation |
Carlsmed, Inc. |
Karen Liu |
| K222317 |
11/10/2022 |
Catalyst EA Convertible Stemmed Shoulder |
Catalyst OrthoScience, Inc. |
Dale Davison |
| K222377 |
11/03/2022 |
Led Mask Platinum Md |
CellReturn Co., LTD. |
Ilsoo Kim |
| K221152 |
11/23/2022 |
CuringPen Dental Curing Light |
Changzhou Sifary Medical Technology Co., Ltd. |
Iris Cai |
| K220351 |
11/18/2022 |
Polso Watch |
Chronisense Medical, Ltd. |
Bridget Ross |
| K222052 |
11/22/2022 |
VitroPRO |
CIVCO Medical Instruments Co., Inc. |
Jim Leong |
| K221593 |
11/17/2022 |
Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus |
ConvaTec, Inc. |
Courtney Smith |
| K220408 |
11/10/2022 |
AVIEW RT ACS |
Coreline Soft Co.,Ltd |
Hyeyi Park |
| K221771 |
11/30/2022 |
EEA Circular Stapler with Tri-Staple Technology |
Covidien |
Leo Chan |
| K222641 |
11/29/2022 |
SigniaÖ Small Diameter Reloads Including Regular (Round) Tip Version |
Covidien |
Robert Zott |
| K220334 |
11/09/2022 |
MONET Anterior Cervical Plate System |
CTL Medical Corporation |
Sean Suh |
| K222550 |
11/01/2022 |
Current Health System |
Current Health Ltd. |
Shyama Ramjagsingh |
| K223110 |
11/03/2022 |
truSculpt iD |
Cutera Inc. |
Julia Brown |
| K223292 |
11/23/2022 |
TempSure System |
Cynosure LLC |
Michael King |
| K221556 |
11/28/2022 |
T-Line Hernia Mesh |
Deep Blue Medical Advances, Inc. |
William Perry |
| K220042 |
11/17/2022 |
Dentca Base Premium, Dentca Base Hi-Impact |
Dentca, Inc. |
Jason Lee |
| K222918 |
11/25/2022 |
DentCare Aligners |
DentCare Dental Lab Pvt Ltd. |
Abin Johns Raju |
| K222054 |
11/22/2022 |
Denti.AI Auto-Chart |
Denti.AI Technology Inc. |
Lyudmila Tuzova |
| K221094 |
11/16/2022 |
OmniTaper EV Dental Implants, DS Implants abutments with EV connection |
Dentsply Sirona |
Courtney Clark |
| K220841 |
11/16/2022 |
PrimeTaper EV Dental Implants ╪3.0, DS Implants abutments with EV connection (XS) |
Dentsply Sirona |
Courtney Clark |
| K221391 |
11/10/2022 |
WOLF ThrombectomyÖ SmartClaw Catheter |
DeVoro Medical, Inc |
Vanessa Fowler |
| K221471 |
11/22/2022 |
E3 and Profile |
Diagnosys LLC |
Jeffrey Farmer |
| K202755 |
11/05/2022 |
Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack |
DiaSorin Molecular LLC |
Sharon Young |
| K222734 |
11/08/2022 |
Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing |
Diversatek Healthcare |
Alyssa Roelli |
| K222477 |
11/18/2022 |
Hair Growth Device |
Dongguan Lescolton Medical Equipment Co., Ltd |
Qixiang Liu |
| K223124 |
11/18/2022 |
EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG |
DRTECH Corporation |
Ella An |
| K221833 |
11/07/2022 |
HemoSphere Advanced Monitor, HemoSphere ClearSight Module |
Edwards Life Sciences LLC |
Varad Raghuwanshi |
| K223127 |
11/07/2022 |
HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable |
Edwards Lifeciences, LLC |
Michelle Ducca |
| K221704 |
11/22/2022 |
HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion Index (GHI) |
Edwards Lifesciences, LLC |
Michelle Ducca |
| K222496 |
11/18/2022 |
Electromed SmartVest Airway Clearance System |
Electromed, Inc. |
Gregory Spurlock |
| K222395 |
11/02/2022 |
Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo |
Ellex Medical Pty Ltd |
Rashmi Pillay |
| K222044 |
11/30/2022 |
Elos Accurate Customized Abutment |
Elos Medtech Pinol A/S |
Lise Terkelsen |
| K213981 |
11/12/2022 |
Nitrile Examination Gloves |
Emerald Glove Manufacturing Sdn Bhd |
Amran A. Aziz |
| K221282 |
11/20/2022 |
Empatica Health Monitoring Platform |
Empatica S.r.l. |
Alberto Poli |
| K220533 |
11/16/2022 |
Endoscopy Oxygen Mask |
Engineered Medical Systems Inc. |
Tamara Lefevers |
| K222551 |
11/10/2022 |
Humask Pro Vision, Humask Pro Vision 3000 |
Entreprise Premont Inc. |
Charlie Marchand |
| K221744 |
11/15/2022 |
STRATAFIXÖ Spiral MONOCRYLÖ Plus Knotless Tissue Control Device |
Ethicon, Inc. |
Jenny Wang |
| K221552 |
11/08/2022 |
EFAI ChestSuite XR Pneumothorax Assessment System |
Ever Fortune AI Co., Ltd. |
Joseph Chang |
| K222488 |
11/15/2022 |
Everyway Analog OTC TENS |
Everyway Medical Instruments Co., Ltd |
Jimmy Cheng |
| K222198 |
11/09/2022 |
Exo Iris (El2001) |
Exo Imaging Inc. |
Antoanela Gomard |
| K222539 |
11/18/2022 |
Facet Blood Lancets |
Facet Technologies LLC |
James Bonds |
| K223099 |
11/28/2022 |
Facet Manatee Reusable Lancing Base |
Facet Technologies LLC |
James Bonds |
| K221369 |
11/18/2022 |
FBCC Night Guard |
FBCC Inc |
Pablo Osorio |
| K221139 |
11/10/2022 |
Bodygard SFS Surgical Gown Level 4 |
Feliks Plastik Laminasyon Ve Ambalaj Malzemeleri |
Ali Serdar Serteser |
| K222390 |
11/21/2022 |
Flex-ThreadÖ Ulna Intramedullary Nail System |
Flower Orthopedics Corporation DBA Conventus Flower |
Christina Rovaldi |
| K222061 |
11/10/2022 |
Dental LT Clear V2 Resin |
Formlabs Ohio, Inc. |
Ritika Sharma |
| K222480 |
11/14/2022 |
Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2) |
Foshan Nanhai Plus Medical Co., Ltd. |
Eric Li |
| K221677 |
11/10/2022 |
Synapse 3D Base Tools v6.6 |
FUJIFILM Corporation |
Randy Vader |
| K220957 |
11/10/2022 |
FUJIFILM Endoscope Model EB-710P |
FUJIFILM Corporaton |
Randy Vader |
| K222936 |
11/07/2022 |
Humeris« 135 Shoulder System |
FX Shoulder USA, Inc. |
Cory Trier |
| K223171 |
11/10/2022 |
AquaPulse« Irrigation Tubing |
GA Health Company Limited |
Cindy Ye |
| K222895 |
11/22/2022 |
DynamicIQ |
GE Medical Systems SCS |
Tong Zhao |
| K223152 |
11/22/2022 |
Vision 2, EVARVision, TrackVision 2, HeartVision 2 |
GE Medical Systems SCS |
Ning Wen |
| K222160 |
11/22/2022 |
GUS610 Blood pressure monitor |
Globalcare Medical Technology Co., Ltd. |
Chiara Cavagnolo |
| K223355 |
11/03/2022 |
Tera Harz Clear |
Graphy Inc. |
Moon Soo Part |
| K221539 |
11/09/2022 |
GammaTile |
GT Medical Technologies |
Jessica Newhard |
| K222453 |
11/04/2022 |
Self-adhesive Electrode |
Guangdong Comytens Medical Technology Co., Ltd |
Mr. Deng Jiuzhen |
| K223068 |
11/23/2022 |
Medical Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E) |
Guangdong Golden Leaves Technology Development Co., LTD |
Wenhong Zhou |
| K222612 |
11/25/2022 |
Powder-Free Latex examination gloves |
Guangdong Kingfa Sci.&Tech. Co., Ltd. |
Xiaoge Yu |
| K222305 |
11/30/2022 |
MissLanÖ Digital Pregnancy Rapid Test |
Guangzhou Decheng Biotechnology Co. Ltd. |
Weifang Liu |
| K213042 |
11/17/2022 |
Supra Non-Stick Bipolar Forceps |
Guenter Bissinger Medizintechnik GmbH |
Matthias Bissinger |
| K222569 |
11/23/2022 |
Ai Ray Dental X-Ray Device |
Guilin Woodpecker Medical Instrument Co., Ltd. |
Xunxian Wu |
| K211358 |
11/21/2022 |
Implanter incl. Accessories |
Guilin Woodpecker Medical Instrument Co., Ltd. |
Yang Yunfeng |
| K222304 |
11/08/2022 |
Sonata Transcervical Fibroid Ablation System 2.2 |
Gynesonics, Inc. |
Diane King |
| K220820 |
11/17/2022 |
Parky App |
H2O Bilisim Yazilim |
Yagmur Selin Gulmus-Kolay |
| K221722 |
11/15/2022 |
Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) |
Haemonetics Corporation |
Ergang Alexis |
| K222490 |
11/14/2022 |
HBL Blade Assembly |
Hand Biomechanics Lab, Inc |
Dustin Dequine |
| K222225 |
11/11/2022 |
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue) |
Hartalega NGC Sdn. Bhd. |
Kuan Mun Leong |
| K222741 |
11/07/2022 |
DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast) |
HDI, Inc. |
Taekyou Kim |
| K213917 |
11/29/2022 |
QStat Cartridge |
HemoSonics, LLC |
Iskra Mrakovic |
| K220326 |
11/14/2022 |
PosiSep X BAM Hemostat Dressing/Intranasal Splint |
Hemostasis LLC |
Lakshmi Ganesh Bollina |
| K223003 |
11/18/2022 |
Banded Face Mask |
Hubei Medlink Healthcare Co., Ltd |
Niki Wang |
| K221580 |
11/18/2022 |
Single-Use Flexible Cystoscope |
Hunan Vathin Medical Instrument Co., Ltd. |
Du Jing |
| K221581 |
11/18/2022 |
Single-Use Flexible Rhinolaryngoscope |
Hunan Vathin Medical Instrument Co., Ltd. |
Du Jing |
| K222656 |
11/23/2022 |
LDE4 Lancing Device |
i-SENS, Inc. |
H.S. Yoo |
| K220983 |
11/11/2022 |
ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging System |
ImSonic Medical China, INC. |
Xiaohui Hao |
| K220846 |
11/21/2022 |
CORE-SNARE |
Incore Co., Ltd. |
Jae-Hun Lee |
| K222992 |
11/22/2022 |
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 |
| K212164 |
11/11/2022 |
Mapping Suction Probe |
inomed Medizintechnik GmbH |
Alexander Maier |
| K221811 |
11/21/2022 |
Vista BC Sealer |
Inter-Med, Inc. |
Alex Johnson |
| K223039 |
11/28/2022 |
da Vinci E-200 Electrosurgical Generator |
Intuitive Surgical |
Shamsa Karimi |
| K223080 |
11/22/2022 |
da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000) |
Intuitive Surgical, Inc |
Connor McCarty |
| K223132 |
11/09/2022 |
Iridex PASCAL« 532, Iridex PASCAL« 577, Iridex PASCAL« (532nm and 577 nm models) |
Iridex Corporation |
Bill Hyatt |
| K221412 |
11/22/2022 |
ARIX Rib System |
Jeil Medical Corporation |
Sejin Ryu |
| K221247 |
11/01/2022 |
Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable Needle |
Jiangsu Kangbao Medical Equipment Co., Ltd. |
Rujun Tang |
| K222534 |
11/23/2022 |
Nitrile Patient Examination Glove |
Jiangxi Jiangxi Zhonghong Pulin Medical Products Co.,Ltd. |
Zhou Ziyu |
| K211050 |
11/28/2022 |
Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304 |
JKH HEALTH CO., LTD. |
Pu Jiang |
| K222504 |
11/10/2022 |
H1 |
Karl Storz Endoscopy America, Inc. |
Mario Trujillo |
| K220539 |
11/01/2022 |
Klarity SRS Baseplate, Klarity Promise Baseplate |
Klarity Medical & Equipment (GZ) Co., Ltd. |
Lucy Li |
| K203528 |
11/16/2022 |
KNH Surgical Face Mask |
KNH Surgical Face Mask |
Robert Y.L. Pan |
| K223267 |
11/17/2022 |
SKR 3000 |
Konica Minolta, INC. |
Tsutomu Fukui |
| K222372 |
11/21/2022 |
Kowa SL-19 |
Kowa Company, Ltd. |
Nariaki Morita |
| K220874 |
11/07/2022 |
Smooth Drive contra angle and straight handpieces |
Lares Research |
Bruce Holderbein |
| K222628 |
11/16/2022 |
Life Spine ALIF Buttress Plate System |
Life Spine, Inc. |
Angela Batker |
| K221946 |
11/22/2022 |
LED Light Therapy Mask (model: MK66R-B) |
Light Tree Ventures Europe B.V. |
Alain Dijkstra |
| K223320 |
11/02/2022 |
Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate |
Lingshi Hongruida Health Protection Technology Co., Ltd. |
Yin Hongmei |
| K220635 |
11/16/2022 |
Heater-Cooler System 3T |
LivaNova Deutschland GmbH |
Julia E. Leslie |
| K221659 |
11/04/2022 |
Luminopia One |
Luminopia, Inc. |
Scott Xiao |
| K222299 |
11/30/2022 |
Steripath Micro Blood Collection System |
Magnolia Medical Technologies |
Greg Bullington |
| K213459 |
11/23/2022 |
Glenoid Reconstruction System |
Medacta International S.A. |
Stefano Baj |
| K212911 |
11/18/2022 |
Konig Mogen Clamp |
Medline Industries, Inc |
Jennifer Mason |
| K222873 |
11/07/2022 |
Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery system |
Medtronic |
Sarah Meyer |
| K223178 |
11/08/2022 |
SelectSite C304 Deflectable Catheter System, C315 Delivery System |
Medtronic |
Sarah Meyer |
| K212764 |
11/04/2022 |
Medwell Technology Ltd Syringes, various sizes |
Medwell Technology Ltd |
Andy Song |
| K220562 |
11/10/2022 |
TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment |
MegaGen Implant Co., Ltd. |
Hyo-Eun Lee |
| K223185 |
11/10/2022 |
BreathID« Smart System |
Meridian Bioscience Israel Ltd. |
Raffi Werner |
| K222816 |
11/18/2022 |
Opulent TiNbN Coated Knee |
Meril Healthcare Pvt. Ltd. |
Neelam Desai |
| K212936 |
11/21/2022 |
Vision Monitor- MonCvONE |
Metrovision |
Jacques Charlier |
| K220360 |
11/10/2022 |
Tandry CMF Plate System |
Microware Precision Co., Ltd. |
Harrison Du |
| K221762 |
11/16/2022 |
BoneMRI v1.4 |
MRlguidance B.V. |
Marijn van Stralen |
| K222518 |
11/17/2022 |
FX Contra |
Nakanishi INC. |
Masaaki Kikuchi |
| K221210 |
11/23/2022 |
PainShield MD PLUS |
NanoVibronix, Inc. |
Hrishikesh Gadagkar |
| K221250 |
11/22/2022 |
EasyOne Filter |
NDD Medizintechnik AG |
Andreas Senn |
| K222049 |
11/04/2022 |
Yomi Robotic System |
Neocis Inc. |
Olga Lewis |
| K220254 |
11/30/2022 |
Neuron-Spectrum-AM with Neuron-Spectrum.NET Software |
Neurosoft Ltd. |
Michael Durdin |
| K221610 |
11/04/2022 |
Nextra CH Cannulated Hammertoe System |
Nextremity Solutions, Inc. |
Elise Fox |
| K221178 |
11/17/2022 |
Disposable Insulin Pen Needle |
Ningbo Medsun Medical Co., Ltd. |
Liu Ping |
| K221518 |
11/03/2022 |
NP Medical nCompass Extension Set with Stabilizing Base |
NP Medical |
Krishna Govindarajan |
| K212612 |
11/15/2022 |
Omnia Medical TiBrid-SC |
Omnia Medical, LLC |
Morgan Hill |
| K222166 |
11/09/2022 |
SOLIX |
Optovue, Inc. |
Robert Lundberg |
| K222107 |
11/03/2022 |
Black DiamondÖ POCT Spinal System |
Osseus Fusion Systems |
Jonathan Rosen |
| K222168 |
11/03/2022 |
Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets - Preemie and Full-Term, Unistik Heelstik Sterile Single-Use Heel Incision Safety Lancets - MicroPreemie, Preemie, Full-Term and Toddler |
Owen Mumford Ltd |
Darren Mansell |
| K212717 |
11/30/2022 |
Paneffort AAMI Level 3 Isolation Gown |
Paneffort, LLC |
Harry Harry |
| K223227 |
11/17/2022 |
MAVENÖ Patient-Specific Instrumentation |
Paragon 28, Inc |
Greg Kowalczyk |
| K221478 |
11/01/2022 |
Dolphin Blue Imaging |
Patterson Dental Supply, Inc. |
Erin Daly |
| K220465 |
11/16/2022 |
PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT Imaging System with Camera Head PVK-J10 |
PENTAX of America, Inc. |
William Goeller |
| K221822 |
11/04/2022 |
BENCHMARK BMX81 Access System |
Penumbra, Inc |
Sindokht (Sisi) Soltanzadeh |
| K203035 |
11/09/2022 |
Eonis SCID-SMA kit |
PerkinElmer Inc |
Eva Nalian |
| DEN200044 |
11/09/2022 |
Eonis SCID-SMA Kit |
PerkinElmer Inc. |
Casey Fox |
| K221279 |
11/28/2022 |
pNOVUS 21 Microcatheter |
phenox Ltd |
Sarah Cregg |
| K222493 |
11/18/2022 |
CODAÖ Anterior Cervical Plate System |
Pioneer Surgical Technology, Inc., |
Alicia Kaufman |
| K213427 |
11/22/2022 |
PRIMED Pediatric Facemask |
PRIMED Medical Products Inc. |
Mitra Fard |
| K201256 |
11/04/2022 |
Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge |
Procise Diagnostics |
Dan Kiser |
| K222208 |
11/17/2022 |
Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30D |
Qingdao Hisense Medical Equipment Co., Ltd |
Lu Zhonghao |
| K222132 |
11/08/2022 |
Hisense LCD monitor HMD2G21S, HMD3G21S |
Qingdao Hisense Medical Equipment Co., Ltd |
Lu Zhonghao |
| K222067 |
11/10/2022 |
SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set |
Quanta Dialysis Technologies Ltd |
Sam Drew |
| K213294 |
11/10/2022 |
Dermal Cooling System |
R2 Technologies, Inc. |
Ragan Reppond |
| K222476 |
11/17/2022 |
OmegaAI Image Viewer |
RamSoft Inc. |
Deeksha Shukla |
| K220489 |
11/07/2022 |
Durex Patronus CloseFit, Durex Patronus Regular |
RB Health (US) LLC |
Kaitlyn Chan |
| K223257 |
11/21/2022 |
Miro3D Wound Matrix |
Reprise Biomedical |
Carrie Powers |
| K221082 |
11/30/2022 |
Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves û Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl |
Rhino Health Inc. |
Mark Lee |
| K221007 |
11/04/2022 |
cobas HCV |
Roche Molecular Systems, Inc. |
Ashley Malich |
| K222898 |
11/07/2022 |
SafeSource Direct Blue Powder-Free Nitrile Exam Gloves |
SafeSource Direct, LLC |
Justin Hollingsworth |
| K222800 |
11/07/2022 |
Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A) |
Sanhe Laserconn Tech Co., Ltd. |
Xia Aijiang |
| K222732 |
11/07/2022 |
WaveForm A Interbody System |
SeaSpine Orthopedics Corporation |
Jesse Albright |
| K210623 |
11/18/2022 |
FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2 |
Sebia |
Karen Anderson |
| K222951 |
11/21/2022 |
SM-V |
SEDECAL SA |
M¬ Luisa G≤mez de Agⁿero |
| K220302 |
11/16/2022 |
Disposable surgical face mask |
Shandong Aida Medical Products Co., Ltd |
Wang Bing |
| K222472 |
11/30/2022 |
Lancing System, Sterile Lancet for Single Use, Lancing Device |
Shandong Lianfa Medical Plastic Products Co. Ltd. |
Charles Shen |
| K222162 |
11/09/2022 |
Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) |
Shanghai AnQing Medical Instrument Co., Ltd |
Shuwen Fan |
| K222540 |
11/14/2022 |
uPMR 790 |
Shanghai United Imaging Healthcare Co., Ltd. |
Xin Gao |
| K222452 |
11/23/2022 |
Disposable Automatically Retractable Safety Syringes (with detachable needle) |
Shantou Wealy Medical Instrument CO.,Ltd. |
Yanjun Zhu |
| K212910 |
11/17/2022 |
Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece |
Shenzhen Carejoy Technology Co., Ltd. |
Wei Hui |
| K222754 |
11/09/2022 |
ViewMate Multi Ultrasound System |
Shenzhen Mindray Bio-Meidcal Electronics Co., LTD |
Jin Jiahong |
| K222598 |
11/17/2022 |
IPL Hair Removal Device |
Shenzhen Noble Smart Manufacturing Tech Co. Ltd |
Guo Yi |
| K203812 |
11/08/2022 |
Oxyfit Pulse Oximeter |
Shenzhen Viatom Technology Co., Ltd. |
Zhou Saixin |
| K201460 |
11/23/2022 |
Closed System Transfer Device |
Shinva Ande Healthcare Apparatus Co., Ltd. |
XiaoLei Tian |
| K221530 |
11/22/2022 |
ANNE Pediatric |
Sibel Inc. |
Sarah Coughlin |
| K221075 |
11/21/2022 |
Infusion Sets for Single Use |
Sichuan Prius Biotechnology Co., Ltd. |
Yan Liu |
| K221069 |
11/21/2022 |
Infusion Sets for Single Use with Needles |
Sichuan Prius Biotechnology Co., Ltd. |
Yan Liu |
| K221078 |
11/21/2022 |
Intravenous Needles for Single Use,Safety Intravenous Needles for Single Use |
Sichuan Prius Biotechnology Co., Ltd. |
Yan Liu |
| K221281 |
11/17/2022 |
Multitom Rax |
Siemens Medical Solutions |
Denise Adams |
| K222428 |
11/14/2022 |
Syngo Dynamics (Version VA40F) |
Siemens Medical Solutions USA, Inc. |
Jiayan Liu |
| K223062 |
11/04/2022 |
World Total Knee System |
Signature Orthopaedics Pty Ltd. |
Declan Brazil |
| K220658 |
11/18/2022 |
COSY Cervicothoracic Occipital Rod-Screw System |
SIGNUS Medizintechnik GmbH |
Holger Noss |
| K222189 |
11/18/2022 |
SiOxD Wound Matrix |
SiOxMed, LLC. |
Mitch Dellinger |
| K213943 |
11/29/2022 |
SmartSurgN Visualization System |
SmartSurgN Incorporated |
Cathy Mantor |
| K223041 |
11/22/2022 |
Renasys Edge (66803126) |
Smith & Nephew Medical Limited |
Zoe Smith |
| K210980 |
11/14/2022 |
Smith & Nephew Intramedullary Nail Systems |
Smith & Nephew, Inc. |
Leah Hawkins |
| K222475 |
11/10/2022 |
SNOR LOCK |
Solbaro Co., Ltd |
Donghoon Kim |
| K220466 |
11/03/2022 |
ibiomedi Electronic Stethoscope ES-2020 |
Sound Land Corp. |
Chi-Hsun Hung |
| K222497 |
11/09/2022 |
Zaga Zygomatic System |
Southern Implants (Pty) Ltd |
Leith C. Cumming |
| K212317 |
11/07/2022 |
Eclipse MINI Model 98900 |
Spacelabs Healthcare Ltd. |
Roger Moldon |
| K211954 |
11/10/2022 |
Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid |
Spes Medica SRL |
Giorgio Facco |
| K221578 |
11/14/2022 |
Hexanium ACIF |
SpineVision, S.A.S. |
Quang Tran |
| K221678 |
11/10/2022 |
SprintRay High Impact Denture Base |
SprintRay Inc. |
Sara Moghtadernejad |
| K222701 |
11/18/2022 |
MANTA Laser |
SQUALUS MED Ltd. |
Gil Shapira |
| K221165 |
11/20/2022 |
Non-Sterile, Powder-Free Nitrile Examination Glove Violet Blue Tested for use with Chemotherapy Drugs and Fentanyl and Non-Sterile, Powder-Free Nitrile Examination Glove Blue Tested for use with Chemotherapy Drugs and Fentanyl |
Sri Trang Gloves (Thailand) Public Company Limited |
Jordan Smith |
| K222309 |
11/15/2022 |
Gamma4 System |
Stryker GMBH |
Cindy Leon |
| K221855 |
11/09/2022 |
Universal CMF System |
Stryker Leibinger GmbH & Co. KG |
Amelia Kesti |
| K220371 |
11/02/2022 |
Nitrile Two Toned Blue/Green, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Grade Exam Gloves, Tested for Use with the Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit) |
Summit Glove, Inc |
James Hull |
| K223032 |
11/21/2022 |
SIS System (Version 5.6.0) |
Surgical Information Sciences, Inc. |
Ann Quinlan-Smith |
| K222611 |
11/28/2022 |
Male Latex Condoms |
Suzhou Colour-way New Material Co., Ltd. |
Yongping Xu |
| K222258 |
11/01/2022 |
Combined High Frequency X-ray Source |
Suzhou Powersite Electric Co., Ltd. |
Xinyue Lu |
| K214090 |
11/01/2022 |
Back 3 COLOR |
SWIMS America Corp |
Matthieu Commeau |
| K210346 |
11/08/2022 |
Sysmex XW-100 Automated Hematology Analyzer |
Sysmex America, INC. |
Sharita Brooks |
| K212700 |
11/15/2022 |
Dyflex-II |
Taeyeon Medical Co., Ltd. |
Sin-Ae Kang |
| K220794 |
11/10/2022 |
10PL |
Tentech Co. Ltd. |
Lee Dong Gun |
| K222175 |
11/15/2022 |
Bloomi Delight Oil-Based Personal Lubricant |
The Bloomi Inc.. |
Rebecca Story |
| K222246 |
11/21/2022 |
Disposable Sterile Lancet |
Tianjin Rilifine Medical Device Co., Ltd. |
Qiusheng Jiang |
| K222055 |
11/15/2022 |
Disposable Sterile Lancet |
Tianjin Rilifine Medical Device Co., Ltd. |
Qiusheng Jiang |
| K221086 |
11/04/2022 |
CryoRobot Select System |
TMRW Life Sciences, Inc. |
Christina Miracle |
| K211265 |
11/17/2022 |
TFX-LT2000 Therapy Light |
ToeFX, Inc. |
Monika Yazdanian |
| K222535 |
11/18/2022 |
OCS Lung Donor Flush Set |
TransMedics, Inc. |
Miriam Provost |
| K222645 |
11/21/2022 |
Treace Medical Concepts (TMC) Implant Fixation System |
Treace Medical Concepts |
Brittany Grochala |
| K222564 |
11/15/2022 |
Treace Medical Concepts (TMC) Hammertoe Fixation System |
Treace Medical Concepts, Inc. |
Kristina Hall |
| K223274 |
11/28/2022 |
Momentum« MIS Posterior Spinal Fixation System |
Ulrich Medical USA |
Hans Stover |
| K222463 |
11/23/2022 |
EchoGo Heart Failure |
Ultromics Limited |
Jaco Jacobs |
| K221675 |
11/04/2022 |
United U2 femoral head, 22mm delta ceramic head |
United Orthopedic Corporation |
Lois Ho |
| K212736 |
11/22/2022 |
Canady Flex RoboWrist |
US Medical Innovations, LLC |
Jerome Canady |
| K222679 |
11/07/2022 |
Vericor Support Catheter |
VascuPatent Medical (Shenzhen) Co. Ltd. |
Heather Li |
| K222639 |
11/04/2022 |
VHA Radiotherapy Bolus |
VHA DEAN |
Beth Ripley |
| K221558 |
11/15/2022 |
ALPHALOK Plating System |
Vilex LLC |
Brock Johnson |
| K222667 |
11/10/2022 |
Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx |
Vivachek Biotech (Hangzhou) Co., Ltd |
Jessica Chen |
| K221655 |
11/14/2022 |
Multiflex Steerable Sheath |
VizaraMed, Inc. |
Jack P Douglas |
| K220263 |
11/03/2022 |
Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers |
Vortex Surgical Inc |
Andrew Ritts |
| K220630 |
11/28/2022 |
TorchTM Software |
Voximetry, Incorporated |
Sue Wallace |
| K221162 |
11/04/2022 |
UniVy OsteoVy Cervical IBF System |
Vy Spine, LLC |
Jordan Hendrickson |
| K222697 |
11/04/2022 |
Disposable Medical Face Mask (DF3-001) |
Wellmed Dental Medical Supply Co., Ltd. |
Tang Renxian |
| K222420 |
11/21/2022 |
Disposable Blood Pressure Cuff |
Wenzhou Xikang Medical Instruments Co., Ltd. |
Wang Tiance |
| K221123 |
11/22/2022 |
WISE Cortical Strip (WCS) |
WISE S.r.l. |
Luca Ravagnan |
| K212812 |
11/16/2022 |
Surgical Gown |
Xianning Marveldas Protective Articles CO.,Ltd. |
Zhuxiao Kang |
| K222529 |
11/14/2022 |
Surgical Face Mask |
Xiantao Rayxin Medical Products Co., Ltd. |
Maggie Dai |
| K222364 |
11/16/2022 |
Xtrallux Alpha (XA136R-USA), Xtrallux Super Plus (XS276R-USA/XS276L-USA), Xtrallux Turbo Pro (XP316R-USA), Xtrallux Extreme RX (XR352R-USA) |
Xtrallux, LLC |
Carlos Pi±a |
| K223278 |
11/17/2022 |
easy Claire |
Y&J BIO Co., Ltd. |
Youngsam Chun |
| K222980 |
11/21/2022 |
Pentax Medical Valve Set |
Yangzhou Fartley Medical Instrument Technology Co., Ltd. |
Tina Han |
| K222520 |
11/14/2022 |
Zirconia Block |
Yilink (Tianjin) Biotechnology Co., Ltd |
Yaqiong Zhu |
| K220739 |
11/17/2022 |
Disposable Urine Collection Tube |
Zhejiang Gongdong Medical Technology Co., Ltd. |
Handson Wei |
| K221479 |
11/17/2022 |
Persona Personalized Knee System |
Zimmer, Inc. |
Gregory Foster |
