| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K221000 |
04/04/2022 |
ON3D |
3D ONS, Inc. |
Jeong Rae Cho |
| K221213 |
04/27/2022 |
EnSite X EP System |
Abbott |
Alexandra Agre |
| K220949 |
04/01/2022 |
Architect CMV IgG |
Abbott Laboratories |
Shannon Reibling |
| K221057 |
04/11/2022 |
Viatrac 14 Plus Peripheral Dilatation Catheter |
Abbott Vascular |
Jiyoung Dang |
| K221037 |
04/07/2022 |
TruDi Shaver Blade |
Acclarent, Inc. |
Leena Zalavadia |
| K221195 |
04/25/2022 |
OsteoProbe |
Active Life Scientific, Inc. |
Alexander Proctor |
| K221044 |
04/08/2022 |
AcQGuide« VUE Steerable Sheath |
Acutus Medical, Inc. |
Sarah Clay |
| K221050 |
04/11/2022 |
ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System |
Aegis Spine, Inc. |
Kihyang Kim |
| K221183 |
04/25/2022 |
AEYE-DS |
AEYE Health, Inc. |
Zack Dvey-Aharon |
| K221240 |
04/29/2022 |
BriefCase |
Aidoc Medical, Ltd. |
Nimrod Epstein |
| K221215 |
04/27/2022 |
e-motion M25 |
Alber GmbH |
Christoph Hauschel |
| K221223 |
04/28/2022 |
extriCARE« 3000 Negative Wound Pressure Therapy System |
Alleva Medical Devices |
Max Choi |
| K221027 |
04/06/2022 |
Isolation Gown (S, M, L, XL, XXL (Yellow, Blue)) |
Allmed Medical (Hubei) Protective Products Co., Ltd |
Vince Tian |
| K221093 |
04/13/2022 |
X-CUBE 70, X-CUBE 90 |
Alpinion Medical Systems Co., Ltd. |
Boyeon Cho |
| K221108 |
04/15/2022 |
Nitrile Medical Examination Gloves |
Anhui Fulewei Electronic Technology Co.,Ltd |
Beina Gong |
| K220969 |
04/04/2022 |
GelPOINT V-Path Vaginal Access System |
Applied Medical Resources Corporation |
David Yu |
| K220970 |
04/04/2022 |
Renuvion APR Handpiece |
Apyx Medical Corporation(formerly Bovie Medical Corporation) |
Priscilla Herpai |
| K221218 |
04/27/2022 |
Silverlon Wound Contact, Burn Contact Dressings |
Argentum Medical, Inc. |
Kathy Herzog |
| K221175 |
04/25/2022 |
Multi-Lancet Device 2, ReliOn Premier Lancing Device |
Arkray, Inc. |
Shinjiro Sekimoto |
| K221128 |
04/18/2022 |
Arthrex ACL TightRope«, PCL TightRope«, and TightRope« II |
Arthrex Inc. |
Lai Saeteurn |
| K221031 |
04/07/2022 |
Arthrex DualCompression Hindfoot Fusion Nail Implant System |
Arthrex Inc. |
Rebecca R. Homan |
| K220947 |
04/01/2022 |
Arthrex Knotless AC Repair Devices |
Arthrex Inc. |
Ivette Galmez |
| K221099 |
04/14/2022 |
Arthrex Self-Punching PushLock Suture Anchor |
Arthrex Inc. |
Kelsey Roberts |
| K221232 |
04/29/2022 |
Univers Revers Humeral Cup Implant |
Arthrex Inc. |
Ivette Galmez |
| K221125 |
04/18/2022 |
SilentCloud |
Aureliym GmBH |
Markus Haller |
| K221047 |
04/08/2022 |
SILO TFX MIS Sacroiliac Joint Fixation System |
Aurora Spine, Inc. |
Laszlo Garamszegi |
| K220966 |
04/01/2022 |
SINEFIX |
BAAT Medical Products B.V. |
Jasper Springer |
| K221114 |
04/15/2022 |
Immunoglobulin G (IgG) |
Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. |
Tracy Jin |
| K220977 |
04/04/2022 |
ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer |
Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. |
Tracy Jin |
| K220972 |
04/04/2022 |
Access Thyroglobulin |
Beckman Coulter, Inc |
Abhi Kannan |
| K221225 |
04/28/2022 |
Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer |
Beckman Coulter, Inc. |
Kuljeet Kaur |
| K221045 |
04/08/2022 |
Insulin Syringes without needle |
Berpu Medical Technology Co., Ltd |
Buxin Yu |
| K221184 |
04/25/2022 |
ORiGO System |
Bien-Air Surgery SA |
Jonas Guerdat |
| K221036 |
04/07/2022 |
Astroglide Warming |
BioFilm Inc. |
Kevin Jamil |
| K220978 |
04/04/2022 |
TSX Implants |
Biomet 3i LLC |
Mariela Cabarcas |
| K221062 |
04/11/2022 |
RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device |
Bionime Corporation |
Yu Chi Huang |
| K221112 |
04/15/2022 |
CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM) |
Biosense Webster, Inc. |
Phuong Park |
| K220958 |
04/01/2022 |
Real Intelligence Cori |
Blue Belt Technologies, Inc. |
Unnati Bhuptani |
| K221224 |
04/28/2022 |
REAL INTELLIGENCE CORI |
Blue Belt Technologies, Inc. |
Corrine Herlinger |
| K221124 |
04/18/2022 |
MANTIS Clip |
Boston Scientific Corporation |
Jia Huang |
| K220962 |
04/01/2022 |
ROTAPRO Rotational Atherectomy System |
Boston Scientific Corporation |
Heather Schuchard |
| K220986 |
04/04/2022 |
Aquilion Precision (TSX-304A/4) V10.10 with AiCE |
Canon Medical Systems Corporation |
Paul Biggins |
| K221188 |
04/25/2022 |
ZEPTO Precision Capsulotomy System |
Centricity Vision, Inc. |
Neal Hartman |
| K221160 |
04/21/2022 |
Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System |
Cepheid |
Suzette Chance |
| K221051 |
04/11/2022 |
Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank |
Changsha Honchon Technology Co., LTD |
Ling Li |
| K221152 |
04/20/2022 |
CuringPen Dental Curing Light |
Changzhou Sifary Medical Technology Co., Ltd. |
Iris Cai |
| K220953 |
04/01/2022 |
ChoiceSpine TigerSharkÖ M, Modular Interbody System |
ChoiceSpine, LLC |
Kim Finch |
| K220996 |
04/04/2022 |
Duoblade |
CnC Technologies |
InSang Choi |
| K221104 |
04/14/2022 |
ActeraÖ hip system |
Conformis Inc. |
Mary Kruitwagen |
| K221059 |
04/11/2022 |
Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS) |
Conformis Inc. |
Kara Johnson |
| K221204 |
04/26/2022 |
Excipio SV Thrombectomy Device |
Contego Medical Inc. |
Jim Clossick |
| K220973 |
04/04/2022 |
CoreLink Navigation Instruments |
CoreLink, LLC |
Steven Mounts |
| K221003 |
04/05/2022 |
Autosuture EEA Stapler / circular stapler with DST Series Technology / EEA Autosuture Circular Stapler with DST Series Technology / DST Series EEA Stapler / DST EEA |
Covidien |
Sanja Jahr |
| K221005 |
04/05/2022 |
EEA Circular Stapler with Tri-Staple Technology |
Covidien |
Leo Chen |
| K221013 |
04/05/2022 |
GIA Auto Suture Stapler with DST Series Technology |
Covidien |
Robert Zott |
| K221006 |
04/05/2022 |
GIA Stapler with Tri-Staple Technology |
Covidien |
Yanjun Jiao |
| K220991 |
04/04/2022 |
IntelliSep test |
Cytovale Inc. |
Juliet Carrara |
| K221194 |
04/25/2022 |
LEDEX |
Dentmate Technology Co. Ltd. |
Cheng-Feng Chou |
| K221094 |
04/14/2022 |
OmniTaper EV Dental Implants, DS Implants abutments with EV connection |
Dentsply Sirona |
Courtney Clark |
| K220963 |
04/01/2022 |
Simplexa COVID-19 & Flu A/B Direct |
DiaSorin Molecular LLC |
Sharon Young |
| K221150 |
04/20/2022 |
Advanced Bone Plate |
Double Medical Technology Inc. |
Yan Zuo |
| K221221 |
04/27/2022 |
Advanced Intramedullary Nail System |
Double Medical Technology Inc. |
Yan Zuo |
| K221088 |
04/13/2022 |
Anatomic Bone Plate |
Double Medical Technology Inc. |
Yan Zuo |
| K221090 |
04/13/2022 |
Metal Cannulated Screw |
Double Medical Technology Inc. |
Yan Zuo |
| K221118 |
04/18/2022 |
CO2 Mainstream Sensor |
Draegerwerk AG & Co. KGaA |
Lyubov Lange |
| K220956 |
04/01/2022 |
Libby Echo:Prio |
Dyad Medical, Inc |
Ronny Shalev |
| K221231 |
04/29/2022 |
Drug Relief v1 |
DyAnsys, Inc. |
Srini Nageshwar |
| K221028 |
04/07/2022 |
SURGIVISIO Device |
Ecential Robotics |
Sarah Lefevre-Billard |
| K220946 |
04/01/2022 |
SURGIVISIO Device |
Ecential Robotics |
Mathilde Saulpic |
| K221233 |
04/29/2022 |
DT-703 |
ECOTRON Co., Ltd |
Sang Bong Lee |
| K221014 |
04/05/2022 |
Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile |
Effortless Oxygen. LLC |
Samir Ahmad |
| K221136 |
04/19/2022 |
RadiForce MX243W |
EIZO Corporation |
Hiroaki Hashimoto |
| K220988 |
04/04/2022 |
EksoNR |
Ekso Bionics, Inc. |
Scott Davis |
| K221048 |
04/08/2022 |
Episealer Patellofemoral System |
Episurf Medical, Inc. |
Katarina Flodstrom |
| K221070 |
04/12/2022 |
DP4 Microneedling device |
Equipmed USA LLC |
Shaun Kerrigan |
| K221177 |
04/25/2022 |
Erbe's Tubing/Cap Sets |
Erbe USA, Inc. |
Jeff Dill |
| K220992 |
04/04/2022 |
Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple |
Ever Global (Vietnam) Enterprise Corporation |
Jerry Lin |
| K221077 |
04/12/2022 |
Auryon Atherectomy System |
Eximo Medical Ltd. |
Yoel Zabar |
| K220981 |
04/04/2022 |
SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe |
Fehling Surgical Instruments, Inc. |
Hayden Hosch |
| K221139 |
04/19/2022 |
Bodygard SFS Surgical Gown Level 4 |
Feliks Plastik Laminasyon Ve Ambalaj Malzemeleri |
Ali Serdar Serteser |
| K221053 |
04/11/2022 |
Magnes-C Anterior Cervical Plate System |
Fellowship of Orthopaedic Researchers, Inc. |
Stephen D. Cook |
| K221203 |
04/26/2022 |
AHI System |
Fifth Eye Inc. |
Jennifer Baird |
| K221081 |
04/12/2022 |
iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System |
First Source Inc. |
Ronald Viola |
| K221115 |
04/15/2022 |
Flow-Nail |
Flow-FX, LLC |
Patrick J. Sweeney |
| K221121 |
04/18/2022 |
Volumat Polyethylene I.V. Administration Set |
Fresenius Kabi |
Jason Ma |
| K221238 |
04/29/2022 |
FUJIFILM Ultrasonic Endoscope EG-740UT |
FUJIFILM Corporation |
Randy Vader |
| K220957 |
04/01/2022 |
FUJIFILM Endoscope Model EB-710P |
FUJIFILM Corporaton |
Randy Vader |
| K220961 |
04/01/2022 |
Deep Learning Image Reconstruction |
GE Healthcare Japan Corporation |
Wang Xing |
| K221148 |
04/20/2022 |
Vivid iq |
GE Medical Systems Ultrasound & Primary Care Diagnostics LLC |
Lee Bush |
| K221147 |
04/20/2022 |
Vivid T8, Vivid T9 |
GE Medical Systems Ultrasound and Primary Care Diagnostics, |
Lee Bush |
| K221042 |
04/08/2022 |
Renova RP Centesis Pump |
GI Supply, Inc. |
Erika Parry |
| K221168 |
04/22/2022 |
Tinnitogram Signal Generator |
Goldenear Company, Inc. |
Daehee Lee |
| K221199 |
04/26/2022 |
Conductive Silicone Electrode (model: Foot Pad Electrode, Cupping Electrode, Point Electrode) |
Green Island International TCM Group Limited |
Zhang Shuai |
| K221158 |
04/21/2022 |
Single-Use Video Flexible Ureterorenoscope System |
Guangzhou Red Pine Medical Instrument Co., Ltd. |
Lifang Zhang |
| K221038 |
04/07/2022 |
Disposable Medical Masks |
Hantech Medical Device Co., Ltd. |
Arnold Yang |
| K221143 |
04/20/2022 |
Nitrile Exam Gloves (Blue, Black) |
Hebei Astro Medical Supply Co., Ltd. |
Ning Zheng |
| K221164 |
04/22/2022 |
Powder Free Nitrile Examination Glove - Blue, Non-Sterile, Tested for use with Chemotherapy Drugs and Fentanyl |
Hong Seng Gloves SDN BHD |
Zahari Bin Darus |
| K221110 |
04/15/2022 |
LUOFUCON Silver Gelling Fiber Surgical Dressing, LUOFUCON Antibacterial Gelling Fiber Cover Dressing |
Huizhou Foryou Medical Devices Co., Ltd. |
Jie Dong |
| K221052 |
04/11/2022 |
Self-Fitting hearing aids |
Huizhou Jinghao Medical Technology Co., Ltd. |
Yuanxia Mao |
| K221151 |
04/20/2022 |
Beauty LED Mask, Model: KFB265 |
Hunan Guangye Biotechnology Co., Ltd. |
Eileen Li |
| K221019 |
04/06/2022 |
Osteon Precision Milled Suprastructure |
Implant Solutions PTY LTD (aka Osteon Medical) |
Andrea Del Ciotto |
| K220983 |
04/04/2022 |
ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging System |
ImSonic Medical China, INC. |
Xiaohui Hao |
| K221054 |
04/11/2022 |
CORE-INJECTOR |
Incore Co., Ltd. |
Jae-Hun Lee |
| K221084 |
04/13/2022 |
Dyna Locking Trochanteric NailÖ |
Innosys |
Yu-jin Kang |
| K221137 |
04/19/2022 |
Play and Joy Water-Based Lubricant |
InnoveMed Bio-tech Co., Ltd. |
Linda Li |
| DEN220024 |
04/08/2022 |
ScanNav Anatomy Peripheral Nerve Block |
Intelligent Ultrasound Limited |
Nicholas Sleep |
| K221154 |
04/21/2022 |
Infant Heel WarmerTM; Heel Snuggler« |
International Biomedical |
Amy Pieper |
| K221040 |
04/07/2022 |
Electronic Sphygmomanometers, Model: X1, X2, X5, X6, X7,X8, X11) |
Jiangxi AICARE Medical Technology Co., Ltd |
Lizhu Xiao |
| K221173 |
04/25/2022 |
Surgical Mask (Model: 0868F, 0866F) |
Jiangxi SanHao Medical Instruments Co.,Ltd |
Jiali Chen |
| K221157 |
04/21/2022 |
JR Medic |
JR Engineering & Medical Technologies (M) SDN.BHD. |
Ganesan Subramaniam |
| K221169 |
04/22/2022 |
JR MEDIC Nitrile Examination Gloves Powder Free- Black |
JR Engineering & Medical Technologies (M) SDN.BHD. |
Ganesan Subramaniam |
| K221174 |
04/25/2022 |
Telepack + |
KARL STORZ Endoscopy America, Inc |
Mario Trujillo |
| K221004 |
04/05/2022 |
HOPKINS Telescopes |
KARL STORZ Endoscopy America, Inc. |
Alita McElroy |
| K220993 |
04/04/2022 |
Ultrasound System SONIMAGE MX1 |
Konica Minolta, INC. |
Tsutomu Fukui |
| K221226 |
04/28/2022 |
1st Glove Blue Nitrile Examination Gloves Powder Free |
Koove Iot Pvt. Ltd. |
Sudarsan Mohapatra |
| DEN220026 |
04/29/2022 |
VasQ |
Laminate Medical Technologies Ltd. |
Orit Yarden |
| K221061 |
04/11/2022 |
21HQ613D |
LG Electronics Inc. |
Jinhwan Jun |
| K221085 |
04/13/2022 |
LiNA OperaScope Needle |
LiNA Medical ApS |
Jaroslaw Mr≤wczynski |
| K221189 |
04/25/2022 |
OLIZ LTB-1000A |
LTBIO Co., Ltd. |
Min-Ho Kim |
| K221058 |
04/11/2022 |
LungTrainer (MD2 & MD3) |
Lung Trainers, LLC |
Frank Acosta |
| K220974 |
04/04/2022 |
R:GEN |
Lutronic Vision, Inc. |
Haelyung Hwang |
| K221043 |
04/08/2022 |
Doctor Tecar Plus, Doctor Tecar Smart |
Mectronic Medicale S.r.l. |
Gloria Aloisini |
| K221141 |
04/19/2022 |
PageWriter TC35 Cardiograph |
Medizin Systeme Boblingen GmbH |
Judy Yang |
| K220955 |
04/01/2022 |
Hudson RCI Variable concentration Large Volume Nebulizer (1770) |
Medline Industires, Inc. |
Nicole Schaffer |
| K221083 |
04/13/2022 |
Smartlux Mini |
MEDMIX Co., Ltd. |
Yunseok Yu |
| K221087 |
04/13/2022 |
Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4 |
Medtronic Navigation, Inc. |
Silver Wirth |
| K221180 |
04/25/2022 |
Anteralign(TM) Spinal System with Titan NanoLOCK Surface Technology Navigated Instruments |
Medtronic Sofamor Danek USA, INC |
Elizabeth Hamilton |
| K221235 |
04/29/2022 |
neXus Ultrasonic Surgical Aspirator System |
Misonix Inc. |
John Salerno |
| K221220 |
04/27/2022 |
Montross Extremity Medical Hemi Implant System |
Montross Extremity Medical |
William Montross |
| K221025 |
04/06/2022 |
i_ Field 1.5T Superconducting Magnetic Resonance Imaging System |
MRI Division,Beijing Wandong Medical Technology Co.,Ltd. |
Wang Huan |
| K220952 |
04/01/2022 |
MY01 Continuous Compartmental Pressure Monitor |
MY01 Inc. |
Charles Allen |
| K221210 |
04/27/2022 |
PainShield MD PLUS |
NanoVibronix, Inc. |
Hrishikesh Gadagkar |
| K220994 |
04/04/2022 |
Shoulder PacemakerTM |
NCS Lab Srl |
Matteo Mantovani |
| K221021 |
04/06/2022 |
Femoral Trochanteric Nail System û Neonail |
Neoortho Produtos OrtopΘdicos S/A |
Luciane Suzuki |
| K221179 |
04/25/2022 |
SomnoMetry |
Neumetry Medical Inc |
Paul Chen |
| K220976 |
04/04/2022 |
Life Scope PT BSM-1700 Series Bedside Monitor |
Nihon Kohden Corporation |
Sandra Gadeyne |
| K220989 |
04/04/2022 |
Next Generation NetKonnect |
Nihon Kohden Digital Health Solutions, Inc. |
Maria Pronina |
| K221178 |
04/25/2022 |
Disposable Insulin Pen Needle |
Ningbo Medsun Medical Co., Ltd. |
Liu Ping |
| K221064 |
04/11/2022 |
Nuheara IQbuds 2 PRO Hearing Aid |
Nuheara Limited |
John Luna |
| K221046 |
04/08/2022 |
Invu by Nuvo |
Nuvo- Group Ltd. |
Chen Rubinstein |
| K221172 |
04/25/2022 |
FOCUS Interbody System |
OC Medical Devices |
Jack Mathews |
| K221142 |
04/19/2022 |
Kyphoplasty Balloon System |
OK MediNet Korea Co., Ltd. |
Kang Yoo Jin |
| K221097 |
04/14/2022 |
SmileSeries |
Ordont Orthodontic Laboratories, Inc. |
Paul Rudzicka |
| K221197 |
04/25/2022 |
VITROS Immunodiagnostic Products Intact PTH II Reagent Pack |
Ortho Clinical Diagnostics |
Declan Hynes |
| K221193 |
04/25/2022 |
OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm |
OSSIO Ltd. |
Taly Lindner |
| K221126 |
04/18/2022 |
Unistik« 3, sterile single-use safety lancets; Unistik« 3 Value, sterile single-use safety lancets; Abbott SF sterile single-use safety lancets |
Owen Mumford Ltd |
Darren Mansell |
| K221209 |
04/26/2022 |
PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops |
PADM Medical Inc. |
Xiomara Perdomo |
| K221135 |
04/19/2022 |
X-Twist PEEK Suture Anchor |
Parcus Medical LLC |
Calen Souther |
| DEN220025 |
04/19/2022 |
Phagenyx System |
Phagenesis Limited |
Conor Mulrooney |
| K221020 |
04/06/2022 |
Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 F |
Potrero Medical, Inc. |
Priscila Tapia |
| K220960 |
04/01/2022 |
BruxZir Opaque Coloring Liquid |
Prismatik Dentalcraft, Inc. |
So Hyun Park |
| DEN220023 |
04/04/2022 |
Procise ADL |
ProciseDx Inc. |
Kurt Bray |
| K220951 |
04/01/2022 |
PMT Facet Fixation System (PMT FFS) |
Providence Medical Technology, Inc |
Edward Liou |
| K221106 |
04/15/2022 |
Quantib Prostate |
Quantib BV |
Arnault Massink |
| K221144 |
04/20/2022 |
PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG |
Radisen Co., Ltd |
John Lim |
| K221234 |
04/29/2022 |
TargetCool |
RecensMedical Inc. |
Yeonui Lee |
| K221107 |
04/15/2022 |
TRUST |
Rgorithm Korea |
Jun Ho Song |
| K221082 |
04/13/2022 |
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 |
04/05/2022 |
cobas HCV |
Roche Molecular Systems, Inc. |
Ashley Malich |
| K221033 |
04/07/2022 |
UniPrime A, UniPrime E, UniPrime E/C |
S&C Polymer Silicon- und Composite SpezialitΣten GmbH |
Christian B÷ttcher |
| K221134 |
04/19/2022 |
Procedure Mask with Ear Loops and Surgical Mask with Ties |
SafeSource Direct, LLC |
Robbie Wicks |
| K221138 |
04/19/2022 |
Titus Titanium Cervical by SAGICO |
SAGICO VA USA, LLC |
James Gibson |
| K221117 |
04/18/2022 |
RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System |
Samsung Medison Co., Ltd. |
Jee Young Ju |
| K220975 |
04/04/2022 |
V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System |
Samsung Medison Co., Ltd. |
Jee Young Ju |
| K221056 |
04/11/2022 |
ARGUS PB-3000 |
SCHILLER AG |
Iru Rothfuchs |
| K221206 |
04/26/2022 |
Compass Steerable Needle |
Serpex Medical, Inc. |
Sasha Schrode |
| K221192 |
04/25/2022 |
Disposable Nitrile Powder-Free Examination Gloves |
Shandong Maida Medical Technology Co.,Ltd. |
Kitty Xu |
| K221008 |
04/05/2022 |
HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2) |
Shanghai Handy Medical Equipment Co., Ltd |
Marcia Qiu |
| K221222 |
04/27/2022 |
Surgical Face Mask (HNFM0304) |
Shanghai Hua En Industrial CO LTD |
Lisa Zhao |
| K221170 |
04/22/2022 |
Forehead Thermometer, models AOJ-F101, AOJ-F102, AOJ-F103, AOJ-F104 AOJ-F105, AOJ-F106, AOJ-F107 |
Shenzhen AOJ Medical Technology Co., Ltd. |
Jack Wang |
| K221039 |
04/07/2022 |
Infrared Thermometer, models AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F, AOJ-20H, AOJ-20M, AOJ-20T, AOJ-20R and AOJ-20Y |
Shenzhen AOJ Medical Technology Co., Ltd. |
Jack Wang |
| K221001 |
04/04/2022 |
IPL Home Use Hair Removal Device |
Shenzhen Beauty Every Moment intelligent electric Co.,Ltd. |
Luo Huajun |
| K221092 |
04/13/2022 |
Transcutaneous Electrical Nerve Stimulator Model: ST-304 |
Shenzhen Future Electronic Co., Ltd |
Zhao Qihong |
| K221214 |
04/27/2022 |
Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, FZ-100, FZ-200 |
Shenzhen IONKA Medical Technology Co., Ltd. |
Chen Dongfa |
| K220998 |
04/04/2022 |
Transcutaneous Electrical Nerve Stimulator, Model: KTR-405 |
Shenzhen Kentro Medical Electronics Co., Ltd. |
Zewu Zhang |
| K221113 |
04/15/2022 |
Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor |
Shenzhen Mindray Bio-Medical Electronics Co., LTD |
Li Lei |
| K221002 |
04/04/2022 |
IPL Hair Removal Device, Model(s): UI04A, UI04B, UI04C |
Shenzhen Ulike Smart Electronics Co.,Ltd |
Xiaoming Lin |
| K221211 |
04/27/2022 |
Infrared thermometer |
Shenzhen Yolanda Technology Co., Ltd |
Baihua Han |
| K221212 |
04/27/2022 |
Upper Arm Blood Pressure Monitor |
Shenzhen Yolanda Technology Co., Ltd |
Xuejun Wang |
| K220999 |
04/04/2022 |
Hipro Glycosylated Hemoglobin (HbA1c) Test System |
Shijiazhuang Hipro Biotechnology Co., Ltd. |
Emily No Last Name Provided |
| K221041 |
04/08/2022 |
Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System |
Shockwave Medical, Inc. |
Soraya L Hori |
| K221075 |
04/12/2022 |
Infusion Sets for Single Use |
Sichuan Prius Biotechnology Co., Ltd. |
Yan Liu |
| K221069 |
04/12/2022 |
Infusion Sets for Single Use with Needles |
Sichuan Prius Biotechnology Co., Ltd. |
Yan Liu |
| K221078 |
04/12/2022 |
Intravenous Needles for Single Use,Safety Intravenous Needles for Single Use |
Sichuan Prius Biotechnology Co., Ltd. |
Yan Liu |
| K221066 |
04/12/2022 |
Sterile Hypodermic Needles for Single Use |
Sichuan Prius Biotechnology Co., Ltd. |
Yan Liu |
| K221079 |
04/12/2022 |
Sterile Hypodermic Syringes for Single Use |
Sichuan Prius Biotechnology Co., Ltd. |
Yan Liu |
| K221068 |
04/12/2022 |
Sterile Hypodermic Syringes for Single Use with Needles |
Sichuan Prius Biotechnology Co., Ltd. |
Yan Liu |
| K221073 |
04/12/2022 |
Sterile Hypodermic Syringes for Single Use with Safety Needles |
Sichuan Prius Biotechnology Co., Ltd. |
Yan Liu |
| K221080 |
04/12/2022 |
Sterile Safety Hypodermic Needles for Single Use |
Sichuan Prius Biotechnology Co., Ltd. |
Yan Liu |
| K221119 |
04/18/2022 |
RCRP Flex reagent cartridge |
Siemens Healthcare Diagnostics Inc. |
Ian Thompson |
| K221190 |
04/25/2022 |
ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic Ultrasound System |
Siemens Medical Solutions USA, Inc. |
Sulgue Choi |
| K221219 |
04/27/2022 |
syngo.CT CaScoring |
Siemens Medical Solutions USA, Inc. |
Monsuru Bello |
| K221127 |
04/18/2022 |
Sientra, inc. Portfinder |
Sientra, Inc. |
Denise Dajles |
| K221065 |
04/12/2022 |
MediLab |
Sigma Scientific Services LLC |
Jorge Millan |
| K220964 |
04/01/2022 |
VERSAJET Hydrosurgery System (III) |
Smith & Nephew Medical Limited |
Zoe Smith |
| K220959 |
04/01/2022 |
OR3O Dual Mobility System |
Smith & Nephew, Inc. |
Rose Beifuss |
| K221089 |
04/13/2022 |
P12 Elite Series Digital Color Doppler Ultrasound System |
Sonoscape Medical Corp. |
Toki Wu |
| K221140 |
04/19/2022 |
P20 Elite Series Digital Color Doppler Ultrasound System |
Sonoscape Medical Corp. |
Toki Wu |
| K221182 |
04/25/2022 |
Southern Transforaminal Lumbar Interbody Fusion (TLIF) |
Southern Medical (Pty) Ltd |
Dalene Styger |
| K221023 |
04/06/2022 |
Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA Minuteman G3, HA Minuteman G3-R, Minuteman G5 |
Spinal Simplicity LLC |
Adam Rogers |
| K220979 |
04/04/2022 |
SprintRay Denture Base |
SprintRay Inc |
Sara Moghtadernejad |
| K221102 |
04/14/2022 |
LOTUS Series 4 Enhanced Shears, LOTUS Series 5 |
SRA Developments Ltd |
Phillipa Frewin |
| K221165 |
04/22/2022 |
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 |
| K221217 |
04/27/2022 |
SPY Laparoscope |
Stryker |
Christie Samsa |
| K221074 |
04/12/2022 |
OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device |
Stryker Corporation |
Bruce Backlund |
| K221098 |
04/14/2022 |
Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit |
Stryker Corporation |
Maya Schiel |
| K221067 |
04/12/2022 |
Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter |
Surgical Instrument Service and Savings Inc. |
Stephanie Boyle Mays |
| K221029 |
04/07/2022 |
PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch |
Synovis Life Technologies, Inc. |
Megan Sajjad |
| K221032 |
04/07/2022 |
Vascu-Guard Vascular Repair Patch |
Synovis Life Technologies, Inc. |
Sajjad Megan |
| K221071 |
04/12/2022 |
Niti-S Biliary Slim M Stent |
Taewoong Medical Co., Ltd |
Jangsoo Lee |
| K220980 |
04/04/2022 |
Tissue Approximation System (TAS) |
TAS Medical, Inc. |
Michael Tozzi |
| K221131 |
04/18/2022 |
Tasso+ |
Tasso, Inc. |
Trish Kan Brown |
| K221129 |
04/18/2022 |
CloudTMS for OCD |
TeleEMG, LLC |
Joe F Jabre |
| K221185 |
04/25/2022 |
TC Gloves |
Thanh Cong Pharmaceutical and Trading Company Limited |
Nguyen Thi Tu Anh |
| K221186 |
04/25/2022 |
TC Gloves |
Thanh Cong Pharmaceutical and Trading Company Limited |
Nguyen Thi Tu Anh |
| K221198 |
04/26/2022 |
Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL |
Thermo Fisher Scientific |
Cynthia Knapp |
| K221024 |
04/06/2022 |
tremoflo C2 Airwave Oscillometry System |
Thorasys Thoracic Medical Systems, Inc. |
Paul Donnelly |
| K221176 |
04/25/2022 |
Insulin Pen Needle |
Tianjin Huahong Technology Co., Ltd. |
Yuan Ying |
| K221086 |
04/13/2022 |
CryoRobot Select System |
TMRW Life Sciences, Inc. |
Christina Miracle |
| K221111 |
04/15/2022 |
Non-Mydriatic Retinal Camera NW500 |
Topcon Corporation |
Ryota Kitawaki |
| K221163 |
04/22/2022 |
Tunnel Crossing Catheter |
Tractus Vascular, LLC |
Janet Burpee |
| K221181 |
04/25/2022 |
Treace Medical Concepts (TMC) Plating System |
Treace Medical Concepts Inc. |
Melissa Coloroso |
| K221072 |
04/12/2022 |
TRUEdraw Lancing Device, Mini Lancing Device |
Trividia Health |
Jacqueline Davis |
| K221227 |
04/28/2022 |
Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120 |
Tuttnauer Ltd. |
Robert Basile |
| K221149 |
04/20/2022 |
U-Motion II Acetabular System-Extension line |
United Orthopedic Corporation |
Lois Ho |
| K221011 |
04/05/2022 |
AI.ME System |
Venus Concept USA Inc. |
William H McGrail |
| K221022 |
04/06/2022 |
NextDent Ortho Flex |
Vertex-Dental BV |
Connie Peterse-van der Koppel |
| K221241 |
04/29/2022 |
DrAid for Radiology v1 |
VinBrain Joint Stock Company |
Nguyen Nhat Linh |
| K221010 |
04/05/2022 |
Intra.Ox 2.0 Handheld Tissue Oximeter |
ViOptix, Inc. |
Scott Coleridge |
| K221030 |
04/07/2022 |
Model 9100 PFT/DICO |
Vitalograph Ireland Ltd. |
Tony O'Hanlon |
| K221100 |
04/14/2022 |
Viz RV/LV |
Viz.ai, Inc. |
Vi Ma |
| K221162 |
04/22/2022 |
UniVy OsteoVy Cervical IBF System |
Vy Spine, LLC |
Jordan Hendrickson |
| K220990 |
04/04/2022 |
Qorda QD1 |
Winix Inc. |
Daewoon Kang |
| K221016 |
04/05/2022 |
Steriking Packaging for Medical Devices |
Wipak OY |
Hanna Marttila |
| K221123 |
04/18/2022 |
WISE Cortical Strip (WCS) |
WISE S.r.l. |
Luca Ravagnan |
| K221116 |
04/15/2022 |
XACT ACE Robotic System |
XACT Robotics Ltd. |
Chen Levin |
| K221200 |
04/26/2022 |
XBody Go USA, XBody Pro USA |
XBody Hungary Kft. |
Orsolya Balog |
| K221196 |
04/25/2022 |
Disposable Medical Face Mask (ear loop) |
Xiantao Topmed Nonwoven Protective Products Co., Ltd. |
Vivian Zhu |
| K221230 |
04/29/2022 |
TRON |
Xoran Technologies LLC |
Mark McGarrow |
| K220971 |
04/04/2022 |
QuikClot Control+ Hemostatic Dressing |
Z-Medica, LLC |
Soraya King |
| K221049 |
04/11/2022 |
Zavation VariSync Plate System and VariSync Spacer System |
Zavation Medical Products, LLC |
Katie Motley |
| K221026 |
04/06/2022 |
Power Wheelchair |
Zhejiang Innuovo Rehabilitation Devices Co., Ltd |
Leo Zheng |
| K221229 |
04/29/2022 |
Powder Free Nitrile Examination Gloves, (Cobalt Blue and Violet Blue), Powder Free Latex Examination Gloves |
Zibo Blue Sail Health Technology Co., Ltd |
Xu Shulong |
| K220997 |
04/04/2022 |
Wireless TENS/EMS, Bruno, Aela |
ZMI Elecronics Ltd. |
Lawerence Liu |
