| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K220366 |
09/30/2022 |
EmbedMed |
3D LifePrints UK Ltd. |
Henry Pinchbeck |
| K222152 |
09/23/2022 |
3MÖ AttestÖ Hydrogen Peroxide Indicator Tape 1228 |
3M Company |
Yumi Wackerfuss |
| K221249 |
09/16/2022 |
L1P-1F (TRIOS 5) |
3Shape TRIOS A/S |
Klaus Rudbaek Hoj |
| K221283 |
09/06/2022 |
Hammertoe Truss System (HTS) |
4WEB Medical, Inc. |
Lewis Harrison |
| K202144 |
09/23/2022 |
A.B. Dental Devices Dental Implants System |
A.B. Dental Device Ltd. |
Gabi Krauss |
| K220531 |
09/01/2022 |
FOX 810, FOX 980 |
A.R.C. Laser GmbH |
Angela Thyzel |
| K212197 |
09/22/2022 |
WasherCap Fixation System |
Abanza Tecnomed SL. |
Aitor Olaso |
| K221397 |
09/28/2022 |
MitraClip G4 Steerable Guide Catheter |
Abbott Medical |
Cynthia Aguirre |
| K220567 |
09/07/2022 |
Easi-Vue embolic microspheres System |
ABK Biomedical Inc |
Brandi Woods |
| K222561 |
09/23/2022 |
Align |
Acuity Surgical Devices, LLC |
Bryan Cowan |
| K210973 |
09/08/2022 |
MammaPrint FFPE NGS Kit |
Agendia Inc. |
Marcelo Trevino |
| K222329 |
09/28/2022 |
BriefCase |
Aidoc Medical, Ltd. |
Amalia Schreie |
| K222500 |
09/15/2022 |
AIR OPTIX COLORS |
Alcon Laboratories, Inc. |
Sherri Lakota |
| K221637 |
09/29/2022 |
Surgical Gown (Sterile); Surgical Gown (Non-sterile) |
Allmed Medical (Hubei) Protective Products Co., Ltd |
Vince Tian |
| K212926 |
09/16/2022 |
AllureTM Surgical Mask |
Allure Gift Wraps Private Limited |
Mohan Jairam Raisinghani |
| K220553 |
09/16/2022 |
Neuro Omega System, NeuroSmart System |
Alpha Omega Engineering Ltd. |
Efrat Shamgar |
| K221821 |
09/23/2022 |
ATEC IOM Accessory Instruments |
Alphatec Spine, Inc. |
Sandy Gill |
| K211027 |
09/16/2022 |
Altus Spine Pedicle Screw System |
Altus Partners, LLC |
Mark Melton |
| K222442 |
09/28/2022 |
DISPOSABLE VINYL EXAMINATION GLOVES (Pink, Black, Blue) |
Anhui Bytech Medical Supplies Co., Ltd. |
Lijun Chen |
| K221918 |
09/29/2022 |
ReFlow System Mini |
Anuncia Medical, Inc. |
Elsa Chi Abruzzo |
| K220969 |
09/16/2022 |
GelPOINT V-Path Vaginal Access System |
Applied Medical Resources Corporation |
David Yu |
| K212359 |
09/21/2022 |
PWD Negative Pressure Wound Therapy System |
Applied Tissue Technologies LLC |
Michael Broomhead |
| K213855 |
09/02/2022 |
Arrow Pressure Injectable Midline Catheter |
Arrow International LLC Subsidiary of Teleflex Incorporated |
Kim Pennington |
| K222244 |
09/30/2022 |
Arthrex 3.5 mm Locking Compression Plates |
Arthrex Inc. |
Stacy Valdez |
| K220839 |
09/19/2022 |
Arthrex Compression FT Pins |
Arthrex Inc. |
Rebecca R. Homan |
| K221354 |
09/09/2022 |
Arthrex SutureTape |
Arthrex Inc. |
Lai Saeteurn |
| K222078 |
09/14/2022 |
Arthrex SoftStitch |
Arthrex, Inc |
Kelsey Roberts |
| K220563 |
09/01/2022 |
Ambient HipVac 50 Wand with Integrated Finger Switches, RF20000 COBLATION System, WEREWOLF COBLATION System, WEREWOLF+ COBLATION System |
Arthrocare Corporation |
Alexander Brankner |
| K222131 |
09/19/2022 |
NB 1 SA Implant System |
Arum Dentistry Co., Ltd. |
Bo-Yeon Lim |
| K213868 |
09/06/2022 |
ASAHI Gladius Mongo18 PV ES |
Asahi Intecc Co., LTD. |
Tomoya Eguchi |
| K221473 |
09/26/2022 |
Flowart |
Asset Medikal Tasarim AS. |
Ebru Sirali |
| K221481 |
09/23/2022 |
NeutrArt |
Asset Medikal Tasarim AS. |
Ebru Sirali |
| K200073 |
09/30/2022 |
AugMENTA Penile Implant |
Augmenta LLC |
Robert J Cornell |
| K220941 |
09/23/2022 |
HotDog Temperature Management System |
Augustine Temperature Management |
Garrett Augustine |
| K201049 |
09/14/2022 |
FINDER G6PD |
Baebies, Inc. |
Ailen Gillette |
| K222048 |
09/06/2022 |
Spectrum IQ Infusion System with Dose IQ Safety Software |
Baxter Healthcare Corporation |
Jennifer Hoogheem |
| K220607 |
09/21/2022 |
BD MAX Enteric Viral Panel |
Becton, Dickinson and Company |
Joseph Basore |
| K222034 |
09/07/2022 |
RightLance Blood Lancing System |
Beijing Ruicheng Medical Supplies Co., Ltd. |
Yuechao Li |
| K222342 |
09/24/2022 |
Betel Gloves Nitrile Examination Glove Powder Free |
Betel care Sdn. Bhd. |
Abdul Rahman Richard Abdullah |
| K220978 |
09/14/2022 |
TSX Implants |
Biomet 3i LLC |
Mariela Cabarcas |
| K213287 |
09/02/2022 |
StageOne Knee Cement Spacer Molds |
Biomet, Inc. |
Anuja Yardi |
| K221968 |
09/15/2022 |
StageOneÖ Shoulder Cement Spacer Molds |
Biomet, Inc. |
Neha Sreenath |
| K221062 |
09/26/2022 |
RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device |
Bionime Corporation |
Yu Chi Huang |
| K213864 |
09/02/2022 |
Bonebridge Osteosynthesis Plating System |
Bonebridge AG |
Christof Gerber |
| K220112 |
09/07/2022 |
AXIOS Stent and Electrocautery-Enhanced Delivery System |
Boston Scientific Corporation |
Ian Broome |
| K222568 |
09/23/2022 |
OptiCrossÖ 18 Peripheral Imaging Catheter |
Boston Scientific Corporation |
Cassie Clark |
| K222503 |
09/14/2022 |
Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip |
Boston Scientific Corporation |
Jia Huang |
| K220962 |
09/06/2022 |
ROTAPRO Rotational Atherectomy System |
Boston Scientific Corporation |
Heather Schuchard |
| K213989 |
09/08/2022 |
Cranial EM System |
Brainlab AG |
Chiara Cunico |
| K203503 |
09/02/2022 |
Camber Sacroiliac (SI) Fixation System |
Camber Spine Technologies, LLC |
Daniel A. Pontecorvo |
| K222661 |
09/27/2022 |
Digital Radiography CXDI-CS01 |
Canon Inc. |
Akira Hirai |
| K222687 |
09/29/2022 |
Digital Radiography CXDI-Elite, Digital Radiography E1 |
Canon Inc. |
Mr. Akira Hirai |
| K220986 |
09/12/2022 |
Aquilion Precision (TSX-304A/4) V10.10 with AiCE |
Canon Medical Systems Corporation |
Paul Biggins |
| K220342 |
09/27/2022 |
XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3 |
Canon Medical Systems Corporation |
Paul Biggins |
| K220859 |
09/09/2022 |
Powder Free Nitrile Examination Gloves, Colored (Green, Orange, Purple, White, & Black) |
Careglove Global SDN BHD |
Lim Kwee Shyan |
| K214028 |
09/09/2022 |
MICOR Lens Fragmentation System |
Carl Zeiss Meditec Cataract Technology Inc. |
Gary Mocnik |
| K211611 |
09/30/2022 |
QIR Suite |
CASIS Cardiac Simulation & Imaging Software |
Jean-Joseph Christophe |
| K221908 |
09/20/2022 |
JO CUMPLAY Personal Lubricant |
CC Wellness LLC |
Marlent Perez |
| K213947 |
09/08/2022 |
Ultrasonic Endo Activation Device (Model:Actor I pro) |
ChangZhou BoMedent Medical Technology Co.,Ltd |
Yang Chunyuan |
| K221331 |
09/08/2022 |
Disposable Endoscope Valves System |
Changzhou Endoclean Medical Device Co., Ltd. |
Wang Qi |
| K220953 |
09/13/2022 |
ChoiceSpine TigerSharkÖ M, Modular Interbody System |
ChoiceSpine, LLC |
Kim Finch |
| K221906 |
09/28/2022 |
TROJAN Fire & Ice lubricated male natural rubber latex condom |
Church & Dwight Co., Inc. |
Supreet Sahota-Bhatti |
| K222519 |
09/16/2022 |
ClearPoint System |
ClearPoint Neuro, Inc. |
Mary McNamara-Cullinane |
| K214125 |
09/22/2022 |
TRANBERG Thermoguide Therapy System |
Clinical Laserthermia Systems AB |
Dan Mogren |
| K222059 |
09/21/2022 |
SpeediCath Flex Set |
Coloplast |
Preeti Jain |
| K220245 |
09/28/2022 |
Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) |
Contec Medical Systems Co., Ltd. |
Jie Xiao |
| K221761 |
09/14/2022 |
Solea |
Convergent Dental, Inc. |
Jhung Vojir |
| K221003 |
09/30/2022 |
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 |
| K220540 |
09/22/2022 |
ProGrip Self-Gripping Polypropylene Mesh |
Covidien |
Jonas Gulmez |
| K222723 |
09/09/2022 |
AMBARINO High-Class |
Creamed GmbH & Co. Produktions- und Handels KG |
Robert Lemmer |
| K213641 |
09/15/2022 |
MONDRIAN ALIF Cage with Supplementary Fixation Plate |
CTL Medical Corporation |
Sean Suh |
| K212751 |
09/24/2022 |
Powder Free Nitrile Examination Glove |
Dainam Glove Joint Stock Company |
Damon Nguyen |
| K221194 |
09/16/2022 |
LEDEX |
Dentmate Technology Co. Ltd. |
Cheng-Feng Chou |
| K221636 |
09/06/2022 |
EMPHASYS Acetabular System |
DePuy Ireland UC |
Elaine Pears |
| K221809 |
09/20/2022 |
DePuy Synthes 3.5mm Intrapelvic Acetabular System |
DePuy Synthes |
Alyssa Bryan |
| K222877 |
09/23/2022 |
FREEPRINT crown |
DETAX GmbH |
Markus Stratmann |
| K212147 |
09/13/2022 |
Simplexa COVID-19 Direct |
DiaSorin Molecular LLC |
Tara Viviani |
| K211648 |
09/08/2022 |
Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay |
Diazyme Laboratories Inc. |
Abhijit Datta |
| K220579 |
09/01/2022 |
Hybrid C70 |
Digimed Co., Ltd |
Youngbae Kwon |
| K221676 |
09/16/2022 |
Exsalta |
DRW Medical |
Dan Tatum |
| K221425 |
09/13/2022 |
Primary Relief |
DyAnsys, Inc. |
Srini Nageshwar |
| K211204 |
09/15/2022 |
SafePort(TM) Manifold (or Stopcock) |
Elcam Medical ACAL |
Avital Levertov |
| K212217 |
09/16/2022 |
Tempo Smart Button |
Eli Lilly and Company |
Kevin S. Bardonner |
| K222429 |
09/09/2022 |
Ellusa Reusable Bipolar Cable |
Ellusa, LLC |
Suzanne Lucas |
| K222425 |
09/08/2022 |
Ellusa Reusable Neutral Plates |
Ellusa, LLC |
Suzanne Lucas |
| K222627 |
09/28/2022 |
EndoGI S-Path Biliary Stent System |
EndoGI Medical |
Omri Naveh |
| K221987 |
09/01/2022 |
Erchonia GVL |
Erchonia Corporation |
Travis Sammons |
| K221343 |
09/16/2022 |
ECHELON ENDOPATH Staple Line Reinforcement |
Ethicon Endo-Surgery LLC |
Rubina Dosani |
| K222076 |
09/08/2022 |
EFAI ChestSuite XR Pleural Effusion Assessment System |
Ever Fortune.AI Co., Ltd. |
Joseph Chang |
| K222069 |
09/06/2022 |
Ez3D-i/E3 |
Ewoosoft Co., Ltd |
Young Seok Kim |
| K220116 |
09/26/2022 |
Auryon Atherectomy Catheters |
Eximo Medical Ltd. |
Yoel Zabar |
| K212618 |
09/14/2022 |
iRelieve Microcurrent Pain Relief System |
Fast Track Technologies, Inc. |
Geoffrey Pfeifer |
| K220758 |
09/30/2022 |
e-Ortho Shoulder Software v1.1 |
FH Industrie |
Oscar Ramirez |
| K222693 |
09/24/2022 |
Single-use medical latex examination gloves (LG100) |
Fitone Latex Products Co., Ltd. Guangdong |
Christine Ou |
| K212615 |
09/21/2022 |
EpiFaith CV |
Flat Medical Co., Ltd. |
Tseng Shao Wei |
| K220831 |
09/27/2022 |
Dental Implantation Systems, Dental Electrical Motors |
Foshan COXO Medical Instrument Co., Ltd. |
Yongjian Zheng |
| K213267 |
09/08/2022 |
Dynamis Pro Family |
Fotona d.o.o. |
Marko Berdajs |
| K221932 |
09/02/2022 |
Omni Legend |
GE Healthcare |
Alexandra Lifshits |
| K220659 |
09/09/2022 |
AUTOBAHN(R) EVO Femoral Nails |
Globus Medical Inc. |
Jennifer Antonacci |
| K222409 |
09/08/2022 |
CAPTIVATE« Compression Screws |
Globus Medical, Inc. |
Jennifer Antonacci |
| K220330 |
09/08/2022 |
Soundly Anti Snoring Device |
Greystone IP Ltd |
Judy Purvis |
| K221887 |
09/24/2022 |
Nitrile Examination Glove, Pink Color; Nitrile Examination Glove, Black Color, Nitrile Examination Glove, White Color |
Guangdong Kingfa Sci. & Tech. Co., Ltd. |
Xiaoge Yu |
| K222204 |
09/23/2022 |
Medical Surgical Mask |
Guangzhou ZhengKang Medical Equipment Co.,Ltd |
Mike Wu |
| K221748 |
09/13/2022 |
Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves |
Guilin HBM Health Protections, Inc. |
Pu Lei |
| K221548 |
09/28/2022 |
Dental Air Polishing Handpiece |
Guilin Woodpecker Medical Instrument Co., Ltd. |
Xunxian Wu |
| K213883 |
09/27/2022 |
NanoZoomer S360MD Slide scanner system |
Hamamatsu Photonics K.K. |
Shinichi Fujisaka |
| K221038 |
09/01/2022 |
Disposable Medical Masks |
Hantech Medical Device Co., Ltd. |
Arnold Yang |
| K221718 |
09/24/2022 |
Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural) |
Hartalega NGC SDN BHD |
Kuan Mun Leong |
| K213339 |
09/23/2022 |
DENU Composite Resin, DENU Flow Resin |
HDI, Inc. |
Taekyou Kim |
| K214015 |
09/26/2022 |
Palm NRG cellulite body device (model: Palm NRG body device) |
Heat In A Click LLC. |
Guy Levi |
| K221839 |
09/19/2022 |
Lancet |
Hebei Xinle Sci&Tech Co., Ltd |
Jianxun Tian |
| K213575 |
09/13/2022 |
Female IC (Not Finalized) |
Hollister Incorporated |
Michelle Schiltz-Taing |
| K213598 |
09/20/2022 |
LUOFUCON Collagen Wound Dressing |
Huizhou Foryou Medical Devices CO., Ltd. |
Taylor Deng |
| K210478 |
09/30/2022 |
8mm Monopolar Curved Scissors |
Iconocare Health |
Rick Ferreira |
| K212561 |
09/27/2022 |
MTX-C1 |
ILOODA Co., Ltd |
Yun-Jung Ha |
| K222555 |
09/23/2022 |
reepot Nd; YAG laser system |
Ilooda Co., Ltd. |
Yunjung HA |
| K213353 |
09/20/2022 |
Aorta-CAD |
Imagen Technologies, Inc |
Robert Lindsey |
| K222482 |
09/28/2022 |
AGILON XO Shoulder System |
implantcast, GmbH |
Ms. Juliane Hoppner |
| K220081 |
09/28/2022 |
CORE-SPORT |
Incore Co., Ltd. |
Lee Jae-Hun |
| K222642 |
09/20/2022 |
Disposable Nitrile Examination Glove(Tested for use with Chemotherapy Drug) |
Inner Mongolia Cureguard Medical Technology Co.,Ltd. |
Guo Hua |
| K220297 |
09/16/2022 |
True Tulip, True M.I.S. |
Innovative Surgical Designs, Inc. |
Jon Rinehart |
| K220681 |
09/22/2022 |
Talee, Talee PostOP |
Invent Medical USA, LLC |
Jiri Rosicky |
| K222804 |
09/22/2022 |
Irrisept Antimicrobial Wound Lavage |
Irrimax Corporation |
Tanya Eberle |
| K221456 |
09/12/2022 |
Rapid ICH |
iSchemaView Inc. |
James Rosa |
| K222331 |
09/14/2022 |
WatchPAT300 (WP300) |
Itamar Medical, Ltd |
Efrat Litman |
| K213013 |
09/19/2022 |
Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe |
Jeil Tech Co., Ltd. |
Chun-Gi Lee |
| K222155 |
09/16/2022 |
Single Use O-ring gasket syringe with ENFit Connector, Reusable O-ring gasket syringe with ENFit connector |
Jiangsu Caina Medical Co., Ltd. |
Jianwei Pan |
| K220089 |
09/22/2022 |
Disposable Polyp Snare |
Jiangsu Vedkang Medical Science and Technology Co.,Ltd. |
Tang Ting |
| K222266 |
09/26/2022 |
Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80) |
Jingzhou Haixin Green Cross Medical Products Co.,Ltd. |
Lei Da |
| K220251 |
09/06/2022 |
Neodent Implant System - GM Narrow Implant System |
JJGC Industria e Comercio de Materiais Dentarios S.A. |
Mariana Soares Hartmann |
| K213904 |
09/30/2022 |
Kerecis Oral |
Kerecis |
Gudmundur Fertram Sigurjonsson |
| K221568 |
09/12/2022 |
KOLO Evolution XHD Series Ultrasound Diagnostic System |
Kolo Medical (Suzhou) Co., Ltd |
Mike SU |
| K220369 |
09/23/2022 |
Esthetic Colorant |
Kuraray Noritake Dental Inc. |
Yasujiro Ohara |
| K220697 |
09/15/2022 |
Nitrile Patient Examination Gloves, Powder Free |
Lalan Rubbers (Pvt) Ltd |
Renuka Priyangi |
| K222542 |
09/21/2022 |
MCB UNIT Model: V10GMCBUS |
Lamidey Noury Medical |
M. Guillaume Noury |
| K211605 |
09/22/2022 |
Dual Switch |
Laser Engineering, Inc. |
Laurie Dobbs |
| K213417 |
09/29/2022 |
Ghost Spacer System |
Life Spine, Inc. |
Angela Batker |
| K222764 |
09/14/2022 |
LightForce Orthodontic System |
LightForce Orthodontics |
Kelsey Fafara |
| K221085 |
09/02/2022 |
LiNA OperaScope Needle |
LiNA Medical ApS |
Jaroslaw Mr≤wczynski |
| K220177 |
09/01/2022 |
Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K |
Magnus Medical, Inc. |
Brett Wingeier |
| K220080 |
09/29/2022 |
CogNet QmTRIAGE |
MedCognetics, Inc. |
Diane Rutherford |
| K222224 |
09/22/2022 |
SurgiLance« Safety Lancet |
MediPurpose Pte. Ltd. |
Adeline Yi |
| K221360 |
09/27/2022 |
Medline UNITE« Medial Malleolus Peg Plate System |
Medline Industries, LP |
Jennifer Mason |
| K222383 |
09/29/2022 |
AnteralignÖ LS Spinal System with Titan nanoLOCKÖ Surface Technology MAZORX Stealth(TM) Edition |
Medtronic Sofamor Danek USa, Inc. |
Elizabeth Hamilton |
| K210475 |
09/21/2022 |
EQ-M |
Meta Systems Co., Ltd |
Yang Ho Dong |
| K214056 |
09/20/2022 |
Disposable Nitrile Inspection Gloves (Tested for Use with Chemotherapy Drugs) |
Mezorrison Medical Technology (Dongying) Co., Ltd. |
Ping Chen |
| K210567 |
09/30/2022 |
Ultrasonic Surgical System |
Miconvey Technologies Co., Ltd. |
Kang Li |
| K214024 |
09/12/2022 |
SOFIA 88 Catheter |
MicroVention, Inc. |
Alick Tan |
| K220359 |
09/20/2022 |
Tandry Compression Screw System |
Microware Precision Co., Ltd. |
Harrison Du |
| K220441 |
09/16/2022 |
CYGNUSÖ MoRe Anterior Cervical Plate System |
MiRus, LLC |
Jordan Bauman |
| K211178 |
09/02/2022 |
DURAMESH Mesh Suture |
MSi |
Greg Dumanian |
| K212189 |
09/02/2022 |
FibroLux |
Multi Radiance Medical |
Andrey Godes |
| K222121 |
09/19/2022 |
C630G LCD monitor, JUSHA-C630G LCD monitor, C630 LCD monitor, JUSHA-C630 LCD monitor |
Nanjing Jusha Display Technology Co., Ltd. |
Donny Lee |
| K212316 |
09/30/2022 |
DoubleChek DC-1001 |
Nasogastric Feeding Solutions, Ltd. |
Mark Townend |
| K220595 |
09/08/2022 |
NeoNavia Biopsy System |
NeoDynamics AB |
Anna Forsberg |
| K221738 |
09/27/2022 |
NS-HGlio |
Neosoma Inc. |
Aly H Abayazeed |
| K212143 |
09/28/2022 |
Neteera 130H/131H Vital Sign Monitoring Sensor |
Neteera Technologies Ltd. |
Yael Himmel |
| K221179 |
09/21/2022 |
SomnoMetry |
Neumetry Medical Inc |
Paul Chen |
| K203594 |
09/07/2022 |
EyeCTester |
Neuro-Eye Diagnostic Systems LLC |
Jade S. Schiffman |
| K202929 |
09/16/2022 |
Nexpowder |
Nextbiomedical Co., Ltd. |
Jin Young Lee |
| K222090 |
09/30/2022 |
Safety Lancet |
Ningbo Medsun Medical Co., Ltd. |
Liu Ping |
| K220339 |
09/16/2022 |
Esthetic Abutments Nobel Biocare N1 |
Nobel Biocare Services AG |
Bernice Jim |
| K221375 |
09/29/2022 |
CureSight-CS100 |
NovaSight Ltd. |
Ran Yam |
| K221388 |
09/09/2022 |
NuVasive Reline Cervical System |
NuVasive, Incorporated |
Sali Gully |
| K221638 |
09/19/2022 |
Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3 |
Olympus Medical Systems Corp. |
Shinichiro Kawachi |
| K221631 |
09/26/2022 |
Tracheal Intubation Fiberscope OLYMPUS LF-P, VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V |
Olympus Medical Systems Corp. |
Shinichiro Kawachi |
| K221557 |
09/02/2022 |
Visera Hysterovideoscope Olympus HYF Type V |
Olympus Medical Systems Corporation |
Toshio Nakamura |
| K222294 |
09/24/2022 |
Black Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric Acid |
Onetexx SDN BHD |
Freddy Low |
| K213854 |
09/14/2022 |
SavvyWire |
Opsens Inc. |
Marc Chaunet |
| K221684 |
09/08/2022 |
Osstem Abutment System |
Osstem Implant Co., Ltd. |
Seungju Kang |
| K222512 |
09/12/2022 |
Integrity-SI Fusion System |
OsteoCentric Technologies |
Todd Evans |
| K222111 |
09/07/2022 |
Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G |
Owen Mumford Ltd |
Darren Mansell |
| K203336 |
09/15/2022 |
Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30 |
Oxoid Limited (part of Thermo Fisher Scientific) |
Philip Brame |
| K222091 |
09/14/2022 |
Grappler Suture Anchor System |
Paragon 28, Inc. |
Haylie Hertz |
| K214048 |
09/20/2022 |
Millipede 088 Access Catheter |
Perfuze Ltd. |
Anne-Marie Gannon |
| K213960 |
09/06/2022 |
LiverMultiScan v5 (LMSv5) |
Perspectum |
Wigley Ioan |
| DEN220025 |
09/16/2022 |
Phagenyx System |
Phagenesis Limited |
Conor Mulrooney |
| K222648 |
09/27/2022 |
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 |
09/26/2022 |
OtoSight Middle Ear Scope |
PhotoniCare, Inc |
Ryan Shelton |
| K222426 |
09/02/2022 |
Perfetta Moderate Medical Face Mask |
Phu Bao Group Company Limited |
Le Pham Minh Ngoc |
| K220104 |
09/01/2022 |
Knee+ |
Pixee Medical |
Lucie Pecheur |
| K221533 |
09/12/2022 |
Plasma Shield |
Plasmatica LTD |
Adam Sagiv |
| K220944 |
09/09/2022 |
PointCore Surgical Mask |
PointCore, Inc. |
William Christiansen |
| K221686 |
09/15/2022 |
NovoSorb Matrix |
PolyNovo Biomaterials Pty Ltd |
Tarun Nekkenti |
| K221707 |
09/14/2022 |
SafeSept« Transseptal Guidewire (SS-140) |
Pressure Products Medical Device Manufacturing LLC. |
Andrew Armour |
| K213244 |
09/09/2022 |
Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration) |
Prevest Denpro Limited |
Atul Modi |
| K211858 |
09/06/2022 |
TULSA-PRO System |
Profound Medical Inc. |
Goldy Singh |
| K220129 |
09/19/2022 |
Promisemed X-Safety Pen Needle |
Promisemed Hangzhou Meditech Co., Ltd. |
Zearou Yang |
| K222075 |
09/02/2022 |
CellFX System |
Pulse Biosciences, Inc. |
Punam Gollamudi |
| K213674 |
09/22/2022 |
CellFX System |
Pulse Biosciences, Inc. |
Punam Gollamudi |
| K220084 |
09/12/2022 |
Infrared Forehead Thermometer |
Qingdao Yasee Medical Device Co., Ltd. |
Shaoju Tian |
| K220795 |
09/26/2022 |
QT ECG |
QT Medical, Inc. |
Jackal Chen |
| K214035 |
09/13/2022 |
LAITEST Medical Face Mask |
R&R Medical Corporation Ltd |
Wilson Chang |
| K222625 |
09/30/2022 |
Shield System |
Radiaction Ltd. |
Jonathan Yifat |
| K221277 |
09/02/2022 |
Mygen M-3004 RF Generator M-3004 |
RF Medical Co., Ltd |
Kwang S Choi |
| K221450 |
09/12/2022 |
Phosphoric Acid Etching Gel |
Rizhao HuGe Biomaterials Company, Ltd. |
Maggie Zheng |
| K220134 |
09/16/2022 |
cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH |
Roche Diagnostics |
Noel Mencias |
| K220176 |
09/15/2022 |
Elecsys AFP |
Roche Diagnostics |
Jamie Ferguson |
| K222005 |
09/29/2022 |
S.I.N. Instrument Kits |
S.I.N. - Sistema De Implante Nacional S.A. |
Denise Domiciano |
| K213897 |
09/19/2022 |
Pro M Class |
Saeyang Microtech Co., Ltd. |
Chang Hun Jeon |
| K222353 |
09/29/2022 |
GM85 |
Samsung Electronics Co., LTD. |
Jaesang Noh |
| K221534 |
09/16/2022 |
Surgical Face Masks (Ear Loops And Tie-On) |
San-M Package Co., Ltd. |
Akihiko Goto |
| K221957 |
09/02/2022 |
Savewo ClassicMASK |
Savewo Limited |
Melanie Choi |
| K222110 |
09/07/2022 |
Mariner RDX System |
SeaSpine Orthopedics Corporation |
Jesse Albright |
| K221383 |
09/21/2022 |
MedtFine Blood Lancet |
Shanghai Carelife International Trading Co. Ltd. |
Zhang Xiaoying |
| K222647 |
09/13/2022 |
INT Introducer Set |
Shanghai Kindly Medical Instruments Co., Ltd |
Xu Jianhai |
| K222339 |
09/30/2022 |
uDR 380i Pro |
Shanghai United Imaging Healthcare Co., Ltd. |
Xin Gao |
| K222265 |
09/23/2022 |
Diosculpt |
Shanghai Wonderful Opto-Electrics Tech. Co., Ltd. |
Lily Zhou |
| K220143 |
09/08/2022 |
BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens |
Shenzhen Dashicheng Optical Technology Co., Ltd. |
Jiayi Li |
| K222206 |
09/30/2022 |
Air Compression Leg Massager (Models: S9036C, S9036B and S9036A) |
Shenzhen Dongjilian Medical Tech Co., Ltd. |
Zhang Hong |
| K221092 |
09/13/2022 |
Transcutaneous Electrical Nerve Stimulator Model: ST-304 |
Shenzhen Future Electronic Co., Ltd |
Zhao Qihong |
| K222316 |
09/28/2022 |
IPL Hair Removal Device |
Shenzhen Goodwind Technology Development CO., LTD |
Ziming Yang |
| K221214 |
09/21/2022 |
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 |
| K221496 |
09/29/2022 |
Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE, Consona AT, Consona N6 Exp Diagnostic Ultrasound System, Consona N6 Elite, Consona N6T Diagnostic Ultrasound System |
Shenzhen Mindray Bio-medical Electronics Co., Ltd |
Zhang Wei |
| K221300 |
09/29/2022 |
Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI, Consona NT, Nuewa N9, Recho N9, Consona N9 Exp, Consona N9 Elite, Resona N9, Consona N9T, Consona N8, Consona N8 Pro, Consona N8 Super, Consona OR, Consona N8S, Consona O |
Shenzhen Mindray Bio-Medical Electronics Co.,LTD |
Zhang Wei |
| K220920 |
09/07/2022 |
Matreneu Percutaneous Balloon Compression Kit |
Shenzhen Shineyard Medical Device Co. Ltd. |
Yan Ping |
| K221211 |
09/27/2022 |
Infrared thermometer |
Shenzhen Yolanda Technology Co., Ltd |
Baihua Han |
| K222253 |
09/22/2022 |
GlasIonomer FX ULTRA |
Shofu Dental Corporation |
Mauro Malzyner |
| K222605 |
09/29/2022 |
iFuse TORQ« Implant System |
SI-BONE, Inc. |
Meirav Harsat |
| DEN200067 |
09/29/2022 |
INNOVANCE VWF Ac |
Siemens Healthcare Diagnostics Products GmbH |
Petra Dissmann |
| K220783 |
09/07/2022 |
syngo.via RT Image Suite |
Siemens Medical Solutions USA Inc. |
Clayton Ginn |
| K221733 |
09/13/2022 |
MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola Fit |
Siemens Medical Solutions USA, Inc. |
Alina Goodman |
| K221414 |
09/02/2022 |
ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter |
Silk Road Medical, Inc. |
Denise Aycox |
| K221799 |
09/16/2022 |
Electric Wheelchair, Model: 9000N |
Silver Fox Corporation Limited |
Chen Yan |
| K221597 |
09/15/2022 |
CO2 Laser System |
Smedtrum Medical Technology Co., Ltd. |
Crimson Wu |
| K213126 |
09/29/2022 |
Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screws |
Smith & Nephew Inc. |
Thomas Fearnley |
| K221929 |
09/06/2022 |
Smith+Nephew INTELLIO Tablet |
Smith+Nephew |
Kathleen Solomon |
| K212222 |
09/02/2022 |
Soniquence Reusable 3 Button Fingerswitch Wand |
Soniquence, LLC |
Suzanne Lucas |
| K222020 |
09/08/2022 |
HD-550 Video Endoscope System |
Sonoscape Medical Corp. |
Toki Wu |
| K221089 |
09/15/2022 |
P12 Elite Series Digital Color Doppler Ultrasound System |
Sonoscape Medical Corp. |
Toki Wu |
| K221140 |
09/13/2022 |
P20 Elite Series Digital Color Doppler Ultrasound System |
Sonoscape Medical Corp. |
Toki Wu |
| K213379 |
09/21/2022 |
Clearblue « Early Pregnancy Test |
SPD Swiss Precision Diagnostics GmbH |
Joanne Scaife |
| K220979 |
09/14/2022 |
SprintRay Denture Base |
SprintRay Inc |
Sara Moghtadernejad |
| K222328 |
09/28/2022 |
SteriCUBE« Multiple Tray Sterilization Systems |
SteriCUBE, LLC |
Michele Mauzerall |
| K222849 |
09/30/2022 |
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 |
| K222093 |
09/09/2022 |
V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System |
STERIS |
Anthony Piotrkowski |
| K222440 |
09/09/2022 |
Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays |
Steris |
Anthony Piotrkowski |
| K222615 |
09/28/2022 |
SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate |
STERIS Corporation |
Jennifer Nalepka |
| K221074 |
09/16/2022 |
OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device |
Stryker Corporation |
Bruce Backlund |
| K221243 |
09/30/2022 |
OFNat Lubricant (L15) |
Suretex Limited |
KC Nguyen |
| K213034 |
09/29/2022 |
SpineAR SNAP |
Surgical Theater, Inc. |
Kevin Murrock |
| K222046 |
09/30/2022 |
Unscented Menstrual Tampon |
Suzhou Borage Medical Technology Co., Ltd. |
Zhou Nana |
| K221843 |
09/14/2022 |
GEM Biover Microvascular Clamps |
Synovis Micro Companies Alliance, Inc. |
Julie Carlston |
| K221731 |
09/07/2022 |
FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire |
T.A.G. Medical Products Corporation, Ltd |
Shlomi Dines |
| K221966 |
09/15/2022 |
Dynamic TiBase |
Talladium Espana, SL |
Xavier Soca Filella |
| K221378 |
09/30/2022 |
Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile |
Tec Gloves Industry (M) Sdn.Bhd. |
Eunice Arumugam |
| K220336 |
09/30/2022 |
Mg-PSZ Ceramic Femoral Head |
Theken Companies |
Garrett Spurgeon |
| K220830 |
09/15/2022 |
TrueBalanceÖ Surgical System |
These Three Medical, LLC |
Moj Eram |
| K221724 |
09/23/2022 |
Conductive Gel |
Tone-A-Matic International Inc. |
Manuel Chuck |
| K220418 |
09/14/2022 |
Tornier Perform Humeral System û Stemless |
Tornier, Inc. |
Renee Stoffel |
| K220483 |
09/23/2022 |
Platform« Acetabular System |
Total Joint Orthopedics, Inc. |
Chris Weaber |
| K213716 |
09/29/2022 |
InnovaBurn |
Triad Life Sciences, Inc. |
Bill Willis |
| K211902 |
09/28/2022 |
InnovaMatrix PD |
Triad Life Sciences, Inc. |
Bill Willis |
| K221829 |
09/23/2022 |
Wet Flavored Personal Lubricants |
Trigg Laboratories, Inc. |
Marla Bolden |
| K201876 |
09/01/2022 |
Soteria Bed Barrier |
Trinity Guardion |
Bruce Rippe |
| K221227 |
09/20/2022 |
Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120 |
Tuttnauer Ltd. |
Robert Basile |
| K221553 |
09/15/2022 |
Diamond Air+ (UI04A, UI04B, UI04C) |
Ulike Co., Ltd |
Lin Xiaoming |
| K221717 |
09/20/2022 |
Disposable Surgical Gown UM-148 |
Unimax Medical Products Co., Ltd. |
Haibo Ning |
| K222293 |
09/21/2022 |
ArcSP Suprapubic Sling System |
UroCure LLC |
John Nelson |
| K222468 |
09/15/2022 |
ArcTO Transobturator Sling System |
UroCure LLC |
John Nealon |
| K221797 |
09/14/2022 |
BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes and Length Assessment Device |
Varian Medical Systems Inc. |
Peter J. Coronado |
| K221644 |
09/02/2022 |
Synthetic Bone Putty |
Ventris Medical |
John Brunelle |
| K220239 |
09/13/2022 |
Solid State X-ray Imager(Model: FXRD-4386WB) |
Vieworks Co., Ltd. |
Kevin Oh |
| K221241 |
09/01/2022 |
DrAid for Radiology v1 |
VinBrain Joint Stock Company |
Nguyen Nhat Linh |
| K213293 |
09/14/2022 |
V-HEPES PLUS |
Vitromed Langenfeld |
Greg Holland |
| K220236 |
09/21/2022 |
V-Print dentbase |
Voco GmbH |
M. Th. Plaumann |
| K221417 |
09/13/2022 |
CLAROX plus (Model: VX-100) |
VSI Co., Ltd. |
Jake Yu |
| K213770 |
09/13/2022 |
SP-CL Hip Stem and LCU Hip System |
Waldemar Link GmbH & Co. KG |
Pia Mⁿller |
| K220990 |
09/14/2022 |
Qorda QD1 |
Winix Inc. |
Daewoon Kang |
| K221819 |
09/19/2022 |
35g Standard SMMS Surgical Gown; 35g Reinforced SMMS Surgical Gown;43g Standard SMMS Surgical Gown;43g Reinforced SMMS Surgical Gown ;50g Standard SMMS Surgical Gown; 50g Reinforced SMMS Surgical Gown;BVB Surgical Gown |
Winner Medical Co., Ltd. |
Mingni Liu |
| K210929 |
09/13/2022 |
MagiCath II |
Woo Young Medical Co., Ltd. |
Jenny Cho |
| K213759 |
09/23/2022 |
XACT Robotic System, ACE Model |
XACT Robotics, Ltd. |
Dan Sigal |
| K221976 |
09/20/2022 |
Surgical Face Mask (Non-sterile) |
Xiantao Junhui Plastic Products Co., Ltd. |
Fiona Tian |
| K220785 |
09/27/2022 |
Clean Connecting Tube |
Yangzhou Fartley Medical Instrument Technology Co., Ltd. |
Tina Han |
| K213983 |
09/02/2022 |
Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear |
Yung Sheng Optical Co., Ltd |
Wen-Han Chen |
| K222629 |
09/25/2022 |
Resonic Rapid Acoustic Pulse Device |
Zeltiq Aesthetics, Inc. |
Saurabh Jamkhindikar |
| K213023 |
09/30/2022 |
Blood Pressure Monitor(Model:Y30001) |
Zhangzhou Easepal Medical Science And Technology Co.,LTD |
Yuehua Huang |
| K220002 |
09/09/2022 |
Dexus Prosthetics System (Model: MSL1, MSR1) |
Zhejiang Qiangnao Technology Co.,Ltd |
Boyuan Meng |
| K222602 |
09/26/2022 |
Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope: PC200-AS, PC200-AR, PC200-S and PC200-R; HD Medical Video Endoscope Image Processor: PV300) |
Zhuhai Pusen Medical Technology Co., Ltd. |
Changshen Wang |
| K214060 |
09/19/2022 |
LANDMARK REBOA Catheter |
Zien Medical Technologies, Inc. |
Tim Nieman |
| K213856 |
09/15/2022 |
Identity Shoulder System |
Zimmer Inc. |
Patricia Sandborn Beres |
| K220997 |
09/01/2022 |
Wireless TENS/EMS, Bruno, Aela |
ZMI Elecronics Ltd. |
Lawerence Liu |
