| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K211388 |
08/05/2021 |
Lateral Spine Truss System (LSTS) Interbody Fusion Device |
4WEB Medical, Inc. |
Lewis Harrison |
| K211777 |
08/13/2021 |
ARCO FP-S |
A.T.S. Applicazione Tecnologie Speciali S.R.L. |
Livia Pillitteri |
| K201400 |
08/23/2021 |
npSIMS Negative Pressure Surgical Incision Management SystemÖ (npSIMS)Ö |
Aatru Medical LLC |
James J. Rogers |
| K212206 |
08/13/2021 |
Jot Dx Insertable Cardiac Monitor |
Abbott (St. Jude Medical) |
Juni Sarkar |
| K211102 |
08/11/2021 |
FreeStyle Libre 2 Flash Glucose Monitoring System |
Abbott Diabetes Care, Inc. |
Catherine Yang |
| K210958 |
08/13/2021 |
i-STAT CHEM8+ cartridge with the i-STAT 1 System |
Abbott Point of Care Inc. |
Maria Figueroa |
| K203084 |
08/31/2021 |
Ablamap Software |
Ablacon, Inc. |
Frank Rodrigues |
| K200193 |
08/06/2021 |
Kisses Plus Implant System |
ACHIMHAI Medical Corporation |
Ji Ho Jung |
| DEN210013 |
08/19/2021 |
OsteoProbe |
Active Life Scientific, Inc. |
Alexander Proctor |
| K210680 |
08/05/2021 |
AcQMap High Resolution Imaging and Mapping System |
Acutus Medical, Inc. |
Sindhu Sridhar |
| K212345 |
08/27/2021 |
AcQMap High Resolution Imaging and Mapping System |
Acutus Medical, Inc. |
Sindhu Sridhar |
| K211233 |
08/18/2021 |
Hailie Sensor NF0109 |
Adherium (NZ) Ltd |
Chris Mander |
| K203739 |
08/24/2021 |
ELAN 4 Electro Motor System |
Aesculap Inc. |
Kathy Racosky |
| K212145 |
08/31/2021 |
DR 800 with DSA, DR 800 |
Agfa N.V. |
Wim Govaerts |
| K212039 |
08/23/2021 |
CLAREON MONARCH IV IOL Delivery System |
ALCON LABORATORIES, INC. |
Jwalitha Shankardas |
| K210820 |
08/10/2021 |
EAGLE EDGE AXR90 and AXR120 |
Alliage S/A Industrias Medico Odontol≤gica |
Daniel Camargo |
| K211873 |
08/10/2021 |
PSX Interbody System |
Alphatec Spine, Inc. |
Cynthia Dorne |
| K211299 |
08/09/2021 |
X-CUBE 70 |
Alpinion Medical Systems Co., Ltd. |
Boyeon Cho |
| K211300 |
08/09/2021 |
X-CUBE 90 |
Alpinion Medical Systems Co., Ltd. |
Boyeon Cho |
| K210887 |
08/20/2021 |
Altus Spine Sochi OCT Spinal System |
Altus Partners, LLC |
Mark Melton |
| K210730 |
08/10/2021 |
Nitrile Patient Examination Glove |
American Performance Polymers, LLC |
Richard Renehan |
| K202532 |
08/21/2021 |
Disposable Surgical Gowns |
Anhui Medpurest Medical Technology Co.,Ltd |
Long Shushan |
| K211860 |
08/13/2021 |
Powder Free Nitrile Patient Examination Gloves, Blue Color |
Anhui Powerguard Technology Co., Ltd. |
Nick Dai |
| K210464 |
08/24/2021 |
Auto Disable Syringe |
Anhui Tiankang Medical Technology Co.,Ltd. |
Bai Baodong |
| K212083 |
08/31/2021 |
Tactoset Injectable Bone Substitute |
Anika Therapeutics. Inc. |
Wei Zhao |
| K201089 |
08/05/2021 |
ARK Lacosamide Assay |
ARK Diagnostics, Inc. |
Thomas Houts |
| K210687 |
08/11/2021 |
CONTOUR« NEXT ONE Blood Glucose Monitoring System |
Ascensia Diabetes Care |
Stacie Geffner-Atiya |
| K212054 |
08/30/2021 |
Senhance Surgical System |
Asensus Surgical, Inc. |
Taylor Fisher |
| K203820 |
08/17/2021 |
ASPIVIX v1.1 Cervical Suction Tenaculum |
Aspivix S.A. |
Benjamin Klein |
| K201630 |
08/12/2021 |
AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests |
Assure Tech (Hangzhou) Co., Ltd. |
Shisheng Ling |
| K212051 |
08/25/2021 |
RFA-1717DIG, RFA-1717DIC |
ASTEL Inc. |
Yonghwan Jeon |
| K203246 |
08/04/2021 |
Atlas One Step hCG Urine Pregnancy Test (Strip), Atlas One Step hCG Urine Pregnancy Test (Cassette), Atlas One Step hCG Urine Pregnancy Test (Midstream) |
Atlas Link Technology Co., Ltd. |
Xiaoping Hao |
| K210521 |
08/02/2021 |
DEXA-C Cervical Interbody System |
Aurora Spine, Inc. |
Laszlo Garamszegi |
| K210792 |
08/25/2021 |
Auxein Nailing System |
Auxein Medical Private Limited |
Rahul Luthra |
| K203029 |
08/20/2021 |
Auxilock Titanium Interference Screw |
Auxein Medical Private Limited |
Rahul Luthra |
| K203622 |
08/20/2021 |
Medical Gloves |
Beijing Biosis Healing Biological Technology Co., Ltd. |
Ting Jiang |
| K211515 |
08/24/2021 |
Nitrile Examination Gloves |
Beijing Reagent Latex Products Co., Ltd. |
HaiTao Liu |
| K203607 |
08/20/2021 |
MOSS VRS Spinal System |
Biedermann Motech GmbH & Co. KG |
Gerd Federle |
| K211630 |
08/30/2021 |
VITEK 2 AST-Gram Negative Piperacillin / Tazobactam (<=4 - =>128 ╡g/mL) |
bioMerieux, Inc |
Mary Beth Anheuser |
| K202969 |
08/05/2021 |
Biomet Microfixation OmniMax MMF System |
Biomet Microfixation |
Lauren Jasper |
| K211895 |
08/20/2021 |
BC Reflex Uni Knee System |
Bodycad Laboratories, Inc. |
Nadine Adia |
| K211030 |
08/09/2021 |
EXALT Model B Single-Use Bronchoscope (Slim), EXALT Model B Single-Use Bronchoscope (Regular), EXALT Model B Single-Use Bronchoscope (Large), EXALT Monitor |
Boston Scientific Corporation |
Carter Navarro |
| K212228 |
08/13/2021 |
WATCHMAN FXD Curve Access System |
Boston Scientific Corporation |
Alexa M. Keenan |
| K210381 |
08/14/2021 |
I.V. Administration Set |
BQ PLUS Medical Co., Ltd. |
Jin Zhang |
| K210201 |
08/17/2021 |
Deep Transcranial Magnetic Stimulation (DTMS) System |
Brainsway Ltd. |
Ahava Stein |
| K203363 |
08/12/2021 |
Crosser iQ CTO Recanalization System |
C.R. Bard, Inc. |
Aaron Conovaloff |
| K212304 |
08/19/2021 |
Callaly Tampliner (super plus absorbency) |
Calla Lily Personal Care, Ltd. |
Shaun Knights |
| DEN200064 |
08/27/2021 |
Canary Tibial Extension with Canary Health Implanted Reporting Processor (CHIRP) System |
Canary Medical, Inc. |
Nora C.R. York |
| K212056 |
08/04/2021 |
Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR |
Canon Medical Systems Corporation |
Janine F. Reyes |
| K211390 |
08/28/2021 |
Nitrile Blue Powder-free Examination Glove |
Cardinal Health 200, LLC |
William Cisneros |
| K201094 |
08/16/2021 |
iMap 3D Mapping & Navigation System (iMap System) |
CardioNXT, Inc. |
Kirk Mackin |
| K211240 |
08/26/2021 |
ViperCross Support Catheters |
Cardiovascular Systems, Inc. |
Erika Huffman |
| K210724 |
08/03/2021 |
ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Standard, Powder Free Latex Surgical Gloves wit |
Careplus (M) SDN BHD |
Lim Kwee Shyan |
| K203705 |
08/20/2021 |
Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein) |
Careplus (M) SDN BHD |
Lim Kwee Shyan |
| K201857 |
08/20/2021 |
Powder Free Nitrile Examination Glove Black and Dual Color White-Blue |
Careplus (M) SDN BHD |
Lim Kwee Shyan |
| K211588 |
08/13/2021 |
Caretaker Platform, VitalStream Platform, CT5 |
Caretaker Medical |
Jeff Pompeo |
| K203486 |
08/20/2021 |
Otoplan |
CAScination AG |
Jean-Francois Clemence |
| K212204 |
08/11/2021 |
Synovasure Alpha Defensin Lateral Flow Test Kit (1 Kit), Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Flow Test Kit (30 Test), Synovasure Alpha Defensin Cont |
CD Diagnostics Inc |
Pragnya Bakka |
| K211328 |
08/19/2021 |
EIDON FA, EIDON, EIDON AF, EIDON UWFL |
CenterVue SpA |
Luca Scienza |
| K210805 |
08/30/2021 |
Ceribell Instant EEG Headband |
Ceribell, Inc. |
Raymond Woo |
| K203152 |
08/11/2021 |
Disposable Face Mask |
Chaozhou Cecilia Technology Co., Ltd. |
Weng Yu |
| K212355 |
08/26/2021 |
Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large |
Checkpoint Surgical |
Ben Cottrill |
| K210936 |
08/25/2021 |
Elvie Stride |
Chiaro Technology Limited |
Carre King |
| K211449 |
08/31/2021 |
TritonÖ Sacroiliac Joint Fixation System |
ChoiceSpine, LLC |
Kim Finch |
| K210320 |
08/06/2021 |
ClearCorrect System |
ClearCorrect LLC |
Christopher Klaczyk |
| K211104 |
08/19/2021 |
AirSeal« dV Solution- AirSeal« Cannula Cap and AirSeal« Bifurcated Filtered Tube Set |
ConMed Corporation |
Ally Xu |
| K203693 |
08/13/2021 |
Nisus Touch Negative Pressure Wound Therapy Pump |
Cork Medical Products, LLC |
Patrick McGinley |
| K210695 |
08/16/2021 |
CPM Medical Consultants Tibial Revision Knee System |
CPM Medical Consultants, LLC. |
Andy Rynearson |
| K211519 |
08/13/2021 |
Every Cycle Reusable Tampon Applicator |
Cycle, LLC |
Jessica Samson |
| K210569 |
08/16/2021 |
Disposable Monopolar Laparoscopic Shafts and Reusable Handles |
Dannik LLC |
Olga Haberland |
| K212367 |
08/23/2021 |
IMRIS iMRI 3T V |
Deerfield Imaging, Inc. |
Tacy Brinkmeyer |
| K210090 |
08/30/2021 |
Impulse AM Interbody Fusion System |
DeGen Medical |
Craig Black |
| K210362 |
08/19/2021 |
s-Clean Pre-Milled Abutment |
Dentis Co., Ltd. |
Gyu Ri Kim |
| K210610 |
08/27/2021 |
PrimeTaper EV Dental Implant |
Dentsply Sirona, Inc. |
Karl J Nittinger |
| K211609 |
08/25/2021 |
ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) Insert |
DePuy Ireland UC |
Brad Osborne |
| K211657 |
08/05/2021 |
EMPHASYS Femoral Stems |
DePuy Ireland UC |
Erin Combs |
| K210530 |
08/27/2021 |
WOLF Thrombectomy System, 6F |
DeVoro Medical, Inc. |
Michael Wallace |
| K203089 |
08/17/2021 |
Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System |
Dexcom, Inc. |
Bryan Osborne |
| K211319 |
08/19/2021 |
Purism Non-Sterile Powder Free Nitrile Examination Gloves |
Dezhou Purism Medical Technology Co., Ltd. |
Ting Luo |
| K203136 |
08/06/2021 |
Diazyme PLAC« Test for Lp-PLA2 Activity |
Diazyme Laboratories Inc. |
Chao Dou |
| K203174 |
08/02/2021 |
Disposable Medical Mask |
Dong Guan Kinyet Metal Products Co., Ltd |
Emily Zhang |
| K212100 |
08/06/2021 |
Kosmos |
EchoNous, Inc. |
Carly Hom |
| K211540 |
08/09/2021 |
Edma Synthetic Nitrile Examination Gloves |
Edma Group, LLC |
Vio Cretu |
| K211362 |
08/25/2021 |
SCAR 3 |
EL. En Electronic Engineering SPA |
Paolo Peruzzi |
| K203396 |
08/23/2021 |
DEKA SMARTPERIO |
El.En. Electronic Engineering Spa |
Paolo Peruzzi |
| K211068 |
08/04/2021 |
PrevisEA Device |
Entac Medical Inc. |
Buddy Lyons |
| K211863 |
08/12/2021 |
eVolve PACS |
eVolve PACS Inc. |
David Donahue |
| K211791 |
08/20/2021 |
Ez3D-i/E3 |
Ewoosoft Co., Ltd |
Young Seok Kim |
| K211793 |
08/23/2021 |
EzOrtho |
Ewoosoft Co., Ltd |
Young Seok Kim |
| K211969 |
08/13/2021 |
EMM Ultrasonic Transducer Cover |
Exact Medical Manufacturing |
Ryan Power |
| K211527 |
08/20/2021 |
Exo Iris |
Exo Imaging Inc. |
Antoanela Gomard |
| K212297 |
08/20/2021 |
Omni Foot and Ankle Plating System |
Extremity Medical, LLC. |
Brian Smekal |
| K202148 |
08/25/2021 |
E-Fit Infinity System (EF-2090 Controller and EF-100 Unit) |
Fit-Pro Ltd. |
Janos Papp |
| K212103 |
08/30/2021 |
StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2 |
FONA S.r.l |
Luigi Germano |
| K212296 |
08/19/2021 |
Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2 |
FUJIFILM Corporation |
Randy Vader |
| K210790 |
08/25/2021 |
Lateralized and Augmented Baseplates |
FX Shoulder USA, Inc. |
Kathy Trier |
| K211205 |
08/12/2021 |
Prase-C Anterior Cervical Plate System |
GBS Commonwealth Co., Ltd. |
Jimmy Kim |
| K203633 |
08/19/2021 |
Enteral Extension Sets |
GBUK Group Ltd |
Lucy Islip |
| K211524 |
08/27/2021 |
LOGIQ E10s, LOGIQ Fortis |
GE Healthcare |
Bryan Behn |
| K212004 |
08/27/2021 |
MyoSPECT, MyoSpect ES |
GE Healthcare |
George Mashour |
| K211725 |
08/06/2021 |
Senographe Pristina |
GE Healthcare |
Barthelemy Arman |
| K211846 |
08/20/2021 |
Discovery MI Gen2 |
GE Medical Systems, LLC. |
Laura Turner |
| K211684 |
08/27/2021 |
PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E |
Given Imaging Ltd. (Medtronic) |
Efrat Shamgar |
| K210912 |
08/12/2021 |
Excelsius3D |
Globus Medical Inc. |
Kelly Baker |
| K211616 |
08/25/2021 |
ExcelsiusHub |
Globus Medical Inc. |
Kelly Baker |
| K211957 |
08/18/2021 |
QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments |
Globus Medical Inc. |
Jennifer Antonacci |
| K210131 |
08/26/2021 |
ComfortGuard Surgical Isolation Gown |
GRI-Alleset, Inc |
Marty D Paugh |
| K210991 |
08/26/2021 |
Disposable Sterile Syringe, Disposable Sterile Syringe with Needle |
Guangdong Antmed Co., Ltd. |
Zhiying Zhong |
| K202636 |
08/16/2021 |
Metallic Fabric Electrodes |
Guangzhou Xinbo Electronic Co., Ltd. |
Sammy Li |
| K210749 |
08/19/2021 |
Empty EVA Bag |
Haemotronic S.p.a. |
Franciosi Paola |
| K211758 |
08/03/2021 |
Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour) |
Hartalega Ngc Sdn. Bhd. |
Kuan Mun Leong |
| K202952 |
08/26/2021 |
Amber Mill Q Series & Amber Mill Direct Series |
HASS Corp. |
Yongsu Kim |
| K212097 |
08/18/2021 |
Disposable medical surgical mask |
Hebei Titans Hongsen Medical Technology Co., LTD |
Chai Wu |
| K211714 |
08/04/2021 |
Nitrile Exam Gloves, Powder Free,Blue (Tested for Use with Chemotherapy) |
Hengchang (Dongying) Medical Technology Co., Ltd. |
Li Jing |
| K211699 |
08/20/2021 |
Nitrile Exam Gloves, Powder Free, Blue |
Hengchang (Dongying) Medical Technology Co.,Ltd. |
Li Jing |
| K211066 |
08/19/2021 |
Sovereign America Surgical Mask, Model Number: 2000SM2, Sovereign America Surgical Mask, Model Number: 2000SM3 |
Homtex, Inc. |
Jeremy Wootten |
| K201026 |
08/10/2021 |
sOLVe Tube |
HyTek Medical, Inc. |
Nir Hoftman |
| K211883 |
08/11/2021 |
QUANTUM« Patient Specific Instrumentation (PSI) System |
In2Bones SAS |
Morgane Grenier |
| K211179 |
08/12/2021 |
InferRead CT Stroke.AI |
Infervision Medical Technology Co., Ltd. |
Xiaoyan Fan |
| K203344 |
08/25/2021 |
Premilled Titanium Block System |
InnoBioSurg Co., Ltd. |
Sun-Mi Park |
| K202279 |
08/13/2021 |
Insignis Subcutaneous Needle Sets |
Innovative Health Sciences, LLC |
Andy Sealfon |
| K200230 |
08/26/2021 |
Aptiva Celiac Disease IgG Reagent |
Inova Diagnostics, Inc. |
Andrea Seaman |
| K203790 |
08/20/2021 |
GEM Premier 5000 |
Instrumentation Laboratory Co. |
Gabriella Erdosy |
| K211575 |
08/13/2021 |
Omnipod« Insulin Management System, Omnipod DASH« Insulin Management System |
Insulet Corporation |
Dennis Shay |
| K212185 |
08/19/2021 |
Golden Isles Pedicle Screw System |
Intelivation LLC |
Amit Sinha |
| K211813 |
08/18/2021 |
Triton |
Inter-Med / Vista Dental |
Brett Arand |
| K203305 |
08/06/2021 |
Tiger Reusable Sharps Container |
International Marketing Specialists Inc. |
Rod Calderon |
| K203251 |
08/27/2021 |
SOLOPASS System |
inTRAvent Medical Partners, LP |
Adam Barner |
| K211784 |
08/06/2021 |
da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) |
Intuitive Surgical, Inc. |
Brandon Hansen |
| K212048 |
08/26/2021 |
Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion Peripheral Vision Probe) |
Intuitive Surgical, Inc. |
Jennifer Siu |
| K212175 |
08/02/2021 |
DynaCAD |
Invivo Corporation |
Liselotte Kornmann |
| K211916 |
08/20/2021 |
IPS e.max One |
Ivoclar Vivadent AG |
Sandra Cakebread |
| K211075 |
08/05/2021 |
Disposable Medical Nitrile Examination Gloves (Non-Sterile) |
Jiangsu Cherish Medical Technology Co., Ltd |
April Yao |
| K211608 |
08/05/2021 |
Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs) |
Jiangsu Cureguard Glove Co., Ltd. |
Guo Hua |
| K211354 |
08/08/2021 |
Disposable Synthetic Vinyl Nitrile Examination Glove |
Jiangsu Cureguard Glove Co., Ltd. |
Guo Hua |
| K211708 |
08/17/2021 |
Disposable Medical Nitrile Gloves |
Jiangsu Health-Peace Medical Technology Co. Ltd |
Min Liu |
| K211454 |
08/18/2021 |
Surgical mask |
Jiangsu Xingtong Biotechnology Group Co., Ltd. |
Li Hua |
| K203542 |
08/02/2021 |
Neodent Implant System - Mini Abutment 60░ |
JJGC Industria e Comercio de Materiais Dentarios S.A. |
Mariana Soares Hartmann |
| K210336 |
08/13/2021 |
Neodent Implant System - Zirconia Implant System |
JJGC Industria e Comercio de Materiais Dentarios SA |
Mariana Soares Hartmann |
| K203636 |
08/31/2021 |
PlusCare Temperature Probes, Skin Types: PT2252-AS, PTHP-AS, PTMQ-AS, PTSW-AS, PTSM-15AS, PTSL-AS, PTMR-AS; Rectum Types: PT2252-AG, PTHP-AG, PTMQ-AG, PTSW-AG, PTSM-15AG, PTSL-AG, PTMR-AG |
JKH USA, LLC |
Bill Quanqin Dai |
| K212038 |
08/27/2021 |
K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage |
K&J Consulting Corporation |
Barry E. Sands |
| K210619 |
08/24/2021 |
SKR 3000 |
Konica Minolta, Inc. |
Tsutomu Fukui |
| K210957 |
08/31/2021 |
Kubec Xpert 80 Radiography System |
KUB Technologies, Inc. |
Chester Lowe |
| K210956 |
08/31/2021 |
Kubtec Mozart (XPERT42) |
KUB Technologies, Inc. |
Chester Lowe |
| K212070 |
08/30/2021 |
KMTI S141 Lumbar Interbody Fusion System |
Kyocera Medical Technologies, Inc. |
Anthony DeBenedictis |
| K202836 |
08/19/2021 |
GX Navigation Instrument System |
Life Spine Inc. |
Angela Batker |
| K211501 |
08/24/2021 |
Advantage-C PEEK Cervical lnterbody Fusion Device |
lntelivation, LLC |
Jack Griffis |
| K211631 |
08/18/2021 |
Surgical Face Mask |
Macheng Thimble Technology Investment Co., Ltd |
Donghong Sheng |
| K212229 |
08/13/2021 |
White Endoseal MTA |
MARUCHI |
Jang Sung Wook |
| K212322 |
08/18/2021 |
Cellvizio I.V.E. system with Confocal Miniprobes |
Mauna Kea Technologies |
Aline Criton |
| K211435 |
08/06/2021 |
PAO Cortical Screw |
Medacta International SA |
Stefano Baj |
| K210759 |
08/11/2021 |
Solo, Swing Maxi |
Medela LLC |
Mike McAndrew |
| K203538 |
08/02/2021 |
SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs) |
Medline Industries, Inc. |
Jennifer Mason |
| K210838 |
08/25/2021 |
PROWLER SELECT PLUS; PROWLER EX |
Medos International SARL |
Samuel Shimp |
| DEN210003 |
08/23/2021 |
SureTune4 Software |
Medtronic Neuromodulation |
Teal Bjoraker |
| K210841 |
08/16/2021 |
NuVent Eustachian Tube Dilation Balloon |
Medtronic Xomed, Inc. |
Matthew Harmon |
| K212027 |
08/24/2021 |
TurboHawk Plus Directional Atherectomy System |
Medtronic, Inc |
Jenny Andersen |
| K203554 |
08/28/2021 |
AnyOne External Implant System |
MegaGen Implant Co., Ltd. |
You Jung Kim |
| K210339 |
08/02/2021 |
Bullfrog Micro-Infusion Device |
Mercator MedSystems, Inc. |
Kirk P. Seward |
| K202705 |
08/20/2021 |
Prime and DYNASTY« Additive Manufacturing Shells |
MicroPort Orthopedics Inc. |
Gillen Gonzales |
| K201157 |
08/24/2021 |
Prime BIOFOAM« Multi-Hole Shells |
MicroPort Orthopedics Inc. |
Vaidehi Mehta |
| K211026 |
08/03/2021 |
Minitube Dentasleeve Protective Barrier Sleeves |
Minitube AB |
Bengt Myhrman |
| K210800 |
08/20/2021 |
IO Expandable Lumbar Interbody Fusion System |
MiRus, LLC |
Jordan Bauman |
| K211194 |
08/20/2021 |
Molekule Air Pro |
Molekule, Inc. |
Frank Bianco |
| K211584 |
08/19/2021 |
Oral Surgery Contra |
Nakanishi INC. |
Masaaki Kikuchi |
| K212134 |
08/25/2021 |
Diagnostic X-ray System/PLX5200A |
Nanjing Perlove Medical Equipment Co., Ltd. |
Lu Fengfang |
| K210674 |
08/24/2021 |
Shoulder Pacemaker |
NCS Lab Srl |
Matteo Mantovani |
| K211383 |
08/13/2021 |
NFLK-2501 Portable X-ray Unit |
NEUF Inc. |
Woo Sang Lee |
| K212106 |
08/02/2021 |
Relivion |
Neurolief Ltd. |
Michal Kedar-Datel |
| K202621 |
08/05/2021 |
NeuroSENSE Monitoring System, Model NS-901 |
NeuroWave Systems Inc. |
Tatjana Zikov |
| K202781 |
08/27/2021 |
Neuspera Neurostimulation System (NNS) |
Neuspera Medical Inc. |
Alexander Yeh |
| K211413 |
08/27/2021 |
BEE PLIF Cage |
NGMedical GmbH |
Stella Hahn |
| K202745 |
08/23/2021 |
Disposable medical face mask |
Ningbo Jingeao Electronics Inc. |
Yiyun Yu |
| K202746 |
08/27/2021 |
Surgical mask |
Ningbo Jingeao Electronics Inc. |
Yiyun Yu |
| K210256 |
08/19/2021 |
CiRx (R) Surgical Mask |
Ningbo Shun Ye Medical Company, Ltd. |
Frank Yu |
| K211182 |
08/01/2021 |
H2H Powder Free Examination Blue Glove |
NTL Innovation Co., Ltd. |
Puttharaksa Sornkong |
| K211757 |
08/20/2021 |
Simplify Disc |
NuVasive, Inc. |
Beth Neil |
| K202670 |
08/20/2021 |
Nam illumination probe with chopper |
Oculight Ltd. |
Jinman Kim |
| K211431 |
08/02/2021 |
breastscape v1.0 |
Olea Medical |
Nathalie Palumbo |
| K211838 |
08/04/2021 |
Ultrasonic Bipolar Generator USG-410 with accessories |
Olympus Medical Systems Corporation |
Toshiyuki Nakajima |
| K210651 |
08/03/2021 |
Resection Electrodes with HF cable |
Olympus Winter & Ibe GmbH |
Katharina Campbell |
| K200986 |
08/02/2021 |
OPTI« B-Lac Cassette |
OPTI Medical Systems, Inc. |
Theron Gober |
| K210858 |
08/13/2021 |
VITROS Chemistry Products PHBR Slides |
Ortho-Clinical Diagnostics, Inc. |
Darlene Phillips |
| K211704 |
08/31/2021 |
CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer System, CONSTRUX Mini Ti Spacer System, FORZA PEEK Spacer System, FORZA PTC Spacer System, FORZA Ti Spacer System, FORZA XP Expandable Spacer System, Lonestar Cervica |
Orthofix Inc. |
Jacki Koch |
| K211376 |
08/17/2021 |
STARband |
Orthomerica Products Inc. |
David C. Kerr |
| K210998 |
08/17/2021 |
ROSA Hip System |
Orthosoft d/b/a Zimmer CAS |
Paul Hardy |
| K211290 |
08/03/2021 |
Cannulated Fasteners and Nuts |
OsteoCentric Technologies |
Todd Evans |
| K210122 |
08/27/2021 |
Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw) |
Osteonic Co., Ltd. |
Da Kyung Ham |
| K211640 |
08/10/2021 |
Ponto 5 Mini |
Oticon Medical AB |
Anja Ravn |
| K202831 |
08/26/2021 |
The iMask Child's Face Mask |
Pac-Dent, Inc. |
Jiahe Li |
| K203727 |
08/05/2021 |
Harmony Latex Dam, Harmony Non-Latex Dam |
Pamco Distributing Inc. |
Annette Maclean |
| K211322 |
08/30/2021 |
Paratrooper Plantar Plate Repair System |
Paragon 28, Inc. |
Haylie Hertz |
| K211654 |
08/16/2021 |
Penumbra System (Reperfusion Catheter RED 72) |
Penumbra, Inc. |
Nikita Patel |
| K201573 |
08/17/2021 |
Brain Perfusion (BP) application |
Philips Medical Systems Nederland B.V. |
Yoram Levy |
| K211764 |
08/06/2021 |
Vereos PET/CT |
Philips Medical Systems Nederland B.V. |
Carmit Shmuel |
| K210725 |
08/06/2021 |
Nitrile Patient Examination Glove |
PingAn Medical Products Co.,Ltd. |
Zhou Ziyu |
| K210047 |
08/27/2021 |
Stiletto Extended Dwell Catheter |
Piper Access, LLC |
Jay Muse |
| K210946 |
08/12/2021 |
Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles |
Promisemed Hangzhou Meditech Co., Ltd. |
Zearou Yang |
| K211444 |
08/25/2021 |
CellFX System |
Pulse Biosciences, Inc. |
Punam Gollamudi |
| K212105 |
08/23/2021 |
6543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZF |
PZMedical Technology Co., Ltd. |
Peter Yixin Li |
| K211893 |
08/05/2021 |
SelectFlex Neurovascular Access System Family |
Q'Apel Medical Inc |
Ken Peartree |
| K211451 |
08/25/2021 |
Disposable Surgical Mask (non sterile) |
Qinhuangdao Taizhi Medical Technology Co., Ltd. |
Fan Xifan |
| K201246 |
08/03/2021 |
PTA Balloon Catheter (PVQ), MIT PTA Balloon Catheter (PVQ) |
QualiMed USA, LLC. |
Manfred Gulcher |
| K210661 |
08/12/2021 |
SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset |
Quanta Dialysis Technologies Ltd |
Sam Drew |
| K203006 |
08/05/2021 |
R2 Dermabrasion Tip (for Dermal Cooling System) |
R2 Technologies, Inc. |
Ragan Reppond |
| K203696 |
08/27/2021 |
RBknee |
Radiobotics ApS |
Martin Christian Axelsen |
| K212144 |
08/03/2021 |
Remex KA6 |
Remedi Co. Ltd. |
Suho Cho |
| K212324 |
08/23/2021 |
RenovoCath |
RenovoRx, Inc. |
Debra Cogan |
| K210844 |
08/24/2021 |
DreamWear Silicone Pillows Mask |
Respironics, Inc. |
Steve Lawrie |
| K210676 |
08/27/2021 |
XSTAT 30 Pouch |
RevMedx, Inc. |
Amy K Pointer |
| K203236 |
08/16/2021 |
Rhino Health Non-Sterile, Powder-free Nitrile Exam Glove |
Rhino Health Inc |
Mark Lee |
| K203227 |
08/18/2021 |
Elecsys HCG STAT |
ROCHE DIAGNOSTICS |
Adennis N. Cora |
| K211414 |
08/10/2021 |
KHEIRON Spinal Fixation System |
S. M. A. I. O |
Jean-Charles Roussouly |
| K202652 |
08/19/2021 |
Servator P SALF Solution with THAM |
S.A.L.F. spa |
Carmelo Gagliano |
| K201560 |
08/31/2021 |
Auto Lung Nodule Detection |
Samsung Electronics Co.,Ltd. |
Jaesang Noh |
| K211903 |
08/30/2021 |
Shoreline Threaded TruProfile« Plate |
SeaSpine Orthopedics Corporation |
Kavita Chandrashekar |
| K203643 |
08/11/2021 |
Sensatronic Reusable Temperature Probes |
Sensatronic GmbH |
Jens Schwarz |
| K211799 |
08/10/2021 |
Biodentine XP 500, Biodentine XP 200 |
Septodont |
Kimty Bui-Van |
| K210897 |
08/24/2021 |
Disposable Nitrile Examination Gloves |
Shandong DS Safety Technology Co., Ltd. |
Summer Feng |
| K211552 |
08/11/2021 |
Surgical mask |
Shandong Shengquan New Materials Co., Ltd. |
Xiumei Zhang |
| K210643 |
08/04/2021 |
Disposable Surgical Face Mask |
Shandong Zhushi Pharmaceutical Group Co., Ltd |
Junhui Zhu |
| K210510 |
08/12/2021 |
Disposable Surgical Gown |
Shandong Zhushi Pharmaceutical Group Co., Ltd |
Junhui Zhu |
| K202916 |
08/25/2021 |
Balloon Guiding Catheter |
Shanghai Heartcare Medical Technology Co., Ltd |
Zongyu Xue |
| K212066 |
08/16/2021 |
Adena-Zina System |
Shanghai Sanyou Medical Co, LTD |
David Fan |
| K203448 |
08/11/2021 |
uCT ATLAS with uWS-CT-Dual Energy Analysis |
Shanghai United Imaging Healthcare Co., Ltd. |
Xin Gao |
| K210317 |
08/19/2021 |
Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee 1U/ Apogee 1T/ Apogee 1G Digital Color Doppler Ultrasound Imaging System |
Shantou Institute of Ultrasonic Instruments Co., Ltd. (SIUI) |
Flower Cai |
| K210318 |
08/18/2021 |
Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging System |
Shantou Institute of Ultrasonic Instruments Co., Ltd. (SIUI) |
Flower Cai |
| K203613 |
08/27/2021 |
ENFit Reusable Enteral Syringe |
Shantou Wealy Medical Instrument Co., Ltd. |
Yang Songling |
| K210448 |
08/31/2021 |
Adhesive Electrode |
Shaoxing Yingtuo Healthcare Co.,Ltd. |
Haze XU |
| K211620 |
08/19/2021 |
Biodegradable Powder Free Latex Examination Gloves Natural, Blue, Black and Green Colors with protein content labeling claim (50 micrograms or less) |
Shen Wei USA Inc. |
Cheryl Reep |
| K211353 |
08/11/2021 |
Medical Face Mask |
Shenzhen Lyttop Healthcare Limited |
Lily Wu |
| K210373 |
08/27/2021 |
Clear Aligners |
Shenzhen Yinuo Dental Technology Co.LTD |
Mo Yuyum |
| K211041 |
08/30/2021 |
Wrist Blood Pressure Monitor, Model Name:W203, Wrist Blood Pressure Monitor, Model Name:W202, Wrist Blood Pressure Monitor, Model Name:W1681 |
Shenzhen Yuezhongxing Technology Co., Ltd. |
Yuchao Chen |
| K210533 |
08/20/2021 |
Inset Reverse Total Shoulder System |
Shoulder Innovations, Inc. |
Don Running |
| DEN190056 |
08/20/2021 |
ADVIA Centaur Enhanced Liver Fibrosis (ELF) |
Siemens Healthcare Diagnostics Inc. |
Matthew Gee |
| K211373 |
08/27/2021 |
SOMATOM go.Platform Scanners - SOMATOM go.Now, go.Up, go.All, go.Top, SOMATOM X. Platform Scanners - SOMATOM X.cite and SOMATOM X.ceed, Scan&GO Software |
Siemens Medical Solutions USA, Inc. |
Alaine Medio |
| K212007 |
08/12/2021 |
VERTICALE Navigation Instruments |
Silony Medical GmbH |
Ralf Klabunde |
| K210913 |
08/04/2021 |
V12 PRO |
SLK Medical GmbH |
Matthew Reid |
| K200657 |
08/23/2021 |
SmartGuard Anti-Snoring Device |
SmartGuard Rx Inc. |
Brian Larsen |
| K211671 |
08/17/2021 |
Journey II Mid-Level Tibial Inserts |
Smith & Nephew, Inc. |
Kayla Franklin |
| K211634 |
08/26/2021 |
Hypodermic Needle-Pro EDGE Safety Device |
Smiths Medical ASD, Inc. |
Dominique Neisz |
| K211995 |
08/27/2021 |
Sonendo Filling Material 5C |
Sonendo, Inc. |
Steve Ziemba |
| K192823 |
08/13/2021 |
MEGA-TMS |
Soterix Medical, Inc. |
Abhishek Datta |
| K200913 |
08/13/2021 |
Clearblue« Early Digital Pregnancy Test |
SPD Swiss Precision Diagnostics GmbH |
Joanne Scaife |
| K212230 |
08/16/2021 |
TruSPECT Radiological Image Processing Station |
Spectrum Dynamics Medical Ltd |
Igor Naroditsky |
| K210745 |
08/26/2021 |
Heel Incision Safety Lancet |
SteriLance Medical (Suzhou) Inc. |
Yuan Jie |
| K211500 |
08/25/2021 |
AMSCO 600 Medium Steam Sterilizer |
Steris Corporation |
Anthony Piotrkowski |
| K211202 |
08/06/2021 |
1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S 4K Sinuscopes |
Stryker |
Jessie Duong |
| K211502 |
08/04/2021 |
Alpha Vent PEEK Suture Anchor |
Stryker Endoscopy |
Christie Samsa |
| K202752 |
08/27/2021 |
AXS Vecta 46 Intermediate Catheter |
Stryker Neurovascular |
Shivani H. Patel |
| K210502 |
08/27/2021 |
Trevo NXT ProVue Retriever |
Stryker Neurovascular |
Rebecca Rosman |
| K211703 |
08/16/2021 |
Insignia Hip Stem |
Stryker Orthopaedics |
Valerie Giambanco |
| K211553 |
08/04/2021 |
Tecomet Global Unite Short Stem Instrumentation |
Symmetry Medical Manufacturing Inc. DBA Tecomet, Inc. |
Mike Parrish |
| K211516 |
08/24/2021 |
Disposable Vinyl Nitrile Synthetic Gloves Powder Free |
Tangshan Hongyun Plastic Products Co., Ltd. |
Suying Le |
| K210898 |
08/26/2021 |
Disposable Nitrile Examination Gloves (Powder Free, Purple-Blue, Blue) |
Tangshan Lanhai Medical Supplies Co., Ltd. |
Li Ruidong |
| K202425 |
08/19/2021 |
SurgiLattice scaffold |
Tepha, Inc. |
Kavetha Ram |
| K203464 |
08/04/2021 |
DESS Dental Smart Solutions |
Terrats Medical SL |
Roger Terrats |
| K212383 |
08/31/2021 |
EndoNaut |
Therenva SAS |
Audrey Gallois |
| K211255 |
08/28/2021 |
Surgical Mask |
Tianchang Kanghui Protective Products CO LTD |
Mark Wong |
| K211049 |
08/04/2021 |
Tigon Medical Button System |
Tigon Medical |
Jeremy Clark |
| K200904 |
08/05/2021 |
Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 |
Tosoh Bioscience, Inc. |
Louise Musante |
| K203362 |
08/05/2021 |
TRACOE vario |
TRACOE medical GmbH |
Katharina Schrick |
| K211783 |
08/06/2021 |
TriMed Threaded Intramedullary Nail System |
TriMed, Inc. |
David Medoff |
| K203817 |
08/13/2021 |
Tyber Medical Anatomical Plating System |
Tyber Medical LLC |
Mark Schenk |
| K210541 |
08/06/2021 |
ulrichINJECT CT motion |
ulrich GmbH & Co. KG |
Sven Erdmann |
| K203357 |
08/25/2021 |
HVT 2.0 |
Vapotherm Inc. |
Dennis Francoeur |
| K212294 |
08/20/2021 |
Ethos Treatment Management, Ethos Treatment Planning |
Varian Medical Systems, Inc. |
Peter J. Coronado |
| K211806 |
08/03/2021 |
Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven Catheter |
Venclose, Inc. |
Mai-Ly Wilcox |
| K200748 |
08/26/2021 |
Visby Medical Sexual Health |
Visby Medical |
Carolyn Glickman |
| K210203 |
08/19/2021 |
mmRNA appliance |
Vivos Therapeutics, Inc. (formerly Vivos Biotechnologies, I) |
Catheryn Bonar |
| K210971 |
08/18/2021 |
EnteraLoc Flow |
Vonco Products |
Christie Marr |
| K211294 |
08/16/2021 |
Multi-Link X2 ECG Cable and Leadwire System |
Vyaire Medical, Inc. |
Joshua Davis |
| K210327 |
08/12/2021 |
First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign Multi-Drug Screen Test Dip Card, First Sign Multi-Drug Screen Test Cup |
W.H.P.M., Inc. |
John Wan |
| K210671 |
08/13/2021 |
Digital Blood Pressure Monitor WBP Series, including: WBP101, WBP102, WBP103, WBP104, WBP105, WBP106, WBP107 |
Weony (Shenzhen) Technology Co., Ltd. |
Autumn Liu |
| K212323 |
08/25/2021 |
Instinct Plus Endoscopic Clipping Device |
Wilson-Cook Medical Inc. |
Scottie Fariole |
| K211551 |
08/20/2021 |
Wishbone HA |
Wishbone SA |
Emilie Dory |
| K202861 |
08/27/2021 |
Needle Stimulator |
Wuxi Jiajian Medical Instrument Co., Ltd |
Caihong Sun |
| K202802 |
08/26/2021 |
TT Electric Breast Pump, TT Double Electric Breast Pump |
Wuxi Xinzhongrui Baby Supplies Co., Ltd. |
Zhang Chunyan |
| K211576 |
08/19/2021 |
WYZ Surgical Mask |
WYZ Medical Supplies LLC |
Daniel Chen |
| K210288 |
08/26/2021 |
Disposable Manual Resuscitator |
Xiamen Compower Medical Tech. Co., Ltd. |
Lifen Chen |
| K210698 |
08/19/2021 |
ECOMA Level 2 Disposable Surgical Mask with Ear Loops |
Xianning Eco Medical Articles Co., Ltd. |
Wei Zhou |
| K211462 |
08/19/2021 |
Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face Mask |
Xiantao S&J Protective Products Co., Ltd. |
Dove Wei |
| K211563 |
08/13/2021 |
Pitch-Patchs |
Xiros Ltd |
Steve Curran |
| K202536 |
08/11/2021 |
Non-sterile, Powder Free Nitrile Examination Aloe Vera Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, And Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs and Fentanyl Citrate |
YTY Industry (Manjung) SDN BHD |
Punitha Samy |
| K211993 |
08/11/2021 |
Z-LINKPC System |
Zavation Medical Products LLC |
Colby Williams |
| K211513 |
08/18/2021 |
sam X1 Long Duration Ultrasound Device |
ZetrOZ Systems, LLC |
Sabrina Lewis |
| K211434 |
08/05/2021 |
Nitrile Patient Examination Gloves |
Zhangjiagang Huayuan Protective Equipment Co., Ltd. |
Huamei Wang |
| K211897 |
08/03/2021 |
Surgical Face Mask |
Zhejiang Hongyu Medicali Commodity CO., LTD |
Sophie Sophie |
| K212023 |
08/27/2021 |
Virage Navigation System |
Zimmer Biomet Spine, Inc. |
David Pollard |
