| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K220822 |
12/09/2022 |
3D-SHAPER |
3D-Shaper Medical S.L |
Ludovic Humbert |
| K220257 |
02/01/2022 |
Permadyne |
3M Deutschland GmbH |
Ruediger Franke |
| K210135 |
02/24/2022 |
PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing |
3M Health Care Business Group |
Margaret Marsh |
| K222297 |
12/01/2022 |
CentriMag Pre-connected Pack |
Abbott |
Kim Bondarenko |
| K222038 |
12/08/2022 |
CentriMagÖ Blood Pump for use with CentriMagÖ Acute Circulatory Support System |
Abbott (formerly Thoratec Corporation) |
Meera Mehta |
| K223324 |
12/29/2022 |
Total Bilirubin2 |
Abbott Ireland Diagnostics Division |
Magdalena Suszko |
| K223094 |
12/27/2022 |
EnSiteÖ X EP System TactiFlexÖ Ablation Catheter, Sensor EnabledÖ, Software Upgrade; EnSiteÖ X EP System TactiFlexÖ Ablation Catheter, Sensor EnabledÖ, Software License |
Abbott Medical |
Alyssa Timmers |
| K222217 |
12/19/2022 |
ViewFlex Xtra Reprocessed ICE Catheter |
Abbott Medical |
Quynh Phuong Le |
| K213564 |
12/21/2022 |
BiWaze Clear System |
ABMRC LLC |
Leah Noaeill |
| K221796 |
12/30/2022 |
Cyware 4H and Cysart 4H |
Abys Medical |
Arnaud Destainville |
| K220772 |
12/07/2022 |
HydroMID 4F Single Lumen Midline Catheter |
Access Vascular, Inc. |
Brian M. Hanley |
| K210017 |
12/23/2022 |
ACTOnco, ACTOnco IVD |
ACT Genomics |
Pei-Fang Chung |
| K202728 |
02/10/2022 |
Action Trackchair Hawk |
Action Manufacturing Inc. |
Alan Macht |
| K221333 |
12/29/2022 |
Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional |
Acumed LLC |
Saleh Amirriyazi |
| K220047 |
02/08/2022 |
AcQCross Qx Integrated Transseptal Dilator/Needle |
Acutus Medical, Inc. |
Sarah Clay |
| K214041 |
12/30/2022 |
Aesculap AICON Container |
Aesculap Inc. |
Omunique (Nikki) Luke |
| K222626 |
12/06/2022 |
Dental Zirconia Ceramic |
Aidite (Qinhuangdao) Technology Co., Ltd. |
Chen Yingying |
| K222692 |
12/05/2022 |
BriefCase |
Aidoc Medical, Ltd. |
Amalia Schreier |
| K223195 |
12/09/2022 |
AIROS 6P Sequential Compression Device |
AIROS Medical, Inc |
Darren Behuniak |
| K223193 |
12/09/2022 |
AIROS 8P Sequential Compression Device |
AIROS Medical, Inc |
Darren Behuniak |
| K212998 |
02/19/2022 |
Powder Free Nitrile Examination Gloves (White, Blue and Black) |
Alcatron Gloves Factory |
Hui Zhao |
| K222894 |
12/22/2022 |
Invisalign System, Pre-Formed Attachment System |
Align Technology, Inc. |
Manjunath Bisalehalli |
| K221926 |
12/20/2022 |
Invictus« Bone Cement, Invictus Spinal Fixation System |
Alphatec Spine, Inc. |
Aditya Aiyer |
| K222681 |
12/05/2022 |
Altaviz Needle Kit |
Altaviz, LLC |
James Lescoulie |
| K212586 |
02/17/2022 |
Amazing+ |
Amazing Rubber Products Pvt Ltd |
Jayasankar S |
| K212382 |
02/03/2022 |
Ambu« aScopeÖ Gastro, Ambu« aBoxÖ2 |
Ambu A/S |
Mette Anderson |
| K222867 |
12/21/2022 |
AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS) |
Andon Health Co., Ltd. |
Liu Yi |
| K223281 |
12/07/2022 |
Disposable Nitrile Examination Glove |
Anhui Kindguard Medical Supplies Technology Co., Ltd |
Guo Hua |
| K222385 |
12/06/2022 |
Bifurcated Needle |
Anhui Tiankang Medical Technology Co., Ltd. |
Zhang Yong |
| K221590 |
12/02/2022 |
NaviCam Small Bowel Capsule Endoscopy System |
ANKON Technologies Co., Ltd. |
Si Feng Wang |
| K213941 |
02/24/2022 |
Annalise Enterprise CXR Triage Pneumothorax |
Annalise-AI |
Eric Qin |
| K223603 |
12/29/2022 |
Reflow System Mini and ReFlow Mini Flusher |
Anuncia Medical, Inc. |
Elsa Chi Abruzzo |
| K222234 |
12/21/2022 |
GlucoSure ADVANCE Link Blood Glucose Monitoring System |
Apex BioTechnology Corp. |
Lisa Liu |
| K211798 |
02/24/2022 |
Cleaner Plus Thrombectomy System |
Argon Medical Devices, Inc. |
Ana Jimenez-Hughes |
| K213465 |
12/02/2022 |
CardioGraphe |
Arineta Ltd. |
Tanya Shalem |
| K221031 |
12/20/2022 |
Arthrex DualCompression Hindfoot Fusion Nail Implant System |
Arthrex Inc. |
Rebecca R. Homan |
| K221396 |
12/22/2022 |
Arthrex FiberTak Suture Anchor |
Arthrex Inc. |
Lai Saeteurn |
| K221358 |
12/30/2022 |
Isolator« Linear Pen (MLP1); Isolator« TranspolarÖ Pen (MAX1, MAX5), Coolrail« Linear Pen (MCR1); Isolator« Synergy Surgical Ablation System (EMR2, EML2); Isolator« SynergyÖ EnCompass Clamp (OLH, OSH) and Guide System; Isolator« Synergy Access Clamp (EMT1 |
AtriCure, Inc |
Jonathan McElwee |
| K210727 |
02/01/2022 |
HotDog Warming Mattress + Return Electrode |
Augustine Temperature Management LLC |
Temi Ogunse |
| K213110 |
12/16/2022 |
AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In Anchor |
Auxein Medical Private Limited |
Rahul Luthra |
| K212886 |
02/16/2022 |
Broncoflex Agile, Broncoflex Vortex, Screeni |
Axess Vision Technology |
Marie-HΘlΦne Bacheley |
| K213664 |
02/11/2022 |
B. Braun Introcan Safety 2 IV Catheter |
B. Braun Medical Inc. |
Tracy Larish |
| K223386 |
12/06/2022 |
Optima Coil System |
Balt USA, LLC |
Kavita Chandrashekar |
| K222541 |
12/06/2022 |
Bausch + Lomb Preservative Free Lubricating and Rewetting Drops |
Bausch & Lomb Incorporated |
Melissa Thomas |
| K221351 |
12/19/2022 |
Mechanical Guidewire |
Baylis Medical Company Inc. |
May Tsai |
| K221990 |
12/27/2022 |
Access Total ▀hCG (5th IS) |
Beckman Coulter, Inc |
Kate Oelberg |
| K223289 |
12/23/2022 |
Access Vitamin B12 |
Beckman Coulter, Inc. |
Kuljeet Kaur |
| K221826 |
12/21/2022 |
BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30) |
Becton Dickinson, and Company |
Kamisha Gray |
| K223286 |
12/28/2022 |
BD AutoShield DuoÖ Pen Needle |
Becton, Dickinson and Company |
Alec Paterno |
| K223243 |
12/16/2022 |
BD Microtainer« Contact-Activated Lancets; BD Microtainer« QuikheelÖ Lancets |
Becton, Dickinson and Company |
Alexandra Kirby |
| K212724 |
02/04/2022 |
BD Vacutainer UltraTouch Push Button Blood Collection Set |
Becton, Dickinson and Company |
Katherine Kenner Lemus |
| K211400 |
02/11/2022 |
Pulse Oximeter |
Beijing Choice Electronic Technology Co., Ltd. |
Haiying Zhao |
| K212611 |
02/01/2022 |
CO2 Laser Equipment |
Beijing Globalipl Development Co., Ltd. |
Liu Jun |
| K222916 |
12/09/2022 |
US 450 Diode Laser Equipment |
Beijing Globalipl Development Co., Ltd. |
Liu Jun |
| K213533 |
02/16/2022 |
Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL |
Bio Compression Systems, Inc. |
Marc Somelofski |
| K222010 |
12/30/2022 |
Biobeat Platform-2 and BB-613WP Patch |
BioBeat Technologies Ltd. |
Johanan May |
| K222984 |
12/29/2022 |
BioClean Implant Restorative System |
BioClean Dental, LLC |
Russ Bonafede |
| K212721 |
02/04/2022 |
Genex Bone Graft Substitute |
Biocomposites Ltd |
Simon Fitzer |
| K222689 |
12/05/2022 |
Mallya Injection Pen Adapter (Mallya« for Solostar«) |
Biocorp Production |
Alexia Garin |
| K212957 |
12/12/2022 |
BioButton System |
BiolntelliSense Inc. |
Yusi Liu |
| K213241 |
02/25/2022 |
VITEK 2 AST-Yeast Fluconazole (<=0.5->=64 ╡g/mL), VITEK 2 AST-YS Fluconazole (<=0.5->=64 ╡g/mL), VITEK 2 AST-YS Fluconazole |
BioMerieux, Inc. |
Esther Hernandez |
| K212431 |
02/07/2022 |
Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve |
Biomet, Inc. |
Gregory Foster |
| K222760 |
12/28/2022 |
StageOneÖ Select Hip Cement Spacer Molds |
Biomet, Inc. |
Meredith Reed |
| K212849 |
02/04/2022 |
VITEK 2 AST-Gram Positive Linezolid (<=0.5 û >=8 ╡g/mL) |
bioMΘrieux, Inc |
Esther Hernandez |
| K211965 |
02/23/2022 |
StimRouter Neuromodulation System |
Bioness Inc. |
Sageev George |
| K222441 |
12/07/2022 |
Ultrasound System 2300 |
BK Medical Aps |
Sandra Theodoridis |
| K212824 |
02/17/2022 |
Bluezone Model RX-450 Air Purifier |
Bluezone Products, Inc. |
Karen Benedek |
| K213169 |
12/05/2022 |
BPAP System |
BMC Medical Co., Ltd. |
Fang Zheng |
| K223616 |
12/30/2022 |
AcquireÖ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device |
Boston Scientific Corporation |
Kyra McNamara |
| K223592 |
12/29/2022 |
AdvanixÖ Pancreatic Stent and NaviFlexÖ Rapid Exchange (RX) Pancreatic Delivery System and Pushers |
Boston Scientific Corporation |
Kerri LaPlaca |
| K203548 |
02/21/2022 |
EndoArmorÖ + Surgical Gown |
Boston Scientific Corporation |
Laura Kuroski |
| K220012 |
12/21/2022 |
BresoDX1 |
Bresotec Inc |
Esther Sur |
| K222820 |
12/16/2022 |
BRM TOOL Screws, BIOPLAN Subtalar Implant |
BRM Extremities |
Lisa Fazzini |
| K211722 |
02/25/2022 |
Laser treatment system , models Nyx plus, Grace plus, Nemesis, Ares |
Canadian Pioneer Medical Technology Corporation |
Rashid Reza Mir Reza Mir |
| K220098 |
02/04/2022 |
Digital Radiography CXDI-Pro, Digital Radiography D1 |
Canon Inc. |
Akira Hirai |
| K221603 |
12/20/2022 |
Kangaroo OMNIÖ Enteral Feeding Pump (385400 );Kangaroo OMNIÖ Feeding Set 500ml (B5FD );Kangaroo OMNIÖ ENtelliSet 500ml (E5FD );Kangaroo OMNIÖ Feeding Set 1000ml (B10FD );Kangaroo OMNIÖ ENtelliSet 1000ml (E10FD );Kangaroo OMNIÖ ENPlus Spike Set (BSPFD ) |
Cardinal Health LLC |
Varela Fredy |
| K223687 |
12/30/2022 |
X-ray Flat Panel Detectors (EverestView 4343X) |
CareRay Digital Medical Technology Co., Ltd. |
Xu Wei |
| K222195 |
12/30/2022 |
aprevo« Digital Workflow |
Carlsmed, Inc. |
Karen Liu |
| K211327 |
02/10/2022 |
Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed Electrophysiology Catheters, Khelix Fixed Loop Steerable Electrophysiology Catheters, Khelix Variable Loop Steerable Electrophysiology Catheters |
CathRxLtd |
Lucy Huang |
| K214004 |
12/13/2022 |
CCBIO ASCPO Needle |
CC Biotechnology Corporation |
Edgar Yeh |
| K212885 |
02/11/2022 |
Actively Trying Personal Lubricant Rose Scented |
CC Wellness LLC |
Marlent Perez |
| K212705 |
02/09/2022 |
Actively Trying Personal Lubricant Unfragrance |
CC Wellness LLC |
Marlent Perez |
| K212071 |
12/13/2022 |
Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx |
CEFALY Technology |
Rufus Kay Moberly |
| K212213 |
02/09/2022 |
Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System |
Cepheid |
Suzette Chance |
| K222669 |
12/05/2022 |
Cryopush Cold Compression Device |
Chengdu Cryo-Push Medical Technology Co., Ltd |
Zhang Peiyong |
| K212567 |
12/07/2022 |
PVC Hydrophilic Urethral Catheter |
Chengdu Daxan Innovative Medical Tech. Co., Ltd |
Kevin Huang |
| K212833 |
02/28/2022 |
Disposable Nitrile Examination Gloves |
Chifeng Huawei Medical Science & Technology Co., Ltd |
Li Xiaohong |
| K221708 |
12/23/2022 |
CIMILRE Free-T2 Plus |
Cimilre Co., Ltd. |
Not Provided |
| K213622 |
02/14/2022 |
Cionic Neural Sleeve NS-100 |
CIONIC |
Mihai Ionescu |
| K213768 |
12/01/2022 |
Bolt Navigation System |
Circinus Medical Technology, LLC |
Patrick West |
| K212658 |
02/09/2022 |
CloudCath Peritoneal Dialysis Drain Set Monitoring System |
CloudCath |
Brian Fisher |
| K223605 |
12/30/2022 |
ControlSeal Electrode (ELSB) |
Coapt |
Kevin Dwyer |
| K221735 |
12/20/2022 |
Mineral Collagen Composite Bioactive Moldable |
Collagen Matrix, Inc. |
Peggy Hansen |
| K221401 |
12/02/2022 |
Self-Cath and Self-Cath Plus |
Coloplast |
Preeti Jain |
| K213186 |
02/16/2022 |
NovoFlow Reinforced Ureteral Stent |
Coloplast Corp |
Gayatri Ghadge |
| K220070 |
02/04/2022 |
MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens |
CooperVision, Inc. |
Marie Dutton |
| K220052 |
12/16/2022 |
Copan FecalSwab Collection, Transport and Preservation System |
Copan Italia S.p.A. |
Elisabetta Zanella |
| K212977 |
02/17/2022 |
SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands |
Cordis Corporation |
Vidya Venkataraghavan |
| K212786 |
02/23/2022 |
LevaLap Laparoscopic Access Device |
Core Access Surgical Technologies, Inc. |
Marianne D. Jacklyn |
| K214036 |
12/23/2022 |
AVIEW |
Coreline Soft Co.,Ltd. |
Hyeyi Park |
| K211417 |
02/04/2022 |
F3D-C2 Cervical Stand-Alone System |
CoreLink, LLC |
Steven Mounts |
| K203586 |
02/02/2022 |
EndoSerter-PL |
CorneaGen, Inc |
Tom Miller |
| K220238 |
02/25/2022 |
Cohitech Cottonlock Tampons with Reusable Applicator |
Cotton High Tech, S.L. |
Anna Garcia Llado |
| K203150 |
02/25/2022 |
Cool-tip RF Ablation System E Series |
Covidien LLC |
Liron Bar Yaakov |
| K220390 |
12/02/2022 |
CreoDent Solidex Customized Abutment and Screw |
CreoDent Prosthetics, Ltd. |
Calvin Shim |
| K220991 |
12/20/2022 |
IntelliSep test |
Cytovale Inc. |
Juliet Carrara |
| K213313 |
02/09/2022 |
Veinoflow SCD (Model: LBTK-M-I 5006) |
Dalian Labtek Science & Development Co., Ltd. |
Yao Cui |
| K222275 |
12/16/2022 |
Saige-Density |
DeepHealth, Inc. |
B. Nathan Hunt |
| K213918 |
02/09/2022 |
DeGen Navigated Instrumentation |
DeGen Medical |
Craig Black |
| K223142 |
12/22/2022 |
Coltolux Comfort LED Curing Light |
Dent4You AG |
Dr. Tricia Cregger |
| K213599 |
02/23/2022 |
SuperLine |
Dentium Co., Ltd. |
Eunsang Lee |
| K211212 |
02/17/2022 |
LoFric Elle |
Dentsply Sirona |
Rebecca Sporer |
| K223211 |
12/02/2022 |
INHANCETM Shoulder System û Humeral Stems and Stemless |
Depuy Ireland UC |
Yayoi Fujimaki |
| K213919 |
12/07/2022 |
Dexcom G7 Continuous Glucose Monitoring System |
Dexcom, Inc. |
Neeta Sharma |
| K213625 |
02/17/2022 |
Vinyl Examination Gloves |
Dezhou Hengchang Medical Technology Co., Ltd. |
Jing Li |
| K213634 |
02/18/2022 |
Vinyl/Nitrile Blend Exam Glove |
Dezhou Hengchang Medical Technology Co., Ltd. |
Jing Li |
| K211485 |
12/23/2022 |
STA- NeoPTimal |
Diagnostica Stago SAS |
Pauline Vasselon |
| K223403 |
12/09/2022 |
LIAISON Anti-HAV; LIAISON XS |
DiaSorin Inc. |
Kerrie Oetter |
| K213260 |
12/30/2022 |
CMFlexTM |
Dimension Inx Corp. |
Ramille Shah |
| K223140 |
12/20/2022 |
AEON-CÖ Stand Alone System |
Dio Medical Inc |
Milan George |
| K221221 |
12/21/2022 |
Advanced Intramedullary Nail System |
Double Medical Technology Inc. |
Yan Zuo |
| K220921 |
12/12/2022 |
Metal Bone Screw |
Double Medical Technology Inc. |
Yan Zuo |
| K203088 |
02/01/2022 |
Infinity Acute Care System (IACS) Monitoring System |
Draeger Medical Systems, Inc. |
Deborah Herrington |
| K221836 |
12/07/2022 |
Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus |
DrΣgerwerk AG & Co. KGaA |
Luise Lang |
| K220591 |
12/15/2022 |
Proxima |
Dynasthetics LLC |
Joseph Orr |
| K221698 |
12/21/2022 |
Eargo 5 , Eargo 6 |
Eargo, Inc. |
Monica Barrett |
| K220028 |
02/24/2022 |
NightOwl |
Ectosense nv |
Bart Van Pee |
| K222216 |
12/22/2022 |
TruWave Disposable Pressure Transducer |
Edwards Lifesciences LLC |
Carmen Chen |
| K211610 |
02/14/2022 |
Fogarty Occlusion Catheter |
Edwards Lifesciences, LLC |
Anisha Butala |
| K222117 |
12/09/2022 |
Swang-Ganz IQ pulmonary artery catheter |
Edwards Lifesiences, LLC |
Michelle Ducca |
| K211822 |
02/03/2022 |
LifePath Remote Patient Monitoring Platform |
Elastic Care Incorporated |
Ashok Kalle |
| K213991 |
02/22/2022 |
Enbio S |
Enbio Group AG |
Lukasz Rogowski |
| K213286 |
02/19/2022 |
EONS Nitrile Examination Gloves Powder Free |
Eons Gloves (Thailand) Co., Ltd |
Gliaophan Supharkarn |
| K213105 |
12/13/2022 |
Epilaser Absolute |
Epilady 2000 LLC |
Moshe Rosenthal |
| K221048 |
12/23/2022 |
Episealer Patellofemoral System |
Episurf Medical, Inc. |
Katarina Flodstrom |
| K221070 |
12/20/2022 |
DP4 Microneedling device |
Equipmed USA LLC |
Shaun Kerrigan |
| K212419 |
02/04/2022 |
Magnifico Open, Magnifico MSK |
Esaote S.p.A. |
Alberto Carcagni |
| K212380 |
02/22/2022 |
PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture |
Ethicon, Inc. |
Marife Sevek |
| K213606 |
02/14/2022 |
EvoEndo Single-Use Endoscopy System |
EvoEndo Inc |
Heather Underwood |
| K220003 |
02/23/2022 |
EzOrtho v1.3 |
Ewoosoft Co., Ltd |
Young Seok Kim |
| K202845 |
02/24/2022 |
Bodygard SFS Surgical Gown Level 3 |
Feliks Plastik Laminasyon Ve Ambalaj Malzemeleri Sanayi |
Ali Serdar Serteser |
| K214066 |
02/25/2022 |
FEops HEARTguide |
FEops nv |
Peter Mortier |
| K221747 |
12/01/2022 |
Nitrile Patient Examination Gloves Tested For Use With Chemotherapy Drugs |
Fitone Latex Products Co., Ltd. Guangdong |
Christine Ou |
| K201510 |
02/18/2022 |
Traufix osteosynthesis, osteotomy, and arthrodesis devices |
Fixier, S.A. de C.V. |
Vianey Mariana Perez Suarez |
| K222242 |
12/09/2022 |
FloPatch FP120 |
Flosonics Medical |
Caleb Chin |
| K221428 |
12/22/2022 |
PerioStom Dental Dressing |
Forward Science LLC |
Brian Pikkula |
| K220826 |
12/08/2022 |
LED Curing Light |
Foshan COXO Medical Instrument Co., Ltd. |
Yongjian Zheng |
| K220281 |
12/16/2022 |
multiFiltratePRO System |
Fresenius Medical Care Renal Therapies Group, LLC |
Denise Oppermann |
| K223275 |
12/09/2022 |
CELLO II Balloon Guide Catheter |
Fuji Systems Corporation |
Yoshiyuki Suzuki |
| K220053 |
02/04/2022 |
Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI |
FUJIFILM Corporation |
Randy Vader |
| K213689 |
02/17/2022 |
Voluson P6, Voluson P8 |
GE Healthcare |
Bryan Behn |
| K213972 |
02/17/2022 |
Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Software AltiX |
GE Healthcare Information Technologies, Inc. |
James T Turner |
| K213938 |
02/04/2022 |
Revolution Ascend |
GE Healthcare Japan Corporation |
He Haibo |
| K213603 |
02/11/2022 |
SIGNA Artist Evo |
GE Healthcare(Tianjin) Company Limited |
Qiang Ding |
| K221904 |
12/20/2022 |
EK12 V2 Algorithm |
GE Medical Systems Information Technologies, Inc. |
Shlomi Deler |
| K222586 |
12/21/2022 |
Mural Clinical Viewer |
GE Medical Systems Information Technologies, Inc. |
Brandon O'Shea |
| K213999 |
02/18/2022 |
Deep Learning Image Reconstruction |
GE Medical Systems, LLC. |
Amy Yang |
| K221891 |
12/14/2022 |
UNO Negative Pressure Wound Therapy System |
Genadyne Biotechnologies, Inc |
Andrew Goh |
| K214086 |
12/15/2022 |
Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty |
Genoss Co., Ltd. |
Woojung Park |
| DEN210034 |
02/23/2022 |
ONE Male Condom |
Global Protection Corp. |
Davin Wedel |
| K213196 |
12/19/2022 |
MARVELÖ Growing Rods |
Globus Medical Inc. |
Kelly J. Baker |
| K203811 |
02/10/2022 |
GPC Intraheal Intramedullary Nailing System |
GPC Medical Limited |
Vikas Narang |
| K222892 |
12/15/2022 |
Powder Free Polyurethane Examination Gloves, Blue color, Tested for use with Chemotherapy Drugs |
Grand Work Plastic Products Co., Ltd |
Wu Yuli |
| K211746 |
02/18/2022 |
Pocket Ultrasound System |
GuangDong Youkey Medical Co., Ltd. |
Hu Zeyi |
| K213079 |
02/18/2022 |
Ear Thermometer, Model ET001 |
Guangzhou Berrcom Medical Device Co., Ltd. |
Zhigang Du |
| K213084 |
02/25/2022 |
Ear Thermometer, Model ET005, ET008, ET009 |
Guangzhou Berrcom Medical Device Co., Ltd. |
Zhigang Du |
| K212971 |
02/10/2022 |
NPseal |
Guard Medical Inc |
Machiel Van Der Leest |
| K213573 |
02/09/2022 |
PELNAC Wound Matrix |
Gunze Limited |
Hidenori Nishioka |
| K220774 |
12/09/2022 |
RobPath« Total Hip Application |
Hangzhou Lancet Robotics Co., Ltd. |
Rennes Zhang |
| K212447 |
02/18/2022 |
SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test Midstream |
Hangzhou Sejoy Electronics & Instruments Co., Ltd. |
Yanyan Zhang |
| K211570 |
02/10/2022 |
Zeolite Hemostatic Gauze |
Hangzhou Zeo-Innov Life Technology Co., Ltd. |
Lijuan Zhao |
| K212366 |
02/19/2022 |
Heartland Health Surgical Mask |
Heartland Health Products |
Frank Fischer |
| K223433 |
12/13/2022 |
Quantra QPlus System |
HemoSonics, LLC |
Deborah Winegar |
| K212949 |
02/24/2022 |
Sterile Syringe with Safety Needle for Single Use, Sterile Syringe with Needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use, Sterile Needle for Single Use |
Henan Nursecare Biotechnology Co., Ltd |
Yaping Zhang |
| K213812 |
02/02/2022 |
PALACOS MV pro |
Heraeus Medical GmbH |
Ljuba Jaeckel |
| K213801 |
02/04/2022 |
Veuron-Brain-pAb2 |
Heuron Co., Ltd. |
Dong Hoon Shin |
| K220883 |
12/15/2022 |
Small Field Applicator |
Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha |
Tomoyuki Seino |
| K220667 |
12/08/2022 |
Sleeved IC |
Hollister Incorporated |
Sandra Mullen |
| K220150 |
02/17/2022 |
TENS & PMS (Model: SM9126) |
Hong Qiangxing (Shen Zhen) Electronics Limited |
Xu Jianhua |
| K221477 |
12/29/2022 |
AG100s |
Hospitech Respiration Ltd. |
Yoel Bergman |
| K213701 |
02/01/2022 |
Exeter« X3« RimFit« Cup |
Howmedica Osteonics Corp., dba Stryker Orthopaedics |
Lin Song |
| K221862 |
12/08/2022 |
YY-A02-B Overlapped Compression Therapy |
Huizhou XINYI Technology Co., LTD. |
Jason Ye |
| K213635 |
02/28/2022 |
Vathin Video Bronchoscope System |
Hunan Vathin Medical Instrument Co., Ltd. |
Feng Yun |
| K213724 |
02/20/2022 |
Medical Surgical Mask |
Hunan Zhenheyikang Medical Instrument Co., Ltd |
Yilin Yin |
| K220162 |
02/18/2022 |
Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, Alternaria |
Hycor Biomedical |
Irene M. Guzman |
| K223268 |
12/16/2022 |
BrainInsight |
Hyperfine, Inc. |
Christine Kupchick |
| K223247 |
12/06/2022 |
Swoop Portable MR Imaging System |
Hyperfine, Inc. |
Christine Kupchick |
| K222706 |
12/06/2022 |
iCE-SG2 Subcutaneous Electrode Kit |
iCE Neurosystems, Inc. |
Emir Kapetanovic |
| K213830 |
02/01/2022 |
Home use hair removal device, model: Precise Touch Pro |
Iluminage Beauty Co., Limited |
Jacky Lee |
| K222368 |
12/01/2022 |
MIST IC |
Imagine Milling Technologies, LLC |
Felix Chung |
| K213890 |
02/11/2022 |
IMICRYL Impression Materials |
IMICRYL Dis Malzemeleri San. Ve Tic. A.S. |
Husamettin Sonmez |
| K221054 |
12/21/2022 |
CORE-INJECTOR |
Incore Co., Ltd. |
Jae-Hun Lee |
| K211617 |
02/09/2022 |
Infrascanner |
Infrascan, Inc. |
Baruch Ben Dor |
| K223487 |
12/08/2022 |
InkSpace Imaging Body Array |
InkSpace Imaging, Inc. |
Peter Fischer |
| K222733 |
12/11/2022 |
Disposable Nitrile Examination Glove (Tested for use with Chemotherapy Drug) |
Inner Mongolia Boming Medical Supplies Co., Ltd. |
Guo Hua |
| K220517 |
12/20/2022 |
IBS System |
InnoBioSurg Co., Ltd. |
Ga Yun Kim |
| K220079 |
12/14/2022 |
Magicore Narrow System |
InnoBioSurg Co., Ltd. |
Ga Yun Kim |
| K223510 |
12/12/2022 |
Matrix HA Fusion Porous Cervical IBF System |
Innovasis, Inc. |
Michael Thomas |
| K212627 |
02/18/2022 |
True Tulip, True M.I.S. |
Innovative Surgical Designs, Inc. |
Jon Rinehart |
| K222086 |
12/09/2022 |
Inogen Rove 4 Portable Oxygen Concentrator |
Inogen |
Sandra LeClair |
| K223402 |
12/09/2022 |
HemosIL von Willebrand Factor Antigen |
Instrumentation Laboratory Co. |
Nikita Malladi |
| K213632 |
02/10/2022 |
Instylla Delivery Kit |
Instylla, Inc. |
Jennifer Greer |
| K212774 |
02/04/2022 |
VenSure LightGuide |
Intersect ENT |
Yoko Enrile |
| K213710 |
02/17/2022 |
da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System |
Intuitive Surgical, Inc. |
Connor McCarty |
| K221669 |
12/27/2022 |
IOB Warming Blankets |
IOB Medical Inc |
Jiulin Xia |
| K222471 |
12/08/2022 |
IRRAflow Active Fluid Exchange System (AFES) |
IRRAS USA |
Jeanne S Warner |
| K223077 |
12/07/2022 |
ViewFlex Xtra ICE Catheter |
Irvine Biomedical, a St. Jude Medical Company |
Suzanne Pekarna |
| K213165 |
02/08/2022 |
Rapid |
iSchema View Inc. |
James Rosa |
| K211557 |
12/29/2022 |
EndoPATx |
Itamar Medical, Ltd. |
Moti Mikles |
| K213912 |
02/19/2022 |
Disposable Medical Nitrile Examination Gloves |
Jiangsu Maolin Medical Technology Co., Ltd |
Yuan Mao |
| K223004 |
12/04/2022 |
Disposable Nitrile Examination Gloves |
Jiangxi Handspro Products Solutions CO., LTD. |
Jun Yin |
| K213600 |
02/19/2022 |
Medical nitrile examination gloves (Model: SH001) |
Jiangxi SanHao Medical Instruments Co.,Ltd |
Wangfenfang No Last Name provided |
| K212866 |
12/03/2022 |
truSculpt flex |
Johari Digital Healthcare Limited |
Pooja Johari |
| K213297 |
02/09/2022 |
Redline |
Johns Dental Laboratories |
Marni Buis |
| K213057 |
02/18/2022 |
ExamVue Duo |
JPI Healthcare Co, Ltd. |
Sam Kang |
| K221626 |
12/07/2022 |
Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate |
JR Engineering & Medical Technologies (M) SDN. BHD. |
Ganesan Subramaniam |
| K222864 |
12/21/2022 |
8MP Color LCD Monitor CL-R813 |
JVCKENWOOD Corporation |
Hideki Tengeiji |
| K211320 |
02/24/2022 |
CAPRI Corpectomy Cage System |
K2M, Inc. |
Renee Norby |
| K221004 |
12/20/2022 |
HOPKINS Telescopes |
KARL STORZ Endoscopy America, Inc. |
Alita McElroy |
| K222502 |
12/16/2022 |
KLICK (VARIANTS: POWER, RACE, MONSTER) |
KLAXON Mobility GmbH |
Riccardo Colomba |
| K221245 |
12/14/2022 |
PTA Balloon Dilatation Catheter |
Kossel Medtech (Suzhou) Co., Ltd. |
Ron Lv |
| K223105 |
12/22/2022 |
Tesera-K SC System |
Kyocera Medical Technologies, Inc. |
Scott Rucker |
| K223565 |
12/23/2022 |
LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System. |
L&K Biomed Co., Ltd. |
Katherine Kim |
| K222726 |
12/23/2022 |
Smartpump 3.0 Double Electric Breast Pump |
Lansinoh Laboratories |
Lindsay Ewers |
| K220873 |
12/15/2022 |
Perceptive electric dental motor and control unit |
Lares Research |
Bruce Holderbein |
| K223482 |
12/21/2022 |
reVive Light Therapy« Wrinkle and Acne LED Device |
LED Technologies, Inc. |
Lloyd Nelson |
| K214044 |
02/16/2022 |
14HQ901G-B |
LG Electronics Inc. |
Jinhwan Jun |
| K220935 |
12/29/2022 |
Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App |
liberDi, Ltd |
Hezkiah Tsoory |
| K221806 |
12/05/2022 |
TruLift Lateral Expandable Spacer System & Lateral Plate System |
Life Spine Inc. |
Angela Batker |
| K221444 |
12/08/2022 |
LED Eye Perfector, model: EY-36A, EY-36B |
Light Tree Ventures Europe B.V. |
Kim Laurens |
| K221775 |
12/20/2022 |
LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003) |
Light Tree Ventures Europe B.V. |
Kim Laurens |
| K222405 |
12/20/2022 |
Smart SPACE Shoulder Planner and 3D Positioners |
LimaCorporate S.p.A |
Francesca Marello |
| K212800 |
02/25/2022 |
PRIMA Humeral System and SMR Glenosphere ╪42 |
LimaCorporate S.p.A. |
Antonia Trevisan |
| K221902 |
12/21/2022 |
LimFlow Vector |
LimFlow, Inc. |
Zachary Woodson |
| K220384 |
02/24/2022 |
ArtiSential Laparoscopic Instruments-Electrodes |
LivsMed Inc. |
Dong Wook Lee |
| K213210 |
12/08/2022 |
Oxygen Concentrator, Model JAY-5AW |
LONGFIAN SCITECH CO., LTD. |
Shi Lei |
| K213440 |
02/18/2022 |
Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with Chemotherapy Drugs |
Luliang Hongruida Health Protection Technology Co., Ltd. |
Zhang Guocai |
| K213569 |
02/04/2022 |
HOLLYWOOD SPECTRA Laser System |
Lutronic Corporation |
Haewon Park |
| K220974 |
12/27/2022 |
R:GEN |
Lutronic Vision, Inc. |
Haelyung Hwang |
| K221280 |
12/09/2022 |
Vesseal |
Lydus Medical Ltd. |
Jessica Weiss |
| K214110 |
02/19/2022 |
Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile, Tested For Use With Chemotherapy Drugs |
Mah Sing Healthcare Sdn Bhd |
Sazalinda Musa |
| K203113 |
02/25/2022 |
Masimo SedLine Sedation Monitor and Accessories |
Masimo Corporation |
Sindura Penubarthi |
| K221598 |
12/09/2022 |
Wearable breast pump |
Mayborn (UK) Limited |
Sean Neasham |
| K203335 |
02/03/2022 |
MectaScrew Extension |
Medacta International SA |
Stefano Baj |
| K221141 |
12/02/2022 |
PageWriter TC35 Cardiograph |
Medizin Systeme Boblingen GmbH |
Judy Yang |
| K213054 |
12/09/2022 |
Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe |
Medline Industries, Inc. |
Dinah Rincones |
| K223508 |
12/22/2022 |
Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device |
Medtronic Inc. |
Rajitha Nair |
| K223153 |
12/16/2022 |
Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface Technology |
Medtronic Sofamor Danek USA, Inc. |
Alex Underberg |
| K214011 |
02/09/2022 |
CatalyftÖ PL Expandable Interbody System Navigated Instruments, AnteralignÖ TL Spinal System with Titan nanoLOCKÖ Surface Technology Navigated Instruments, and CD HorizonÖ SoleraÖ VoyagerÖ Spinal System Navigated, Guided, and Powered Drivers |
Medtronic Sofamor Danek USA, INC. |
Alex Underberg |
| K223654 |
12/28/2022 |
Medussa-PL Cage |
Medyssey USA, Inc. |
Youngsu Jang |
| K210826 |
02/03/2022 |
Healing Abutment, Cover Screw |
MegaGen Implant Co., Ltd. |
You Jung Kim |
| K222219 |
12/06/2022 |
R2 Studio Q/RCT820 |
MegaGen Implant CO., Ltd. |
Yong Jae Kim |
| K213617 |
02/11/2022 |
Surgical Face Mask |
Megasoft (China) Co., Ltd. |
Sarah Qiu |
| K220232 |
02/20/2022 |
Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange |
Megine Industries Sdn Bhd |
Benjamin Ng Soong Jing |
| K213548 |
02/21/2022 |
Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with Chemotherapy |
Mercator Medical (Thailand) LTD |
Praneet Inthajak |
| K221896 |
12/19/2022 |
BreathID Hp System |
Meridian Bioscience Israel Ltd. |
Raffi Werner |
| K222806 |
12/22/2022 |
Kodiak C Spinal Implant System |
Met One Technologies, LLC |
Adrian Carbonell |
| K202965 |
12/21/2022 |
CURA-Temp |
Mgnewton LTD. |
Byoung Wook Ahn |
| K201191 |
02/07/2022 |
ELEC-LED |
MICRO-NX Co., Ltd. |
Jong-Kun Kee |
| K213875 |
12/21/2022 |
DRI TM Tricyclics Serum Tox Assay |
Microgenics Corporation |
Pranjali Shinde |
| K223050 |
12/21/2022 |
AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060) |
MicroVention Inc. |
Riddhi Pandya |
| K213976 |
02/03/2022 |
Contour ProtΘgΘAI |
MIM Software Inc. |
Lynn Hanigan |
| K221410 |
12/02/2022 |
Maestro Platform |
Moon Surgical |
Anne Osdoit |
| K220007 |
02/10/2022 |
Pure-Vu EVS System |
Motus GI Medical Technologies Ltd. |
Mark Pomeranz |
| K222308 |
12/20/2022 |
Al Smile Aligner |
Nanjing Jiahe Dental Technology Co., Ltd. |
Charles Shen |
| K223190 |
12/12/2022 |
HiveÖ Standalone Cervical System |
NanoHive Medical LLC |
Ian Helmar |
| DEN220017 |
12/23/2022 |
BioXmark |
Nanovi A/S |
Hsiao-Qing Chow |
| K213392 |
02/22/2022 |
INLIANT Surgical Navigation System |
Navigate Surgical Technologies Inc. |
Marty Dymek |
| K222750 |
12/08/2022 |
Yomi Robotic System |
Neocis Inc. |
Joshua Davis |
| K221021 |
12/06/2022 |
Femoral Trochanteric Nail System û Neonail |
Neoortho Produtos OrtopΘdicos S/A |
Luciane Suzuki |
| K212545 |
02/11/2022 |
FlexitSystem Knee osteotomy system |
Neosteo |
JD Webb |
| K211711 |
02/25/2022 |
OmniTom Elite |
NeuroLogica Corporation, a subsidiary of Samsung Electronics |
Ninad Gujar |
| K210356 |
02/04/2022 |
Noris Medical Dental Implants System |
Noris Medical Ltd |
Simha Sibony |
| K220217 |
02/25/2022 |
Normatec 3 |
NormaTec Industries, LP |
Steve Henderson |
| K212271 |
02/04/2022 |
smart-sync |
northh medical GmbH |
Kai-Kristoph Fehrs |
| K213107 |
02/17/2022 |
Powder Free Blue Nitrile Examination Gloves |
Novid PPE Sdn. Bhd. |
Er Chai Chuan |
| K213654 |
02/23/2022 |
NuVasive Reline Cervical System |
NuVasive, Incorporated |
Sali Gully |
| K221344 |
12/28/2022 |
nView s1 with nav option |
nView medical |
Lisa Last |
| K220197 |
02/23/2022 |
Trigon HA Wedge Fixation System |
Nvision Biomedical Technologies, Inc |
Diana Langham |
| K223226 |
12/01/2022 |
TrigonÖ HA Stand-Alone Wedge Fixation System |
Nvision Biomedical Technologies, Inc. |
Diana Langham |
| K220843 |
12/07/2022 |
OAKTREE Anterior Lumbar Plate and Screw System |
Oak Tree Engineering, LLC. |
Douglas W. Neary |
| K203541 |
02/25/2022 |
Okamoto 002 Lubricated Polyurethane Male Condom |
Okamoto U.S.A. Inc. |
Yu Tadano |
| K221690 |
12/29/2022 |
OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5R), LIGHT GUIDE ADAPTER (MAJ-1413) |
Olympus Medical Systems Corp. |
Shinichiro Kawachi |
| K221660 |
12/28/2022 |
RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP |
Olympus Medical Systems Corp. |
Shinichiro Kawachi |
| K221355 |
12/12/2022 |
VITROS Immuodiagnostic Products CA 125 II Reagent Pack |
Ortho Clinical Diagnostics |
Rebecca Lewis |
| K211712 |
02/11/2022 |
3░ Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity Lumbosacral Fixation System, Hallmark Anterior Plate System, NewBridge Laminoplasty Fixation System, CETRA Anterior Cervical Plate System |
Orthofix US LLC |
Jacki Koch |
| K221193 |
12/23/2022 |
OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm |
OSSIO Ltd. |
Taly Lindner |
| K212570 |
02/11/2022 |
OsteoPlan System |
OsteoMed LLC |
Diane Rutherford |
| K220928 |
12/16/2022 |
Overjet Calculus Assist |
Overjet Inc. |
Adam Odeh |
| K212654 |
02/04/2022 |
Micro C Medical Imaging System, M01 |
OXOS Medical, Inc. |
Evan Ruff |
| K202674 |
12/12/2022 |
Medidenta High Speed Handpieces |
Pac-Dent, Inc. |
Jiahe Li |
| K213982 |
02/17/2022 |
Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires |
Pacific Instruments |
Tracy Sullivan |
| K223184 |
12/16/2022 |
Phantom Metatarsal Shortening System |
Paragon 28, Inc. |
Haylie Hertz |
| K222767 |
12/30/2022 |
PeekMed web (v1) |
Peek Health, S.A. |
Sara Silva |
| K211603 |
02/02/2022 |
Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses |
Pegavision Corporation |
Estela Lin |
| K211661 |
02/28/2022 |
ENFit enteral syringes (NUTRIFIT) |
Pentaferte Italia S.R.L. |
Rosa Di Gioia |
| K213235 |
12/21/2022 |
PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System |
PENTAX of America, Inc. |
William Goeller |
| K223072 |
12/02/2022 |
PENTAX Medical Video Esophagoscope EE17-J10 |
PENTAX of America, Inc. |
William Goeller |
| K222358 |
12/20/2022 |
Indigo Aspiration System - Lightning Flash |
Penumbra, Inc. |
Deanna Kimlinger |
| K222808 |
12/20/2022 |
Penumbra System (Reperfusion Catheter RED 43) |
Penumbra, Inc. |
Micaela Victoria |
| K222002 |
12/30/2022 |
Persyst 15 EEG Review and Analysis Software |
Persyst Development Corporation |
Dari Darabbeigi |
| K223311 |
12/22/2022 |
Philips CT 3500 |
Philips Healthcare (Suzhou) Co., Ltd |
Xu Diana |
| K223442 |
12/23/2022 |
MR 5300 and MR 7700 R11 MR Systems |
Philips Medical Systems Nederlands B.V. |
Susan Quick |
| K223353 |
12/02/2022 |
DropSafeTM SicuraTM |
Pikdare SpA |
Roberta Zanoni |
| K222527 |
12/14/2022 |
Nitrile Patient Examination Glove |
PingAn Medical Products Co.,Ltd. |
Zhou Ziyu |
| K220520 |
12/15/2022 |
PM Excellence SEQUR 100 Surgical Face Mask |
PM Excellence LLC |
Nina Bektic-Marrero |
| K212239 |
12/23/2022 |
XENOVIEW 3.0T Chest Coil |
Polarean, Inc. |
Neil Wadehra |
| K223071 |
12/23/2022 |
Xenoview VDP |
Polarean, Inc. |
Neil Wadehra |
| K220124 |
02/17/2022 |
YandR System, VoluDerm Handpiece, VoluDerm Tips |
Pollogen Ltd. |
Sharon Ravid |
| K193406 |
02/26/2022 |
CardioChek Plus Test System; CardioChek Plus Home Test System |
Polymer Technology Systems, Inc. d/b/a PTS Diagnostics |
Margo Enright |
| K222896 |
12/20/2022 |
AirRay |
POSKOM Co.,Ltd. |
Jeong Hyun Seong |
| K214002 |
12/23/2022 |
CRYOcheck Chromogenic Factor IX |
Precision BioLogic Inc. |
Karen Black |
| K221642 |
12/12/2022 |
SIRIUS Endoscope System |
Precision Robotics (Hong Kong) Limited |
Ping Lai Benny Lo |
| K223632 |
12/06/2022 |
Premier's MultiMatch Universal Chameleon Restorative Composite |
Premier Dental Products Company |
Jessica Huang |
| K214100 |
02/24/2022 |
Luminice |
Premier North America Inc. |
Ellis Tamari |
| K214102 |
02/23/2022 |
Glidewell Appliance Resin, Hard/Soft |
Prismatik Dentalcraft, Inc. |
Jiahe Li |
| K223244 |
12/21/2022 |
Pristine Arthroscopic Visualization System |
Pristine Surgical |
Stewart B Davis |
| K222137 |
12/05/2022 |
OK Plus Indicator |
Propper Manufacturing Co., Inc. |
Andrew Sharavara |
| K220951 |
12/09/2022 |
PMT Facet Fixation System (PMT FFS) |
Providence Medical Technology, Inc |
Edward Liou |
| K203337 |
02/11/2022 |
PainTB, PainTJ |
Ptech Co., Ltd. |
Yosung Choi |
| K222340 |
12/01/2022 |
Chartis Precision Catheter |
Pulmonx Corporation |
Aniket Khakhadiya |
| K221910 |
12/14/2022 |
QRS Dental Implants System |
QRS Medical Ltd. |
Iman Khorshid |
| K211800 |
12/08/2022 |
Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer |
Quality in Flow Ltd. |
Omer Pechter |
| K211228 |
02/02/2022 |
Rosso |
Quanta System SpA |
Francesco Dell'Antonio |
| K211645 |
02/24/2022 |
Epione |
Quantum Surgical SAS |
Lagacherie Elise |
| K214062 |
02/04/2022 |
Radialis PET Camera |
Radialis Inc. |
Michael Waterston |
| K213647 |
02/17/2022 |
Durex Patronus Wide |
RB Health (US) LLC |
Kaitlyn Chan |
| K222798 |
12/16/2022 |
Rejoni Intrauterine Catheter |
Rejoni, Inc. |
Brian Bergeron |
| K202234 |
02/10/2022 |
NervAlign Nerve Cuff |
Renerve Ltd |
David Rhodes |
| K220786 |
12/01/2022 |
STAR Apollo Mapping System |
Rhythm Al, Ltd |
Linda D'Abate |
| K221612 |
12/05/2022 |
ClearRead CT |
Riverain Technologies, Inc. |
Jonathan Jackson |
| K214022 |
02/17/2022 |
Accu-Chek Softclix Blood Lancing System |
Roche Diabetes Care, Inc. |
Cameron Smith |
| K221842 |
12/07/2022 |
Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF |
Roche Diagnostics |
Greg Mondics |
| K221765 |
12/23/2022 |
ONLINE DAT Benzodiazepines II |
Roche Diagnostics |
Khoa Tran |
| K214094 |
02/24/2022 |
ROKI Surgical Mask |
ROKI Co., Ltd. |
Takamasa Murata |
| K221981 |
12/29/2022 |
SafeR Syringe and SafeR Sting |
Roncadelle Operations srl |
Massimo Rossi |
| K221453 |
12/15/2022 |
S.I.N. Dental Implant System |
S.I.N. û Sistema de Implante Nacional S.A. |
Denise Domiciano |
| K210636 |
02/15/2022 |
Morpheus |
S4S UK Ltd. |
Matthew Everatt |
| K222715 |
12/03/2022 |
Black Nitrile Powder Free Patient Examination Glove, Non Sterile |
Safeskin Retailing (HK) Limited |
Alvin Ho |
| K222720 |
12/03/2022 |
Blue Nitrile Powder Free Patient Examination Glove, Non Sterile |
Safeskin Retailing (HK) Limited |
Alvin Ho |
| K222713 |
12/03/2022 |
White Nitrile Powder Free Patient Examination Glove, Non Sterile |
Safeskin Retailing (HK) Limited |
Alvin Ho |
| K210864 |
02/17/2022 |
Safety Pen Needle |
Sandstone Medical (Suzhou) Inc. |
Juanjuan Sun |
| K220419 |
02/16/2022 |
Apapro Desensitizer |
Sangi Co, Ltd |
Douglas Mercadante |
| K222753 |
12/09/2022 |
SeaSpine 7D Navigation Instruments |
SeaSpine Orthopedics Corporation |
Laeitia Cousin |
| K202644 |
02/18/2022 |
Acetaminophen |
Sekisui Diagnostics P.E.I. INC. |
Penny White |
| K213554 |
02/02/2022 |
Sentient Manufacturing Laser Fiber |
Sentient Manufacturing LLC |
Jim Mousseau |
| K211058 |
12/22/2022 |
Lp(a) Ultra |
Sentinel CH. SpA |
Patricia DupΘ |
| K202926 |
02/10/2022 |
Micro Catheter |
Shanghai Heartcare Medical Technology Co., Ltd. |
Zongyu Xue |
| K220010 |
12/16/2022 |
Daylily Single Use Sterile Embryo Transfer Catheter |
Shanghai Horizon Medical Technology Co., Ltd. |
Beibei Xing |
| K210313 |
12/30/2022 |
EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter |
Shanghai MicroPort EP MedTech Co., Ltd. |
Xia Tian |
| K211530 |
02/08/2022 |
PathBuilder Steerable Introducer |
Shanghai MicroPort EP MedTech Co., Ltd. |
Tian Xia |
| K211686 |
02/22/2022 |
Flexible Video-Choledo-Cysto-Ureteroscope System |
Shanghai SeeGen Photoelectric Technology Co., Ltd |
Yvonne Fei |
| K211024 |
02/11/2022 |
Electric Breast Pump |
Shantou Huihengqi Electronic Technology Co., Ltd. |
Gensong Yang |
| K222125 |
12/01/2022 |
Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F and AOJ-30G |
Shenzhen AOJ Medical Technology Co., Ltd. |
Jack Wang |
| K221039 |
12/20/2022 |
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 |
| K213503 |
02/18/2022 |
Wrist Blood Pressure Monitor, models AOJ-35A, AOJ-35B, AOJ-35C, AOJ-35D, AOJ-35E |
Shenzhen AOJ Medical Technology Co., Ltd. |
Queena Chen |
| K211619 |
12/29/2022 |
Multi-Parameter Patient Monitor |
Shenzhen Comen Medical Instruments CO., LTD. |
Hongbo Yan |
| K213043 |
02/25/2022 |
Levator Elite (Model LE9011) |
Shenzhen Dongdixin Technology Co., Ltd. |
Siping Yuan |
| K212300 |
02/25/2022 |
Pulse Oximeter |
Shenzhen Mericonn Technology Co., Ltd. |
Jiang Chuanyuan |
| K221113 |
12/02/2022 |
Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor |
Shenzhen Mindray Bio-Medical Electronics Co., LTD |
Li Lei |
| K221267 |
12/15/2022 |
VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor |
Shenzhen Mindray Bio-Meidcal Electronics Co., LTD |
Li Lei |
| K223239 |
12/08/2022 |
8ch Wrist Coil |
Shenzhen RF Tech Co., Ltd. |
Gary Wang |
| K222924 |
12/23/2022 |
Leg Massager RF-ALM070 |
Shenzhen Ruiyi Business Technology Co., Ltd. |
Jacky Li |
| K222710 |
12/01/2022 |
IPL Cooling Hair Removal Device |
Shenzhen Siken 3D Technology Development Co., Ltd. |
Jingquan Liu |
| K220046 |
12/13/2022 |
Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11 |
Shenzhen Superbio Technology Co.,Ltd. |
Wenhau Yan |
| K212180 |
02/11/2022 |
Wearable Breast Pump (Model S12) |
Shenzhen TPH Technology Co., Ltd. |
Peter Chen |
| K212410 |
02/01/2022 |
VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium |
Shenzhen VitaVitro Biotech Co.,Ltd. |
Donghai Pan |
| K213430 |
12/30/2022 |
Fingertip Pulse Oximeter |
Shenzhen Witleaf Medical Electronics Co.,Ltd |
Wu Tao |
| K220277 |
02/17/2022 |
Digital Intraoral X-ray Sensor |
Shenzhen Xpectvision Technology Co.,Ltd. |
Mengsi Peng |
| K214003 |
02/18/2022 |
Dental Zirconia Pre-shaded Block |
Shenzhen Yurucheng Dental Materials Co., Ltd. |
Fiya Liao |
| K214005 |
02/18/2022 |
Zirconia Dental Ceramics |
Shenzhen Yurucheng Dental Materials Co., Ltd. |
Fiya Liao |
| K213984 |
12/16/2022 |
Oximeter (Model: JZK-301,JZK-303,JZK-305,JZK-307) |
ShenZhen ZhengKang Technology Co., Ltd. |
Huayong Yang |
| K222748 |
12/23/2022 |
ShiNeo Silicone Implant |
Shineo Technology Co., Ltd |
Wan-Chun Lai |
| K220688 |
12/02/2022 |
SilentZPro 2.0 |
Shinrin-Yoku Traders LLC |
Ryan Bruss |
| K222774 |
12/22/2022 |
iFuse Bedrock Granite« Implant System |
SI-BONE, Inc. |
Meirav Harsat |
| K212559 |
12/16/2022 |
CardioPhase« hsCRP |
Siemens Healthcare Diagnostics Products GmbH |
Martina Pfeiff |
| K212212 |
02/18/2022 |
Multitom Rax with True2scale Body Scan Option |
Siemens Medical Solutions |
Denise Adams |
| K213487 |
02/11/2022 |
ACUSON P500 Ultrasound System |
Siemens Medical Solutions USA, Inc. |
Sulgue Choi |
| K223547 |
12/22/2022 |
Biograph Vision Quadra PET/CT System |
Siemens Medical Solutions USA, Inc. |
Alaine Medio |
| K223410 |
12/07/2022 |
Cios Select (VA21) Flat Panel |
Siemens Medical Solutions USA, Inc. |
Patricia D. Jones |
| K223409 |
12/06/2022 |
Cios Select (VA21) Image Intensifier |
Siemens Medical Solutions USA, Inc. |
Patricia D. Jones |
| K213693 |
02/25/2022 |
MAGNETOM Vida with syngo MR XA50A |
Siemens Medical Solutions USA, Inc. |
Karthik Pillai |
| K223649 |
12/22/2022 |
VERTICALE« Navigation Instruments |
Silony Medical GmbH |
Ralf Klabunde |
| K222118 |
12/01/2022 |
2-Way 100% Silicone Cleartract Catheter |
SILQ Technologies, Corp. |
D. Verne Sharma |
| K222538 |
12/21/2022 |
NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter |
Sino Medical Sciences Technology Inc. |
Jianhua Sun |
| K213874 |
02/11/2022 |
MAVERICK External Fixation System |
Smith & Nephew, Inc. |
Brad Sheals |
| K223112 |
12/08/2022 |
MAVERICK Mini External Fixation System |
Smith & Nephew, Inc. |
Allison Francis |
| K223218 |
12/02/2022 |
Parietene Macroporous Mesh |
Sofradim Production |
Jhony Mallet |
| K222320 |
12/06/2022 |
MedDream |
Softneta UAB |
Laura Baroniene |
| K223237 |
12/16/2022 |
SofWave System |
Sofwave Medical Ltd. |
Ruthie Amir |
| K213653 |
12/19/2022 |
4CIS BLACK MARLIN PLIF CAGE SYSTEM, 4CIS DOLPHIN TLIF CAGE SYSTEM |
Solco Biomedical Company India Private Limited |
Darshak Shah |
| K223647 |
12/29/2022 |
CLEAR+BRILLIANT TOUCH« Laser System |
Solta Medical, Inc. |
Aditi Chaubal |
| K220071 |
02/03/2022 |
Soniquence Reusable Neutral Plate |
Soniquence, LLC |
Suzanne Lucas |
| K221182 |
12/08/2022 |
Southern Transforaminal Lumbar Interbody Fusion (TLIF) |
Southern Medical (Pty) Ltd |
Dalene Styger |
| K223472 |
12/15/2022 |
TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian Motorized Dilator Sheath, 11 French (575-011); TightRail Guardian Motorized Dilator Sheath, 13 French (575-013) |
Spectranetics Inc. |
Jordan Baum |
| K222837 |
12/08/2022 |
Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters |
Spectranetics Inc. |
Taylor Olen |
| K214076 |
12/19/2022 |
EsCem |
SPIDENT CO., LTD. |
J.M. Ahn |
| K222516 |
12/01/2022 |
Mercury« II Spinal System |
Spinal Elements, Inc. |
Julie Lamothe |
| K223273 |
12/22/2022 |
ASTRA Spine System |
SpineCraft, LLC |
Ami Akallal-Asaad |
| K223251 |
12/16/2022 |
Hexanium PLIF |
SpineVision, S.A.S. |
Quang Tran |
| K222623 |
12/14/2022 |
Digital Crown |
SprintRay Inc. |
Sara Moghtadernejad |
| K221102 |
12/15/2022 |
LOTUS Series 4 Enhanced Shears, LOTUS Series 5 |
SRA Developments Ltd |
Phillipa Frewin |
| K213058 |
02/08/2022 |
O'Star Nitrile Examination Gloves Powder Free |
Star Investment And Trade Joint Stock Company |
Do Van Binh |
| K223369 |
12/02/2022 |
truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5 Pack, PN 2000181; 20Fr CDT 5 Pack, PN ACCCC3CDT05; Active Venting Spray Kit, 20 Fr CDT, PN 2000177; Active Venting Spray Kit 16 Fr CDT, PN 20000516; Rapid AV Catheter |
STERIS Corporation |
Carroll Martin |
| K213824 |
02/03/2022 |
Sonopet iQ Ultrasonic Aspirator System |
Stryker Corporation |
Thomas Flannelly |
| K222650 |
12/09/2022 |
Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate |
Stryker Craniomaxillofacial (CMF) |
Zainab Amini |
| K220108 |
02/09/2022 |
SDC4K Information Management System with Device and Voice Control Package |
Stryker Endoscopy |
Divya Sekar |
| K213328 |
02/11/2022 |
Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System |
Stryker GmbH |
Cindy Leon |
| K222552 |
12/09/2022 |
120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen Collection Manifold Kit (0750-200-000);V2 Specimen Collection Tray (0750-210-000) |
Stryker Instruments |
Tu Nguyen |
| K223294 |
12/20/2022 |
SpineJack« Expansion Kit |
Stryker Instruments |
Bruce Backlund |
| K213777 |
02/04/2022 |
Stryker Resorbable Fixation System |
Stryker Leibinger Micro Implants |
Gregory Gohl |
| K222533 |
12/14/2022 |
Target Tetra Detachable Coils |
Stryker Neurovascular |
Jonathan Bemben |
| K222019 |
12/04/2022 |
Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001), Reprocessed RD SET Inf Pulse Oximeter Sensor (4002), Reprocessed RD SET Adt Pulse Oximeter Sensor (4003) |
Stryker Sustainability Solutions |
Michael Wong |
| K222262 |
12/22/2022 |
Sunrise |
Sunrise SA |
Gregoire Lejeune |
| K211855 |
02/25/2022 |
Ion Facet Screw System |
SurGenTec, LLC |
Andrew Shoup |
| K214097 |
02/25/2022 |
Explorer Air II |
SurgVision GmbH |
Daniela Mahan |
| K203793 |
02/14/2022 |
RithmID-SD Steerable Diagnostic Electrophysiology Catheter |
Synaptic Medical Corporation |
Charles Yang |
| K212863 |
02/19/2022 |
Surgical Face Mask |
Taiwan Comfort Champ Manufacturing Co., Ltd. |
Jen Ke-Min |
| K220554 |
12/16/2022 |
Caduceus S |
Taiwan Main Orthopaedic Biotechnology Co., Ltd. |
Jacky Fan |
| K203234 |
02/15/2022 |
t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app) |
Tandem Diabetes Care, Inc. |
Ashley Reynolds |
| K212079 |
02/02/2022 |
TeesuVac Breast Biopsy Device Mark 1 |
TeesuVac ApS |
John Hvidkjaer |
| K211248 |
02/11/2022 |
ArtUs |
Telemed |
Yury Sokolov |
| K213500 |
02/21/2022 |
TMG Nitrile Powder Free Examination Glove |
Thai Medical Glove Co., Ltd. |
Noppadol Polbundit |
| K222575 |
12/06/2022 |
HurriChem Device Kit |
ThermaSolutions LLC |
Gregg Giza |
| K210208 |
02/17/2022 |
Titan Condoms |
Titan Condoms LLC |
Neville Muringayi |
| K212011 |
02/14/2022 |
Vinyl Powder Free Examination Glove |
Top Glove Vietnam Company Limited |
Natrisya Nur Binti Abdul Rahman |
| K222770 |
12/13/2022 |
Conductive Gel |
Top-Rank Health Care Co.,Ltd. |
Gangfeng Lou |
| K220881 |
12/18/2022 |
INOUE BALLOON A |
Toray Industries, Inc. |
Satoshi Kakuyama |
| DEN220012 |
12/16/2022 |
Tornier Pyrocarbon Humeral Head |
Tornier SAS |
Loucinda Bjorklund |
| K220136 |
02/16/2022 |
Treace Medical Concepts (TMC) Plating System |
Treace Medical Concepts, Inc. |
Kristina Hall |
| K212378 |
02/23/2022 |
Arsenal Ankle Plating System |
Trilliant Surgical |
Sofia Middleton |
| K222637 |
12/21/2022 |
TriMed Wrist Fixation System 3 |
TriMed, Inc. |
David Medoff |
| K220778 |
12/02/2022 |
Chemical Indicator for Steam |
True Indicating LLC |
Thomas Riha |
| K210832 |
02/02/2022 |
EVOCLEAN CLEANsert Ultrasonic Insert |
TTBIO CORP. |
Sheng-Chieh Su |
| K221555 |
12/15/2022 |
Dozee VS |
Turtle Shell Technologies Private Limited |
Gaurav Parchani |
| K222608 |
12/16/2022 |
Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS |
Tuttnauer LTD. |
Robert Basile |
| K220147 |
02/16/2022 |
Aspiron S ACP System |
U&I Corporation |
So-yeon Jang |
| K211510 |
02/24/2022 |
uLab Systems Dental Aligner Kit |
uLab Systems, Inc. |
Amir Albolfathi |
| K220471 |
02/22/2022 |
VALO X, VALO X Accessory Lenses |
Ultradent Products, Inc. |
Adam Black |
| K222213 |
12/19/2022 |
Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103, UC-104) |
Unimed Medical Supplies, Inc. |
Hui Zhang |
| K220611 |
12/02/2022 |
SUREcore Plus Biopsy Instrument |
Uro-1, Inc. |
Thomas Lawson |
| K220926 |
12/12/2022 |
Spectra Wearable |
Uzinmedicare Co., Ltd. |
Jisun Lee |
| K220286 |
12/21/2022 |
ELECTROCYN soma |
V3bio Sdn. Bhd |
Shudipta Choudhury |
| K221318 |
12/13/2022 |
HVT 2.0 |
Vapotherm Inc. |
Michael J. Webb |
| K221791 |
12/01/2022 |
ProBeam 360░ Proton Therapy System |
Varian Medical Systems, Inc. |
Peter J. Coronado |
| K212167 |
02/09/2022 |
R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire |
Vascular Solutions LLC |
Beka Vite |
| K212211 |
02/09/2022 |
Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold catheter, GuideLiner V3 catheter, TrapLiner catheter |
Vascular Solutions LLC |
Rebecca Astrup |
| K213462 |
02/11/2022 |
EzRay M18 (Model: VMX-P400) |
Vatech Co., Ltd |
Daniel Kim |
| K221011 |
12/20/2022 |
AI.ME System |
Venus Concept USA Inc. |
William H McGrail |
| K221342 |
12/13/2022 |
REDEMPTION Beaming System |
Vilex, LLC |
Louis Monaco |
| K222351 |
12/21/2022 |
inspiredÖ VHB20 Heated Humidifier |
Vincent Healthcare Products Limited |
Patrick Dennis |
| K221911 |
12/21/2022 |
VINNO 6PRO, VINNO 6EXP, VINNO 5PRO, VINNO 5EXP, VINNO 3, VINNO 3PRO, VINNO 3EXP |
VINNO Technology (Suzhou) Co.,Ltd. |
Cordelia Liu |
| K222164 |
12/23/2022 |
Visant Medical Canalicular Plug |
Visant Medical, Inc. |
Vartan Ghazarossian |
| K223394 |
12/07/2022 |
Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A) |
Visionary Optics LLC |
Donald R. Sanders |
| K213814 |
02/02/2022 |
Viveve 2.0 System |
Viveve, Inc. |
Kevin Robison |
| K222872 |
12/30/2022 |
DNA Appliance |
Vivos Therapeutics, Inc. |
Kimberly Griffith |
| K213319 |
02/18/2022 |
Viz ANEURYSM, Viz ANX |
Viz.ai, Inc. |
Gregory Ramina |
| K212930 |
02/16/2022 |
LumiVy Lumbar IBF System |
Vy Spine, LLC |
Jordan Hendrickson |
| K213750 |
02/28/2022 |
VyLinkÖ Spinal Screw System |
Vy Spine, LLC |
Jordan Hendrickson |
| K222919 |
12/19/2022 |
GORE« ENFORM Biomaterial |
W. L. Gore and Associates, Inc. |
Barbara L Smith |
| K213565 |
02/01/2022 |
JETi AIO Peripheral Thrombectomy System |
Walk Vascular, LLC |
Namratha Manthani |
| K221859 |
12/29/2022 |
Atalante |
Wandercraft SAS |
Matthieu Masselin |
| K223045 |
12/07/2022 |
3-Ply Disposable Medical Mask |
Wealth Lead Industrial Limited |
Ethel Chiu Man Mok |
| K220036 |
12/16/2022 |
Wellead Ureteral Catheter |
Well Lead Medical Co., Ltd. |
Jenny Zhu |
| K222528 |
12/29/2022 |
Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence Stimulation/EMG Electrode Probe, Well-Life Probe Electrode |
Well-Life Healthcare Limited |
Jenny Hsieh |
| K213091 |
02/19/2022 |
Well-Life TENS/EMS/Heating Stimulator |
Well-Life Healthcare Limited |
Jenny Hsieh |
| K220137 |
02/17/2022 |
Lunderquist Extra Stiff Wire Guide |
William Cook Europe ApS |
Mie Dyrholm |
| K213311 |
02/09/2022 |
Lucy Breast Pump |
Willow Innovations, Inc. |
Nelson Lam |
| K221720 |
12/21/2022 |
Extra Silver Gelling Fiber Dressing |
Winner Medical Co., Ltd. |
Mingni Liu |
| K221377 |
12/22/2022 |
SteriKing LT-Blueline Pouches with Tyvek |
Wipak OY |
Hanna Marttila |
| K213601 |
12/16/2022 |
Surgical Mask |
Wuhan Zonsen Medical Products Co., Ltd |
Cynthia Ye |
| K213688 |
02/18/2022 |
Nitrile Examination Gloves (Model: ZMG1351) |
Wuhan Zonsen Medical Products Co.,Ltd |
Cynthia Ye |
| K211701 |
02/01/2022 |
X-Guide« Surgical Navigation System |
X-Nav Technologies, LLC |
Kimberly Chan |
| K211679 |
02/17/2022 |
Xtractor device |
Xcardia Innovation Ltd. |
Benny Rousso |
| K212935 |
02/19/2022 |
Air Pressure Foot Massager |
Xiamen Simo Electronic Co., Ltd |
Wang Qinsheng |
| K222651 |
12/13/2022 |
Surgical Face Mask |
Xiantao Sanda Industrial Co., Ltd |
Rong Min |
| K223055 |
12/05/2022 |
Disposable Medical Face Mask |
Xiantao Zhuobo Industrial Co., LTD |
Chen Xiaodong |
| K222978 |
12/27/2022 |
Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device |
Xiros Ltd |
Steve Curran |
| K213893 |
12/21/2022 |
Comfort Gown, Safewear Gown |
Xuchang Zhengde Environstar Medical Products Co., Ltd. |
Vincent Yu |
| K220971 |
12/14/2022 |
QuikClot Control+ Hemostatic Dressing |
Z-Medica, LLC |
Soraya King |
| K222614 |
12/05/2022 |
Zavation Spinal System |
Zavation Medical Products, LLC |
Frankie Cummins |
| K213677 |
12/20/2022 |
Bonafix 2 Plus |
Zentek Medical LLC |
Michael Vinnik |
| K201403 |
02/02/2022 |
NATtrol BD MAX Vaginal Panel External Controls |
Zeptometrix |
Shawn Smith |
| K221800 |
12/14/2022 |
Infrared Thermometer (Model: Y20001, Y20002) |
Zhangzhou Easepal Medical Science And Technology Co.,Ltd. |
Flower Flower |
| K212668 |
02/23/2022 |
Sclerotherapy Needle |
Zhejiang Chuangxiang Medical Technology Co., LTD. |
Lucius Long |
| K210229 |
02/15/2022 |
Sterile Auto-Disable Syringes with/without Needle for Single Use |
Zhejiang Kangkang Medical-Devices CO., Ltd. |
Chun Guo |
| K223334 |
12/16/2022 |
Sterile Hypodermic Needles for Single Use |
Zhejiang kindly Medical Devices Co., Ltd. |
Zhang Qian |
| K222949 |
12/22/2022 |
Air Compression Leg Massager (Model: LY-670D) |
Zhejiang Luyao Electronics Technology Co., Ltd |
Joyce Lin |
| K222815 |
12/04/2022 |
Powder Free Nitrile Examination Gloves (Blue, White and Black), Tested For Use With Chemotherapy Drugs and Fentanyl |
Zibo Lanhua Medical Packaging Material Co., Ltd |
Lily Wang |
| K213306 |
02/18/2022 |
Powder Free Nitrile Examination Gloves, Blue,Test For Use With Chemotherapy Drugs |
Zibo Sinocare Plastic Products Co., Ltd |
Mila Guo |
| K220020 |
02/04/2022 |
Cryo 7 |
Zimmer MedizinSysteme GmbH |
Ute Killet |
| K213722 |
12/14/2022 |
ICE Ceramics, ICE Stains, Fresco |
Zirkonzahn srl |
Julian Steger |
| K212622 |
02/11/2022 |
Zyter RPM |
Zyter, Inc. |
Lakshmi Narayana Babu |
