| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K220822 |
12/09/2022 |
3D-SHAPER |
3D-Shaper Medical S.L |
Ludovic Humbert |
| 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 |
| K221333 |
12/29/2022 |
Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional |
Acumed LLC |
Saleh Amirriyazi |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| K213110 |
12/16/2022 |
AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In Anchor |
Auxein Medical Private Limited |
Rahul Luthra |
| 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 |
| K222916 |
12/09/2022 |
US 450 Diode Laser Equipment |
Beijing Globalipl Development Co., Ltd. |
Liu Jun |
| 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 |
| 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 |
| K222760 |
12/28/2022 |
StageOneÖ Select Hip Cement Spacer Molds |
Biomet, Inc. |
Meredith Reed |
| K222441 |
12/07/2022 |
Ultrasound System 2300 |
BK Medical Aps |
Sandra Theodoridis |
| 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 |
| K220012 |
12/21/2022 |
BresoDX1 |
Bresotec Inc |
Esther Sur |
| K222820 |
12/16/2022 |
BRM TOOL Screws, BIOPLAN Subtalar Implant |
BRM Extremities |
Lisa Fazzini |
| 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 |
| K214004 |
12/13/2022 |
CCBIO ASCPO Needle |
CC Biotechnology Corporation |
Edgar Yeh |
| 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 |
| 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 |
| K221708 |
12/23/2022 |
CIMILRE Free-T2 Plus |
Cimilre Co., Ltd. |
Not Provided |
| K213768 |
12/01/2022 |
Bolt Navigation System |
Circinus Medical Technology, LLC |
Patrick West |
| 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 |
| K220052 |
12/16/2022 |
Copan FecalSwab Collection, Transport and Preservation System |
Copan Italia S.p.A. |
Elisabetta Zanella |
| K214036 |
12/23/2022 |
AVIEW |
Coreline Soft Co.,Ltd. |
Hyeyi Park |
| 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 |
| K222275 |
12/16/2022 |
Saige-Density |
DeepHealth, Inc. |
B. Nathan Hunt |
| K223142 |
12/22/2022 |
Coltolux Comfort LED Curing Light |
Dent4You AG |
Dr. Tricia Cregger |
| 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 |
| 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 |
| 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 |
| K222216 |
12/22/2022 |
TruWave Disposable Pressure Transducer |
Edwards Lifesciences LLC |
Carmen Chen |
| K222117 |
12/09/2022 |
Swang-Ganz IQ pulmonary artery catheter |
Edwards Lifesiences, LLC |
Michelle Ducca |
| 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 |
| K221747 |
12/01/2022 |
Nitrile Patient Examination Gloves Tested For Use With Chemotherapy Drugs |
Fitone Latex Products Co., Ltd. Guangdong |
Christine Ou |
| 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 |
| 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 |
| 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 |
| K213196 |
12/19/2022 |
MARVELÖ Growing Rods |
Globus Medical Inc. |
Kelly J. Baker |
| 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 |
| K220774 |
12/09/2022 |
RobPath« Total Hip Application |
Hangzhou Lancet Robotics Co., Ltd. |
Rennes Zhang |
| K223433 |
12/13/2022 |
Quantra QPlus System |
HemoSonics, LLC |
Deborah Winegar |
| 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 |
| K221477 |
12/29/2022 |
AG100s |
Hospitech Respiration Ltd. |
Yoel Bergman |
| K221862 |
12/08/2022 |
YY-A02-B Overlapped Compression Therapy |
Huizhou XINYI Technology Co., LTD. |
Jason Ye |
| 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 |
| K222368 |
12/01/2022 |
MIST IC |
Imagine Milling Technologies, LLC |
Felix Chung |
| K221054 |
12/21/2022 |
CORE-INJECTOR |
Incore Co., Ltd. |
Jae-Hun Lee |
| 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 |
| 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 |
| 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 |
| K211557 |
12/29/2022 |
EndoPATx |
Itamar Medical, Ltd. |
Moti Mikles |
| K223004 |
12/04/2022 |
Disposable Nitrile Examination Gloves |
Jiangxi Handspro Products Solutions CO., LTD. |
Jun Yin |
| K212866 |
12/03/2022 |
truSculpt flex |
Johari Digital Healthcare Limited |
Pooja Johari |
| 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 |
| 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 |
| 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 |
| K221902 |
12/21/2022 |
LimFlow Vector |
LimFlow, Inc. |
Zachary Woodson |
| K213210 |
12/08/2022 |
Oxygen Concentrator, Model JAY-5AW |
LONGFIAN SCITECH CO., LTD. |
Shi Lei |
| K220974 |
12/27/2022 |
R:GEN |
Lutronic Vision, Inc. |
Haelyung Hwang |
| K221280 |
12/09/2022 |
Vesseal |
Lydus Medical Ltd. |
Jessica Weiss |
| K221598 |
12/09/2022 |
Wearable breast pump |
Mayborn (UK) Limited |
Sean Neasham |
| 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 |
| K223654 |
12/28/2022 |
Medussa-PL Cage |
Medyssey USA, Inc. |
Youngsu Jang |
| K222219 |
12/06/2022 |
R2 Studio Q/RCT820 |
MegaGen Implant CO., Ltd. |
Yong Jae Kim |
| 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 |
| 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 |
| K221410 |
12/02/2022 |
Maestro Platform |
Moon Surgical |
Anne Osdoit |
| 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 |
| 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 |
| K221344 |
12/28/2022 |
nView s1 with nav option |
nView medical |
Lisa Last |
| 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 |
| 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 |
| K221193 |
12/23/2022 |
OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm |
OSSIO Ltd. |
Taly Lindner |
| K220928 |
12/16/2022 |
Overjet Calculus Assist |
Overjet Inc. |
Adam Odeh |
| K202674 |
12/12/2022 |
Medidenta High Speed Handpieces |
Pac-Dent, Inc. |
Jiahe Li |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| K222798 |
12/16/2022 |
Rejoni Intrauterine Catheter |
Rejoni, Inc. |
Brian Bergeron |
| 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 |
| 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 |
| 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 |
| 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 |
| K222753 |
12/09/2022 |
SeaSpine 7D Navigation Instruments |
SeaSpine Orthopedics Corporation |
Laeitia Cousin |
| K211058 |
12/22/2022 |
Lp(a) Ultra |
Sentinel CH. SpA |
Patricia DupΘ |
| 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 |
| 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 |
| K211619 |
12/29/2022 |
Multi-Parameter Patient Monitor |
Shenzhen Comen Medical Instruments CO., LTD. |
Hongbo Yan |
| 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 |
| K213430 |
12/30/2022 |
Fingertip Pulse Oximeter |
Shenzhen Witleaf Medical Electronics Co.,Ltd |
Wu Tao |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| K222650 |
12/09/2022 |
Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate |
Stryker Craniomaxillofacial (CMF) |
Zainab Amini |
| 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 |
| 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 |
| K220554 |
12/16/2022 |
Caduceus S |
Taiwan Main Orthopaedic Biotechnology Co., Ltd. |
Jacky Fan |
| K222575 |
12/06/2022 |
HurriChem Device Kit |
ThermaSolutions LLC |
Gregg Giza |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| K222872 |
12/30/2022 |
DNA Appliance |
Vivos Therapeutics, Inc. |
Kimberly Griffith |
| K222919 |
12/19/2022 |
GORE« ENFORM Biomaterial |
W. L. Gore and Associates, Inc. |
Barbara L Smith |
| 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 |
| 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 |
| 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 |
| K221800 |
12/14/2022 |
Infrared Thermometer (Model: Y20001, Y20002) |
Zhangzhou Easepal Medical Science And Technology Co.,Ltd. |
Flower Flower |
| 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 |
| K213722 |
12/14/2022 |
ICE Ceramics, ICE Stains, Fresco |
Zirkonzahn srl |
Julian Steger |
