| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K223597 |
12/02/2022 |
23andMe« Personal Genome Service« (PGS«) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) |
23andMe, Inc. |
Marianna Frendo |
| K223780 |
12/16/2022 |
Lumos 3DX |
3Dio |
Douglas Hansen |
| K223602 |
12/02/2022 |
Traumatic brain injury (TBI) test |
Abbott Laboratories |
Lisa Kelly |
| K223710 |
12/12/2022 |
i-STAT CG8+ cartridge with the i-STAT 1 System |
Abbott Point of Care Inc. |
Jacquelyn Gesumaria |
| K223755 |
12/15/2022 |
i-STAT G cartridge with the i-STAT 1 System |
Abbott Point of Care Inc. |
Mojgan Soleimani |
| K223857 |
12/23/2022 |
i-STAT G3+ cartridge with the i-STAT 1 System |
ABBOTT POINT OF CARE, INC |
Jacquelyn Gesumaria |
| K223666 |
12/07/2022 |
AblacathÖ Mapping Catheter |
Ablacon, Inc. |
Frank Rodriguez |
| K223725 |
12/13/2022 |
Restrata« MiniMatrix |
Acera Surgical, Inc. |
Tamas Kovacs |
| K223669 |
12/07/2022 |
SecurePortIV Advanced Catheter Securement Adhesive |
Adhezion Biomedical, LLC. |
Richard Jones |
| K223714 |
12/12/2022 |
UniFit Dental Implant System |
Adin Dental Implant Systems Ltd. |
Ilana Lutvak |
| K223689 |
12/09/2022 |
Disposable Needle Guides and Grids |
Advance Medical Designs, Inc. |
David Mackie |
| K223719 |
12/12/2022 |
Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System |
Aegis Spine, Inc. |
Kihyang Kim |
| K223596 |
12/02/2022 |
SQ.line KERRISON |
Aesculap Inc. |
Benjamin Oswald |
| K223878 |
12/27/2022 |
Aevumed RAPID Suture Anchors |
Aevumed, Inc. |
Saif Khalil |
| K223805 |
12/19/2022 |
Agnes |
Agnes Medical Co., Ltd |
Jiwon Kim |
| K223659 |
12/06/2022 |
Jazz |
AI Medical AG |
Christian Federau |
| K223742 |
12/14/2022 |
Dental Ceramic Blocks |
Aidite (Qinhuangdao) Technology Co., Ltd |
Chen Yingying |
| K223819 |
12/21/2022 |
SI-Cure Sacroiliac Joint Fusion System |
Alevio, LLC |
Trey Robbins |
| K223816 |
12/20/2022 |
Dental CT Scanner AXR |
Alliage S/A Industrias Medico Odontol≤gica. |
Daniel Camargo |
| K223621 |
12/05/2022 |
DeepXray |
Alpha Intelligence Manifolds, Inc. |
Qingzong Tseng |
| K223765 |
12/15/2022 |
ATEC Lateral Navigation Instruments |
Alphatec Spine, Inc. |
Sandy Gill |
| K223611 |
12/02/2022 |
Calibrate LTX Interbody System |
Alphatec Spine, Inc. |
Neha Mohindroo |
| K223782 |
12/16/2022 |
Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD 5.0/2.2 Sampler Set |
Ambu A/S |
Kristian Moltved |
| K223656 |
12/06/2022 |
AmeriWater MediQA Reverse Osmosis System (MSP3HF) |
AmeriWater, Llc |
Brian Bowman |
| K223838 |
12/22/2022 |
CatalysÖ Precision Laser System |
AMO Manufacturing USA, LLC |
Laarni Ricafort |
| K223581 |
12/01/2022 |
Solero Microwave Tissue Ablation (MTA) System and Accessories |
AngioDynamics, Inc. |
Kasey E Newcomb |
| K223584 |
12/01/2022 |
Pre-Filled Normal Saline Flush Syringe |
Anhui Tianyang Pharmaceutical Co., Ltd. |
Zhang Shunlin |
| K223860 |
12/23/2022 |
IntegrityÖ Bone Staple Fixation System |
Anika Therapeutics Inc. |
Shajunath Nirupama |
| K223915 |
12/29/2022 |
Tactoset |
Anika Therapeutics. Inc. |
Wei Zhao |
| K223883 |
12/27/2022 |
Daye Tampon |
Annes Daye Ltd |
Valentina Milanova |
| K223603 |
12/02/2022 |
Reflow System Mini and ReFlow Mini Flusher |
Anuncia Medical, Inc. |
Elsa Chi Abruzzo |
| K223901 |
12/28/2022 |
ApneaRX Pro |
Apnea Sciences Coporation |
James Fallon |
| K223759 |
12/15/2022 |
Arthrex SynergyID Endoscopic Imaging System |
Arthex Inc. |
Troy Brooks |
| K223634 |
12/05/2022 |
Customized Abutment |
Arum Dentistry Co., Ltd. |
Boyeon Lim |
| K223866 |
12/23/2022 |
CarevixÖ Suction Cervical Stabilizer |
Aspivix SA |
Mauro Rinaldi |
| K223871 |
12/23/2022 |
Miria Skin Treatment System |
Avava, Inc. |
Jay Bhawalkar, PhD |
| K223905 |
12/28/2022 |
Vivio« LVEDP System |
Avicena, LLC |
Sean Brady |
| K223640 |
12/05/2022 |
Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48) |
AxoGen Corporation |
Jonathan White |
| K223679 |
12/08/2022 |
Access AMH |
Beckman Coulter Inc |
Kate Oelberg |
| K223921 |
12/29/2022 |
Access CEA |
Beckman Coulter, Inc |
Abhi Kannan |
| K223590 |
12/01/2022 |
Access Folate Assay |
Beckman Coulter, Inc. |
Dr. Kuljeet Kaur |
| K223653 |
12/06/2022 |
BD Vaginal Panel |
Becton, Dickinson and Company |
Joseph Basore |
| K223919 |
12/29/2022 |
B.Light Clear Evo and B.Light Restore Evo |
Bemer INT. AG |
Sandra Schwarzenberger |
| K223754 |
12/15/2022 |
BraveCX |
Bering Ltd |
Drozdov Ignat |
| K223846 |
12/20/2022 |
iLet« ACE Pump |
Beta Bionics, Inc |
Vikram Verma |
| K223713 |
12/12/2022 |
Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate |
Better Care Plastic Technology Co., Ltd |
Zhu Chunyan |
| K223697 |
12/09/2022 |
MRI compatibility for existing BioHorizons dental implants and abutments |
BioHorizons Implant Systems, Inc. |
Paul Leppo |
| K223631 |
12/05/2022 |
Comprehensive Segmental Revision System(SRS) |
Biomet Orthopedics |
Alexandria Irwin |
| K223856 |
12/23/2022 |
NuEra Tight RF Family |
BIOS s.r.l. |
Manuela Brambilla |
| K223907 |
12/28/2022 |
NuEra Tight RF Model APMD145.M70-US |
BIOS s.r.l. |
Martina De Iturbe |
| K223733 |
12/13/2022 |
CARTO« 3 EP Navigation System with CARTOSOUNDÖ 4D Version 7.4 |
Biosense Webster, Inc. |
Phuong Park |
| K223766 |
12/15/2022 |
NUVISIONÖ NAV Ultrasound Catheter |
Biosense Webster, Inc. |
Sheba Chacko |
| K223644 |
12/06/2022 |
Neuronaute with IceCap 2 & IceCap 2 Small |
Bioserenity |
Madubuike Okafor |
| K223830 |
12/21/2022 |
Ultrasound System 2300 |
BK Medical Aps |
Inesa Cernajute |
| K223616 |
12/05/2022 |
AcquireÖ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device |
Boston Scientific Corporation |
Kyra McNamara |
| K223592 |
12/01/2022 |
AdvanixÖ Pancreatic Stent and NaviFlexÖ Rapid Exchange (RX) Pancreatic Delivery System and Pushers |
Boston Scientific Corporation |
Kerri LaPlaca |
| K223824 |
12/21/2022 |
POLARSHEATHÖ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAPÖ Circular Mapping Catheter (UPN:M004CRBS7210), POLARMAPÖ EP Electrical Cable (UPN:M004CRBS62000), SMARTFREEZEÖ Esophageal Temperature Sensor (ETS) Cable: -SMARTFREEZEÖ Esophageal Temperature S |
Boston Scientific Corporation |
Derek Charchuk |
| K223633 |
12/05/2022 |
RubiconÖ Control Support Catheter (H749394323506A1) |
Boston Scientific Corporation |
Mary-Jo Foley |
| K223645 |
12/06/2022 |
I.V. Administration Set, I.V. Extension Set |
BQ PLUS Medical Co., Ltd |
Jin Zhang |
| K223864 |
12/23/2022 |
Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial |
Brainlab AG |
Esther Moreno Garcia |
| K223734 |
12/13/2022 |
ENT EM |
Brainlab AG |
Esther Moreno Garcia |
| K223676 |
12/08/2022 |
SomniCheck |
BrainMatterZ, LLC |
Kevin Wilson |
| K223837 |
12/22/2022 |
SPIRA«-C Integrated Fixation System |
Camber Spine Technologies |
Brooks McAdam |
| K223803 |
12/19/2022 |
Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System |
Canary Medical USA LLC |
Kevin Leung |
| K223726 |
12/13/2022 |
Aquilion Precision (TSX-304A/4) V10.14 with AiCE |
Canon Medical Systems Corporation |
Paul Biggins |
| K223687 |
12/09/2022 |
X-ray Flat Panel Detectors (EverestView 4343X) |
CareRay Digital Medical Technology Co., Ltd. |
Xu Wei |
| K223842 |
12/22/2022 |
DRX - Compass |
Carestream Health, Inc. |
Jessica DeRyke |
| K223655 |
12/06/2022 |
Catalyst R1 Reverse Shoulder System |
Catalyst OrthoScience, Inc. |
Dale Davison |
| K223787 |
12/19/2022 |
ECGenius System |
CathVision ApS |
Mads Matthiesen |
| K223794 |
12/19/2022 |
hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS |
CEFLA S.C. |
Lorenzo Bortolotti |
| K223752 |
12/15/2022 |
Black Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Chloroquine, Cyclosporin A, Retrovir, Gastric Acid and Fentanyl |
Central Medicare Sdn. Bhd. |
Chua Kah Ying |
| K223763 |
12/15/2022 |
ZeptoLink IOL Positioning System |
Centricity Vision, Inc. |
Neal Hartman |
| K223776 |
12/16/2022 |
PEEK Spinal Infusion Cage |
Changzhou Geasure Medical Apparatus and Instruments Co., Ltd |
Jing Huang |
| K223890 |
12/27/2022 |
NAJA Gastrointestinal Catheter |
Chess Medical Inc. |
Dr. Yen-I Chen |
| K223869 |
12/23/2022 |
ChoiceSpine Blackhawk Ti Cervical Spacer System |
ChoiceSpine, LLC |
Kim Finch |
| K223615 |
12/05/2022 |
Digital ClarusScope System, Digital NeuroPEN System |
Clarus Medical, LLC |
Mark F. Brown |
| K223914 |
12/29/2022 |
ACTIVÖ Cap |
Cleansite Medical, Inc. |
Neal Hartman |
| K223900 |
12/28/2022 |
babyLance Safety Heelstick (BLM, BLN, BLP) |
Clinical Innovations, LLC |
Alex Garrett |
| K223738 |
12/14/2022 |
Alpha Control Liner System (ACLS) |
Coapt |
Blair Lock |
| K223605 |
12/02/2022 |
ControlSeal Electrode (ELSB) |
Coapt |
Kevin Dwyer |
| K223916 |
12/29/2022 |
PUMA-G System |
CoapTech Inc. |
Jack Kent |
| K223672 |
12/07/2022 |
Instrument Case P1340904 |
Cochlear |
Denis DiMartino |
| K223821 |
12/21/2022 |
Self-Cath Closed System |
Coloplast |
Preeti Jain |
| K223897 |
12/28/2022 |
Excipio LV Thrombectomy Device |
Contego Medical Inc. |
Jim Clossick |
| K223648 |
12/06/2022 |
Cook« Spectrum« 2 MRC Central Venous Catheter |
Cook Advanced Technologies |
Matthew Waninger |
| K223708 |
12/12/2022 |
Entasis 3D Dual-Lead Sacroiliac Implant System |
CoreLink, LLC |
Steven Mounts |
| K223828 |
12/21/2022 |
BENCOX Delta Option Heads |
Corentec Co., Ltd. |
Yoorim Bae |
| K223705 |
12/12/2022 |
EndoflipTM 300 |
Covidien LLC |
Liron Bar Yaakov |
| K223809 |
12/20/2022 |
PrecisionTAVI (v1.1) |
DASI Simulations |
Ana Minyayev |
| K223784 |
12/16/2022 |
Precision TC2, Precision TC3, Precision TC4, SEG 100, SEG 150, SEG200 |
Deltronix Equipamentos Ltda |
Carlos Paulim |
| K223756 |
12/15/2022 |
SimProÖ Now, GentleCathÖ Hydrophilic |
Dentsply Sirona |
Laura Sobrin |
| K223931 |
12/30/2022 |
Dexcom G6 Continuous Glucose Monitoring (CGM) System |
Dexcom, Inc. |
Brittney Shaver |
| K223790 |
12/19/2022 |
Huvex Interspinous Fusion System |
Dio Medical Corp. |
Milan George |
| K223757 |
12/15/2022 |
Bonelogic |
Disior Ltd |
Aarno Jussila |
| K223753 |
12/14/2022 |
Cervical Plate System |
Double Medical Technology Inc. |
Yan Zuo |
| K223826 |
12/21/2022 |
NanoDrop Lancet |
Drawbridge Health, Inc. |
Dan McEvoy |
| K223694 |
12/09/2022 |
Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042) |
Duearity AB |
Anneli Johansson |
| K223902 |
12/28/2022 |
FibroScan« device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630) |
Echosens |
Fanny Patoureaux |
| K223651 |
12/06/2022 |
Cerebral Adaptive Index (CAI) Algorithm |
Edwards Lifesciences, LLC |
Sara Pesian |
| K223865 |
12/23/2022 |
HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Pressure Controller, Heart Reference Sensor |
Edwards Lifesciences, LLC |
Sara Pesian |
| K223823 |
12/21/2022 |
Disposable Surgical Face Mask |
Efofex, Inc. |
Siddhant Doshi |
| K223768 |
12/15/2022 |
RadiForce RX270 |
EIZO Corporation |
Hiroaki Hashimoto |
| K223884 |
12/27/2022 |
ELITONE Urge Urinary Incontinence Device |
Elidah Inc |
Gloria Kolb |
| K223822 |
12/21/2022 |
ACTIVBRAIDÖ |
Embody, Inc. |
Brianna Schehr |
| K223791 |
12/19/2022 |
TalWire |
Embrace Medical Ltd. |
Anat Kaufman |
| K223779 |
12/16/2022 |
EMPOWRÖ blade stem |
Encore Medical LLC |
Trey Thorsen |
| K223891 |
12/27/2022 |
Cobra Catheter System |
Endovascular Engineering |
Debra Cogan |
| K223671 |
12/07/2022 |
CONDUIT LLIF Straight Inserters |
Enztec Limited |
James Sheat |
| K223674 |
12/07/2022 |
eZSUREÖ Empty Fluid Container (models 426030, 426040, 426110) |
Epic Medical Pte Ltd |
Freddie Lee |
| K223629 |
12/05/2022 |
SpiroSphere, SpiroSphereECG, CardioSphere |
eResearchTechnology GmbH |
Kristin Feld |
| K223760 |
12/15/2022 |
ECHELON LINEARÖ 60 mm Cutter (GLC60);ECHELON LINEARÖ 80mm Cutter (GLC80);ECHELON LINEARÖ 100 mm Cutter (GLC100);ECHELON LINEARÖ Cutters 60mm Blue Reload (GLCR60B);ECHELON LINEARÖ Cutters 60mm Green Reload (GLCR60G);ECHELON LINEARÖ Cutters 80mm Blue Reloa |
Ethicon Endo-Surgery |
Alicia Butler |
| K223820 |
12/21/2022 |
EzDent-i / E2 / Prora View/ Smart M Viewer |
Ewoosoft Co., Ltd |
Young Seok Kim |
| K223933 |
12/30/2022 |
Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws |
Exactech, Inc |
Valdimir Talley |
| K223833 |
12/22/2022 |
Exactech« Equinoxe« Reverse Humeral Liners and Humeral Adapter Trays |
Exactech, Inc |
Liz Howell |
| K223622 |
12/05/2022 |
FaceHeart Vitals Software Development Kit (FH vitals SDK) |
FaceHeart Corp. |
Morris Chung |
| K223855 |
12/23/2022 |
FEops HEARTguideTM, FEops HEARTguideTM ALPACA |
FEops nv |
Peter Mortier |
| K223684 |
12/08/2022 |
F&P 820 Humidification System |
Fisher & Paykel Healthcare Ltd |
Reena Daken |
| K223696 |
12/09/2022 |
F&P Solo Mask Range |
Fisher & Paykel Healthcare Ltd |
Reena Daken |
| K223843 |
12/22/2022 |
FloPatch FP120 |
Flosonics Medical |
Caleb Chin |
| K223827 |
12/21/2022 |
FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01 |
FUJIFILM Corporation |
Randy Vader |
| K223801 |
12/19/2022 |
FX V135(TM) Shoulder Prosthesis |
FX Shoulder USA, Inc |
Cory Trier |
| K223832 |
12/22/2022 |
Vivid S60N, Vivid S70N |
GE Medical System Ultrasound and Primary Care Diagnostics |
Lee Bush |
| K223847 |
12/22/2022 |
CREEDÖ Cannulated Screws |
GLW, Inc. |
Arundhati Radhakrishnan |
| K223868 |
12/23/2022 |
PYXIS 3D Titanium Cage System |
GS Medical Co. Ltd. |
Sam Camp |
| K223930 |
12/30/2022 |
A1417MCW/A1717MCW/F1417MCW |
H&abyz Co., Ltd. |
Jimin Han |
| K223889 |
12/27/2022 |
Stativ« Knotted UHMWPE Suture Anchor |
Healthium Medtech Limited |
Pankaj Dawar |
| K223895 |
12/28/2022 |
Disposable Medical Nitrile Examination Gloves |
Hebei Titans Hongsen Medical Technology Co., Ltd. |
Xiaojing Shao |
| DEN220087 |
12/02/2022 |
Edison System |
HistoSonics, Inc. |
Daniel Kosednar |
| K223922 |
12/30/2022 |
SOMNUM (V.1.1.2.) |
Honeynaps Co., Ltd |
Tony Lee |
| K223706 |
12/12/2022 |
PMMA BLOCK |
Huliang(shanghai) Bio-Tech Co., Ltd. |
Quansheng Wang |
| K223718 |
12/12/2022 |
HandXÖ Self-Righting Needle Holder |
Human Xtensions Ltd. |
Maija Wallenstein |
| K223836 |
12/22/2022 |
Vathin« Video Bronchoscope System |
Hunan Vathin Medical Instrument Co., Ltd. |
Du Jing |
| K223646 |
12/06/2022 |
IB Lab LAMA |
IB Lab GmbH |
Richard Ljuhar |
| K223606 |
12/02/2022 |
LifeShieldÖ Infusion Safety Software Suite |
ICU Medical, Inc. |
Pernell Abrantes |
| K223607 |
12/02/2022 |
Plum DuoÖ Infusion System |
ICU Medical, Inc. |
Yuliya Matlin |
| K223811 |
12/20/2022 |
Lung-CAD |
Imagen Technologies, Inc |
Rebecca Jones, PhD |
| K223728 |
12/13/2022 |
Micro Rx |
IMDS Operations B.V. |
Edwin Schulting |
| K223781 |
12/16/2022 |
QuantisalÖ II Oral Fluid Collection Device |
Immunalysis Corporation |
Shubhajit Mitra |
| K223867 |
12/23/2022 |
IDS ACTH II |
Immunodiagnostic Systems Limited |
Mick Henderson |
| K223613 |
12/05/2022 |
InThrill Thrombectomy System |
Inari Medical, Inc |
Ellen Nguyen |
| K223609 |
12/02/2022 |
RevCoreÖ Thrombectomy Catheter. |
Inari Medical, Inc. |
Suzanne Moreno |
| K223929 |
12/30/2022 |
LagunaÖ Clot Retriever System and MalibuÖ Aspiration Catheter System (Laguna Thrombectomy System) |
Innova Vascular, Inc. |
Ryan Kenney |
| K223892 |
12/28/2022 |
DentMix VPS Impression Material |
Innovative Product Brands, Inc. |
Shane Nielsen |
| K223608 |
12/02/2022 |
GEM Premier 7000 with IQM3 |
Instrumentation Laboratory Company |
Gabriella Erdosy |
| K223700 |
12/12/2022 |
BOSSÖ |
Intelon Optics, Inc. |
Pavana Mysore Ganesh |
| K223911 |
12/29/2022 |
Lumen 155-SF |
Intricon Corporation |
David Akbari |
| K223660 |
12/06/2022 |
SaintView |
Inviz Corporation |
Priscilla Chung |
| K223624 |
12/05/2022 |
Emerald Herbst |
Island Dental Lab, Inc dba Emerald Dental |
Israel Wettenstein |
| K223675 |
12/07/2022 |
WatchPAT ONE (WP1) |
Itamar Medical, LTD |
Efrat Litman |
| K223685 |
12/09/2022 |
SmoothCool HR System |
Jeisys Medical Inc |
Sang Hoon Hwang |
| K223709 |
12/12/2022 |
Kyphoplasty Balloon Catheter |
Jiangsu Changmei Medtech Co., Ltd. |
Yang Lifan |
| K223740 |
12/14/2022 |
Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5) |
Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd. |
Heidi Zhang |
| K223638 |
12/05/2022 |
Neodent Implant System - Helix Short Implant System |
JJGC Industria e Comercio de Materiais Dentarios S.A. |
Barbara Uzae |
| K223662 |
12/06/2022 |
Neodent Implant System - Helix Short Surgical Kit Cases |
JJGC Industria e Comercio de Materiais Dentarios S.A. |
Barbara Uzae |
| K223885 |
12/27/2022 |
HOPKINS Telescopes |
Karl Storz Endoscopy America, Inc. |
Jordan Lydia Verla |
| K223923 |
12/30/2022 |
HOPKINS Telescopes |
KARL STORZ Endoscopy-America, Inc |
Alita McElroy |
| K223814 |
12/20/2022 |
Genesis ACTIVE Implant System |
Keystone Dental Inc. |
Nancy DeAngelo |
| K223927 |
12/30/2022 |
360CAS |
Kico Knee Innovation Company Pty Limited |
Danyon Munro |
| K223749 |
12/14/2022 |
U by Kotex« Click« Unscented Menstrual Tampons |
Kimberly-Clark Corporation |
Jeremy Paulsen |
| K223588 |
12/01/2022 |
PALLAS Premium |
Laseroptek Co., Ltd. |
Hong Chu |
| K223673 |
12/07/2022 |
Surgeon Controlled Arm |
Levita Magnetics International Corp. |
Alberto Rodriguez-Navarro, MD |
| K223789 |
12/19/2022 |
21HQ513D |
LG Electronics Inc. |
Jinhwan Jun |
| K223893 |
12/28/2022 |
Infrared Heat (Model: E0221) |
Light Tree Ventures Europe B.V. |
Alain Dijkstra |
| K223642 |
12/06/2022 |
LED Lip Perfector, model: ZC-05 |
Light Tree Ventures Europe B.V. |
Alain Dijkstra |
| K223876 |
12/23/2022 |
SMR Shoulder System |
LimaCorporate S.p.A. |
Francesca Marello |
| K223932 |
12/30/2022 |
SafeAir combi (SFR-combi-US) |
LiNA Medical ApS |
Jaroslaw Mrowczynski |
| K223834 |
12/22/2022 |
AccuCheck |
Manteia Technologies Co., Ltd. |
Yingkai Lin |
| K223724 |
12/13/2022 |
MOZI TPS |
Manteia Technologies Co., Ltd. |
Chao Fang |
| K223721 |
12/12/2022 |
Masimo Stork |
Masimo Corporation |
Sindura Penubarthi |
| K223795 |
12/19/2022 |
FairFix QT Adjustable Button |
Medacta International S.A. |
Stefano Baj |
| K223582 |
12/01/2022 |
MectaLock TI Triple Loaded Suture Anchor |
Medacta International S.A. |
Stefano Baj |
| K223769 |
12/15/2022 |
NextARÖ Spine Platform |
Medacta International S.A. |
Stefano Baj |
| K223853 |
12/23/2022 |
Medartis APTUS« Ulna Plates |
Medartis AG |
Claudia De Santis |
| K223729 |
12/13/2022 |
FLOWpresso |
Medella Health Limited |
Desiree De Spong |
| K223835 |
12/22/2022 |
MA-40, MA-112 |
Medify Air LLC |
Pragati Anand |
| K223739 |
12/14/2022 |
VS Tabletop Tonometer |
Medimaging Integrated Solution Inc |
Joanne Wang |
| K223926 |
12/30/2022 |
VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box |
Medimaging Integrated Solution Inc. (MiiS) |
Jung-Yi Yen |
| K223813 |
12/20/2022 |
Aveta System 2.0 |
Meditrina, Inc. |
Csaba Truckai |
| K223688 |
12/09/2022 |
CONDUITÖ Lateral Lumbar Intervertebral Fusion Cage, CONDUITÖ Instruments |
Medos International S└RL |
Delano Martins |
| K223788 |
12/19/2022 |
The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter |
MedSource International LLC |
Amanda Salentine |
| K223764 |
12/15/2022 |
INFINITY OCT System |
Medtronic Sofamor Danek USA, Inc. |
Laura Beth Parr |
| K223630 |
12/05/2022 |
Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification System |
Medtronic, Inc. |
Kerry Luyster |
| K223654 |
12/06/2022 |
Medussa-PL Cage |
Medyssey USA, Inc. |
Youngsu Jang |
| K223909 |
12/29/2022 |
R2GATE Lite TM |
MegaGen Implant Co. Ltd |
Tae Gyoun Lee |
| K223872 |
12/23/2022 |
Low Profile Companion Sheath |
Merit Medical Systems, Inc. |
Kirk McIntosh |
| K223670 |
12/07/2022 |
MESI mTablet ECG Diagnostic System, MESI mTablet ECG |
MESI, Development of Medical Devices, Ltd; MESI, D.O.O. |
Jakob Susteric |
| K223802 |
12/19/2022 |
accufit |
Mettler Electronics Corporation |
An Le |
| K223898 |
12/28/2022 |
VitalFlowTM Centrifugal Pump |
Michigan Critical Care Consultants, Inc. (d.b.a MC3 Inc.) |
Martha Rumford |
| K223774 |
12/16/2022 |
Contour ProtΘgΘAI |
MIM Software Inc. |
Lynn Hanigan |
| K223800 |
12/19/2022 |
MIM û Additional Tracers |
MIM Software Inc. |
Megan Fontanez |
| K223722 |
12/12/2022 |
MIO Blood Glucose Monitoring System |
Mio Labs Inc. |
Mark Qian |
| K223628 |
12/05/2022 |
NEBA« Compact EEG2R Mobile Headset |
Neba Health, LLC |
Howard Merry |
| K223797 |
12/19/2022 |
Neuro20 Pro System |
Neuro20 Technologies |
Dennis Schmitt |
| K223627 |
12/05/2022 |
PreView-IIIÖ Anterior Cervical Plate System |
Nexus Spine, LLC |
Jared Crocker |
| K223677 |
12/08/2022 |
Titanium Abutment Blank Nobel Biocare N1 TCC |
Nobel Biocare AB |
Bernice Jim |
| K223785 |
12/16/2022 |
N9+ |
Nonagon Ltd. |
Orly Maor |
| K223731 |
12/13/2022 |
NuVasive Modulus-C Interbody System |
Nuvasive, Inc. |
Meet Vaghani |
| K223761 |
12/15/2022 |
OIC Intramedullary Screw System |
Orthopaedic Implant Company |
Douglas Fulton |
| K223786 |
12/19/2022 |
Orthex External Fixation System |
OrthoPediatrics Corp. |
Yan Li |
| K223924 |
12/30/2022 |
LW Implant System |
Ossvis Co., Ltd. |
Young Jae Kim |
| K223650 |
12/06/2022 |
REMEDY Stemmed Knee Spacer |
OsteoRemedies, LLC |
Eric Stookey |
| K223854 |
12/23/2022 |
Unistik« ShieldLock, Unistik VacuFlip |
Owen Mumford Ltd |
Darren Mansell |
| DEN220091 |
12/14/2022 |
Dream Sock |
Owlet Baby Care, Inc. |
Jim Fidacaro |
| K223589 |
12/01/2022 |
Grappler Suture Anchor R3FLEX IOL System |
Paragon 28, Inc. |
Haylie Hertz |
| K223874 |
12/23/2022 |
BAROguard |
Paragonix Technologies |
Nathan Yetton |
| K223840 |
12/22/2022 |
eRapid Nebulizer System |
PARI Respiratory Equipment, Inc. |
Michael Judge |
| K223918 |
12/29/2022 |
AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub |
Philips Medical Systems Nederland B.V. |
Jeanette Becker |
| K223771 |
12/16/2022 |
Lumify Diagnostic Ultrasound System |
Philips Ultrasound |
Sudipta Chakrabarti |
| K223804 |
12/19/2022 |
PercuNav Image Fusion and Interventional Navigation System |
Philips Ultrasound LLC |
Courtney Nix |
| K223625 |
12/05/2022 |
CapnoSpotÖ Pneumothorax Decompression Indicator |
Pneumeric, Inc. |
Johnathon M.E. Aho |
| K223632 |
12/05/2022 |
Premier's MultiMatch Universal Chameleon Restorative Composite |
Premier Dental Products Company |
Jessica Huang |
| K223798 |
12/19/2022 |
Glidewell TuffSplintÖ Appliance Resin |
Prismatik Dentalcraft, Inc. |
Jiahe Li |
| K223643 |
12/06/2022 |
Verifine« Ease Lancing Device, Verifine« Lancing Device |
Promisemed Hangzhou Meditech Co., Ltd. |
Zearou Yang |
| K223873 |
12/23/2022 |
Boppli Infant Blood Pressure Monitor |
PyrAmes Inc. |
Xina Quan |
| K223686 |
12/09/2022 |
Medical Protective Masks |
Qinhuangdao Taizhi Medical Technology Co., Ltd. |
Fan Xifan |
| K223758 |
12/15/2022 |
Epione |
Quantum Surgical SAS |
Elise Lagacherie |
| K223879 |
12/27/2022 |
Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M) |
Quara S.r.l. |
Raffaella Tommasini |
| K223612 |
12/05/2022 |
Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA) |
Ranfac Corporation |
Eric Kreuz |
| K223620 |
12/05/2022 |
Reprieve by RegenesisTM |
Regenesis Biomedical Inc. |
Randy Chavez |
| K223747 |
12/14/2022 |
Whitsundays Mask System |
ResMed Pty Ltd (Registration Number: 3004604967) |
Shu-Ying Huang |
| K223681 |
12/08/2022 |
Respiree Cardio-Respiratory Monitor |
Respiree PTE Ltd. |
Gurpreet Singh |
| K223859 |
12/23/2022 |
Rhino Non-sterile Powder-Free Nitrile Exam Glove û Periwinkle Color Tested for Use with Chemotherapy Drugs and Fentanyl |
Rhino Health Inc. |
Mark Lee |
| K223637 |
12/05/2022 |
Elecsys proBNP II, Elecsys proBNP II STAT |
Roche Diagnostics |
Jane Phillips |
| K223783 |
12/16/2022 |
cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System |
Roche Molecular Systems, Inc. |
Aradhana Karthikeyan |
| K223591 |
12/01/2022 |
cobas« SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas« Liat« System |
Roche Molecular Systems, Inc. |
Aradhana Karthikeyan |
| K230036 |
12/27/2022 |
Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand ) |
RTI Surgical, Inc |
Lynne Witkowski |
| K223841 |
12/22/2022 |
KBA3D |
S.M.A.I.O. |
Jean-Charles Roussouly |
| K223810 |
12/20/2022 |
Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) |
SB-Kawasumi Laboratories, Inc. |
Shiro Agehama |
| K223913 |
12/29/2022 |
Socrates Aspiration System |
Scientia Vascular Inc |
Thomas Lippert |
| K223903 |
12/28/2022 |
Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl SMALL SIZE (NGPF102); MEDIUM SIZE (NGPF103); LARGE SIZE (NGPF104); X-LARGE SIZE (NGPF105) |
Semperit Investments Asia PTE LTD. |
Alexander Weinert |
| K223745 |
12/14/2022 |
Novae« Dual Mobility System, Hype« Hip System |
Serf |
Jean-Charles Moncenis |
| K223678 |
12/08/2022 |
Sterile Syringes for Single Use |
Shanghai Kindly Enterprise Development Group Co., Ltd. |
Amy Li |
| K223778 |
12/16/2022 |
Diode Laser Hair Removal System (RD-SLD600) |
Shanghai Omni Laser Skinology Co., Ltd. |
Avril Ouyang |
| K223928 |
12/30/2022 |
Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T001N, T011C, T016K |
Shenzhen Fansizhe Science And Technology Co., Ltd |
Endang Cheng |
| K223882 |
12/27/2022 |
Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02) |
Shenzhen Honpal Optoelectronic Technology Co., Ltd. |
Wang Tianming |
| K223825 |
12/21/2022 |
Tens & Ems Device |
Shenzhen Jian Feng Electronic Technology Co., Ltd |
Feng Wen |
| K223693 |
12/09/2022 |
Electric breast pump (model: M5) |
Shenzhen Lutejiacheng Technology Co., Ltd. |
Athena Pan |
| K223807 |
12/20/2022 |
Reusable Temperature Probe, Disposable Temperature Probe |
Shenzhen SINO-K Medical Technology Co.,Ltd |
Lao Chengxin |
| K223886 |
12/27/2022 |
Wearable Breast Pump (Model S18) |
Shenzhen TPH Technology Co., Ltd. |
Peter Chen |
| K223618 |
12/05/2022 |
IPL Hair Removal Device, Model(s): UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD |
Shenzhen Ulike Smart Electronics Co.,Ltd |
Shane Xie |
| K223690 |
12/09/2022 |
iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) |
Shenzhen YHLO Biotech Co., LTD. |
Ying Dai |
| K223711 |
12/12/2022 |
ANNE One |
Sibel Health Inc. |
Sarah Coughlin |
| K223812 |
12/20/2022 |
Sensis Vibe (VD15) |
Siemens Medical Solutions USA Inc. |
Patricia D Jones |
| K223735 |
12/13/2022 |
ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System |
Siemens Medical Solutions USA, Inc |
Sulgue Choi |
| K223635 |
12/05/2022 |
Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer |
Sienco, Inc. |
Jennifer Aiken |
| K223912 |
12/29/2022 |
InterCollagen« Guide |
SigmaGraft Inc. |
Elcin Chang |
| K223649 |
12/06/2022 |
VERTICALE« Navigation Instruments |
Silony Medical GmbH |
Ralf Klabunde |
| K223806 |
12/19/2022 |
VERTICALE« Triangular Fixation System |
Silony Medical GmbH |
Ralf Klabunde |
| K223663 |
12/07/2022 |
SIMDA Abutment |
SIMDA Co., Ltd. |
Young Woo Cha |
| K223875 |
12/23/2022 |
MOBINEURO Alita Intraoperative MRI System |
Sino Canada Health Engineering Research Institute (Hefei) |
Gong Zhang |
| K223682 |
12/08/2022 |
Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit |
Sirius Medical Systems B.V. |
Bram Schermers |
| K223762 |
12/15/2022 |
Smith & Nephew ACCORDÖ Cable System |
Smith & Nephew |
Allison Francis |
| K223647 |
12/06/2022 |
CLEAR+BRILLIANT TOUCH« Laser System |
Solta Medical, Inc. |
Aditi Chaubal |
| K223775 |
12/16/2022 |
EZ-STIK Electrodes |
South Dakota Partners |
Mike Plunkett |
| K223815 |
12/20/2022 |
ONE DROP Lancing Device |
STAT Medical Devices |
Hemel Mariano |
| DEN220090 |
12/12/2022 |
EasySepÖ Human Bone Marrow CD138 Positive Selection Kit (100-0748) |
STEMCELL Technologies Canada Inc. |
Jason Peng |
| K223717 |
12/12/2022 |
Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack |
STERIS Corporation |
Gregory Land |
| K223715 |
12/02/2022 |
Celerity Incubator |
STERIS Corporation |
Gregoy Land |
| K223770 |
12/15/2022 |
Sonopet 1Q 3 7cm 1Q Large |
Stryker Corporation |
Thomas Flannelly |
| K223772 |
12/16/2022 |
PRO Plating System, Stryker Trauma Pelvic Set (Matta) |
Stryker GMbH |
Danielle Jannuzzi Madureira |
| K223767 |
12/15/2022 |
Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ortho Q Guidance System |
Stryker Leibinger GmbH & Co. KG |
Megan B Guilbault |
| K223623 |
12/05/2022 |
SubtleMR (2.3.x) |
Subtle Medical Inc. |
Ajit Shankaranarayanan |
| K223626 |
12/05/2022 |
Niti-S Biliary Speed D Stent |
Taewoong Medical Co., Ltd |
Jangsoo Lee |
| K223593 |
12/01/2022 |
Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar |
Taiwan Surgical Corporation |
Ken Chen |
| K223639 |
12/05/2022 |
VisAble.IO |
TechsoMed |
Dalia Dickman, PhD |
| K223863 |
12/23/2022 |
BONHAWA Respiratory Humidifier |
Telesair, Inc. |
Yong (Bryan) Liu |
| K223680 |
12/08/2022 |
Eneka Pro |
TermoSalud |
Cristina Cifuentes Pantoja |
| K223844 |
12/22/2022 |
Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8ug/ml (Streptococcus species) and 0.000125-8ug/ml (Haemophilus influenzae) |
Thermo Fisher Scientific |
Cynthia Knapp |
| K223848 |
12/22/2022 |
IntrisoundÖ Tuned Lumen« 155 Hearing Aids |
Tuned Ltd |
Orit lanco |
| K223748 |
12/14/2022 |
Nitrile Exam Gloves (Chemotherapy Drug Tested) |
US Medical Glove Company LLC |
Jorge A. Alcazar |
| K223839 |
12/22/2022 |
TrueBeam, TrueBeam STx, Edge, VitalBeam |
Varian Medical Systems, Inc. |
Peter J. Coronado |
| K223917 |
12/29/2022 |
VINNO E20, VINNO E10,VINNO E10P,VINNO E10E, VINNO X1,VINNO X1E,VINNO X1P, VINNO X2,VINNO X2E,VINNO X2P |
VINNO Technology (Suzhou) Co.,Ltd |
Cordelia Liu |
| K223920 |
12/29/2022 |
VINNO G50, VINNO G55, VINNO M50, VINNO E30, VINNO X5, VINNO X6, VINNO X7, VINNO M55, VINNO E35, VINNO X65, VINNO X55, VINNO X35, VINNO G55E, VINNO G55P, VINNO M55E, VINNO M55P, VINNO E35E, VINNO E35P |
VINNO Technology (Suzhou) Co.,Ltd |
Cordelia Liu |
| K223595 |
12/02/2022 |
vPATCH |
Virility Medical, Ltd. |
Tal Golan |
| K223818 |
12/21/2022 |
Model 9160 VitaloQUB |
Vitalograph Ireland Ltd. |
Tony O'Hanlon |
| K223683 |
12/08/2022 |
EnteraLoc Flow |
Vonco Products |
Christie Marr |
| K223852 |
12/22/2022 |
VySpanÖ PCT System |
Vy Spine, LLC |
Jordan Hendrickson |
| K223858 |
12/23/2022 |
Lexa MINI (RIS-303, RIS-305) |
W&H Sterilization S.r.l. |
Paola Zampino |
| K223862 |
12/23/2022 |
Hair Boom 69, Hair BoomAir, Hair Boom, Ulike Hair UpUp |
Won Tech Co., Ltd. |
Hyun Sik Yoon |
| K223727 |
12/13/2022 |
Lavieen |
Won Tech Co., Ltd. |
Hyun Sik Yoon |
| K223600 |
12/02/2022 |
Sterilization Wrap |
Wuhan Zonsen Medical Products Co., Ltd. |
Linna Ye |
| K223585 |
12/01/2022 |
Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear |
Yung Sheng Optical Co., Ltd. |
Wen-Han Chen |
| K223808 |
12/20/2022 |
Zavation Navigation Instrument System |
Zavation Medical Products, LLC |
Katie Motley |
| K223741 |
12/14/2022 |
Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use Flexible Video Cystoscope/Choledochoscope:PC200-AS, PC200-AR, PC200-S and PC200-R;HD Medical Video Endoscope Image Processor: PV300) |
Zhuhai Pusen Medical Technology Co., Ltd. |
Changshen Wang |
| K223746 |
12/14/2022 |
Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard XP Console, Thermogard HQ Console |
Zoll Circulation, Inc. |
Brian Robey |
