| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K233373 |
10/02/2023 |
Flowflex« Plus COVID-19 Home Test |
Acon Laboratories, Inc. |
Qiyi Xie |
| K233378 |
10/02/2023 |
ABCcolla« Collagen ADM Scaffold |
ACRO Biomedical Co., Ltd. |
Dar-Jen Hsieh |
| K233496 |
10/30/2023 |
EndeavorOTC |
Akili Interactive Labs, Inc. |
Bhupinder Singh |
| K233395 |
10/03/2023 |
Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S) |
Alliage S/A Industrias MΘdico Odontol≤gica |
Daniel Camargo |
| K233446 |
10/19/2023 |
AMC Health CareConsole |
AMC Health |
Hernani Castro |
| K233432 |
10/12/2023 |
10F Sheath and Dilator Set |
Argon Medical Devices, Inc. |
Ana Jimenez-Hughes |
| K233451 |
10/20/2023 |
Arthrex Synergy Vision Endoscopic Imaging System |
Arthrex, Inc. |
Lai Saeteurn |
| K233407 |
10/05/2023 |
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH2); AtriClip LAA Exclusion Syst |
AtriCure, Inc. |
Stephanie Hadnot |
| K233441 |
10/18/2023 |
The Vest APX System (PVAPX1) |
Baxter Healthcare Corportation |
Steven Co |
| K233438 |
10/13/2023 |
SleepStageML |
Beacon Biosignals, Inc. |
Delphine Lemoine |
| K233480 |
10/26/2023 |
Access SHBG |
Beckman Coulter Inc. |
Kate Oelberg |
| K233416 |
10/10/2023 |
Cryojet Plus (SHE-ACP001-1) |
Beijing Sano Laser S&T Development Co., Ltd |
Zhang Hongbo |
| K233418 |
10/10/2023 |
Biofourmis Everion+ (G2) |
Biofourmis Singapore Pte. Ltd. |
Seth Kuzdzal |
| K233442 |
10/18/2023 |
troCarWashÖ System |
Biotex, Inc. |
Wade Munsch |
| K233368 |
10/02/2023 |
Allograft Delivery Device (OFAC-C) |
Bioventus LLC |
Shanna Hu |
| K233490 |
10/27/2023 |
SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty |
Bioventus LLC |
Kellie Stefaniak |
| K233503 |
10/31/2023 |
14F iSLEEVE Introducer Set |
Boston Scientific Corporation |
Alyssa Manno |
| K233452 |
10/20/2023 |
Vivo 45 LS |
Breas Medical AB |
Ivan Liljegren |
| K233500 |
10/31/2023 |
Benesta Tissue Removal Device |
Caldera Medical, Inc. |
Vicki Gail |
| K233472 |
10/25/2023 |
CVAC Aspiration System + CVAC Image Processor |
Calyxo, Inc. |
Joseph Catanese III |
| K233483 |
10/27/2023 |
FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration) |
Cardio Flow Inc. |
Michael Kallok |
| K233381 |
10/02/2023 |
DRX-Evolution Plus System |
Carestream Health, Inc. |
Robert Faust |
| K233421 |
10/10/2023 |
RESCAN 700 |
Carl Zeiss Meditec AG |
Katrin Faber |
| K233447 |
10/19/2023 |
CeQur SimplicityÖ On-Demand Insulin Delivery System |
CeQur SA |
Michael Simpson |
| K233411 |
10/06/2023 |
Folysil Silicone Catheter |
Coloplast Corp |
Brian Schmidt |
| K233458 |
10/23/2023 |
CM005 Standard (CM005); CM004 Mini (CM004) |
Connexicon Medical Ltd. |
Martin Brennan |
| K233460 |
10/23/2023 |
CM00622 LINC Skin Closure System (CM00622 LINC) |
Connexicon Medical Ltd. |
Martin Brennan |
| K233402 |
10/04/2023 |
Bard 3DMax Mesh |
Davol Inc., Subsidiary of C.R. Bard, Inc. |
Richard Spaziano |
| K233380 |
10/02/2023 |
TRIDENT Mobile Fluoroscopy System |
Dornier MedTech America |
John Hoffer |
| K233405 |
10/05/2023 |
Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test Claim |
Eco Medi Glove Sdn. Bhd. |
Suresh Kumar |
| K233401 |
10/04/2023 |
Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile) |
Eieling Technology Limited |
Yangmin Lin |
| K233465 |
10/24/2023 |
RadiForce MX317W |
EIZO Corporation |
Hiroaki Hashimoto |
| K233409 |
10/06/2023 |
Eko Low Ejection Fraction Tool (ELEFT) |
Eko Health, Inc. |
Sam Huang |
| K233473 |
10/25/2023 |
DEKA LOTUS |
El.EN S.p.A. |
Paolo Peruzzi |
| K233470 |
10/25/2023 |
DEKA LILY |
El.En. S.p.A. |
Paolo Peruzzi |
| K233481 |
10/26/2023 |
AltiVate Reverse« Glenoid |
Encore Medical, L.P. |
Sherri Mellingen |
| K233482 |
10/26/2023 |
Equinoxe« Central Screw Baseplate System |
Exactech Inc. |
Liz Howell |
| K233502 |
10/31/2023 |
TERA HARZ II |
Graphy Inc. |
Moon Soo Park |
| K233428 |
10/11/2023 |
Easycess Aspiration Pump |
Guangzhou Easycess Medical Co., Ltd |
Xingcheng Liu |
| K233449 |
10/20/2023 |
Avantik VTM |
Hanchang Medic Co., Ltd. (Han Chang Medic) |
Hyunsoo Shin |
| K233417 |
10/10/2023 |
AllTest Fentanyl Urine Test Cassette |
Hangzhou AllTest Biotech Co.,Ltd |
Rosa Wu |
| K233461 |
10/23/2023 |
Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A) |
Hi-Dow International, Inc. |
Eric Chen |
| K233389 |
10/02/2023 |
EK Digital Abutments |
Hiossen, Inc. |
Peter Lee |
| K233466 |
10/24/2023 |
Edison System |
HistoSonics, Inc. |
Daniel Kosednar |
| K233498 |
10/31/2023 |
Stryker Orthopaedics Hip Systems Labeling Update |
Howmedica Osteonics Corp. dba Stryker Orthopaedics |
Julia Bally |
| K233457 |
10/20/2023 |
RUS |
Hutom Inc. |
Heejoo Yun |
| K233367 |
10/02/2023 |
iDart Lyme IgG ImmunoBlot Kit |
ID-FISH Technology, Inc. |
Jyotsna Shah |
| K233436 |
10/13/2023 |
IlluminOss Photodynamic Bone Stabilization System |
IlluminOss Medical, Inc. |
Robert Rabiner |
| K233374 |
10/02/2023 |
Secret Pro |
ILOODA Co., Ltd |
Kathy Maynor |
| K233444 |
10/19/2023 |
InkSpace Imaging Small Body Array |
InkSpace Imaging, Inc. |
Peter Fischer |
| K233445 |
10/19/2023 |
Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter |
Integra LifeSciences Production Corporation |
Amanda Erwin |
| K233448 |
10/20/2023 |
Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set |
Integra LifeSciences Production Corporation |
Amanda Erwin |
| K233372 |
10/02/2023 |
KARL STORZ Fiber Telescopes for Urology |
Karl Storz SE & Co. Kg |
Alita McElroy |
| K233501 |
10/31/2023 |
ôLARGAN Health AI-Techö Sleep Apnea and Sleep Quality Examination System (ST-SLP03A) |
Largan Medical Co., Ltd |
Shih-min Chen |
| K233455 |
10/20/2023 |
ARx MIS Spinal Screw System |
Life Spine, Inc. |
Angela Batker |
| K233453 |
10/20/2023 |
Applied BiosystemsÖ TaqPathÖ COVID-19 Diagnostic PCR Kit |
Life Technologies Corporation |
Ian McGill |
| K233410 |
10/06/2023 |
LIAISON PLEX Respiratory Flex Assay |
Luminex Corporation |
Tara Viviani |
| K233386 |
10/02/2023 |
MonikÖ - Disposable Endoscopic Trocar |
M/s. Meril Endo Surgery Private Limited. |
Umesh Sharma |
| K233408 |
10/06/2023 |
Materialise Shoulder SystemÖ, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner |
Materialise N.V. |
Giulia Girola |
| K233366 |
10/02/2023 |
SYMPHONY OCT System |
Medos International SARL |
Sheree Geller |
| K233433 |
10/12/2023 |
Sphere-9Dx Diagnostic Catheter (AFR-00009) |
Medtronic |
Matthew Lobeck |
| K233397 |
10/03/2023 |
Cosine-10TM Diagnostic Catheter |
Medtronic, Inc. |
Karine Lortie |
| K233450 |
10/20/2023 |
MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary Cylinder; Comfort Cap; Healing Cap; Healing Cap Screw; Milling Abutment; EZ Post Abutment; Extra EZ Post Abutment; EZ Post Cylinder; ZrGEN Abutment; Multi-unit Abutment |
MegaGen Implant Co., Ltd. |
Seo MinGi |
| K233420 |
10/10/2023 |
Axium Detachable Coil; Axium Prime Detachable Coil |
Micro Therapeutics, lnc. d/b/a ev3 Neurovascular |
Lekshmi Ajaykumar Pillai |
| K233507 |
10/31/2023 |
EVOLUTION« Tibial Cones |
Microport Orthopedics Inc. |
Jonas Susaraba |
| K233364 |
10/02/2023 |
Axon Therapy |
NeuraLace Medical Inc. |
Joe Milkovits |
| K233375 |
10/02/2023 |
Tranquil-L Interbody System |
Nexus Spine, LLC |
Jared Crocker |
| K233398 |
10/03/2023 |
Faros Surgical System |
Oertli Instrumente AG |
Marianne Kesseli |
| K233499 |
10/31/2023 |
Sapphire NC ULTRA Coronary Dilatation Catheter |
OrbusNeich Medical (Shenzhen) Co., Ltd. |
Jerry Cheung |
| K233505 |
10/31/2023 |
Sapphire ULTRA Coronary Dilatation Catheter |
OrbusNeich Medical (Shenzhen) Co., Ltd. |
Jerry Cheung |
| K233476 |
10/25/2023 |
Z1 Hip System |
Orchard Medical Development |
Brett Zarda |
| K233429 |
10/11/2023 |
OTS 25 (100-1) |
OTS Medical Ltd. |
Assaf Dekel |
| K233362 |
10/02/2023 |
Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0) |
Pelvital USA, Inc. |
Lydia Zeller |
| K233440 |
10/18/2023 |
Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341) |
Philips Medizin Systeme Boeblingen GmbH |
Trang Adams |
| K233435 |
10/13/2023 |
Peace N Quiet (0.7.0) |
PNQ Health |
Kurtis Goos |
| K233434 |
10/13/2023 |
Silent Nite« Sleep Appliance with the Glidewell HingeÖ (SNGLHG) |
Prismatik Dentalcraft, Inc |
Jiahe Li |
| K233419 |
10/10/2023 |
GBR System |
Proimtech Saglik Urunleri Anonim Sirketi |
Hakan Cevik |
| K233439 |
10/16/2023 |
HD60 Series Ultrasound Diagnostic System |
Qingdao Hisense Medical Equipment Co., Ltd |
Yalan Wu |
| K233493 |
10/30/2023 |
Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Shaver Handpiece (R-10023); Veriflow (R-10003); Exoflow (R-10017); 3-in-1 Shaver 4.2mm (R-10008); 3-in-1 Shaver 5.0mm (R-10014); Dynablator (R-10005); Standard Burr (R-10021); Standard Sha |
Relign Corporation |
Nathan Nguyen |
| K233415 |
10/10/2023 |
DELTAWAVE Nasal Pillows System |
RemSleep Holdings |
Tom Wood |
| K233468 |
10/24/2023 |
Iconix Anchor |
Riverpoint Medical |
Bianca Silva de Sousa |
| K233454 |
10/20/2023 |
ONLINE TDM Methotrexate |
Roche Diagnostics Operations |
Elina Voronovsky |
| K233414 |
10/10/2023 |
Shoreline ACS Interbody System; Shoreline RT Interbody System |
SeaSpine Orthopedics Corporation |
Kendal Moulton |
| K233477 |
10/26/2023 |
Cryo-straw (Type I, Type III); Warming Kit (A-4ML, B-8ML); Vitrification Kit (A-3ML, B-6ML) |
Shandong Wego Ruisheng Medical Device Co., Ltd |
Yan Tian |
| K233508 |
10/31/2023 |
iFuse Bedrock Granite« Implant System |
Si-Bone, Inc. |
Jayasri Prabakaran |
| K233396 |
10/03/2023 |
Cannulated Screw System |
Smith & Nephew Inc. |
Chelsea Bagley |
| K233497 |
10/31/2023 |
Rest Assure System |
Somnomed, Inc. |
Ty Cowart |
| K233399 |
10/04/2023 |
Microdacyn Wound Care Solution |
Sonoma Pharmaceuticals, Inc. |
Everardo Garibay Ramirez |
| K233471 |
10/25/2023 |
Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm length (HAR1136) |
Stryker Sustainability Solutions |
Aphrodeja Crutch |
| K233425 |
10/11/2023 |
FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035) |
Sutter Medizintechnik GmbH |
Simone Peschl |
| K233394 |
10/03/2023 |
Gem Flow Now (GEM2770-FN) |
Synovis Micro Companies Alliance |
Julie Carlston |
| K233413 |
10/06/2023 |
Ultraphon Chemical Indicator (TRO-T and TRO-B) |
True Indicating LLC |
Thomas Riha |
| K233423 |
10/10/2023 |
Tyber Medical Anatomical Plating System û Line extension to the Mini-Frag System |
Tyber Medical, LLC. |
Lisa Boyle |
| K233488 |
10/27/2023 |
Intra.OxÖ 2.0 Handheld Tissue Oximeter |
ViOptix, Inc. |
Scott Coleridge |
| K233391 |
10/02/2023 |
cCeLL - In vivo |
VPIX Medical, Inc. |
Kyungmin Hwang |
| K233504 |
10/31/2023 |
Lexa MINI (RIS-303, RIS-305) |
W&H Sterilization S.r.l. |
Paola Zampino |
| K233464 |
10/23/2023 |
WSA Self-Fitting Hearing Aid Gen 2 |
WSAUD A/S |
La-Shaunda Joseph |
| K233492 |
10/30/2023 |
EMS Neck Massager |
Xiamen Comfier Technology Co., Ltd |
Petoula N/A |
| K233509 |
10/31/2023 |
Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System |
Zavation Medical Products LLC |
Colby Williams |
| K233403 |
10/04/2023 |
Flexset System |
Zeto, Inc. |
Aswin Gunasekar |
| K233443 |
10/19/2023 |
VitalÖ Navigation System |
ZimVie Spine (Zimmer Biomet Spine, Inc.) |
Anjanet Mort |
| K233486 |
10/27/2023 |
731 Series Ventilator |
Zoll Medical Corporation |
Jeffrey Churchill |
| K233485 |
10/27/2023 |
M-Wave |
Zynex Medical Inc. |
Thomas Sandgaard |
