| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K223597 |
08/31/2023 |
23andMe« Personal Genome Service« (PGS«) Cancer Predisposition Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) |
23andMe, Inc. |
Marianna Frendo |
| K223150 |
08/24/2023 |
APS Metal Plate & Screw System |
A Plus Biotechnology Co., Ltd |
Frank Hsu |
| K221925 |
08/10/2023 |
ID NOW COVID-19 2.0 |
Abbott Diagnostics Scarborough, Inc. |
Jessica E. Stahle |
| K220031 |
08/04/2023 |
Alinity h-series System |
Abbott Laboratories |
Neha Vatsyayan |
| K222850 |
08/10/2023 |
HAVAb IgG II |
ABBOTT LABORATORIES |
Dominic Tunzi |
| K231415 |
08/10/2023 |
EnSiteÖ X EP System |
Abbott Medical |
Alyssa Timmers |
| K231344 |
08/02/2023 |
ActivSight Intraoperative Imaging System |
Activ Surgical Inc. |
Nicholas Child |
| K212766 |
08/24/2023 |
Maxiocel Chitosan Wound Dressing |
Advamedica Inc. |
Leo Mavely |
| K223689 |
08/02/2023 |
Disposable Needle Guides and Grids |
Advance Medical Designs, Inc. |
David Mackie |
| K232010 |
08/04/2023 |
iTEMPSHIELD |
AION Biosystems Inc. |
Joseph Azary |
| K223180 |
08/25/2023 |
AIRAscore |
AIRAmed GmbH |
Maximilian Stalter |
| K231156 |
08/30/2023 |
Enzyme Packed Cartridge - RELiZORB |
Alcresta Therapeutics, Inc. |
Matthew King |
| K231718 |
08/18/2023 |
Holmium Medical Laser |
Allengers Global Healthcare Private Limited |
Harpreet Singh |
| K230428 |
08/10/2023 |
Ambu« aScopeÖ 5 Broncho 2.7/1.2, Ambu« aScopeÖ 5 Broncho 4.2/2.2, Ambu« aBoxÖ 2 |
Ambu A/S |
Karina Matthiesen |
| K222773 |
08/17/2023 |
Feeding Tube |
Anhui Tiankang Medical Technology Co., Ltd. |
Zhang Yong |
| K222772 |
08/17/2023 |
Oral/Enteral Syringe with ENFit connector |
Anhui Tiankang Medical Technology Co., Ltd. |
Zhang Yong |
| K230756 |
08/12/2023 |
TK Pre-Filled Normal Saline Flush Syringe |
Anhui Tiankang Medical Technology Co., Ltd. |
Bai Baodong |
| K223584 |
08/12/2023 |
Pre-Filled Normal Saline Flush Syringe |
Anhui Tianyang Pharmaceutical Co., Ltd. |
Zhang Shunlin |
| K223538 |
08/17/2023 |
Integrity Implant |
Anika Therapeutics, Inc. |
Wei Zhao |
| K230672 |
08/04/2023 |
Annabella Breast Pump |
Annabella Ltd. |
Uri Yaffe |
| K231094 |
08/15/2023 |
Annalise Enterprise CTB Triage-OH |
Annalise-AI Pty Ltd |
Haylee Bosshard |
| K223883 |
08/18/2023 |
Daye Tampon |
Annes Daye Ltd |
Valentina Milanova |
| K230079 |
08/23/2023 |
Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential |
Ansell Healthcare Products, LLC. |
Don Cronk |
| K223500 |
08/10/2023 |
SuperBall Meniscal Repair System |
Arcuro Medical Ltd. |
Lee Ranon |
| K232343 |
08/30/2023 |
AC3Ö Series IABP |
Arrow International, LLC |
Sheila Payzant |
| K231857 |
08/08/2023 |
Arthrex TightRope II |
Arthrex Inc. |
Kristi Frisch |
| K230976 |
08/24/2023 |
Arthrex Radiopaque FiberTape Cerclage sutures |
Arthrex, Inc |
Stacy Valdez |
| K231323 |
08/31/2023 |
Ancora-SB |
Aspero Medical, Inc. |
Mark Rentschler |
| K232015 |
08/03/2023 |
ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0) |
ATMOS MedizinTechnik GmbH & Co. KG |
Reinhold Storch |
| K220938 |
08/22/2023 |
Nova HD+ |
Aura Wellness, LLC |
Scott Blomberg |
| K223303 |
08/30/2023 |
SpineryÖ RF Ablation System |
Axon Spine Medical System |
Salvatore Accardo |
| K223479 |
08/16/2023 |
AQUAbase nX |
B. Braun Medical Inc. |
Rushtin Chaklader |
| K223539 |
08/18/2023 |
Dreem 3S |
Beacon Biosignals, Inc. |
Delphine Lemoine |
| K221114 |
08/02/2023 |
Immunoglobulin G (IgG) |
Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. |
Tracy Jin |
| K223590 |
08/23/2023 |
Access Folate Assay |
Beckman Coulter, Inc. |
Dr. Kuljeet Kaur |
| K213670 |
08/25/2023 |
BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes |
Becton Dickinson and Company |
Katherine Kenner Lemus |
| K222563 |
08/31/2023 |
BD Kiestra IdentifA |
Becton, Dickinson and Company |
Laura Stewart |
| K230172 |
08/12/2023 |
Pulse Oximeter |
Beijing Choice Electronic Technology Co., Ltd. |
Haiying Zhao |
| K223713 |
08/07/2023 |
Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate |
Better Care Plastic Technology Co., Ltd |
Zhu Chunyan |
| K222245 |
08/21/2023 |
ACR Screw System |
BioMaterials Korea, Inc |
Young-yeop Kim |
| K222972 |
08/25/2023 |
BioProtect Balloon ImplantÖ System |
BioProtect, Ltd. |
Itay Barnea |
| K223856 |
08/11/2023 |
NuEra Tight RF Family |
BIOS s.r.l. |
Manuela Brambilla |
| K231963 |
08/01/2023 |
REAL INTELLIGENCEÖ CORIÖ |
Blue Belt Technologies, Inc. |
Corrine Herlinger |
| K230268 |
08/10/2023 |
ZenPro 40 |
Bluecore Company Co Ltd |
Bill Choi |
| DEN220073 |
08/16/2023 |
Revi System |
BlueWind Medical Ltd. |
Roni Diaz |
| K221361 |
08/29/2023 |
circulÖ pro Ring |
BodiMetrics, LLC |
Mark Goettling |
| K231328 |
08/19/2023 |
LUX-Dx II (M302); LUX-Dx II+ (M312) |
Boston Scientific Corp |
Melissa Klamerus |
| K232162 |
08/14/2023 |
Autotome Pro RX 39 Sphincterotome; Autotome Pro RX 44 Sphincterotome; Jagtome Pro RX 44 Sphincterotome; Jagtome Pro RX 39 Sphincterotome; Dreamtome Pro RX 44 Sphincterotome; Hydratome Pro RX 44 Sphincterotome; Jagtome Revolution Pro RX 39 Sphincterotome |
Boston Scientific Corporation |
Stephanie Gorman |
| DEN230019 |
08/18/2023 |
AXIOS Stent and Electrocautery-Enhanced Delivery System (10mm x 10mm Stent); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mm x 10mm Stent) |
Boston Scientific Corporation |
Alexis Erazo |
| K223633 |
08/08/2023 |
RubiconÖ Control Support Catheter (H749394323506A1) |
Boston Scientific Corporation |
Mary-Jo Foley |
| K230551 |
08/08/2023 |
Visual-ICE Cryoablation System |
Boston Scientific Corporation |
Amy McKinney |
| DEN220052 |
08/22/2023 |
BrachyGel Vaginal Hydrogel Packing System |
BrachyFoam, Inc. d/b/a Advaray |
Timothy Showalter, MD, MPH |
| K223553 |
08/02/2023 |
Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine |
Brainlab AG |
Sadwini Suresh |
| K231656 |
08/30/2023 |
Brainomix 360 e-MRI |
Brainomix Limited |
Zsolt Szrnka |
| K230415 |
08/17/2023 |
Cadwell Guardian |
Cadwell Industries, Inc. |
Jason Ford |
| K230355 |
08/30/2023 |
Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR |
Canon Medical Systems Corporation |
Janine F Reyes |
| K232132 |
08/03/2023 |
LifeSPARC System |
CardiacAssist, Inc. |
Arielle Drummond |
| K232058 |
08/03/2023 |
YosemiteView 4343W/YosemiteView 3643W |
CareRay Digital Medical Technology Co., Ltd. |
Xu Wei |
| K231676 |
08/28/2023 |
CALLISTO eye |
Carl Zeiss Meditec AG |
Hans-Joachim Miesner |
| K223787 |
08/04/2023 |
ECGenius System |
Cath Vision ApS |
Mads Matthiesen |
| K231481 |
08/17/2023 |
Xpert Xpress CoV-2/Flu/RSV plus |
Cepheid« |
Suzette Chance |
| K232052 |
08/08/2023 |
Ceribell Instant EEG Headband |
Ceribell, Inc. |
Raymond Woo |
| K231204 |
08/18/2023 |
CochlearÖ Osia« System; CochlearÖ Osia« OSI300 Implant; CochlearÖ Magnet Cassette; CochlearÖ Non-Magnetic Cassette; CochlearÖ Osia« 2(I) Sound Processor; CochlearÖ Osia« Fitting Software 2; CochlearÖ Osia« Smart App |
Cochlear |
Denis DiMartino |
| K231604 |
08/24/2023 |
Instrument Case |
Cochlear Americas |
Whitney Alexander |
| K231942 |
08/02/2023 |
Mineral Collagen Composite Bioactive Extra Moldable |
Collagen Matrix, Inc. |
Victoria Augustine |
| K230165 |
08/25/2023 |
Luja CoudΘ (20118 Male CH8 - small packaging (Pocket size)), Luja CoudΘ (20111 Male CH10 - small packaging (Pocket size)), Luja CoudΘ (20112 Male CH12 - small packaging (Pocket size)), Luja CoudΘ (20114 Male CH14 - small packaging (Pocket size)), Luja Cou |
Coloplast |
Troy Thome |
| K223821 |
08/02/2023 |
Self-Cath Closed System |
Coloplast |
Preeti Jain |
| K232116 |
08/16/2023 |
CoreLink Navigation Instruments |
CoreLink, LLC |
Steven Mounts |
| K232126 |
08/16/2023 |
EEAÖCircular Stapler with Tri-StapleÖ Technology and OrVilÖ Transoral Circular Stapler Anvil |
Covidien |
Helen Chen |
| K223130 |
08/30/2023 |
ShileyÖ Pediatric Oral/Nasal Endotracheal Tube with TaperGuardÖ Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160) |
Covidien |
Anila Tarte |
| K231491 |
08/16/2023 |
TAÖ Stapler and Loading Unit with DST SeriesÖ Technology |
Covidien |
Emily Jacobs |
| K231506 |
08/24/2023 |
Current Health System |
Current Health Ltd |
Giovanni Maggi |
| K230126 |
08/04/2023 |
Dentis s-Clean Regular Abutment |
Dentis Co., Ltd |
Gyu Ri Kim |
| K231503 |
08/22/2023 |
CUPTIMIZEÖ Advanced |
DePuy Orthopaedics, Inc |
Sierra Robinson |
| K220253 |
08/18/2023 |
Eco Abutment, Multiunit Abutment |
DIO Corporation |
Cho Hye-won |
| K230642 |
08/11/2023 |
Electronic Blood Pressure Monitor |
Dongguan kangweile Electronic Technology Co., Ltd. |
Zhixin Gao |
| K230610 |
08/23/2023 |
Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (Level 3, MF2104 Series), Disposable Surgical Gown (Level 4, MF2105 Series) |
Dongguan Shin Yi Healthcare Products Factory |
Shuge Zhao |
| K231370 |
08/04/2023 |
Dewin Blastocyst Medium (with HSA and without HSA) |
DonneVie Medical Technology (Shanghai) Co. Ltd. |
Hannah Hang Yin |
| K231959 |
08/01/2023 |
EXPD 4357; EXPD 4357P |
DRTECH Corporation |
Lee Youna |
| K230871 |
08/17/2023 |
EXTRON 5; EXTRON 7 |
DRTECH Corporation |
Kim Minjeong |
| K231126 |
08/02/2023 |
Eblator Device |
E Surgical, LLC |
Michael Blomeyer |
| K230579 |
08/18/2023 |
Smart Wedge algorithm |
Edwards Lifesciences, LLC |
Jennifer Wilbur |
| K231905 |
08/14/2023 |
Electro-Spec Steri-Caps |
Electro-Spec, Inc |
Jeff Smith |
| K231409 |
08/11/2023 |
Erchonia FX-405 |
Erchonia Corporation |
Travis Sammons |
| K232313 |
08/29/2023 |
LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320) |
Ethicon Endo Surgery, LLC. |
Lakrisha Tinner |
| K232100 |
08/08/2023 |
Efai Pacs Picture Archiving and Communication System Pro |
Ever Fortune.AI Co., Ltd. |
Joseph Chang |
| K222443 |
08/09/2023 |
Air Smart Extra Spirometer |
FeelLife Health Inc. |
May Xiao |
| K232226 |
08/29/2023 |
ARROW Off-Centred Humeral Insert |
FH Industrie |
Naoual Rahimi |
| K231602 |
08/01/2023 |
Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing |
GA Health Company Limited |
Cindy Ye |
| K230626 |
08/11/2023 |
PortraitÖ Central Viewer Application (Portrait CV A01), Portrait Ö Core Services (Portrait CSS01), PortraitÖ Clinical Alarming Unit (Portrait CAU01); PortraitÖ Mobile Patient Monitor (Portrait HUB01), PortraitÖ Sensor Battery (Portrait SBT01), PortraitÖ B |
GE Medical Systems Information Technologies, Inc. |
Joel Kent |
| K231301 |
08/15/2023 |
Vscan Air |
GE Medical Systems Ultrasound and Primary Care Diagnostics |
Bush Lee |
| K230620 |
08/08/2023 |
Gentuity« HF-OCT Imaging System with Vis-Rx« Micro-Imaging Catheter |
Gentuity, LLC |
Padmini Gagnon |
| K230588 |
08/17/2023 |
Aer-O-Scope Colonoscope System |
GI View Ltd. |
Sharon Goldfarb |
| K221894 |
08/03/2023 |
Lumbar Expandable lnterbody Spacers -Additional Indications/Implants |
Globus Medical Inc. |
Kelly Baker |
| K231333 |
08/04/2023 |
STRETTOÖ Cable System |
Globus Medical Inc. |
Jennifer Antonacci |
| K223114 |
08/02/2023 |
Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors |
Gm Dos Reis Industria E Comerico Ltda |
Iara Guimaraes |
| K223507 |
08/04/2023 |
CL-DP40 (DrÆs Light PRIME), CL-DP40 (DrÆs Light CHOICE) |
Good Doctors Co., Ltd. |
Heeseop Lim |
| K232039 |
08/09/2023 |
Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate |
Grand Work Plastic Products Co., Ltd. |
Wu Yuli |
| K230420 |
08/11/2023 |
Dr. pen Microneedling System |
Guangzhou Ekai Electronic Technology Co., Ltd. |
Guihua Chen |
| K231164 |
08/09/2023 |
Conductive carbon film electrode |
Guangzhou Xinbo Electronic Co., Ltd. |
Sammy Li |
| K231167 |
08/09/2023 |
Conductive Silicone Rubber Electrode |
Guangzhou Xinbo Electronic Co., Ltd. |
Sammy Li |
| K231205 |
08/22/2023 |
GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray |
GuruNanda LLC |
Puneet Nanda |
| K230298 |
08/16/2023 |
Celsi Monitor |
Hadleigh Health Technologies |
Molly McCabe |
| K231389 |
08/16/2023 |
Harvest Dental HD Gum Strip |
Harvest Dental Products, LLC |
Colleen Boswell |
| K213271 |
08/31/2023 |
MedicloseTM System |
Health Value Creation BV, trading as Corporis Medical |
Kim Sondeijker |
| K231404 |
08/04/2023 |
T-Button« A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button« S Adjustable Loop UHMWPE Suture PEEK Button, Open Button |
Healthium Medtech Limited |
Pankaj Dawar |
| K232215 |
08/24/2023 |
Quantra Hemostasis Analyzer |
HemoSonics, LLC |
Debbie Winegar |
| K223551 |
08/03/2023 |
Sterile Water for Inhalation in 1L Flexoval « bottles. |
Hometa Inc |
Raza Mohammed |
| K223922 |
08/16/2023 |
SOMNUM (V.1.1.2.) |
Honeynaps Co., Ltd |
Tony Lee |
| K231829 |
08/15/2023 |
Xenix Medical Sacroiliac Fixation System |
HT Medical d.b.a. Xenix Medical |
Teresa Cherry |
| K230625 |
08/10/2023 |
ReliOn Premier BLU Blood Glucose Monitoring System |
i-SENS, Inc. |
H.S. Yoo |
| K223606 |
08/24/2023 |
LifeShieldÖ Infusion Safety Software Suite |
ICU Medical, Inc. |
Pernell Abrantes |
| K223607 |
08/24/2023 |
Plum DuoÖ Infusion System |
ICU Medical, Inc. |
Yuliya Matlin |
| K232006 |
08/04/2023 |
LEGACY« IPC |
IG Technology Ltd |
Ivan Green |
| K223133 |
08/03/2023 |
VisiRad XR |
Imidex Inc. |
Kris Zeschin |
| K223867 |
08/18/2023 |
IDS ACTH II |
Immunodiagnostic Systems Limited |
Mick Henderson |
| K231087 |
08/16/2023 |
Guided Surgery Kit |
Implant Direct Sybron Manufacturing, LLC |
Reina Choi |
| K231455 |
08/15/2023 |
Implant-One System |
Implant Logistics, Inc. |
Thomas Arendt |
| K231174 |
08/02/2023 |
BPBIO750 |
InBody Co, Ltd. |
Kichul Cha |
| K230376 |
08/07/2023 |
Reprocessed Agilis NxT Steerable Introducer |
Innovative Health, LLC. |
Rick Ferreira |
| K223608 |
08/10/2023 |
GEM Premier 7000 with IQM3 |
Instrumentation Laboratory Company |
Gabriella Erdosy |
| K231098 |
08/07/2023 |
LineSider« Spinal System |
Integrity Implants Inc. |
Alexa Kamer |
| K223660 |
08/14/2023 |
SaintView |
Inviz Corporation |
Priscilla Chung |
| K230380 |
08/03/2023 |
Surgical Face Masks, Model: EFMDS-L50Pn BLU |
Iris USA |
Michael Cruz |
| K231557 |
08/24/2023 |
ZENEX FreeMilling & CCM Cast Abutment |
Izenimplant Co., Ltd. |
Ji-Hwan Jeong |
| K230663 |
08/14/2023 |
Density |
Jeisys Medical Inc. |
Bora Kim |
| K223709 |
08/16/2023 |
Kyphoplasty Balloon Catheter |
Jiangsu Changmei Medtech Co., Ltd. |
Yang Lifan |
| K230566 |
08/25/2023 |
Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor |
Joytech Healthcare Co.,Ltd |
Ren Yunhua |
| K223519 |
08/11/2023 |
Carex Hybrid Personal Lubricant |
Karex Industries Sdn. Bhd. |
Lai Peng Lim |
| K222128 |
08/08/2023 |
Protective Gown AAMI Level 4 |
Kenpax International Limited |
Solomon Chen |
| K223533 |
08/31/2023 |
Little Wave Arc; Little Wave Flip |
Ki Mobility LLC |
Mark Murphy |
| K223527 |
08/31/2023 |
Little Wave Clik, Rogue XP, Little Wave XP, Spark |
Ki Mobility LLC |
Mark Murphy |
| K231435 |
08/28/2023 |
KIMTECHÖ PolarisÖ Xtra Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid |
Kimberly-Clark Corporation |
Kimberly Tempas |
| K231872 |
08/25/2023 |
Polaris Bipolar Electrosurgical Generator (29-1000); Polaris Irrigation Module (29-1600); Polaris Light Source Module (29-1900); Dual Footswitch (29-1020) |
Kirwan Surgical Products LLC |
Matthew Prario |
| K220085 |
08/24/2023 |
KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit |
KRONUS, Inc. |
Delaney Sauer |
| K231680 |
08/24/2023 |
AccelFix Lumbar Expandable Cage System |
L&K BioMed Co., Ltd. |
Katherine Kim |
| K232311 |
08/14/2023 |
LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System |
L&K Biomed Co., Ltd. |
Katherine Kim |
| K223673 |
08/04/2023 |
Surgeon Controlled Arm |
Levita Magnetics International Corp. |
Alberto Rodriguez-Navarro, MD |
| K232127 |
08/15/2023 |
21HQ513D, 32HL512D, 31HN713D, 32HQ713D |
LG Electronics Inc. |
Daseul An |
| K231422 |
08/28/2023 |
Precision GI |
Limaca Medical Ltd |
Assaf Klein |
| K231823 |
08/11/2023 |
NOxBOXi Nitric Oxide Delivery System |
Linde Gas & Equipment Inc. |
Dave Loflin |
| K232291 |
08/24/2023 |
Essenz HLM, Essenz ILBM |
LivaNova Deutschland GmbH |
Florian Goetz |
| K231731 |
08/21/2023 |
Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4 |
McGovern Medical School |
K. Lance Gould |
| K232144 |
08/18/2023 |
Sterile Products of the APTUS System |
Medartis AG |
Claudia De Santis |
| K232324 |
08/30/2023 |
StealthFix Intraosseous Fixation System |
Medartis Inc. |
Chelsea Kozior |
| K230577 |
08/16/2023 |
Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL) |
Medcare Saglik Urunleri Sanayi Ve Ticaret Anonim Sirketi |
Muge Ersahin |
| K220828 |
08/07/2023 |
SQA-iO Sperm Quality Analyzer |
Medical Electronic Systems LTD |
Marcia Deutsch |
| K223813 |
08/21/2023 |
Aveta System 2.0 |
Meditrina, Inc. |
Csaba Truckai |
| K231418 |
08/14/2023 |
ENDOGATORÖ Hybrid Irrigation Tubing |
Medivators |
Disha Kabrawala |
| K231885 |
08/09/2023 |
Medline UNITE« REFLEX« Nitinol Staple System |
Medline Industries, LP |
Jennifer Mason |
| K232141 |
08/16/2023 |
CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System (Modular Extended Tab Head) |
Medtronic Sofamor Danek USA, Inc. |
Kelly McDonnell |
| K232190 |
08/22/2023 |
6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter |
Medtronic Vascular |
Colleen Gentile |
| K231580 |
08/30/2023 |
NIMÖ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35) |
Medtronic Xomed, Inc. |
Alexandra Oliver |
| K232218 |
08/24/2023 |
ZeniusÖ Spinal System |
Medyssey USA, Inc. |
Youngsu Jang |
| K231246 |
08/30/2023 |
VentraxÖ Delivery System (VTR851) |
Merit Medical Systems, Inc. |
Jenny Soderquist |
| K230364 |
08/25/2023 |
VitalFlowÖ Console |
Michigan Critical Care Consultants, Inc. (d.b.a MC3 Inc.) |
Martha Rumford |
| K223898 |
08/25/2023 |
VitalFlowTM Centrifugal Pump |
Michigan Critical Care Consultants, Inc. (d.b.a MC3 Inc.) |
Martha Rumford |
| K230155 |
08/30/2023 |
Mick Valencia Applicator Set |
Mick Radio-Nuclear Instruments, Inc. |
James Hurlman |
| K230690 |
08/17/2023 |
Tandry Locking Plate System |
Microware Precision Co., Ltd. |
Harrison Du |
| K220145 |
08/24/2023 |
Monaghan medical filtered mouthpiece kit |
Monaghan Medical Corporation |
Cari J Reil |
| K231274 |
08/24/2023 |
Natural Cycles |
Natural Cycles Nordic AB |
Raoul Scherwitzl, PhD |
| K231018 |
08/14/2023 |
Yomi Robotic System |
Neocis Inc. |
Joshua Davis |
| K230581 |
08/16/2023 |
TOPA12 Portable X-ray Unit |
NEUF Inc. |
Woo Sang Lee |
| K221959 |
08/31/2023 |
Q21 |
NeuroField Inc. |
Nicholas J. Dogris |
| K230314 |
08/16/2023 |
Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors) |
New Era Medicare Sdn. Bhd. |
Fatin Nor Irdina binti Ahmad Fauzi |
| K231763 |
08/21/2023 |
Stable-C Interbody System |
Nexus Spine, LLC |
Jared Crocker |
| K223431 |
08/04/2023 |
Citric Complete Liquid Citric Acid Concentrate |
Nipro Renal Solutions USA, Corp. |
Vincent DeGrandchamp |
| K223468 |
08/30/2023 |
Nexis« compressive screws |
Novastep |
Gilles Audic |
| K231255 |
08/25/2023 |
NovoFine« Plus |
Novo Nordisk Inc. |
Hiral Palkhiwala Shah |
| K223445 |
08/10/2023 |
ArtiFascia |
Nurami Medical Ltd. |
Hannoch Marksheid |
| K230765 |
08/29/2023 |
Precice Ankle Salvage System |
NuVasive Specialized Orthopedics, Inc. |
Miriam Cervantes |
| K230632 |
08/11/2023 |
VersiHD with GuideMe software |
NxStage Medical, Inc. |
Denise Oppermann |
| K223367 |
08/30/2023 |
Ochsner Connected Inhaler Sensor |
Ochsner Clinic Foundation |
Hakm Murad |
| K231777 |
08/18/2023 |
Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W) |
Olympus Winter & Ibe GmbH |
Ian Pericevic |
| K222946 |
08/23/2023 |
Oneday Mini Implant System |
Oneday Biotech Co., Ltd. |
Jae Hyun Song |
| K223573 |
08/18/2023 |
Onera Sleep Test System (Onera STS) |
Onera B.V. |
Ruben de Francisco Martin |
| K231673 |
08/18/2023 |
P200TE (A10700) |
Optos Plc |
Rachel Reay |
| K231525 |
08/09/2023 |
VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack |
Ortho Clinical Diagnostics |
Declan Hynes |
| K231517 |
08/23/2023 |
VITROS Immunodiagnostic Products CEA Reagent Pack |
Ortho Clinical Diagnostics |
Rebecca Lewis |
| K213418 |
08/30/2023 |
MONTAGE Settable, Resorbable Hemostatic Bone Putty |
Orthocon, Inc. |
Howard Schrayer |
| K231903 |
08/25/2023 |
Montage-QS Settable, Resorbable Bone Putty |
Orthocon, Inc. |
Aniq Darr |
| K231266 |
08/21/2023 |
Pediatric Nailing Platform Tibia |
OrthoPediatrics Corp. |
Yan Li |
| K223924 |
08/08/2023 |
LW Implant System |
Ossvis Co., Ltd. |
Young Jae Kim |
| K223463 |
08/11/2023 |
Otsuka Digital Feedback Device-RW |
Otsuka America Pharmaceutical, Inc. |
Nancy Teague |
| K231496 |
08/22/2023 |
TITAN 3-D Wedge System |
Paragon 28 Inc |
Haylie Hertz |
| K231867 |
08/21/2023 |
Grappler Suture Anchor System |
Paragon 28, Inc. |
Edward Wells-Spicer |
| K223874 |
08/15/2023 |
BAROguard |
Paragonix Technologies |
Nathan Yetton |
| K223840 |
08/11/2023 |
eRapid Nebulizer System |
PARI Respiratory Equipment, Inc. |
Michael Judge |
| K232030 |
08/02/2023 |
Ingenia Elition R5.7.1 SP4 MR Systems |
Philips Medical Systems Nederland B.V. |
Ioana Ulea |
| K223574 |
08/22/2023 |
IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062), IntelliVue Patient Monitor MX500 (866064), IntelliVue Patient Monitor MX550 (866066) |
Philips Medizin Systeme Boeblingen GmbH |
Siegfried Breitling |
| K231123 |
08/30/2023 |
Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Case - classic flat pack (CL-02); Phoenix Contact Lens Case - sunglass shape flat pack (CL-03) |
Phoenix Innovative Healthcare Manufacturers Pvt. Ltd. |
Michael Stuart |
| K222148 |
08/16/2023 |
HemoScreen Hematology Analyzer |
PixCell Medical Technologies, Ltd. |
Yaara Ben Yosef |
| K231096 |
08/18/2023 |
Automatic Continuous Effusion Shunt (ACES) System ACES System |
Pleural Dynamics, Inc. |
Martin Mayse |
| K230384 |
08/11/2023 |
PolyWear« Personal Protective Level 3 Gown |
Polyconversions, INC |
William Smith |
| K231407 |
08/29/2023 |
StarFin |
Premium Medical Technology LLC |
Kuowei Chang |
| K231696 |
08/11/2023 |
Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal |
Prevest Denpro Limited |
Atul Modi |
| K231024 |
08/30/2023 |
AquaBeam Robotic System |
PROCEPT BioRobotics Corporation |
Sara Muddell |
| K230297 |
08/11/2023 |
PMT Expandable Cage (PMT EXP) |
Providence Medical Technology, Inc |
Edward Liou |
| K230304 |
08/09/2023 |
Polyisoprene Surgical Gloves |
Puyang Linshi Medical Supplies Co., Ltd. |
Catherine Liu |
| K222786 |
08/25/2023 |
072 Aspiration System |
QÆApel Medical, Inc. |
Kim Ky |
| K230899 |
08/22/2023 |
qXR-PTX-PE |
Qure.ai Technologies |
Ayushi Mahendra |
| K232008 |
08/08/2023 |
Disposable Medical Examination Nitrile Gloves |
Raxwell Industrial LLC |
Xianda Yao |
| K232287 |
08/31/2023 |
RAYSCAN a-Expert3D |
Ray Co., Ltd. |
Sooji Huh |
| K230094 |
08/25/2023 |
Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors |
Responsive Arthroscopy LLC |
Garrett Ahlborg |
| K231458 |
08/03/2023 |
Extremity Staple |
restor3d |
Anika Moorjani |
| K232153 |
08/18/2023 |
AvΘli |
Revelle Aesthetics, Inc. |
Melissa Viotti |
| K231278 |
08/01/2023 |
Knotless Suture Anchor |
Riverpoint Medical, LLC |
Bianca Silva de Sousa |
| K213131 |
08/10/2023 |
Accu-Chek Guide Solo diabetes manager blood glucose monitoring system |
Roche Diabetes Care GmbH |
Wolfgang Handel |
| K213134 |
08/10/2023 |
Accu-Chek Solo micropump system with interoperable technology |
Roche Diabetes Care GmbH |
Wolfgang Handel |
| K222525 |
08/28/2023 |
Alveoair Digital Spirometer |
Roundworks Technologies Private Limited |
Prashant Patel |
| K231583 |
08/15/2023 |
Route 92 Medical Full Length 054 Access System |
Route 92 Medical, Inc. |
Kirsten Valley |
| K231838 |
08/15/2023 |
RxSight« Insertion Device (63002) |
RxSight, Inc. |
Maureen OConnell |
| K223122 |
08/03/2023 |
MENIX«; MENIX« DUO |
S.B.M. SAS (Science & Bio Materials) |
Anne Cospin-Latapie |
| K231439 |
08/11/2023 |
Powder Free White, Black, and Purple Nitrile Examination Glove |
S&S Glove Corporation |
Poppy Farrah Rossa |
| K221138 |
08/04/2023 |
Titus Titanium Cervical by SAGICO |
SAGICO VA USA, LLC |
James Gibson |
| K223560 |
08/21/2023 |
Plato 17 Microcatheter |
Scientia Vascular Inc |
Max Alfonso |
| K231954 |
08/01/2023 |
Aristotle 18 Guidewire; Aristotle 24 Guidewire |
Scientia Vascular, Inc. |
Bailey Johannsen |
| K231654 |
08/03/2023 |
NorthStar OCT System |
SeaSpine Inc. |
Jesse Albright |
| K230486 |
08/21/2023 |
Cove Strip |
SeaSpine Orthopedics Corporation |
Cindy Toyama |
| K232185 |
08/21/2023 |
SM-IV |
Sedecal SA |
M¬ Luisa G≤mez de Agⁿero |
| K222993 |
08/18/2023 |
Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, Green Tested For Use with 13 Chemotherapy Drugs; Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, White Tested For Use with 32 Chemotherapy Drugs |
Sentienx Sdn Bhd |
Sahrudin Shah Bin Abu Bakar |
| K231183 |
08/25/2023 |
Non absorbable Surgical Polyester Suture |
Shandong Haidike Medical Products Co.,Ltd. |
Yan Wang |
| K231408 |
08/11/2023 |
Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile |
Shandong Intco Medical Products Co, Ltd. |
Max Li |
| K222103 |
08/24/2023 |
Nitrile Patient Examination Gloves, Powder Free, Pink Color |
Shandong YINGHNG Medical Products Co., Ltd. |
Emily Dong |
| K230447 |
08/16/2023 |
Sterile Syringe Bulk Tray |
Shanghai Kindly Enterprise Development Group Co., Ltd |
Hualong Liu |
| K230342 |
08/16/2023 |
Phototherapy System (OL-PDT950) |
Shanghai Omni Laser Skinology Co., Ltd. |
Avril Ouyang |
| K230162 |
08/01/2023 |
uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy Analysis |
Shanghai United Imaging Healthcare Co., Ltd. |
Xin Gao |
| K232353 |
08/31/2023 |
Powder Free Nitrile Examination Gloves (Black) |
Shanxi Hongjin Plastic Technology Co., Ltd. |
Wu Zhigang |
| K231026 |
08/18/2023 |
12MP Color LCD Monitor C1216W, C12*** (* = 0 to 9, A to Z or blank, and the difference among models means the product is named according to different appearance colors and customer models) |
Shenzhen Beacon Display Technology Co.,Ltd. |
Li Yafei |
| K230409 |
08/25/2023 |
Wrist Type Blood Pressure Monitor (W05,W1101L) |
Shenzhen Jamr Technology Co., Ltd. |
Haiyu Zhang |
| K231085 |
08/18/2023 |
1.5T HD T/R Knee Array (10-F34127) |
Shenzhen RF Tech Co., Ltd. |
Wang Gary |
| K231961 |
08/30/2023 |
NIBPCuff |
Shenzhen SINO-K Medical Technology Co.,Ltd |
Lao Chengxin |
| K223807 |
08/25/2023 |
Reusable Temperature Probe, Disposable Temperature Probe |
Shenzhen SINO-K Medical Technology Co.,Ltd |
Lao Chengxin |
| K223711 |
08/10/2023 |
ANNE One |
Sibel Health Inc. |
Sarah Coughlin |
| K231750 |
08/15/2023 |
MA012 Aluminum wheelchair, MS019 steel wheelchair |
Sichuan AST Medical Equipment Co., Ltd. |
Mae Tse |
| K222439 |
08/08/2023 |
Atellica« CH Phencyclidine (Pcp), Atellica« CH Vancomycin (Vanc) |
Siemens Healthcare Diagnostics Inc. |
Joy Anoop |
| K232214 |
08/25/2023 |
OMNI Surgical System |
Sight Sciences Inc., |
Ranjani Madhavan |
| K223912 |
08/17/2023 |
InterCollagen« Guide |
SigmaGraft Inc. |
Elcin Chang |
| K230013 |
08/30/2023 |
Silk'n Titan Allways |
Silk'n Beauty Ltd. |
Amit Goren |
| K231286 |
08/02/2023 |
Chemfort« Catheter Adaptor |
Simplivia Healthcare LTD. |
Shay Shaham |
| K231623 |
08/28/2023 |
Distal Elbow Plating System |
Skeletal Dynamics Inc |
Alexandra Rodriguez Rojas |
| K231626 |
08/31/2023 |
OSPREY Closed IV Catheter System (OspreyV2) |
SkyDance Vascular, Inc. |
Scott Pease |
| K223163 |
08/18/2023 |
Sleepiz One+ |
Sleepiz AG |
Marta Stepien |
| K231620 |
08/01/2023 |
Nuubo Smart |
Smart Solutions Technologies SL |
Borja Gonzal Vez |
| K231276 |
08/30/2023 |
SmartCardia 7L Platform |
SmartCardia SA |
Srinivasan Murali |
| K230613 |
08/02/2023 |
SKEEPER |
Smartsound Corporation |
Jungho Lee |
| K231394 |
08/09/2023 |
Intense Pulsed Light System |
Smedtrum Medical Technology Co., Ltd. |
Crimson Wu |
| K231376 |
08/09/2023 |
Q-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX With Needles, Minitape) |
Smith & Nephew Inc. |
Pragnya Bakka |
| K223526 |
08/18/2023 |
ALLEVYN Ag+ Border Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Border Sacrum Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Surgical Antimicrobial Silicone Gel Adhesive Com |
Smith & Nephew Medical Limited |
Hannah Sharp |
| K232005 |
08/04/2023 |
HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue Cobraid) |
Smith & Nephew, Inc. |
Camille Fleischer |
| K231537 |
08/28/2023 |
SofWave System |
Sofwave Medical Ltd. |
Ruthie Amir, MD |
| K230159 |
08/28/2023 |
SoundBite« Crossing System XS Peripheral |
Soundbite Medical Solutions, Inc. |
Diane Marceau |
| K230873 |
08/01/2023 |
Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments |
Southern Implants (Pty) Ltd |
Colin Saffy |
| K230607 |
08/14/2023 |
SPICCA Cervical Fusion Cages |
Southern Medical (Pty) Ltd |
Nathan Wright |
| K230608 |
08/14/2023 |
SPICCA Stand-Alone Cervical Fusion Cages |
Southern Medical (Pty) Ltd |
Dalene Styger |
| K231457 |
08/18/2023 |
SPARK Scan |
SPARK Neuro Inc. |
Marinela Gombosev |
| K223542 |
08/03/2023 |
TubaVent Balloon Dilatation System |
Spiggle & Theis Medizintechnik GmbH |
Claudia Winterschladen |
| K231593 |
08/02/2023 |
Sapphire X3 Anterior Cervical Plate System |
Spinal Elements, Inc |
Julie Lamothe |
| K223167 |
08/17/2023 |
Spirair Nasal Septal Strap |
Spirair, Inc. |
James Kintzing |
| K231488 |
08/07/2023 |
CelerityÖ HP Chemical Indicator; CelerityÖ HP Multivariable Chemical Indicator; VERIFY HPU Chemical Indicator; VERIFY VH2O2 Indicator Tape |
STERIS |
Anthony Piotrkowski |
| K231490 |
08/07/2023 |
Celerity 20 HP Biological Indicator; VERIFY V24 Self-Contained Biological Indicator |
STERIS Corporation |
Gregory Land |
| K231501 |
08/07/2023 |
PRO-LITE Sterilization Tray |
STERIS Corporation |
Jennifer Nalepka |
| K223476 |
08/07/2023 |
V-PRO maX 2 Low Temperature Sterilization System |
Steris Corporation |
Anthony Piotrkowski |
| K231500 |
08/07/2023 |
Vis-U-All Low Temperature Sterilization Pouches |
Steris Corporation |
Jennifer Nalepka |
| K232157 |
08/18/2023 |
Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control |
Stryker Corporation |
Janki Bhatt |
| K231093 |
08/30/2023 |
AlphaVent Suture Anchors |
Stryker Endoscopy |
Katie Farraro |
| K231262 |
08/18/2023 |
Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System |
Stryker GmbH |
Danese Joiner-Fox |
| K231257 |
08/18/2023 |
Pangea Utility Plating System, Pangea Platform |
Stryker GmbH |
Danese Joiner-Fox |
| K231599 |
08/24/2023 |
Stryker MP, Mandible, HMMF and MMF AXS Screws |
Stryker Leibinger GmbH & Co. KG |
Amelia Kesti |
| K230733 |
08/05/2023 |
Stryker Resorbable Fixation System |
Stryker Leibinger GmbH & Co. KG |
Gregory Gohl |
| K231208 |
08/14/2023 |
Stryker Resorbable Fixation System |
Stryker Leibinger GmbH & Co. KG |
Gregory Gohl |
| K231611 |
08/31/2023 |
HOLO PortalÖ Surgical Guidance System |
Surgalign Spine Technologies |
Jeremy Markovich |
| K231831 |
08/03/2023 |
TiLink-L Joint Fusion System |
SurGenTec |
Andrew Shoup |
| K232295 |
08/30/2023 |
LAA Exclusion System |
Syntheon, LLC |
Toygar Unal |
| K231400 |
08/04/2023 |
Bladeless Trocar û Artemis Lap Cannula |
T.A.G. Medical Products Corporation, Ltd |
Shlomi Dines |
| K230419 |
08/03/2023 |
Sequel Tampon with Plastic Applicator |
Tampro Inc |
Greta Meyer |
| K223639 |
08/28/2023 |
VisAble.IO |
TechsoMed |
Dalia Dickman, PhD |
| K230603 |
08/30/2023 |
Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen SnapLock Adapter (Luer Connection) (CA-000010-19); Arrow Non-Stimulating Next Gen SnapLock Adapter (Neuraxial Connection) (CA-000014-19); Arrow Stimulating SnapLock Adap |
Teleflex Medical |
Kristen Bisanz |
| K231944 |
08/24/2023 |
CATAMARAN SI Joint Fusion System |
Tenon Medical, Inc. |
Susan Noreiga |
| K231053 |
08/18/2023 |
Unicare (K-UNICARE-USA) |
TensCare Ltd |
Saskia Eldridge-Hinmers |
| K231434 |
08/14/2023 |
DESS Dental Smart Solutions |
Terrats Medical SL |
Roger Terrats |
| K230832 |
08/16/2023 |
Powdered Free Sterile Natural Rubber Latex Surgical Gloves |
The Egyptian Company For Medical & Electronic Industries |
Alaa Elsayed |
| K231994 |
08/25/2023 |
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam-durlobactam in the dilution range of 0.015/4-32/4 ug/mL |
Thermo Fisher Scientific |
Cynthia Knapp |
| K231988 |
08/30/2023 |
Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dalbavancin in the dilution range of 0.0005-2╡g/ml |
Thermo Fisher Scientific |
Joel Mathew |
| K231433 |
08/31/2023 |
The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL |
Thermo Fisher Scientific |
Cynthia Knapp |
| K230014 |
08/25/2023 |
MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption |
Tonica Elektronik A/S |
Jan Kj°ller |
| K232387 |
08/28/2023 |
Treace Medical Concepts (TMC) Compression Implant System |
Treace Medical Concepts |
Brittany Grochala |
| K222635 |
08/04/2023 |
Premier Resolution System |
Trinity Biotech (Primus Corporation, dba Trinity Biotech) |
Kaitlyn Eastman |
| K232243 |
08/23/2023 |
EVO 700 series high speed handpiece |
Ttbio Corp. |
Sheng-Chieh Su |
| K232498 |
08/18/2023 |
UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio |
Ultradent Product, Inc. |
Ruth Gardner |
| K230928 |
08/25/2023 |
Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter |
Vein 360 LLC |
Suzanne Meyer |
| K230221 |
08/28/2023 |
QDOSE« Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy) |
Versant Medical Physics and Radiation Safety |
Darrell R. Fisher |
| K231493 |
08/11/2023 |
NITINEX Memory Compression Staple |
Vilex, LLC |
Brock Johnson |
| K231978 |
08/31/2023 |
BioSieveÖ Marijuana Test Panel 50; BioSieveÖ Marijuana Test Strip 50; BioSieveÖ Dx Marijuana Test Strip 20; BioSieveÖ Dx Marijuana Test Strip 50; BioSieveÖ Dx Marijuana Test Panel 20; BioSieveÖ Dx Marijuana Test Panel 50 |
VivaChek Biotech (Hangzhou) Co., Ltd |
Jessica Chen |
| DEN230003 |
08/03/2023 |
Viz HCM |
Viz.ai, Inc. |
Gregory Ramina |
| K231380 |
08/10/2023 |
AirLife DuoThermÖ Humidification System |
Vyaire Medical, Inc. |
Megan Walsh |
| K230488 |
08/31/2023 |
EL27-Compact; Sterile EHL-Probes |
Walz Elektronik GmbH |
Bernd Vollmer |
| K222888 |
08/11/2023 |
BlueStar CGM insulin dose calculator |
Welldoc, Inc. |
Ian Cadieux |
| K231289 |
08/30/2023 |
S-Patch Ex Wearable ECG Patch |
Wellysis Corp. |
DoGyun Im |
| K231807 |
08/15/2023 |
primaLOKÖ SP Interspinous Fusion System |
Wenzel Spine, Inc. |
William Wilson |
| K230812 |
08/23/2023 |
Withings Scan Monitor 2.0 |
Withings |
Khushboo Surendran |
| K223727 |
08/25/2023 |
Lavieen |
Won Tech Co., Ltd. |
Hyun Sik Yoon |
| K231054 |
08/14/2023 |
V-Laser |
WON TECH Co., Ltd. |
Hyun Sik Yoon |
| K230578 |
08/31/2023 |
Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl |
WRP Asia Pacific Sdn. Bhd. |
Saravanan Ramasamy |
| K231548 |
08/03/2023 |
Meical Diode Laser, Model S1Pro |
Wuhan Pioon Technology Co., Ltd. |
Feng Zhang |
| K223600 |
08/25/2023 |
Sterilization Wrap |
Wuhan Zonsen Medical Products Co., Ltd. |
Linna Ye |
| K231420 |
08/10/2023 |
Aura 10 PET/CT |
XEOS Medical |
Bjorn Delbeecke |
| K231510 |
08/22/2023 |
Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL) |
Xiantao Zhibo Non-Woven Products Co., Ltd. |
Fen Peng |
| K230748 |
08/02/2023 |
Disposable Ureteral Access Sheath |
YouCare Technology Co., Ltd. (Wuhan) |
Bing Hu |
| K231811 |
08/22/2023 |
Zavation Connector System |
Zavation Medical Products, LLC |
Noah Slack |
| K231616 |
08/31/2023 |
ZEUS IFA(TM) nDNA Test System, ZEUS dIFine |
ZEUS Scientific |
Mark Kopnitsky |
| K231341 |
08/14/2023 |
Organic cotton tampon, Viscose tampon |
Zhejiang Tianqing Manufacturing Technology Group Co., Ltd. |
Roy Du |
| K231114 |
08/09/2023 |
Zimmer« Natural Nail« System Cephalomedullary Nails; Affixus« Natural Nail« Humeral Nail System |
Zimmer Switzerland Manufacturing GmbH |
Annemie Kausch Rehor |
| K232150 |
08/18/2023 |
ZSFab Cervical Interbody System |
ZSFab Inc. |
Xuewei Ma |
