| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K232083 |
07/13/2023 |
BriefCase-Quantification |
Aidoc Medical, Ltd. |
Amalia Schreier |
| K232010 |
07/06/2023 |
iTEMPSHIELD |
AION Biosystems Inc. |
Joseph Azary |
| K232029 |
07/07/2023 |
VersaWrap Nerve Protector |
Alafair Biosciences Inc |
Angela Mallery |
| K232233 |
07/27/2023 |
Invisalign System with Mandibular Advancement Featuring Occlusal Blocks |
Align Technology, Inc. |
John Ray |
| K232035 |
07/07/2023 |
Impala |
AliveCor, Inc. |
Samip Shah |
| K232173 |
07/21/2023 |
Ascend VBR System, Ascend NanoTec VBR System |
Alphatec Spine, Inc. |
Sandy Gill |
| K232097 |
07/13/2023 |
IdentiTi ALIF Interbody Systems |
Alphatec Spine, Inc. |
Andrew Zhang |
| K232044 |
07/10/2023 |
Invictus Robotic Navigation Instruments |
Alphatec Spine, Inc. |
Unnati Bhuptani |
| K232275 |
07/31/2023 |
Invictus« Spinal Fixation System |
Alphatec Spine, Inc. |
Cynthia Dorne |
| K232088 |
07/13/2023 |
Altris IMS |
Altris, Inc. |
Andrew Kuropyatnyk |
| K232011 |
07/06/2023 |
Cleo |
American Orthodontics |
Laura Richmond |
| K231968 |
07/03/2023 |
Tactoset« Injectable Bone Substitute |
Anika Therapeutics, Inc. |
Wei Zhao |
| K231960 |
07/03/2023 |
NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether |
AnX Robotica Corporation |
Tim Thomas |
| K232017 |
07/07/2023 |
ARK Methotrexate II Assay |
ARK Diagnostics, Inc. |
Thomas Houts |
| K232211 |
07/26/2023 |
REUNION Sacroiliac Joint Fusion System |
Astura Medical |
Parker Kelch |
| K232015 |
07/06/2023 |
ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0) |
ATMOS MedizinTechnik GmbH & Co. KG |
Reinhold Storch |
| K231972 |
07/03/2023 |
Advanta VXT Vascular Graft, Flixene Vascular Graft |
Atrium Medical Corporation |
Hannah Scribner |
| K232057 |
07/11/2023 |
B▄HLMANN fCAL« turbo and CALEX« Cap |
B▄HLMANN Laboratories AG |
Laura Zurbrugg |
| K232084 |
07/13/2023 |
Stellaris Elite vision enhancement system |
Bausch and Lomb |
Rekha Janarthanan |
| K232164 |
07/21/2023 |
Access NT-proBNP |
Beckman Coulter Inc. |
Rachel Clark |
| K232175 |
07/21/2023 |
XN Knee Prosthesis System |
Beijing Chunlizhengda Medical Instruments Co. LTD |
Xie Fengbao |
| K232165 |
07/21/2023 |
Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single Use- Disposable Needles; Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles |
Berpu Medical Technology Co., Ltd. |
Buxin Yu |
| K232224 |
07/27/2023 |
iLet« Dosing Decision Software |
Beta Bionics, Inc. |
Liz Cooper |
| K232070 |
07/12/2023 |
Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black, Green) |
Better Care Plastic Technology Co., Ltd. |
Zhu Chunyan |
| K232266 |
07/31/2023 |
Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate |
Better Care Plastic Technology Co., Ltd. |
Zhu Chunyan |
| K232240 |
07/28/2023 |
Microwave Ablation System (BD-GT) |
Betters (Suzhou)Medical Co., Ltd. |
Lei Liu |
| K232241 |
07/28/2023 |
Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018) |
Betters(Suzhou) Medical Co., Ltd |
Lei Liu |
| K232201 |
07/25/2023 |
VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 ╡g/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 ╡g/mL), VITEK 2 Streptococcus Penicillin |
bioMerieux, Inc |
Jared Bronson |
| K231963 |
07/03/2023 |
REAL INTELLIGENCEÖ CORIÖ |
Blue Belt Technologies, Inc. |
Corrine Herlinger |
| K232162 |
07/21/2023 |
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 |
| K232038 |
07/10/2023 |
BioStar Single Use Transbronchial Aspiration Needle |
Broncus Medical, Inc. |
Charles Ogbonna |
| K232172 |
07/21/2023 |
BTL-785BNF Handpiece |
BTL Industries Inc. |
David Chmel |
| K232256 |
07/28/2023 |
Alcantara Thoracolumbar Plate System |
Camber Spine Technologies, LLC |
Brooks McAdam |
| K232132 |
07/18/2023 |
LifeSPARC System |
CardiacAssist, Inc. |
Arielle Drummond |
| K232058 |
07/11/2023 |
YosemiteView 4343W/YosemiteView 3643W |
CareRay Digital Medical Technology Co., Ltd. |
Xu Wei |
| K232051 |
07/10/2023 |
VISULAS green |
Carl Zeiss Meditec |
Tanesha Bland |
| K232159 |
07/20/2023 |
QEVO System |
Carl Zeiss Meditec AG |
Eva Jankovics |
| K232282 |
07/31/2023 |
aprevo« anterior and lateral lumbar interbody fusion device, aprevo« transforaminal lumbar interbody fusion device |
Carlsmed, Inc. |
Karen Liu |
| K231955 |
07/03/2023 |
aprevo« Digital Segmentation |
Carlsmed, Inc. |
Karen Liu |
| K232022 |
07/07/2023 |
CAS-One IR |
Cascination AG |
Andreas Meschberger |
| K232091 |
07/13/2023 |
JO Coconut Hybrid Cooling Personal Lubricant |
CC Wellness LLC |
Marlent Perez |
| K232090 |
07/13/2023 |
JO Coconut Hybrid Warming Personal Lubricant |
CC Wellness LLC |
Marlent Perez |
| K231990 |
07/05/2023 |
Apex Locator |
Cefla S.C. |
Daidone Simona |
| K232052 |
07/10/2023 |
Ceribell Instant EEG Headband |
Ceribell, Inc. |
Raymond Woo |
| K232244 |
07/28/2023 |
Disposable Endoscope Valves System |
Changzhou Endoclean Medical Device Co., Ltd. |
Qi Wang |
| K232068 |
07/12/2023 |
HyperLight Portable X-ray Unit |
Changzhou Sifary Medical Technology Co., Ltd. |
Tao Huan |
| K232257 |
07/28/2023 |
Clarius Bladder AI |
Clarius Mobile Health Corp. |
Agatha Szeliga |
| K232102 |
07/14/2023 |
ClearPoint Array System (Version 1.2) |
ClearPoint Neuro, Inc. |
Brennan Sullivan |
| K232116 |
07/17/2023 |
CoreLink Navigation Instruments |
CoreLink, LLC |
Steven Mounts |
| K232126 |
07/17/2023 |
EEAÖCircular Stapler with Tri-StapleÖ Technology and OrVilÖ Transoral Circular Stapler Anvil |
Covidien |
Helen Chen |
| K232133 |
07/18/2023 |
Co2 Laser System, Models: PureLase And VanLase |
CPMT Laser (Canadian Pioneer Medical Technology Corporation) |
Rashid Reza Mir Sayah |
| K231997 |
07/05/2023 |
SIRONA 100 Therapy Laser System (OEM's Model EVANLAS) |
Cure Point Therapeutics, Inc. |
Harold Kraft |
| K232062 |
07/11/2023 |
Uni-port |
Dalim Medical Corp. |
Ji Hoon Eom |
| K231964 |
07/03/2023 |
Novii+ Wireless Patch System |
Datex Ohmeda |
Isabel McGann |
| K232252 |
07/28/2023 |
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black), Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Orange) |
Dehai (Shandong) Medical Gloves, Co., Ltd. |
Max Li |
| K232238 |
07/28/2023 |
Goyo Mouthpiece S |
Dimedikorea |
DongHun Lee |
| K232207 |
07/26/2023 |
D╖KuttingÖ PTA Scoring Balloon Dilatation Catheter |
DK Medical Technology Co., Ltd. |
Shi Quan |
| K232056 |
07/11/2023 |
IPL Hair Removal Device, Model(s): PB1, PB2, PB3, PB4, TM002 |
Dongguan Lide Electric Appliance Co., Ltd |
Xiang Guojun |
| K231969 |
07/03/2023 |
BASEN Wearable Breast Pump (Model: YM-801, YM-803, YM-805, YM-806, YM-808) |
Dongguanshi Yiyingmei Technology Co., Ltd. |
Chen Jian |
| K232178 |
07/24/2023 |
GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series) |
DRGEM Corporation |
Park Sunghee |
| K232082 |
07/13/2023 |
EXPD 4343S |
DRTECH Corporation |
Lee Juhee |
| K231959 |
07/03/2023 |
EXPD 4357; EXPD 4357P |
DRTECH Corporation |
Lee Youna |
| K231971 |
07/03/2023 |
DEKA PHYSIQ 360 |
El.En. S.p.A |
Paolo Peruzzi |
| K232014 |
07/06/2023 |
CONDUITÖ ATP Inserters |
Enztec Limited |
James Sheat |
| K232086 |
07/13/2023 |
spineEOS |
EOS imaging |
Mathilde Masurel |
| K232033 |
07/07/2023 |
HYBRIDknife« flex |
Erbe Elektromedizin GmbH |
Matthias Kollek |
| K232100 |
07/14/2023 |
Efai Pacs Picture Archiving and Communication System Pro |
Ever Fortune.AI Co., Ltd. |
Joseph Chang |
| K232002 |
07/05/2023 |
Vantage« Total Ankle System |
Exactech Inc. |
Liz Howell |
| K232204 |
07/25/2023 |
ReyaGel (RG03 - MTP gel 3mL) |
FetTech |
Clay Fette |
| K232226 |
07/27/2023 |
ARROW Off-Centred Humeral Insert |
FH Industrie |
Naoual Rahimi |
| K231956 |
07/03/2023 |
F&P Optiflow+ Duet Nasal Cannula |
Fisher & Paykel Healthcare Ltd |
Reena Daken |
| DEN230050 |
07/17/2023 |
Body Temperature Software (BTS) |
Fitbit LLC |
Nathan Austin |
| K232242 |
07/28/2023 |
BEAR 2 Body |
FOREO Inc. |
Evan Feldstein |
| K231977 |
07/03/2023 |
PEACH 2, PEACH 2 Duo, PEACH 2 go |
Foreo Inc. |
Evan Feldstein |
| K232087 |
07/13/2023 |
Dental LT Comfort Resin |
Formlabs Ohio, Inc. |
Ritika Sharma |
| K232118 |
07/17/2023 |
ANDORATE« Valve Kit |
GA Health Company Limited |
Cindy Ye |
| K232186 |
07/24/2023 |
LOGIQ e |
GE Medical Systems Ultrasound and Primary Care Diagnostic, |
Lee Bush |
| K231989 |
07/05/2023 |
LOGIQ E10s, LOGIQ Fortis |
GE Medical Systems Ultrasound and Primary Care Diagnostic, |
Bryan Behn |
| K231966 |
07/03/2023 |
LOGIQ E10 |
GE Medical Systems Ultrasound and Primary care Diagnostics, |
Bryan Behn |
| K231965 |
07/03/2023 |
Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 |
GE Medical Systems Ultrasound and Primary Care Diagnostics, |
Bryan Behn |
| K232085 |
07/13/2023 |
DVAS (DVAS-M, DVAS-W) |
GENORAY CO., Ltd |
Inyoung Kim |
| K232158 |
07/20/2023 |
GenX-CR |
Genoray Co., Ltd. |
Inyoung Kim |
| K232174 |
07/21/2023 |
rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono |
Genoss Co., Ltd. |
Hayoung Sung |
| K232025 |
07/07/2023 |
Hushd Pro Avera |
Good Sleep Co Pte Ltd. |
Joel Simoson |
| K232013 |
07/06/2023 |
Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040, AW18-09040040/AA18-09040040, AW18-14540040, AW18-05050040/AA18-05050040, AW18-09050040/AA18-09050040, AW18-14550040, AW18-05060040/AA18-05060040, AW18-09060040/AA18-09060040, AW18-14 |
Goodman Co., Ltd. |
Aida Kanechika |
| K232059 |
07/11/2023 |
Tympanostomy Tubes |
Grace Medical, Inc. |
Mark Melton |
| K232039 |
07/10/2023 |
Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate |
Grand Work Plastic Products Co., Ltd. |
Wu Yuli |
| K232043 |
07/10/2023 |
Endoscopic Video Image Processor (RP-IPD-V2000A, RP-IPD-V2000B, RP-IPD-V2000C, RP-IPD-V2000D), Single-Use Video Gastroscope (RP-GI-G02A, RP-GI-G02B), Single-Use Video Colonoscope (RP-GI-C02A, RP-GI-C02B) |
Guangzhou Red Pine Medical Instrument Co., Ltd. |
Weihua Yang |
| K232003 |
07/06/2023 |
Endoscopic Video Image Processor, Single-Use Video Hysteroscope |
Guangzhou Red Pine Medical Instrument Co.,Ltd. |
Xiangfei Li |
| K232018 |
07/07/2023 |
Citrated: K, KH, RTH, FFH |
Haemonetics Corporation |
Julie Ewend |
| K232181 |
07/24/2023 |
Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13) |
Hebei JT Medical Co., Ltd. |
Karen Liu |
| K232215 |
07/26/2023 |
Quantra Hemostasis Analyzer |
HemoSonics, LLC |
Debbie Winegar |
| K232032 |
07/07/2023 |
PROBEAT-FR |
Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha |
Tomoko Irisa |
| K232189 |
07/24/2023 |
OrionXR |
Hoth Intelligence Inc. |
Jonathan Cohen |
| K232072 |
07/12/2023 |
AMICA-GEN AGN-H-1.3, AMICA-GEN AGN 3.3, AMICA-PROBE 17G & 18G |
HS Hospital Service SPA |
Nevio Tosoratti |
| K232143 |
07/19/2023 |
Applanation Tonometer HT-5000 |
Huvitz Co., Ltd. |
Heo Hyung-Min |
| K232048 |
07/10/2023 |
CogentÖ Hemodynamic Monitoring System; CogentÖ HMS |
ICU Medical |
Diane Stockman |
| K232006 |
07/06/2023 |
LEGACY« IPC |
IG Technology Ltd |
Ivan Green |
| K232095 |
07/13/2023 |
SeptiCyte RAPID |
Immunexpress, Inc |
LaKesha Hunt-Dickens |
| K232089 |
07/13/2023 |
SOZO Pro |
ImpediMed Limited |
Dennis Schlaht |
| K232216 |
07/26/2023 |
Hemoblock_S (Prescription); Hemoblock_S (OTC) |
Incore Co., Ltd. |
Jae-Hun Lee |
| K231973 |
07/03/2023 |
PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove |
Ineo Tech Sdn Bhd |
Pierre Hoerner |
| K232260 |
07/31/2023 |
Thinline Sheath Introducer |
Inneuroco Inc. |
Marc Litzenberg |
| K232139 |
07/18/2023 |
Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens |
Innova Vision Inc. |
Celine Hsu |
| K232080 |
07/13/2023 |
Puracyn« Plus Antimicrobial Irrigation Solution |
Innovacyn, Inc. |
Hungnan Lo |
| K232037 |
07/10/2023 |
Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath |
Innovative Health, LLC. |
Rick Ferreira |
| K232028 |
07/07/2023 |
Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100) |
IQ Endoscopes Limited |
Chris Jenkins |
| K232156 |
07/20/2023 |
Rapid ASPECTS (v3) |
iSchemaView, Inc. |
Jim Rosa |
| K232064 |
07/11/2023 |
Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate) |
Isikel Manufacturing LLC |
Chris Betts |
| K232170 |
07/21/2023 |
Ti Link Abutment |
Izenimplant Co., Ltd. |
Mi-Kyung Kwon |
| K232245 |
07/28/2023 |
VedDilator ^TM (3-Stage Balloon Dilation Catheter) |
Jiangsu Vedkang Medical Science and Technology Co., Ltd. |
Bao Tian |
| K232099 |
07/13/2023 |
Neodent Implant System - GM Zygomatic Implant System |
JJGC Ind·stria e ComΘrcio de Materiais Dentßrios S.A. |
Mariana Soares Hartmann |
| K232270 |
07/31/2023 |
DVT Motion Pneumatic Compression Device |
Koge Micro Tech Co., Ltd. |
Doris Chiu |
| K232114 |
07/14/2023 |
TRIBRID« Unicompartmental Knee System |
Kyocera Medical Technologies Inc. |
Jason Lansdown |
| K232111 |
07/14/2023 |
NeoBeat, NeoBeat Mini |
Laerdal Medical AS |
Mari Kaada |
| K232031 |
07/07/2023 |
LUNA 3D |
LAP GmbH Laser Applikationen |
Sebastian Boldhaus |
| K232202 |
07/25/2023 |
Aperio GT 450 DX |
Leica Biosystems Imaging, Inc. |
April Komplin |
| K232127 |
07/17/2023 |
21HQ513D, 32HL512D, 31HN713D, 32HQ713D |
LG Electronics Inc. |
Daseul An |
| K232094 |
07/13/2023 |
Orchid Safety Release ValveTM |
Linear Health Sciences LLC |
Daniel Clark |
| K231957 |
07/03/2023 |
SafeBreak« Vascular |
Lineus Medical |
Vance Clement |
| K232076 |
07/13/2023 |
Fibercure |
Lumendo AG |
Mark Bispinghoff |
| K232274 |
07/31/2023 |
IPL hair removal device |
Lumenessa Corp |
Peter Kim |
| K232246 |
07/28/2023 |
1) PINIONÖ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2) PINIONÖ PGA-PCL Knotless Suture - Absorbable Polyglycolic Acid - Poly (Glycolide-Co-Caprolactone) Knotless Suture |
M/s. Meril Endo Surgery Private Limited |
Umesh Sharma |
| K232123 |
07/17/2023 |
MectaLIF Anterior Lag Extension |
Medacta International S.A. |
Stefano Baj |
| K232280 |
07/31/2023 |
NextARÖ TSA Platform |
Medacta International S.A. |
Stefano Baj |
| K232251 |
07/28/2023 |
APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line Extension |
Medartis AG |
Claudia De Santis |
| K232105 |
07/14/2023 |
APTUS Foot System 2.8-3.5 |
Medartis AG |
Claudia De Santis |
| K232144 |
07/19/2023 |
Sterile Products of the APTUS System |
Medartis AG |
Claudia De Santis |
| K232222 |
07/26/2023 |
Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo) |
Medency S.r.l. |
Alessandro Zorgati |
| K232161 |
07/20/2023 |
DeepRhythm Platform |
Medicalgorithmics S.A. |
Maciej Gamrot |
| K232182 |
07/24/2023 |
One-Fil |
Mediclus Co., Ltd. |
Priscilla Chung |
| K232042 |
07/10/2023 |
NexPortÖ Trocar System (TS211001); NexPortÖ Trocar System (TS211002); NexPortÖ Trocar System (TS211003); NexPortÖ Trocar System (TS211010); NexPortÖ Trocar System (TS211011); NexPortÖ Trocar System (TS211012); NexPortÖ Trocar System (TS221001); NexPortÖ T |
MediConcepts Technology (Shenzhen) Company Limited |
Nick Xu |
| K232067 |
07/11/2023 |
Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use Suction Valve, Defendo Fujifilm 500/600 Single Use Biopsy Valve, Endogator Fujifilm 500/600 Single Use Connector |
Medivators (A Subsidiary of STERIS Corporation) |
Nick Wang |
| K232004 |
07/06/2023 |
Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve, Defendo Pentax Single Use Suction Valve, Endogator Pentax Single Use Connector |
Medivators (A Subsidiary of STERIS Corporation) |
Nick Wang |
| K231976 |
07/03/2023 |
StealthStation Cranial Software, v3.1.5 (9735585) |
Medtronic Navigation, Inc. |
Rishi Mehta |
| K232141 |
07/18/2023 |
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 |
07/24/2023 |
6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter |
Medtronic Vascular |
Colleen Gentile |
| K232218 |
07/26/2023 |
ZeniusÖ Spinal System |
Medyssey USA, Inc. |
Youngsu Jang |
| K231967 |
07/03/2023 |
ARi ExCon Implant System |
MegaGen Implant Co., Ltd. |
Kyung-Hee Back |
| K232107 |
07/14/2023 |
░M Warmer System |
MEQU A/S |
Ulrik Andersen |
| K232045 |
07/10/2023 |
MeVis Liver Suite |
MeVis Medical Solutions AG |
Rolf Rzodeczko |
| K232154 |
07/20/2023 |
MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation |
MiRus, LLC |
Jordan Bauman |
| K232146 |
07/19/2023 |
Anovo Pedestal |
Momentis Surgical Ltd. |
Maya Leib Shlomo |
| K232023 |
07/07/2023 |
Momentum Spine |
Momentum Health Inc. |
Evan Dimentberg |
| DEN230051 |
07/27/2023 |
Myocene |
Myocene |
Jean-Yves Mignolet |
| K232053 |
07/11/2023 |
SimpleSense-BP, SimpleSense-BP Software Application |
Nanowear Inc. |
Venkatesh Varadan |
| K232049 |
07/10/2023 |
IS-III active Short Implant |
Neobiotech Co., Ltd. |
Young-Ku Heo |
| K232253 |
07/28/2023 |
Modius Stress |
Neurovalens Limited |
Jason Mckeown |
| K232227 |
07/27/2023 |
ABLATE-IQ |
NeuWave Medical, Inc. |
Allison Francis |
| K232121 |
07/17/2023 |
Power wheelchair (Model:BC-EA8000) |
Ningbo Baichen Medical Devices Co., Ltd. |
Wu Xiao Long |
| K232200 |
07/25/2023 |
Disposable Injection Needles |
Ningbo Xinwell Medical Technology Co., Ltd |
Lei Xi |
| K232075 |
07/12/2023 |
StatStrip Glucose Hospital Meter System |
Nova Biomedical Corporation |
Abhinav Kulkarni |
| K232001 |
07/05/2023 |
Nu Skin RenuSpa iO |
NSE Products, Inc |
McKay Noll |
| K232267 |
07/31/2023 |
Precice Max System |
NuVasive Specialized Orthopedics, Incorporated |
Madison Heffron |
| K232169 |
07/21/2023 |
FITBONE« Transport and Lengthening System |
Orthofix Srl |
Elvira Taccarelli |
| K232140 |
07/18/2023 |
OTS Hip |
Ortoma AB |
Linus Bystr÷m |
| K232012 |
07/06/2023 |
N1 |
Osstem Implant Co., Ltd. |
Jimin Hyun |
| K232220 |
07/26/2023 |
SS Abutment System |
Osstem Implant Co., Ltd. |
Seungju Kang |
| K232261 |
07/31/2023 |
TME Temporary Myocardial Electrode |
Osypka AG |
Nicola Osypka |
| K232276 |
07/31/2023 |
Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 ╡g) SUD20 |
Oxoid Limited (Part of Thermo Fisher Scientific) |
Amie Lovatt |
| K232249 |
07/28/2023 |
PENTAX Medical Gas/Water Feeding Valve OE-B14 |
PENTAX of America, Inc. |
William Goeller |
| K231970 |
07/03/2023 |
PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video Bronchoscope EB15-S01, PENTAX Medical Mobile Processor ONE-M, PENTAX Medical Mobile Processor Plug-In ONE-Dock |
PENTAX of America, Inc. |
William Goeller |
| K231974 |
07/03/2023 |
PATHFAST«hs-cTnI-II |
PHC Corporation |
Misato Igarashi |
| K232021 |
07/07/2023 |
Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T |
Philips Healthcare (Suzhou) Co., Ltd. |
Li Sherry |
| K232030 |
07/07/2023 |
Ingenia Elition R5.7.1 SP4 MR Systems |
Philips Medical Systems Nederland B.V. |
Ioana Ulea |
| K232283 |
07/31/2023 |
PhySoftAMS« |
Physician Software Systems, LLC |
Lewis Mitchell |
| K232007 |
07/06/2023 |
CAAS MR Solutions |
Pie Medical Imaging B.V. |
Annemiek Bouts |
| K232147 |
07/19/2023 |
CAAS Workstation |
Pie Medical Imaging B.V. |
Annemiek Bouts |
| K232176 |
07/21/2023 |
STELLAR Knee |
PolarisAR Inc. |
Paul Mikus |
| K232234 |
07/27/2023 |
Nouvo Safety Set |
Poly Medicure Limited |
Ramdas Sharma |
| K232166 |
07/21/2023 |
PreXion3D Expedition |
PreXion Corporation |
Kenji Tanaka |
| K232255 |
07/28/2023 |
EZSensor XHD |
Qpix Solutions Inc. |
Seungman Yun |
| K232236 |
07/27/2023 |
Echo |
Quanta System Spa |
Dario Bandiera |
| K232231 |
07/27/2023 |
QP-Brain« |
Quibim S.L. |
Angel Alberich Bayarri |
| K231982 |
07/05/2023 |
Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2 |
Qura S.r.l. |
Raffaella Tommasini |
| K232112 |
07/14/2023 |
R&G Surgical Mask |
R&G Seguridad e Higiene Industrial S.A.C. |
Pola Guanilo |
| K231995 |
07/05/2023 |
AcuityUDR |
Radmedix LLC |
Gabriel Issa |
| K232008 |
07/06/2023 |
Disposable Medical Examination Nitrile Gloves |
Raxwell Industrial LLC |
Xianda Yao |
| K232273 |
07/31/2023 |
RM Electrode (RMH 23-01) |
RetMap, Inc. |
Shresta Patangay |
| K232153 |
07/19/2023 |
AvΘli |
Revelle Aesthetics, Inc. |
Melissa Viotti |
| K232149 |
07/19/2023 |
BowTieÖ SI Joint Fusion System |
SAIL Fusion, LLC |
Benjamin Arnold |
| K232063 |
07/11/2023 |
SaliPen |
Saliwell Ltd. |
Ben Z. Beiski |
| K232050 |
07/10/2023 |
saremco print BRIDGETEC |
Saremco Dental AG |
Franca Schmid |
| K231954 |
07/03/2023 |
Aristotle 18 Guidewire; Aristotle 24 Guidewire |
Scientia Vascular, Inc. |
Bailey Johannsen |
| K232096 |
07/13/2023 |
Transpara Density 1.0.0 |
Screenpoint Medical B.V. |
Robin Barwegen |
| K232027 |
07/07/2023 |
CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument |
Sebia |
Karen Anderson |
| K232208 |
07/26/2023 |
Sectra Digital Pathology Module (Version 3.3) |
Sectra AB |
Edoardo Mastrovito |
| K232185 |
07/24/2023 |
SM-IV |
Sedecal SA |
M¬ Luisa G≤mez de Agⁿero |
| K232228 |
07/27/2023 |
Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, Accurature Multi-drug Urine Test Dip Card |
Shanghai Accurature Diagnostics Co., Ltd. |
Shuang He |
| K232055 |
07/11/2023 |
Vial Adapter |
Shanghai Ling Fu Technology Co., Ltd. |
Esther Zhang |
| K232069 |
07/12/2023 |
Expandable Lumbar Fusion Cage (Type I,Type II) |
Shanghai REACH Medical Instrument Co., Ltd. |
Jian Shen |
| K232223 |
07/26/2023 |
PlaDuo System |
ShenB Co Ltd |
Sunny Kang |
| K232128 |
07/17/2023 |
Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y) |
Shenzhen AOJ Medical Technology Co., Ltd. |
Jack Wang |
| K231984 |
07/05/2023 |
Clinical Automatic Blood Pressure Monitor (DBP-01P,DBP-01HP) |
Shenzhen Hingmed Medical Instrument Co., Ltd. |
Huang YongBan |
| K232183 |
07/24/2023 |
IPL Hair Removal Device, Model(s): T1, T2, T3, T7, T10 |
Shenzhen Koli Technology Co.,Ltd |
Qizhen Fu |
| K231985 |
07/05/2023 |
Disposable Grounding Pad |
Shenzhen Mecun Medical Supply Co., Ltd. |
Zheng Bo |
| K231979 |
07/05/2023 |
Mecun SpO2 sensor |
Shenzhen Mecun Medical Supply Co., Ltd. |
Zheng Bo |
| K231961 |
07/03/2023 |
NIBPCuff |
Shenzhen SINO-K Medical Technology Co.,Ltd |
Lao Chengxin |
| K232124 |
07/17/2023 |
IPL Hair Removal, Model: W-1095, W-1098 |
Shenzhen Wochuan Electronic Co., Ltd |
Rebecca Jiang |
| K232145 |
07/19/2023 |
ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System |
Siemens Medical Solutions USA, Inc. |
Sulgue Choi |
| K232206 |
07/25/2023 |
SOMATOM Pro.Pulse |
Siemens Medical Solutions USA, Inc. |
Clayton Ginn |
| K232136 |
07/18/2023 |
syngo.CT Applications |
Siemens Medical Solutions USA, Inc. |
Clayton Ginn |
| K232000 |
07/05/2023 |
syngo.via MI Workflows; Scenium; syngo MBF |
Siemens Medical Solutions USA, Inc. |
Clayton Ginn |
| K232155 |
07/20/2023 |
syngo.CT Dual Energy |
Siemens Medical Solutions, USA, Inc. |
Monsuru K. Bello |
| K232214 |
07/26/2023 |
OMNI Surgical System |
Sight Sciences Inc., |
Ranjani Madhavan |
| K232271 |
07/31/2023 |
SIMDA abutment |
Simda Co., Ltd. |
Cha Young Woo |
| K232005 |
07/06/2023 |
HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue Cobraid) |
Smith & Nephew, Inc. |
Camille Fleischer |
| K232177 |
07/24/2023 |
Lightin System, Lightin, Lightin Generator |
Solmedix Co., Ltd |
Hyeroung Lee |
| K232285 |
07/31/2023 |
U-Lite PRO |
Sonoscanner SARL |
Vincent Lux |
| K232259 |
07/31/2023 |
Patriot-SI Posterior Implant System |
Spinal Simplicity LLC |
Adam Rogers |
| K232157 |
07/20/2023 |
Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control |
Stryker Corporation |
Janki Bhatt |
| K232250 |
07/28/2023 |
SurgiCount+ System |
Stryker Instruments |
Patti Arndt |
| K232279 |
07/31/2023 |
LifeStyles NRL Textured Condom |
Suretex Limited |
Alison Arnot |
| K232262 |
07/31/2023 |
LumenEye« X1 endoscope (LX1-SCP-203); LumenEye« X1 consumables (LX1-CSB-201); LumenEye« X1 Consumable Carton (25 Sets) (LX1-CSP-201 ) |
SurgEase Innovations Limited |
Roger Parker |
| K232130 |
07/17/2023 |
Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter |
Surgical Instrument Services and Savings, Inc |
Stephanie Boyle Mays |
| K231986 |
07/05/2023 |
Modus IR |
Synaptive Medical Inc. |
Tahmina Afzali |
| K232151 |
07/19/2023 |
Dynamic TiBase |
Talladium Espa±a, SL |
Xavier Soca Filella |
| K232115 |
07/14/2023 |
TDM Large Bone Plate and Screw System |
TDM CO., LTD |
Dave Kim |
| K232171 |
07/21/2023 |
Purema« H Hemoconcentrator (EtO Sterilized) |
Tecnoideal America |
Paul Rodbhajon |
| K232103 |
07/14/2023 |
Terragene« Chemdye« Multivariable Chemical Indicator (CD40), Terragene« Chemdye« Chemical Process Indicator (CD42), Terragene« Cintape« Chemical Process Indicator Tape (CT40) |
Terragene SA |
Hernando Carrizo |
| K232235 |
07/27/2023 |
Magstim«Horizon« 3.0 TMS Therapy System; Horizon« 3.0 System; Horizon« 3.0; Horizon« 3.0 with Navigation; Horizon« 3.0 with StimGuide Pro |
The Magstim Company Ltd. |
Daniel Gregory |
| K232152 |
07/19/2023 |
NerivioInfinity |
Theranica Bioelectronics ltd |
Alon Ironi |
| K231994 |
07/05/2023 |
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 |
07/05/2023 |
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 |
| K231975 |
07/03/2023 |
PNK Total Knee System |
TJC Life Co., Ltd |
Srinu Krotha |
| K232074 |
07/12/2023 |
Serafin« |
TNS Co., Ltd. |
Won-gun Chang |
| K232020 |
07/07/2023 |
Iontophoresis Electrodes |
TOP-RANK Health Care Co., Ltd. |
Yao Feijie |
| K232265 |
07/31/2023 |
BLUEPRINTÖ Patient Specific Instrumentation |
Tornier SAS |
Aymen Azaiez |
| K232060 |
07/11/2023 |
TOSAMA Reusable Applicator |
Tosama, d.o.o. |
Janez Obreza |
| K232258 |
07/31/2023 |
XO ConstrainÖ Percutaneous Transluminal Angioplasty Constraining Catheter |
Transit Scientific, LLC |
Lilly Myers |
| K232243 |
07/28/2023 |
EVO 700 series high speed handpiece |
Ttbio Corp. |
Sheng-Chieh Su |
| K232040 |
07/10/2023 |
Gynatrof |
Tyros Biopharma Inc. |
Anthony Gouvoussis |
| K232237 |
07/28/2023 |
Tyto Insights for Wheeze Detection |
Tyto Care Ltd. |
Stella Raizelman Perry |
| K232047 |
07/10/2023 |
VIVACE |
Unimom.Co |
Chon Yeong-Bin |
| K232113 |
07/14/2023 |
Halcyon, Ethos Radiotherapy System |
Varian Medical Systems Inc. |
Peter J. Coronado |
| K232092 |
07/13/2023 |
Great Basin Toxigenic C. difficile Direct Test (CDF2) |
Vela Operations USA |
Larry Rea |
| K232192 |
07/24/2023 |
Venus Versa PRO System |
Venus Concept Inc. |
William H. McGrail |
| K232205 |
07/25/2023 |
Vesco QÖ Enteral Feeding Pump; Vesco QÖ 500mL Bag Feed Set; Vesco QÖ 1000mL Bag Feed Set; Vesco QÖ 40mm Screw Cap Feed Set; Vesco QÖ ENPlus Feed Set |
Vesco Medical, LLC |
Chris O'Keefe |
| K232125 |
07/17/2023 |
V-PVP |
VITROMED GmbH |
Greg Holland |
| K231978 |
07/03/2023 |
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 |
| K232167 |
07/21/2023 |
VySpanÖ PCT System |
Vy Spine, LLC |
Jordan Hendrickson |
| K232077 |
07/13/2023 |
Atalante X |
Wandercraft SAS |
Matthieu Masselin |
| K231996 |
07/05/2023 |
Steriking« LT-Blueline Pouches with Tyvek« |
Wipak OY |
Hanna Marttila |
| K231999 |
07/05/2023 |
Steriking« LT-Blueline Pouches with Tyvek« |
Wipak OY |
Hanna Marttila |
| K232106 |
07/14/2023 |
Air Gap Fiber |
WON TECH Co., Ltd. |
Hyun Sik Yoon |
| K232093 |
07/13/2023 |
Woo More Play Coconut Love Oil |
Woo Essentials, Inc. |
Mackie Swan |
| K232079 |
07/13/2023 |
Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green); Natural Rubber Latex (Strip&Coat)/(Strip&Pack) Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentany |
WRP Asia Pacific Sdn. Bhd. |
Saravanan Ramasamy |
| K232117 |
07/17/2023 |
Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064) |
Wuhan Lotuxs Technology Co., Ltd. |
Na Wu |
| K232148 |
07/19/2023 |
X-Guide Surgical Navigation System |
X-Nav Technologies, LLC |
Kimberly Chan |
| K232210 |
07/26/2023 |
X-trodes System M |
X-Trodes |
Ziv Peremen |
| K232046 |
07/10/2023 |
Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection |
Xeridiem Medical Devices, A Spectrum Plastics Group Company |
Steve Murray |
| K232193 |
07/25/2023 |
Electrically Power Wheelchairs (Models:YLB-W-0812-A01, YLB-W-0812-A02, YLB-W-0812-A03) |
Yurob Rehabilitation Medical Co.,Ltd. |
Pan Daoping |
| K232268 |
07/31/2023 |
STERI-OSS Implant System |
Zeros Co., Ltd. |
Uk Hyon Joo |
| K232163 |
07/21/2023 |
Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle |
Zhejiang Horizon Medical Technology Co., Ltd. |
Wu Tang |
| K232199 |
07/25/2023 |
Bariatric Heavy Duty Wheelchair (YJ-010B 20ÆÆDS; YJ-010B 20ÆÆDE; YJ-010B 20ÆÆDFS; YJ-010B 20ÆÆDFE;YJ-010B 20ÆÆADS; YJ-010B 20ÆÆADE; YJ-010B 20ÆÆADFS; YJ-010B 20ÆÆADFE; YJ-010B 22ÆÆDS; YJ-010B 22ÆÆDE; YJ-010B 22ÆÆDFS;YJ-010B 22ÆÆDFE; YJ-010B 22ÆÆADS;YJ-010 |
Zhenjiang Assure Medical Equipment Co., Ltd. |
Ying Mei |
| K232198 |
07/25/2023 |
Reclining wheelchair (YJ-011S 16öD, YJ-011S 16öDF, YJ-011S 18öD, YJ-011S 18öDF, YJ-011S 20öD, YJ-011S 20öDF) |
Zhenjiang Assure Medical Equipment Co., Ltd. |
Ying Mei |
| K232230 |
07/27/2023 |
YJ-K1/K2 Wheelchair (YJ-K1F 16 NDE; YJ-K1F 16 NDS; YJ-K1F 18 NDE; YJ-K1F 18 NDS; YJ-K1F 20 NDE; YJ-K1F 20 NDS; YJ-K1F 18 NDEE; YJ-K1F 16 VDE; YJ-K1F 16 VDS; YJ-K1F 18 VDE; YJ-K1F 18 VDS; YJ-K1F 20 VDE; YJ-K1F 20 VDS; YJ-K2 16 VDFE; YJ-K2 16 VDFS; YJ-K2 18 |
Zhenjiang Assure Medical Equipment Co., Ltd. |
Ying Mei |
| K232150 |
07/19/2023 |
ZSFab Cervical Interbody System |
ZSFab Inc. |
Xuewei Ma |
