510(k) Clearances in 2023 — Page 62

3,346 510(k) clearances total

Browse FDA 510(k) clearances granted in 2023. RegDataLab tracks 3,346 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2023 (page 62 of 67)
510(k) clearancesDetails
K221452 — DiLumen C1, EZ1 and Tool MountLumendi, LLC Feb 10, 2023
K223194 — Glass CeramicShenzhen Xiangtong Co., Ltd. Feb 10, 2023
K223467 — Disposable Isolation GownNanning Tecbod Biological Technology Co., Ltd. Feb 10, 2023
K223249 — Pro-Tx Endorectal Balloon (PROT-25)Dxtx Medical, Inc. Feb 10, 2023
K222129 — Nitrile Examination Powder Free Glove, Blue Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim, Nitrile Examination Powder Free Glove, Black Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance ClaimTop Glove Medical (Thailand) Co., Ltd. Feb 10, 2023
K221474 — PRIMUS Healthcare Sterilizer (Model PSS11-HC)Primus Sterilizer Company, LLC Feb 10, 2023
K220657 — Medical Infrared Thermometer (Model: RST-TC59-1001, RST-TC60-1001)Zhejiang Rongsheng Industrial Co., Ltd. Feb 10, 2023
K223786 — Orthex External Fixation SystemOrthoPediatrics Corp. Feb 10, 2023
K223425 — MD.ai ViewerMdai, Inc. Feb 10, 2023
K223680 — Eneka ProTermosalud Feb 10, 2023
K221476 — PerifitX6 Innovations Feb 10, 2023
K220715 — ARTSMedia In Vitro Culture Medium (AM-IVC Medium)Artsmedia Denmark Aps Feb 10, 2023
K223438 — TELIGEN System Peripheral Motor Nerve Stimulation IndicationsMedos International SARL Feb 10, 2023
K223208 — Safety LancetSuzhou Zhenwu Medical Co., Ltd. Feb 10, 2023
K223413 — Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems Feb 10, 2023
K222596 — S90 Exp Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp. Feb 10, 2023
K223678 — Sterile Syringes for Single UseShanghai Kindly Enterprise Development Group Co., Ltd. Feb 9, 2023
K203211 — Insulin syringe with integrated needle DLDlp Medical Products, Corp. Feb 9, 2023
K222073 — VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL)bioMerieux, Inc. Feb 9, 2023
K230089 — ETHICON LINX® Esophagus Sizing ToolTorax Medical, Inc. Feb 9, 2023
K222041 — CYGNUS-C Standalone ACIF SystemGS Medical Co., Ltd. Feb 9, 2023
K220505 — ATTIVAItalian Engineering S.R.L. Feb 9, 2023
K221223 — extriCARE® 3000 Negative Wound Pressure Therapy SystemAlleva Medical Devices Feb 9, 2023
K230073 — OktiCompumedics Limited Feb 9, 2023
K230063 — G Surgical Marksman Spinal Deformity SystemG Surgical, LLC Feb 9, 2023
K223559 — Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs)Nephron Pharmaceuticals Corporation Feb 9, 2023
K221400 — hygh-tec drainageCreative Balloons GmbH Feb 9, 2023
K221694 — External Drainage SystemJmed(Shenzhen) Technology Limited Feb 9, 2023
K223338 — Toothsi, SmilealignersMakeo Healthcare Technologies Private Limited Feb 9, 2023
K223038 — Access CortisolBeckman Coulter, Inc. Feb 8, 2023
K222685 — NIRA Model 2Dermal Photonics Corp Feb 8, 2023
K221472 — Filter and HME/FilterNingbo Huakun Medical Equipment Co., Ltd. Feb 8, 2023
K223304 — Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)Xiamen Probtain Medical Technology Co., Ltd. Feb 8, 2023
K222247 — Hailie Sensor NF0110Adherium (Nz), Ltd. Feb 8, 2023
K223686 — Medical Protective MasksQinhuangdao Taizhi Medical Technology Co., Ltd. Feb 7, 2023
K222928 — Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa R9 Exp Diagnostic Ultrasound Sysem, Nuewa R9 Pro/ Nuewa R9S/ Resona 7/ Resona 7CV/Resona 7EXP/Resona 7S/ Resona 70B Diagnostic Ultrasound System, Resona 7PRO/Imagyn 7/ Resona Y/Resona R9W/Resona R7W Nuewa R9W/Nuewa R7W Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. Feb 7, 2023
K223146 — EVOLUTION SPINE Interbody SystemEvolution Spine Feb 7, 2023
K222451 — SAVE GBRDentis Co., Ltd. Feb 7, 2023
K222398 — Care Team PortalVivify Health, Inc. Feb 6, 2023
K222955 — Xenta Drug Screen Cup, Xenta Drug Screen DipcardXenta Biomedical Science Co., Ltd. Feb 6, 2023
K230270 — 3M™ VitCal Liner/Base3M Espe Dental Products Feb 6, 2023
K212701 — Eminent Spine 3D Cervical Interbody Fusion SystemEminent Spine Feb 6, 2023
K221980 — Disposable Powder Free Vinyl Examination Gloves, Beige/ClearEver Global (Vietnam) Enterprise Corporation Feb 6, 2023
K223735 — ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Feb 6, 2023
K221531 — ClotTriever Thrombectomy SystemInari Medical, Inc. Feb 6, 2023
K223296 — Videa Perio AssistVideahealth, Inc. Feb 6, 2023
K223169 — NerivioTheranica Bioelectronics , Ltd. Feb 6, 2023
K230095 — ScanX Swift 2.0, ScanX Swift View 2.0Durr Dental SE Feb 6, 2023
K223444 — Powder Free Blue Nitrile Examination GloveS&S Glove Corporation Feb 6, 2023
K222570 — COPAL knee mouldsHeraeus Medical GmbH Feb 4, 2023
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