510(k) Clearances — Page 178

176,223 clearances total

Browse all FDA 510(k) medical device clearances. RegDataLab tracks 176,223 clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances (page 178 of 3,525)
ClearancesDetails
K231889 — Endoscopic Ultrasonic Diagnostic Equipment /Disposable Sterile Endoscopic Ultrasonic Probe (USW-S1,USW140-S20MS)Ultrasound Biotechnology (Shanghai) Co., Ltd. Dec 21, 2023
K233741 — Hoffmann LRF SystemStryker GmbH Dec 21, 2023
K232888 — Disposable Laryngeal ElectrodesSuzhou Haishen Medical Device Associates Co., Ltd. Dec 21, 2023
K232744 — syngo Virtual Cockpit (VB10A)Siemens Healthcare GmbH Dec 21, 2023
K233154 — SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC Dec 21, 2023
K231099 — SMR Hybrid Glenoid SystemLima Corporate S.P.A. Dec 21, 2023
K233813 — Bearing nsPVA Express™Merit Medical Systems, Inc. Dec 21, 2023
K233016 — Dental Glass CeramicsShenzhen Yurucheng Dental Materials Co., Ltd. Dec 21, 2023
K232870 — TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1)Varian Medical Systems, Inc. Dec 21, 2023
K233848 — Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)Gynesonics, Inc. Dec 21, 2023
K231660 — Digital image scanner of dentalJiangsu Dynamic Medical Technology Co., Ltd. Dec 20, 2023
K232992 — 10THERMATentech, Inc. Dec 20, 2023
K231402 — HP PTA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd. Dec 20, 2023
K231968 — Tactoset® Injectable Bone SubstituteAnika Therapeutics, Inc. Dec 20, 2023
K232048 — Cogent™ Hemodynamic Monitoring System; Cogent™ HMSIcu Medical Dec 20, 2023
K233130 — Blood Pressure MonitorGuangdong Transtek Medical Electronics Co., Ltd. Dec 20, 2023
K233839 — Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT Intervertebral body fusion system; The Peridot-TD Anterior Cervical Intervertebral body fusion system; The Peridot-TD Intervertebral body fusion systemGbs Commonwealth Co., Ltd. Dec 20, 2023
K230850 — United Orthopedic Knee Patient Specific InstrumentationEnhatch, Inc. Dec 20, 2023
K233782 — SmoothSkin Pure Adapt (SSG3)Cyden Limited Dec 20, 2023
K233492 — EMS Neck MassagerXiamen Comfier Technology Co., Ltd. Dec 20, 2023
K230736 — MagnetOs PuttyKuros Biosciences B.V Dec 20, 2023
K230955 — syngo Application SoftwareSiemens Medical Solutions USA, Inc. Dec 20, 2023
K223585 — Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily WearYung Sheng Optical Co., Ltd. Dec 20, 2023
K231354 — Pocket Ultrasound System (C10)Beijing Konted Medical Technology Co.,Ltd Dec 20, 2023
K233176 — uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd. Dec 20, 2023
K232017 — ARK Methotrexate II AssayArk Diagnostics, Inc. Dec 20, 2023
K233017 — TM Plating SystemTyber Medical, LLC Dec 20, 2023
K231227 — SureFlex HD Steerable Sheath, VersaCross HD Steerable SheathBaylis Medical Company, Inc. Dec 20, 2023
K231411 — INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd. Dec 20, 2023
K232444 — Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy DrugsGrand Work Plastic Products Co., Ltd. Dec 20, 2023
K231780 — Perifit Care+X6 Innovations Dec 20, 2023
K230855 — BD Vacutainer® Serum Separator (SST™) Blood Collection TubesBecton, Dickinson And Company Dec 20, 2023
K232286 — Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna InstrumentQuidel Corporation Dec 20, 2023
K231556 — SPECTRUM® GV Bone CementOsteoremedies, LLC Dec 20, 2023
K230545 — Inessa SystemTriple Jump Israel , Ltd. Dec 20, 2023
K232736 — Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen Fentanyl/Tramadol Dip Card Test, Chemtrue® Multi-Panel Drug Screen Cup Test, Chemtrue® Multi-Panel Drug Screen Dip Card TestChemtron Biotech, Inc. Dec 20, 2023
K230840 — PMT Facet Fixation System, Lumbar (PMT FFS-LX)Providence Medical Technology, Inc. Dec 19, 2023
K231671 — IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470), IntelliVue 4-Slot Module Rack FMX-4 (866468)Philips Medizin Systeme Boeblingen GmbH Dec 19, 2023
K233448 — Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter SetIntegra Lifesciences Production Corporation Dec 19, 2023
K222810 — TD-7301 Peak Flow meterGostar Co., Ltd. Dec 19, 2023
K233163 — ZENEX Implant System_ShortIzenimplant Co., Ltd. Dec 19, 2023
K232560 — Angled AbutmentArum Dentistry Co., Ltd. Dec 19, 2023
K221199 — Conductive Silicone Electrode (model: Foot Pad Electrode, Cupping Electrode, Point Electrode)Green Island International Tcm Group Limited Dec 19, 2023
K231526 — CORAIL Cemented Femoral StemDepuy Ireland UC Dec 19, 2023
K232458 — JETi™Hydrodynamic Thrombectomy SystemABBOTT MEDICAL Dec 19, 2023
K233551 — GORE® ACUSEAL Vascular GraftW. L. Gore & Associates, Inc. Dec 19, 2023
K233470 — DEKA LILYEl.En S.P.A. Dec 19, 2023
K233132 — PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB)Primus Sterilizer Company, LLC Dec 19, 2023
K231587 — MAGNETOM Cima.XSiemens Medical Solutions USA, Inc. Dec 18, 2023
K231066 — CuratOR EX3242-FDEizo Corporation Dec 18, 2023
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