510(k) Clearances in 2023 — Page 8

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 8 of 67)
510(k) clearancesDetails
K232000 — syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc. Nov 28, 2023
K232117 — Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)Wuhan Lotuxs Technology Co., Ltd. Nov 28, 2023
K230883 — VersaPump Infusion SystemEmed Technologies Corporation Nov 28, 2023
K232713 — Blood Pressure MonitorGuangdong Transtek Medical Electronics Co., Ltd. Nov 28, 2023
K232252 — 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. Nov 28, 2023
K231631 — BriefCase-QuantificationAidoc Medical , Ltd. Nov 28, 2023
K222845 — Clench Relief Mouth Piece PRO RX, Clench Relief Mouth PieceFrey Oral Technologies, LLC Nov 28, 2023
K232624 — CardioPhase® hsCRPSiemens Healthcare Diagnostic Products GmbH Nov 27, 2023
K231104 — ABPMproSomnomedics GmbH Nov 27, 2023
K233243 — ClearPoint System (Software Version 2.2)ClearPoint Neuro, Inc. Nov 27, 2023
K230493 — BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection TubeBecton, Dickinson And Company Nov 27, 2023
K233343 — SteriCap Safety Needle; VitreJect Safety NeedleOcuject, LLC Nov 27, 2023
K232222 — Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L. Nov 27, 2023
K233332 — Statera-C™ Spinal SystemK&J Consulting Corp. Nov 27, 2023
K230379 — Portable (Ultrasonic) NebulizerDongguan Simzo Electronic Technology Co., Ltd. Nov 27, 2023
K232658 — T-Top 10 & T-Top T-Top 11Tuttnauer U.S.A Co, Ltd. Nov 27, 2023
K233171 — PF Keep; Cad Cam Keep BlockClemde SA DE CV Nov 27, 2023
K231661 — CryoThin™ Surgical System and AccessoriesMedinux (Tianjin) Technologies Co., Ltd. Nov 27, 2023
K233160 — NeuTrace EP Mapping System v.2.1Anumana, Inc. Nov 25, 2023
K230319 — Passio Pump Drainage SystemBearpac Medical Nov 24, 2023
K230701 — Stim2GoPAJUNK GmbH Medizintechnologie Nov 24, 2023
K230311 — HyperSutureThreadstone, LLC Nov 24, 2023
K232059 — Tympanostomy TubesGrace Medical, Inc. Nov 24, 2023
K233525 — MF SC Facial Toning SystemMicro Current Technology, Inc. Nov 24, 2023
K231797 — Medifun Lancing Device, Model No. LD-E1Medifun Corporation Nov 22, 2023
K232593 — FITme Customized Silicone ImplantKeosan Trading Co. Nov 22, 2023
K230529 — HealiAid Dental Collagen Wound DressingMaxigen Biotech, Inc. Nov 22, 2023
K222712 — Fogg System Patient Monitoring CablesFogg System Company, Inc. Nov 22, 2023
K231245 — Digital Blood Pressure Monitor (Arm Type)Guangdong Genial Technology Co., Ltd. Nov 22, 2023
K222499 — Disposable Endoscope Valves KitShanghai SeeGen Photoelectric Technology Co., Ltd. Nov 22, 2023
K233110 — Carnation Ambulatory MonitorBardy Diagnostics, Inc. Nov 22, 2023
K232600 — DxFLEX Flow Cytometer; ClearLLab 10C PanelsBeckman Coulter, Inc. Nov 22, 2023
K233078 — Posterior Cervical Spine SystemDouble Medical Technology, Inc. Nov 22, 2023
K232635 — IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100)Boston Scientific Nov 22, 2023
K232621 — Blood pressure monitorGuangdong Transtek Medical Electronics Co., Ltd. Nov 22, 2023
K230604 — IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)Philips Medizin Systeme Boeblingen GmbH Nov 22, 2023
K232001 — Nu Skin RenuSpa iONse Products, Inc. Nov 21, 2023
K233049 — TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with QwikCheck™ Chemical IndicatorCs Medical, LLC Nov 21, 2023
K232988 — Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation Nov 21, 2023
K232898 — Quantisal™ Oral Fluid Collection DeviceImmunalysis Corporation Nov 21, 2023
K232719 — ProMIS Extension Rod SystemPremia Spine, Ltd. Nov 21, 2023
K232573 — INFINITI™ Ambi Angiographic CatheterCordis US Corp Nov 21, 2023
K233333 — KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control UnitKarl Storz SE & CO. KG Nov 21, 2023
K231975 — PNK Total Knee SystemTjc Life Co., Ltd. Nov 21, 2023
K230211 — CranioXpandKLS-Martin L.P. Nov 21, 2023
K232977 — Biophotas Celluma CONTOURBiophotas, Inc. Nov 21, 2023
K232496 — Brainomix 360 Triage StrokeBrainomix Limited Nov 21, 2023
K222511 — Oxy2ProSouthmedic, Inc. Nov 21, 2023
K221606 — Absorbable Cranial Flap Fixation SystemChendu Medart Medical Scientific Co., Ltd. Nov 21, 2023
K233191 — TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC Nov 21, 2023
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