510(k) Clearances in 2023 — Page 16

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 16 of 67)
510(k) clearancesDetails
K232481 — RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC Oct 13, 2023
K232437 — Paragon 8F Balloon Guide CatheterWallaby Medical Oct 13, 2023
K232822 — Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior cervical interbody fusion - ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system)Gbs Commonwealth Co., Ltd. Oct 13, 2023
K231744 — VyLink™ Spinal Screw SystemVy Spine, LLC Oct 13, 2023
K223697 — MRI compatibility for existing BioHorizons dental implants and abutmentsBioHorizons Implant Systems, Inc. Oct 13, 2023
K230125 — Neuroblade SystemClearmind Biomedical Oct 13, 2023
K230495 — Serena Sleep Night GuardMeris Investment Group Oct 13, 2023
K223863 — BONHAWA Respiratory HumidifierTelesair, Inc. Oct 13, 2023
K211676 — Motiva Flora SmoothSilk Tissue ExpanderMotiva USA, LLC Oct 13, 2023
K232504 — Calibrate CCX Interbody SystemAlphatec Spine, Inc. Oct 13, 2023
K232429 — Titan Dental DesignClearadvance, LLC Oct 13, 2023
K231642 — Veuron-Brain-pAb3Heuron Co., Ltd. Oct 13, 2023
K230440 — Xpert® Xpress CoV-2 plusCepheid® Oct 13, 2023
K230370 — SpotLight/SpotLight Duo (with DLIR option)Arineta , Ltd. Oct 13, 2023
K222143 — APIS (R), VERIS (TM)Sweetbio, Inc. Oct 13, 2023
K231495 — The Evolve System with the Transform ApplicatorInMode , Ltd. Oct 13, 2023
K231708 — Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48)Axogen Corporation Oct 12, 2023
K231486 — Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC Oct 12, 2023
DEN200076 — ORiMasimo Corporation Oct 12, 2023
K232448 — FREEPRINT® splintmasterDetax GmbH Oct 12, 2023
K231475 — MONTAGE-QS Settable, Resorbable Bone PuttyOrthocon, Inc. Oct 12, 2023
K231152 — Collagen Wound DressingWinner Medical Co., Ltd. Oct 12, 2023
K232809 — Cross Vascular RF Generator and Footswitch (optional accessory)Cross Vascular, Inc. Oct 12, 2023
K230707 — Skypro, Surgical Gown 6021Skypro Medical Supplies Company Oct 12, 2023
K230650 — Monopolar Electrode Surgical InstrumentVhmed (Nantong) Co. , Ltd. Oct 12, 2023
K232838 — Monkey RingsTM External Fixation SystemParagon 28, Inc. Oct 12, 2023
K231551 — StethophoneSparrow Acoustics, Inc. Oct 12, 2023
K231814 — ValvuloPro Valvuloplasty Balloon CatheterDongguan TT Medical, Inc. Oct 12, 2023
K232802 — TMINI™ Miniature Robotic SystemTHINK Surgical, Inc. Oct 12, 2023
K231231 — MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation DevicesParagon 28, Inc. Oct 12, 2023
K231574 — Scenaria View 4.2FUJIFILM Healthcare Americas Corporation Oct 12, 2023
K222222 — Artemis, Artemis TPO, Artemis MXEigen Oct 12, 2023
K232998 — Montage- XT Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc. Oct 12, 2023
K232852 — Cross Vascular RF Transseptal Needle, Cross Vascular Connection CableCross Vascular, Inc. Oct 12, 2023
K230717 — Exactech® Vantage® Total Ankle SystemExactech, Inc. Oct 12, 2023
K223126 — SurgiAid® Collagen Wound DressingMaxigen Biotech, Inc. Oct 11, 2023
K232574 — VASSALLO GT Crossing14Filmec Co. , Ltd. Oct 11, 2023
K232578 — VASSALLO GT 018 G12; VASSALLO GT 018 G30Filmec Co. , Ltd. Oct 11, 2023
K233233 — EMPHASYS Femoral StemsDepuy Ireland UC Oct 11, 2023
K231050 — Arm Blood Pressure MonitorAlicn Medical Shenzhen, Inc. Oct 11, 2023
K232499 — IPL Hair Removal Device (LS-T106, LS-T107, LS-T108)Shenzhen Lescolton Electrical Appliance Co., Ltd. Oct 11, 2023
K230116 — Vital™ Spinal Fixation SystemZimvie Spine (Zimmer Biomet Spine, Inc.) Oct 11, 2023
K232460 — Disposable electrosurgical pencil (MD1000)Shenzhen Mecun Medical Supply Co., Ltd. Oct 11, 2023
K222025 — G4Derm / G4Derm Plus Synthetic Wound MatrixGel4Med, Inc. Oct 11, 2023
K230618 — MegaGen Dental Implant Systems Portfolio - MR ConditionalMegagen Implant Co., Ltd. Oct 11, 2023
K232070 — Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black, Green)Better Care Plastic Technology Co., Ltd. Oct 11, 2023
K232090 — JO Coconut Hybrid Warming Personal LubricantCC Wellness, LLC Oct 11, 2023
K230220 — NeuViz 128 Multi-Slice CT Scanner SystemNeusoft Medical Systems Co., Ltd. Oct 11, 2023
K232981 — Synq Software Version 1.3Synaptive Medical, Inc. Oct 11, 2023
K232344 — Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 ORGE Medical Systems SCS Oct 11, 2023
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