510(k) Clearances

174,759 clearances total

K232846 — Light Based Hair Removal DeviceShenzhen Meik Beauty Industry Co., Ltd. Thu Dec 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K232795 — Led Mask Platinum Exclusive MDStg24 Co., Ltd. Thu Dec 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231127 — S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. Thu Dec 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K232661 — Myocardial Strain Software ApplicationCircle Cardiovascular Imaging Thu Dec 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231206 — DLP Silicone Coronary Artery Ostial CannulaeMedtronic, Inc. Thu Dec 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230137 — Reliance® Fusion Sterilization WrapsAhlstrom-Munksjo Nonwovens, LLC Thu Dec 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K233334 — Aquilion Serve SP (TSX-307B/1) V1.3Canon Medical Systems Corporation Wed Dec 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230677 — Cork Medical VERSA Negative Pressure Wound System (VCMPP-100)Cork Medical Wed Dec 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231125 — 2008T BlueStar Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC Wed Dec 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231675 — OneRF Ablation SystemNeuroone Medical Technologies Corp. Wed Dec 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231465 — Q-Pad Test SystemQurasense Wed Dec 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K233562 — LINQ II Insertable Cardiac MonitorMedtronic, Inc. Wed Dec 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K232206 — SOMATOM Pro.PulseSiemens Medical Solutions USA, Inc. Wed Dec 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K233521 — QT ECG (QTERD100)QT Medical, Inc. Wed Dec 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K222930 — Evolve Nitric Oxide Delivery SystemMallinckrodt Manufacturing, LLC Wed Dec 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K233042 — Sterile Nitrile Examination Gloves Powder Free Tested for Use with Chemotherapy Drugs and Fentanyl CitrateShandong Intco Medical Products Co, Ltd. Wed Dec 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K232769 — BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed) Wed Dec 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K233597 — Sonosite LX Ultrasound SystemFUJIFILM Sonosite, Inc. Wed Dec 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230712 — SG Lanset I, SG Lancets, Soft LancetsSewon Medical Co. Wed Dec 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230734 — Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009)Precision Healing, LLC Tue Dec 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231615 — Disposable Endoscopic BipolarJiangsu Hope Biomedical Science & Technology Co., Ltd. Tue Dec 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K232814 — Electronic Blood Pressure MonitorZhuhai Yueja Medical Device Technology Co., Ltd. Tue Dec 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K232220 — SS Abutment SystemOsstem Implant Co., Ltd. Tue Dec 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K222057 — THERMOCLICKT&R BIOFAB CO., Ltd. Tue Dec 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231005 — Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 2Supermax Healthcare Canada-Supermax Medical Tue Dec 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231230 — Optina-4C (MHRC-C1N)Optina Diagnostics, Inc. Tue Dec 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K233490 — SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC Tue Dec 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K232434 — BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived KitBd Tue Dec 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223170 — Electronic Blood Pressure Monitor, model: HTD6602USHetaida Technology Co., Ltd. Tue Dec 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K233568 — Ceevra Reveal 3+Ceevra, Inc. Tue Dec 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231923 — Liberty SI Lateral Implant SystemSpinal Simplicity, LLC Tue Dec 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K232440 — Adravision PerioAdra Corporation Tue Dec 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K233335 — Tablo® Hemodialysis SystemOutset Medical, Inc. Tue Dec 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230648 — Access hsTnIBeckman Coulter, Inc. Mon Dec 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K233347 — Verruca-Freeze® HCryosurgery, Inc. Mon Dec 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K232693 — Tyber Medical Distal Radius Plating SystemTyber Medical, LLC Mon Dec 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K232308 — Monarch Blood Collection SetThe Monarch Company Mon Dec 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K220525 — RESPONDER Polysaccharide HemostatStarch Medical, Inc. Mon Dec 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230724 — arcad® 2.0 Duo & Quadro osteosynthesis compressive staplesNovastep Mon Dec 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223783 — cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc. Mon Dec 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K232581 — Medical Disposable Sterile Needle ElectrodeSuzhou Haishen Medical Device Associates Co., Ltd. Mon Dec 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
DEN230045 — SonuSound Health Systems, Inc. Mon Dec 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231895 — Maxtec MaxBlend2+pMaxtec, LLC Mon Dec 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K232932 — Intense Pulse Light Therapeutic ApparatusShenzhen Greatro Electronic Technology Co., Ltd. Mon Dec 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K233397 — Cosine-10TM Diagnostic CatheterMedtronic, Inc. Sat Dec 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K233149 — CATHTONG III Tapered PICC CatheterL&Z Us, Inc. Fri Dec 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230528 — Extension SetMedcaptain Life Science Co., Ltd. Fri Dec 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231057 — Antibacterial Gel Wound DressingWinner Medical Co., Ltd. Fri Dec 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K232093 — Woo More Play Coconut Love OilWoo Essentials, Inc. Fri Dec 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230391 — BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection TubeBecton, Dickinson and Company Fri Dec 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
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