510(k) Clearances — Page 198

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 198 of 3,525)
ClearancesDetails
K231030 — Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation Sep 14, 2023
K230746 — Non absorbable Surgical Polypropylene SutureShandong Haidike Medical Products Co., Ltd. Sep 14, 2023
K232146 — Anovo PedestalMomentis Surgical , Ltd. Sep 14, 2023
K223833 — Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc. Sep 14, 2023
K232467 — CleanCart A, CleanCart C, AK 98 Hemodialysis MachineBaxter Healthcare Corporation Sep 14, 2023
K231576 — cNeuro cPETCombinostics OY Sep 14, 2023
K232189 — OrionXRHoth Intelligence, Inc. Sep 14, 2023
K231353 — AccuCTP ProArteryFlow Technology Co., Ltd. Sep 14, 2023
K232462 — ThermPix Thermovisual CameraUsa Therm, Inc. Sep 14, 2023
K232124 — IPL Hair Removal, Model: W-1095, W-1098Shenzhen Wochuan Electronic Co., Ltd. Sep 14, 2023
K232487 — Provecta 3D Prime and Provecta 3D Prime CephDurr Dental SE Sep 14, 2023
K223885 — HOPKINS TelescopesKarl Storz Endoscopy America, Inc. Sep 14, 2023
DEN230021 — ensoETMAdvanced Cooling Therapy, Inc. D/B/A Attune Medical Sep 13, 2023
K221640 — AlloMap Heart Molecular Expression TestingCaredx, Inc. Sep 13, 2023
K230735 — Ultimate rTMS; Yingchi rTMSBrain Ultimate, Inc. Sep 13, 2023
K232485 — AMSCO 600 Steam SterilizerSteris Sep 13, 2023
K230609 — NG Delivery CatheterBalt USA, LLC Sep 13, 2023
K223811 — Lung-CADImagen Technologies, Inc. Sep 13, 2023
K222831 — CRYOcheck Factor VIII Deficient Plasma with VWFPrecision Biologic, Inc. Sep 13, 2023
K230750 — OSSIOfiber® Cannulated Trimmable Fixation NailOSSIO , Ltd. Sep 13, 2023
K232158 — GenX-CRGenoray Co., Ltd. Sep 13, 2023
K231317 — TrueBeam, TrueBeam STx, Edge, VitalBeamVarian Medical Systems, Inc. Sep 12, 2023
K230598 — Stone Extraction BasketsJiangsu Vedkang Medical Science And Technology Co., Ltd. Sep 12, 2023
K213767 — Endure ETCO2/02 Nasal CannulaEndure Industries, Inc. Sep 12, 2023
K232526 — XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5Canon Medical Systems Corporation Sep 12, 2023
K231112 — Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerMaterialise NV Sep 12, 2023
K232459 — VelacurSonic Incytes Sep 12, 2023
K231766 — Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI) Sep 12, 2023
K231892 — Definium Pace SelectGe Hualun Medical Systems Co. , Ltd. Sep 12, 2023
K231748 — Cartesion Prime (PCD-1000A/3) V10.15Canon Medical Systems Corporation Sep 12, 2023
K231011 — Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulseMeridian AG Sep 12, 2023
K222938 — Ablation-fitR.A.W. S.R.L Sep 12, 2023
K231283 — SiteRite™ 9 Ultrasound SystemBard Access Systems, Inc. (C.R. Bard, Inc.) Sep 11, 2023
K223755 — i-STAT G cartridge with the i-STAT 1 SystemAbbott Point Of Care, Inc. Sep 11, 2023
K230362 — Planar LED mateShenzhen Leaflife Technology Co., Ltd. Sep 11, 2023
K232192 — Venus Versa PRO SystemVenus Concept, Inc. Sep 11, 2023
K230881 — Change Healthcare Cardiology Hemodynamics™Change Healthcare Israel , Ltd. Sep 11, 2023
K231746 — VERIFY Spore Test Strip for S40 Sterilant ConcentrateSTERIS Corporation Sep 11, 2023
K231504 — TITANEX™ MICROBEAM Screw System, TITANEX™ ARTEMIS Screw SystemVilex, LLC Sep 11, 2023
K230517 — Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends Orthopedics 2.9 mm Suture Anchor, and Legends Orthopedics 5.5 mm Knotless Suture Anchor)Jarmon Medical, LLC (Dba Legends Orthopedics) Sep 11, 2023
K232154 — MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC Sep 11, 2023
K232002 — Vantage® Total Ankle SystemExactech, Inc. Sep 11, 2023
K223864 — Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software CranialBrainlab AG Sep 9, 2023
K231723 — Sterile Safety Hypodermic Needles for Single UseWepon Medical Technology Co., Ltd. Sep 8, 2023
K230372 — VitreJect SyringeOcuject, LLC Sep 8, 2023
K232686 — CorVista® SystemCorvista Health, Inc. Sep 8, 2023
K231727 — Sterile Auto-Disable Syringes with/without Needle for Single UseWepon Medical Technology Co., Ltd. Sep 8, 2023
K222921 — Minuteful-kidney testHealthy.Io, Ltd. Sep 8, 2023
K231643 — Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)Syntex Healthcare Products Co., Ltd. Sep 8, 2023
K232386 — ILUMIEN™ OPTIS™ System, OPTIS™ Integrated System, OPTIS™ Mobile System, with AptiVue™ Imaging Software version E.6ABBOTT MEDICAL Sep 8, 2023
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