510(k) Clearances — Page 152

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 152 of 3,525)
ClearancesDetails
K232333 — Anti-bacterial bandageJinhua Jingdi Medical Supplies Co., Ltd. May 31, 2024
K241226 — Fixtemp® C&B 4:1Dreve Denatmid GmbH May 31, 2024
K232107 — °M Warmer SystemMequ A/S May 31, 2024
K240394 — multiFlux 1000 (F00012408)Fresenius Medical Care Renal Therapies Group, LLC May 31, 2024
K232601 — BroncTru™ Transbronchial Access ToolBroncus Medical, Inc. May 31, 2024
K232715 — Distinct® Digital Pregnancy TestACON Laboratories, Inc. May 31, 2024
K233842 — iHealth COVID-19 Antigen Rapid TestIhealth Labs, Inc. May 31, 2024
K222196 — Deep TMS SystemBrainsway , Ltd. May 31, 2024
K233295 — LFR-260Evolution Optiks Limited May 31, 2024
K231151 — Kenota 1 Total IgE; Kenota 1 (instrument)Kenota, Inc. May 31, 2024
K241055 — Electro Lube NXTSteris May 31, 2024
K240612 — CINA-VCFAvicenna.Ai May 31, 2024
K223427 — Mimics Enlight CMFMaterialise NV May 31, 2024
K241218 — Tyber Medical Anatomical Plating SystemTyber Medical, LLC May 31, 2024
K240254 — Blood Pressure Monitor (TMB-2296-BT)Guangdong Transtek Medical Electronics Co., Ltd. May 31, 2024
K233729 — Ringer perfusion balloon catheter, 2.00 x 20mm (5881); Ringer perfusion balloon catheter, 2.50 x 20mm (5882); Ringer perfusion balloon catheter, 2.50 x 30mm (5883); Ringer perfusion balloon catheter, 3.00 x 20mm (5884); Ringer perfusion balloon catheter, 3.00 x 30mm (5885); Ringer perfusion balloon catheter, 3.50 x 20mm (5886); Ringer perfusion balloon catheter, 3.50 x 30mm (5887); Ringer perfusion balloon catheter, 4.00 x 20mm (5888); Ringer perfusion balloon catheter, 4.00 x 30mm (58Vascular Solutions, LLC May 31, 2024
K233674 — Freedom Wrist Arthroplasty SystemAscension Orthopedics, Inc. May 30, 2024
K232505 — Endovenous Radiofrequency Generator, Endovenous Radiofrequency CatheterZhejiang Curaway Medical Technology Co., Ltd. May 30, 2024
K240838 — Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc. May 30, 2024
K241194 — BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel MiniBiofire Diagnostics, LLC May 30, 2024
K241289 — SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative ControlMaine Molecular Quality Controls, Inc. May 30, 2024
K233025 — Revolution External Plating SystemNew Standard Device Dba Metalogix May 30, 2024
K234003 — The Circadia C200 SystemCircadia Technologies, Ltd. May 30, 2024
K232934 — SunsphereHangzhou Yangshun Medical Technology Co.,Ltd May 30, 2024
K233126 — aetherSlideAetherai Co., Ltd. May 30, 2024
K240687 — SofWave SystemSofwave Medical, Ltd. May 30, 2024
K233655 — Lingo Glucose SystemAbbott May 29, 2024
K232741 — SmartAdjust(TM) technologyInsulet Corporation May 29, 2024
K241235 — Arthrex TightRope IIArthrex, Inc. May 29, 2024
K233481 — AltiVate Reverse® GlenoidEncore Medical L.P. May 29, 2024
K233389 — EK Digital AbutmentsHiossen, Inc. May 29, 2024
K233166 — NET Recovery Corp/NET DeviceNet Recovery May 29, 2024
K240049 — LINK(TM) External FixatorMetric Medical Devices, Inc. May 29, 2024
K240159 — InnoVoyce VYLOInnovoyce May 29, 2024
K241190 — PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile SyringePoonglim Pharmatech, Inc. May 29, 2024
K232672 — EasyScreen Gastrointestinal Parasite Detection KitGenetic Signatures Limited May 29, 2024
K241207 — SmartClaw™ Thrombectomy Catheter, 20 mm (FD0660-01), SmartClaw™ Thrombectomy Catheter, 32 mm (FD0660-02)Devoro Medical, Inc. May 29, 2024
K240784 — Temperature Sensor Probe (ABL-18TP20)Varian Medical Systems, Inc. May 29, 2024
K233076 — Laser Speckle Imaging System (RFLSI CZW)Rwd Life Science Co., Ltd. May 28, 2024
K240629 — Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and FentanylXingyu Medical Tech Co., Ltd. May 28, 2024
K241177 — React 71 CatheterMicro Therapeutics Lnc. D/B/A Ev3 Neurovascular May 28, 2024
K223629 — SpiroSphere, SpiroSphereECG, CardioSphereEresearchtechnology GmbH May 28, 2024
K240305 — ANNE LimbSibel Health, Inc. May 28, 2024
K240304 — Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5)Enpuno Biotechnology Co., Ltd. May 28, 2024
K240874 — Luna Diode Laser System (TL-S20S-TWC, TL-S20S-755A , TL-S20S-810B)Theralaser Medtech (China) Co., Ltd. May 28, 2024
K233344 — Regenalase Laser SystemIpg Medical May 28, 2024
K240410 — EVOLVE Nitric Oxide Delivery SystemMalinckrodt Manufacturing, LLC May 28, 2024
K240749 — PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc. May 28, 2024
K240592 — Wolff's Law Anterior Cervical Plate SystemSpinal Simplicity, LLC May 24, 2024
K231939 — Renasys EdgeSmith & Nephew Medical, Ltd. May 24, 2024
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