510(k) Clearances — Page 79
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,388 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K240355 — FROG (Filter Removal of Glass) | Carrtech Corp Fri Apr 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250481 — Extension Feeding Set with ENFit Connectors | SKY Medical, a.s. Fri Apr 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250224 — handLITE (TN19S) | iSMART Developments, Ltd. Fri Apr 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250834 — Zimmer Biomet Ceramic Heads (22.2mm diameter) | Zimmer Biomet Fri Apr 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240775 — PeriBeam® Pericardial Membrane | Tamabio Fri Apr 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250842 — PADLOCK CLIP EFTR Kit (00713229) | STERIS Corporation Fri Apr 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241188 — Acucy® Influenza A&B Test with the Acucy® 2 System | SEKISUI Diagnostics, LLC Fri Apr 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243013 — LIAISON PLEX Gram-Negative Blood Culture Assay | Luminex Corporation Fri Apr 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250146 — SofWave System | Sofwave Medical, Ltd. Fri Apr 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250459 — DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution | Technoflex Sas. Fri Apr 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241996 — ULTRA 1040 | Ecoray Co., Ltd. Fri Apr 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242129 — VitalRhythm | Vitalconnect, Inc. Thu Apr 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250270 — Luja Set | Coloplast Corp. Thu Apr 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243750 — SimpleStitch Suturing System | Envision Endoscopy Thu Apr 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242337 — FlowGuide (FG60F); GuidionShort (GS60F) | Imds Operations B.V. Thu Apr 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242992 — RayCare (2024A SP1) | RaySearch Laboratories AB (PUBL) Thu Apr 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243459 — Ultimate rTMS for OCD (M-series) | Brain Ultimate, Inc. Thu Apr 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242056 — miacare (DELiGHT daily wear/ DELiGHT 1-day/ CONFiDENCE Color daily wear/CONFiDENCE Color 1-day) Contact Lens with EautraSil Plus | Benq Materials Corporation Thu Apr 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250455 — FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM) | Fluoptics Sas (A Getinge Group Company} Thu Apr 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250889 — EXULT Knee Replacement System | Corentec Co., Ltd. Thu Apr 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250499 — RELiZORB (100300/100301) | Alcresta Therapeutics, Inc. Thu Apr 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243878 — CLARUS (700) | Carl Zeiss Meditec, Inc. Thu Apr 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243337 — Dental Cone Beam Computed Tomography System | Yofo Medical Technology Co., Ltd. Thu Apr 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243460 — Ultimate rTMS | Brain Ultimate, Inc. Thu Apr 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN240062 — Minder System | Epi-Minder Pty, Ltd. Thu Apr 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250829 — Lacevo Wearable Breast Pump (Model S70) | Shenzhen TPH Technology Co., Ltd. Thu Apr 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250850 — Nanox.ARC X | Nano-X Imaging , Ltd. Wed Apr 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241733 — HEBE (NP0000763) | Novasonix Technology S.L. Wed Apr 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243513 — DCM (PW-DCM) | Pneumowave, Ltd. Wed Apr 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242500 — LARALAB | Laralab GmbH Wed Apr 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243853 — Clarius Prostate AI | Clarius Mobile Health Corp. Wed Apr 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242806 — Medyssey Navigation System | Medyssey Co, Ltd. Wed Apr 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250809 — Stellar M22 | Lumenis Be, Ltd. Wed Apr 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242647 — MySegmenter (v2.0.0) | Mysegmenter Technologies, Inc. Wed Apr 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243055 — Préime DermaFacial Collagen+ | EMA Aesthetics , Ltd. Tue Apr 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250833 — SwissMembrane X; SwissMembrane X Socket | Geistlich Pharma AG Tue Apr 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242786 — TearCare MGX System | Sight Sciences, Inc. Tue Apr 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250803 — Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup | Anhui Deepblue Medical Technological Co., Ltd. Tue Apr 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242773 — Electro Lube NXT | Steris Tue Apr 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250650 — SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option | Arineta , Ltd. Tue Apr 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250327 — OptaBlate Radiofrequency (RF) Generator System | Stryker Instruments Tue Apr 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242932 — Skin Clinic Nitro Clear Wart Remover | Cryoconcepts LP Tue Apr 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250824 — Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrive Steerable Ureteral Stent Set; Contour Ureteral Stent; Contour SureDrive Steerable Ureteral Stent Set; Contour VL Variable Length Ureteral Stent; Contour VL SureDrive Steerable Ureteral Stent Set; Polaris Ultra Ureteral Stent; Polaris Loop Ureteral Stent; Tria Firm Ureteral Stent; Tria Soft Ureteral Stent; Percuflex Urinary Diversion Stent Set | Boston Scientific Corporation Tue Apr 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242658 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxacin in the dilution range of 0.008-16 ug/mL | Thermo Fisher Scientific Tue Apr 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250212 — LapBox Power Tissue Containment System | Ark Surgical Tue Apr 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250802 — STERRAD® 100NX Sterilizer with ALLClear Technology (10104) | Advanced Sterilization Products, Inc. Mon Apr 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250301 — Merge Universal Viewer (MUV) | Merge Healthcare Incorporated Mon Apr 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250402 — AVAVA Skin Treatment System | AVAVA, Inc. Mon Apr 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250823 — Any-Com Flow | Mediclus Co., Ltd. Mon Apr 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250094 — Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089); Atlas Stim Headbox (HD) (31-0601-0132); ASHB FIBER OPTIC DUPLEX CONN 2m (31-0204-0001); ASHB FIBER OPTIC DUPLEX CONN 7m (31-0204-0002); ATLAS Stim Headbox Software (36-0301-0006); Atlas Headbox Interface Cable (NK) (31-0204-003); Atlas Headbox Interface Cable (Touchproof) (31-0204-004); Atlas Headbox Interface Cable (HD) (31-0204-005); Atlas Headbox Expansion Panel (31-0607-0014) | Neuralynx, Inc. Mon Apr 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |