510(k) Clearances — Page 84
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,388 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K241065 — ChecQ (AC100) | Dentis Co., Ltd. Fri Mar 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242888 — Electrohydraulic Lithotriptor (TCS-B3-II) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. Fri Mar 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250556 — Porous Biologic Scaffold | Ventris Medical Fri Mar 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240761 — Arisure® Closed Male Luer with Spike Adapter (YM060) | Yukon Medical, LLC Fri Mar 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241833 — V-GRAD | Vitromed GmbH Fri Mar 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250403 — Catamaran SI Joint Fusion System | Tenon Medical Fri Mar 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243649 — BD Vacutainer® Multiple Sample Luer Adapter | Becton, Dickinson and Company Fri Mar 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242107 — CaseMONO Culture (CMON); CaseMONO w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF) | Casebioscience, Inc. Fri Mar 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242909 — FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors | Edwards Lifesciences, LLC Fri Mar 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242053 — FX CorAL 40 (F00009214); FX CorAL 50 (F00009215) | Fresenius Medical Care Renal Therapies Group, LLC Fri Mar 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243808 — Rayvolve PTX-PE | AZmed Fri Mar 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243451 — FiAPC plus probes | Erbe Elektromedizin GmbH Fri Mar 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243980 — ARVIS Surgical Navigation System | Kico Knee Innovation Company Pty Limited Fri Mar 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250513 — IntelliSep Test (CV-ICG-048) | Cytovale, Inc. Fri Mar 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250106 — Signos Glucose Monitoring System | Signos, Inc. Fri Mar 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250186 — GoLIF! Lumbar Interbody Fusion System | Getset Surgical, SA Fri Mar 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241890 — Philips Holter Analysis System | Philips Medizin Systeme Böblingen GmbH Fri Mar 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250561 — Natural Cycles | Natural Cycles Nordic AB Fri Mar 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250463 — Ameda GLO Wearable Breast Pump (Model W8S) | Shenzhen TPH Technology Co., Ltd. Thu Mar 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243922 — Revogene | Meridian Bioscience, Inc. Thu Mar 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242771 — Tesera-k PL System and Tesera-k XL System | Kyocera Medical Technologies, Inc. Thu Mar 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243016 — Starlight Imaging Catheter | Spectrawave, Inc. Thu Mar 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243975 — Knee+ | Pixee Medical Thu Mar 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241704 — Endoscopic Water Pump | Hangzhou AGS MedTech Co., Ltd. Thu Mar 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243292 — brAIn Shoulder Positioning | Avatar Medical Thu Mar 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243928 — ViaOne Epicardial Access System | Cardiovia , Ltd. Thu Mar 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243988 — RootMend MRR | Riverpoint Medical, LLC Thu Mar 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242770 — EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG | DRTECH Corporation Thu Mar 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241884 — HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens (HPM38) | Hunan Haipuming Technology Co., Ltd. Thu Mar 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241961 — Vent Creativity Knee v1.0 (Hermes) | Vent Creativity Thu Mar 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250468 — iSLEEVE Introducer Set | Boston Scientific Thu Mar 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242958 — Joylux Intimacy Gel (PG3100) | Joylux, Inc. Thu Mar 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243472 — 1NEED Pro | Campomats S.R.L. Wed Mar 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241791 — Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D) | Gigaalaser Company , Ltd. Wed Mar 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243987 — TriMed Elbow and Forearm System | TriMed, Inc. Wed Mar 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243999 — TriMed Ankle Fixation System | TriMed, Inc. Wed Mar 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250042 — PeekMed web | Peek Health, S.A. Wed Mar 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243092 — AcuPebble Ox (200) | Acurable Limited Wed Mar 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250429 — DSPS-Prominent® baseplate, MR (113820); DSPS-Prominent® baseplate (113120); DSPS-Prominent® Cradle-I (113140); DSPS-Prominent® Cradle-II (113150); DSPS-Prominent® Cradle-III (113160); DSPS-Prominent® Cradle-IV (113170); DSPS-Prominent® Cradle-VI (113180); DSPS-Prominent® Cradle-VII (113260); Mask DSPS®-PROSCVRL set/5 (113760); Mask DSPS®-PROSC set/5 (113770); Mask DSPS®-PROSCVR set/5 (113780); Mask DSPS®-PROSCL set/5 (113790); Mask DSPS®-PROSHVRL set/5 (113890); Mask DSPS®-PROSH set | Macromedics BV Wed Mar 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242486 — Tyber Medical Anatomical Plating System | Tyber Medical, LLC Wed Mar 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242241 — Sunny | ShenB Co., Ltd. Wed Mar 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243689 — AVIEW | Coreline Soft Co., Ltd. Wed Mar 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250502 — SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series 4000, AMERI-TOUCH Series 5000) | Safesource Direct, LLC Wed Mar 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN240018 — CORIS System | Nanosonics Limited Wed Mar 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241842 — Luer-Split MAJ-2092 | Olympus Medical Systems Corporation Wed Mar 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250210 — Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P); Full HD Visualization Endoscopic Image Processor (HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D); Endoscopic Image Processor (HDVS-S100A, HDVS-S100D)) | Scivita Medical Technology Co., Ltd. Wed Mar 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243443 — EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP | DRTECH Corporation Wed Mar 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250171 — IPL Hair Removal Device (BE965A, BE965B, BE965C) | Shenzhen Yang WO Electronic Co., Ltd. Wed Mar 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250131 — IPL Hair Removal Device (M8011, M8012, M8013, M8015, M8021, M8022, M8023, M8025, M7011, M7012, M7021, M7023) | Mustech Electronics Co., Limited Wed Mar 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243807 — Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P | Olympus Medical Systems Corp. Tue Mar 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |