510(k) Clearances — Page 129
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K241713 — HiRise (1040-230) | Curvebeam, LLC Fri Jul 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241715 — Dental Glass Ceramics Blocks (HT,LT,ST) | Aidite (Qinhuangdao) Technology Co., Ltd. Fri Jul 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241085 — Valleylab FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN) | Covidien, LLC Fri Jul 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234077 — SPIRA® Anterior Lumbar Spacers | Camber Spine Technologies Fri Jul 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN220042 — Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH) | Terragene S.A. Fri Jul 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240240 — Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent® GM, Straumann® BLX, Implant Direct® Legacy®, Implant Direct® InterActive®, Implant Direct® RePlant® Implant Systems | Prismatik Dentalcraft, Inc. Fri Jul 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234009 — Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | Mighty Oak Medical Fri Jul 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241378 — S.I.N. Instrument Kits | S.I.N. - Sistema DE Implante Nacional S.A. Fri Jul 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241500 — Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS) | Guangzhou Red Pine Medical Instrument Co., Ltd. Fri Jul 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232372 — Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME) | Peters Surgical Fri Jul 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241727 — BriefCase-Triage | Aidoc Medical , Ltd. Fri Jul 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241720 — VersaCross Connect Transseptal Dilator | Baylis Medical Company, Inc. Fri Jul 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240920 — HemoCare Bicarbonate Concentrate Set (BCS) | Deka Research and Development Fri Jul 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233557 — HemoCare Hemodialysis System | Deka Research and Development Fri Jul 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233834 — Infinity Gateway Suite | Draeger Medical Systems, Inc. Fri Jul 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234124 — Single Use Hemoclips | Promisemed Hangzhou Meditech Co., Ltd. Fri Jul 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241707 — OCuSOFT AMENITY (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL | Unicon Optical Co., Ltd. Fri Jul 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241329 — SubtleSYNTH (1.x) | Subtle Medical, Inc. Thu Jul 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241460 — Manual Wheelchair | Lichtmega Technology Co., Ltd. Thu Jul 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241711 — Oscar Peripheral Multifunctional Catheter system | Biotronik, Inc. Thu Jul 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241706 — MicroMatrix® UBM Particulate | Acell, Inc. Thu Jul 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233791 — Drivewire 24 Guidewire | Rapid-Medical , Ltd. Thu Jul 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233874 — tmCMF Solution | Techmah Cmf Thu Jul 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241006 — Natural Cycles | Natural Cycles Nordic AB Thu Jul 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241022 — Sterile single use tip cleaner (WK800-S10 , WK800-S20) | Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd Thu Jul 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240493 — CUSA® Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation Thu Jul 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241000 — ATTUNE Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and Universal Femoral Metaphyseal Sleeves; DePuy Sigma PS Femoral Components; DePuy Sigma Cruciate Retaining (C/R) Porocoat Femoral Components; S-ROM NOILES Rotating Hinge Knee System; DePuy P.F.C. SIGMA Total Knee System; DePuy SIGMA Total Knee System; | Depuy Ireland UC Thu Jul 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241724 — Cytal® Wound Matrix; Cytal® Burn Matrix | Acell, Inc. Thu Jul 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241661 — Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented Mask | Sleepnet Corporation Wed Jul 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240527 — HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6) | Devicor Medical Products, Inc. Wed Jul 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233453 — Applied Biosystems TaqPath COVID-19 Diagnostic PCR Kit | Life Technologies Corporation Wed Jul 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240666 — Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811); Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841); Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface NON STERILE (BB811-NS) | Medtronic Perfusion Systems Wed Jul 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240016 — IPL Hair Removal Device (YT01,YT02,YT03,YT04) | Shenzhen Jianrong Biomedical Electronics Co., Ltd. Wed Jul 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241426 — GPS Advanced; 5 cc GPS Advanced Cannula | Prosidyan, Inc. Wed Jul 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232177 — Lightin System, Lightin, Lightin Generator | Solmedix Co., Ltd. Wed Jul 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233628 — AOS Interstitial Templates, Needles, and Accessories | Alpha-Omega Services, Inc. Wed Jul 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241683 — Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031404020 ); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031406020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031408020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031410020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031412020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031415020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H749390314 | Boston Scientific Corporation Wed Jul 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240614 — Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS | Oticon Medical AB Wed Jul 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233937 — OW100S | Softwave/Trt, LLC Tue Jul 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241316 — Zirconia Block | Hunan Hualian Special Ceramics Co., Ltd. Tue Jul 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232551 — EM-07 Cordless Endo Motor | Forum Engineering Technologies (96) , Ltd. Tue Jul 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241343 — IPL Hair Removal Device (LS-T121, LS-T121A, LS-T121B, LS-T121C, LS-T130, LS-T130A, LST130B, LS-T133, LS-T135, LS-T136, LS-T137, LS-T134, LS-T138, LS-T139, LS-T140) | Shenzhen Lescolton Electrical Appliance Co., Ltd. Tue Jul 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240966 — Prima Plus Conical Implant System | Keystone Dental, Inc. Tue Jul 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241019 — aprevo® TLIF-C Articulating System | Carlsmed Tue Jul 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240610 — deepLive | Damae Medical Tue Jul 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241372 — Advisor HD Grid X Mapping Catheter, Sensor Enabled | ABBOTT MEDICAL Tue Jul 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233584 — RhythmStar System | RhythMedix, LLC Mon Jul 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240502 — da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. Mon Jul 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241293 — LED Light Therapy Device, ELIXIR MD | Yassen Wellness, LLC Mon Jul 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240120 — Merlexi Craft Bariatric series of manual wheelchairs | Turbo Wheelchair Co., Inc. Fri Jul 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |