510(k) Clearances — Page 145
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K232060 — TOSAMA Reusable Applicator | Tosama, D.O.O. Fri Apr 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232587 — MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer | Shenzhen New Industries Biomedical Engineering Co., Ltd. Fri Apr 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240418 — Stryker Orthopaedics Hip Systems Labeling Update | Howmedica Osteonics Corp., Dba Stryker Orthopaedics Fri Apr 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240109 — Medical electronic thermometer (FC01, FC02) | Zhuzhou Goldenhot Medical Technology Co., Ltd. Fri Apr 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240686 — Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card | Healgen Scientific,, LLC Fri Apr 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232489 — VenusX | Linatech, LLC Fri Apr 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240571 — OASIS MRI System | Fujifilm Healthcare Corporation Fri Apr 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232164 — Access NT-proBNP | Beckman Coulter, Inc. Fri Apr 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232608 — Duo Hands-free Breast Pump | Medela, LLC Fri Apr 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232999 — Lyric4 Hearing Aid | Sonova AG Thu Apr 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240720 — TiLink-P SI Joint Fusion System | SurGenTec, LLC Thu Apr 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K202531 — Azer Scientific Universal Transport Medium | Azer Scientific, Inc. Thu Apr 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240719 — OC JuggerKnot Soft Anchor | Riverpoint Medical Thu Apr 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233698 — True Enhance DL | Ge Healthcare Japan Corporation Thu Apr 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233757 — TitanPico Laser Workstation (PICO-450) | Rhein Laser Technologies Co., Ltd. Thu Apr 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221847 — Ni2 Implant System | Newton Implant Systems, Inc. Thu Apr 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233509 — Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System | Zavation Medical Products, LLC Wed Apr 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234057 — NIRVANA | El.En S.P.A. Wed Apr 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233313 — Keikku Electronic stethoscope | Lapsi Health Holding B.V. Wed Apr 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233561 — 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) | Topcon Corporation Wed Apr 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240089 — Face Patches (MT-12MA, MT-12MC) | Shenzhen Kaiyan Medical Equipment Co., Ltd. Wed Apr 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233789 — 8Q10 Surclear Smoke Plume Evacuation System | Surnic Corporation Wed Apr 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240654 — SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette | Safecare Biotech (Hangzhou) Co., Ltd. Wed Apr 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232523 — Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7% | Mankind Pharma Limited Wed Apr 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232641 — Neorad Pacs (Neorad Pacs) | Everrtech Software Pvt, Ltd. Wed Apr 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240744 — uMR 680 | Shanghai United Imaging Healthcare Co., Ltd. Wed Apr 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232409 — Electromagnetic Stimulation Systems | Shanghai Apolo Medical Technology Co., Ltd. Wed Apr 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240760 — CELERITY HP Indicator Tape | Steris Wed Apr 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN230023 — Rho | 16 Bit, Inc. Tue Apr 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232623 — Universal Endometrial Applicator Set (GM11009840) | Varian Medical Systems, Inc. Tue Apr 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232599 — TransForm McCarthy Mitral Annuloplasty Ring (TF) | Genesee Biomedical, Inc. Tue Apr 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233999 — GalaFLEX LITE Scaffold | Tepha, Inc. Tue Apr 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233263 — Disposable Trocars | Hangzhou Kangji Medical Instrument Co., Ltd. Tue Apr 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232147 — CAAS Workstation | Pie Medical Imaging BV Tue Apr 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240291 — EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM | Ever Fortune.Ai, Co., Ltd. Mon Apr 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240423 — TDM Anterior Cervical Plate System | Tdm Co., Ltd. Mon Apr 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240021 — Powder Free Nitrile Examination Glove 3.5, Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Yue Kang Anhui Medical Products Co., Ltd. Mon Apr 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231728 — BiWaze Clear System | Abmrc, LLC Mon Apr 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K212878 — Sample preservation solution | Zhejiang Gene Science Co., Ltd. Mon Apr 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233935 — DigiLine Direct Print Aligner System | Park Dental Research Corporation Fri Apr 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232919 — Ambu® aScope Gastro Large; Ambu® aBox 2 | Ambu A/S Fri Apr 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240647 — Virage® Navigation System | Zimvie Spine (Zimmer Biomet Spine, Inc.) Fri Apr 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234105 — Catalyst F1x Shoulder System | Catalyst Orthoscience, Inc. Fri Apr 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN210058 — ELEOSx Limb Salvage System | Onkos Surgical Fri Apr 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232103 — Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40) | Terragene S.A. Fri Apr 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232115 — TDM Large Bone Plate and Screw System | Tdm Co., Ltd. Fri Apr 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240737 — G Surgical Marksman MIS System | G Surgical, LLC Fri Apr 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233249 — APPRAISE-HRI | The Surgeon General, Department of the Army (TSG-DA) Fri Apr 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233666 — CorVista System with PH Add-On | Analytics For Life, Inc. Fri Apr 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN220015 — Orthobond Mariner Pedicle Screw System | Orthobond Coporation Fri Apr 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |