510(k) Clearances — Page 169
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K230604 — IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030) | Philips Medizin Systeme Boeblingen GmbH Wed Nov 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233333 — KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit | Karl Storz SE & CO. KG Tue Nov 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232001 — Nu Skin RenuSpa iO | Nse Products, Inc. Tue Nov 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233049 — TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with QwikCheck Chemical Indicator | Cs Medical, LLC Tue Nov 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232898 — Quantisal Oral Fluid Collection Device | Immunalysis Corporation Tue Nov 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232388 — High Pressure Tubing | Ningbo Dizegens Medical Science Co.,Ltd Tue Nov 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232719 — ProMIS Extension Rod System | Premia Spine, Ltd. Tue Nov 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232573 — INFINITI Ambi Angiographic Catheter | Cordis US Corp Tue Nov 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231975 — PNK Total Knee System | Tjc Life Co., Ltd. Tue Nov 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232977 — Biophotas Celluma CONTOUR | Biophotas, Inc. Tue Nov 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221606 — Absorbable Cranial Flap Fixation System | Chendu Medart Medical Scientific Co., Ltd. Tue Nov 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232549 — NemoCast | Software Nemotec S.L. Tue Nov 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230211 — CranioXpand | KLS-Martin L.P. Tue Nov 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222511 — Oxy2Pro | Southmedic, Inc. Tue Nov 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232496 — Brainomix 360 Triage Stroke | Brainomix Limited Tue Nov 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233191 — TotalTi ACDF by SAGICO | Spinal Analytics & Geometrical Implant Co, LLC Tue Nov 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232576 — Medical Nitrile Examination Gloves | Jiangsu Complete Sincerity Medical New Materials Co., Ltd. Tue Nov 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232546 — Meta G UCLA Abutment | Cowellmedi Co., Ltd. Tue Nov 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233084 — Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system | Gbs Commonwealth Co., Ltd. Tue Nov 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233245 — MagnetOs Flex Matrix | Kuros Biosciences B.V Tue Nov 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230834 — CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H | Trismed Co., Ltd. Tue Nov 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230641 — Ultrasonic Scaler Tips | Guilin Refine Medical Instrument Co., Ltd. Tue Nov 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233010 — Beagank 4T Plus | Belega, Inc. Tue Nov 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233053 — DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 Intraoral Sensor | Dental Imaging Technologies Corporation Tue Nov 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223615 — Digital ClarusScope System, Digital NeuroPEN System | Clarus Medical, LLC Tue Nov 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231443 — Mini-OSTEO Pedicle Fixation System | Osteomed Indústria E Comércio DE Implantes Ltda Tue Nov 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230773 — Endoscopy Irrigation Tubing | Zhejiang Chuangxiang Medical Technology Co., Ltd. Tue Nov 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232988 — Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound System | Canon Medical Systems Corporation Tue Nov 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230287 — SaviSafe Safety Device | Suzhou Savicred Biotechnology Co., Ltd. Tue Nov 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230627 — Zilia Ocular FC (ZIL-10002) | Zilia, Inc. Mon Nov 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233346 — Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 0.5mm Tip with Cable (HMAL18/005); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 1.0mm Tip with Cable (HMAL18/010); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 1.5mm Tip with Cable (HMAL18/015); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 200mm, 0.5mm Tip with Cable (HMAL20/005); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 200mm, 1.0mm Tip with Cable (HMAL20/010); | Hg Innovations, Ltd. Mon Nov 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231941 — ARIETTA x10 | FUJIFILM Healthcare Americas Corporation Mon Nov 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232545 — The SensiTox B. anthracis Toxin Test | First Light Diagnostics, Inc. Mon Nov 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230700 — RIWOtrack Navigation System | Fiagon GmbH Mon Nov 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232575 — Hair Removal Device, Model(s): R2815-G Pro, R2815-G | Shenzhen Jianchao Intelligent Technology Co., Ltd. Mon Nov 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231692 — Ziehm Vision RFD | Ziehm Imaging GmbH Mon Nov 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233351 — Single Use Non-Stick McPherson Bipolar Forceps, 110mm, 0.5mm Tip with Cable (HNSAG-5110M); Single Use Non-Stick Jeweller Bipolar Forceps, 115mm, 0.5mm Tip with Cable (HNSAG-5115J); Single Use Non-Stick Jeweller Bipolar Forceps, 115mm, 1.0mm Tip with Cable (HNSAG-1115J); Single Use Non-Stick Adson Bipolar Forceps, 120mm, 1.0mm Tip with Cable (HNSAG-1120A); Single Use Non-Stick Adson Bipolar Forceps, 120mm, 0.5mm Tip with Cable (HNSAG-5120A); Single Use Non-Stick Adson Bipolar Force | Hg Innovations, Ltd. Mon Nov 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231498 — TraumaCad Neo | Brainlab , Ltd. Mon Nov 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232555 — Harmony | Topcon Healthcare Solutions Mon Nov 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230954 — Samfilcon B Custom Contact Lens | Bausch + Lomb, Incorporated Fri Nov 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232512 — Masimo W1 | Masimo Corporation Fri Nov 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232501 — AI Platform (AIP001) | Exo, Inc. Fri Nov 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232925 — Gastric Alimetry System | Alimetry , Ltd. Fri Nov 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231600 — SENDERO Microcatheter | Okami Medical, Inc. Fri Nov 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231559 — Multi-Unit DAS System | Talladium España, SL Fri Nov 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230190 — Polyver Silver Alginate Dressing (Prescription and OTC) | Roosin Medical Co., Ltd. Fri Nov 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231020 — Alinity c Tricyclic Antidepressants Reagent Kit | Microgenics Corporation Fri Nov 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232974 — EKGenius Smart System | Ekgenius, LLC Fri Nov 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232538 — DUAL COLOR NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL | Wrp Asia Pacific Sdn. Bhd. Fri Nov 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232028 — Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100) | Iq Endoscopes Limited Fri Nov 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |