510(k) Clearances — Page 154
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K240173 — Treace Medical Systems (TMC) Plating System | Treace Medical Concepts, Inc. Thu Feb 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233996 — Ulthera System (UC-1 Control Unit PRIME) | Ulthera, Inc. Thu Feb 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231875 — Vaginal Tactile Ultrasound Imager | Advanced Tactile Imaging, Inc. Thu Feb 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233439 — HD60 Series Ultrasound Diagnostic System | Qingdao Hisense Medical Equipment Co., Ltd. Wed Feb 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232265 — BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. Wed Feb 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240194 — ProCinch, QuadCinch | Riverpoint Medical Wed Feb 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231561 — Pulmonary Function Tester, Model: A9 | Guangzhou Homesun Medical Technology Co., Ltd. Wed Feb 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN230064 — BraidE Embolization Assist Device | Rapid Medical , Ltd. Wed Feb 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232148 — X-Guide Surgical Navigation System | X-Nav Technologies, LLC Wed Feb 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233199 — ROSA® Shoulder System | Orthosoft Inc (D/B/A Zimmer Cas) Wed Feb 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231753 — Oneday Implant Abutment | Oneday Biotech Co., Ltd. Wed Feb 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233325 — Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A) | Visionary Optics, LLC Wed Feb 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232502 — Cocoon Convective Warming System, Model CWS7000 | Care Essentials Pty, Ltd. Wed Feb 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233454 — ONLINE TDM Methotrexate | Roche Diagnostics Operations Tue Feb 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233760 — Mjolnir Pro. (Multielectrode plasma) | Shenzhen Leaflife Technology Co., Ltd. Tue Feb 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233471 — Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm length (HAR1136) | Stryker Sustainability Solutions Tue Feb 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231896 — Diode Laser Therapy System | Beijing Adss Development Co., Ltd. Tue Feb 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233194 — TS Abutment System | Osstem Implant Co., Ltd. Tue Feb 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233150 — NET BRAND Osteosynthesis Nailing System | Narang Medical , Ltd. Tue Feb 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240146 — BD Prevue II Peripheral Vascular Access System | Bard Access Systems, Inc. Sun Feb 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232771 — Montage Flowable Settable, Resorbable Bone Paste | Orthocon, Inc. Fri Feb 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233906 — S-Patch (S-Patch ExL) | Wellysis Corp. Fri Feb 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232420 — Zenition 30 | Philips Medical Systems Nederland B.V. Fri Feb 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231657 — AGILON® XO Shoulder Replacement System | Implantcast GmbH Fri Feb 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232645 — Airgle Room Air Purifier | Airgle Corporation Fri Feb 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234005 — Access CK-MB | Beckman Coulter, Inc. Fri Feb 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231513 — Oral Matrix | Beijing Biosis Healing Biolog Ical Technology Co., Ltd. Fri Feb 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240148 — SCIg60 Infusion System | Emed Technologies Corporation Fri Feb 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240137 — Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System | Neos Surgery S.L Fri Feb 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233708 — NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01) | Synaptic Medical Corporation Fri Feb 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230235 — Medline Luer Lock Syringes | Medline Industries, LP Fri Feb 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231453 — SnapHammer Hammertoe Correction System | Nvision Biomedical Technologies, Inc. Fri Feb 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232043 — Endoscopic Video Image Processor (RP-IPD-V2000A, RP-IPD-V2000B, RP-IPD-V2000C, RP-IPD-V2000D), Single-Use Video Gastroscope (RP-GI-G02A, RP-GI-G02B), Single-Use Video Colonoscope (RP-GI-C02A, RP-GI-C02B) | Guangzhou Red Pine Medical Instrument Co., Ltd. Fri Feb 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231985 — Disposable Grounding Pad | Shenzhen Mecun Medical Supply Co., Ltd. Fri Feb 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233652 — Contour Hand/Wrist (Q7000232) | Quality Electrodynamics Fri Feb 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232087 — Dental LT Comfort Resin | Formlabs Ohio, Inc. Fri Feb 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233658 — Biowy Tym Tube (TT) | Biowy Corporation Fri Feb 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240119 — VasQ | Laminate Medical Technologies , Ltd. Fri Feb 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240157 — InVision 1.5 Surgical Theatre | Deerfield Imaging, Inc. Thu Feb 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231659 — MS55 Plus Digital Color Doppler Ultrasound System (MS55); P25 Expert Digital Color Doppler Ultrasound System (P25 Expert); P12 Plus Digital Color Doppler Ultrasound System (P12 Plus); P11 Plus Portable Digital Color Doppler Ultrasound System (P11 Plus); P9 Plus Ultrasound Diagnostic System (P9 Plus); P3 Plus Ultrasound Diagnostic System (P3 Plus) | Medisono Thu Feb 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234036 — SONIK MONARK 100 | Neuro Spinal Innovation, Inc. Thu Feb 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222917 — Breathing circuit bacterial/viral filter | Shaoxing Haitech Medical Products Co., Ltd. Thu Feb 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223493 — PBC Separator with Selux AST System | Selux Diagnostics, Inc. Thu Feb 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232245 — VedDilator ^TM (3-Stage Balloon Dilation Catheter) | Jiangsu Vedkang Medical Science and Technology Co., Ltd. Thu Feb 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234028 — COPAL® exchange G hip spacer; COPAL® G+V | Heraeus Medical GmbH Thu Feb 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240130 — Medical Monitor (21HQ613D) | Lg Electronics.Inc Thu Feb 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232915 — EpiMonitor | Empatica S.r.l. Thu Feb 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231522 — EMPHASYS Dual Mobility System | Depuy Ireland UC Thu Feb 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233656 — Contour Shoulder | Quality Electrodynamics Thu Feb 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231107 — Bronchoscope System | Hunan Endoso Life Technology Co., Ltd. Thu Feb 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |