510(k) Clearances — Page 169

176,223 clearances total

Browse all FDA 510(k) medical device clearances. RegDataLab tracks 176,223 clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances (page 169 of 3,525)
ClearancesDetails
DEN230025 — MIRA Surgical SystemVirtual Incision Feb 23, 2024
K232228 — Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, Accurature Multi-drug Urine Test Dip CardShanghai Accurature Diagnostics Co., Ltd. Feb 23, 2024
K233784 — ENSO (Model 2)Hinge Health, Inc. Feb 23, 2024
K240212 — COGNiTiON™ Staple SystemOrtho Solutions UK , Ltd. Feb 23, 2024
K233640 — Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS Interbody System; Transcend SPS Interbody System;Transcend NanoTec SPS Interbody SystemAlphatec Spine, Inc. Feb 22, 2024
K232831 — Quiver Aspiration PumpAnoxia Medical, Inc. Feb 22, 2024
K233544 — MESHEETDentis Co., Ltd. Feb 22, 2024
K231876 — MultiPulse HoPLUSAsclepion Laser Technologies GmbH Feb 22, 2024
K214037 — Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-TracErgo-Flex Technologies, LLC Feb 22, 2024
K240313 — Oligio XWontech Co., Ltd. Feb 22, 2024
K233749 — Revolution Ascend SlidingGe Hangwei Medical Systems Co., Ltd. Feb 22, 2024
K223826 — NanoDrop LancetDrawbridge Health, Inc. Feb 22, 2024
K240193 — R501 - R502 aortic root cannulae with and without vent line (R501-15: R501-20: R501-26. R502-15; R502-20: R502-26)Sorin Group Italia S.R.L. Feb 22, 2024
K232163 — Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration NeedleZhejiang Horizon Medical Technology Co., Ltd. Feb 22, 2024
K232074 — Serafin®Tns Co., Ltd. Feb 22, 2024
K240174 — 1688 4K Camera System with Advanced Imaging ModalityStryker Endoscopy Feb 22, 2024
K233775 — Vivatmo proBosch Healthcare Solutions GmbH Feb 22, 2024
K240173 — Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc. Feb 22, 2024
K233996 — Ulthera System (UC-1 Control Unit PRIME)Ulthera, Inc. Feb 22, 2024
K231875 — Vaginal Tactile Ultrasound ImagerAdvanced Tactile Imaging, Inc. Feb 22, 2024
K233439 — HD60 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd. Feb 21, 2024
DEN230064 — BraidE Embolization Assist DeviceRapid Medical Ltd. Feb 21, 2024
K232265 — BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S. Feb 21, 2024
K232148 — X-Guide Surgical Navigation SystemX-Nav Technologies, LLC Feb 21, 2024
K240194 — ProCinch, QuadCinchRiverpoint Medical Feb 21, 2024
K233199 — ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas) Feb 21, 2024
K231561 — Pulmonary Function Tester, Model: A9Guangzhou Homesun Medical Technology Co., Ltd. Feb 21, 2024
K231753 — Oneday Implant AbutmentOneday Biotech Co., Ltd. Feb 21, 2024
K233325 — Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A)Visionary Optics, LLC Feb 21, 2024
K232502 — Cocoon Convective Warming System, Model CWS7000Care Essentials Pty, Ltd. Feb 21, 2024
K233454 — ONLINE TDM MethotrexateRoche Diagnostics Operations Feb 20, 2024
K233471 — Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm length (HAR1136)Stryker Sustainability Solutions Feb 20, 2024
K231896 — Diode Laser Therapy SystemBeijing Adss Development Co., Ltd. Feb 20, 2024
K233194 — TS Abutment SystemOsstem Implant Co., Ltd. Feb 20, 2024
K233760 — Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd. Feb 20, 2024
K233150 — NET BRAND Osteosynthesis Nailing SystemNarang Medical , Ltd. Feb 20, 2024
K240146 — BD Prevue™ II Peripheral Vascular Access SystemBard Access Systems, Inc. Feb 18, 2024
K232645 — Airgle Room Air PurifierAirgle Corporation Feb 16, 2024
K233906 — S-Patch (S-Patch ExL)Wellysis Corp. Feb 16, 2024
K231513 — Oral MatrixBeijing Biosis Healing Biolog Ical Technology Co., Ltd. Feb 16, 2024
K231657 — AGILON® XO Shoulder Replacement SystemImplantcast GmbH Feb 16, 2024
K232420 — Zenition 30Philips Medical Systems Nederland B.V. Feb 16, 2024
K234005 — Access CK-MBBeckman Coulter, Inc. Feb 16, 2024
K231985 — Disposable Grounding PadShenzhen Mecun Medical Supply Co., Ltd. Feb 16, 2024
K232771 — Montage Flowable Settable, Resorbable Bone PasteOrthocon, Inc. Feb 16, 2024
K230235 — Medline Luer Lock SyringesMedline Industries, LP Feb 16, 2024
K240148 — SCIg60 Infusion SystemEmed Technologies Corporation Feb 16, 2024
K231453 — SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc. Feb 16, 2024
K233708 — NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01)Synaptic Medical Corporation Feb 16, 2024
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. Feb 16, 2024
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