510(k) Clearances — Page 143
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K234065 — CDI OneView Monitoring System | Terumo Cardiovascular Systems Corporation Thu Apr 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232796 — LUOFUCON® Collagen Particles (Collagen Wound Dressing) | Huizhou Foryou Medical Devices Co., Ltd. Thu Apr 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240855 — Dental Cone-beam Computed Tomography | Yian Medical Technology (Haining) Co., Ltd. Thu Apr 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234025 — 22.2mm BIOLOX® delta Ceramic V40 Femoral Heads | Howmedica Osteonics Corp., Dba Stryker Orthopaedics Wed Apr 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233172 — NextAR Spine Platform | Medacta International S.A. Wed Apr 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234056 — canturio® se (Canturio Smart Extension) | Canary Medical USA, LLC Wed Apr 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240623 — Omnia Medical TiBrid-SA System | Omnia Medical, LLC Wed Apr 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240208 — DESS Dental Smart Solutions | Terrats Medical SL Wed Apr 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233764 — SSS-NX (Serum Substitute Supplement-NX) | Fujifilm Irvine Scientific Wed Apr 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232181 — Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13) | Hebei JT Medical Co., Ltd. Wed Apr 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240093 — IPL Home Use Hair Removal Device (SJ15) | Shenzhen Shuge Medical Beauty Devices Co., Ltd. Wed Apr 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240822 — Image Management V15 | Philips Medical Systems Technologies Wed Apr 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240850 — EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems | Philips Ultrasound, LLC Wed Apr 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240839 — OpenRad Cloud | Openrad Services Uk, Ltd. Wed Apr 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240319 — DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040) | Pro Med Instruments GmbH Wed Apr 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234147 — ReNew XR Handpiece, 25cm, with Reference Markings (3943M); ReNew XR Handpiece, 34cm, with Reference Markings (3941M); ReNew XR Handpiece, 42cm, with Reference Markings (3942M); ReNew XR Handpiece, Ratcheted, 25cm, with Reference Markings (3946M); ReNew XR Handpiece, Ratcheted, 34cm, with Reference Markings (3944M); ReNew XR Handpiece, Ratcheted, 42cm, with Reference Markings (3945M) | Microline Surgical, Inc. Tue Apr 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240816 — MeDioStar | Asclepion Laser Technologies GmbH Tue Apr 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240518 — swiftPro System | Emblation Limited Tue Apr 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233537 — FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System | Abbott Diabetes Care, Inc. Tue Apr 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233329 — Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set | Route 92 Medical, Inc. Tue Apr 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234107 — Solar Anorectal Manometry Catheter (Model Number: K1210AC-L-2212) | Laborie Medical Technologies, Corp. Tue Apr 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222958 — mJOULE RF System and Accessories | Sciton, Inc Tue Apr 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240902 — Dexcom G7 Continuous Glucose Monitoring System | Dexcom, Inc. Tue Apr 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233849 — BTL-499 | BTL Industries, Inc. Tue Apr 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240058 — AEYE-DS | Aeye Health, Inc. Tue Apr 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231699 — QUANTUM® Patient Specific Instrumentation (PSI) System | In2bones Sas Tue Apr 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233948 — Provisio SLT IVUS System | Provisio Medical, Inc. Tue Apr 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223515 — MamaLift Plus | Curio Digital Therapeutics, Inc. Mon Apr 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232319 — Black Pearl Nitrile Examination Glove | Ug Global Resources Sdn. Bhd. Mon Apr 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240115 — Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY,Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa I8, Nuewa I8 Exp, NuewaI8S, Nuewa I8T, Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp, Nuewa IY Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Mon Apr 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233966 — Anterior Spine Truss System-Stand Alone (ASTS-SA) | 4Web Medical, Inc. Mon Apr 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234041 — Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5811BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5810VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5810BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5920VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5920BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5923TS) | Andon Health Co, Ltd. Mon Apr 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233582 — Rapid | Ischemaview, Inc. Mon Apr 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240182 — Access EPO | Beckman Coulter, Inc. Mon Apr 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234068 — ART-Plan (v.2.2.0) | Therapanacea Sas Mon Apr 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233311 — Acumed Wrist Plating System | Acumed, LLC Mon Apr 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232149 — BowTie SI Joint Fusion System | Sail Fusion, LLC Sat Apr 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240378 — FAQ 201, FAQ 202 | Foreo, Inc. Fri Apr 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232566 — NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System; Mariner Pedicle Screw Systems: Mariner Outrigger Revision System; Mariner MIS Pedicle Screw System; Mariner Deformity System; Mariner RDX System | SeaSpine Orthopedics Corporation Fri Apr 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240508 — Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel) | Laclede, Inc. Fri Apr 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234073 — ICE Aspiration System | Expanse Medical, Inc. Fri Apr 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232216 — Hemoblock_S (Prescription); Hemoblock_S (OTC) | Incore Co., Ltd. Fri Apr 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232962 — Patient Monitor (iX10, iX12, iX15) | Edan Instruments, Inc. Fri Apr 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240753 — Miro3D Fibers Wound Matrix | Reprise Biomedical, Inc. Fri Apr 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232377 — Healgen Rapid COVID-19 Antigen Test | Healgen Scientific,, LLC Fri Apr 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233106 — AccuCath Ace Intravascular Catheter | Bard Access Systems, Inc. (C.R. Bard, Inc.) Fri Apr 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234119 — UniSpace® Stand-Alone C Cage | Innosys Co., Ltd. Fri Apr 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232204 — ReyaGel (RG03 - MTP gel 3mL) | Fettech Fri Apr 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230120 — KeYi Total Knee System | Beijing Keyi Medical Device Technology Co., Ltd. Fri Apr 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233373 — Flowflex® Plus COVID-19 Home Test | ACON Laboratories, Inc. Fri Apr 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |