510(k) Clearances — Page 118
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K242186 — Neo Sculptor (OF-NEO001) | Ofan Intelligent Technology (Guangzhou) Co. , Ltd. Tue Sep 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241230 — Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008 | Togo Medikit Co., Ltd. Tue Sep 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240660 — Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-active | Kulzer, LLC Tue Sep 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232938 — Traus SSG30 Surgical System | Saeshin Precision Co., Ltd. Mon Sep 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234089 — DNA Appliance | Vivos Therapeutics Mon Sep 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241771 — Liftendo; Liftendo 2.0 | Medical San Indústria DE Equipamentos Médicos Ltda. Mon Sep 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240638 — Power Wheelchair (YH-E7007) | Ningbo Youhuan Automation Technology Co., Ltd. Mon Sep 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241762 — OneMark | View Point Medical Mon Sep 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241379 — Powered Wheelchair (NXN20-205, NXN20-205M) | Zhejiang Nysin Medical Co., Ltd. Mon Sep 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234050 — HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap, HALYARD® SEQUENTIAL Sterilization Wrap and HALYARD® SMART-FOLD® Sterilization Wrap | O&M Halyard, Inc. Mon Sep 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241335 — Eversense 365 Continuous Glucose Monitoring (CGM) System | Senseonics, Incorporated Mon Sep 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241893 — CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays | Medos International SARL Mon Sep 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241201 — TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite/Anesus TEX20 Pro/Eagus TEX20/Eagus TEX20T/Eagus TEX21/Eagus TEX21T/Eros/TE X Plus/Anesus TEX10 Pro/TEX9U/TEX9M/Eagus TEX11/Eagus TEX11T/EagusTEX10/Eagus TEX10T/Eagus TEX/Ares Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Mon Sep 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241156 — Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter, Supreme Electrophysiology Catheter (401150, 401206, 401207, 401210, 401211, 401212, 401222, 401223, 401226, 401227, 401228, 401260, 401261, 401271, 401305, 401306, 401309, 401310, 401311, 401312, 401317, 401353, 401357, 401381, 401392, 401399, 401400, 401425, 401430, 401433, 401434, 401435, 401436, 401438, 401441, 401442, 401443, 401444, 401445, 401448, 401449, 401450, 401451, 401453, 401466, 401468, 401 | Surgical Instrument Service and Savings, Inc. Sat Sep 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240544 — Epitomee | Epitomee Medical , Ltd. Fri Sep 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233399 — Microdacyn Wound Care Solution | Sonoma Pharmaceuticals, Inc. Fri Sep 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240977 — DenQ Sub SLA Implant System | Denq Fri Sep 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241722 — Elos Accurate® Hybrid Base; Elos Accurate® Customized Abutment | Elos Medtech Pinol A/S Fri Sep 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240188 — Vitruvian Liposaber | Black & Black Surgical, Inc. Fri Sep 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240929 — Sleep Apnea Notification Feature (SANF) | Apple, Inc. Fri Sep 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240176 — V-VITFREEZE and V-VITWARM | Vitromed GmbH Fri Sep 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241875 — TheRay Collared and Collarless Femoral Stem | Nextstep Arthropedix Fri Sep 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242441 — Revian Lyte (10011) | Revian, Inc. Fri Sep 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240087 — RT Carbon ECG Leads | Ivy Biomedical Systems, Inc. Fri Sep 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234063 — T2Candida 1.1 Panel | T2biosystems, Inc. Fri Sep 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240232 — EK D3.3 and Ultra Wide Implants | Hiossen, Inc. Fri Sep 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241695 — Extremity All Suture System | Field Orthopaedics Thu Sep 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241280 — Constellation (CON-001) | Q Bio, Inc. Thu Sep 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241710 — 3M Attest Super Rapid Readout Biological Indicator 1492V; 3M Attest Auto-reader 490; 3M Attest Auto-reader 490H; 3M Attest Mini Auto-reader 490M | 3M Company Thu Sep 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240168 — N7-S | Nuga Medical Co., Ltd. Thu Sep 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240803 — Surgikor Fixation One, Abutment Blanks and Abutments | Surgikor, LLC Thu Sep 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240942 — CINA-CSpine | Avicenna.Ai Thu Sep 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231982 — Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2 | Qura S.R.L Thu Sep 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241524 — Elucid PlaqueIQ | Elucid Bioimaging, Inc. Thu Sep 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K220999 — Hipro Glycosylated Hemoglobin (HbA1c) Test System | Shijiazhuang Hipro Biotechnology Co., Ltd. Thu Sep 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241493 — Glidewell 3DP Denture Base Resin | Prismatik Dentalcraft, Inc. Thu Sep 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241249 — Orthopantomograph OP 3D LX (PAN 3D); Orthopantomograph OP 3D LX (PAN CEPH 3D) | Palodex Group OY Thu Sep 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240880 — VitalFlow Set with Balance Biosurface | Medtronic, Inc. Thu Sep 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240787 — Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518) | Biotronik, Inc. Thu Sep 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241582 — Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700) | Canon Medical Systems Corporation Thu Sep 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN230081 — Hearing Aid Feature (HAF) | Apple, Inc. Thu Sep 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242136 — Electric wheelchair (C001) | Zhejiang Hfizer Medical Equipment Co., Ltd. Thu Sep 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242401 — EXULT Knee Replacement System | Corentec Co., Ltd. Thu Sep 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241432 — MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Thu Sep 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233732 — CoolSculpting Elite System | Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics Thu Sep 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241745 — Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with 46 Chemotherapy Drugs, the Opioid Fentanyl citrate, simulated Gastric Acid, Fentanyl in Gastric Acid, the tranquilizer Xylazine, and Xylazine in Fentanyl citrate (Blue) | Ksg Medicare Sdn. Bhd. Wed Sep 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240271 — Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) | Linshom Medical, Inc. Wed Sep 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241438 — Signus Tetris St; Signus Tetris R St | Signus Medizintechnik GmbH Wed Sep 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240683 — Rx Knee System | Signature Orthopaedics Pty, Ltd. Wed Sep 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241380 — FETOLY-HEART | Diagnoly Wed Sep 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |