510(k) Clearances — Page 167
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K232581 — Medical Disposable Sterile Needle Electrode | Suzhou Haishen Medical Device Associates Co., Ltd. Mon Dec 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN230045 — Sonu | Sound Health Systems, Inc. Mon Dec 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231895 — Maxtec MaxBlend2+p | Maxtec, LLC Mon Dec 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232932 — Intense Pulse Light Therapeutic Apparatus | Shenzhen Greatro Electronic Technology Co., Ltd. Mon Dec 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233397 — Cosine-10TM Diagnostic Catheter | Medtronic, Inc. Sat Dec 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233159 — pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504 | Fresenius Medical Care Renal Therapies Group, LLC Fri Dec 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232093 — Woo More Play Coconut Love Oil | Woo Essentials, Inc. Fri Dec 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231057 — Antibacterial Gel Wound Dressing | Winner Medical Co., Ltd. Fri Dec 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232249 — PENTAX Medical Gas/Water Feeding Valve OE-B14 | Pentax of America, Inc. Fri Dec 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233529 — BD Nexiva Diffusics Closed IV Catheter System with BD MaxZero Needle-free Connector | Becton Dickinson Infusion Therapy Systems, Inc. Fri Dec 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230528 — Extension Set | Medcaptain Life Science Co., Ltd. Fri Dec 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230391 — BD MiniDraw Capillary Blood Collection System with BD MiniDraw SST Capillary Blood Collection Tube | Becton, Dickinson and Company Fri Dec 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231179 — Slinky Catheter | Anoxia Medical, Inc. Fri Dec 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233301 — ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories | Lumenis Be, Ltd. Fri Dec 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233149 — CATHTONG III Tapered PICC Catheter | L&Z Us, Inc. Fri Dec 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232758 — Comatryx OTC | Strukmyer Medical, LLC Fri Dec 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231476 — TRUENESS AIR Blood Glucose Monitoring System; TRUENESS Blood Glucose Monitoring System | Sinocare, Inc. Fri Dec 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231817 — AlignerFlow LC | Voco GmbH Fri Dec 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232418 — Single Platform SP1 Implant System | Southern Implants (Pty), Ltd. Fri Dec 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232438 — Dental Glass Ceramics Blocks | Aibodent Biotechnology Co., Ltd. Fri Dec 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230988 — Vial2Bag Advanced® 13mm Admixture Device | West Pharma. Services IL, Ltd. Fri Dec 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232856 — Syngo Carbon Clinicals | Siemens Healthcare GmbH Fri Dec 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230621 — LaproGlide Disposable Monopolar PTFE Coated Laparoscopic Probes | Surgical Principals, Inc. Fri Dec 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230639 — Align Cervical Interbody Fusion System | Acuity Surgical Devices, LLC Fri Dec 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232708 — Intense pulsed light therapy device | Hebei Zhemai Technology Co., Ltd. Fri Dec 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231272 — OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail | OSSIO , Ltd. Fri Dec 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231211 — Medline ComfortTemp Patient Warming System | Medline Industries, LP Fri Dec 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232155 — syngo.CT Dual Energy | Siemens Medical Solutions USA, Inc. Thu Nov 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230669 — L-Cath Single and Dual Lumen Catheters, L-Cath Midline Catheters | Argon Medical Devices Thu Nov 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232262 — LumenEye® X1 endoscope (LX1-SCP-203); LumenEye® X1 consumables (LX1-CSB-201); LumenEye® X1 Consumable Carton (25 Sets) (LX1-CSP-201 ) | Surgease Innovations Limited Thu Nov 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232611 — TruLift Micro Expandable Spacer System & TruLift Expandable Spacer System | Life Spine, Inc. Thu Nov 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232709 — Diode laser therapy device | Hebei Zhemai Technology Co., Ltd. Thu Nov 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230061 — Insulin Syringe | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. Thu Nov 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232716 — Q-Switched Nd:Yag laser | Hebei Zhemai Technology Co., Ltd. Thu Nov 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233503 — 14F iSLEEVE Introducer Set | Boston Scientific Corporation Thu Nov 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230587 — Wrist Pulse Oximeter | Beijing Choice Electronic Technology Co., Ltd. Thu Nov 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233552 — IDEAL Ziploop | Riverpoint Medical Thu Nov 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233500 — Benesta Tissue Removal Device | Caldera Medical, Inc. Thu Nov 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221787 — Auxein's DHS/DCS Plate System | Auxein Medical Private Limited Thu Nov 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231877 — NavaClick Injection System | Lineage Biomedical, Inc. Thu Nov 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233545 — EPIQ Series Diagnostic Ultrasound System | Philips Ultrasound, LLC Thu Nov 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231393 — Radical the Dude 7F Guide Catheter | Maduro Medical, Inc. Thu Nov 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231546 — Somfit | Compumedics Limited Thu Nov 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232069 — Expandable Lumbar Fusion Cage (Type I,Type II) | Shanghai Reach Medical Instrument Co, Ltd. Wed Nov 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232244 — Disposable Endoscope Valves System | Changzhou Endoclean Medical Device Co., Ltd. Wed Nov 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230179 — 6440 MyLabX90 | Esaote, S.p.A. Wed Nov 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233527 — Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 MIS Fusion Plate | Spinal Simplicity, LLC Wed Nov 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231482 — uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, uCT ATLAS with uWS-CT-Dual Energy Analysis | Shanghai United Imaging Healthcare Co., Ltd. Wed Nov 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230646 — SUREcore Prime Biopsy Instrument | Uro-1 Medical, Inc. Wed Nov 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231821 — XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-090-S, E26-110-S, E26-130-S, E26-150-S, E26-175-S, E26-220-S, E26-090-B, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,) | Transit Scientific, LLC Wed Nov 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |