510(k) Clearances — Page 18

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 18 of 3,525)
ClearancesDetails
K260636 — Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingStryker Sustainability Solutions Jun 18, 2026
K253050 — RadOncAIInformai Jun 18, 2026
K260946 — LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)Guangdong Newdermo Biotech Co., Ltd. Jun 18, 2026
K250806 — Dental Implant SystemA.B. Dental Devices , Ltd. Jun 18, 2026
K252839 — ZywieZ3 Sensor & AdhesiveZywie, Inc. Jun 18, 2026
K260190 — ARTHURROPCA ApS Jun 18, 2026
K261246 — SRGC-06GC America, Inc. Jun 18, 2026
K261099 — Blood Volume Analyzer (200)Daxor Corporation Jun 18, 2026
DEN250025 — Syncron-EAutonomous Healthcare, Inc. Jun 18, 2026
K260820 — VIVIX-S 4386W (FXRD-4386WA)Vieworks Co., Ltd. Jun 18, 2026
K261707 — MEMO 4D Curve™ Semirigid mitral annuloplasty ringCorcym S.R.L. Jun 18, 2026
K251559 — InstaTRU Instant Biological Indicator for Steam (IBI-05)True Indicating, LLC Jun 18, 2026
K252982 — CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc. Jun 18, 2026
K261713 — Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation Jun 18, 2026
K253126 — Wrist Blood Pressure Monitor (XW-05)Shenzhen Ziqing Medical Equipment Co., Ltd. Jun 18, 2026
K261651 — Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized Orthopedics Jun 18, 2026
K260178 — Pelvic Muscle Trainer (KM510, KM516B)Shenzhen Konmed Technology Co., Ltd. Jun 18, 2026
K252066 — inspired™ Heated Breathing Circuit (510-008); inspired™ Heated Breathing Circuit (510-009); inspired™ Auto-feed Humidification Chamber (VHC10); inspired™ Auto-feed Humidification Chamber (VHC20)Vincent Healthcare Products Limited Jun 18, 2026
K253116 — 3D MAC Titanium Cranial Plate (TCP) SystemThe Surgeon General, Department Of The Army (TSG-DA) Jun 18, 2026
K254254 — Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)Shenzhen Root Innovation Technology Co., Ltd. Jun 18, 2026
K253812 — Power Wheelchair (W5915B, W5915C, W5915D)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd Jun 18, 2026
K253824 — Powder Free Nitrile Examination Gloves Non-Sterile BlackKanglongda Vietnam Protection Technology Company Limited Jun 18, 2026
K260006 — INOSS SystemInosys, Inc. Jun 17, 2026
K253155 — Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd. Jun 17, 2026
K253255 — Non-Sterile Ultrasound Gel Sterile Ultrasound GelFoshan Pingchuang Medical Technology Co., Ltd. Jun 17, 2026
K253055 — Sine Monitoring Parkinson’s Disease Tremor Dyskinesia Apple Watch (“SMPDTDAW”)Nordic Kinetics AB Jun 17, 2026
K253634 — CoolSeal Generator® (CSL-200-90)Hologic, Inc. Jun 17, 2026
K261631 — Amplatzer TorqVue Exchange SystemAbbott Medical Jun 17, 2026
K252399 — Portable Oxygen ConcentratorHonsun (Nantong) Co., Ltd. Jun 17, 2026
K261544 — Hydro Irrigation SystemStryker Instruments Jun 17, 2026
K261570 — PICOSURE WORKSTATIONCynosure, LLC Jun 17, 2026
K261672 — twiist Automated Insulin Delivery (AID) SystemDeka Research And Development Jun 17, 2026
K261638 — Bonvadis®Oneness Biotech Co., Ltd. Jun 17, 2026
K260916 — FLEXI-PORT™ Power Injectable Implantable PortPortal Access, Inc. Jun 17, 2026
K260867 — Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black)Hartalega NGC Sdn. Bhd. Jun 17, 2026
K260428 — RIVOS™ EUS Access Device (M00553900)Boston Scientific Corporation Jun 17, 2026
K253045 — “Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd. Jun 17, 2026
K260538 — Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )Shenzhen Root Innovation Technology Co., Ltd. Jun 17, 2026
K253333 — Assisted Reproduction Laser System (Model ILS-400M)Hua Yue Medical Technology Co., Ltd. Jun 17, 2026
K253137 — FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TFujifilm Corporation Jun 16, 2026
K261833 — NEUROMARK System (NMK00301)Neurent Medical , Ltd. Jun 16, 2026
K253723 — BOSSMedpark Co., Ltd. Jun 16, 2026
K253159 — Prophecy Incompass Surgical Planning SystemWright Medical Technology, Inc. (Stryker) Jun 16, 2026
K253069 — Lipoprotein (a) Molarity AssayDiazyme Laboratories, Inc. Jun 16, 2026
K253264 — myAblation Guide (VC10A)Siemens Healthcare GmbH Jun 16, 2026
K253046 — HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd. Jun 16, 2026
K260831 — Z1 Hip SystemZimmer, Inc. Jun 16, 2026
K253231 — Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500)Hubei Yjt Technology Co.,Ltd Jun 16, 2026
K260693 — VicorderCS (VCS-SYS-1100)80 Beats Medical GmbH Jun 16, 2026
K260844 — ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Jun 16, 2026
← Previous Page 18 of 3525 Next →