FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
4681–4704 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 21, 2025
Materialise Personalized Guides and Models for Craniomaxillofacial Surgery
K243637 · DZJ
Materialise NV
Dental · 88d
Cleared Feb 21, 2025
Sonio Suspect
K243614 · POK
Sonio
Radiology · 91d
Cleared Feb 21, 2025
Medicom Sterilization Pouch and Reel
K243431 · FRG
Medicom Asia-Pacific Holdings Ltd....
General Hospital · 108d
Cleared Feb 21, 2025
LYMA Laser PRO
K243330 · OHS
Lyma Life , Ltd.
General & Plastic Surgery · 120d
Cleared Feb 21, 2025
Custom Abutments
K243278 · NHA
Institut Straumann AG
Dental · 128d
Cleared Feb 21, 2025
Paradigm System
K243258 · OLO
Proprio, Inc.
Orthopedic · 129d
Cleared Feb 21, 2025
Upper Arm Electronic Blood Pressure Monitor (U87Y series (models including...
K243115 · DXN
Shenzhen Urion Technology Co., Ltd.
Cardiovascular · 144d
Cleared Feb 21, 2025
Green X 12 SE (PHT-40CHS)
K243088 · OAS
VATECH Co., Ltd.
Radiology · 144d
Cleared Feb 21, 2025
Sterilization Pouches and Reels
K242898 · FRG
Shanghai Jianzhong Medical Packaging...
General Hospital · 151d
Cleared Feb 21, 2025
Wearable breast pump (model W8)
K242850 · HGX
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 154d
Cleared Feb 21, 2025
QuickRad
K242838 · LLZ
Aikenist Technologies Pvt, Ltd.
Radiology · 155d
Cleared Feb 21, 2025
ScanDiags Ortho L-Spine MR-Q
K242607 · QIH
Scandiags AG
Radiology · 171d
Cleared Feb 21, 2025
Fassier-Duval Telescoping IM System
K241983 · HSB
Orthopediatrics Canada Ulc Dba Pega...
Orthopedic · 228d
Cleared Feb 21, 2025
Extremity Medical External Fixation System
K241563 · KTT
Extremity Medical, LLC
Orthopedic · 266d
Cleared Feb 21, 2025
Moldable Bone Void Filler and Moldable Bone Void Filler + CCC
K241555 · MQV
Rti Surgical, Inc.
Orthopedic · 266d
Cleared Feb 21, 2025
Synthetic Bone Graft Particulate
K241186 · LYC
Shenzhen Dazhou Medical Technology...
Dental · 298d
Cleared Feb 20, 2025
SparkTM Clear Aligner System
K250487 · NXC
Ormco Corporation
Dental · 1d
Cleared Feb 20, 2025
Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7,...
K250214 · IYN
Edan Instruments, Inc.
Radiology · 27d
Cleared Feb 20, 2025
Green Card Bowie-Dick Test (BD115)
K250172 · JOJ
Steritec Products, Inc. (A Getinge...
General Hospital · 30d
Cleared Feb 20, 2025
Defendo Fujifilm 700 Single Use Cleaning Adapter
K250140 · ODC
Steris Corparation
Gastroenterology & Urology · 34d
Cleared Feb 20, 2025
Dochek® Multi-Drug Urine Test Cup
K250067 · NGL
Guangzhou Decheng Biotechnology Co.,...
Toxicology · 41d
Cleared Feb 20, 2025
Arthrex FiberTape and TigerTape Cerclage Sutures
K243344 · JDQ
Arthrex, Inc.
Orthopedic · 118d
Cleared Feb 20, 2025
CER-S
K243312 · DQK
Cardiocalm Srl
Cardiovascular · 121d
Cleared Feb 20, 2025
Alinity h-series System
K243283 · GKZ
Abbott Laboratories
Hematology · 126d