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
3025–3048 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 25, 2025
CRYOcheck Chromogenic Factor VIII
K251440 · GGP
Precision Biologic, Inc.
Hematology · 108d
Cleared Aug 25, 2025
Quantra QStat Cartridge
K251404 · QFR
Hemosonics, LLC
Hematology · 111d
Cleared Aug 25, 2025
Sparrow Ascent
K251246 · PZR
Spark Biomedical, Inc.
Neurology · 125d
Cleared Aug 25, 2025
NobelZygoma TiUltra Implant system
K243834 · DZE
Nobel Biocare AB
Dental · 255d
Cleared Aug 25, 2025
PRO Pen Microneedling System (6883)
K243800 · QAI
Dermalogica, LLC
General & Plastic Surgery · 257d
Cleared Aug 25, 2025
NeuroEars-Anna™
K243709 · GWN
Neuroears, Inc.
Ear, Nose, Throat · 266d
Cleared Aug 25, 2025
Neurovascular Insight V1.0
K243680 · LLZ
Olea Medical S.A.S.
Radiology · 269d
Cleared Aug 25, 2025
Maxx Libertas Bipolar Hip Head (Bipolar Hip)
K243634 · KWY
Maxx Orthopedics, Inc.
Orthopedic · 273d
Cleared Aug 22, 2025
GBrain MRI
K252362 · QIH
Galileo Cds, Inc.
Radiology · 24d
Cleared Aug 22, 2025
Stem Extension Line (USTAR II System)
K252303 · KRO
United Orthopedic Corporation
Orthopedic · 29d
Cleared Aug 22, 2025
CARTO™ 3 EP Navigation System V8.1
K252302 · DQK
Biosense Webster, Inc.
Cardiovascular · 29d
Cleared Aug 22, 2025
One-Fil Putty Injectable
K251884 · KIF
Mediclus Co., Ltd.
Dental · 63d
Cleared Aug 22, 2025
CEREGLIDE 71 Catheter System
K251828 · NRY
Cerenovus, Inc.
Neurology · 70d
Cleared Aug 22, 2025
CareSuperb COVID-19/Flu A&B Antigen Combo Home Test
K251604 · SCA
Access Bio, Inc.
Microbiology · 87d
Cleared Aug 22, 2025
PROMO
K251443 · IZL
DRGEM Corporation
Radiology · 105d
Cleared Aug 22, 2025
CoraForce Microcatheter, CoraFlex Microcatheter
K251277 · DQY
Reflow Medical, Inc.
Cardiovascular · 120d
Cleared Aug 22, 2025
Diagnostic Ultrasound System (MX7)
K251192 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 127d
Cleared Aug 22, 2025
CPS Locator 3D Delivery Catheter
K250147 · DQY
Centerpoint Systems
Cardiovascular · 213d
Cleared Aug 22, 2025
EnDrive (EnDriveUS)
K243692 · EKX
Advanced Technology Research (A.T.R.)...
Dental · 266d
Cleared Aug 22, 2025
MammoScreen BD
K243685 · QIH
Therapixel
Radiology · 266d
Cleared Aug 22, 2025
Monoject™ 1mL Tuberculin Syringe Luer-Lock Tip (1180100777)
K243660 · FMF
Cardinalhealth
General Hospital · 268d
Cleared Aug 21, 2025
The Acumed Wrist Fixation System - 2.4mm Screws
K252356 · HRS
Acumed, LLC
Orthopedic · 23d
Cleared Aug 21, 2025
Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use...
K252244 · LZA
Ever Global (Vietnam) Enterprise...
General Hospital · 34d
Cleared Aug 21, 2025
MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS...
K251647 · DZE
Dentsply Sirona, Inc.
Dental · 84d