FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
2233–2256 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 22, 2025
Hair Growth Laser Cap
K252325 · OAP
Cosmo Far East Technology Limited
General & Plastic Surgery · 89d
Cleared Oct 22, 2025
SIros-X System
K252322 · OUR
Genesys Spine
Orthopedic · 89d
Cleared Oct 22, 2025
ANDI 2.0
K252298 · QIH
Imeka Solutions, Inc.
Radiology · 91d
Cleared Oct 22, 2025
electric breast pump (FZ-P8)
K251977 · HGX
Ningbo Youhe Electrical Appliance...
Obstetrics & Gynecology · 117d
Cleared Oct 22, 2025
Flowflex Plus RSV + Flu A/B + COVID Home Test
K251749 · SCA
ACON Laboratories, Inc.
Microbiology · 138d
Cleared Oct 22, 2025
Giraffe OmniBed Carestation (CS1)
K251663 · FMZ
Datex-Ohmeda, Inc.
General Hospital · 145d
Cleared Oct 22, 2025
Mandibular Advancement Device L07
K251628 · LRK
Dcstar, Inc.
Dental · 147d
Cleared Oct 22, 2025
WELLlife COVID-19 Antigen Test Rx
K251289 · QVF
Guangzhou Wondfo Biotech Co., Ltd.
Microbiology · 180d
Cleared Oct 22, 2025
Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018,...
K251185 · QEW
Intervene
Cardiovascular · 189d
Cleared Oct 22, 2025
Sirona Advanced Imaging Suite
K251030 · LLZ
Sirona Medical
Radiology · 202d
Cleared Oct 22, 2025
XC11 ICE System, USA
K250955 · OBJ
Yorlabs, Inc.
Cardiovascular · 205d
Cleared Oct 22, 2025
Alegria Flash CTD Screen
K250666 · LLL
Zeus Scientific
Immunology · 231d
Cleared Oct 21, 2025
TriALTIS™ Spine System
K253249 · NKB
Medos International SARL
Orthopedic · 22d
Cleared Oct 21, 2025
Aevumed FASE Suture Anchor
K253040 · MBI
Aevumed, Inc.
Orthopedic · 29d
Cleared Oct 21, 2025
HemoSphere Stream Module
K253034 · DQK
Edwards Lifesciences
Cardiovascular · 29d
Cleared Oct 21, 2025
Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor
K253033 · ONB
Simplivia Healthcare , Ltd.
General Hospital · 29d
Cleared Oct 21, 2025
OLYMPIC Posterior Spinal Fixation System
K252346 · NKB
Astura Medical
Orthopedic · 85d
Cleared Oct 21, 2025
Introducer Sheath Set
K251838 · DYB
Cardiocycle Medical(Suzhou) Co., Ltd.
Cardiovascular · 127d
Cleared Oct 21, 2025
Neuromuscular Transmission Monitor TOF3D (2510091)
K250887 · KOI
MIPM Mammendorfer Institut f?r Physik...
Anesthesiology · 210d
Cleared Oct 21, 2025
Disposable Balloon Catheter (B5-2Q)
K250409 · FGE
Olympus Medical Systems Corporation
Gastroenterology & Urology · 250d
Cleared Oct 21, 2025
Fine TTO™
K250394 · PBF
Bodycad Laboratories, Inc.
Orthopedic · 251d
Cleared Oct 21, 2025
ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M)
K250126 · GEI
Livsmed, Inc.
General & Plastic Surgery · 277d
Cleared Oct 21, 2025
NeuroAlign software
K231897 · HAW
Medivis, Inc.
Neurology · 846d
Cleared Oct 20, 2025
InkSpace Imaging Small Body Array (SBA12PH30x)
K253182 · MOS
Inkspace Imaging, Inc.
Radiology · 24d