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
2545–2568 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 17, 2025
DENTURE SOFT EX (Pink set)
K252035 · EBI
Kamemizu Chemical Industry Co., Ltd.
Dental · 79d
Cleared Sep 17, 2025
Vitaform Procedural Mask - Blue (Vitaform Blue)
K251902 · FXX
Vitacore Industries, Inc.
General Hospital · 89d
Cleared Sep 17, 2025
Carpentier-Edwards Physio Annuloplasty Ring (4450)
K251688 · KRH
Edwards Lifesciences, LLC
Cardiovascular · 107d
Cleared Sep 17, 2025
Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061)
K251623 · IRP
Shenzhen Yicai Health Technology Co.,...
Physical Medicine · 112d
Cleared Sep 17, 2025
PlasmaFlow X Compression Sleeve Device (XPF0001)
K251446 · JOW
Manamed, LLC
Cardiovascular · 131d
Cleared Sep 17, 2025
ECHELON Synergy
K251386 · LNH
Fujifilm Corporation
Radiology · 135d
Cleared Sep 17, 2025
Assert-IQ (DM5000)
K251221 · MXD
Abbott
Cardiovascular · 149d
Cleared Sep 17, 2025
Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses
K251095 · LPL
Pegavision Corporation
Ophthalmic · 160d
Cleared Sep 17, 2025
FG Bone Graft M
K244006 · LYC
Full Golden Biotech Co., Ltd.
Dental · 265d
Cleared Sep 17, 2025
Double Tube Herbst Appliance
K243752 · LRK
The Tmj Clinic PC
Dental · 286d
Cleared Sep 16, 2025
ACCUJECT Injector Set 2.1-1P (LP604590)
K252540 · MSS
Medicel AG
Ophthalmic · 35d
Cleared Sep 16, 2025
Medline Microtek C-Flo Bag Decanter, Sterile (2000S)
K251676 · LHI
Microtek Medical, LLC
General Hospital · 109d
Cleared Sep 16, 2025
Insight Enhanced™ DRF (EN-1002-01)
K251650 · JAA
Imaging Engineering, LLC
Radiology · 110d
Cleared Sep 16, 2025
SFIT Abutment
K242287 · NHA
Cowellmedi Co., Ltd.
Dental · 410d
Cleared Sep 15, 2025
Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)
K252598 · FAJ
Shanghai AnQing Medical Instrument...
Gastroenterology & Urology · 28d
Cleared Sep 15, 2025
SpaceFix Shoulder Spacer
K252443 · MBB
G21, S.R.L.
Orthopedic · 42d
Cleared Sep 15, 2025
Zener® (model ZEN-001-B1)
K252128 · FRA
Uvx, Inc.
General Hospital · 70d
Cleared Sep 15, 2025
IPL Hair Removal Device (MLY-M011)
K251914 · OHT
Miley Technology (Hebei) Co., Ltd.
General & Plastic Surgery · 84d
Cleared Sep 15, 2025
Disposable Prophy Angle (3399-60, 3399-090, 3399-105)
K251869 · EGS
Premium Plus (Dongguan) Limited
Dental · 89d
Cleared Sep 15, 2025
iGPS Navigation Instruments
K251780 · OLO
SI-BONE, Inc.
Orthopedic · 97d
Cleared Sep 15, 2025
Sober Self-Test
K250609 · DIC
Sober Ip, LLC
Toxicology · 199d
Cleared Sep 15, 2025
InferOperate Suite
K250237 · QIH
Beijing Infervision Healthcare...
Radiology · 231d
Cleared Sep 14, 2025
CloudTMS Edge
K250689 · OBP
Teleemg, LLC
Neurology · 192d
Cleared Sep 13, 2025
BrainsWay Deep TMS System
K251449 · OBP
Brainsway , Ltd.
Neurology · 127d