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
1945–1968 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 25, 2025
Geistlich Mucograft® /Geistlich Mucograft® Seal
K252253 · NPL
Geistlich Pharma AG
Dental · 127d
Cleared Nov 25, 2025
Hushd Avera
K252161 · LRK
Good Sleep CO Pte , Ltd.
Dental · 138d
Cleared Nov 25, 2025
enCore Night Guard
K252004 · OBR
Encore Guards
Dental · 151d
Cleared Nov 25, 2025
Spectra Platinum
K251932 · HGX
Uzinmedicare Co., Ltd.
Obstetrics & Gynecology · 154d
Cleared Nov 25, 2025
RCT700
K251798 · OAS
Ray Co., Ltd.
Radiology · 166d
Cleared Nov 25, 2025
NX01 (NX01)
K251550 · OMC
Naox Technologies Sas
Neurology · 188d
Cleared Nov 25, 2025
PennPET Explorer Positron Emission Tomograph
K251401 · KPS
Trustees of the University of...
Radiology · 203d
Cleared Nov 25, 2025
Akura Thrombectomy System
K251070 · QEW
Akura Medical
Cardiovascular · 232d
Cleared Nov 25, 2025
Scaida BrainCT-ICH (v1.0)
K250694 · QAS
Mlhealth 360
Radiology · 263d
Cleared Nov 25, 2025
FEops HEARTguide Simulation Application
K250635 · QQI
Feops NV
Cardiovascular · 267d
Cleared Nov 24, 2025
NeVa PV Thrombectomy Device
K253407 · QEX
Vesalio, Inc.
Cardiovascular · 55d
Cleared Nov 24, 2025
Thulium Fiber Laser System (TFL-A)
K252787 · GEX
Guangzhou Potent Medical Equipment...
General & Plastic Surgery · 83d
Cleared Nov 24, 2025
Holmium Laser System (Potent HP90)
K252771 · GEX
Guangzhou Potent Medical Equipment...
General & Plastic Surgery · 83d
Cleared Nov 24, 2025
F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB,...
K252704 · GEI
F Care Systems USA, LLC
General & Plastic Surgery · 89d
Cleared Nov 24, 2025
Transcutaneous Electrical Nerve Stimulator (RJTENS-2)
K252688 · NUH
Bozhou Rongjian Medical Appliance...
Neurology · 90d
Cleared Nov 24, 2025
AlphaVac Multipurpose Mechanical Aspiration System F1885
K252509 · QEZ
AngioDynamics, Inc.
Cardiovascular · 108d
Cleared Nov 24, 2025
a2z-Unified-Triage
K252366 · QAS
A2z Radiology Ai, Inc.
Radiology · 117d
Cleared Nov 24, 2025
Voluson Expert 18
K252328 · IYN
GE Medical Systems Ultrasound and...
Radiology · 122d
Cleared Nov 24, 2025
The BAG manual resuscitator and accessories
K251631 · BTM
Laerdal Medical AS
Anesthesiology · 180d
Cleared Nov 24, 2025
Dakota LP System
K250769 · ODP
Precision Spine, Inc.
Orthopedic · 256d
Cleared Nov 24, 2025
BCM2-Body Composition Monitor
K250634 · DSB
Fresenius Medical Care Renal...
Gastroenterology & Urology · 266d
Cleared Nov 24, 2025
Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)
K242503 · DTZ
Eurosets S.R.L
Cardiovascular · 459d
Cleared Nov 22, 2025
KARL STORZ Cholangiography Set
K250927 · GCJ
Karl Storz SE & CO. KG
General & Plastic Surgery · 239d
Cleared Nov 21, 2025
TERA HARZ Hard Denture (THD-C-500)
K253681 · EBI
Graphy, Inc.
Dental