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
12097–12120 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 26, 2022
EsoCheck Cell Collection Device
K222366 · EOX
Lucid Diagnostics, Inc.
Gastroenterology & Urology · 83d
Cleared Oct 26, 2022
Medical Examination Gloves (Nitrile) (XS, S, M, L, XL)
K222498 · LZA
Humanwell Healthcare Group Medical...
General Hospital · 69d
Cleared Oct 26, 2022
VASSALLO GT EXT
K222631 · DQX
Filmecc Co., Ltd.
Cardiovascular · 56d
Cleared Oct 26, 2022
TEMA Elbow system - Line extension
K222807 · JDB
Lima Corporate S.P.A.
Orthopedic · 40d
Cleared Oct 26, 2022
EzRay Air 2 Wall (Model: VEX-S350W)
K223058 · EHD
VATECH Co., Ltd.
Radiology · 26d
Cleared Oct 26, 2022
DigiX FDX
K223060 · KPR
Allengers Medical Systems Limited
Radiology · 26d
Cleared Oct 26, 2022
Adcura® Sagittae® Lateral Lumbar Interbody Fusion Devices
K223065 · MAX
Adcura, Inc.
Orthopedic · 26d
Cleared Oct 26, 2022
Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs)
K223235 · LZA
Pt. Sintong Unigolden Glove
General Hospital · 13d
Cleared Oct 25, 2022
Disposable Surgical Face Mask
K212649 · FXX
Lyncmed Medical Technology (Beijing)...
General Hospital · 428d
Cleared Oct 25, 2022
Hudson RCI Triflo II Incentive Deep Breathing Exerciser
K220565 · BWF
Medline Industries, Inc.
Anesthesiology · 239d
Cleared Oct 25, 2022
JR MEDIC Nitrile Examination Gloves Powder Free- Black
K221169 · LZA
Jr Engineering & Medical Technologies...
General Hospital · 186d
Cleared Oct 25, 2022
EndoNaut
K222070 · OWB
Therenva Sas
Radiology · 103d
Cleared Oct 25, 2022
Unistik® Pro
K222303 · FMK
Owen Mumford, Ltd.
General & Plastic Surgery · 85d
Cleared Oct 25, 2022
Leltek Ultrasound Imaging System (Model: LU700 Series)
K222365 · IYN
Leltek, Inc.
Radiology · 82d
Cleared Oct 25, 2022
Rexious Spinal Fixation System
K222415 · NKB
Dio Medical Corporation
Orthopedic · 76d
Cleared Oct 25, 2022
3Dicom MD
K222470 · LLZ
Singular Health Pty, Ltd.
Radiology · 70d
Cleared Oct 25, 2022
Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction...
K222968 · LNH
Canon Medical Systems Corporation
Radiology · 28d
Cleared Oct 24, 2022
KODEX – EPD™ System 1.5.0
K212493 · DQK
Philips Medical Systems Nederland,...
Cardiovascular · 441d
Cleared Oct 24, 2022
The GIRO Growth Modulation System
K220190 · OBT
Pega Medical, Inc.
Orthopedic · 273d
Cleared Oct 24, 2022
MectaLIF Anterior Extension
K221545 · OVD
Medacta International S.A.
Orthopedic · 150d
Cleared Oct 24, 2022
Neurosteer EEG Recorder
K221563 · OMC
Neurosteer, Inc.
Neurology · 146d
Cleared Oct 24, 2022
SafetiCET Safety Lancet
K221783 · FMK
Nsp Tech Pte, Ltd.
General & Plastic Surgery · 125d
Cleared Oct 24, 2022
Soft Palate Elevator
K222127 · LRK
The Tmj Clinic PC
Dental · 98d
Cleared Oct 22, 2022
cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems
K213804 · QQX
Roche Molecular Systems, Inc.
Microbiology · 320d