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
12961–12984 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 21, 2022
Wei Nasal Jet Tube
K211543 · BTR
Well Lead Medical Co., Ltd.
Anesthesiology · 428d
Cleared Jul 21, 2022
BTI Interna Narrow/Plus Dental Implant System UnicCa
K211952 · DZE
B.T.I. Biotechnology Institute, Sl.
Dental · 393d
Cleared Jul 21, 2022
Syringe with permanently attached needle
K213158 · FMF
Berpu Medical Technology Co., Ltd.
General Hospital · 296d
Cleared Jul 21, 2022
Insufflation Retention Device
K213773 · FDF
Bpendo, LLC
Gastroenterology & Urology · 231d
Cleared Jul 21, 2022
Celerity Incubator
K213881 · FRC
STERIS Corporation
General Hospital · 220d
Cleared Jul 21, 2022
Pump Alignment Syringe
K220184 · FMF
Jiangsu Caina Medical Co.,Ltd
General Hospital · 178d
Cleared Jul 21, 2022
Manual Wheelchair
K220671 · IOR
Hebei Ruilangde Medical Equipment...
Physical Medicine · 136d
Cleared Jul 21, 2022
Life Scope PT BSM-1700 Series Bedside Monitor
K220976 · KOI
Nihon Kohden Corporation
Anesthesiology · 108d
Cleared Jul 21, 2022
Cionic Neural Sleeve NS-100
K221823 · GZI
Cionic
Physical Medicine · 28d
Cleared Jul 20, 2022
Root Apex Locator
K212178 · LQY
Foshan Coxo Medical Instrument Co., Ltd.
Dental · 373d
Cleared Jul 20, 2022
AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial...
K213060 · KTI
Micro-Tech (Nanjing) Co., Ltd.
Anesthesiology · 301d
Cleared Jul 20, 2022
Pentaflush
K214080 · NGT
Pentaferte Italia S.R.L.
General Hospital · 205d
Cleared Jul 20, 2022
AutoSeg
K220039 · LLZ
Ai Medic, Inc.
Radiology · 196d
Cleared Jul 20, 2022
Biofeedback Nerve and Muscle Stimulator
K220161 · KPI
Shenzhen Konmed Technology Co., Ltd.
Gastroenterology & Urology · 181d
Cleared Jul 20, 2022
Pediatric Nailing Platform Femur
K220679 · HSB
OrthoPediatrics Corp.
Orthopedic · 134d
Cleared Jul 20, 2022
Libby Echo:Prio
K220956 · QIH
Dyad Medical, Inc.
Radiology · 110d
Cleared Jul 20, 2022
TruDi Shaver Blade
K221037 · PGW
Acclarent, Inc.
Ear, Nose, Throat · 104d
Cleared Jul 20, 2022
AF Laser
K221363 · PDZ
ShenB Co., Ltd.
General & Plastic Surgery · 70d
Cleared Jul 20, 2022
Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW)
K221512 · MQB
Vieworks Co., Ltd.
Radiology · 57d
Cleared Jul 20, 2022
Vario-Cup System
K221794 · KWY
Waldemar Link GmbH & Co. KG
Orthopedic · 29d
Cleared Jul 19, 2022
Tiche PTA Balloon Dilatation Catheter
K212215 · LIT
Brosmed Medical Co., Ltd.
Cardiovascular · 369d
Cleared Jul 19, 2022
Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular...
K213357 · DXH
Verily Life Sciences, LLC
Cardiovascular · 280d
Cleared Jul 19, 2022
ZEUS System (Zio Watch)
K213409 · DQK
iRhythm Technologies, Inc.
Cardiovascular · 273d
Cleared Jul 19, 2022
MAGIC Flow-Dependent Microcatheter
K213435 · KRA
Balt USA, LLC
Neurology · 270d