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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
13825–13848 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 17, 2022
Lunderquist Extra Stiff Wire Guide
K220137 · DQX
William Cook Europe Aps
Cardiovascular · 30d
Cleared Feb 17, 2022
TENS & PMS (Model: SM9126)
K220150 · NUH
Hong Qiangxing (Shenzhen) Electronics...
Neurology · 29d
Cleared Feb 17, 2022
Digital Intraoral X-ray Sensor
K220277 · MUH
Shenzhen Xpectvision Technology Co.,...
Radiology · 17d
Cleared Feb 16, 2022
Broncoflex Agile, Broncoflex Vortex, Screeni
K212886 · EOQ
Axess Vision Technology
Ear, Nose, Throat · 159d
Cleared Feb 16, 2022
LumiVy Lumbar IBF System
K212930 · MAX
Vy Spine, LLC
Orthopedic · 155d
Cleared Feb 16, 2022
NovoFlow Reinforced Ureteral Stent
K213186 · FAD
Coloplast Corp.
Gastroenterology & Urology · 140d
Cleared Feb 16, 2022
Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL,...
K213533 · IRP
Bio Compression Systems, Inc.
Physical Medicine · 103d
Cleared Feb 16, 2022
14HQ901G-B
K214044 · MQB
Lg Electronics.Inc
Radiology · 51d
Cleared Feb 16, 2022
Treace Medical Concepts (TMC) Plating System
K220136 · HRS
Treace Medical Concepts, Inc.
Orthopedic · 29d
Cleared Feb 16, 2022
Aspiron S ACP System
K220147 · KWQ
U&I Corporation
Orthopedic · 28d
Cleared Feb 16, 2022
Apapro Desensitizer
K220419 · LBH
Sangi Co, Ltd.
Dental · 2d
Cleared Feb 15, 2022
t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)
K203234 · QFG
Tandem Diabetes Care, Inc.
Chemistry · 469d
Cleared Feb 15, 2022
Sterile Auto-Disable Syringes with/without Needle for Single Use
K210229 · MEG
Zhejiang Kangkang Medical-Devices...
General Hospital · 383d
Cleared Feb 15, 2022
Morpheus
K210636 · LRK
S4S UK , Ltd.
Dental · 361d
Cleared Feb 14, 2022
RithmID-SD Steerable Diagnostic Electrophysiology Catheter
K203793 · DRF
Synaptic Medical Corporation
Cardiovascular · 413d
Cleared Feb 14, 2022
Fogarty Occlusion Catheter
K211610 · MJN
Edwards Lifesciences, LLC
Cardiovascular · 265d
Cleared Feb 14, 2022
Vinyl Powder Free Examination Glove
K212011 · LYZ
Top Glove Vietnam Company Limited
General Hospital · 231d
Cleared Feb 14, 2022
EvoEndo Single-Use Endoscopy System
K213606 · FDS
EvoEndo, Inc.
Gastroenterology & Urology · 91d
Cleared Feb 14, 2022
Cionic Neural Sleeve NS-100
K213622 · GZI
Cionic
Neurology · 90d
Cleared Feb 11, 2022
PainTB, PainTJ
K203337 · NHN
Ptech Co., Ltd.
Physical Medicine · 456d
Cleared Feb 11, 2022
Electric Breast Pump
K211024 · HGX
Shantou Huihengqi Electronic...
Obstetrics & Gynecology · 311d
Cleared Feb 11, 2022
ArtUs
K211248 · IYN
Telemed
Radiology · 291d
Cleared Feb 11, 2022
Pulse Oximeter
K211400 · DQA
Beijing Choice Electronic Technology...
Anesthesiology · 282d
Cleared Feb 11, 2022
3° Anterior Cervical Plating System, Reliant Anterior Cervical Plating...
K211712 · KWQ
Orthofix US, LLC
Orthopedic · 253d