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
13537–13560 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 22, 2022
LOGIQ P10, LOGIQ P9, LOGIQ P8
K214039 · IYN
GE Medical Systems Ultrasound and...
Radiology · 89d
Cleared Mar 22, 2022
Shani Darden LED light therapy mask
K214103 · OLP
Harpar Grace International
General & Plastic Surgery · 83d
Cleared Mar 22, 2022
StealthFix Intraosseous Fixation System
K220181 · JDR
Nextremity Solutions, Inc.
Orthopedic · 60d
Cleared Mar 22, 2022
Medline UNITE IM Fibula Implant
K220511 · HWC
Medline Industries, LP
Orthopedic · 28d
Cleared Mar 21, 2022
WatchPAT200U (WP200U)
K203839 · MNR
Itamar Medical , Ltd.
Anesthesiology · 446d
Cleared Mar 21, 2022
Multi-Functional Electrosurgical Knife
K212999 · KNS
Anrei Medical (Hangzhou) Co., Ltd.
Gastroenterology & Urology · 182d
Cleared Mar 21, 2022
Solus Gold Embolization Device
K213200 · KRD
Artio Medical, Inc.
Cardiovascular · 173d
Cleared Mar 21, 2022
NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball...
K213246 · ETN
Medtronic Xomed, Inc.
Ear, Nose, Throat · 172d
Cleared Mar 21, 2022
BriefCase
K213721 · QAS
Aidoc Medical , Ltd.
Radiology · 117d
Cleared Mar 21, 2022
AFFINITY Proximal Tibia System
K220199 · HRS
Techfit Digital Surgery, Inc.
Orthopedic · 56d
Cleared Mar 18, 2022
Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3...
K203237 · FYA
Dukal Corporation
General Hospital · 500d
Cleared Mar 18, 2022
Albumin BCP2
K203530 · CJW
Abbott Ireland Diagnostics Division
Chemistry · 471d
Cleared Mar 18, 2022
Non-contact Infrared Thermometer (Models WL-301, WL-501, WL-601, WL-701)
K210171 · FLL
Sichuan Youkede Medical Equipment...
General Hospital · 420d
Cleared Mar 18, 2022
LYMA Laser
K210823 · OHS
Lyma Life , Ltd.
General & Plastic Surgery · 364d
Cleared Mar 18, 2022
ARISTE AB Mesh
K211132 · FTL
Ariste Medical, LLC
General & Plastic Surgery · 336d
Cleared Mar 18, 2022
OPTRELL Mapping Catheter with TRUEref Technology
K211438 · MTD
Biosense Webster, Inc.
Cardiovascular · 312d
Cleared Mar 18, 2022
F&P Evora Full Face Mask
K212371 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 231d
Cleared Mar 18, 2022
Stable-L Standalone Lumbar Interbody System
K212498 · OVD
Nexus Spine, LLC
Orthopedic · 221d
Cleared Mar 18, 2022
TempSure System
K212891 · GEI
Cynosure, LLC
General & Plastic Surgery · 189d
Cleared Mar 18, 2022
Vintage Prime Press
K212939 · EIH
Shofu Dental Corporation
Dental · 184d
Cleared Mar 18, 2022
DePuy Synthes Radial Head Replacement System
K213563 · KWI
DePuy Synthes
Orthopedic · 129d
Cleared Mar 18, 2022
Cardio Flow Peripheral Guide Wire
K213834 · DQX
Cardio Flow Inc.,
Cardiovascular · 99d
Cleared Mar 18, 2022
BeautiBond Xtreme
K213965 · KLE
Shofu Dental Corporation
Dental · 88d
Cleared Mar 18, 2022
15L Cycler Drainage Bag
K214016 · KDJ
Baxter Healthcare Corporation
Gastroenterology & Urology · 86d