FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
14641–14664 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Mar 18, 2022
Needle Stimulator (Model: RJNS6-1)
K220153 · BWK
Bozhou Rongjian Medical Appliance...
Neurology · 58d
Cleared Mar 18, 2022
Powder Free Nitrile Examination Gloves, Blue and Violet Blue, Test For Use...
K220228 · LZA
Shandong Blue Sail Health Technology...
General Hospital · 50d
Cleared Mar 18, 2022
EMERGE Anterior Cervical Plate System
K220275 · KWQ
Evolution Spine
Orthopedic · 46d
Cleared Mar 18, 2022
CELERITY 20 HP Challenge Pack
K220473 · FRC
Steris
General Hospital · 28d
Cleared Mar 18, 2022
Merits P335 Powered Wheelchair
K220529 · ITI
Merits Health Products Co., Ltd.
Physical Medicine · 22d
Cleared Mar 18, 2022
SURGIVISIO Device
K220627 · OWB
Ecential Robotics
Radiology · 14d
Cleared Mar 17, 2022
Single Use Hand Switch Monopolar Forceps with Smoke Evacuation, Single Use...
K210315 · GEI
Modern Medical Equipment...
General & Plastic Surgery · 407d
Cleared Mar 17, 2022
SICtapered & SICvantage tapered
K210489 · DZE
Sic Invent AG
Dental · 391d