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
21529–21552 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 19, 2019
L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight...
K192292 · OWN
Stryker
General & Plastic Surgery · 88d
Cleared Nov 19, 2019
Dolphin Medical Imaging USB Ultrasound System
K192573 · IYO
Dolphin Medical Imaging, LLC
Radiology · 62d
Cleared Nov 19, 2019
Dannik Laparoscopic Suction Irrigation System
K192643 · GCJ
Dannik
General & Plastic Surgery · 56d
Cleared Nov 18, 2019
JTL-250-01
K182732 · MUU
Jointechlabs, Inc.
General & Plastic Surgery · 416d
Cleared Nov 18, 2019
FluoroCal
K182917 · LBH
Bisco, Inc.
Dental · 395d
Cleared Nov 18, 2019
Digital Thermometer
K183393 · FLL
Joytech Healthcare Co. , Ltd.
General Hospital · 346d
Cleared Nov 18, 2019
Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01)
K190797 · HIH
Reed Medical (Zhejiang) Co., Ltd.
Obstetrics & Gynecology · 235d
Cleared Nov 18, 2019
CLEARFIL MAJESTY ES Flow
K191980 · EBF
Kuraray Noritake Dental, Inc.
Dental · 117d
Cleared Nov 18, 2019
PolyLock Small Bone Plating System
K192323 · HRS
Fusion Orthopedics, LLC
Orthopedic · 83d
Cleared Nov 18, 2019
Impella CP Introducer
K192769 · DYB
Abiomed, Inc.
Cardiovascular · 49d
Cleared Nov 16, 2019
3M Comply Hydrogen Peroxide Chemical Indicator
K192937 · JOJ
3M Company
General Hospital · 29d
Cleared Nov 15, 2019
ROSA Bracket
K182672 · NJM
Gni Co., Ltd.
Dental · 415d
Cleared Nov 15, 2019
KeyPrint KeySplint Soft
K183598 · MQC
Keystone Industries
Dental · 324d
Cleared Nov 15, 2019
Dornier Ureteral Stent
K190312 · FAD
Dornier Medtech America, Inc.
Gastroenterology & Urology · 276d
Cleared Nov 15, 2019
TDM Plate and Screw Systems
K190391 · HRS
Tdm Co., Ltd.
Orthopedic · 269d
Cleared Nov 15, 2019
Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA
K190397 · QBK
Immunalysis Corporation
Toxicology · 269d
Cleared Nov 15, 2019
EM SA Implant System
K191201 · DZE
Hiossen, Inc.
Dental · 193d
Cleared Nov 15, 2019
SmartSPACE Shoulder System
K191247 · KWS
Techmah Medical, LLC
Orthopedic · 190d
Cleared Nov 15, 2019
Arcus Head Fixation Frame
K191701 · HBL
Mri Interventions, Inc.
Neurology · 143d
Cleared Nov 15, 2019
Gabriel Feeding Tube with Balloon, and EnFit Connector
K191784 · PIF
Syncro Medical Innovations, Inc.
Gastroenterology & Urology · 135d
Cleared Nov 15, 2019
Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting...
K191921 · PFO
Cochlear Americas
Ear, Nose, Throat · 120d
Cleared Nov 15, 2019
Ophthalmic Yag Laser System YC-200
K192045 · HQF
Nidek Co., Ltd.
Ophthalmic · 107d
Cleared Nov 15, 2019
DRSplus
K192113 · MYC
Centervue S.P.A.
Ophthalmic · 102d
Cleared Nov 15, 2019
SPY Portable Handheld Imaging (SPY-PHI) System
K192174 · OWN
Novadaq Technologies Ulc. (Now A Part...
General & Plastic Surgery · 95d