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
28561–28584 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 17, 2017
BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)
K171404 · HQD
Bausch & Lomb, Incorporated
Ophthalmic · 66d
Cleared Jul 14, 2017
VITROS Chemistry Products hsCRP Reagent
K160712 · DCK
Ortho-Clinical Diagnostics
Chemistry · 486d
Cleared Jul 14, 2017
Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation System
K162153 · HWC
Ascension Orthopedics
Orthopedic · 346d
Cleared Jul 14, 2017
MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer
K162698 · JLW
Shenzhen New Industries Biomedical...
Chemistry · 290d
Cleared Jul 14, 2017
Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single...
K162707 · GDW
Golden Stapler Surgical Co., Ltd.
General & Plastic Surgery · 289d
Cleared Jul 14, 2017
Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts
K162803 · DSY
Vascutek, Ltd.
Cardiovascular · 282d
Cleared Jul 14, 2017
Bonafix TWO - Dental Implant System
K162853 · DZE
Bonafix Surgical and Dental Implants
Dental · 276d
Cleared Jul 14, 2017
ViMove2
K163150 · IKN
Dorsavi, Ltd.
Neurology · 247d
Cleared Jul 14, 2017
Neodent Implant System - GM Line
K163194 · DZE
Jjgc Industria E Comercio DE...
Dental · 241d
Cleared Jul 14, 2017
Soules Intrauterine Insemination Catheter
K163318 · MQF
Cook Incorporated
Obstetrics & Gynecology · 233d
Cleared Jul 14, 2017
RTHawk, HeartVista Cardiac Package
K170090 · LNH
Heartvista, Inc.
Radiology · 185d
Cleared Jul 14, 2017
In2Bones Fracture and Correction System
K170518 · HRS
In2bones USA, LLC
Orthopedic · 143d
Cleared Jul 14, 2017
sensiFirm
K170637 · PBX
El Global Trade, Ltd.
General & Plastic Surgery · 134d
Cleared Jul 14, 2017
Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with...
K170686 · LZA
Brightway Holdings Sdn. Bhd.
General Hospital · 129d
Cleared Jul 14, 2017
True Spinal Fixation System
K170710 · NKB
Innovative Surgical Designs, Inc.
Orthopedic · 128d
Cleared Jul 14, 2017
Aegis Transit System
K170757 · EWY
Boston-Biomedical Associates
Ear, Nose, Throat · 123d
Cleared Jul 14, 2017
Dictum Health
K170798 · MWI
Dictum Health, Inc.
Cardiovascular · 119d
Cleared Jul 14, 2017
eCareCoordinator
K171029 · DRG
Visicu, Inc.
Cardiovascular · 99d
Cleared Jul 14, 2017
SIGNA Premier
K171128 · LNH
Ge Medical Systems, LLC
Radiology · 88d
Cleared Jul 14, 2017
Alma LipoFlow System
K171242 · MUU
Alma Lasers, Inc.
General & Plastic Surgery · 78d
Cleared Jul 14, 2017
HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation System
K171413 · NQW
Globus Medical, Inc.
Orthopedic · 60d
Cleared Jul 14, 2017
truFreeze Rapid AV Spray Kit
K171522 · GEH
CSA Medical, Inc.
General & Plastic Surgery · 50d
Cleared Jul 14, 2017
Contact Lens Case
K171539 · LRX
E-Link Plastic & Metal Industrial...
Ophthalmic · 49d
Cleared Jul 14, 2017
MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18...
K171747 · HCG
Codman & Shurtleff, Inc.
Neurology · 31d