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
22417–22440 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 01, 2019
Biotronik Stylets
K191469 · DRB
Biotronik, Inc.
Cardiovascular · 59d
Cleared Aug 01, 2019
MAGLUMI 2000 25-OH Vitamin D
K191499 · MRG
Shenzhen New Industries Biomedical...
Chemistry · 56d
Cleared Aug 01, 2019
AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System...
K191559 · FEQ
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 49d
Cleared Jul 31, 2019
StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial...
K190672 · HAW
Medtronic Navigation, Inc.
Neurology · 138d
Cleared CT Jul 31, 2019
P200TxE
K190732 · OBO
Optos Plc.
Ophthalmic · 132d
Cleared Jul 31, 2019
DemeTECH DemeFORCE Nonabsorbable Surgical Suture
K190777 · GAT
Demetech Corporation
General & Plastic Surgery · 127d
Cleared Jul 31, 2019
Fluobeam LX
K190891 · QDG
Fluoptics
General & Plastic Surgery · 117d
Cleared Jul 31, 2019
EyeBOX
K191183 · QEA
Oculogica, Inc.
Neurology · 90d
Cleared Jul 31, 2019
Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent...
K191510 · DHB
Hycor Biomedical
Immunology · 55d
Cleared Jul 31, 2019
Diode Laser Therapy Systems
K191611 · GEX
Wingderm Electro-Optics , Ltd.
General & Plastic Surgery · 44d
Cleared Jul 31, 2019
Mobius3D
K191761 · IYE
Varian Medical Systems, Inc.
Radiology · 30d
Cleared Jul 31, 2019
Inion BioRestore
K191764 · MQV
Inion OY
Orthopedic · 30d
Cleared Jul 31, 2019
GORE BIO-A Tissue Reinforcement
K191773 · OWT
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 29d
Cleared Jul 31, 2019
AOCup Lens Case with AODisc
K191795 · LPN
Alcon Laboratories, Inc.
Ophthalmic · 28d
Cleared Jul 31, 2019
HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25)
K191931 · JTN
Hardy Diagnostics
Microbiology · 12d
Cleared Jul 30, 2019
Hamilton-G5
K180295 · CBK
Hamiton Medical AG
Anesthesiology · 544d
Cleared Jul 30, 2019
Blood Transfer Accessory (BTA)
K181743 · JKA
Nsp Tech Pte, Ltd.
General Hospital · 393d
Cleared Jul 30, 2019
Blood Collection Accessory (BUCA)
K181754 · JKA
Nsp Tech Pte, Ltd.
General Hospital · 393d
Cleared Jul 30, 2019
Powder Free Blue Nitrile Examination Gloves - Tested for Use with...
K182089 · LZA
Platinum Glove Industries Sdn. Bhd.
General Hospital · 362d
Cleared Jul 30, 2019
Transcutaneous Electrical Nerve Stimulator
K183288 · NUH
Shenzhen Kentro Medical Electronics...
Neurology · 246d
Cleared Jul 30, 2019
Marinr Steerable Intracardiac Electrode Catheter, StableMapr Steerable...
K183547 · DRF
Medtronic
Cardiovascular · 222d
Cleared Jul 30, 2019
Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter
K190132 · DRF
Medtronic
Cardiovascular · 183d
Cleared Jul 30, 2019
Endotracheal Tube
K190274 · BTR
Tianjin Medis Medical Device Co., Ltd.
Anesthesiology · 172d
Cleared Jul 30, 2019
Addivation Medical Cervical Interbody System
K190291 · ODP
Addivation Medical, LLC
Orthopedic · 169d