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
23209–23232 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 23, 2019
EverCrossTM 0.035 OTW PTA Dilatation Catheter
K190753 · LIT
Medtronic, Inc. (Formerly D.B.A. Ev3,...
Cardiovascular · 29d
Cleared Apr 22, 2019
FluChip-8G Influenza A+B Assay
K182513 · OZE
Indevr, Inc.
Microbiology · 222d
Cleared CT Apr 22, 2019
Comprehensive Nano Stemless Shoulder
K182516 · PKC
Biomet Manufacturing Corp
Orthopedic · 221d
Cleared Apr 22, 2019
LC GLOSSFILL XR
K182778 · EBF
S&C Polymer Silicon- Und Composite...
Dental · 203d
Cleared Apr 22, 2019
exGraft, exGraft Carbon
K183613 · DSY
Peca Labs
Cardiovascular · 117d
Cleared Apr 22, 2019
CryoLab
K190407 · GEH
Cryoconcepts LP
General & Plastic Surgery · 60d
Cleared Apr 19, 2019
FUSION Plus Curing Light
K180065 · EBZ
Dentlight, Inc.
Dental · 465d
Cleared Apr 19, 2019
OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor
K181571 · PLC
Mark Abramson, D.D.S., Inc.
Dental · 309d
Cleared Apr 19, 2019
ASSURE® Anterior Cervical Plate System
K183056 · KWQ
Globus Medical, Inc.
Orthopedic · 168d
Cleared Apr 19, 2019
Relieva Tract Balloon Dilation System
K183090 · QGK
Acclarent, Inc.
Ear, Nose, Throat · 164d
Cleared Apr 19, 2019
CapsoCam Plus (SV-3)
K183192 · NEZ
CapsoVision, Inc.
Gastroenterology & Urology · 151d
Cleared Apr 19, 2019
ATLAS Plating System
K190415 · HRS
MiRus, LLC
Orthopedic · 57d
Cleared Apr 19, 2019
Cepheid Xpert C. difficile/Epi Control Panel
K190463 · PMN
Microbiologics, Inc.
Microbiology · 52d
Cleared Apr 19, 2019
SPY Portable Handheld Imaging (SPY-PHI) System
K190729 · OWN
Novadaq Technologies Ulc. (Now A Part...
General & Plastic Surgery · 29d
Cleared Apr 19, 2019
Ez3D-i/E3
K190791 · LLZ
Ewoosoft Co., Ltd.
Radiology · 23d
Cleared Apr 18, 2019
Orthodontic Appliance
K181747 · NXC
Shandong Huge Dental Material...
Dental · 290d
Cleared Apr 18, 2019
Psychemedics Microplate EIA for Fentanyl in Hair
K182103 · DJG
Psychemedics Corporation
Toxicology · 258d
Cleared Apr 18, 2019
Hi-Torque Vektor, .014, 195cm, Str, Hi-Torque Vektor, .014, 195cm, J,...
K182457 · DQX
Brivant Limited (Lake Region Medical)
Cardiovascular · 223d
Cleared Apr 18, 2019
Lung Vision System
K183593 · LLZ
Bodyvision Medical , Ltd.
Radiology · 118d
Cleared Apr 18, 2019
CryoTouch
K183601 · GEH
Cryoconcepts LP
General & Plastic Surgery · 113d
Cleared Apr 18, 2019
MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV)...
K190109 · JWY
Beckman Coulter, Inc.
Microbiology · 85d
Cleared Apr 18, 2019
CancelleX Porous Titanium Lumbar Interbody Device
K190364 · MAX
Xenco Medical, LLC
Orthopedic · 62d
Cleared Apr 18, 2019
NeoForm Annuloplasty Ring
K190506 · KRH
Genesee Biomedical, Inc.
Cardiovascular · 48d
Cleared Apr 18, 2019
Guide Sheath
K190644 · DYB
Surmodics,Inc.
Cardiovascular · 36d