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
11449–11472 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 18, 2023
EOlife®
K221841 · BTM
Archeon
Anesthesiology · 267d
Cleared Mar 18, 2023
InterOss Collagen
K221808 · NPM
Sigmagraft, Inc.
Dental · 269d
Cleared Mar 17, 2023
EMPOWR Stem Extender, 50mm
K230441 · JWH
Encore Medical, L.P Dba Enovis
Orthopedic · 24d
Cleared Mar 17, 2023
Arthrex 3.9 mm SwiveLock Anchor
K230435 · MAI
Arthrex, Inc.
Orthopedic · 28d
Cleared Mar 17, 2023
LOQTEQ® VA Elbow Plates 2.7/3.5 System
K230141 · HRS
Aap Implantate AG
Orthopedic · 58d
Cleared Mar 17, 2023
Denture Base Resin
K230115 · EBI
Aidite (Qinhuangdao) Technology Co.,...
Dental · 59d
Cleared Mar 17, 2023
Aevumed RAPID Suture Anchors
K223878 · MBI
Aevumed, Inc.
Orthopedic · 80d
Cleared Mar 17, 2023
Ablacath™ Mapping Catheter
K223666 · MTD
Ablacon, Inc.
Cardiovascular · 100d
Cleared Mar 17, 2023
InThrill Thrombectomy System
K223613 · QEW
Inari Medical, Inc.
Cardiovascular · 102d
Cleared Mar 17, 2023
Viz AAA
K223443 · QFM
Viz. Ai, Inc.
Radiology · 123d
Cleared Mar 17, 2023
DeGen Impulse AM™ System
K223418 · MAX
Degen Medical
Orthopedic · 127d
Cleared Mar 17, 2023
Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug...
K223162 · LDJ
Healgen Scientific, LLC
Toxicology · 161d
Cleared Mar 17, 2023
Alio
K223073 · DRG
Alio, Inc.
Gastroenterology & Urology · 168d
Cleared Mar 17, 2023
Prism
K222101 · HCC
Graymatters Health , Ltd.
Neurology · 242d
Cleared Mar 17, 2023
FemDx FalloView
K221965 · MKO
Femdx Medsystems, Inc.
Obstetrics & Gynecology · 255d
Cleared Mar 17, 2023
KARL STORZ Bipolar Resectoscopes with HF Cable
K221893 · FJL
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 261d
Cleared Mar 17, 2023
Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes
K221782 · DRS
Merit Medical Pte. , Ltd.
Cardiovascular · 269d
Cleared Mar 17, 2023
NeuroRPM
K221772 · GYD
New Touch Digital, Inc.
Neurology · 269d
Cleared Mar 17, 2023
SMR Stemless Anatomic
K221758 · PKC
Lima Corporate S.P.A.
Orthopedic · 274d
Cleared Mar 17, 2023
MagVenture TMS Atlas Neuro Navigation System
K221544 · HAW
Tonica Elektronik A/S
Neurology · 294d
Cleared Mar 17, 2023
RCRP Flex reagent cartridge
K221119 · DCN
Siemens Healthcare Diagnostics, Inc.
Immunology · 333d
Cleared Mar 17, 2023
Simplexa COVID-19 & Flu A/B Direct
K220963 · QOF
Diasorin Molecular, LLC
Microbiology · 350d
Cleared Mar 16, 2023
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel
K230404 · PCH
Biofire Diagnostics, LLC
Microbiology · 29d
Cleared Mar 16, 2023
BENCOX Delta Option Heads
K223828 · LZO
Corentec Co., Ltd.
Orthopedic · 85d