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
11665–11688 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 23, 2023
T-Line Hernia Mesh
K230227 · FTL
Deep Blue Medical Advances, Inc.
General & Plastic Surgery · 27d
Cleared Feb 23, 2023
1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)
K230216 · GCJ
Stryker
General & Plastic Surgery · 28d
Cleared Feb 23, 2023
OrthoButton AL
K230212 · MBI
Riverpoint Medical, LLC
Orthopedic · 28d
Cleared Feb 23, 2023
Neuro20 Pro System
K223797 · NGX
Neuro20 Technologies
Physical Medicine · 66d
Cleared Feb 23, 2023
LED light therapy mask (FM-01, FM-02, FM-03)
K223544 · OHS
Guangdong Newdermo Biotech Co., Ltd.
General & Plastic Surgery · 90d
Cleared Feb 23, 2023
Renuvion® APR Handpiece
K223262 · GEI
Apyx Medical Corporation
General & Plastic Surgery · 122d
Cleared Feb 23, 2023
Monaco RTP System
K223233 · MUJ
Elekta Solutions AB
Radiology · 127d
Cleared Feb 23, 2023
MOSAIQ® OIS (Oncology Information System)
K223229 · IYE
Elekta Solutions AB
Radiology · 128d
Cleared Feb 23, 2023
Symphony Thrombectomy System
K223216 · QEW
Truvic Medical, Inc.
Cardiovascular · 129d
Cleared Feb 23, 2023
Elekta Unity
K223209 · IYE
Elekta Solutions AB
Radiology · 129d
Cleared Feb 23, 2023
OXY-1 System
K223161 · DTZ
Abiomed, Inc.
Cardiovascular · 139d
Cleared Feb 23, 2023
Belun Sleep System BLS-100
K222579 · MNR
Belun Technology Company Limited
Anesthesiology · 182d
Cleared Feb 23, 2023
Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic...
K221591 · GCJ
Schoelly Fiberoptic GmbH
General & Plastic Surgery · 266d
Cleared Feb 23, 2023
Brainomix 360 e-ASPECTS
K221564 · POK
Brainomix Limited
Radiology · 268d
Cleared Feb 23, 2023
Disposable Surgical Gown, Level 4
K221559 · FYA
Stringking
General Hospital · 268d
Cleared Feb 23, 2023
Everion+ System
K213863 · MSX
Biofourmis Singapore Pte., Ltd.
Cardiovascular · 440d
Cleared Feb 22, 2023
The Alma Soprano Titanium
K230371 · GEX
Alma Lasers, Inc.
General & Plastic Surgery · 9d
Cleared Feb 22, 2023
Swoop® Portable MR Imaging System™
K230208 · LNH
Hyperfine, Inc.
Radiology · 28d
Cleared Feb 22, 2023
Disposable Pre-calibrated Brain Biopsy Needle 2.0
K230201 · HAW
PAJUNK GmbH Medizintechnologie
Neurology · 28d
Cleared Feb 22, 2023
BoneMRI v1.6
K230197 · QIH
Mriguidance B.V.
Radiology · 28d
Cleared Feb 22, 2023
Rosa Knee System
K230180 · OLO
Orthosoft Inc. (d/b/a) Zimmer CAS
Orthopedic · 30d
Cleared Feb 22, 2023
eFOLDi Scooter, Lite
K223492 · INI
Suntech UK , Ltd.
Physical Medicine · 93d
Cleared Feb 22, 2023
Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)
K223298 · LYY
Shandong Intco Medical Products Co, Ltd.
General Hospital · 118d
Cleared Feb 22, 2023
Delta III Pro
K221903 · LNS
Dornier Medtech America, Inc.
Gastroenterology & Urology · 237d