FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
5425–5448 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 26, 2024
REGENETEN™ Bioinductive Implant
K242631 · OWY
Smith & Nephew Inc., Endoscopy Div.
Orthopedic · 84d
Cleared Nov 26, 2024
Digital Temp
K242559 · EBG
Sprintray, Inc.
Dental · 90d
Cleared Nov 26, 2024
OsseoFit Interfacing Anchor
K242494 · MBI
Riverpoint Medical, LLC
Orthopedic · 96d
Cleared Nov 26, 2024
da Vinci SP Surgical System (SP1098)
K242318 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 113d
Cleared Nov 26, 2024
MROpen Evo (03-2000-00)
K242258 · LNH
Asg Superconductors S.P.A.
Radiology · 118d
Cleared Nov 26, 2024
SureCath Set
K242049 · EZD
Coloplast Corp.
Gastroenterology & Urology · 137d
Cleared Nov 26, 2024
HyperFlex™ Bunion Correction System
K241995 · HRS
Footbridge Medical
Orthopedic · 140d
Cleared Nov 26, 2024
NeuroMatch
K241390 · OMB
LVIS Corporation
Neurology · 195d
Cleared Nov 26, 2024
Cellinew
K240897 · GEI
VIOL Co., Ltd.
General & Plastic Surgery · 239d
Cleared Nov 26, 2024
R2P Radifocus Glidewire Advantage
K240818 · DQX
Terumo Corporation
Cardiovascular · 246d
Cleared Nov 26, 2024
LungProtect
K240650 · KDN
Traferox Technologies, Inc.
Gastroenterology & Urology · 264d
Cleared Nov 26, 2024
PrimmaArt
K231859 · EBG
Dentscare Ltda
Dental · 522d
Cleared Nov 26, 2024
4CIS® Chiron Spinal Fixation System
K231655 · NKB
Solco Biomedical Co., Ltd.
Orthopedic · 539d
Cleared Nov 25, 2024
Aptima BV Assay
K243345 · PQA
Hologic, Inc.
Microbiology · 28d
Cleared Nov 25, 2024
World Liner
K243162 · MEH
Signature Orthopaedics Pty, Ltd.
Orthopedic · 56d
Cleared Nov 25, 2024
AccurSound Electronic Stethoscope (AS101)
K242971 · DQD
Heroic Faith International , Ltd.
Cardiovascular · 60d
Cleared Nov 25, 2024
3M™ Attest™ Super Rapid Readout Biological Indicator 1493
K242538 · FRC
3M Company
General Hospital · 91d
Cleared Nov 25, 2024
JARVIS Glenoid Reverse Shoulder Prosthesis
K242253 · PHX
FH Industrie
Orthopedic · 117d
Cleared Nov 25, 2024
Customized Abutment
K242245 · NHA
Arum Dentistry Co., Ltd.
Dental · 117d
Cleared Nov 25, 2024
Versus™ Catheter (VS110-8B)
K241851 · QEY
Liquet Medical, Inc.
Cardiovascular · 151d
Cleared Nov 25, 2024
Transpara (2.1.0)
K241831 · QDQ
Screenpoint Medical B.V.
Radiology · 153d
Cleared Nov 25, 2024
MIS LYNX Conical Connection Implant System
K241692 · DZE
Dentsply Sirona, Inc.
Dental · 166d
Cleared Nov 25, 2024
Electric Wheelchair (KR8803)
K241588 · ITI
Zhejiang Kairui Medical Device Co., Ltd.
Physical Medicine · 175d
Cleared Nov 25, 2024
WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281)
K240575 · GXY
Eemagine Medical Imaging Solutions GmbH
Neurology · 269d