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
5017–5040 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 13, 2025
QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen...
K243262 · SCA
Osang, LLC
Microbiology · 90d
Cleared Jan 13, 2025
AAMI Level 4 Protective
K242689 · QPC
Azac Group
General Hospital · 129d
Cleared Jan 13, 2025
LetsGetChecked Impress
K242680 · FMK
Privapath Diagnostics Ltd (Dba...
General & Plastic Surgery · 129d
Cleared Jan 13, 2025
MegaGen Dental Implant Abutment
K242030 · NHA
Megagen Implant Co., Ltd.
Dental · 186d
Cleared Jan 13, 2025
Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62D0L,...
K241431 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 237d
Cleared Jan 13, 2025
SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option
K241200 · JAK
Arineta , Ltd.
Radiology · 258d
Cleared Jan 13, 2025
Pantheon Proximal Femur Reconstruction (PFR) System
K241059 · LPH
Adler Ortho S.P.A
Orthopedic · 270d
Cleared Jan 13, 2025
Vivo 45 LS
K233452 · NOU
Breas Medical AB
Anesthesiology · 451d
Cleared Jan 12, 2025
Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue Expander
K243836 · LCJ
Mentor Worldwide, LLC
General & Plastic Surgery · 30d
Cleared Jan 11, 2025
Electric Wheelchair (YE200)
K241641 · ITI
Shenzhen Yattll Industry Co., Ltd.
Physical Medicine · 218d
Cleared Jan 10, 2025
NuVasive Pulse System
K243814 · OLO
Globus Medical, Inc.
Orthopedic · 30d
Cleared Jan 10, 2025
Erchonia Zerona® VZ8
K243811 · OLI
Erchonia Corporation
General & Plastic Surgery · 30d
Cleared Jan 10, 2025
Safety Winged Blood Collection Sets
K243806 · FMI
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 30d
Cleared Jan 10, 2025
Ulike Reglow Light Therapy Device (UM10)
K243492 · OHS
Shenzhen Ulike Smart Electronics Co.,...
General & Plastic Surgery · 59d
Cleared Jan 10, 2025
Universal Tendon Spacer
K243477 · HXA
Askorn Medical
Orthopedic · 63d
Cleared Jan 10, 2025
Arthrex SS VAL and VAL KreuLock™ Compression Screw System
K243195 · HWC
Arthrex, Inc.
Orthopedic · 101d
Cleared Jan 10, 2025
Bowhead ERA Wheelchairs
K243111 · IOR
Bowhead Design Corp.
Physical Medicine · 102d
Cleared Jan 10, 2025
ZZIREN™ Orogastric Tube
K242901 · KNT
Tools For Surgery, LLC
Gastroenterology & Urology · 109d
Cleared Jan 10, 2025
BioCode Gastrointestinal Pathogen Panel (GPP)
K242877 · PCH
Applied BioCode, Inc.
Microbiology · 109d
Cleared Jan 10, 2025
Safecare Urinary Tract Infection Test
K242767 · JMT
Safecare Biotech (Hangzhou) Co., Ltd.
Chemistry · 119d
Cleared Jan 10, 2025
Blood Pressure Monitor (RAK260, RAK262, RAK263, RAK266, RAK268, RAK269,...
K242528 · DXN
Shenzhen Ruiankang Technology Co., Ltd.
Cardiovascular · 137d
Cleared Jan 10, 2025
OverCEM SA Universal
K242366 · EMA
Overfibers S.R.L.
Dental · 154d
Cleared Jan 10, 2025
Triopsy Actuator (TMSDGB)
K242228 · KNW
Triopsy Medical, Inc.
Gastroenterology & Urology · 164d
Cleared Jan 10, 2025
Xpert Xpress CoV-2/Flu/RSV plus
K242071 · QOF
Cepheid
Microbiology · 178d