FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
3553–3576 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 29, 2025
TENS AND EMS (TENS and Muscle Stimulator) ( Model...
K243856 · NUH
Shenzhen Astec Technology Co., Ltd.
Neurology · 164d
Cleared May 29, 2025
Portable Video Processor (EA101), Flexible Bronchoscope BS41H-12EU,...
K243497 · EOQ
Shanghai AnQing Medical Instrument...
Ear, Nose, Throat · 198d
Cleared May 29, 2025
PM2+ System and SmartPICC Stylet
K243484 · LJS
Piccolo Medical, Inc.
Cardiovascular · 202d
Cleared May 29, 2025
SuturePatch Tissue Reinforcement
K243480 · OWX
Arthrex, Inc.
Orthopedic · 202d
Cleared May 29, 2025
SIGNEX
K243469 · HRS
Osteonic Co., Ltd.
Orthopedic · 202d
Cleared May 29, 2025
BiliWrap
K243372 · LBI
Gerium Medical, Ltd.
General Hospital · 211d
Cleared May 29, 2025
27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT)
K243309 · FMI
Terumo Europe N.V.
General Hospital · 220d
Cleared May 28, 2025
OptiMap™ System
K251344 · DQK
Boston Scientific Corporation
Cardiovascular · 28d
Cleared May 28, 2025
myAir
K250624 · BZD
ResMed Corp
Anesthesiology · 86d
Cleared May 28, 2025
TAIMedImg DeepMets
K250427 · QKB
Taiwan Medical Imaging Co., Ltd.
Radiology · 103d
Cleared May 28, 2025
CoLumboX
K250367 · QIH
Smart Soft Healthcare AD
Radiology · 107d
Cleared May 28, 2025
Europa (Alternative: AiRTouch) portable X-ray system
K244049 · IZL
Livermoretech, Inc.
Radiology · 148d
Cleared May 28, 2025
OsteoFlo HydroFiber
K243949 · MQV
SurGenTec, LLC
Orthopedic · 156d
Cleared May 28, 2025
Zionic Pro Max (Radiofrequency)
K243716 · PBX
Termosalud S.L.
General & Plastic Surgery · 177d
Cleared May 28, 2025
Rapid MLS
K243378 · QIH
Ischemaview, Inc.
Radiology · 210d
Cleared May 28, 2025
Zoom 7X Catheter
K243047 · NRY
Imperative Care, Inc.
Neurology · 243d
Cleared May 28, 2025
Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0
K242793 · EOQ
Shenzhen Insighters Medical...
Ear, Nose, Throat · 254d
Cleared May 28, 2025
MRidium 3870 MRI Infusion Pump System (3870)
K242752 · FRN
Iradimed Corporation
General Hospital · 258d
Cleared May 28, 2025
Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US)
K242699 · FGB
Opcom Medical, Inc.
Gastroenterology & Urology · 261d
Cleared May 28, 2025
Disposable Prophy Angle
K240950 · EGS
Pacific Care Limited
Dental · 415d
Cleared May 27, 2025
BEAUTIFIL II
K251578 · EBF
Shofu Dental Corporation
Dental · 5d
Cleared May 27, 2025
OSSIOfiber® Suture Anchor
K251309 · MAI
OSSIO , Ltd.
Orthopedic · 29d
Cleared May 27, 2025
DeepRhythmAI
K250932 · DQK
Medicalgorithmics S.A.
Cardiovascular · 60d
Cleared May 27, 2025
Neodent Implant System - Custom Abutments
K250614 · NHA
Jjgc Ind?stria E Com?rcia DE...
Dental · 88d