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
1009–1032 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 18, 2026
HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO...
K251967 · FXX
O&M Halyard, Inc.
General Hospital · 265d
Cleared Mar 17, 2026
LASER THERMAL THERAPY KIT
K260632 · GEX
Elesta S.P.A
General & Plastic Surgery · 19d
Cleared Mar 17, 2026
Q Pedicle Instruments
K260546 · OLO
K2m, Inc.
Orthopedic · 27d
Cleared Mar 17, 2026
Super Upper Limbs Versalock Plating System
K260390 · HRS
GM Dos Reis Industria e Comercio Ltda.
Orthopedic · 39d
Cleared Mar 17, 2026
MDx-Chex for BCY
K254167 · PMN
Streck, LLC
Microbiology · 84d
Cleared Mar 17, 2026
APS Spear Locking Plate
K254053 · HRS
A Plus Biotechnology Co., Ltd.
Orthopedic · 90d
Cleared Mar 17, 2026
Grappler Suture Anchor PCFD Tether System
K253886 · MBI
Paragon 28, Inc.
Orthopedic · 103d
Cleared Mar 17, 2026
GUARDIAN™ Quick Dip Residual Chlorine (5212)
K253863 · FKJ
Serim Research
Gastroenterology & Urology · 104d
Cleared Mar 17, 2026
BTL-785NEH
K253750 · GEI
BTL Industries, Inc.
General & Plastic Surgery · 112d
Cleared Mar 17, 2026
EchoNavigator R5.0
K253614 · QIH
Philips Medical Systems Nederland B.V.
Radiology · 119d
Cleared Mar 17, 2026
Cala kIQ Plus
K253587 · QBC
Cala Health, Inc.
Neurology · 120d
Cleared Mar 17, 2026
Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System...
K252971 · GEX
C.R. Bard, Inc.
General & Plastic Surgery · 181d
Cleared Mar 17, 2026
Electrical Scooter (SM4226)
K252813 · INI
Lerado Zhongshan Peaceful Cove...
Physical Medicine · 194d
Cleared Mar 17, 2026
BreathePal Bilevel (GFM50-MD2201)
K252078 · MNS
Compal Electronics, Inc.
Anesthesiology · 258d
Cleared Mar 17, 2026
enCore Impression Material
K251926 · SHI
Encore Guards
Dental · 267d
Cleared Mar 16, 2026
Ulike Reglow Light Therapy Device (UM10)
K260511 · OHS
Shenzhen Ulike Smart Electronics Co.,...
General & Plastic Surgery · 27d
Cleared Mar 16, 2026
SINEFIX
K254176 · MBI
BAAT Medical Products B.V.
Orthopedic · 83d
Cleared Mar 16, 2026
LED Light Therapy Mask (Models: T2, RLD10)
K254079 · OHS
Shenzhen Desida Technology Co., Ltd.
General & Plastic Surgery · 88d
Cleared Mar 16, 2026
CarboClear® Posterior Cervical Screw System
K254045 · NKG
CarboFix Orthopedics , Ltd.
Orthopedic · 89d
Cleared Mar 16, 2026
Data Analysis Facilitation Suite (DAFS)
K253944 · QIH
Voronoi Health Analytics Incorporated
Radiology · 96d
Cleared Mar 16, 2026
APTUS Shoulder Proximal Humerus System, PentaLock 3.5
K253916 · HRS
Medartis AG
Orthopedic · 98d
Cleared Mar 16, 2026
Lifemotion Disposable Membrane Oxygenator
K253838 · DTZ
Lifemotion Medical Technology Co., Ltd.
Cardiovascular · 105d
Cleared Mar 16, 2026
Healgen® Accurate Oral Fluid Drug Test
K253705 · DJC
Healgen Scientific, LLC
Toxicology · 112d
Cleared Mar 16, 2026
Millipede System
K253590 · NRY
Perfuze, Ltd.
Neurology · 119d