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: 2026–2026 ×
1,642 results
1009–1032 of 1,642
Search insights Median review: 137d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Mar 18, 2026
LimFlow Vector
K260188 · MGZ
LimFlow, Inc.
Cardiovascular · 55d
Cleared Mar 18, 2026
DynaNail Mini
K254110 · HWC
MedShape, Inc.
Orthopedic · 89d
Cleared Mar 18, 2026
VISUREF 600
K253834 · HJO
Carl Zeiss Vision GmbH
Ophthalmic · 107d
Cleared Mar 18, 2026
Safety Pen Needle
K253622 · FMI
Ningbo Medsun Medical Co., Ltd.
General Hospital · 120d
Cleared Mar 18, 2026
EUROPA™ Posterior Cervical Fusion Navigated Instruments
K253444 · OLO
MiRus, LLC
Orthopedic · 167d
Cleared Mar 18, 2026
AlignRT Plus (8.0)
K253012 · IYE
Vision Rt, Ltd.
Radiology · 180d
Cleared Mar 18, 2026
Fusion FibFix Nail
K252961 · HSB
Fusion Orthopedics USA, LLC
Orthopedic · 183d
Cleared Mar 18, 2026
syngo.via RT Image Suite VC10
K252304 · MUJ
Varian Medical Systems, Inc.
Radiology · 237d
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
Not Cleared Mar 17, 2026
Tyto Insights for Eardrum Bulging Detection
DEN250014 · SHL
Tyto Care , Ltd.
Ear, Nose, Throat · 330d