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
1321–1344 of 1,642
Search insights Median review: 137d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Feb 13, 2026
Contour Light (CL-100)
K243854 · OLI
Contour Research, LLC
General & Plastic Surgery · 424d
Cleared Feb 12, 2026
Saberscope™ Laparoscope (SAS-A-536L)
K260177 · GCJ
Xenocor, Inc.
General & Plastic Surgery · 22d
Cleared Feb 12, 2026
L12 LED Light Source with AIM
K260108 · OWN
Stryker Endoscopy
General & Plastic Surgery · 29d
Cleared Feb 12, 2026
LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281)
K254007 · OHS
SZ KKS Silicone&Electronic Co., Ltd.
General & Plastic Surgery · 59d
Cleared Feb 12, 2026
IMAGE1 (TC400US)
K253972 · OWN
Karl Storz SE & CO. KG
General & Plastic Surgery · 63d
Cleared Feb 12, 2026
ISE indirect K for Gen.2
K253491 · CEM
Roche Diagnostics
Chemistry · 111d
Cleared Feb 12, 2026
Glucose HK Gen.3
K253490 · CFR
Roche Diagnostics
Chemistry · 111d
Cleared Feb 12, 2026
Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application
K253381 · OLO
Medtronic Navigation, Inc.
Orthopedic · 135d
Cleared Feb 12, 2026
Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175,...
K253354 · MQF
Guangzhou Hehong Biotech Co., Ltd.
Obstetrics & Gynecology · 135d
Cleared Feb 12, 2026
Lumbar Spine Truss System - Plating Solution (LSTS-PS)
K253201 · KWQ
4Web, Inc.
Orthopedic · 139d
Cleared Feb 12, 2026
Healgen® Accurate Oral Fluid Drug Test COT/THC
K252523 · NFW
Healgen Scientific, LLC
Toxicology · 185d
Cleared Feb 12, 2026
Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)
K252490 · FMK
Tianjin Huahong Technology Co., Ltd.
General & Plastic Surgery · 188d
Cleared Feb 12, 2026
Well-Life Incontinence Stimulation System (WL-2405i(P))
K251760 · KPI
Well-Life Healthcare , Ltd.
Gastroenterology & Urology · 248d
Cleared Feb 12, 2026
Wrist Fracture System
K251732 · HRS
Met One Technologies, LLC
Orthopedic · 251d
Cleared Feb 12, 2026
PuraCath Firefly Needleless Connector IT (9005)
K251375 · FPA
Puracath Medical, Inc.
General Hospital · 286d
Cleared Feb 11, 2026
iFuse INTRA Ti™ Implant System
K253488 · OUR
SI-BONE, Inc.
Orthopedic · 110d
Cleared Feb 11, 2026
Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona...
K253049 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 142d
Cleared Feb 11, 2026
AXS Lift Intracranial Base Catheter
K253032 · QJP
Stryker Neurovascular
Neurology · 142d
Cleared Feb 11, 2026
AI4CMR v2.0
K252084 · QIH
Ai4medimaging Medical Solutions S.A.
Radiology · 224d
Cleared Feb 11, 2026
ArmSure Fluoroscopic Positioning System
K251992 · OWB
Savfe Co. , Ltd.
Radiology · 229d
Cleared Feb 11, 2026
CURIS II RF Generator (REF 360100-05)
K251813 · GEI
Sutter Medizintechnik GmbH
General & Plastic Surgery · 243d
Cleared Feb 11, 2026
SteriHub™ Disinfecting Device and Protective Cover
K251592 · QBP
1World Vista Medical
General Hospital · 264d
Not Cleared Feb 11, 2026
Delivery Date AI
DEN250007 · SHE
Ultrasound AI
Radiology · 331d
Cleared Feb 10, 2026
SpaceOAR Vue System (SV-2101)
K260119 · OVB
Boston Scientific Corporation
Radiology · 27d