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
5761–5784 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 18, 2024
XeliteMed VertehighFix High Viscosity Spinal Bone Cement
K241775 · NDN
Xelite Biomed , Ltd.
Orthopedic · 90d
Cleared Sep 18, 2024
Response Ortho Metaphyseal Hinge Fixator System
K241769 · KTT
Response Ortho Solutions, LLC
Orthopedic · 90d
Cleared Sep 18, 2024
InnoCare Specialty Foley Catheter
K241424 · EZL
Innocare Urologics, LLC
Gastroenterology & Urology · 121d
Cleared Sep 18, 2024
Perpak™ Sterilization Tyvek Pouch
K241123 · FRG
Km Corp.
General Hospital · 148d
Cleared Sep 18, 2024
EdgeLife Handheld Wireless Ultrasound System (E8200)
K234153 · IYN
Edgelife Technologies, LLC
Radiology · 264d
Cleared Sep 18, 2024
TiGEN Abutment, PMMA Abutment and Scan Healing Abutment
K234142 · NHA
Megagen Implant Co., Ltd.
Dental · 264d
Cleared Sep 18, 2024
Copra Supreme
K233064 · EIH
Whitepeaks Dental Solutions GmbH
Dental · 358d
Cleared Sep 18, 2024
LOWTEM Crystal 120
K231893 · MLR
Lowtem Co., Ltd.
General Hospital · 448d
Cleared Sep 18, 2024
Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene®...
K231383 · FRC
Terragene S.A.
General Hospital · 495d
Cleared Sep 17, 2024
Neo Sculptor (OF-NEO001)
K242186 · NGX
Ofan Intelligent Technology...
Physical Medicine · 54d
Cleared Sep 17, 2024
TriMed Bridge Plates
K241942 · HRS
TriMed, Inc.
Orthopedic · 77d
Cleared Sep 17, 2024
Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008
K241230 · DYB
Togo Medikit Co., Ltd.
Cardiovascular · 138d
Cleared Sep 17, 2024
Robin's Egg
K240689 · OAP
Telebrands Corporation
General & Plastic Surgery · 188d
Cleared Sep 17, 2024
Signum composite flow
K240660 · EBF
Kulzer, LLC
Dental · 193d
Cleared Sep 17, 2024
Air compression Leg Massager (MM0520, MM0521, MM0522)
K240373 · IRP
Zhangzhou Easepal Medical Science and...
Physical Medicine · 223d
Cleared Sep 17, 2024
STS
K240293 · BZC
Techbopulm, Ltd.
Anesthesiology · 229d
Cleared Sep 17, 2024
PADLOCK CLIP EFTR Kit (00713229)
K240274 · PKL
STERIS Corporation
Gastroenterology & Urology · 230d
Cleared Sep 17, 2024
3D Printed PEEK Interbody System
K240250 · MAX
Nvision Biomedical Technologies, Inc.
Orthopedic · 231d
Cleared Sep 17, 2024
Medline Reusable Sterilization Wrappers
K234132 · FRG
Medline Industries, LP
General Hospital · 264d
Cleared Sep 17, 2024
KLS Martin Drill-Free MMF Screw
K233721 · DZL
KLS-Martin L.P.
Dental · 301d
Cleared Sep 16, 2024
CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays
K241893 · OLO
Medos International SARL
Orthopedic · 80d
Cleared Sep 16, 2024
Liftendo
K241771 · GEX
Medical San Ind?stria DE Equipamentos...
General & Plastic Surgery · 88d
Cleared Sep 16, 2024
OneMark
K241762 · NEU
View Point Medical
General & Plastic Surgery · 88d
Cleared Sep 16, 2024
Powered Wheelchair (NXN20-205, NXN20-205M)
K241379 · ITI
Zhejiang Nysin Medical Co., Ltd.
Physical Medicine · 124d