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
4249–4272 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 14, 2025
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K242244 · QKQ
Lumea, Inc.
Pathology · 226d
Cleared Mar 14, 2025
mBôs (Monogram mBôs TKA System)
K242121 · OLO
Monogram Orthopaedics, Inc.
Orthopedic · 238d
Cleared Mar 14, 2025
Bronchoscope System, The Single-use Bronchoscope (Single-use Bronchoscope:...
K242010 · EOQ
Shenzhen Sanping Image Technology...
Ear, Nose, Throat · 247d
Cleared Mar 14, 2025
DeepRESP
K241960 · OLZ
Nox Medical Ehf
Neurology · 254d
Cleared Mar 14, 2025
VerteGlide Spinal Growth Guidance System
K241816 · PGM
OrthoPediatrics Corp.
Orthopedic · 263d
Cleared Mar 14, 2025
PLANET Onco Dose (3.2)
K241765 · LLZ
Dosisoft SA
Radiology · 267d
Cleared Mar 14, 2025
VITEK COMPACT PRO
K234012 · LON
bioMerieux, Inc.
Microbiology · 451d
Cleared Mar 13, 2025
Turbo-Elite Laser Atherectomy Catheter
K250385 · MCW
Spectranetics
Cardiovascular · 30d
Cleared Mar 13, 2025
Freedom Total Knee System (All-poly Tibial Plate)
K250382 · JWH
Maxx Orthopedics, Inc.
Orthopedic · 30d
Cleared Mar 13, 2025
Surgify Halo (54.085.SHD.H1)
K250380 · HBE
Surgify Medical OY
Neurology · 30d
Cleared Mar 13, 2025
xvision Spine system
K250255 · SBF
Augmedics, Ltd.
Orthopedic · 44d
Cleared Mar 13, 2025
neoLaser Laser Surgery Fibers
K250113 · GEX
G.N.S Neolaser , Ltd.
General & Plastic Surgery · 56d
Cleared Mar 13, 2025
FlowTriever2 Catheter
K250088 · QEW
Inari Medical, Inc.
Cardiovascular · 58d
Cleared Mar 13, 2025
308nm UV Phototherapy System (UV-K)
K244022 · FTC
Boston Aesthetics, Inc.
General & Plastic Surgery · 76d
Cleared Mar 13, 2025
Photon Therapy Apparatus (BL-10)
K243993 · GEX
Xemis Medical Technology (Shenzhen)...
General & Plastic Surgery · 77d
Cleared Mar 13, 2025
IceCap product line
K243788 · GXY
Bioserenity Medical Devices Group
Neurology · 94d
Cleared Mar 13, 2025
Ziehm Vision FD
K243735 · OWB
Ziehm Imaging GmbH
Radiology · 99d
Cleared Mar 13, 2025
CryoFreeze Wart and Skin Tag Remover
K243487 · GEH
Cryosurgery, Inc.
General & Plastic Surgery · 125d
Cleared Mar 13, 2025
MY01 Continuous Compartmental Pressure Monitor
K242997 · LXC
MY01, Inc.
Orthopedic · 168d
Cleared Mar 13, 2025
SiOxC Cream
K242406 · FRO
Sioxmed, LLC
General & Plastic Surgery · 211d
Cleared Mar 13, 2025
MedCAD® AccuStride™ System
K241811 · PBF
Medcad
Orthopedic · 265d
Cleared Mar 12, 2025
EVOL® ha – Hyper C Cervical Interbody Fusion System
K250605 · ODP
Cutting Edge Spine, LLC
Orthopedic · 12d
Cleared Mar 12, 2025
DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System
K250411 · GCJ
Dannik, LLC
General & Plastic Surgery · 27d
Cleared Mar 12, 2025
PICOALEX
K243957 · GEX
Wontech Co., Ltd.
General & Plastic Surgery · 79d