FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
4537–4560 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Mar 12, 2025
RCT600
K243903 · OAS
Ray Co., Ltd.
Radiology · 83d
Cleared Mar 12, 2025
2430TCA with Xmaru W
K243849 · MUE
Rayence Co., Ltd.
Radiology · 86d
Cleared Mar 12, 2025
BioFire Warrior Panel
K243822 · PRD
Biofire Defense, LLC
Microbiology · 90d
Cleared Mar 12, 2025
Walking rehabilitation training electric wheelchair (ZW518)
K243783 · IPL
Shenzhen Zuowei Technology Co., Ltd.
Physical Medicine · 93d
Cleared Mar 12, 2025
Wireless TENS & EMS Unit
K243763 · NGX
Changsha Anxiang Medical Technology...
Neurology · 96d
Cleared Mar 12, 2025
Delphi Amplifier
K243746 · GWL
Quantalx Neroscience
Neurology · 97d
Cleared Mar 12, 2025
ReWalk® 7 Personal Exoskeleton (50-20-0005)
K241822 · PHL
Rewalk Robotics Ltd. Dba Lifeward
Neurology · 261d
Cleared Mar 11, 2025
Arthrex TightRope Soft Button, RT
K250424 · MBI
Arthrex, Inc.
Orthopedic · 25d
Cleared Mar 11, 2025
iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D)
K250374 · HBE
Stryker Instruments
Neurology · 29d
Cleared Mar 11, 2025
RemunityPRO™ Pump for Remodulin® (treprostinil) Injection
K250357 · FRN
Deka Research & Development Corp.
General Hospital · 32d
Cleared Mar 11, 2025
Origin™ TT Stem
K243029 · LZO
Signature Orthopaedics Pty, Ltd.
Orthopedic · 165d
Cleared Mar 11, 2025
8mm Monopolar Curved Scissors (470179)
K242610 · QSM
Iconocare Health
General & Plastic Surgery · 189d
Cleared Mar 11, 2025
Better Diagnostics Caries Assist (BDCA) Version 1.0
K241725 · MYN
Better Diagnostics AI Corp.
Radiology · 270d