FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: 2026–2026 ×
2,517 results
1561–1584 of 2,517
Search insights Median review: 135d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Apr 22, 2026
VANISH PRO
K253765 · GEX
Ddc Technologies, Inc.
General & Plastic Surgery · 148d
Cleared Apr 22, 2026
myosmart. (13E522)
K253256 · GXY
Otto Bock Healthcare Products GmbH
Neurology · 205d
Cleared Apr 22, 2026
ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit
K253230 · GEH
Erbe Elektromedizin GmbH
General & Plastic Surgery · 205d
Cleared Apr 22, 2026
EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)
K253163 · QAS
Ever Fortune.Ai, Co., Ltd.
Radiology · 208d
Cleared Apr 22, 2026
uOmnispace.MR
K253077 · QIH
Shanghai United Imaging Healthcare...
Radiology · 211d
Cleared Apr 22, 2026
Verrix EVA™ STEAM Biological Indicator (BI) (Model: 1200), Verrix EVA™ STEAM...
K252306 · QVB
Steritec Products
General Hospital · 272d
Cleared Apr 21, 2026
Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line
K260921 · MBI
Tigon Medical
Orthopedic · 33d
Cleared Apr 21, 2026
EvoEndo Single-Use Endoscopy System
K260573 · FDS
EvoEndo, Inc.
Gastroenterology & Urology · 60d
Cleared Apr 21, 2026
IPL Hair Removal (SL-B301, SL-B300, SL-B330, SL-B330-1, SL-B287-1, SL-B371,...
K260518 · OHT
Shenzhen Semlamp Intelligent...
General & Plastic Surgery · 63d
Cleared Apr 21, 2026
ETEST Gepotidacin (GEP) (0.016-256 µg/mL)
K260447 · JWY
Biom?rieux SA
Microbiology · 69d
Cleared Apr 21, 2026
CD Horizon™ ModuLeX™ Fenestrated Screw Set
K260216 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 88d
Cleared Apr 21, 2026
BosCATH Support Catheter
K254046 · QJP
Sonorous NV, Inc.
Neurology · 125d
Cleared Apr 21, 2026
Korotkoff sound blood pressure monitor
K253982 · DXN
Beijing Hanvon Health Technology Co.,...
Cardiovascular · 130d
Cleared Apr 21, 2026
RhythmStar System (SL)
K250793 · QYX
RhythMedix, LLC
Cardiovascular · 403d
Cleared Apr 20, 2026
EnSite™ X EP System
K260212 · DQK
Abbott Medical
Cardiovascular · 87d
Cleared Apr 20, 2026
Q-Switched Nd: YAG Laser System (Glamor Q)
K260153 · GEX
Nanjing Bestview Laser S&T Co., Ltd.
General & Plastic Surgery · 90d
Cleared Apr 20, 2026
Power Wheelchair (N5919 series)
K253806 · ITI
Zhejiang Innuovo Rehabilitation...
Physical Medicine · 143d
Cleared Apr 20, 2026
xStep (xStep)
K253638 · SDO
Spinex, Inc.
Physical Medicine · 152d
Cleared Apr 20, 2026
Luminoah FLOW™ Enteral Nutrition System
K253558 · LZH
Luminoah
General Hospital · 154d
Cleared Apr 20, 2026
SAGI Cervical Cage System
K253213 · OVE
ZheJiang Decans Medical Devices Co.,...
Orthopedic · 203d
Cleared Apr 20, 2026
Non-sterile Level 3 Surgical Gown (4025)
K253003 · FYA
Hubei Xinxin Non-Woven Co., Ltd.
General Hospital · 213d
Cleared Apr 20, 2026
Lunar Astra
K252718 · KGI
GE Medical Systems Ultrasound &...
Radiology · 235d
Cleared Apr 20, 2026
Folliscan
K252332 · QIH
Mim Fertility
Radiology · 269d
Cleared Apr 20, 2026
SmartSurgN Visualization System
K242163 · OWN
Smartsurgn, Inc.
General & Plastic Surgery · 635d