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
721–744 of 1,642
Search insights Median review: 137d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Apr 17, 2026
EdgeFlow UW20
K252237 · IYO
Edgecare, Inc.
Radiology · 274d
Not Cleared Apr 17, 2026
XplantR Explant Tool
DEN250033 · SHR
Hjarta Care, LLC
Cardiovascular · 253d
Cleared Apr 16, 2026
Hot Pink Pad Warming System
K260903 · DWJ
Xodus Medical, Inc.
Cardiovascular · 29d
Cleared Apr 16, 2026
Redermo Wound Matrix
K260020 · QSZ
Beijing Kreate Medical Co., Ltd.
General & Plastic Surgery · 101d
Cleared Apr 16, 2026
Foundation Surgical Navigated Lateral Disc Prep Instruments
K260011 · OLO
Foundation Surgical Group, Inc.
Orthopedic · 104d
Cleared Apr 16, 2026
ARx® SAI Implant System
K254274 · NKB
Life Spine, Inc.
Orthopedic · 107d
Cleared Apr 16, 2026
Verisafe Safety Sterile Needles (SSN)
K254273 · FMI
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 107d
Cleared Apr 16, 2026
Next Generation 088 Catheter
K254223 · QJP
Balt USA, LLC
Neurology · 108d
Cleared Apr 16, 2026
Enso for Migraine
K254216 · PCC
Hinge Health, Inc.
Neurology · 108d
Cleared Apr 16, 2026
Julva Velvé Water-Based Personal Lubricant
K254101 · NUC
Golden Isles Medical, Inc.
Obstetrics & Gynecology · 118d
Cleared Apr 16, 2026
Disposable Radiofrequency Cannula
K253907 · GXI
Abbott Medical
Neurology · 132d
Cleared Apr 16, 2026
Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, 4...
K253892 · FAJ
Strauss Surgical USA
Gastroenterology & Urology · 133d
Cleared Apr 16, 2026
DESS Dental Smart Solutions
K253804 · NHA
Terrats Medical SL
Dental · 139d
Cleared Apr 16, 2026
Glean Urodynamics System Male Delivery System (GUS-1000-M)
K253537 · EXQ
Bright Uro, Inc.
Gastroenterology & Urology · 154d
Cleared Apr 16, 2026
Freedom DS™ Decompression System
K253523 · HRX
Spinal Simplicity
Orthopedic · 154d
Cleared Apr 16, 2026
ORIO-3D Cage System
K253260 · ODP
SpineCraft
Orthopedic · 199d
Cleared Apr 16, 2026
uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors
K253170 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 202d
Cleared Apr 16, 2026
High Pressure Syringe
K253048 · DXT
Shenzhen Maiwei Biotech Co., Ltd.
General Hospital · 206d
Cleared Apr 16, 2026
Insufflator (OPTO-IFL1000)
K252318 · HIF
Guangdong Optomedic Technologies, Inc.
Obstetrics & Gynecology · 265d
Cleared Apr 16, 2026
Zenith Micro Guidewire
K252317 · MOF
Suzhou Zenith Vascular SciTech Limited
Neurology · 265d
Cleared Apr 16, 2026
Endoflux™ Biliary & Pancreatic Stent Sets
K251658 · FGE
Medi-Globe GmbH
Gastroenterology & Urology · 321d
Cleared Apr 16, 2026
ClearTip TBNA Type
K251478 · KTI
Finemedix Co., Ltd.
Anesthesiology · 338d
Cleared Apr 15, 2026
PATH BGC
K260938 · QJP
Crossroads Neurovascular, Inc.
Neurology · 26d
Cleared Apr 15, 2026
SureSmile Aligner (ASSY500020)
K260722 · NXC
Dentsply Sirona, Inc.
Dental · 41d