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: 2026–2026 ×
1,922 results
1729–1752 of 1,922
Search insights Median review: 132d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Jan 27, 2026
InbellaIgnite RF System
K251435 · GEI
Inbella Medical, Inc.
General & Plastic Surgery · 264d
Cleared Jan 27, 2026
BriefCase-Triage
K251195 · QAS
Aidoc Medical , Ltd.
Radiology · 285d
Cleared Jan 26, 2026
Ascent3T Neonatal Magnetic Resonance Imaging System
K253499 · LNH
Eyas Medical Imaging, Inc.
Radiology · 89d
Cleared Jan 26, 2026
Tablo Hemodialysis System (PN-0008000, PN-0006000U)
K253412 · KDI
Outset Medical, Inc.
Gastroenterology & Urology · 118d
Cleared Jan 26, 2026
MAC 7 Resting ECG Analysis System
K251670 · DPS
Ge Medical Systems Information...
Cardiovascular · 241d
Cleared Jan 24, 2026
Holmium Laser Therapeutic Apparatus (HZ-40)
K253633 · GEX
Guangzhou Potent Medical Equipment...
General & Plastic Surgery · 66d
Cleared Jan 24, 2026
Vydence Family of Lasers
K252753 · GEX
Vydence Medical Industria E Commercio...
General & Plastic Surgery · 148d
Cleared Jan 23, 2026
HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape)
K253761 · NEU
Devicor Medical Products, Inc.
General & Plastic Surgery · 59d
Cleared Jan 23, 2026
Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable...
K253748 · MAX
Life Spine, Inc.
Orthopedic · 59d
Cleared Jan 23, 2026
3.0T AIR 32CH HNA
K253738 · MOS
Ge Healthcare Coils (Usa Instruments,...
Radiology · 60d
Cleared Jan 23, 2026
LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072,...
K253712 · OHS
Shenzhen Rainbow Technology Co., Ltd.
General & Plastic Surgery · 60d
Cleared Jan 23, 2026
TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A)
K253669 · OAP
Shenzhen Kaiyan Medical Equipment...
General & Plastic Surgery · 63d
Cleared Jan 23, 2026
Elitone for Men
K253285 · QAJ
Elidah, Inc.
Gastroenterology & Urology · 116d
Cleared Jan 23, 2026
Syntex Exam Gloves
K253160 · LZA
Basic Medical Technology, Inc.
General Hospital · 119d
Cleared Jan 23, 2026
Pneumo Dissector Hook
K252957 · GCJ
Ab Medica Sas
General & Plastic Surgery · 129d
Cleared Jan 23, 2026
POINT Kinguide Agile Robotic Arm Surgical Stereotactic System
K252755 · OLO
Point Robotics MedTech, Inc.
Orthopedic · 147d
Cleared Jan 23, 2026
New Day Skin Spray
K252568 · FRO
Silk Holdings, Inc.
General & Plastic Surgery · 162d
Cleared Jan 23, 2026
AccuContour 4.0
K251351 · QKB
Manteia Technologies Co., Ltd.
Radiology · 268d
Cleared Jan 23, 2026
Evidence MultiSTAT DOA Urine MultiPlex
K250741 · DJG
Randox Laboratories Limited
Toxicology · 318d
Cleared Jan 23, 2026
BodyGuardian Remote Monitoring System (BGRMS v3.0)
K243349 · DSI
Boston Scientific Cardiac Diagnostic...
Cardiovascular · 452d
Cleared Jan 22, 2026
AV Vascular
K253735 · QIH
Philips Medical Systems Nederland B.V.
Radiology · 59d
Cleared Jan 22, 2026
Genie MAX Large Bore Introducer Sheath
K253652 · DYB
Cultiv8 1, LLC
Cardiovascular · 63d
Cleared Jan 22, 2026
Pump In Style® Pro+
K253498 · HGX
Medela, LLC
Obstetrics & Gynecology · 85d
Cleared Jan 22, 2026
Straumann Variobase Abutments XC for Bridge/Bar
K253315 · NHA
Institut Straumann AG
Dental · 114d