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
1441–1464 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jan 22, 2026
IPDmilled Blanks
K253253 · NHA
Implant Protesis Dental 2004, S.L.
Dental · 115d
Cleared Jan 22, 2026
AI-Rad Companion Brain MR
K253057 · QIH
Siemens Healthcare GmbH
Radiology · 122d
Cleared Jan 22, 2026
Perin Health System (PHD80060-2)
K252984 · DRG
Perin Health Devices, LLC
Cardiovascular · 126d
Cleared Jan 22, 2026
OLYMPIC Posterior Spinal Fixation System
K252885 · PML
Astura Medical
Orthopedic · 134d