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
889–912 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 01, 2026
Synchrony
K253473 · DQK
Stereotaxis, Inc.
Cardiovascular · 173d
Cleared Apr 01, 2026
Prana System
K253405 · GEI
Prana Surgical
General & Plastic Surgery · 183d
Cleared Apr 01, 2026
GentleCath Air for Men
K252943 · EZD
Convatec Limited
Gastroenterology & Urology · 198d
Cleared Apr 01, 2026
GEM Flex Coil 16-L Array, 3.0T Receive Only
K252876 · MOS
Shenzhen RF Tech Co., Ltd.
Radiology · 203d
Cleared Apr 01, 2026
Polywin Safety (14G x 51mm
K252513 · FOZ
Poly Medicure Limited
General Hospital · 233d
Cleared Apr 01, 2026
MOD-C
K242303 · ODP
Orthomod, LLC
Orthopedic · 604d
Cleared Mar 28, 2026
CO2 Laser System
K260257 · GEX
Sanhe Meditech Co., Ltd.
General & Plastic Surgery · 59d
Cleared Mar 28, 2026
ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)
K252360 · SAT
Anumana, Inc.
Cardiovascular · 242d
Cleared Mar 27, 2026
S-scan Open (100001800)
K260746 · LNH
Esaote, S.P.A.
Radiology · 21d
Cleared Mar 27, 2026
VyPlate™ Anterior Cervical Plate System
K260697 · KWQ
Vy Spine, LLC
Orthopedic · 23d
Cleared Mar 27, 2026
SF Push-in Anchor
K260294 · MAI
Surgical Fusion Technologies GmbH
Orthopedic · 57d
Cleared Mar 27, 2026
Strauss Surgical cystoscope, hysteroscope and accessories Instruments
K260271 · FAJ
American Medical Endoscopy, Inc.
Gastroenterology & Urology · 58d
Cleared Mar 27, 2026
AVENTIX PFX System (PFX01)
K260255 · GEI
Aventix Medical, Inc.
Ear, Nose, Throat · 58d
Cleared Mar 27, 2026
SYMPHONY Navigation Ready Instruments
K260240 · OLO
Medos International SARL
Orthopedic · 60d
Cleared Mar 27, 2026
MDx-Chex for BCP
K260041 · PMN
Streck, LLC
Microbiology · 80d
Cleared Mar 27, 2026
CyClean Cord
K254239 · MVL
SS GLOBAL
Dental · 88d
Cleared Mar 27, 2026
Power wheelchair (ZS-EW8026)
K254206 · ITI
Ningbo Zhishan Medical Technology...
Physical Medicine · 88d
Cleared Mar 27, 2026
Automated Aortic Stenosis Software (AutoAS)
K254161 · POK
GE Medical Systems Ultrasound &...
Radiology · 95d
Cleared Mar 27, 2026
EVO Q30 Diagnostic Ultrasound System
K254099 · IYN
Samsung Medison Co., Ltd.
Radiology · 98d
Cleared Mar 27, 2026
Electrically Powered Wheelchair (Model YC-01)
K253980 · ITI
Yurob Rehabilitation Medical Co., Ltd.
Physical Medicine · 105d
Cleared Mar 27, 2026
GPA (hexafocon A) Rigid Gas Permeable Contact Lenses
K253822 · HQD
Zhuhai Fitlens Medical Technology...
Ophthalmic · 119d
Cleared Mar 27, 2026
Spectral CT Verida Family
K253649 · JAK
Philips Medical Systems Technologies...
Radiology · 127d
Cleared Mar 27, 2026
Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction...
K253625 · LNH
Canon Medical Systems Corporation
Radiology · 129d
Cleared Mar 27, 2026
EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic...
K253595 · IYN
Philips Ultrasound, LLC
Radiology · 129d