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
3313–3336 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 20, 2025
LED LIGHT MASK (A093)
K250880 · OHS
Foshan Guangyu Weilai Medical...
General & Plastic Surgery · 88d
Cleared Jun 20, 2025
TMINI Miniature Robotic System
K250877 · OLO
THINK Surgical, Inc.
Orthopedic · 88d
Cleared Jun 20, 2025
Disposable Endoscopy Valve Set
K250732 · ODC
Yangzhou Fartley Medical Instrument...
Gastroenterology & Urology · 101d
Cleared Jun 20, 2025
AdheResp Smart Breath-actuated Mesh Nebulizer
K250583 · CAF
Hcmed Innovations Co., Ltd.
Anesthesiology · 113d
Cleared Jun 20, 2025
EsCem RMGI
K250566 · EMA
Spident Co., Ltd.
Dental · 114d
Cleared Jun 20, 2025
Us2.ca
K250151 · SDJ
Eko.Ai Pte Ltd. D/B/A Us2.Ai
Cardiovascular · 150d
Cleared Jun 20, 2025
Incompass Total Ankle System
K250037 · HSN
Wright Medical Technology, Inc....
Orthopedic · 163d
Cleared Jun 20, 2025
LED Facial Mask
K243978 · OHS
Shenzhen Sunsred Technology Co.,Ltd
General & Plastic Surgery · 179d
Cleared Jun 20, 2025
PAL Sterilization Case
K243589 · KCT
Microaire Surgical Instruments, LLC
General Hospital · 212d
Cleared Jun 20, 2025
CT Scanner TSX-501R/1 V11.1
K243398 · JAK
Canon Medical Systems Corporation
Radiology · 232d
Cleared Jun 20, 2025
Alinity i Rubella IgG
K243168 · LFX
Abbott Laboratories
Microbiology · 263d
Cleared Jun 20, 2025
HybridAPC probe
K243120 · GEI
Erbe Elektromedizin GmbH
General & Plastic Surgery · 263d
Cleared Jun 20, 2025
BD Intelliport System
K243062 · PHC
Becton Dickinson
General Hospital · 266d
Cleared Jun 20, 2025
Navient Image Guided Navigation System (ENT) (955-NC-NC)
K243053 · PGW
Claronav
Ear, Nose, Throat · 266d
Cleared Jun 20, 2025
Reusable Temperature Probe (T1306, T2306, T3306, T4306)
K243000 · FLL
Shenzhen Medke Technology Co., Ltd.
General Hospital · 267d
Cleared Jun 20, 2025
CollOvine™ Wound Dressing
K242985 · KGN
Ovigenex, LLC
General & Plastic Surgery · 267d
Cleared Jun 20, 2025
Atellica IM Thyroglobulin (Tg)
K242981 · MSW
Siemens Healthcare Diagnostics, Inc.
Immunology · 267d
Cleared Jun 20, 2025
External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar...
K242974 · JXG
Sophysa
Neurology · 267d
Cleared Jun 20, 2025
Celsi Warmer
K242964 · DWJ
Hadleigh Health Technologies
Cardiovascular · 267d
Cleared Jun 20, 2025
Medconn Glycated Hemoglobin Test system
K242911 · PDJ
Shanghai Medconn Medical Technology...
Chemistry · 269d
Cleared Jun 20, 2025
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae...
K242843 · JWY
Thermo Fisher Scientific
Microbiology · 273d
Cleared Jun 19, 2025
Electrosurgical Pads
K251235 · GEI
Baisheng Medical Co., Ltd.
General & Plastic Surgery · 58d
Cleared Jun 19, 2025
EpiMonitor
K250515 · POS
Empatica S.R.L.
Neurology · 118d
Cleared Jun 19, 2025
Leone Orthodontic Implant TAD (Temporary Anchorage Device)
K242944 · OAT
Leone S.P.A.
Dental · 267d