FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
17857–17880 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 25, 2021
EchoS Family
K202514 · MUA
Echolight S.P.A
Radiology · 178d
Cleared Feb 25, 2021
Tixel System
K202988 · GEI
Novoxel , Ltd.
General & Plastic Surgery · 148d
Cleared Feb 25, 2021
NinesMeasure
K202990 · LLZ
Nines, Inc.
Radiology · 148d
Cleared Feb 25, 2021
iFuse-TORQ™ Implant System
K203247 · OUR
SI-BONE, Inc.
Orthopedic · 113d
Cleared Feb 25, 2021
Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C
K203332 · FLL
Hetaida Technology Co., Ltd.
General Hospital · 105d
Cleared Feb 25, 2021
Classic
K203477 · LRK
Orthoapnea S.L.
Dental · 90d
Cleared Feb 25, 2021
Surgical Masks
K203524 · FXX
Bain Medical Equipment (Guangzhou)...
General Hospital · 86d
Cleared Feb 25, 2021
OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence...
K203578 · NQQ
Perimeter Medical Imaging Ai, Inc.
General & Plastic Surgery · 80d
Cleared Feb 25, 2021
STOP U Model UXV Device
K203665 · PAY
Pollogen, Ltd.
General & Plastic Surgery · 71d
Cleared Feb 25, 2021
Phenom Catheters
K210230 · DQY
Micro Therapeutics Lnc. D/B/A Ev3...
Neurology · 28d
Cleared Feb 24, 2021
Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit
K200734 · PBY
Sirius Medical Systems B.V.
General & Plastic Surgery · 341d
Cleared Feb 24, 2021
PROXEO Twist Cordless Polishing System PL-40 H
K201703 · EKX
W&H Dentalwerk Buermoos GmbH
Dental · 247d
Cleared Feb 24, 2021
Trinity ELE Plus and Trinity ELE Plus Pro
K201906 · NFO
Carol Cole Company Dba Nuface
Neurology · 230d
Cleared Feb 24, 2021
Nitrile Powder Free Examination Glove, Blue Tested for Use with 32...
K202003 · LZA
Gmp Medicare Sdn. Bhd.
General Hospital · 219d
Cleared Feb 24, 2021
Practical Navigation Surgical Guidance System (PNSGS)
K202184 · OLO
Practical Navigation, LLC
Orthopedic · 204d
Cleared Feb 24, 2021
4K UHD Laparoscope
K203255 · GCJ
Scivita Medical Technology Co., Ltd.
General & Plastic Surgery · 112d
Cleared Feb 24, 2021
ExtremiLOCK Lateral Ankle Fusion Plates
K203479 · HRS
Osteomed
Orthopedic · 89d
Cleared Feb 24, 2021
Triever Catheters
K210195 · QEW
Inari Medical
Cardiovascular · 30d
Cleared Feb 24, 2021
BioWaveGO RX
K210202 · GZJ
Biowave Corporation
Neurology · 30d
Cleared Feb 24, 2021
CITRESPLINE and CITRELOCK ACL Implants
K210239 · MAI
Acuitive Technologies, Inc.
Orthopedic · 26d
Cleared Feb 23, 2021
Velano ExT Extension Set
K200439 · FPA
Velano Vascular
General Hospital · 365d
Cleared Feb 23, 2021
Veolity
K201501 · OEB
Mevis Medical Solutions AG
Radiology · 263d
Cleared Feb 23, 2021
ClarifEye R1.0, ClarifEye Needle
K201743 · OWB
Philips Medical Systems Nederlands B.V.
Radiology · 243d
Cleared Feb 23, 2021
GenesisZr 4Y+ (ST1100) Zirconia
K201915 · EIH
United Dental Resources Corporation
Dental · 228d