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: Cleared only ×
175,230 results
5665–5688 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 30, 2024
Safety Lancet
K242627 · FMK
Ningbo Medsun Medical Co., Ltd.
General & Plastic Surgery · 57d
Cleared Oct 30, 2024
Caduceus S
K242271 · SBF
Taiwan Main Orthopaedic Biotechnology...
Orthopedic · 90d
Cleared Oct 30, 2024
Edison System
K241902 · QGM
HistoSonics, Inc.
General & Plastic Surgery · 121d
Cleared Oct 30, 2024
NeurAxis IB-Stim (01-1020)
K241533 · QHH
Neuraxis
Gastroenterology & Urology · 153d
Cleared Oct 30, 2024
RemedyLogic AI MRI Lumbar Spine Reader
K241108 · QIH
Remedy Logic, Inc.
Radiology · 191d
Cleared Oct 30, 2024
MedicCO2LON (MedicCO2LON)
K240847 · FCX
Ide Vision, Ltd.
Gastroenterology & Urology · 217d
Cleared Oct 30, 2024
DRI Ecstasy Plus Assay
K240670 · DKZ
Microgenics Corporation
Toxicology · 233d
Cleared Oct 30, 2024
ZENEX Implant System_Long
K240560 · DZE
Izenimplant Co., Ltd.
Dental · 244d
Cleared Oct 30, 2024
LAGIS Endoscopic Instruments - Grasper (DI-5670-33D, DI-5670-45D,...
K240334 · GCJ
Lagis Enterprise Co., Ltd.
General & Plastic Surgery · 268d
Cleared Oct 30, 2024
Wearable Digital Thermometer (T31)
K240333 · FLL
Guangdong Genial Technology Co., Ltd.
General Hospital · 268d
Cleared Oct 30, 2024
Zio AT® device (A100A1001)
K240177 · DSI
iRhythm Technologies, Inc.
Cardiovascular · 281d
Cleared Oct 29, 2024
Persona the Personalized Knee System
K243247 · MBH
Zimmer, Inc.
Orthopedic · 18d
Cleared Oct 29, 2024
OC JuggerKnotless Soft Anchor
K243203 · MBI
Riverpoint Medical
Orthopedic · 28d
Cleared Oct 29, 2024
AtriCure cryoICE BOX (ACM)
K243157 · GXH
AtriCure, Inc.
Neurology · 29d
Cleared Oct 29, 2024
TRACHEOBRONXANE™ DUMON®
K243126 · NWA
Novatech SA
Anesthesiology · 29d
Cleared Oct 29, 2024
Mammotome AutoCore™ Single Insertion Core Biopsy System
K243095 · KNW
Devicor Medical Products, Inc.
General & Plastic Surgery · 29d
Cleared Oct 29, 2024
Riptide Aspiration System
K243080 · NRY
Micro Therapeutics, Inc. d/b/a ev3...
Neurology · 29d
Cleared Oct 29, 2024
QIAstat-Dx Meningitis/Encephalitis (ME) Panel
K242256 · PLO
QIAGEN GmbH
Microbiology · 90d
Cleared Oct 29, 2024
Catheter Surface Flap Applicator Set (GM11011830)
K241965 · JAQ
Varian Medical Systems
Radiology · 118d
Cleared Oct 29, 2024
Video Bronchoscope System
K241612 · EOQ
Hunan Vathin Medical Instrument Co.,...
Ear, Nose, Throat · 146d
Cleared Oct 29, 2024
QualityFlow O2 Series (QualityFLOW O2)
K241366 · CBP
Dehas Medical Systems GmbH
Anesthesiology · 168d
Cleared Oct 29, 2024
Electric Wheelchair (ME23-EW16-BC200-01)
K241189 · ITI
Jiaxing Xiaoxiang Medical Equipment...
Physical Medicine · 183d
Cleared Oct 29, 2024
DeGen Medical Patient Specific Implant (PSI) System
K241077 · OVD
Degen Medical
Orthopedic · 193d
Cleared Oct 29, 2024
Tigon Medical Fractures, Instability, and Reconstruction (FIRE)
K240175 · HWC
Tigon Medical
Orthopedic · 280d