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
10825–10848 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 22, 2023
MPXA-2000
K222036 · QIH
Medipixel, Inc.
Radiology · 254d
Cleared Mar 22, 2023
CardioSTAT® ECG Test Solution
K223049 · DSH
Icentia, Inc.
Cardiovascular · 174d
Cleared Mar 22, 2023
Ceribell Instant EEG Headcap
K223086 · GXY
Ceribell, Inc.
Neurology · 173d
Cleared Mar 22, 2023
Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar
K223593 · GCJ
Taiwan Surgical Corporation
General & Plastic Surgery · 111d
Cleared Mar 22, 2023
POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular...
K223824 · DRA
Boston Scientific Corporation
Cardiovascular · 91d
Cleared Mar 22, 2023
SPIRA®-C Integrated Fixation System
K223837 · OVE
Camber Spine Technologies
Orthopedic · 90d
Cleared Mar 22, 2023
Stativ® Knotted UHMWPE Suture Anchor
K223889 · MBI
Healthium Medtech Limited
Orthopedic · 85d
Cleared Mar 22, 2023
Epi-Stop Nasal Gel/epistaxis pack
K230142 · LYA
Biomed Ent, Inc.
Ear, Nose, Throat · 63d
Cleared Mar 22, 2023
Arise™ UHP Dilatation Catheter
K230191 · LIT
Creagh Medical, Ltd.
Cardiovascular · 57d
Cleared Mar 22, 2023
HF Surgery Generator 400KHZ
K230194 · GEI
Richard Wolf Medical Instruments...
General & Plastic Surgery · 57d
Cleared Mar 22, 2023
Motive™ Electrode
K230533 · GXY
Cymedica Orthopedics, Inc.
Neurology · 23d
Cleared Mar 22, 2023
Tryptik Ti
K230583 · ODP
Spineart SA
Orthopedic · 20d
Cleared Mar 21, 2023
OviTex PRS (Long Term Resorbable)
K214070 · FTM
Tela Bio
General & Plastic Surgery · 449d
Cleared Mar 21, 2023
Genomadix Cube CYP2C19 System
K220026 · NTI
Genomadix, Inc.
Toxicology · 440d
Cleared Mar 21, 2023
EasyTouch Lancing Device
K222617 · QRK
Stat Medical Devices
General & Plastic Surgery · 203d
Cleared Mar 21, 2023
Retraction, CWM-910T, APOLEX Tite
K222709 · GEI
Chungwoo Co., Ltd.
General & Plastic Surgery · 194d
Cleared Mar 21, 2023
FlightPlan for Embolization
K223490 · LLZ
GE Medical Systems SCS
Radiology · 120d
Cleared Mar 21, 2023
Instrument Case P1340904
K223672 · KCT
Cochlear
General Hospital · 104d
Cleared Mar 21, 2023
Entasis 3D Dual-Lead Sacroiliac Implant System
K223708 · OUR
Corelink, LLC
Orthopedic · 99d
Cleared Mar 21, 2023
Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or...
K223844 · JWY
Thermo Fisher Scientific
Microbiology · 89d
Cleared Mar 21, 2023
DSM Biomedical Calcium Phosphate Cement
K230054 · MQV
Dsm Biomedical
Orthopedic · 74d
Cleared Mar 21, 2023
LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface
K230471 · JWH
Waldemar Link GmbH & Co. KG
Orthopedic · 28d
Cleared Mar 21, 2023
Nio Color 2MP (MDNC-2521)
K230520 · PGY
Barco N.V.
Radiology · 22d
Cleared Mar 21, 2023
Syngo Carbon Space VA30A
K230561 · LLZ
Siemens Healthcare GmbH
Radiology · 21d