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
24769–24792 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 20, 2018
The Graft Natural Bone Substitute
K173188 · NPM
Purgo Biologics, Inc.
Dental · 291d
Cleared Jul 20, 2018
NicoletOne
K173366 · OLZ
Natus Neurology Incorporated
Neurology · 267d
Cleared Jul 20, 2018
AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening...
K173675 · FRO
Convatec Limited
General & Plastic Surgery · 232d
Cleared Jul 20, 2018
TV-100
K173973 · CBK
Bio-Med Devices, Inc.
Anesthesiology · 203d
Cleared Jul 20, 2018
Athena Cervical Plate System
K180022 · KWQ
Medyssey USA, Inc.
Orthopedic · 198d
Cleared Jul 20, 2018
EcoFit Vit E Acetabular System
K180263 · LZO
Implantcast GmbH
Orthopedic · 171d
Cleared Jul 20, 2018
WATCHMAN TruSeal Access System
K180864 · DQY
Boston Scientific
Cardiovascular · 109d
Cleared Jul 20, 2018
TruDi NAV Suction Instruments
K180948 · PGW
Acclarent, Inc.
Ear, Nose, Throat · 100d
Cleared Jul 20, 2018
Free Testosterone AccuBind ELISA Test System
K181017 · CDZ
Monobind, Inc.
Chemistry · 101d
Cleared Jul 20, 2018
GuardianTM Burr Hole Cover System
K181382 · GXR
St Jude Medical
Neurology · 56d
Cleared Jul 20, 2018
JGH1 Core Deccompression Procedure Kit
K181585 · MQV
AgNovos Healthcare USA, LLC
Orthopedic · 35d
Cleared Jul 20, 2018
Digital Diagnostic Mobile X-ray System
K181626 · IZL
Samsung Electronics Co., Ltd.
Radiology · 30d
Cleared Jul 20, 2018
GC85A
K181629 · KPR
Samsung Electronics Co., Ltd.
Radiology · 30d
Cleared Jul 20, 2018
GR40CW
K181631 · MQB
Samsung Electronics Co., Ltd.
Radiology · 30d
Cleared Jul 20, 2018
Aurora
K181636 · MUH
Sodium Systems, LLC
Radiology · 29d
Cleared Jul 20, 2018
Bandit guidewire
K181647 · DQX
Vascular Solutions, Inc.
Cardiovascular · 28d
Cleared Jul 19, 2018
Disposable Electrosurgical Pencils
K170369 · GEI
Cathay Manfacturing Corp.
General & Plastic Surgery · 528d
Cleared Jul 19, 2018
Atellica IM High-Sensitivity Troponin I (TNIH)
K171566 · MMI
Siemens Healthcare Diagnostics, Inc.
Chemistry · 415d
Cleared Jul 19, 2018
Latitud Hip Replacement System
K172857 · LPH
Meril Healthcare Pvt. , Ltd.
Orthopedic · 302d
Cleared Jul 19, 2018
da Vinci Xi Surgical System, da Vinci X Surgical System
K173585 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 241d
Cleared Jul 19, 2018
Medline Burn and Wound Dressing
K173911 · FRO
Medline Industries, Inc.
General & Plastic Surgery · 209d
Cleared Jul 19, 2018
Ultrasonic Doppler (Model YM-2T8)
K180419 · KNG
Shenzhen Imdk Medical Technology Co.,...
Obstetrics & Gynecology · 154d
Cleared Jul 19, 2018
DentiqGuide
K180629 · LLZ
3D Industrial Imaging Co., Ltd.
Radiology · 132d
Cleared Jul 19, 2018
CuffLink Implant System Biocomposite
K180763 · MAI
Conmed Corporation
Orthopedic · 118d