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
23185–23208 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 08, 2019
Coala Heart Monitor
K182040 · DXH
Coala Life AB
Cardiovascular · 193d
Cleared Feb 08, 2019
ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ...
K182833 · EIH
The Argen Corporation
Dental · 122d
Cleared Feb 08, 2019
LINK MP Monoblock Hip Prosthesis
K183141 · LZO
Waldemar Link GmbH & Co. KG
Orthopedic · 87d
Cleared Feb 08, 2019
Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint...
K183186 · MOS
Shanghai United Imaging Healthcare...
Radiology · 81d
Cleared Feb 08, 2019
Carestream DRX-1 System with DRX Plus 2530 Detectors
K183245 · MQB
Carestream Health, Inc.
Radiology · 79d
Cleared Feb 08, 2019
Ammonia II
K183517 · JIF
Roche Diagnostics Operations (Rdo)
Chemistry · 52d
Cleared Feb 07, 2019
AcQMap High Resolution Imaging and Mapping System
K181577 · DQK
Acutus Medical, Inc.
Cardiovascular · 237d
Cleared Feb 07, 2019
SafeAir Smoke Evacuator compact
K182224 · FYD
Lina Medical Aps
General Hospital · 175d
Cleared Feb 07, 2019
Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal
K182259 · FTM
Acell, Inc.
General & Plastic Surgery · 170d
Cleared Feb 07, 2019
ROSA ONE Brain Application
K182417 · HAW
Medtech S.A
Neurology · 155d
Cleared Feb 07, 2019
dpl SpotLite
K183118 · OLP
Led Technologies, Inc.
General & Plastic Surgery · 90d
Cleared Feb 07, 2019
ArcTV Transvaginal Sling System
K183134 · OTN
Urocure, LLC
Gastroenterology & Urology · 86d
Cleared Feb 07, 2019
SonoSite SII Ultrasound System
K183235 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 79d
Cleared Feb 07, 2019
Parcus GFS BTB
K183331 · MBI
Parcus Medical, LLC
Orthopedic · 66d
Cleared Feb 07, 2019
Biomet Headless Compression and Twist-Off Screws
K190035 · HWC
Biomet, Inc.
Orthopedic · 30d
Cleared Feb 06, 2019
CO2 Sampling Line
K181981 · CCK
Tylenol Medical Instruments Co., Ltd.
Anesthesiology · 196d
Cleared Feb 06, 2019
RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH2, RHINO-LARYNGO VIDEOSCOPE OLYMPUS...
K182102 · EOB
Olympus Medical Systems Corp.
Ear, Nose, Throat · 187d
Cleared Feb 06, 2019
WavelinQ 4F EndoAVF System
K182796 · PQK
C.R. Bard, Inc.
Cardiovascular · 128d
Cleared Feb 06, 2019
Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion...
K182885 · KWQ
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 114d
Cleared Feb 06, 2019
SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments,...
K183119 · OUR
Globus Medical, Inc.
Orthopedic · 89d
Cleared Feb 06, 2019
Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and Black
K183435 · GDW
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 57d
Cleared Feb 06, 2019
Omnia Medical Rotary PLIF System
K183659 · MAX
Omnia Medical, LLC
Orthopedic · 41d
Cleared Feb 06, 2019
DAILIES Colors, DAILIES Colors Toric, DAILIES Colors Progressives
K190045 · LPL
Alcon Laboratories, Inc.
Ophthalmic · 28d
Cleared Feb 05, 2019
Absoanchor Microimplant
K181142 · OAT
Dentos, Inc.
Dental · 280d