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
20761–20784 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 24, 2020
3D Predict
K200214 · NXC
3D Smile USA, Inc.
Dental · 27d
Cleared Feb 23, 2020
T2 Alpha Tibia Nailing System, IMN Screws System
K193308 · HSB
Stryker Trauma GmbH
Orthopedic · 86d
Cleared Feb 21, 2020
Omnia Medical TiBrid Cervical Cage, Omnia Medical TiBrid Lateral Cage, Omnia...
K190363 · MAX
Omnia Medical, LLC
Orthopedic · 371d
Cleared Feb 21, 2020
AR_N SLA Type Implant System
K190641 · DZE
Biotem Co., Ltd.
Dental · 345d
Cleared Feb 21, 2020
Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL...
K191030 · PCA
Life Technologies Corporation
Toxicology · 309d
Cleared Feb 21, 2020
Unity Subcutaneous Infusion System for Remodulin
K191313 · QJY
DEKA Research & Development
General Hospital · 282d
Cleared Feb 21, 2020
Novalung System
K191407 · QJZ
Fresenius Medical Care Renal...
Cardiovascular · 269d
Cleared Feb 21, 2020
Biatain Silicone Ag
K191536 · FRO
Coloplast A/S
General & Plastic Surgery · 256d
Cleared Feb 21, 2020
Beamscan MR
K191646 · IYE
Ptw-Freiburg...
Radiology · 246d
Cleared Feb 21, 2020
Cardiac Monitor 1500
K191697 · DSB
Zynex Medical, Inc.
Cardiovascular · 241d
Cleared Feb 21, 2020
ULTepap Expiratory Positive Airway Pressure (EPAP) Device
K191728 · OHP
Bryggs Medical, LLC
Anesthesiology · 239d
Cleared Feb 21, 2020
DORO LUCENT® iXI and iMRI Headrest System
K191740 · HBL
Pro-Med Instruments GmbH
Neurology · 235d
Cleared Feb 21, 2020
Upper Arm Blood Pressure Monitor
K191894 · DXN
Shenzhen Zhengkang Technology Co., Ltd.
Cardiovascular · 221d
Cleared Feb 21, 2020
Tina-quant C-Reactive Protein IV
K192072 · DCN
Roche Diagnostics Operations (Rdo)
Immunology · 203d
Cleared Feb 21, 2020
UCLA CCM Abutment
K192263 · NHA
Dio Corporation
Dental · 184d
Cleared Feb 21, 2020
Coolief Radiofrequency Generator (CRG) System
K192491 · GXD
Avanos Medical, Inc.
Neurology · 163d
Cleared Feb 21, 2020
Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60
K192600 · GEX
Quanta System Spa
General & Plastic Surgery · 154d
Cleared Feb 21, 2020
PatCom Single-Use Introducer
K192691 · FED
H&A Mui Enterprises, Inc.
Gastroenterology & Urology · 148d
Cleared Feb 21, 2020
Glenoid Baseplate with Screw
K192799 · PHX
Fx Shoulder USA, Inc.
Orthopedic · 144d
Cleared Feb 21, 2020
Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i
K192832 · JAK
Canon Medical Systems Corporation
Radiology · 142d
Cleared Feb 21, 2020
OASIS MRI System
K192851 · LNH
Hitachi Healthcare Americas
Radiology · 141d
Cleared Feb 21, 2020
TGS Guidewire and updated Scopis Software
K193118 · PGW
Stryker Ent
Ear, Nose, Throat · 101d
Cleared Feb 21, 2020
LightForce Orthodontic System (LFO System)
K200148 · NJM
Lightforce Orthodontics
Dental · 30d
Cleared Feb 21, 2020
3MP Monochrome Digital Mammography LCD Monitor MS-S300
K200161 · PGY
Jvckenwood Corporation
Radiology · 30d