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
19033–19056 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 15, 2020
EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT...
K201605 · MAX
Eit Emerging Implant Technologies GmbH
Orthopedic · 30d
Cleared Jul 15, 2020
TxTiHA IBF System, AxTiHA Stand-Alone ALIF System
K201614 · MAX
Innovasis, Inc.
Orthopedic · 30d
Cleared Jul 15, 2020
Nalu Neurostimulation SCS system
K201618 · GZB
Boston Scientific Neuromodulation
Neurology · 30d
Cleared Jul 15, 2020
Magicore II System
K201621 · NHA
Innobiosurg Co., Ltd.
Dental · 30d
Cleared Jul 14, 2020
EMBOTRAP III Revascularization Device
K193063 · NRY
Neuravi, Ltd.
Neurology · 253d
Cleared Jul 14, 2020
Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit...
K193097 · LNH
Canon Medical Systems Corporation
Radiology · 250d
Cleared Jul 14, 2020
Mako Total Knee Application
K193515 · OLO
Mako Surgical Corp.
Orthopedic · 208d
Cleared Jul 14, 2020
Orbit Subretinal Delivery System
K200325 · FMF
Orbit Biomedical
Ophthalmic · 155d
Cleared Jul 13, 2020
TRAUS SUS20
K192561 · DZI
Saeshin Precision Co., Ltd.
Dental · 300d
Cleared Jul 13, 2020
Digiscan FDX
K200218 · OWB
Allengers Medical Systems Limited
Radiology · 167d
Cleared Jul 13, 2020
Medline Powder Free Examination Gloves (Tested for use with Chemotherapy Drugs)
K200960 · LZA
Medline Industires, Inc.
General Hospital · 94d
Cleared Jul 13, 2020
Biodesign Staple Line Reinforcement
K201000 · FTM
Cook Biotech Incorporated
General & Plastic Surgery · 88d
Cleared Jul 13, 2020
PROBEAT-CR
K201042 · LHN
Hitachi , Ltd.
Radiology · 84d
Cleared Jul 13, 2020
ExacTrac Dynamic
K201276 · IYE
Brainlab AG
Radiology · 61d
Cleared Jul 13, 2020
Allograft MIS Delivery System
K201338 · FMF
Lifenet Health
General & Plastic Surgery · 54d
Cleared Jul 12, 2020
Automatic Upper Arm Blood Pressure Monitor
K193627 · DXN
Dongguan E-Test Technology Co., Ltd.
Cardiovascular · 199d
Cleared Jul 12, 2020
AGE Automatic Wrist Blood Pressure Monitor
K193628 · DXN
Dongguan E-Test Technology Co., Ltd.
Cardiovascular · 199d
Cleared Jul 10, 2020
Ezra Plexo Software
K192969 · QIH
Ezra Ai, Inc.
Radiology · 261d
Cleared Jul 10, 2020
Paragon 28 APEX 3D Total Ankle Replacement System
K192994 · HSN
Paragon 28, Inc.
Orthopedic · 259d
Cleared Jul 10, 2020
AI-Rad Companion Engine
K193294 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 226d
Cleared Jul 10, 2020
NextAR TKA Platform
K193559 · SBF
Medacta Inernational SA
Orthopedic · 200d
Cleared Jul 10, 2020
Automatic Upper Arm Blood Pressure Monitor
K193624 · DXN
Dongguan E-Test Technology Co., Ltd.
Cardiovascular · 197d
Cleared Jul 10, 2020
ExcelsiusGPS Cranial 1.0 Module
K200047 · OLO
Globus Medical, Inc.
Neurology · 183d
Cleared Jul 10, 2020
Infrascanner
K200203 · OPT
Infrascan, Inc.
Neurology · 164d