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
9697–9720 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 28, 2023
Electrocardiograph: SE-1200 Pro and SE-1201 Pro
K222902 · DPS
Edan Instruments, Inc.
Cardiovascular · 308d
Cleared Jul 28, 2023
FlowStar Touch Digital Mixer Flowmeter
K222794 · BZR
Baldus Sedation GmbH & Co. KG
Anesthesiology · 315d
Cleared Jul 28, 2023
HJY VisualNext Endoscopic Vision System
K222735 · GWG
Hjy Smart Medical Device Co., Ltd.
Neurology · 322d
Cleared Jul 28, 2023
PatCom Distal Chip Endoscope
K222587 · EOB
H&A Mui Enterprises, Inc.
Ear, Nose, Throat · 336d
Cleared Jul 27, 2023
Therm-X
K231912 · IRP
Zenith Technical Innovations
Physical Medicine · 28d
Cleared Jul 27, 2023
SURGIVISIO Device
K231886 · OLO
Ecential Robotics
Orthopedic · 30d
Cleared Jul 27, 2023
LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))
K231555 · OHS
iSMART Developments, Ltd.
General & Plastic Surgery · 58d
Cleared Jul 27, 2023
Altaviz Needle Kit II
K231261 · FMI
Altaviz, LLC
General Hospital · 87d
Cleared Jul 27, 2023
IBS-B MIS Beveled Screw System
K231236 · HWC
In2bones USA, LLC
Orthopedic · 90d
Cleared Jul 27, 2023
MDx-Chex for BC-GN
K231223 · PMN
Streck
Microbiology · 90d
Cleared Jul 27, 2023
MDx-Chex for BC-GP
K231221 · PMN
Streck
Microbiology · 90d
Cleared Jul 27, 2023
Brainomix 360 Triage ICH
K231195 · QAS
Brainomix Limited
Radiology · 91d
Cleared Jul 27, 2023
R2P Navicross
K231044 · DQY
Terumo Medical Corporation
Cardiovascular · 106d
Cleared Jul 27, 2023
Cardinal Health™ SmartGown™ EDGE Breathable Surgical Gown with ASSIST™...
K230838 · FYA
Cardinal Health200, LLC
General Hospital · 122d
Cleared Jul 27, 2023
Rapid Aneurysm Triage and Notification
K230074 · QFM
Ischemaview, Inc.
Radiology · 198d
Cleared Jul 27, 2023
cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas®...
K223591 · QOF
Roche Molecular Systems, Inc.
Microbiology · 238d
Cleared Jul 27, 2023
Teleflex Rusch SoftSimplastic Foley Catheters
K212077 · EZL
Teleflexmedical, Inc.
Gastroenterology & Urology · 755d
Cleared Jul 26, 2023
DEPUY SYNTHES MAXFRAME AUTOSTRUT System
K231922 · KTT
DePuy Synthes
Orthopedic · 27d
Cleared Jul 26, 2023
ecoFIX®
K231787 · MAI
Science & Bio Materials (S.B.M.) Sas
Orthopedic · 36d
Cleared Jul 26, 2023
uMI Panorama
K231572 · KPS
Shanghai United Imaging Healthcare...
Radiology · 56d
Cleared Jul 26, 2023
ApolloKnee
K231172 · OLO
Corin U.S.A. Limited
Orthopedic · 92d
Cleared Jul 26, 2023
Global Hypoperfusion Index (GHI) Algorithm
K231038 · QNL
Edwards Lifesciences, LLC
Cardiovascular · 105d
Cleared Jul 26, 2023
Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B
K222994 · DXN
Shenzhen AOJ Medical Technology Co.,...
Cardiovascular · 301d
Cleared Jul 26, 2023
CarboClear Cervical Cage System, CarboClear Cervical VBR System
K222874 · ODP
Carbofix Orthpedics , Ltd.
Orthopedic · 307d