FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
9433–9456 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jul 26, 2023
HS Fiber Cerclage
K220765 · JDQ
Riverpoint Medical, LLC
Orthopedic · 497d
Cleared Jul 25, 2023
EZ-IO Intraosseous Vascular Access System
K231924 · FMI
Teleflex Medical
General Hospital · 25d
Cleared Jul 25, 2023
A-TAP (previously called Arthrotap)
K231900 · FMF
Elcam Medical Acal
General Hospital · 27d
Cleared Jul 25, 2023
Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN...
K231878 · FGB
STERIS Corporation
Gastroenterology & Urology · 29d
Cleared Jul 25, 2023
Reprocessed ViewFlex Xtra ICE Catheter (D087031)
K231621 · OWQ
Stryker Sustainability Solutions
Cardiovascular · 53d
Cleared Jul 25, 2023
MOBILETT Impact
K231577 · IZL
Siemens Medical Solutions
Radiology · 55d
Cleared Jul 25, 2023
Exceed™ Biplanar Expandable Interbody System
K231275 · MAX
Spine Wave, Inc.
Orthopedic · 84d
Cleared Jul 25, 2023
ANDI
K230913 · QIH
Imeka Solutions, Inc.
Radiology · 116d
Cleared Jul 25, 2023
Apyx
K230730 · PBQ
Escala Medical
Obstetrics & Gynecology · 131d
Cleared Jul 25, 2023
IDENTIFY
K230576 · IYE
Varian Medical Systems, Inc.
Radiology · 146d
Cleared Jul 25, 2023
Patient Specific Planning Solution™ 3D Bone Models
K230540 · LLZ
Biomet Manufacturing Corp
Radiology · 148d