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
9865–9888 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 08, 2023
Promisemed Safety Huber Needle
K230715 · PTI
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 85d
Cleared Jun 08, 2023
Zionic Aesthetic
K230659 · PBX
Termosalud
General & Plastic Surgery · 91d
Cleared Jun 08, 2023
Acumen Hypotension Prediction Index (HPI) Algorithm
K230057 · QAQ
Edwards Lifesciences, LLC
Cardiovascular · 150d
Cleared Jun 08, 2023
Ablamap® System
K230008 · DQK
Ablacon, Inc.
Cardiovascular · 156d
Cleared Jun 08, 2023
AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub
K223918 · DQK
Philips Medical Systems Nederland B.V.
Cardiovascular · 161d
Cleared Jun 08, 2023
SNUCONE Tissue Level Implant System
K222792 · DZE
Snucone Co., Ltd.
Dental · 265d
Cleared Jun 08, 2023
SIDDHARTH-II
K222762 · IYE
Panacea Medical Technologies Pvt. , Ltd.
Radiology · 268d
Cleared Jun 08, 2023
XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System,...
K222684 · NKB
Stryker Spine
Orthopedic · 275d
Cleared Jun 08, 2023
Irreversible Electroporation Ablation Generator, Irreversible Electroporation...
K222001 · OAB
Zhejiang Curaway Medical Technology...
General & Plastic Surgery · 336d
Cleared Jun 08, 2023
AlloX2 Pro Tissue Expanders
K214124 · LCJ
Sientra, Inc.
General & Plastic Surgery · 525d
Cleared Jun 07, 2023
Intimate Rose Vaginal Dilators
K231430 · HDX
Plus EV Holdings Dba Intimate Rose
Obstetrics & Gynecology · 21d
Cleared Jun 07, 2023
Ambra PACS
K231360 · LLZ
Dicom Grid Dba Ambra Health
Radiology · 28d
Cleared Jun 07, 2023
Fix2Lock(PEEK Self Punching)
K231322 · MBI
Osteonic Co., Ltd.
Orthopedic · 30d
Cleared Jun 07, 2023
C350/C350G LCD Monitor
K231170 · PGY
Nanjing Jusha Display Technology Co.,...
Radiology · 43d
Cleared Jun 07, 2023
Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot...
K231002 · MBI
Suzhou Endophix Co., Ltd.
Orthopedic · 61d
Cleared Jun 07, 2023
HyperVue™ Imaging System
K230691 · NQQ
Spectrawave, Inc.
Cardiovascular · 86d
Cleared Jun 07, 2023
BD BBL™ Sensi-Disc™ Lefamulin 20µg (LMU-20)
K230651 · JTN
Becton, Dickinson and Company
Microbiology · 90d
Cleared Jun 07, 2023
AETOS Shoulder System
K230572 · KWS
Smith & Nephew, Inc.
Orthopedic · 98d
Cleared Jun 07, 2023
TiLink-L SI Joint Fusion System
K230446 · OUR
SurGenTec, LLC
Orthopedic · 106d
Cleared Jun 07, 2023
Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide...
K230381 · PSW
Cs Medical, LLC
General Hospital · 114d
Cleared Jun 07, 2023
Xenco Medical InterAlign Cervical Interbody System
K223059 · OVE
Xenco Medical, LLC
Orthopedic · 250d
Cleared Jun 07, 2023
Infrared Thermometer
K222248 · FLL
Alicn Medical (Shenzhen), Inc.
General Hospital · 316d
Cleared Jun 07, 2023
Fenom Pro
K213611 · MXA
Caire Diagnostics, Inc.
Chemistry · 569d
Cleared Jun 07, 2023
STA R Max 3, STA Compact Max 3
K212183 · JPA
Diagnostica Stago S.A.S
Hematology · 694d