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
8833–8856 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 25, 2023
BeneHold™ Surgical Incise Drape with CHG antimicrobial II
K230645 · KKX
Avery Dennison Medical , Ltd.
General Hospital · 231d
Cleared Oct 25, 2023
K3900 Ultrasound Imaging System
K230511 · IYO
Maui Imaging
Radiology · 243d
Cleared Oct 25, 2023
Penumbra LP Coil System
K230284 · HCG
Penumbra, Inc.
Neurology · 265d
Cleared Oct 25, 2023
VVR Generator system
K222997 · GEI
Starmed Co., Ltd.
General & Plastic Surgery · 392d
Cleared Oct 25, 2023
Newclip Patient-matched instrumentation non sterile PSI
K221615 · PBF
Newclip Technics
Orthopedic · 509d
Cleared Oct 25, 2023
UNIdental Symphony Implant System
K221315 · DZE
Unidental Co., Ltd.
Dental · 537d
Cleared Oct 24, 2023
16 Breast Coil
K233348 · MOS
Philips Medical System Nederlands B.V.
Radiology · 25d
Cleared Oct 24, 2023
MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel System
K233185 · GEI
C2dx, Inc.
General & Plastic Surgery · 26d
Cleared Oct 24, 2023
Knotilus+ PEEK Knotless Anchor
K232683 · MBI
Stryker Endoscopy
Orthopedic · 53d
Cleared Oct 24, 2023
FilteredFlo Warming Blankets
K232638 · DWJ
Iob Medical, Inc.
Cardiovascular · 55d
Cleared Oct 24, 2023
Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal System
K232586 · NKB
K&J Consulting Corp.
Orthopedic · 60d
Cleared Oct 24, 2023
Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360...
K232584 · OWQ
Vein 360, LLC
Cardiovascular · 60d
Cleared Oct 24, 2023
Steerant™ Super Stiff Guidewire
K232570 · DQX
Medtronic Vascular
Cardiovascular · 61d
Cleared Oct 24, 2023
Laser Cap, Model: Hat-01
K232356 · OAP
Hubei Yjt Technology Co.,Ltd
General & Plastic Surgery · 78d
Cleared Oct 24, 2023
PlaDuo System
K232223 · GEI
ShenB Co., Ltd.
General & Plastic Surgery · 90d
Cleared Oct 24, 2023
REUNION Sacroiliac Joint Fusion System
K232211 · OUR
Astura Medical
Orthopedic · 90d
Cleared Oct 24, 2023
spineEOS
K232086 · LLZ
Eos Imaging
Radiology · 103d
Cleared Oct 24, 2023
VISULAS green
K232051 · HQF
Carl Zeiss Meditec
Ophthalmic · 106d
Cleared Oct 24, 2023
Aco Apache Ultrasound System
K231509 · IYN
Aco Healthcare Co., Ltd.
Radiology · 152d
Cleared Oct 24, 2023
Acumen IQ finger cuff
K230919 · DXN
Edwards Lifesciences, LLC
Cardiovascular · 204d
Cleared Oct 24, 2023
Sonopuls 190
K230472 · IMI
Enraf-Nonius, B.V.
Physical Medicine · 244d
Cleared Oct 23, 2023
Shadow Knotless All-Suture Anchors
K233258 · MBI
Responsive Arthroscopy, LLC
Orthopedic · 25d
Cleared Oct 23, 2023
Ripley Spinal Screw System by SAGICO
K232561 · NKB
Sagico VA USA, LLC
Orthopedic · 60d
Cleared Oct 23, 2023
AI-Rad Companion Brain MR
K232305 · QIH
Siemens Medical Solutions U.S.A.
Radiology · 83d