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
10129–10152 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 09, 2023
Renuvion® Micro Handpiece
K230586 · GEI
Apyx Medical Corporation
General & Plastic Surgery · 99d
Cleared Jun 09, 2023
Gamma4 System
K230512 · HSB
Stryker GmbH
Orthopedic · 105d
Cleared Jun 09, 2023
Orthopantomograph™ OP 3D LX
K230505 · OAS
Palodex Group OY
Radiology · 105d
Cleared Jun 09, 2023
Ear Pressure Relief Device(Model:ER813B)
K230502 · MJV
Ningbo Albert Novosino Co., Ltd.
Ear, Nose, Throat · 105d
Cleared Jun 09, 2023
TheraFace Mask
K230293 · OHS
Therabody, Inc.
General & Plastic Surgery · 127d
Cleared Jun 09, 2023
HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted...
K223865 · DQK
Edwards Lifesciences, LLC
Cardiovascular · 168d
Cleared Jun 09, 2023
CT Perfusion V1.0
K223091 · LLZ
Olea Medical
Radiology · 252d
Cleared Jun 09, 2023
LVIS NeuroMatch
K222450 · OMB
LVIS Corporation
Neurology · 298d
Cleared Jun 09, 2023
NovoGen Wound Matrix
K220498 · KGN
Novabone Products, LLC
General & Plastic Surgery · 472d
Cleared Jun 08, 2023
OCD MT Cap (85-00397-000)
K231350 · QCI
Neuronetics
Neurology · 30d
Cleared Jun 08, 2023
Disposable Laparoscopic Trocar
K231042 · GCJ
Changzhou Ankang Medical Instruments...
General & Plastic Surgery · 57d
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