FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
16561–16584 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared CT Aug 05, 2021
NeuroSENSE Monitoring System, Model NS-901
K202621 · OLW
Neurowave Systems, Inc.
Anesthesiology · 329d
Cleared Aug 05, 2021
Biomet Microfixation OmniMax MMF System
K202969 · JEY
Biomet Microfixation
Dental · 309d
Cleared Aug 05, 2021
R2 Dermabrasion Tip (for Dermal Cooling System)
K203006 · QPZ
R2 Technologies, Inc.
General & Plastic Surgery · 308d
Cleared Aug 05, 2021
TRACOE vario
K203362 · JOH
Tracoe Medical GmbH
Anesthesiology · 262d
Cleared Aug 05, 2021
Harmony Latex Dam, Harmony Non-Latex Dam
K203727 · MSC
Pamco Distributing, Inc.
Obstetrics & Gynecology · 227d
Cleared Aug 05, 2021
AcQMap High Resolution Imaging and Mapping System
K210680 · DQK
Acutus Medical, Inc.
Cardiovascular · 150d
Cleared Aug 05, 2021
Disposable Medical Nitrile Examination Gloves (Non-Sterile)
K211075 · LZA
Jiangsu Cherish Medical Technology...
General Hospital · 115d
Cleared Aug 05, 2021
Lateral Spine Truss System (LSTS) Interbody Fusion Device
K211388 · MAX
4Web Medical, Inc.
Orthopedic · 92d
Cleared Aug 05, 2021
Nitrile Patient Examination Gloves
K211434 · LZA
Zhangjiagang Huayuan Protective...
General Hospital · 87d
Cleared Aug 05, 2021
Disposable Nitrile Medical Examination Glove (Tested for Use with...
K211608 · LZA
Jiangsu Cureguard Glove Co., Ltd.
General Hospital · 72d
Cleared Aug 05, 2021
EMPHASYS Femoral Stems
K211657 · LZO
Depuy Ireland UC
Orthopedic · 69d
Cleared Aug 05, 2021
SelectFlex Neurovascular Access System Family
K211893 · QJP
Q'Apel Medical, Inc.
Neurology · 45d
Cleared Aug 04, 2021
Atlas One Step hCG Urine Pregnancy Test (Strip), Atlas One Step hCG Urine...
K203246 · LCX
Atlas Link Technology Co., Ltd.
Chemistry · 273d
Cleared Aug 04, 2021
DESS Dental Smart Solutions
K203464 · NHA
Terrats Medical SL
Dental · 253d
Cleared Aug 04, 2021
Disposable Surgical Face Mask
K210643 · FXX
Shandong Zhushi Pharmaceutical Group...
General Hospital · 154d
Cleared Aug 04, 2021
V12 PRO
K210913 · IRP
Slk Medical GmbH
Physical Medicine · 128d
Cleared Aug 04, 2021
Tigon Medical Button System
K211049 · MBI
Tigon Medical
Orthopedic · 118d
Cleared CT Aug 04, 2021
PrevisEA Device
K211068 · DQD
Entac Medical, Inc.
Gastroenterology & Urology · 114d
Cleared Aug 04, 2021
Alpha Vent PEEK Suture Anchor
K211502 · MBI
Stryker Endoscopy
Orthopedic · 82d
Cleared Aug 04, 2021
Tecomet Global Unite Short Stem Instrumentation
K211553 · PHX
Symmetry Medical Manufacturing Inc....
Orthopedic · 77d
Cleared Aug 04, 2021
Nitrile Exam Gloves, Powder Free,Blue (Tested for Use with Chemotherapy)
K211714 · LZA
Hengchang (Dongying) Medical...
General Hospital · 62d
Cleared Aug 04, 2021
Ultrasonic Bipolar Generator USG-410 with accessories
K211838 · LFL
Olympus Medical Systems Corporation
General & Plastic Surgery · 51d
Cleared Aug 04, 2021
Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR
K212056 · LNH
Canon Medical Systems Corporation
Radiology · 34d
Cleared Aug 03, 2021
PTA Balloon Catheter (PVQ), MIT PTA Balloon Catheter (PVQ)
K201246 · LIT
Qualimed USA, LLC
Cardiovascular · 452d