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
4225–4248 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 17, 2025
DOC Band 3D
K244056 · OAN
Cranial Technologies, Inc.
Neurology · 76d
Cleared Mar 17, 2025
Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire)
K243869 · OBP
The Magstim Company Limited
Neurology · 90d
Cleared Mar 17, 2025
LAGIS Suction Irrigation System
K243867 · GCJ
Lagis Enterprise Co., Ltd.
General & Plastic Surgery · 90d
Cleared Mar 17, 2025
LVivo Software Application
K243862 · QIH
Dia Imaging Analysis, Ltd.
Radiology · 91d
Cleared Mar 17, 2025
aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior...
K243802 · OVD
Carlsmed, Inc.
Orthopedic · 96d
Cleared Mar 17, 2025
Ziehm Solo FD
K243646 · OWB
Ziehm Imaging GmbH
Radiology · 111d
Cleared Mar 17, 2025
MAIA (AHMACME001)
K243504 · MYC
Centervue S.P.A.
Ophthalmic · 125d
Cleared Mar 17, 2025
Air Compression Leg Massager (K-705)
K242140 · IRP
Jiale Health Technology Shenzhen Co.,...
Physical Medicine · 238d
Cleared Mar 17, 2025
SERV MEDICAL CDSS
K241975 · LLZ
Serv Medical Pte., Ltd.
Radiology · 255d
Cleared Mar 16, 2025
Catapult Guide Sheath
K250439 · DYB
Contract Medical International, GmbH
Cardiovascular · 30d
Cleared Mar 14, 2025
Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor
K250526 · MAI
Arthrex, Inc.
Orthopedic · 18d
Cleared Mar 14, 2025
AION TempShield™
K250401 · FLL
Aion Biosystems, Inc.
General Hospital · 30d
Cleared Mar 14, 2025
Visalys® Bulk Fill 1 x 4 g Syringe (15060)
K250267 · EBF
Kettenbach GmbH & Co. KG
Dental · 43d
Cleared Mar 14, 2025
KOROT Blood Pressure Monitor (KOROT P3 Accurate)
K250091 · DXN
Korot Co., Ltd.
Cardiovascular · 59d
Cleared Mar 14, 2025
Ruby XL System
K250079 · KRD
Penumbra, Inc.
Cardiovascular · 60d
Cleared Mar 14, 2025
Porcelain Powder (Enamel/ Modifier,Stain/Glaze,Stain/Glaze-A,Modeling Fluid )
K250025 · EIH
Aidite (Qinhuangdao) Technology Co.,...
Dental · 67d
Cleared Mar 14, 2025
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B...
K243931 · OZE
Centers For Disease Control and...
Microbiology · 84d
Cleared Mar 14, 2025
NEXXT MATRIXX® SI System
K243838 · OUR
Nexxt Spine
Orthopedic · 91d
Cleared Mar 14, 2025
Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818)
K243599 · FOZ
Arrow International, LLC (A...
General Hospital · 113d
Cleared Mar 14, 2025
Solution Administration Sets
K243529 · FPA
Baxter Healthcare Corporation
General Hospital · 120d
Cleared Mar 14, 2025
One-Fil Putty
K243353 · KIF
Mediclus Co., Ltd.
Dental · 136d
Cleared Mar 14, 2025
Promisemed Safety Huber Needles
K243332 · PTI
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 141d
Cleared Mar 14, 2025
BodyTom 64
K242811 · JAK
Neurologica Corporation, A Subsidiary...
Radiology · 177d
Cleared Mar 14, 2025
Maestro System (REF100)
K242323 · QZB
Moon Surgical
General & Plastic Surgery · 220d