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
2065–2088 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 10, 2025
Withings BeamO (SCT02)
K252474 · DPS
Withings
Cardiovascular · 96d
Cleared Nov 10, 2025
Symani Surgical System
K252287 · SAQ
Medical Microinstruments, Inc.
General & Plastic Surgery · 110d
Cleared Nov 10, 2025
IntelliVue Patient Monitor MX750
K251702 · MHX
Philips Medizin Systeme B?blingen GmbH
Cardiovascular · 161d
Cleared Nov 10, 2025
NeVasc Aspiration System
K251006 · NRY
Vesalio, Inc.
Neurology · 223d
Cleared Nov 09, 2025
Lunderquist Extra Stiff Wire Guide
K251596 · DQX
William Cook Europe Aps
Cardiovascular · 166d
Cleared Nov 07, 2025
MultiMatch Flow Chameleon AntiMicrobial Composite
K253513 · EBF
Premier Dental Products Company
Dental · 1d
Cleared Nov 07, 2025
AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA
K253039 · HKX
Topcon Corporation
Ophthalmic · 46d
Cleared Nov 07, 2025
Medical Diode Laser Systems (VeinCure)
K252564 · GEX
Baoding Te'Anzhou Electronic...
General & Plastic Surgery · 85d
Cleared Nov 07, 2025
CO2 Laser Therapy System (K106)
K252519 · GEX
Hebei Keylaser Sci-Tech Co.,Ltd
General & Plastic Surgery · 88d
Cleared Nov 07, 2025
Fibresolve (with PCCP)
K252041 · QWO
Imvaria, Inc.
Radiology · 130d
Cleared Nov 07, 2025
Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER,...
K251853 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 143d
Cleared Nov 07, 2025
Inion CPS 1.5 Baby Bioabsorbable Fixation System
K251441 · JEY
Inion OY
Dental · 182d
Cleared Nov 07, 2025
BrainsWay Deep TMS System
K251391 · OBP
Brainsway , Ltd.
Neurology · 186d
Cleared Nov 07, 2025
ulrichINJECT CT Motion (XD 8000)
K251295 · IZQ
Ulrich GmbH & Co. KG
General Hospital · 196d
Cleared Nov 07, 2025
S.I.N. Tapered Pro Conical Zygoma Implant System
K251129 · DZE
S.I.N. Implant System Ltda
Dental · 210d
Cleared Nov 07, 2025
Electric Wheelchair (Rollz Motion Electric 2M)
K250819 · ITI
Rollz International BV
Physical Medicine · 234d
Cleared Nov 07, 2025
Primeprint Direct Aligner
K250739 · NXC
Dreve Dentamid GmbH
Dental · 241d
Cleared Nov 07, 2025
SugarBug (1.x)
K250264 · MYN
Bench7, Inc.
Radiology · 282d
Cleared Nov 07, 2025
Triathlon Pro
K243131 · NUH
Sigma Biomedical
Neurology · 403d
Cleared Nov 06, 2025
Motive™ Muscle Stimulator for Lower Back (OT01-1003)
K253478 · NGX
Motive Health, Inc.
Physical Medicine · 23d
Cleared Nov 06, 2025
BriefCase-Triage
K253265 · QAS
Aidoc Medical , Ltd.
Radiology · 38d
Cleared Nov 06, 2025
Tandem Mobi insulin pump with interoperable technology
K253074 · QFG
Tandem Diabetes Care, Inc.
Chemistry · 44d
Cleared Nov 06, 2025
Venus Nova (FP-2001)
K252845 · GEI
Venus Concept, Inc.
General & Plastic Surgery · 59d
Cleared Nov 06, 2025
AIO Breathe
K252525 · LRK
Aiomega, LLC
Dental · 87d