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: 2026–2026 ×
1,642 results
193–216 of 1,642
Search insights Median review: 137d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Jun 11, 2026
Acorn 3D Software (AC-SEG-4009)
K260322 · QIH
Mighty Oak Medical
Radiology · 132d
Cleared Jun 11, 2026
PROBEAT-CR
K260174 · LHN
Hitachi High-Tech Corp.
Radiology · 141d
Cleared Jun 11, 2026
Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)
K254145 · NHA
Smart Denture Conversions, LLC
Dental · 171d
Cleared Jun 11, 2026
MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System
K254087 · KTT
Synthes USA Products, LLC
Orthopedic · 175d
Cleared Jun 11, 2026
Anura Mobile Core SDK (M1)
K253650 · QME
Nuralogix Corporation
Cardiovascular · 203d
Cleared Jun 11, 2026
UNEEG EpiSight System
K253607 · SEM
Uneeg Medical A/S
Neurology · 205d
Cleared Jun 11, 2026
Fluoride Varnish (Type A,Type C)
K253052 · LBH
Nagy Oral Technology Qinhuangdao Co.,...
Dental · 262d
Cleared Jun 11, 2026
i-STAT hs-TnI cartridge with the i-STAT Alinity System
K253051 · MMI
Abbott Point of Care, Inc.
Chemistry · 262d
Cleared Jun 11, 2026
Respiration Rate algorithm
K251326 · BZQ
Edwards Lifesciences, LLC
Anesthesiology · 408d
Cleared Jun 11, 2026
Dental X-ray System
K250839 · OAS
Changzhou Boen Zhongding Medical...
Radiology · 448d
Cleared Jun 11, 2026
AViTA Breast Pump
K250129 · HGX
Avita Corporation
Obstetrics & Gynecology · 510d
Cleared Jun 10, 2026
Intra-Operative Positioning System (IOPS) (MC-1)
K261329 · DQK
Centerline Biomedical
Cardiovascular · 49d
Cleared Jun 10, 2026
RxSight® Insertion Device
K261174 · MSS
Rxsight, Inc.
Ophthalmic · 62d
Cleared Jun 10, 2026
MSS - Humeral reverse liners extension
K261016 · PHX
Medacta International, SA
Orthopedic · 75d
Cleared Jun 10, 2026
Profoject™ Safety Pen Needles
K260855 · FMI
CMT Health PTE., Ltd.
General Hospital · 86d
Cleared Jun 10, 2026
Anteralign LS coverplate
K260810 · OVD
Tyber Medical, LLC
Orthopedic · 90d
Cleared Jun 10, 2026
Tinnitus Therapy
K260614 · KLW
Sivantos GmbH
Ear, Nose, Throat · 105d
Cleared Jun 10, 2026
“Tech-Image” Video Endoscope System
K260414 · GCJ
Tech-Image CO., LTD.
General & Plastic Surgery · 121d
Cleared Jun 10, 2026
Colli-Pee•Dx Urine Collection Kit
K254121 · SIH
DNA Genotek, Inc.
Microbiology · 173d
Cleared Jun 10, 2026
Cryo And Thermo Therapy System
K253919 · IRP
Xiamen Weiyou Intelligent Technology...
Physical Medicine · 184d
Cleared Jun 10, 2026
DeepXray Spina
K253192 · SAO
Alpha Intelligence Manifolds, Inc.
Radiology · 257d
Cleared Jun 10, 2026
LARS ACJ
K253115 · HTN
Movmedix S.A.S.
Orthopedic · 259d
Cleared Jun 10, 2026
Penumbra System (Thunderbolt Aspiration Tubing)
K250690 · NRY
Penumbra, Inc.
Neurology · 460d
Cleared Jun 09, 2026
ERBECRYO 2 Cryosurgical Unit and Accessories
K261806 · GEH
Erbe Elektromedizin GmbH
General & Plastic Surgery · 8d