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: 2026–2026 ×
1,922 results
481–504 of 1,922
Search insights Median review: 132d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
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
Cleared Jun 09, 2026
TekBrace Solo Soft Tissue Reinforcement Device
K261621 · QUW
Theramicro
Orthopedic · 25d
Cleared Jun 09, 2026
BOBBY Balloon Guide Catheter
K261549 · QJP
MicroVention, Inc., d/b/a Terumo Neuro
Neurology · 29d
Cleared Jun 09, 2026
Mother's Nature W1 Warming Wearable Breast Pump
K260864 · HGX
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 84d
Cleared Jun 09, 2026
Materialise Shoulder System™, Materialise Shoulder Guide and Models,...
K260802 · QHE
Materialise NV
Orthopedic · 90d
Cleared Jun 09, 2026
ES-Series
K260748 · IYN
E-Scopics
Radiology · 95d
Cleared Jun 09, 2026
DESS Dental Smart Solutions
K260564 · NHA
Terrats Medical SL
Dental · 110d
Cleared Jun 09, 2026
LAP-iX2N
K253165 · GEI
Sejong Medical Co., Ltd.
General & Plastic Surgery · 256d
Cleared Jun 09, 2026
Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)
K252914 · NUC
Hathor Professional Skincare , Ltd.
Obstetrics & Gynecology · 270d