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
217–240 of 1,642
Search insights Median review: 137d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
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
Cleared Jun 09, 2026
ChanPin Pedicle Screw Spinal System
K251251 · NKB
Chanpin Medtak Co., Ltd.
Orthopedic · 412d
Cleared Jun 08, 2026
Dexcom G7 Continuous Glucose Monitoring System
K261402 · QBJ
Dexcom, Inc.
Chemistry · 40d
Cleared Jun 08, 2026
2D Hip Planning Software
K261352 · LLZ
One Ortho
Radiology · 45d
Cleared Jun 08, 2026
EchoNext
K260332 · QXO
Pathwai, Inc.
Cardiovascular · 126d
Cleared Jun 08, 2026
Apollo Quattro (APQ-10M)
K253542 · IPF
Weero Co., Ltd.
Neurology · 206d
Cleared Jun 08, 2026
Virgo Mobility Scooter (Virgo-D,Virgo-F)
K253257 · INI
Jiangsu Intco Medical Products Co., Ltd.
Physical Medicine · 252d
Cleared Jun 08, 2026
ELEOS™ with NanoCept® Technology Limb Salvage System
K253066 · QZZ
Onkos Surgical, Inc.
Orthopedic · 259d
Cleared Jun 08, 2026
Lipocosm Harmonic System
K251944 · QPB
Lipocosm, LLC
General & Plastic Surgery · 349d
Cleared Jun 05, 2026
FieldFlex Steerable Sheath
K261492 · DYB
CenterPoint Systems, LLC
Cardiovascular · 30d
Cleared Jun 05, 2026
APTUS Clavicle System 2.8
K260761 · HRS
Medartis AG
Orthopedic · 88d
Cleared Jun 05, 2026
Fastep COVID-19 Antigen Pen Home Test
K260754 · QYT
Assure Tech., LLC
Microbiology · 88d
Cleared Jun 05, 2026
Vial Adapter
K260301 · LHI
Hangzhou Qiantang Longyue...
General Hospital · 126d
Cleared Jun 05, 2026
Perfect-O Ostial Positioning Catheter
K260289 · DQY
Balosmark, Inc.
Cardiovascular · 127d
Cleared Jun 05, 2026
Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts
K260105 · DXC
Edwards Lifesciences
Cardiovascular · 143d
Cleared Jun 05, 2026
Power Wheelchair (N5515A, N5516, N5517A, N5519)
K260056 · ITI
Zhejiang Innuovo Rehabilitation...
Physical Medicine · 148d
Cleared Jun 05, 2026
EyeBOX SNAP
K254086 · QEA
Oculogica, Inc.
Neurology · 169d