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
505–528 of 1,922
Search insights Median review: 132d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
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
Cleared Jun 05, 2026
OsteoCool™ RF Ablation System
K253656 · GEI
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 197d
Cleared Jun 05, 2026
Digital C-ARM with 3D
K253296 · OXO
Allengers Medical Systems Limited
Radiology · 249d
Cleared Jun 05, 2026
Catalyze
K253204 · KGN
BioTissue Holdings, Inc.
General & Plastic Surgery · 252d
Cleared Jun 05, 2026
Temperature probes (T2252-PG)
K253162 · FLL
Unimed Medical Supplies, Inc.
General Hospital · 252d
Cleared Jun 05, 2026
VEOFIX Snap Off Screw
K253108 · HWC
Steps Ortho
Orthopedic · 254d
Cleared Jun 05, 2026
Alma TED+ System
K251684 · OAP
Alma Lasers, Inc.
General & Plastic Surgery · 368d
Cleared Jun 05, 2026
iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma...
K243192 · LPH
Nextstep Arthopedix, LLC
Orthopedic · 613d
Cleared Jun 04, 2026
Sonio Suspect
K261519 · POK
Sonio
Radiology · 28d