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: Cleared only ×
175,230 results
505–528 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 04, 2026
Signature™ ONE System
K261510 · QHE
Orthosoft Inc. (d/b/a) Zimmer CAS
Orthopedic · 28d
Cleared Jun 04, 2026
Spectra Platinum Mini
K260956 · HGX
Uzinmedicare Co., Ltd.
Obstetrics & Gynecology · 73d
Cleared Jun 04, 2026
LIAISON Murex HBsAg Qual
K260770 · LOM
DiaSorin, Inc.
Microbiology · 87d
Cleared Jun 04, 2026
LumiGlam Laser System (SHE-LSP601-3)
K260690 · GEX
Beijing Sano Laser S&T Development...
General & Plastic Surgery · 93d
Cleared Jun 04, 2026
Dental Cone Beam Computed Tomography System
K260662 · OAS
Yofo Medical Technology Co., Ltd.
Radiology · 94d
Cleared Jun 04, 2026
DEEPVESSEL Plaque
K260497 · QIH
Keya Medical Technology Co., Ltd.
Radiology · 111d