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
1369–1392 of 1,642
Search insights Median review: 137d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Feb 06, 2026
Stainless Steel Surgical Kits
K251614 · KCT
Dentsply Sirona, Inc.
General Hospital · 255d
Cleared Feb 06, 2026
LAIA XR
K251577 · LLZ
Augmented Reality Software S.L.
Radiology · 260d
Cleared Feb 06, 2026
Atellica® IM TSH3-Ultra II (TSH3ULII)
K251543 · JLW
Siemens Healthcare Diagnostics, Inc.
Chemistry · 262d
Cleared Feb 06, 2026
INTEGRE LIO
K251507 · HQF
Quantel Medical
Ophthalmic · 266d
Cleared Feb 06, 2026
Median LCS (internal name) / eyonis LCS (trade name) (1.0)
K251474 · QDQ
Median Technologies
Radiology · 269d
Cleared Feb 06, 2026
Spectra S1 Pro
K251423 · HGX
Uzinmedicare Co., Ltd.
Obstetrics & Gynecology · 274d
Cleared Feb 06, 2026
SafeBeat Rx App
K251218 · DQK
Safebeat Rx, Inc.
Cardiovascular · 291d
Cleared Feb 06, 2026
Aptiva APS IgA Reagent
K243979 · MSV
Inova Diagnostics, Inc.
Immunology · 410d
Cleared Feb 06, 2026
Athelas Home
K243348 · GKZ
Athelas, Inc.
Hematology · 466d
Not Cleared Feb 06, 2026
Amferia Wound Dressing
DEN250006 · SHA
Amferia AB
General & Plastic Surgery · 340d
Cleared Feb 05, 2026
CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with...
K260028 · QEW
Argon Medical Devices, Inc.
Cardiovascular · 31d
Cleared Feb 05, 2026
Primevision 3D
K253959 · OAS
Dentsply Sirona
Radiology · 57d
Cleared Feb 05, 2026
SIGNA™ Sprint Select
K253779 · LNH
Ge Medical Systems, LLC
Radiology · 71d
Cleared Feb 05, 2026
INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK
K251949 · QEW
Penumbra, Inc.
Cardiovascular · 225d
Cleared Feb 05, 2026
Encora X1
K251517 · QBC
Encora, Inc.
Neurology · 265d
Cleared Feb 04, 2026
Signature™ ONE System
K260104 · QHE
Orthosoft Inc. (d/b/a) Zimmer CAS
Orthopedic · 22d
Cleared Feb 04, 2026
E3D™-C Interbody System
K260038 · OVE
Evolution Spine
Orthopedic · 29d
Cleared Feb 04, 2026
UltraScore™ Focused Force PTA Balloon
K260012 · PNO
Bard Peripheral Vascular, Inc.
Cardiovascular · 30d
Cleared Feb 04, 2026
G7® Revision Acetabular System
K252623 · LPH
Zimmer, Inc.
Orthopedic · 169d
Cleared Feb 04, 2026
Henan Yadu Level 4 Surgical Gowns (Reinforced)
K252301 · FYA
Yadu Medical (Henan) Co., Ltd.
General Hospital · 195d
Cleared Feb 04, 2026
Luna® Ti Interbody Fusion System
K250773 · MAX
Spinal Elements, Inc.
Orthopedic · 327d
Cleared Feb 03, 2026
Dexcom G7 Continuous Glucose Monitoring (CGM) System
K253737 · QBJ
Dexcom, Inc.
Chemistry · 71d
Cleared Feb 03, 2026
SmartGuard Technology
K253701 · QJI
Medtronic Minimed
Chemistry · 71d
Cleared Feb 03, 2026
T2 Alpha Femur Retrograde Nailing System
K253640 · HSB
Stryker GmbH
Orthopedic · 76d