Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

270 results for "Empi"
1–24 of 270
Search insights Median review: 91d Cleared: 100% Top manufacturer: Empi Lead specialty: Orthopedic
Cleared Jun 26, 2026
VERTICALE® Navigation Instruments
K253921 · OLO
Silony Medical GmbH
Orthopedic · 200d
Cleared Jun 16, 2026
LimiFlex® Dynamic Sagittal Tether Instrument Set
K253374 · SGL
Empirical Spine
Orthopedic · 259d
Cleared May 15, 2026
Varion Thoracolumbar Fixation System
K260989 · NKB
Kyocera Medical Technologies Inc. (KMTI)
Orthopedic · 51d
Cleared Apr 24, 2026
ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System
K260549 · ODP
Zsfab, Inc.
Orthopedic · 65d
Cleared Apr 16, 2026
Foundation Surgical Navigated Lateral Disc Prep Instruments
K260011 · OLO
Foundation Surgical Group, Inc.
Orthopedic · 104d
Cleared Apr 01, 2026
MOD-C
K242303 · ODP
Orthomod, LLC
Orthopedic · 604d
Cleared Feb 23, 2026
Duet™ Spinal Fixation System
K253169 · NKB
Box Spine, LLC
Orthopedic · 150d
Cleared Feb 19, 2026
VERTICALE GPS Instruments
K254148 · OLO
Silony Medical GmbH
Orthopedic · 59d
Cleared Feb 13, 2026
Hive™ Standalone Cervical System and Hive™ C Interbody System
K254105 · ODP
NanoHive Medical, LLC
Orthopedic · 56d
Cleared Feb 03, 2026
Navigation Module of the Cortium® System
K252087 · OLO
Ulrich Medical USA, Inc.
Orthopedic · 216d
Cleared Jan 13, 2026
Swedge™ Pedicle Screw Fixation System Bezier Rod
K252461 · NKB
Spinal Resources, Inc.
Orthopedic · 161d
Cleared Dec 19, 2025
Southern Craniomaxillofacial (CMF) System
K253373 · JEY
Southern Medical (Pty) , Ltd.
Dental · 80d
Cleared Nov 25, 2025
ZSFab Lumbar Interbody System
K252610 · MAX
Zsfab, Inc.
Orthopedic · 99d
Cleared Nov 24, 2025
Dakota LP System
K250769 · ODP
Precision Spine, Inc.
Orthopedic · 256d
Cleared Oct 27, 2025
OsteoCentric Navigated Instruments System
K250520 · OLO
Osteocentric Technologies, Inc.
Orthopedic · 248d
Cleared Aug 27, 2025
ELID (Endoscopic Less Invasive Decompression) System
K243774 · HRX
Lesspine Innovations
Orthopedic · 264d
Cleared Aug 25, 2025
NeuroEars-Anna™
K243709 · GWN
Neuroears, Inc.
Ear, Nose, Throat · 266d
Cleared Jul 30, 2025
CORUS™ Navigation System-GX
K251060 · OLO
Providence Medical Technology, Inc.
Orthopedic · 117d
Cleared Jul 23, 2025
Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the...
K251073 · OLO
Innovasis, Inc.
Orthopedic · 106d
Cleared Jul 01, 2025
Momentum® Posterior Spinal Fixation System
K251719 · NKB
Ulrich Medical USA, Inc.
Orthopedic · 27d
Cleared Jun 12, 2025
OneLIF™ Interbody Fusion System
K251459 · OVD
Novapproach Spine, LLC
Orthopedic · 31d
Cleared Apr 10, 2025
Skyway Anterior Cervical Plate System
K250486 · KWQ
Kyocera Medical Technologies Inc. (KMTI)
Orthopedic · 50d
Cleared Apr 10, 2025
Tesera-k SC System
K242928 · OVE
Kyocera Medical Technologies, Inc.
Orthopedic · 198d
Cleared Apr 10, 2025
Initia T3 Acetabular Hemispherical Shell System
K242045 · LPH
Kyocera Medical Technologies, Inc.
Orthopedic · 272d