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"
25–48 of 270
Search insights Median review: 91d Cleared: 100% Top manufacturer: Empi Lead specialty: Orthopedic
Cleared Mar 24, 2025
Innovasis Navigation Instruments
K250182 · OLO
Innovasis, Inc.
Orthopedic · 61d
Cleared Mar 20, 2025
Tesera-k PL System and Tesera-k XL System
K242771 · MAX
Kyocera Medical Technologies, Inc.
Orthopedic · 188d
Cleared Mar 14, 2025
NEXXT MATRIXX® SI System
K243838 · OUR
Nexxt Spine
Orthopedic · 91d
Cleared Jan 24, 2025
AxCess® Expandable Interbody System
K243739 · MAX
Elliquence, LLC
Orthopedic · 51d
Cleared Dec 24, 2024
Insulin Syringes
K242434 · FMF
Chirana T. Injecta
General Hospital · 130d
Cleared Dec 17, 2024
Reform Pedicle Screw System
K242297 · NKB
Precision Spine, Inc.
Orthopedic · 137d
Cleared Nov 07, 2024
Vertiwedge® Intraosseous System
K241468 · MQP
Foundation Surgical Group, Inc.
Orthopedic · 167d
Cleared Nov 05, 2024
Skyway Anterior Cervical Plate System
K243015 · KWQ
Kyocera Medical Technologies, Inc.
Orthopedic · 39d
Cleared Oct 04, 2024
BPS Wrist Fracture System
K242343 · HRS
Orthonovis, Inc.
Orthopedic · 58d
Cleared Oct 02, 2024
Interwedge® Standalone Lateral
K241487 · OVD
Foundation Surgical Group, Inc.
Orthopedic · 131d
Cleared Jun 14, 2024
INNOVERSE Navigation Instruments
K241082 · OLO
Innosys Co., Ltd.
Orthopedic · 56d
Cleared May 03, 2024
CORUS Navigation Access System
K240625 · OLO
Providence Medical Technology, Inc.
Orthopedic · 58d
Cleared Apr 04, 2024
TRIBRID® Unicompartmental Knee System
K232114 · HSX
Kyocera Medical Technologies, Inc.
Orthopedic · 265d
Cleared Feb 29, 2024
Accu-Joint Hemi Implant
K240268 · KWD
Accufix Surgical, Inc.
Orthopedic · 29d
Cleared Dec 08, 2023
F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and...
K231743 · MAX
Corelink, LLC
Orthopedic · 177d
Cleared Oct 27, 2023
CoreLink Robotic Navigation Instruments
K231494 · OLO
Corelink, LLC
Orthopedic · 157d
Cleared Sep 28, 2023
Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion...
K232605 · OUR
Lesspine Innovations
Orthopedic · 31d
Cleared Sep 12, 2023
Skyway Anterior Cervical Plate System
K231766 · KWQ
Kyocera Medical Technologies Inc. (KMTI)
Orthopedic · 88d
Cleared Aug 16, 2023
CoreLink Navigation Instruments
K232116 · OLO
Corelink, LLC
Orthopedic · 30d
Cleared Aug 14, 2023
SPICCA Stand-Alone Cervical Fusion Cages
K230608 · OVE
Southern Medical (Pty) , Ltd.
Orthopedic · 164d
Cleared Jul 28, 2023
SI-Cure Sacroiliac Joint Fusion System
K231951 · OUR
Alevio, LLC
Orthopedic · 28d
Cleared Jul 12, 2023
NanoHive Medical Lumbar Interbody System
K231241 · MAX
NanoHive Medical, LLC
Orthopedic · 75d
Cleared Jun 27, 2023
RI.KNEE Adjustable Tibia Cut Guide
K230876 · OLO
Enztec Limited
Orthopedic · 89d
Cleared May 25, 2023
S-COMP Reform® POCT Navigation Instruments
K231229 · OLO
Precision Spine, Inc.
Orthopedic · 27d