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"
121–144 of 270
Search insights Median review: 91d Cleared: 100% Top manufacturer: Empi Lead specialty: Orthopedic
Cleared Jun 12, 2019
Lateral Plate System
K190016 · KWQ
Corelink, LLC
Orthopedic · 160d
Cleared Jun 10, 2019
SPINEART Navigation Instrument System
K183630 · OLO
Spineart SA
Orthopedic · 166d
Cleared May 29, 2019
Revolution External Plating System
K181630 · KTT
New Standard Device Dba Metalogix
Orthopedic · 343d
Cleared Mar 22, 2019
OsteoCentric Bone Plate and Screw System
K190430 · HWC
Osteocentric Trauma
Orthopedic · 28d
Cleared Mar 04, 2019
SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices
K190193 · MAX
Spineex, Inc.
Orthopedic · 28d
Cleared Jan 08, 2019
Choice Spine Navigation System
K182721 · OLO
Choicespine, LP
Orthopedic · 102d
Cleared Dec 10, 2018
Mega Plus Spine System
K183080 · NKB
Bk Meditech, Co., Ltd.
Orthopedic · 35d
Cleared Nov 26, 2018
TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws
K182346 · MBH
Exactech, Inc.
Orthopedic · 90d
Cleared Nov 09, 2018
Arco™-SA Lumbar Cage System
K182195 · OVD
Neurostructures, Inc.
Orthopedic · 87d
Cleared Nov 08, 2018
Neurostructures Cavetto® [MAX] Cervical Cage System
K181590 · ODP
Neurostructures, Inc.
Orthopedic · 143d
Cleared Oct 25, 2018
SMV Scientific K-Wire and Pins
K182171 · JDW
Summit Medventures
Orthopedic · 76d
Cleared Oct 05, 2018
SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices
K181531 · MAX
Spineex, Inc.
Orthopedic · 116d
Cleared Oct 03, 2018
Outlet Sacroiliac Joint Fusion System
K181881 · OUR
Sij Surgical
Orthopedic · 82d
Cleared Sep 27, 2018
DualX
K181397 · MAX
Innovasive, Inc.
Orthopedic · 121d
Cleared Sep 20, 2018
Chiral Surgical Pedicle Screw System
K181995 · NKB
Chiral Surgical
Orthopedic · 56d
Cleared Aug 10, 2018
CoreLink® M3™ Stand-Alone Anterior Lumbar System
K180814 · OVD
Corelink, LLC
Orthopedic · 134d
Cleared Jul 13, 2018
Viking Lumbar Polyaxial Screw System
K180655 · NKB
Presidio Surgical
Orthopedic · 122d
Cleared Jul 11, 2018
ROCCIA ALIF, ROCCIA TLIF
K180963 · MAX
Silony Medical GmbH
Orthopedic · 90d
Cleared Jun 13, 2018
Atlas Spine Expandable Cervical Interbody System
K180675 · ODP
Atlas Spine, Inc.
Orthopedic · 90d
Cleared May 08, 2018
A-CIFT SoloFuse
K172484 · OVE
Spinefrontier, Inc.
Orthopedic · 264d
Cleared Apr 11, 2018
Reform® POCT System
K172495 · NKG
Precision Spine, Inc.
Orthopedic · 236d
Cleared Mar 29, 2018
Arco™-SA Lumbar Cage System
K173082 · OVD
Neurostructures, Inc.
Orthopedic · 181d
Cleared Mar 15, 2018
Mega Plus Spine System
K173180 · NKB
Bk Meditech, Co., Ltd.
Orthopedic · 167d
Cleared Mar 08, 2018
ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws,...
K171320 · HRS
Meril Healthcare Pvt. , Ltd.
Orthopedic · 308d