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"
49–72 of 270
Search insights Median review: 91d Cleared: 100% Top manufacturer: Empi Lead specialty: Orthopedic
Cleared May 02, 2023
CoreLink Navigation Instruments
K230880 · OLO
Corelink, LLC
Orthopedic · 33d
Cleared Apr 28, 2023
INTEGRATE -C Interbody Fusion System
K222004 · ODP
Happe Spine
Orthopedic · 295d
Cleared Mar 21, 2023
Entasis 3D Dual-Lead Sacroiliac Implant System
K223708 · OUR
Corelink, LLC
Orthopedic · 99d
Cleared Feb 13, 2023
Curiteva Porous PEEK Cervical Interbody Fusion System
K213030 · ODP
Curiteva, Inc.
Orthopedic · 510d
Cleared Jan 18, 2023
SI-Cure Sacroiliac Joint Fusion System
K223819 · OUR
Alevio, LLC
Orthopedic · 28d
Cleared Jan 10, 2023
Haymaker® Screw System
K222799 · HWC
Orthocircle Spine D.B.A. OC Medical...
Orthopedic · 116d
Cleared Dec 22, 2022
Tesera-K SC System
K223105 · OVE
Kyocera Medical Technologies, Inc.
Orthopedic · 83d
Cleared Dec 12, 2022
Hive™ Standalone Cervical System
K223190 · OVE
NanoHive Medical, LLC
Orthopedic · 60d
Cleared Dec 08, 2022
Southern Transforaminal Lumbar Interbody Fusion (TLIF)
K221182 · MAX
Southern Medical (Pty) , Ltd.
Orthopedic · 227d
Cleared Oct 26, 2022
Adcura® Sagittae® Lateral Lumbar Interbody Fusion Devices
K223065 · MAX
Adcura, Inc.
Orthopedic · 26d
Cleared Oct 19, 2022
Proximerge 2 Dental Implant System
K211409 · DZE
Quadric Biomed, LLC
Dental · 531d
Cleared Oct 18, 2022
DualXSLIM(R) T/PLIF
K222203 · MAX
Amplify Surgical, Inc.
Orthopedic · 85d
Cleared Oct 14, 2022
Southern Anterior Screw Fixated Cage (SASCA)
K221447 · OVD
Southern Medical (Pty) , Ltd.
Orthopedic · 149d
Cleared Aug 09, 2022
NextGen Pedicle Screw System
K221776 · NKB
Corelink, LLC
Orthopedic · 49d
Cleared Jul 14, 2022
E-GPS Navigated Instruments
K220862 · OLO
Precision Spine, Inc.
Orthopedic · 112d
Cleared Jun 28, 2022
DePuy CONDUIT LLIF SQUID Inserter
K220449 · MAX
Enztec Limited
Orthopedic · 132d
Cleared Jun 15, 2022
MEDOJECT fine Pen Needles
K220614 · FMI
Chirana T. Injecta
General Hospital · 104d
Cleared Jun 01, 2022
CoreLink Navigation Instruments
K220973 · OLO
Corelink, LLC
Orthopedic · 58d
Cleared Apr 01, 2022
Dakota ALIF System
K213118 · OVD
Precision Spine, Inc.
Orthopedic · 186d
Cleared Mar 01, 2022
Blue Topaz Sacroiliac Screw System
K213590 · OUR
Osseus Fusion Systems, LLC
Orthopedic · 109d
Cleared Feb 04, 2022
F3D-C2 Cervical Stand-Alone System
K211417 · OVE
Corelink, LLC
Orthopedic · 273d
Cleared Jan 19, 2022
CoreLink Navigation Instruments
K214059 · OLO
Corelink, LLC
Orthopedic · 23d
Cleared Jan 18, 2022
CHIRANA Insulin Syringes
K201044 · FMF
Chirana T. Injecta
General Hospital · 637d
Cleared Jan 07, 2022
Tesera-k ALIF System
K212980 · OVD
Kyocera Medical Technologies, Inc.
Orthopedic · 112d