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"
193–216 of 270
Search insights Median review: 91d Cleared: 100% Top manufacturer: Empi Lead specialty: Orthopedic
Cleared Feb 12, 2015
PedFuse Pedicle Screw System
K143377 · MNH
Spinefrontier, Inc.
Orthopedic · 79d
Cleared Dec 19, 2014
Reform Pedicle Screw System
K143248 · NKB
Precision Spine, Inc.
Orthopedic · 37d
Cleared Dec 18, 2014
Interspinous Plate System
K142378 · PEK
Precision Spine, Inc.
Orthopedic · 114d
Cleared May 06, 2013
EMPI PHOENIX
K124016 · IPF
Djo, LLC
Physical Medicine · 130d
Cleared Jun 10, 2011
EMPIRA RX PTCA DILATATION CATHETER, EMPRIA NC RX PTCA DILATATION CATHETER
K110133 · LOX
Creganna-Tactx Medical
Cardiovascular · 143d
Cleared Sep 21, 2010
EXACTECH NOVATION EMPIRE ACETABULAR AUGMENT WITH INTEGRIP MODEL...
K101761 · LPH
Exactech, Inc.
Orthopedic · 90d
Cleared Mar 05, 2010
EMPI CONTINUUM
K093324 · IPF
Empi
Physical Medicine · 133d
Cleared Jun 05, 2009
EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATOR
K090922 · GZJ
Empi
Neurology · 65d
Cleared Nov 16, 2007
HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEM
K072946 · EGJ
Empi
Physical Medicine · 30d
Cleared May 14, 2007
DUPEL TRANSPORT IONTOPHORESIS SYSTEM
K070427 · EGJ
Empi
Physical Medicine · 90d
Cleared Jan 22, 2007
SELECT TENS, MODEL 4600S
K061650 · GZJ
Empi
Neurology · 223d
Cleared Jan 25, 2006
ENCOMPASS.NET
K053455 · LLZ
Empiric Systems, LLC
Radiology · 47d
Cleared Jan 21, 2005
INFINITY PLUS ELECTROTHERAPY SYSTEM
K041920 · IPF
Empi
Physical Medicine · 189d
Cleared Dec 17, 2004
INFINITY ELECTROTHERAPY SYSTEM
K042057 · LIH
Empi
Neurology · 140d
Cleared Apr 08, 2003
EMPI ACTION PATCH IONTOPHORESIS SYSTEM
K030395 · EGJ
Empi
Physical Medicine · 62d
Cleared Jun 18, 2002
300 PV COMPLETE ELECTROTHERAPY SYSTEM
K021100 · IPF
Empi
Physical Medicine · 75d
Cleared Dec 21, 2000
EMPIRE N BLOOD PRESSURE MANOMETERS
K002955 · DXQ
Rudolf Riester GmbH & Co. KG
Cardiovascular · 90d
Cleared Sep 10, 1999
DUPEL IONTOPHORESIS SYSTEM
K991991 · EGJ
Empi
Physical Medicine · 88d
Cleared Dec 28, 1998
DUPEL B.L.U.E. SMALL IONTOPHORESIS ELECTRODE
K983484 · EGJ
Empi
Physical Medicine · 84d
Cleared Nov 03, 1998
SMALL VAGINAL/RECTAL ELECTRODE
K983206 · KPI
Empi
Gastroenterology & Urology · 50d
Cleared Aug 14, 1997
INNOVA RECTAL REUSABLE ELECTRODE/COMFORTPULSE REGULAR OR SMALL REUSABLE...
K972054 · KPI
Empi
Gastroenterology & Urology · 73d
Cleared Jun 30, 1997
INNOSENSE PELVIC FLOOR STIMULATION AND ELECTROMYOGRAPHY SYSTEM
K971527 · KPI
Empi
Gastroenterology & Urology · 63d
Cleared May 30, 1997
DUPEL II BUFFERED IONTOPHORESIS ELECTRODES
K970491 · EGJ
Empi
Physical Medicine · 109d
Cleared Apr 22, 1997
MINNOVA PELVIC FLOOR STIMULATION SYSTEM
K970307 · KPI
Empi
Gastroenterology & Urology · 85d