FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

253 results for "Empi"
169–192 of 253
Search insights Median review: 90d Cleared: 100% Top manufacturer: Empi Lead specialty: Orthopedic
Cleared Jun 04, 2015
Sure Lok Mini Posterior Cervical/Upper Thoracic System
K150851 · KWP
Precision Spine, Inc.
Orthopedic · 65d
Cleared May 28, 2015
Ascendant TM Cervical Spacer System
K150130 · ODP
Exactech, Inc.
Orthopedic · 127d
Cleared May 13, 2015
SpineFrontier Lumbar Interbody Fusion Device System
K142504 · MAX
Spinefrontier, Inc.
Orthopedic · 250d
Cleared May 11, 2015
The Octane Straight Intervertebral Fusion Device, Ti Coated
K150152 · MAX
Exactech, Inc.
Orthopedic · 108d
Cleared Apr 24, 2015
SpineFrontier SIJFuse Sacroiliac Joint Fusion Device System
K150017 · OUR
Spinefrontier, Inc.
Orthopedic · 109d
Cleared Apr 02, 2015
Reliance Interspinous Plate System
K142217 · PEK
Reliance Medical Systems, LLC
Orthopedic · 233d
Cleared Feb 27, 2015
Exactech Ambassador
K143576 · KWQ
Exactech, Inc.
Orthopedic · 72d
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