FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

224 results for "Empi"
145–168 of 224
Search insights Median review: 90d Cleared: 100% Top manufacturer: Empi Lead specialty: Orthopedic
Cleared Feb 23, 2018
Cavetto-SA Cervical Cage System
K173077 · OVE
Neurostructures, Inc.
Orthopedic · 147d
Cleared Jun 28, 2016
Gibralt® Spine System and Gibralt® Occipital Spine System
K160697 · NKG
Exactech, Inc.
Orthopedic · 106d
Cleared May 28, 2015
Ascendant TM Cervical Spacer System
K150130 · ODP
Exactech, Inc.
Orthopedic · 127d
Cleared May 11, 2015
The Octane Straight Intervertebral Fusion Device, Ti Coated
K150152 · MAX
Exactech, Inc.
Orthopedic · 108d
Cleared Feb 27, 2015
Exactech Ambassador
K143576 · KWQ
Exactech, Inc.
Orthopedic · 72d
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