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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

40 results for "Regulatory Insight, Inc."
25–40 of 40
Search insights Median review: 143d Cleared: 100% Top manufacturer: Erchonia Corporation Lead specialty: Physical Medicine
Cleared Aug 30, 2018
Anchor plate
K173623 · OAT
Biomaterials Korea, Inc.
Dental · 279d
Cleared Jul 18, 2018
Ultra Facial Toning System
K181062 · NFO
Micro Current Technology, Inc.
Neurology · 86d
Cleared Jul 11, 2018
Intelli-C
K173631 · OWB
Nrt X-Ray A/S
Radiology · 229d
Cleared Jun 15, 2018
Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro...
K170835 · EGJ
Hightech Development
Physical Medicine · 452d
Cleared May 21, 2018
Erchonia FX-635
K180197 · NHN
Erchonia Corporation
Physical Medicine · 117d
Cleared Feb 09, 2018
Southern Implants PEEK Abutments
K172160 · NHA
Southern Implants (Pty), Ltd.
Dental · 206d
Cleared Jan 13, 2018
MR4 Laser
K171354 · NHN
Multi Radiance Medical
Physical Medicine · 249d
Cleared Dec 16, 2016
Zerona Z6 OTC
K162578 · OLI
Erchonia Corporation
General & Plastic Surgery · 92d
Cleared Feb 18, 2016
Erchonia EVRL
K152196 · NHN
Erchonia Corporation
Physical Medicine · 197d
Cleared Jan 04, 2016
Erchonia PL Touch
K153052 · NHN
Erchonia Corporation
Physical Medicine · 76d
Cleared May 21, 2015
Erchonia Zerona 6 headed scanner EZ6
K150446 · OLI
Erchonia Corporation
General & Plastic Surgery · 90d
Cleared Jan 15, 2015
Erchonia Zerona Z6 OTC
K143007 · OLI
Erchonia Corporation
General & Plastic Surgery · 87d
Cleared Sep 10, 2014
KEGEL SMART, KEGELSMART PEARL
K140780 · HIR
Regulatory Insight, Inc.
Gastroenterology & Urology · 166d
Cleared Apr 06, 2012
ETHEREA
K112505 · GEX
Regulatory Insight, Inc.
General & Plastic Surgery · 220d
Cleared Mar 08, 2002
SL 803, SL 804, SL 807, SL 809, SL 506, SL 501, SL 805 AND SL 801 MECHANICAL...
K020100 · IOR
Regulatory Insight, Inc.
Physical Medicine · 56d
Cleared Mar 08, 2002
EN 600-658, EN 600-666, EN 600-664, EN 600-690, EN 600-651, EN 600-663, EN...
K020094 · IOR
Regulatory Insight, Inc.
Physical Medicine · 56d