FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

53 results for "Regulatory Insight, Inc."
25–48 of 53
Search insights Median review: 143d Cleared: 100% Top manufacturer: Erchonia Corporation Lead specialty: Physical Medicine
Cleared Jun 01, 2019
Erchonia FX-635
K190572 · NHN
Erchonia Corporation
Physical Medicine · 87d
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 13, 2017
Prodigio Stain Powder
K171167 · EIH
Operart, LLC
Dental · 236d
Cleared May 19, 2017
MICRORUPTOR 6
K160677 · GEX
Meridian AG
General & Plastic Surgery · 435d
Cleared Jan 13, 2017
LELO RESPECT HEX Natural Rubber Latex Condom
K162511 · HIS
Lelo, Inc.
Obstetrics & Gynecology · 127d
Cleared Dec 16, 2016
Zerona Z6 OTC
K162578 · OLI
Erchonia Corporation
General & Plastic Surgery · 92d
Cleared Jun 30, 2016
Lelo Hex Natural Rubber Latex Condom
K160644 · HIS
Lelo, Inc.
Obstetrics & Gynecology · 115d
Cleared Jun 03, 2016
LunulaLaser
K153164 · PDZ
Erchonia Medical, Inc.
General & Plastic Surgery · 214d
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 Oct 23, 2015
FEMTO LDV Z8 Surgical Laser
K150323 · OOE
Sie Ag,Surgical Instrument Engineering
Ophthalmic · 256d
Cleared Oct 20, 2015
Palm TENS
K150308 · NUH
Heat IN A Click, LLC
Neurology · 253d
Cleared Oct 14, 2015
Megasorb, Mitsu, Mitsu FST, Filaxyn, Filapron
K150717 · GAM
M/s. Meril Endo Surgery Private Limited.
General & Plastic Surgery · 209d
Cleared Aug 06, 2015
VIKINI Diode Laser System
K151232 · GEX
Ilooda Co,., Ltd.
General & Plastic Surgery · 90d
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 Jan 13, 2015
3B Laser 500, 3B Laser 200, LA-X P 500, LA-X P 200
K142722 · ILY
Livetec GmbH
Physical Medicine · 112d
Cleared Dec 15, 2014
BBS REVOLUTION
K142329 · IYO
Dbmedx, Inc.
Radiology · 117d