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

45 results for "A. Stein - Regulatory Affairs Consulting , Ltd."
25–45 of 45
Search insights Median review: 127d Cleared: 100% Top manufacturer: Inmode MD , Ltd. Lead specialty: General & Plastic Surgery
Cleared Feb 23, 2018
InMode VLaze
K173677 · GEX
Inmode MD , Ltd.
General & Plastic Surgery · 85d
Cleared Dec 08, 2017
InMode PLUS System
K172302 · PBX
Inmode MD , Ltd.
General & Plastic Surgery · 130d
Cleared Oct 10, 2017
InMode RF System
K171593 · GEI
Inmode MD , Ltd.
General & Plastic Surgery · 132d
Cleared Sep 15, 2017
Mazor X
K172522 · OLO
Mazor Robotics , Ltd.
Orthopedic · 25d
Cleared Aug 11, 2017
Silk'n Infinity
K171433 · OHT
Home Skinovations , Ltd.
General & Plastic Surgery · 88d
Cleared Aug 07, 2017
InMode Diolaze XL
K170738 · GEX
Inmode MD , Ltd.
General & Plastic Surgery · 150d
Cleared Apr 04, 2017
Mazor X
K163221 · OLO
Mazor Robotics , Ltd.
Orthopedic · 139d
Cleared Feb 02, 2017
Titan 3W
K160835 · INI
Tzora Active Systems , Ltd.
Physical Medicine · 314d
Cleared Dec 12, 2016
InMode RF System
K163190 · GEI
Inmode MD , Ltd.
General & Plastic Surgery · 28d
Cleared Aug 19, 2016
InMode System MiniFX Handpiece
K160329 · PBX
Inmode MD , Ltd.
General & Plastic Surgery · 196d
Cleared Jul 29, 2016
HeatLux Pro II
K152087 · ILY
Home Skinovations , Ltd.
Physical Medicine · 368d
Cleared Jul 12, 2016
InMode Plus System
K153568 · PBX
Inmode MD , Ltd.
General & Plastic Surgery · 211d
Cleared Apr 15, 2016
Forma System, Forma Light System
K160195 · ONF
Formatk Systems , Ltd.
General & Plastic Surgery · 79d
Cleared Feb 19, 2016
InMode RF System
K151793 · GEI
Inmode MD , Ltd.
General & Plastic Surgery · 233d
Cleared Jan 04, 2016
InMode FRF Applicator
K151273 · GEI
Inmode MD , Ltd.
General & Plastic Surgery · 236d
Cleared Nov 17, 2015
Renaissance X System
K152041 · OLO
Mazor Robotics , Ltd.
Orthopedic · 118d
Cleared Aug 05, 2015
Titan
K150086 · INI
Tzora Active Systems , Ltd.
Physical Medicine · 202d
Cleared Jun 23, 2015
Digi-One
K143476 · IYN
Rimed , Ltd.
Radiology · 200d
Cleared Mar 31, 2015
HeatLux Pro I
K150175 · ILY
Home Skinovations , Ltd.
Physical Medicine · 64d
Cleared Jan 13, 2015
InMode Diolaze Device
K142952 · GEX
Inmode MD , Ltd.
General & Plastic Surgery · 95d
Cleared Dec 19, 2014
Legacy BX
K142910 · GEI
Venus Concept USA, Inc.
General & Plastic Surgery · 74d