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."
1–24 of 45
Search insights Median review: 127d Cleared: 100% Top manufacturer: Inmode MD , Ltd. Lead specialty: General & Plastic Surgery
Cleared Aug 21, 2026
Solo Scope Colonoscope System
K261015 · FDF
Gi View , Ltd.
Gastroenterology & Urology · 147d
Cleared Nov 07, 2025
BrainsWay Deep TMS System
K251391 · OBP
Brainsway , Ltd.
Neurology · 186d
Cleared Sep 13, 2025
BrainsWay Deep TMS System
K251449 · OBP
Brainsway , Ltd.
Neurology · 127d
Cleared May 31, 2024
Deep TMS System
K222196 · OBP
Brainsway , Ltd.
Neurology · 679d
Cleared Apr 23, 2024
AEYE-DS
K240058 · PIB
Aeye Health, Inc.
Ophthalmic · 106d
Cleared Aug 30, 2023
Silk'n Titan Allways
K230013 · PAY
Silk'N Beauty , Ltd.
General & Plastic Surgery · 239d
Cleared Aug 26, 2022
BrainsWay Deep TMS System
K220819 · OBP
Brainsway , Ltd.
Neurology · 158d
Cleared Jun 30, 2022
InMode Multi-system
K221571 · GEX
Inmode , Ltd.
General & Plastic Surgery · 30d
Cleared Nov 10, 2021
Reverso
K212107 · GEI
Intelis Instruments , Ltd.
General & Plastic Surgery · 127d
Cleared Jul 19, 2021
Evolve System with the T3 Applicator
K210877 · PBX
Inmode , Ltd.
General & Plastic Surgery · 117d
Cleared Jul 12, 2021
InMode RF Pro System
K210492 · GEI
Inmode MD , Ltd.
General & Plastic Surgery · 143d
Cleared Apr 23, 2021
Brainsway Deep TMS System
K203735 · OBP
Brainsway , Ltd.
Neurology · 123d
Cleared Mar 05, 2021
InMode Evolve System with the Tone Applicator
K201285 · IPF
Inmode , Ltd.
Physical Medicine · 296d
Cleared Aug 21, 2020
Brainsway Deep TMS System
K200957 · QMD
Brainsway , Ltd.
Neurology · 134d
Cleared Jul 22, 2020
InMode RF Multi-System
K201150 · GEI
Inmode , Ltd.
General & Plastic Surgery · 84d
Cleared Jul 02, 2020
InMode System with the Morhpeus8 Applicators
K200947 · GEI
Inmode , Ltd.
General & Plastic Surgery · 85d
Cleared Dec 27, 2019
InMode System with the Morpheus8 (Fractora) Applicators
K192695 · GEI
Inmode MD , Ltd.
General & Plastic Surgery · 92d
Cleared Oct 29, 2019
EmFace Device
K191855 · PBX
Inmode MD , Ltd.
General & Plastic Surgery · 111d
Cleared Dec 11, 2018
Magma Spark Pro (Magma Spark Plus, Alpha)
K183307 · GEX
Formatk Systems , Ltd.
General & Plastic Surgery · 13d
Cleared Sep 26, 2018
InMode RF System
K182325 · GEI
Inmode MD , Ltd.
General & Plastic Surgery · 30d
Cleared Jun 14, 2018
InMode Diolaze System
K180719 · GEX
Inmode MD , Ltd.
General & Plastic Surgery · 87d
Cleared Jun 01, 2018
InMode System with Fractora3D/3D-90 Applicators
K180189 · GEI
Inmode MD , Ltd.
General & Plastic Surgery · 129d
Cleared May 09, 2018
Silk'n MODEL H5003 device
K180279 · NGX
Home Skinovations , Ltd.
Physical Medicine · 98d
Cleared Apr 30, 2018
Mazor X
K180307 · OLO
Mazor Robotics , Ltd.
Orthopedic · 87d