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

103 results for "Mtechgroup"
73–96 of 103
Search insights Median review: 95d Cleared: 100% Top manufacturer: Rayence Co., Ltd. Lead specialty: Radiology
Cleared May 26, 2017
SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System
K163140 · OWB
Gemss Medical Systems Co., Ltd.
Radiology · 198d
Cleared Apr 06, 2017
Huvitz Imaging System
K161829 · NFJ
Huvitz Co., Ltd.
Ophthalmic · 275d
Cleared Apr 04, 2017
System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight
K170731 · MUH
VATECH Co., Ltd.
Radiology · 25d
Cleared Jan 24, 2017
EzRay Air W
K163705 · EHD
VATECH Co., Ltd.
Radiology · 26d
Cleared Jan 11, 2017
Lympha-Flow(LF1200)
K160178 · IRP
Daesung Maref Co., Ltd.
Physical Medicine · 350d
Cleared Nov 03, 2016
Intermittent Pneumatic Compression system
K160180 · JOW
Daesung Maref Co., Ltd.
Cardiovascular · 281d
Cleared Oct 28, 2016
PaX-i3D Green Premium (Model: PCT-90LH)
K160882 · OAS
VATECH Co., Ltd.
Radiology · 211d
Cleared Oct 28, 2016
FRAXIS DUO
K160312 · GEX
Ilooda Co,., Ltd.
General & Plastic Surgery · 266d
Cleared Oct 20, 2016
Green Smart (Model: PHT-35LHS)
K162660 · OAS
VATECH Co., Ltd.
Radiology · 24d
Cleared Oct 14, 2016
ANYVIEW-500R Fluoroscopic Mobile X-Ray System
K160279 · OWB
Ecotron Co., Ltd.
Radiology · 255d
Cleared Oct 06, 2016
1717WCC / 1717WGC
K162519 · MQB
Rayence Co., Ltd.
Radiology · 27d
Cleared Oct 06, 2016
1012WCC, 1012WGC
K162518 · MQB
Rayence Co., Ltd.
Radiology · 27d
Cleared Sep 01, 2016
EzRay Air (Model VEX-P300)
K161063 · EHD
VATECH Co., Ltd.
Radiology · 139d
Cleared Sep 01, 2016
Hi bebe plus
K160274 · HGX
Bistos Co., Ltd.
Obstetrics & Gynecology · 212d
Cleared Jun 09, 2016
BSD4343 Digital Flat Panel X-ray Detector
K160204 · MQB
Bontech, Inc.
Radiology · 133d
Cleared May 20, 2016
GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System
K160065 · OXO
Gemss Medical Systems Co., Ltd.
Radiology · 128d
Cleared May 12, 2016
Venous Assist System
K150980 · JOW
Daesung Maref Co., Ltd.
Cardiovascular · 394d
Cleared Apr 08, 2016
Xmaru View V1 and Xmaru PACS, Medical Image Processing Software
K160579 · LLZ
Rayence Co., Ltd.
Radiology · 38d
Cleared Jan 22, 2016
TAURUS C1
K151996 · EIA
Shinhung Company, Ltd.
Dental · 186d
Cleared Nov 10, 2015
Digital Dental Intra Oral Sensor, EzSensor Classic, EzSensor HD, HDI-P, HDI-S
K153060 · MUH
Rayence Co., Ltd.
Radiology · 20d
Cleared Oct 23, 2015
Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D Smart
K152106 · OAS
VATECH Co., Ltd.
Radiology · 86d
Cleared Jul 24, 2015
EPX-Series Mobile X-ray System
K151038 · IZL
Ecotron Co., Ltd.
Radiology · 95d
Cleared Jul 19, 2015
EzSensor Soft, EzSensor Soft i, EzSensor Bio, and EzSensor Bio i
K151707 · MUH
Rayence Co., Ltd.
Radiology · 25d
Cleared Jul 13, 2015
Aura DR 43C-AG flat panel detector
K151014 · MQB
Abyzr Co., Ltd.
Radiology · 88d