17 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TREK OTW CORONARY DILATATION CATHETER MINI TREK OTW CORONARY DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772813827·GENUMEDI PRO SILVER SIZE II
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450743751·
Vatech Clismile
FDA UDI
Rayence Co., Ltd.·08800018601327·This product is an orthodontic bracket and is u...
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970430·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973691·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973073·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970447·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973905·
Critical Cover
FDA UDI
Alpha Pro Tech, Inc.·10817583021622·Frock, GenPro, White, Raglan Sleeve, Elastic Wr...
MRI-Q SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
LAD, MODEL LAD-01
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 21, 2024
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
UNKNOWN·Product code ITJ·May 20, 2013
MBT TRAY SLEEVE POR M/L 37MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code NJL·September 26, 2014
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·May 4, 2011
Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.
FDA Enforcement
Class II
·Terminated·Ecolab Inc·September 30, 2015