2,501 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CardioDay V2.5
FDA 510(k)
FDA Class 2
·Cardiovascular
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776116415·Keyhole Bracket
Avalign
FDA UDI
Avalign Technologies, Inc.·00190776020675·Keyhole Bracket
MIXJECT WITH SPRAY HEAD
FDA 510(k)
FDA Class 2
·General Hospital
DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, MODEL APOGEE 3500, CONVEX ARRAY TRANSDUCER, MODEL C3L60C
FDA 510(k)
FDA Class 2
·Radiology
NA
FDA UDI
Zimmer, Inc.·00889024084940·
MAGNETOM Verio Dot Upgrade. Model Number: 10684334.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
PUMP 1886 780G OUS BLE PUMP MG/DL
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·April 28, 2023
670G INSULIN PUMP MMT-1780KL
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·June 10, 2023
630G INSULIN PUMP MMT-1715KL 630G
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·July 6, 2023
640G INSULIN PUMP MMT-1712K
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 13, 2023
PUMP MMT-1712KL 640G V4.10 BK SF MG
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 8, 2023
PUMP MMT-1712KL 640G V4.10 BK SF MG
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·December 8, 2023
MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·October 11, 2023
PUMP MMT-1782K 670G V4.11 MM
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·March 9, 2023
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 6, 2013
UNKNOWN ZIMMER KNEE
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·July 12, 2011
LADARVISION
FDA Adverse Event
Injury
·ALCON- ORLANDO TECHNOLOGY CENTER·Product code LZS·September 4, 2008
PUMP MMT-1712KL 640G V4.10 BK SF MG
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·January 31, 2023
MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·January 28, 2023