10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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syngo Application Software VD11
FDA 510(k)
FDA Class 2
·Radiology
AGC KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304222069·
DELIKIT PUTTY, DELIKIT HEAVY BODY, DELIKIT LIGHT BODY
FDA 510(k)
FDA Class 2
·Dental
MODIFICATION TO: DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL DP-9900
FDA 510(k)
FDA Class 2
·Radiology
CARELINK
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code DXY·June 8, 2013
OCTRODE PERCUTANEOUS LEAD
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 30, 2011
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code NIQ·September 5, 2008
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024