14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACCOLADE HFX FEMORAL STEM
FDA 510(k)
FDA Class 2
·Orthopedic
N/A
FDA UDI
GEORGE TIEMANN & CO.·B58210517410·
PROGLIDE
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code MGB·July 25, 2025
PROGLIDE
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code MGB·July 25, 2025
PERCLOSE PROGLIDE¿
FDA Adverse Event
Injury
·ABBOTT VASCULAR INC.·Product code MGB·August 15, 2025
RADIONICS RF DISC CATHETER ELECTRODE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CRIT-LINE MONITOR III TQA (CLM TQA)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PERCLOSE PROGLIDE¿
FDA Adverse Event
Injury
·ABBOTT VASCULAR INC.·Product code MGB·August 13, 2025
PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code MGB·October 2, 2023
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 10, 2013
LEAD MODEL 302
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·May 23, 2008
TELIGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·April 12, 2011
2.5MM DRILL BIT/QC/GOLD/180MM
FDA Adverse Event
Injury
·SYNTHES ELMIRA·Product code HWE·September 9, 2016
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) 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