14 results · 22ms · Sources: EU EUDAMED, 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