14 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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THE BELMONT BUDDY LITE FLUID WARMER
FDA 510(k)
FDA Class 2
·Hematology
9300
FDA UDI
HANS RUDOLPH, INC.·00874750009275·9351 INSP OCCL SUB W/1410
SE-300 VACUUM THERAPY SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SL3
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
POLYMOBIL PLUS
FDA Adverse Event
Malfunction
·SIEMENS HEALTHINEERS AG·Product code IZL·February 24, 2026
U BY KOTEX SLEEK
FDA Adverse Event
Malfunction
·K-C AFC MANUFACTURING, S. DE R.L. DE C.V·Product code HEB·August 31, 2018
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 14, 2013
UNKNOWN DEPUY S ROM STEM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·May 19, 2011
ETS-FLEX - ENDOSCOPIC ARTICULATING LINEAR CUTTER (VASCULAR.THIN) - 35 MM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code GDW·August 11, 2008
U BY KOTEX SLEEK
FDA Adverse Event
Malfunction
·K-C AFC MANUFACTURING, S. DE R.L. DE C.V·Product code HEB·June 27, 2018
MOBILETT ELARA MAX
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE GMBH·Product code IZL·December 18, 2020
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
FDA Enforcement
Class I
·Ongoing·Covidien·November 8, 2023
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Model Number L231, PROPONENT DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025