11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MEGA 2000 SOFT PATIENT RETURN ELECTRODE PAD
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ULTRAPOWER
FDA UDI
Conmed Corporation·10845854004470·7MM ULTRAPOWER BUR, ROUND COARSE DIAMOND (RED)
LUBRIGEL PERSONAL LUBRICANT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ANDERSEN INTESTINAL TUBE, MILLER-ABBOTT TYPE (AN 22)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GORE VIABAHN ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code NIP·March 13, 2013
MAXCEM ELITE
FDA Adverse Event
Injury
·KERR CORPORATION·Product code EMA·March 16, 2011
EASY LOAD INSERTER
FDA Adverse Event
Injury
·BAUSCH & LOMB·Product code MSS·March 27, 2008
UNK_THERMOCOOL SF NAV
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code LPB·October 2, 2025
Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Enforcement
Class II
·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014