18 results
·
21ms
·
Sources: EU EUDAMED, US FDA
VISERA CYSTOVIDEOSCOPE OLYMPUS CYF TYPE V/VA
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VERIDIAN
FDA UDI
VERIDIAN HEALTHCARE LLC·00845717000192·Heritage Aneroid Sphygmomanometer, Child
ULTRAPOWER
FDA UDI
Conmed Corporation·10845854004623·ULTRAPOWER BUR, ROUND COARSE DIAMOND (RED), 4 MM
XBO1-824-18/19/20 BIOPSY FORCEPS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CRYOCARE SURGICAL SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INTROCAN SAFETY®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code DYB·April 11, 2025
INTROCAN SAFETY®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FOZ·April 8, 2025
ENDOCARE, CRYOCARE, CRYOPROBE
FDA Adverse Event
Malfunction
·HEALTHTRONICS, INC.·Product code GEH·April 2, 2012
INTROCAN SAFETY®
FDA Adverse Event
Injury
·B BRAUN MELSUNGEN AG·Product code FOZ·April 1, 2025
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·March 26, 2013
MAXCEM ELITE
FDA Adverse Event
Injury
·KERR CORPORATION·Product code EMA·March 16, 2011
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 27, 2008
MONOBLOC REAMER D. 8.0 MM L. 475 MM
FDA Adverse Event
Injury
·ORTHOFIX SRL·Product code HTO·May 3, 2021
INTROCAN SAFETY®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FOZ·March 20, 2025
INTROCAN SAFETY®
FDA Adverse Event
Injury
·B BRAUN MELSUNGEN AG·Product code FOZ·April 10, 2025
INTROCAN SAFETY®
FDA Adverse Event
Injury
·B BRAUN MELSUNGEN AG·Product code DYB·March 18, 2026
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