12 results
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33ms
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Sources: EU EUDAMED, US FDA
SHARGHP A.V. FISTULA NEEDLE SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VERSALINK TITANIUM ROD-TO-ROD COUPLERS
FDA 510(k)
FDA Class 2
·Orthopedic
HARDYDISK NOVOBIOCIN, 30MCG, MODEL Z883
FDA 510(k)
FDA Class 2
·Microbiology
PROFILE BIABUT 4.0 -Ø5.5
FDA Adverse Event
Injury
·DENTSPLY IMPLANTS MANUFACTURING GMBH·Product code DZE·February 24, 2026
ACCU-CHEK ® SMARTVIEW TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·December 27, 2013
ACCU-CHEK ® SMARTVIEW TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·December 27, 2013
MICRO RECIPROCATING SAW
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code HBE·March 20, 2013
SPECTRANETICS LASER SHEATH II
FDA Adverse Event
Injury
·SPECTRANETICS CORPORATION·Product code MFA·March 8, 2011
INSYNC SENTRY
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·March 10, 2008
ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG
FDA Adverse Event
Injury
·COOK INC·Product code MIH·May 23, 2016
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