12 results · 33ms · Sources: EU EUDAMED, US FDA

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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