13 results · 21ms · Sources: EU EUDAMED, US FDA

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SYNGO LUNG CAD

FDA 510(k)
FDA Class 2 ·Radiology

MAR COR SERVICES SEMPER PURE RO MACHINE

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

CODMAN SLIM-LOC SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN(LH) 65 UNITS BLOOD COLLECTION TUBES

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·September 12, 2019

CARE ASSIST BED

FDA Adverse Event
Malfunction ·Product code FNL·April 3, 2013

ONE TOUCH ULTRALINK METER

FDA Adverse Event
Malfunction ·LIFESCAN, INC.·Product code NBW·June 19, 2008

NSEAL

FDA Adverse Event
Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GEI·April 20, 2011

VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK

FDA Adverse Event
Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code JLW·February 2, 2016

VITROS ECI IMMUNODIAGNOSTIC SYSTEM

FDA Adverse Event
Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code KHO·February 2, 2016

VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK

FDA Adverse Event
Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code JLW·February 2, 2016

WALLFLEX COLONIC

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code MQR·December 31, 2024

BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN(LH) 65 UNITS BLOOD COLLECTION TUBES

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·August 21, 2019

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