15 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NAVITRACK SYSTEM-OPTICAL TKR CT-LESS, MODEL 900.120
FDA 510(k)
FDA Class 2
·Neurology
CD HORIZON® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00885074034553·BONE SCREW 7021760 10 DEG ILC 7.5X60 SS
BD BACTEC¿ FOS¿ (FASTIDIOUS ORGANISM SUPPLEMENT) KIT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code MDB·July 27, 2021
STARFLOW HV
FDA 510(k)
FDA Class 2
·Dental
RADIOLUCENT COLLES FRACTURE KIT
FDA 510(k)
FDA Class 2
·Orthopedic
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code LXH·February 10, 2020
GOBED II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·March 26, 2013
ARCHITECT HAVAB IGM REAGENT
FDA Adverse Event
Malfunction
·ABBOTT·Product code LOL·March 17, 2011
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·March 19, 2008
OSS 3CM ELLIP DIAPHYSEAL SEG
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·September 9, 2019
OSS POROUS IM STEM 15.5 X 150
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·September 9, 2019
OSS 3CM ELLIP DIAPHYSEAL SEG
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·September 10, 2019
OSS POROUS IM STEM 15.5 X 150
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·September 10, 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
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