16 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RESORBABLE SCREW ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
I IMAGE
FDA UDI
FGX INTERNATIONAL INC.·00193033447017·
I IMAGE
FDA UDI
FGX INTERNATIONAL INC.·00193033446980·
I IMAGE
FDA UDI
FGX INTERNATIONAL INC.·00193033447024·
I IMAGE
FDA UDI
FGX INTERNATIONAL INC.·00193033447000·
I IMAGE
FDA UDI
FGX INTERNATIONAL INC.·00193033446997·
I IMAGE
FDA UDI
FGX INTERNATIONAL INC.·00193033446973·
R&D PROJECT DW271#11A
FDA 510(k)
FDA Class 2
·Dental
ML BLADE, MODEL ML7030
FDA 510(k)
FDA Class 1
·Ophthalmic
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT·Product code CBK·March 1, 2013
INRATIO
FDA Adverse Event
Injury
·ALERE SAN DIEGO, INC.·Product code GJS·March 1, 2011
HEARTPORT VENT CATHETER
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code DWF·March 12, 2008
UNKNOWN POLY SCREW
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·June 29, 2021
Pinnacle Destination Guiding Sheath, 6 French, 90 cm, Straight Tip, Tuohy-Borst Valve, Lot MD24, MD31, ME07, & ME14. 510(k) K012812 Guiding Sheath is used to facilitate the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal arteries for the Renal Guiding Sheath and the carotid arteries for the Carotid Guiding Sheath.
FDA Recall
Terminated
·Terumo Medical Corporation·Product code DYB·June 24, 2010
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