19 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ADVANCE MEDICAL DESIGNS FLUID POUCH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040017388·Zirlux 16+ D98,5*30 (step) B1
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033359266·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033359273·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033359259·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033359297·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033359303·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033359310·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033359280·
ASPIJECT SELF-ASPIRATING DENTAL INJECTION SYRINGE
FDA 510(k)
FDA Class 2
·Dental
NEUROGEN NERVE GUIDE
FDA 510(k)
FDA Class 2
·Neurology
MULTI-LINK 8
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·March 29, 2010
MULTI-LINK 8
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·March 29, 2010
ENDOPATH ETS
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code KOG·November 7, 1997
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 13, 2013
HEARTMATE II SYSTEM CONTROLLER
FDA Adverse Event
Malfunction
·THORATEC CORP.·Product code DSQ·February 1, 2011
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC.·Product code LFR·May 16, 2007
MULTI-LINK 8
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·March 12, 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