14 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LIFE 2
FDA 510(k)
FDA Class 2
·Dental
NA
FDA UDI
Smith & Nephew, Inc.·03596010080929·CURETTE OPEN 7MM
Invictus Development and Engineering Surgical Illuminator
FDA UDI
Lumitex, Inc.·00812432022969·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033450475·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450291955·
True Position®
FDA UDI
ATLAS SPINE, INC.·M68112080127170·27mm x 17mm Lordotic Spacer
STERILE PISTON SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
SUNMAX BLUE NITRILE POWDERED EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
BILATERAL DOUBLE BALLOON SET
FDA Adverse Event
Malfunction
·PAJUNK GMBH MEDIZINTECHNOLOGIE·Product code KOG·December 7, 2006
UNKNOWN
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·March 20, 2013
UNKNOWN DEPUY ASR CUP
FDA Adverse Event
Injury
·DEPUY INTL LTD·Product code KWA·February 24, 2011
BD PARADIGM LINK GLUCOSE MONITOR
FDA Adverse Event
Malfunction
·NOVA BIOMEDICAL CORPORATION·Product code NBW·March 11, 2008
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
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018