15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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R 72
FDA 510(k)
FDA Class 2
·Radiology
STIMATE N601 TENS
FDA 510(k)
FDA Class 2
·Neurology
MEDTRADE PRODUCTS ALGINATE ISLAND
FDA 510(k)
FDA Unclassified
·Unknown
LIFESTENT FLEXSTAR XL BILIARY STENT
FDA Adverse Event
Injury
·ANGIOMED GMBH & CO.·Product code FGE·November 21, 2008
LIFESTENT FLEXSTAR XL BILIARY STENT
FDA Adverse Event
Malfunction
·ANGIOMED GMBH & CO.·Product code FGE·November 5, 2008
LIFESTENT FLEXSTAR XL BILIARY STENT
FDA Adverse Event
Malfunction
·ANGIOMED GMBH & CO. MEDIZINTECHNIK·Product code FGE·February 20, 2009
LIFESTENT FLEXSTAR XL BILIARY STENT
FDA Adverse Event
Malfunction
·ANGIOMED GMBH & CO.·Product code FGE·November 4, 2008
LIFESTENT FLEXSTAR XL BILIARY STENT
FDA Adverse Event
Malfunction
·ANGIOMED GMBH & CO, MEDIZINTECHNIK·Product code FGE·February 13, 2009
HELIMEND ADV. 20 X 30
FDA Adverse Event
Malfunction
·INTEGRA YORK PA, INC.·Product code LYC·March 27, 2013
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 9, 2011
PRECISON XTRA/OPTIUM
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·April 17, 2008
BACFIX ROD, UNKNOWN
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code HSB·January 16, 2020
Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024
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
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018