14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AVALIGN
FDA Adverse Event
Malfunction
·AVALIGN GERMAN SPECIALTY INSTRUMENTS·Product code HAE·June 17, 2019
INSTRUMED RONGEUR
FDA 510(k)
FDA Class 2
·Neurology
Harvard Temp C&B A1
FDA UDI
Harvard Dental International GmbH·EHAR70816511·Temporary crown and bridge material 10:1
BIO-RAD %CDT TIA
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MODIFICATION TO CERASORB ORTHO
FDA 510(k)
FDA Class 2
·Orthopedic
RX ACCULINK CAROTID STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code NIM·May 18, 2009
RX ACCUNET EMBOLIC PROTECTION SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code NTE·October 19, 2007
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·Product code OYC·April 29, 2013
ECHELON*FLEX60 ARTICULATING
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·May 9, 2011
PUMP MMT-522NAB PRDGM INS V2.2 BL EN
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·July 23, 2008
BD VACUTAINER BLOOD TRANSFER DEVICE
FDA Adverse Event
Malfunction
·BD CARIBE LTD.·Product code JKA·October 16, 2024
Femoral Nail, LEFT T2 GTN ¿12x360 mm, Product Number 18501236S
FDA Enforcement
Class II
·Terminated·Stryker GmbH·July 18, 2018
Femoral Nail, A/R T2 Femur ¿12x360 mm, Product Number 18251236S
FDA Enforcement
Class II
·Terminated·Stryker GmbH·July 18, 2018
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