20 results
·
29ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
KSEA DION-GRACIA SET
FDA 510(k)
FDA Class 2
·Cardiovascular
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450252871·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450266083·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450265741·
NINE WEST
FDA UDI
FGX INTERNATIONAL INC.·00193033238110·
NINE WEST
FDA UDI
FGX INTERNATIONAL INC.·00193033238103·
NINE WEST
FDA UDI
FGX INTERNATIONAL INC.·00193033238097·
NINE WEST
FDA UDI
FGX INTERNATIONAL INC.·00193033238080·
EEG REAL PATIENT SPIKE AND EVENT DETECTOR MODULE, MODEL EX-SP-RP (PROPOSED)
FDA 510(k)
FDA Class 2
·Neurology
SURGISIS PERIPHERAL VASCULAR PATCH
FDA 510(k)
FDA Class 2
·Cardiovascular
QUICK-SET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·August 11, 2025
QUICK-SET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·August 11, 2025
TOSHIBA Kalare Diagnostic X-Ray System K110785
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code JAA·April 3, 2013
GENERATOR REFURB PULSAR2
FDA Adverse Event
Malfunction
·MEDTRONIC ADVANCED ENERGY, LLC·Product code MUL·March 19, 2013
ANEURX ABDOMINAL STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR SANTA ROSA·Product code MIH·March 2, 2011
RIATA ACTIVE FIXATION LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·March 10, 2008
TOSHIBA Kalare Diagnostic X-Ray System K110785
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·July 17, 2013
BD VACUTAINER BLOOD COLLECTION TUBE
FDA Adverse Event
Other
·BD·Product code JKA·September 1, 2011
STOPPER FOR LISS INSERTION GUIDES
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code FZX·July 17, 2019
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