16 results
·
25ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MONARCH SPINAL SYSTEMS
FDA 510(k)
FDA Class 2
·Orthopedic
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036010645·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450456064·
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0132140·Trial, TLIF, 27L OB CRV 7Deg, 14mm
BETSEY JOHNSON
FDA UDI
FGX INTERNATIONAL INC.·00193033477939·
BETSEY JOHNSON
FDA UDI
FGX INTERNATIONAL INC.·00193033477946·
BETSEY JOHNSON
FDA UDI
FGX INTERNATIONAL INC.·00193033477953·
WRISTORE FIXATOR
FDA 510(k)
FDA Class 2
·Orthopedic
BIOMET LATERAL TROCH PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
IMPL TWIST MTX 3.75 MM 10 MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·June 17, 2024
RAPTOR GRASPER, SP, ERG TA
FDA Adverse Event
Malfunction
·CAREFUSION·Product code GCJ·March 20, 2013
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 22, 2014
MULTI-LINK RX VISION CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·March 14, 2008
SINGLE USE BIOPSY VALVE (STERILE)
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT·Product code EOQ·July 26, 2021
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 Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018