16 results · 25ms · Sources: EU EUDAMED, US FDA

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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