14 results · 22ms · Sources: EU EUDAMED, US FDA

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DATEX-OHMEDA HMEF MINI

FDA 510(k)
FDA Class 2 ·Anesthesiology

BIOLOK SCREW, BIOSTEON SCREW

FDA 510(k)
FDA Class 2 ·Orthopedic

SENORX BIOPSY DEVICE, DRIVER, CONTROL MODULE, INCLUDING ACCESSORIES (POWER CORD,CONNECTOR CORDS AND FOOTSWITCH), VACUUMS

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

MARGRON STEM (K032641)

FDA Adverse Event
Injury ·PORTLAND ORTHOPAEDICS PTY LTD·Product code KWY·May 31, 2005

SCREW, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES BETTLACH·Product code HWC·September 23, 2015

PROFEMUR(R) Z STEM PLASMA SPRAYED

FDA Adverse Event
Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LPH·March 27, 2013

TERUMO CDI 500 BLOOD PARAMETER MONITOR

FDA Adverse Event
Other ·TERUMO CARDIOVASCULAR SYSTEMS CORP·Product code DRY·February 14, 2011

ASCENSION PIP

FDA Adverse Event
Other ·ASCENSION ORTHOPEDICS, INC.·Product code KWF·March 31, 2008

APPLIANCE, FIXATION, NAIL

FDA Adverse Event
Injury ·SYNTHES USA·Product code KTT·August 18, 2015

APPLIANCE,FIXATION,NAIL

FDA Adverse Event
Injury ·SYNTHES BETTLACH·Product code KTT·October 10, 2016

ENDOLOOP LIGATURE UNKNOWN PRODUCT

FDA Adverse Event
Injury ·ETHICON INC.·Product code GEA·December 15, 2021

EVOLUT FX PLUS VALVE

FDA Adverse Event
Malfunction ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·March 13, 2025

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