11 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AEQUALIS HUMERAL NAIL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
EZ SET INFUSION SET
FDA 510(k)
FDA Class 2
·General Hospital
S&T SINGLE USE MICRO ANASTOMOSIS CLAMP
FDA 510(k)
FDA Class 2
·Cardiovascular
ALTRX NEUT 28IDX46OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·March 18, 2014
DLT TS CER HD 12/14 28MM +1.5
FDA Adverse Event
Injury
·DEPUY IRELAND·Product code LZO·March 18, 2014
ARTICULEZE M HEAD 36MM +1.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·April 29, 2013
PARADIGM INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·April 28, 2011
IN TOUCH ZX
FDA Adverse Event
Malfunction
·STRYKER MEDICAL QUEBEC, LP·Product code FNL·July 22, 2008
PEEK CAGE, UNKNOWN TYPE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code MAX·February 9, 2021
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014
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