15 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ZIMMER UNIVERSAL LOCKING SYSTEM: 3.5 MM LOCKING PLATES AND SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
RONGEUR #27 CLEVELAND GARDNER
FDA UDI
W.H. Holden, Inc.·D928100825270·
BD INTEGRA
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code MEG·September 17, 2024
HEDROCEL VERTEBRAL BODY REPLACEMENT
FDA 510(k)
FDA Class 2
·Orthopedic
KSEA SIALOENDOSCOPES AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
WAVEWRITER ALPHA?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 13, 2026
MALLINCKRODT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TYCOHEALTHCARE·Product code JOH·November 18, 2010
MALLINCKRODT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TYCOHEALTHCARE·Product code BTR·December 9, 2010
MALLINCKRODT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TYCOHEALTHCARE·Product code BTR·February 1, 2011
CORAIL2 STD SIZE 11
FDA Adverse Event
Injury
·DEPUY FRANCE·Product code MEH·April 29, 2013
LOGICAL DOUBLE KIT
FDA Adverse Event
Malfunction
·SMITHS MEDICAL INTERNATIONAL LTD.·Product code DRS·April 28, 2011
IN TOUCH ZX
FDA Adverse Event
Malfunction
·STRYKER MEDICAL QUEBEC, LP·Product code FNL·July 21, 2008
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
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015