13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
FDA 510(k)
FDA Class 1
·General Hospital
MONSOON CRITICAL CARE JET VENTILATOR AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Anesthesiology
COM-MED O.R. TOWEL - NON-STERILE, BLUE, GREEN, WHITE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
WAVEWRITER ALPHA 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·December 6, 2024
5.0MM CANNULATED LOCKING SCREW50MM
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HWC·April 29, 2013
STANDARD FOOTSWITCH
FDA Adverse Event
Malfunction
·COVIDIEN LP (VALLEYLAB)·Product code GEI·April 28, 2011
ONE TOUCH ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·July 22, 2008
BDINTIMA-II Y 20GAX1.16IN PRN/EC SLM
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·January 17, 2025
ZCA ALL-POLY ACETABULAR CUP
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·May 9, 2023
BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·February 24, 2025
BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·February 28, 2025
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