10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODIFICATION TO:MICROFUSE BONE VOID FILLER
FDA 510(k)
FDA Class 2
·Orthopedic
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 26, 2021
RS NITRILSTAT MEDICAL EXAMINATION GLOVES, POWDER FREE (NON-STERILE)
FDA 510(k)
FDA Class 1
·General Hospital
CYBERCASES BY BAUSCH & LOMB
FDA 510(k)
FDA Class 2
·Ophthalmic
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 29, 2013
RPM DIAGNOSTIC REFERENCE CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC, EP TECHNOLOGIES, INC.·Product code DRF·July 24, 2008
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·April 13, 2011
ARCHITECT IPTH REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code CEW·March 19, 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