15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LDR SPINE ROI-C IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014607146·SKYTRON 3500 3" STANDARD
SYRINGE 20ML LL S/C 48
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·April 28, 2025
HARMONE-SCHWARZER EEG SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
MEDTRONIC SOLAN FIBEROPTIC CORNEAL LIGHT PROBE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VISION HOLLOW FIBER OXYGENATOR
FDA Adverse Event
Malfunction
·GISH BIOMEDICAL, INC.·Product code DTZ·February 18, 2011
X SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·April 9, 2013
STARCLOSE SE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·May 6, 2011
ACRYSOF
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD/HUNTINGTON·Product code HQL·July 23, 2008
NEEDLE 18X1-1/2 BLUNT FILL
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code GAA·April 24, 2025
E-POLY TIBIAL BEARINGS
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JWH·July 12, 2017
NEEDLE 18X1-1/2 BLUNT FILL
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code GAA·April 24, 2025
NEEDLE 18X1-1/2 BLUNT FILL
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code GAA·April 24, 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
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018