11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CD HORIZON SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BD VACUTAINER K2E 3.6MG PLUS BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·November 2, 2021
SIEMENS 1.5T TXRX 15 CH KNEE
FDA Adverse Event
Other
·QUALITY ELECTRODYNAMICS·Product code MOS·October 5, 2011
HORIZONS PAPILLOTOME
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
STARS2000 POWER CANNULA
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
UNKNOWN
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·July 26, 2024
LIGACLIP** ENDOSCOPIC CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·April 29, 2013
PASSPORT 2
FDA Adverse Event
Malfunction
·MINDRAY DS USA, INC.·Product code MHX·May 5, 2011
WATERBATH GAS STRUT
FDA Adverse Event
Other
·MEDTEC, INC. (DBA. CIVCO MEDICAL SOLUTIONS)·Product code ILJ·July 25, 2008
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
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