12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COTTONS 100% NATURAL COTTON TAMPONS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450179673·
NA
FDA UDI
STRYKER CORPORATION·07613327056464·Insert, Park Forceps
QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA
FDA 510(k)
FDA Class 2
·Immunology
PVS 1500 SDS
FDA 510(k)
FDA Class 2
·Cardiovascular
CERENOVUS ENTERPRISE
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code NJE·January 24, 2025
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·April 9, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·May 6, 2011
PULSE GEN MODEL UNK
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·July 18, 2008
EVOLUT FX DCS
FDA Adverse Event
Malfunction
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·July 18, 2025
ANTI-SIPHON PCA EXTENSION SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - AIBONITO·Product code FRN·February 4, 2011
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