11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MAGNETOM Free.Max, MAGNETOM Free.Star
FDA 510(k)
FDA Class 2
·Radiology
ambIT*
FDA UDI
Avanos Medical, Inc.·00193494000363·ambIT* RPS Kit-Spike Cassette with Filter
ambIT
FDA UDI
SUMMIT MEDICAL PRODUCTS, INC.·00850000509061·ambIT Kit Basic w Spike & Filter Cassette
AMBIT ELECTRONIC PAIN CONTROL PUMP
FDA Adverse Event
Malfunction
·AVANOS MEDICAL, INC.·Product code FRN·March 27, 2023
ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
TRUEMED HAND, FOOT AND ANKLE PLATES SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
VAPR VUE GENERATOR
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code GEI·January 28, 2019
STYLUS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES PUERTO RICO, INC. DBA ANGIOTECH·Product code GES·October 31, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 23, 2011
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 11, 2013
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021