13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FAMA Male Latex Condoms
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
K-Systems
FDA UDI
Coopersurgical, Inc.·00888937025033·G95 Mini Incubator
ambIT*
FDA UDI
Avanos Medical, Inc.·00193494001476·ambIT* PreSet* v1.5 System w/Male Filter Cass
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776156107·LAP MONO ELECTRODE 5MM 33CM REAR CONNECTOR
ELMED
FDA UDI
ELMED INCORPORATED·00842180109629·5 MM DIA., 33 CM INSULATED NEEDLE TIP ELECTRODE...
VELOGENE GENOMIC IDENTIFICATIONASSAY FOR VRE
FDA 510(k)
FDA Class 2
·Microbiology
ZAVATION IBF SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
STYLUS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES PUERTO RICO, INC. DBA ANGIOTECH·Product code HNN·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
LIFE SCOPE PT
FDA Adverse Event
Malfunction
·NIHON KOHDEN CORPORATION·Product code MHX·December 26, 2023
LIFE SCOPE PT
FDA Adverse Event
Malfunction
·NIHON KOHDEN CORPORATION·Product code MHX·December 8, 2023
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