28 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Revolution Peripheral Atherectomy System
FDA 510(k)
FDA Class 2
·Cardiovascular
ULTRA BEAUTY
FDA 510(k)
FDA Class 2
·Neurology
BDPROBETEC ET CT/GC AMPLIFIED DNA ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
MEDLINE-MICROTEK
FDA Adverse Event
Malfunction
·MICROTEK MEDICAL LLC·Product code PUI·February 20, 2026
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE REHABILITATION EQUIP·Product code CAW·October 30, 2014
TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code LOX·August 15, 2011
GYNECARE TVT RETROPUBIC SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 9, 2013
LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects.
FDA Enforcement
Class I
·Terminated·DePuy Orthopaedics, Inc.·February 27, 2013
BD BBL¿ MIDDLEBROOK OADC ENRICHMENT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code PPM·September 2, 2025
BD BBL¿ MIDDLEBROOK OADC ENRICHMENT
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code PPM·September 3, 2025
BD BBL¿ MIDDLEBROOK OADC ENRICHMENT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code PPM·September 2, 2025
BD BBL¿ MIDDLEBROOK OADC ENRICHMENT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code PPM·September 2, 2025
BD BBL¿ MIDDLEBROOK OADC ENRICHMENT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code PPM·September 2, 2025
BD BBL¿ MIDDLEBROOK OADC ENRICHMENT
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code PPM·September 3, 2025
BD BBL¿ MIDDLEBROOK OADC ENRICHMENT
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code PPM·September 3, 2025
BD BBL¿ MIDDLEBROOK OADC ENRICHMENT
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code PPM·September 3, 2025
BD BBL¿ MIDDLEBROOK OADC ENRICHMENT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code PPM·September 2, 2025
BD BBL¿ MIDDLEBROOK OADC ENRICHMENT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code PPM·September 2, 2025
BD BBL¿ MIDDLEBROOK OADC ENRICHMENT
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code PPM·September 3, 2025
BD BBL¿ MIDDLEBROOK OADC ENRICHMENT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code PPM·September 2, 2025