17 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GEISTLICH PERIO-SYSTEM COMBI-PACK , GEISTLICH BIO-GIDE PERIO
FDA 510(k)
FDA Class 2
·Dental
UNIMAX
FDA UDI
PARAMOUNT SURGICALS, INC.·00852647007245·HORIZONTAL PLATE STANDARD 57.5 MM
PREFERNCE IMRT TREATMENT PLANNING MODULE
FDA 510(k)
FDA Class 2
·Radiology
ORTHO MTA (MINERAL TRIOXIDE AGGREGATE)
FDA 510(k)
FDA Class 2
·Dental
PENCAN®
FDA Adverse Event
Injury
·B BRAUN MELSUNGEN AG·Product code BSP·May 6, 2025
GMK-REVISION OFFSET ADAPTER 5 MM
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code LXH·February 8, 2017
ECHI GREENVILLE NC 2
FDA Adverse Event
Other
·SORIN GROUP USA, INC.·Product code DTZ·November 22, 2011
ECHI GREENVILLE NC 2
FDA Adverse Event
Other
·SORIN GROUP USA, INC.·Product code DTZ·November 30, 2011
STONYBROOK HSP NY NY 1
FDA Adverse Event
Other
·SORIN GROUP USA, INC.·Product code OEZ·September 15, 2015
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 14, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 24, 2014
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·May 26, 2011
C21785 IT TREVISO
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code GEI·December 14, 2012
PENCAN®
FDA Adverse Event
Injury
·B BRAUN MELSUNGEN AG·Product code BSP·April 10, 2025
D731 MICRO 27 ARTERIAL FILTER WITH 27 MICRON PHISIO COATING
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTM·May 18, 2022
D731 MICRO 27 ARTERIAL FILTER WITH 27 MICRON PHISIO COATING
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTM·March 17, 2022
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021