17 results · 23ms · Sources: EU EUDAMED, 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