10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BioRoot Flow 0.5g, BioRoot Flow 2g
FDA 510(k)
FDA Class 2
·Dental
GENESIS II LONG STEM 10MMX70MM
FDA Adverse Event
Injury
·SMITH AND NEPHEW, INC.·Product code JWH·October 2, 2018
JOURNEY TIBIA BASE NP LT SZ 4
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·October 2, 2018
DURA BLUE STERILIZATION WRAP
FDA 510(k)
FDA Class 2
·General Hospital
SOLOGARD LOCKING PLUS SYRINGE WITH NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·August 15, 2011
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·October 29, 2008
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 9, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023