10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Star+ VPS Scannable Impression Material
FDA 510(k)
FDA Class 2
·Dental
ONE TOUCH ULTRA
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·February 22, 2005
AERODR SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
AVANTE LED CURING UNIT, MODEL N44
FDA 510(k)
FDA Class 2
·Dental
BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·October 1, 2022
ATTAIN OTW
FDA Adverse Event
Injury
·MPRI·Product code LWP·June 7, 2013
SYNCHRON CX5 DELTA CLINICAL ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·June 24, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 10, 2008
GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 3+
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·March 9, 2017
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024