13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Perforated Baskets
FDA 510(k)
FDA Class 2
·General Hospital
ADVIA® Chemistry CO2 Calibrator/Diluent
FDA UDI
Siemens Healthcare Diagnostics Inc.·00630414227887·Setpoint CO2 - ADVIA Chem. - CAL - 2x21mL
TORC BODY
FDA 510(k)
FDA Class 2
·Physical Medicine
CDR PANX, MODEL 4792
FDA 510(k)
FDA Class 2
·Dental
OPTILITE® FREELITE® KAPPA FREE KIT
FDA Adverse Event
Injury
·THE BINDING SITE LIMITED·Product code DFH·March 30, 2026
OPTILITE® FREELITE® KAPPA FREE KIT
FDA Adverse Event
Injury
·THE BINDING SITE LIMITED·Product code DFH·March 31, 2026
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 6, 2014
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·July 25, 2011
UNKNOWN DEPUY TIBIAL INSERT
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code JWH·July 17, 2013
PRODIGY AUTOCODE
FDA Adverse Event
Injury
·OK BIOTECH CO., LTD.·Product code NBW·March 17, 2019
MAKOPLASTY® PARTIAL KNEE END EFFECTOR
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·July 5, 2016
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025