22 results · 25ms · Sources: EU EUDAMED, US FDA

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CURVE Laser System

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

EV1000 PLATFORM MODEL: EV1000A, EV1000DB, EV1000M

FDA 510(k)
FDA Class 2 ·Cardiovascular

ROCHE ELECSYS PTH TEST SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

CRE PULMONARY

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KTI·March 31, 2025

VERSACROSS CONNECT LAAC ACCESS SOLUTION

FDA Adverse Event
Injury ·BAYLIS MEDICAL COMPANY INC.·Product code DRE·April 6, 2023

CRE PULMONARY

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KTI·June 11, 2025

CRE PULMONARY

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KTI·May 30, 2025

CRE PULMONARY

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KTI·March 5, 2025

CRE PULMONARY

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KTI·June 5, 2025

CRE PULMONARY

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KTI·January 28, 2025

CRE PULMONARY

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KTI·July 28, 2025

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·July 12, 2011

PINNACLE MTL INS NEUT36IDX50OD

FDA Adverse Event
Injury ·8010379 DEPUY INTL., LTD.·Product code KWA·June 14, 2013

RESTORE ULTRA

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO·Product code LGW·September 16, 2008

VERSACROSS ACCESS SOLUTION

FDA Adverse Event
Injury ·BAYLIS MEDICAL COMPANY INC.·Product code DXF·April 19, 2023

CRE PULMONARY

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KTI·September 30, 2025

VERSACROSS ACCESS SOLUTION

FDA Adverse Event
Injury ·BAYLIS MEDICAL COMPANY INC.·Product code DYB·April 20, 2023

VERSACROSS CONNECT LAAC ACCESS SOLUTION

FDA Adverse Event
Injury ·BAYLIS MEDICAL COMPANY INC.·Product code DXF·April 25, 2023

CRE PULMONARY

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KTI·May 12, 2025

CRE PULMONARY

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KTI·January 10, 2025