21 results
·
24ms
·
Sources: EU EUDAMED, US FDA
BIOPSY POSITIONER
FDA 510(k)
FDA Class 2
·Radiology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517564214·CoRoent Ant TLIF PEEK, 11x13x28mm 4°
Medetz Surgical Instruments
FDA UDI
Medetz Surgical Instruments LLC·G223113284220·McIntyre anterior chamber cannula, 26 gauge, 12...
LAMINOPLASY PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
LUMEND FRONTRUNNER CTO CORONARY CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
OPTICROSS HD
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·March 28, 2025
OPTICROSS? HD
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·July 7, 2025
OPTICROSS? HD
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·July 22, 2025
OPTICROSS? HD
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·February 11, 2025
OPTICROSS? HD
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·April 3, 2025
OPTICROSS? HD
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·December 11, 2025
OPTICROSS? HD
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·September 16, 2025
OPTICROSS? HD
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·January 13, 2026
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 8, 2013
ASR ACETABULAR CUPS 54
FDA Adverse Event
Injury
·DEPUY INTL., LTD.·Product code KWA·May 20, 2011
DIMENSION CLINICAL CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JJE·August 8, 2008
4.5 BROAD SCP PLT 26-H STER
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017
OPTICROSS? HD
FDA Adverse Event
Death
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·May 22, 2025
OPTICROSS? HD
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·February 26, 2025
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