15 results
·
21ms
·
Sources: EU EUDAMED, US FDA
KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set
FDA 510(k)
FDA Class 2
·Orthopedic
MONACO RTP SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
IDS-ISYS IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION VERIFIERS, AND IDS-ISYS IGFBP-3 CAL...
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CAPSUREFIX NOVUS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 22, 2011
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 7, 2013
2250051-2008-00316
FDA Adverse Event
Malfunction
·Product code JTC·July 9, 2008
UNKNOWN
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·July 26, 2024
ROADRUNNER EXTRA-SUPPORT BARE MANDRIL WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·January 19, 2021
CONQUEST PRO 12 ST
FDA Adverse Event
Injury
·ASAHI INTECC CO., LTD.·Product code DQX·July 16, 2025
PERFORMER MULLINS GUIDING SHEATH
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·January 20, 2023
PERFORMER MULLINS GUIDING SHEATH
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·January 24, 2024
ASTATO XS 9-12
FDA Adverse Event
Malfunction
·ASAHI INTECC CO., LTD.·Product code DQX·June 24, 2025
PERFORMER INTRODUCER
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·November 4, 2022
FreeStyle Libre Reader, REF: 71936-01, 71937-01, 71938-01 a component of the FreeStyle Libre 14 Day Flash Glucose Monitoring System
FDA Recall
Open, Classified
·Abbott Diabetes Care, Inc.·Product code PZE·February 13, 2023
FreeStyle Libre Reader, REF: 71936-01, 71937-01, 71938-01 a component of the FreeStyle Libre 14 Day Flash Glucose Monitoring System
FDA Enforcement
Class I
·Ongoing·Abbott Diabetes Care, Inc.·April 12, 2023