14 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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QLAB Advanced Quantification Software
FDA 510(k)
FDA Class 2
·Radiology
Halyard
FDA UDI
Avanos Medical, Inc.·10680651931921·HYH,UBLOCK,UBT,-,-,10
TEMPUS IC PROFESSIONAL PATIENT MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002
FDA 510(k)
FDA Class 1
·General Hospital
QUADRA-P FEMORAL STEMS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·November 18, 2025
OCTRODE PERCUTANEOUS LEAD
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 21, 2011
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 21, 2013
UNKNOWN DEPUY INSERT
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·September 29, 2008
VERSAFITCUP DM DOUBLE MOBILITY HC LINER 50/28
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·May 17, 2021
CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 60
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·July 10, 2024
LINER: MPACT DM DOUBLE MOBILITY HC LINER 28/DMH
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·January 13, 2023
MPACT ACETABULAR SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·February 6, 2025
MECTACER BIOLOX DELTA FEMORAL BALL HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·July 16, 2025
Mutlidiagnost-Eleva with Flat Detector 708034 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Nederlands·May 9, 2018