14 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Rx Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
BIODERM SCIENCES WOUND DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
0180 INTUITION, 0072 PRECISION
FDA 510(k)
FDA Class 2
·Radiology
CERTAIN EP HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 4MM(H)
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NHA·March 29, 2021
BD VACUTAINER® ONE USE HOLDER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·December 27, 2019
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE.LTD.·Product code FRN·November 25, 2008
STERILE WATER FOR IRRIGATION
FDA Adverse Event
Malfunction
·HOSPIRA·Product code KPE·August 26, 2011
PAINSMART IOD
FDA Adverse Event
Malfunction
·MOOG DEVICE GROUP·Product code FRN·July 16, 2013
INSPIRE 7F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
FDA Adverse Event
Injury
·SORIN GROUP ITALIA SRL·Product code DTZ·September 15, 2022
INSPIRE 7F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL.·Product code DTZ·March 12, 2024
INSPIRE 7F
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·June 24, 2025
INSPIRE 7F
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·February 5, 2025
RECLAIM Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025