75 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RocaJJ Soft Stents
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
POWDER FREE NITRILE EXAMINATION GLOVES WHITE COLORED NON-STERILE
FDA 510(k)
FDA Class 1
·General Hospital
BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
OBTURATOR FOR VENFLON/SAFELON1.0X32
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·December 10, 2019
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 15, 2014
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·July 23, 2011
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 17, 2013
AMISTEM-P COLLARED
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·December 18, 2025
CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø50
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·September 15, 2023
AMISTEM-P COLLARED
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·March 30, 2026
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 6.0MM FLEXTEND PEDIATRIC PLUS VEE TRACH TUBE , Product Code/List Number/Item Code 60PFP60
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024
VERSAFITCUP CC TRIO 01.26.45.0050 ACETABULAR SHELL CC TRIO Ø 50
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·November 25, 2021
BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·July 22, 2022
AMISTEM-P
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·March 30, 2026
CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL Ø 56
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·December 14, 2021
LINER: VERSAFITCUP DOUBLE MOBILITY HC 48/28
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·September 27, 2021
VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 52/28
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·August 2, 2023
STEM: AMISTEM-P COLLARED AMISTEM-P COLLARED STD STEM SIZE 3
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·September 7, 2023
CUP: VERSAFITCUP CC TRIO 01.26.45.0048 ACETABULAR SHELL CC TRIO DIAM 48
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·September 15, 2021
BALL HEADS: BIPOLAR HEAD BIPOLAR HEAD Ø28X50
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KWY·September 2, 2019