90 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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THEKEN SPINE VU EPOD AND VU LPOD SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Malecot
FDA UDI
COOK INCORPORATED·00827002147720·Malecot Nephrostomy Catheter/Stent Set
THERMO TEK IR FOREHEAD THERMOMETER, MODEL 718F
FDA 510(k)
FDA Class 2
·General Hospital
NORAV HOLTER SYSTEM, MODEL NH-300 V1.07
FDA 510(k)
FDA Class 2
·Cardiovascular
QUADRA BROACH SIZE 0
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL, SA·Product code JDI·September 7, 2012
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·February 3, 2026
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·April 29, 2013
ENVE
FDA Adverse Event
Injury
·CAREFUSION 203, INC.·Product code CBK·April 27, 2011
840 VENTILATOR
FDA Adverse Event
Malfunction
·PURITAN BENNETT CORP.·Product code CBK·July 23, 2008
VERSAFITCUP CC TRIO 01.26.45.1150 ACETABULAR SHELL CC TRIO NO-HOLE Ø 50
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·December 7, 2021
PROGRESSIVE MEDICAL Laparoscopic Electrode PTFE Coated L Hook 33cm. Intended for the cutting of soft tissue and coagulation.
FDA Enforcement
Class II
·Terminated·Unimed Surgical Products, Inc.·May 29, 2013
VERSAFITCUP CC TRIO ACETABULAR SHELL 58
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code LZO·April 8, 2013
COCR BALL HEADS 32 SIZE M.
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·July 29, 2011
QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 4
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·December 19, 2017
QUADRA H FEMORAL STEMS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·May 15, 2026
QUADRA R FEMORAL STEMS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·March 3, 2026
VERSAFITCUP ACETABULAR SHELL CC TRIO DIAM 48
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·February 10, 2022
LINER: MPACT HOODED PE HC LINER Ø32/D
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·October 23, 2019
QUADRA H FEMORAL STEMS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·December 2, 2025
VERSAFITCUP CC TRIO ACETABULAR SHELL Ø 56
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·May 27, 2016