42 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PATIENT MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
AED
FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657018180·Wide Jaw Punch small 3.5mm 30 degree right
AFFIITY CP CENTRIFUGAL BLOOD PUMP
FDA 510(k)
FDA Class 2
·Cardiovascular
IPLAN
FDA 510(k)
FDA Class 2
·Neurology
REMINGTON I-LIGHT HAIR REMOVAL SYSTEM
FDA Adverse Event
Injury
·SHASER INC·Product code ONF·May 21, 2021
MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S - 4
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·April 21, 2017
BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE S
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·March 17, 2023
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 20, 2013
TIP FOR DHS®/DCS® IMPACTOR
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code HWA·September 26, 2014
TAPERED IMPLANT DENSE BONE TAP 6 X 11.5MM
FDA Adverse Event
Injury
·BIOMET 3I·Product code HWX·June 10, 2011
BALL HEADS: COCR BALL HEAD 12/14 32 SIZE S -3.5
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·January 8, 2021
AMISTEM H FEMORAL CEMENTLESS STEM SIZE 1 STD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code LZO·February 27, 2014
VERSAFITCUP CC TRIO ACETABULAR SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·May 26, 2026
MECTACER BIOLOX DELTA FEMORAL BALL HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·December 20, 2024
MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633. The MAYFIELD Skull Clamps (A3059) are indicated for use in open and percutaneous craniotomies, as well as spinal surgery when rigid skeletal fixation is necessary.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corporation·December 26, 2012
VERSAFITCUP CC TRIO NO-HOLE ACETABULAR SHELL Ø 48
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·November 23, 2017
CUP: VERSAFITCUP CC TRIO Ø 48
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·May 2, 2019
AMISTEM H SIZE 2 STD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·November 8, 2013
VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 52
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·April 6, 2018
VERSAFITCUP CC TRIO ACETABULAR SHELL Ø 50
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·April 7, 2017