14 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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CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, PHASED AND CONVEX PROBE, PENCIL AND CONVEX PROBE
FDA 510(k)
FDA Class 2
·Radiology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517574954·CoRoent Ant TLIF Ti, 14x10x36mm 4°
SEMKEN TISSUE FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896076471·SEMKEN TISSUE FORCEPS WITH TUNGSTEN CARBIDE PLA...
CERVICAL PLATE VARIABLE SELF-DRILLING SCREW DIAM. 4X16MM (2X)
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code KWQ·November 10, 2016
CERVICAL PLATE FIXED SELF-TAPPING SCREW DIAM. 4X14MM (2X)
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KWQ·September 13, 2018
GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MEDPOR CRANIOFACIAL IMPLANTS WITH EMBEDDED TITANIUM MESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MECTA C VARIABLE SELF-DRILLING SCREW DIAM. 4X18MM (2X)
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code KWQ·June 24, 2022
CERVICAL PLATE VARIABLE SELF-TAPPING SCREW DIAM. 4X14MM (2X)
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KWQ·June 8, 2018
TENDRIL ST
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC. CRMD·Product code DTB·January 13, 2014
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·May 31, 2013
GRASEBY 500 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·SMITHS MEDICAL INTL. LTD.·Product code FRN·June 17, 2011
CERVICAL PLATE FIXED SELF-TAPPING SCREW DIAM. 4X18MM (2X)
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code KWQ·September 15, 2021
STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a board range of medical devices and surgical instruments.
FDA Enforcement
Class II
·Terminated·Advanced Sterilization Products·April 10, 2013