13 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Powder Free Green Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Pink Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Purple Nitrile Examination Gloves (XS/S/M/L/XL)
FDA 510(k)
FDA Class 1
·General Hospital
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
Akros Scruture Anchor LisFranc Repair Kit
FDA 510(k)
FDA Class 2
·Orthopedic
META-C CERVICAL PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·October 27, 2023
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
530G INSULIN PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·November 10, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·September 9, 2011
1.85MM X 16MM FLUTED ROUTER
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOL·Product code HBC·July 17, 2013
CERVICAL PLATE FIXED SELF-TAPPING SCREW DIAM. 4X18MM (2X)
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code KWQ·September 15, 2021
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025