28 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Pain Therapy Device(Model: P.T.S-X)
FDA 510(k)
FDA Class 2
·Physical Medicine
Zavation
FDA UDI
Zavation LLC·00197157002794·CIF 14x18, 7 deg, -11
IWL2020 Blood Glucose Monitoring System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
INFINITY CENTRALSTATION WITH INFINITY M300
FDA 510(k)
FDA Class 2
·Cardiovascular
CANNULATED CONNECTING SCREW FOR STANDARD INSERTION HANDLE
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code FZX·January 29, 2021
MPACT ACETABULAR SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·January 23, 2026
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 6, 2014
XIA DEFORMITY UNI-PLANAR SCREW 5.5 X 45MM
FDA Adverse Event
Injury
·STRYKER SPINE BORDEAUX·Product code NKB·August 17, 2011
TOTAL ASR ACET IMP SIZE 62
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD.8010379·Product code KWA·July 16, 2013
MECTACER BIOLOX DELTA FEMORAL BALL HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·November 13, 2024
MECTACER BIOLOX DELTA FEMORAL BALL HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·August 13, 2025
MPACT ACETABULAR SYSTEM IMPLANTS
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code LPH·November 5, 2025
MPACT ACETABULAR SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·December 18, 2025
FOLYSIL TIEMANN CATH 5/15ML
FDA Adverse Event
Injury
·COLOPLAST A/S·Product code EZL·October 24, 2018
FOLYSIL TIEMANN CATH 5/15ML
FDA Adverse Event
Injury
·COLOPLAST A/S·Product code EZL·October 24, 2018
FOLYSIL TIEMANN CATH 5/15ML
FDA Adverse Event
Injury
·COLOPLAST A/S·Product code EZL·October 24, 2018
MECTACER BIOLOX DELTA FEMORAL BALL HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·August 27, 2025
AMISTEM-P COLLARED
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·April 14, 2025
MPACT ACETABULAR SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·February 6, 2026
IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.
FDA Enforcement
Class II
·Ongoing·Philips Medical Systems Nederland B.V.·May 14, 2025