59 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DIMENSION CLINICAL CHEMISTRY SYSTEM LIPASE CALIBRATOR, MODEL DC56
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810057371035·STRETCHER PAD 26" W X 2" H X 74" L STANDARD
K091319
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·January 9, 2026
XIA SPINE SYSTEM HOOKS
FDA 510(k)
FDA Class 2
·Orthopedic
STRYKER TITANIUM CROSS-SCREW SYSTEM, MODEL 234-500-1XX
FDA 510(k)
FDA Class 2
·Orthopedic
REMSTAR AUTO A-FLEX
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·January 12, 2026
REMSTAR AUTO A-FLEX, SYS ONE, 60 SRS, FR
FDA Adverse Event
Injury
·RESPIRONICS, INC·Product code BZD·August 5, 2021
REMSTAR PRO C-FLEX
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·December 31, 2025
REMSTAR
FDA Adverse Event
Injury
·RESPIRONICS, INC.·Product code BZD·October 22, 2024
BIPAP PRO BIFLEX
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·March 5, 2026
REMSTAR
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·October 28, 2024
DREAMSTATION AUTO CPAP
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·April 10, 2025
REMSTAR PRO C-FLEX+
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·January 7, 2026
ALTRX NEUT 36IDX60OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LPH·April 26, 2013
LIGASURE IMPACT
FDA Adverse Event
Injury
·COVIDIEN LP (VALLEYLAB)·Product code GEI·April 28, 2011
ACRYSOF RESTOR
FDA Adverse Event
Injury
·ALCON RESEARCH,, LTD./HUNTINGTON·Product code MFK·July 24, 2008
REMSTAR PLUS C-FLEX
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·July 17, 2024
REMSTAR PLUS C-FLEX
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·January 5, 2026
REMSTAR PRO C-FLEX+
FDA Adverse Event
Malfunction
·RESPIRONICS INC·Product code BZD·May 20, 2022
REMSTAR AUTO A-FLEX
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·May 23, 2022