86 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
FDA 510(k)
FDA Class 1
·General Hospital
K131982
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·February 23, 2024
VITEK 2 GRAM NEGATIVE ERTAPENEM
FDA 510(k)
FDA Class 2
·Microbiology
MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M ADAPTER EX3180
FDA 510(k)
FDA Class 2
·Cardiovascular
PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X40MM LOT. 1
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·December 13, 2019
M.U.S.T. POLYAXIAL PEDICLE SCREW
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·November 10, 2025
PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X30MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·May 14, 2024
PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 7X35MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·March 10, 2021
PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X35MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·November 22, 2023
M.U.S.T. RODS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KWP·March 31, 2026
BIPAP PRO BIFLEX
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·March 2, 2026
DREAMSTATION BIPAP AUTOSV
FDA Adverse Event
Malfunction
·RESPIRONICS, INC·Product code MNS·March 30, 2022
MYSPINE MC DRILL BASED GUIDE L05
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PQC·December 10, 2019
REMSTAR SYSTEM ONE 60 SERIES
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·October 31, 2024
REMSTAR SYSTEM ONE 60 SERIES
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·January 19, 2026
REMSTAR AUTO
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·August 20, 2021
REMSTAR PRO
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·August 20, 2021
MECTALIF OBLIQUE (TI PEEK) TIPEEK 10X24X10 L5°
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MAX·June 25, 2024
DREAMSTATION BIPAP AUTOSV
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code MNS·March 30, 2022
OMNILAB ADVANCED PLUS
FDA Adverse Event
Malfunction
·RESPIRONICS, INC·Product code MNS·March 31, 2022