27 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40
FDA 510(k)
FDA Class 2
·Orthopedic
MODIFICATION TO DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
REUNITE FUSION SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
BIPAP AUTOSV ADVANCED SYSTEM ONE
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code MNS·February 25, 2022
DREAMSTATION AUTO CPAP
FDA Adverse Event
Injury
·RESPIRONICS, INC·Product code BZD·November 2, 2021
OMEGA-21 VERTEBRAL FIXATION SYSTEM
FDA Adverse Event
Malfunction
·BIOMET SPAIN, S.L.·Product code MNH·February 21, 2020
ROD, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code MNH·May 14, 2019
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·March 26, 2019
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 16, 2013
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·September 4, 2014
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·April 18, 2011
ILIAC SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code MNH·October 16, 2019
PEDICLE SCREW, UNKNOWN TYPE OR SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code MNH·August 30, 2021
UNKNOWN LUMBAR IMPLANT
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code MAX·April 11, 2022
CLOSURE TOP UNSPECIFIED
FDA Adverse Event
Malfunction
·ZIMMER BIOMET SPINE INC.·Product code NKB·April 20, 2021
CLOSURE TOP UNSPECIFIED
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code NKB·April 20, 2021
CLOSURE TOP UNSPECIFIED
FDA Adverse Event
Malfunction
·ZIMMER BIOMET SPINE INC.·Product code MNH·April 20, 2021
POLARIS SCREW, DIA. 6.5 X UNKNOWN LENGTH
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE, INC.·Product code NKB·May 28, 2025
POLARIS SCREW, DIA. 6.5 X UNKNOWN LENGTH
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE, INC.·Product code NKB·May 28, 2025
POLARIS SCREW, DIA. 6.5 X UNKNOWN LENGTH
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE, INC.·Product code NKB·May 28, 2025