14 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SFI-BAR IMPLANT ABUTMENTS
FDA 510(k)
FDA Class 2
·Dental
CUFFINK
FDA 510(k)
FDA Class 2
·Orthopedic
ELECYSYS SHBG
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 29, 2025
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 4, 2024
UNKNOWN PATHINDER NXT OR INSTINCT JAVA IMPLANT
FDA Adverse Event
Malfunction
·ZIMMER BIOMET SPINE INC.·Product code NKB·September 24, 2022
POUNCE VENOUS THROMBECTOMY SYSTEM
FDA Adverse Event
Injury
·SURMODICS INC·Product code QEW·May 16, 2024
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 29, 2013
S4S/SUR-FIT NATURA 2 PC - 2 PC STOMAHESIVE (SH) WAFER W/FLEXIBLE COLLAR
FDA Adverse Event
Injury
·CONVATEC INC.·Product code EXE·September 29, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·June 17, 2011
ROD, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code NKB·May 9, 2019
PEDICLE SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code NKB·May 9, 2019
PEDICLE SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code NKB·May 9, 2019
Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026