14 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CINtec Histology
FDA 510(k)
FDA Class 2
·Pathology
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·04546540366696·PLATE BENDER, LEFT, 1.2/1.7MM
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613154731794·TENSION PLIERS FOR ANCHOR SCREWS
SILICONE SPHERES
FDA 510(k)
FDA Class 2
·Ophthalmic
ULTRACISION HARMONIC SCALPEL BLADES WITH PROTECTIVE SLEEVE, MODELS DH105, DH145, SH105, SH145
FDA 510(k)
FDA Unclassified
·Unknown
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 6, 2025
ULTRACISION SURG DEV, BLADES 5MM, OPEN
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.(CINCINNATI)·Product code LFL·June 15, 2006
ULTRACISION SURG DEV, BLADES 5MM, OPEN
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code LFL·June 19, 2006
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 29, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 15, 2011
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·July 8, 2013
PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code MBL·October 17, 2025
PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code MEH·October 15, 2025
MR Coils The MR Coil is intended to be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician.
FDA Enforcement
Class III
·Terminated·Invivo Corporation·October 28, 2020