21 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DENTAL BONE SCREWS; DENTAL BONE SCREWS, CONTINUING; SCREW SYSTEM TX; SCREW SYSTEM TX PROFESSIONAL
FDA 510(k)
FDA Class 2
·Dental
Proximal Lateral Tibia Plate
FDA UDI
I.T.S. GmbH·09120034307133·Proximal Lateral Tibia Plate, 12-Hole, Left
CRILE-WOOD NEEDLE HOLDER
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896075870·CRILE-WOOD NEEDLE HOLDER STRAIGHT TUNGSTEN CARB...
SYRINGE 0.3ML 31G 6MM S/C U-100 RELION
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMI·January 25, 2021
KYPHX DIRECTIONAL INFLATABLE BONE TAMP, MODELS K16A AND K17A
FDA 510(k)
FDA Class 2
·Orthopedic
D-STAT DRY SILVER; D-STAT DRY CLEAR SILVER; D-STAT DRY WRAP SILVER; THROMBIX SILVER
FDA 510(k)
FDA Unclassified
·Unknown
SYRINGE 0.3ML 31G 6MM S/C U-100 RELION
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·February 3, 2021
TENSION FREE VAGINAL TAPE - RETROPUBIC UNKNOWN PRD
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·October 9, 2018
TENSION FREE VAGINAL TAPE - RETROPUBIC UNKNOWN PRD
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·October 9, 2018
FUJIFILM 600 SERIES ENDOSCOPE EC-600WM
FDA Adverse Event
Malfunction
·FUJIFILM CORPORATION·Product code FDF·January 22, 2025
I.T.S. LRS (Locking Reconstruction System) with the below descriptions and corresponding article numbers. 1. DFL (Distal Femur Locking) Distal Femur Plate; Article Numbers: 21301-5, 21301-7, 21301-9, 21301-13, 21302-5, 21302-7, 21302-9, 21302-13. 2. PTL (Proximal Lateral Tibia Locking) Proximal Lateral Tibia Plate; Article Numbers: 21321-7, 21321-12, 21322-7, 21322-12. 3.PTL (Proximal Lateral Tibia Locking) Proximal Medial Tibia Plate; Article Numbers: 21325-4, 21325-7.
FDA Enforcement
Class II
·Ongoing·I.T.S. GmbH·April 1, 2026
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 29, 2013
SELUTE PICOTIP
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·October 1, 2014
ZENITH FLEX AA ENDOVASCULAR GRAFT ILIAC LEG
FDA Adverse Event
Injury
·COOK, INC.·Product code MIH·June 14, 2011
ZELTIQ COOLCORE (6.3)
FDA Adverse Event
Injury
·ZELTIQ AESTHETICS INC.·Product code OOK·June 19, 2014
TENSION FREE VAGINAL TAPE - RETROPUBIC UNKNOWN PRD
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·October 10, 2018
TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·October 9, 2018
TENSION FREE VAGINAL TAPE - RETROPUBIC UNKNOWN PRD
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·October 9, 2018
TENSION FREE VAGINAL TAPE - RETROPUBIC UNKNOWN PRD
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·October 9, 2018
SYRINGE 0.3ML 31G 6MM S/C U-100 RELION
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·April 23, 2021