21 results · 25ms · Sources: EU EUDAMED, 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