20 results · 27ms · Sources: EU EUDAMED, US FDA

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ZQUIET PRO-PLUS

FDA 510(k)
FDA Class 2 ·Dental

XTRACT SYRINGE KEY SYSTEM

FDA 510(k)
FDA Class 2 ·General Hospital

MODIFICATION TO ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000), ARTHROCARE PATIENT CABLE, FOOT CONTROL, POWER CORD, WANDS

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

UNKNOWN_NEUROVASCULAR_PRODUCT

FDA Adverse Event
Death ·CONCENTRIC MEDICAL·Product code NRY·December 13, 2012

AGC DA2000 KN TIB BRG 71/75X8

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code NRA·April 9, 2026

UNKNOWN_NEUROVASCULAR_PRODUCT

FDA Adverse Event
Death ·CONCENTRIC MEDICAL·Product code NRY·December 13, 2012

UNKNOWN_NEUROVASCULAR_PRODUCT

FDA Adverse Event
Death ·CONCENTRIC MEDICAL·Product code NRY·December 13, 2012

OBTAPE TRANSOBTURATOR SLING

FDA Adverse Event
Injury ·MENTOR WORLDWIDE LLC·Product code OTN·May 8, 2013

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·September 26, 2014

ENRHYTHM DR

FDA Adverse Event
Injury ·MEDTRONIC MED REL, INC.·Product code DXY·June 13, 2011

UNKNOWN_NEUROVASCULAR_PRODUCT

FDA Adverse Event
Death ·CONCENTRIC MEDICAL·Product code NRY·December 13, 2012

UNKNOWN_NEUROVASCULAR_PRODUCT

FDA Adverse Event
Death ·CONCENTRIC MEDICAL·Product code NRY·December 18, 2012

SELDRILL-SCHANZSCR Ø5 L200/80 SST

FDA Adverse Event
Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018

VANGUARD ROCC POR FEM S55 R

FDA Adverse Event
Malfunction ·BIOMET UK LTD.·Product code MBH·January 22, 2026

VANGUARD ROCC POR FEM S57.5 L

FDA Adverse Event
Malfunction ·BIOMET UK LTD.·Product code MBH·January 22, 2026

VANGUARD ROCC POR FEM S57.5 L

FDA Adverse Event
Malfunction ·BIOMET FRANCE S.A.R.L.·Product code MBH·May 13, 2025

TINBN VANGUARD INT PS ANAT FM R 75MM

FDA Adverse Event
Malfunction ·BIOMET UK LTD.·Product code MBH·June 4, 2025

VANGUARD ROCC POR FEM S55 R

FDA Adverse Event
Malfunction ·BIOMET FRANCE S.A.R.L.·Product code MBH·June 4, 2025

SELDRILL-SCHANZSCR Ø5 L200/80 SST

FDA Adverse Event
Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018

Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024