19 results · 22ms · Sources: EU EUDAMED, US FDA

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Dental Air Polishing Handpiece

FDA 510(k)
FDA Class 1 ·Dental

Tyber Medical

FDA UDI
Tyber Medical, LLC·M695502P221548S1·PLIF 22mm x 8mm x 15mm x 4 °, TyPEEK, Sterile

Tyber Medical

FDA UDI
Tyber Medical, LLC·M695302P221548S1·PLIF 22mm x 8mm x 15mm x 4 °, PEEK, Sterile

SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS)

FDA 510(k)
FDA Class 2 ·Orthopedic

FOTONA DUALIS ND:YAG/ER:YAG LASER SYSTEM

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

GMK SPHERE CEMENTLESS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MBH·May 25, 2026

GMK SPHERE TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 21, 2024

GMK 3D METAL TIBIAL TRAY

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·May 12, 2025

GMK SPHERIKA CEMENTLESS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MBH·March 16, 2026

COBAS 6000 E601 MODULE

FDA Adverse Event
Malfunction ·HITACHI HIGH TECH. CORP.·Product code JJE·November 5, 2008

XCEL DILATING TIP TROCAR

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·August 24, 2011

MERIDIAN FILTER SYSTEM- FEMORAL

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·July 1, 2013

GMK SPHERIKA CEMENTLESS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MBH·December 19, 2025

GMK SPHERIKA CEMENTLESS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MBH·December 24, 2025

GMK 3D METAL TIBIAL TRAY

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 11, 2025

MECTALIF ANT - LAG

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code OVD·April 12, 2024

SPECIFIC DEVICE NOT REPORTED

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code PHX·January 27, 2025

GMK 3D METAL TIBIAL TRAY

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·September 29, 2025

Model Number L111, ESSENTIO DR SL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025