479 results · 24ms · Sources: EU EUDAMED, US FDA

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AQUASIL ULTRA MONOPHASE/HEAVY/LV SMART WETTING IMPRESSION MATERIAL

FDA 510(k)
FDA Class 2 ·Dental

Safco FG Diamonds

FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310214163·FG Diamond 848-016 flat end taper coarse 5/pack

Cook

FDA UDI
COOK INCORPORATED·00827002161559·Open-End Tapered Tip Ureteral Catheter (Right)

OneTouch Ultra

FDA UDI
LifeScan U.S. LLC·00353885006231·One Touch Ultra Control Solution

Cook

FDA UDI
COOK INCORPORATED·00827002170056·Open-End Tapered Tip Ureteral Catheter (Right)

MUSCLE IMAGING SYSTEM (MIS)

FDA 510(k)
FDA Class 2 ·Radiology

CONFOSCAN 2 CONFOCAL MICROSCOPE

FDA 510(k)
FDA Class 2 ·Ophthalmic

GMK SPHERE TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·September 23, 2025

GMK-SPHERE PATELLA RESURFACING SIZE 2

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·June 25, 2024

GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T4-I3 R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 14, 2019

GMK SPHERE TOTAL KNEE SYSTEM

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code JWH·November 21, 2025

GMK SPHERE FEMORAL COMPONENT SIZE 4 LEFT

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 3, 2016

GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·June 22, 2021

GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·June 10, 2021

GMK SPHERE TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·October 2, 2025

GMK SPHERE TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 30, 2026

GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 26, 2019

FREESTYLE FLASH

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·May 29, 2007

INTERSTIM II

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·March 26, 2013

ALLURA XPER FD10

FDA Adverse Event
Malfunction ·PHILIPS HEALTHCARE·Product code IZI·February 8, 2011