23 results · 26ms · Sources: EU EUDAMED, US FDA

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K3Pro Konus New Abutments and Implants

FDA 510(k)
FDA Class 2 ·Dental

APEX Knee System

FDA UDI
Omni Life Science, Inc.·00841690189442·Apex Revision Knee System - Revision Tibia Tray...

Ophthalmic Retractor

FDA UDI
KATENA PRODUCTS, INC.·00841668101100·HELVESTON "GREAT BIG BARBIE" RETRACTOR 11MM

Ophthalmic Retractor

FDA UDI
KATENA PRODUCTS, INC.·00841668101094·HELVESTON "BIG BARBIE" RETRACTOR 9MM

APEX Knee System

FDA UDI
Omni Life Science, Inc.·00841690189435·Apex Revision Knee System - Revision Tibia Tria...

BILI BLUE F20T12/BBY AND F40T12/BBY

FDA 510(k)
FDA Class 2 ·General Hospital

STRONG DENTAL HANDPIECES

FDA 510(k)
FDA Class 1 ·Dental

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·January 29, 2021

SOLAR 8000

FDA Adverse Event
Malfunction ·GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES·Product code MHX·January 31, 2007

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·November 10, 2023

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 20, 2020

STELLARIS OPTIMIZED STABILITY VAC PK 6/BX

FDA Adverse Event
Malfunction ·BAUSCH & LOMB, INC.·Product code HQC·October 8, 2014

XEN 45 GTS

FDA Adverse Event
Injury ·ALLERGAN (IRVINE)·Product code KYF·July 12, 2019

XEN 45 GTS

FDA Adverse Event
Injury ·ALLERGAN (IRVINE)·Product code KYF·July 12, 2019

QUICKSITE LV

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, CRMD·Product code OJX·January 11, 2014

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011

SITTER SELECT

FDA Adverse Event
Malfunction ·J. T. POSEY CO.·Product code KMI·June 10, 2013

FUHRMAN PLEURAL & PNEUMOPERICARDIAL DRAINAGE SET

FDA Adverse Event
Injury ·COOK, INC.·Product code DQY·March 29, 2007

TRAM451N

FDA Adverse Event
Malfunction ·GE HEALTHCARE·Product code DRT·March 14, 2007

FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET

FDA Adverse Event
Death ·COOK INC·Product code GBX·August 11, 2022