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

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Microlife Upper Arm Automatic Digital Blood Pressure Monitor

FDA 510(k)
FDA Class 2 ·Cardiovascular

Ophthalmic Speculum

FDA UDI
KATENA PRODUCTS, INC.·00841668100318·ALPHONSO INFANT SPECULUM

Sklar®

FDA UDI
SKLAR CORPORATION·10649111076169·SKLHN GORNEY SCISS STR 7 1/4"

Ophthalmic Speculum

FDA UDI
KATENA PRODUCTS, INC.·00841668100325·INFANT WIRE SPECULUM 4MM BLADE

FDI GLUCOSE CONTROL SOLUTION FOR FREESTYLE

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ATLANTIS ABUTMENT FOR ZIMMER INTERFACE

FDA 510(k)
FDA Class 2 ·Dental

153-450

FDA Adverse Event
Injury ·SANTA BARBARA·Product code FTR·January 25, 2006

153-450

FDA Adverse Event
Injury ·SANTA BARBARA·Product code FTR·January 25, 2006

HUMAPEN ERGO 3 ML

FDA Adverse Event
Injury ·ELI LILLY AND CO.·Product code KZE·November 1, 2002

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·June 8, 2013

EASYTRAK 2

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code OJX·July 7, 2011

SMART CONTROL NITINOL STENT SYSTEM

FDA Adverse Event
Injury ·CORDIS DE MEXICO·Product code FGE·September 5, 2008

FLEXOR SHUTTLE TIBIAL GUIDING SHEATH

FDA Adverse Event
Injury ·COOK INC·Product code DYB·October 29, 2025

FLEXOR SHUTTLE TIBIAL GUIDING SHEATH

FDA Adverse Event
Injury ·COOK INC·Product code DYB·October 29, 2025

DYB INTRODUCER, CATHETER

FDA Adverse Event
Injury ·COOK INC·Product code DYB·November 12, 2025

FLEXOR SHUTTLE SELECT GUIDING SHEATH

FDA Adverse Event
Injury ·COOK INC·Product code DYB·October 29, 2025

UNKNOWN

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·September 15, 2020

FLEXOR SHUTTLE SELECT GUIDING SHEATH

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·February 7, 2020

Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator

FDA Enforcement
Class II ·Ongoing·Abbott·November 8, 2023

ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

FDA Enforcement
Class II ·Ongoing·Elekta, Inc.·December 13, 2023