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

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DISPOSABLE THERMOMETER PROBE SHEATHS

FDA 510(k)
FDA Class 2 ·General Hospital

Ophthalmic Speculum

FDA UDI
KATENA PRODUCTS, INC.·00841668100608·KATENA DOUBLE-X SPECULUM K-WIRE SMALL

FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

SURETEK REPROCESSED LAPAROSCOPIC INSTRUMENTS

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

BD LUER-LOK¿ SYRINGE

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·May 31, 2023

APOLLO GENERATOR

FDA Adverse Event
Malfunction ·PENUMBRA, INC.·Product code GWG·June 11, 2015

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 8, 2014

STENOSCOP

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 24, 2011

PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

FDA Adverse Event
Malfunction ·RICE CREEK MFG·Product code LWP·June 7, 2013

ELAN 4 MIS SLEEVE F/1-RING HANDPIECES

FDA Adverse Event
Injury ·AESCULAP AG·Product code HBC·October 28, 2018

smiths medical ProPort Low Profile Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9Fr Introducer, REF 21-4187-24

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD, Inc.·March 26, 2025

ELAN 4 ELECTRO MOTOR CABLE W/HAND SWITCHHIGH SPEED POWER SYSTEMS

FDA Adverse Event
Malfunction ·AESCULAP AG·Product code HBC·November 5, 2018

ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

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