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

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ARZO TAPCATH ESOPHAGEAL RECORDING CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

VuePoint

FDA UDI
Nuvasive, Inc.·00887517177094·VuePoint Cross Conn, 3.5x36mm Fixed Rod

SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDE

FDA 510(k)
FDA Class 2 ·Dental

OCULAR SCIENCES, INC. BIOMEDICS 52 (OCUFILCON D) UV BLOCKING DAILY WEAR SOFT CONTACT LENS

FDA 510(k)
FDA Class 2 ·Ophthalmic

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE REHABILITATION EQUIP·Product code CAW·June 30, 2014

EON MINI

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·January 2, 2013

ECLIPSE FILTER SYSTEM-FEMORAL

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·November 11, 2010

The 9025TRU Arterial Blood Gas (ABG) Kit is used to obtain arterial blood sampling for pH, Blood Gas, Electrolyte and Metabolite Analysis.

FDA Enforcement
Class II ·Terminated·Cardinal Health·September 7, 2016

Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024

smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024