13 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
QIAstat-Dx® Respiratory Panel Plus
FDA 510(k)
FDA Class 2
·Microbiology
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994556233·CASE 9233100 CASE
SCHWERT
FDA UDI
A. Schweickhardt GmbH & Co. KG·E89652331000·O-ring uncolored, package of 10
suitab...
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113769·AIR INJECT CANNULA 30GA
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702778618·ELVAREX 2/KNEE HIGH/SLANT-OPEN TOE-ELEPHANTIASI...
CAREFINE PEN NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
TAIWAN KING STRONG POWERED WHEELCHAIR, TP 01
FDA 510(k)
FDA Class 2
·Physical Medicine
ZENIX
FDA UDI
Zoll Medical Corporation·00812394022984·ZENIX, HOSPITAL CRITICAL CARE TRANSPORT CONFIGU...
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·November 18, 2008
AC POWER MODULE
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·July 26, 2011
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·July 18, 2013
epoc BGEM Test Card (Catalogue number CT-1004-00-00). quantitative testing of samples for pH, pCO2, pO2, Sodium Potassium , Ionized Calcium, Glucose, Lactate and Hematocrit.
FDA Enforcement
Class II
·Terminated·Epocal·August 21, 2013
CODMAN Disposable Perforator, 14mm. Cranial perforator.
FDA Enforcement
Class I
·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025