13 results
·
23ms
·
Sources: EU EUDAMED, US FDA
NANOBLUTM 500
FDA 510(k)
FDA Class 2
·General Hospital
DD tempMED
FDA UDI
Dental Direkt GmbH·EDDIK113201·DD tempMED are pre-colored dental milling blank...
ASP
FDA UDI
SEDATELEC·03760262493459·The ASP Multi, Semi-Permanent Needle, is an ori...
RAUMEDIC- ICP-MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
TINA-QUANT APOLIPOPROTEIN B VER.2
FDA 510(k)
FDA Class 2
·Immunology
COOK® CERVICAL RIPENING BALLOON
FDA Adverse Event
Malfunction
·COOK INC·Product code PFJ·July 18, 2016
COOK® CERVICAL RIPENING BALLOON
FDA Adverse Event
Malfunction
·COOK INC·Product code PFJ·July 19, 2016
IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP·Product code LLZ·February 28, 2014
ACCU-CHEK RAPID-D
FDA Adverse Event
Malfunction
·FRESENIUS KABI DEUTSCHLAND GMBH·Product code FPA·May 15, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 3, 2011
Accu-Chek FlexLink 1 infusion set; 10/60; Ref number 04540875001. (Distributed outside of the U.S. only).
FDA Recall
Terminated
·Disetronic Medical Systems, Inc.·Product code LZG·March 31, 2006
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
FDA Enforcement
Class I
·Ongoing·Covidien·November 8, 2023
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021