11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NMI CONTROL SYRINGE, 7 ML NMI CONTROL SYRINGE, 8 ML
FDA 510(k)
FDA Class 2
·Cardiovascular
pillow, Maquet Transfer Board
FDA UDI
Noras MRI products GmbH·04251269204760·
FUJI VII CAPSULE
FDA 510(k)
FDA Class 2
·Dental
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
THREADED HAMMER GUIDE CONNECTOR
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code LXH·September 17, 2021
PLUM Y-BLOOD SET W/FLR CALVE 110IN NDEHP
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·May 8, 2013
IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP.·Product code LLZ·February 28, 2014
ASR ACETABULAR IMPLANT 54
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD·Product code KWA·May 20, 2011
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021
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
Model Number L231, PROPONENT DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025