12 results
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19ms
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Sources: EU EUDAMED, US FDA
SNYDER HEMOVAC CHEST DRAINAGE SOLUTION
FDA 510(k)
FDA Class 2
·General Hospital
ACUMED
FDA UDI
Acumed LLC·10806378045349·Driver, 1.5mm Hex, Acu-Sinch®
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209121052·
microTargeting™ Multi-Oblique Tool Guide
FDA UDI
FHC, INC.·00873263008614·Multi-Oblique Platform 2.5mm Tool Guide (60mm), 1X
CRANIOCAP
FDA 510(k)
FDA Class 2
·Neurology
MICRUS ASCENT OCCLUSION BALLOON CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
OT VERIO PRO PLUS METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 8, 2014
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·October 18, 2012
LEAVE ACTIVE PFC CVD 8MM SZ3
FDA Adverse Event
Injury
·DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS·Product code JWH·August 10, 2010
CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for periods appropriate to cardiopulmonary bypass Part Number: 701072780, (CARDIOHELP-I US); 701048012 (CARDIOHELP-I NON US)
FDA Recall
Open, Classified
·Maquet Medical Systems USA·Product code DTQ·November 6, 2023
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022