10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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A,FDA2 LYOPHILIZED HEMO CONTROL
FDA 510(k)
FDA Class 2
·Hematology
NA
FDA UDI
WELMED INC.·00849296007009·
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209126989·
ACUMED
FDA UDI
Acumed LLC·10806378045301·3.5mm Hexalobe Short Screw Caddy Lid
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
FDA 510(k)
FDA Class 1
·General Hospital
SmartLinx Vitals Plus Patient Monitoring System
FDA 510(k)
FDA Class 2
·Cardiovascular
ACCU-CHEK ® MOBILE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·May 8, 2014
PENTA
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·October 18, 2012
UNKNOWN DEPUY ACS LINER
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDI·August 10, 2010
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