9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Smart Photon Micro-current Device, Model: EP-300
FDA 510(k)
FDA Class 2
·Neurology
Shannon Recta Round Shank
FDA UDI
Gebr. Brasseler GmbH & Co. KG·14053613289587·
NON REINFORCED SURGICAL GOWNS, FILM REINFORCED SURGICAL GOWNS, FABRIC REINFORCED SURGICAL GOWNS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INNERSCAN BODY COMPOSITION MONITOR, INNERSCAN SEGMENTAL BODY COMPOSITION MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 9, 2024
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 10, 2014
INSIGNIA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 14, 2011
ACCU-CHEK ® MOBILE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·June 11, 2013
OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02-35, 35MM; e) 200-02-38, 38MM; f) 200-02-41, 41MM;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·June 26, 2024