10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SLEEPWEAVER ANEW FULL FACE SOFT CLOTH PAP MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450186770·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450521106·
SMITH & NEPHEW MDF MODULAR SLEEVE
FDA 510(k)
FDA Class 2
·Orthopedic
TRITON SELF CONTAINED DENTAL SYSTEM, TRITON SELF CONTAINED DENTAL SYSTEM, WITH CASE
FDA 510(k)
FDA Class 1
·Dental
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 28, 2025
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 24, 2013
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·September 30, 2014
TRANSSEPTAL NEEDLE, BRK SERIES, ADULT 18 GA, 71CM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, AF DIVISION·Product code DRC·June 13, 2011
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024