15 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BriefCase-Triage
FDA 510(k)
FDA Class 2
·Radiology
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776416539·Cobb Elevator, 11", 1.25" Wide End, Round Handle
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776410483·COBB ELEVATOR 11 LONG 1.5" WIDE ROUND HANDLE
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780455806·Integra® Jarit® Cobb-Type Spinal Elevator, Roun...
AngioSystems Tray
FDA UDI
ANGIOSYSTEMS, INCORPORATED·00816611026557·
ORL Video NasoPharyngo-Larngoscope
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
ELECTRODE
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 28, 2024
VERSACARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·November 6, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 15, 2011
PINNACLE MTL INS NEUT36IDX52OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·July 26, 2013
VERSAONE
FDA Adverse Event
Malfunction
·DAVIS & GECK CARIBE LTD·Product code GCJ·July 17, 2024
PRODIGY AUTOCODE
FDA Adverse Event
Injury
·OK BIOTECH CO., LTD.·Product code NBW·March 15, 2018
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013