11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ASAHI RG3 GUIDEWIRE/ASAHI RG3 SOFT GUIDEWIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
TENSION SLEEVE 10mm
FDA UDI
Aktormed GmbH·04260463843392·
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613097554·Farrior Round Oblique Ear Speculum, Size 2, 7mm...
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613097561·Farrior Round Oblique Ear Speculum, Size 3, 8mm...
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613097547·Farrior Round Oblique Ear Speculum, Size 1, 6mm...
ARCHER SUPER STIFF GUIDEWIRES
FDA 510(k)
FDA Class 2
·Cardiovascular
AEQUALIS SHOULDER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·October 3, 2014
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD.·Product code MCM·June 3, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·June 27, 2011
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022