21 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TRABECULAR METAL REVISION SHELL LINERS
FDA 510(k)
FDA Class 2
·Orthopedic
Epimed
FDA UDI
EPIMED INTERNATIONAL, INC·00818788020123·RX Coudé® Epidural Needle 16g TW x 4.5"
Integra® Miltex®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780500742·Integra® Miltex® Hank Uterine Dilator, 10-1/2",...
Integra® Miltex®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780488323·Integra® Miltex® Hank Uterine Dilator, 10-1/2",...
FIX-C 3D Ti ACIF System
FDA UDI
Jeil Medical Corporation·08800089453313·
FIX-C 3D Ti ACIF System
FDA UDI
Jeil Medical Corporation·08800089453306·
FIX-C 3D Ti ACIF System
FDA UDI
Jeil Medical Corporation·08800089453290·
FIX-C 3D Ti ACIF System
FDA UDI
Jeil Medical Corporation·08800089453351·
FIX-C 3D Ti ACIF System
FDA UDI
Jeil Medical Corporation·08800089453283·
FIX-C 3D Ti ACIF System
FDA UDI
Jeil Medical Corporation·08800089453337·
FIX-C 3D Ti ACIF System
FDA UDI
Jeil Medical Corporation·08800089453320·
FIX-C 3D Ti ACIF System
FDA UDI
Jeil Medical Corporation·08800089453344·
ACUMATCH GXL 15DEG LINER 36MM SZ J
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·April 19, 2024
INFANT FLOW SYSTEM, MODEL M672P
FDA 510(k)
FDA Class 2
·Anesthesiology
PASCO MIC AND MIC/ID PANELS
FDA 510(k)
FDA Class 2
·Microbiology
VIRTUOSO DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·April 10, 2013
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·September 2, 2014
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·April 12, 2011
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015