11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CS2 MULTI-HOLE ACETABULAR SHELL
FDA 510(k)
FDA Class 2
·Orthopedic
UniTip Catheter
FDA UDI
Unisensor AG·07640172971406·
Symmetry Surgical
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482000236·Symmetry® Guide, Guard, Small
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776353735·Cloward Style Drill Guard
ECT DIGITAL THERMOMETER
FDA 510(k)
FDA Class 2
·General Hospital
VARELISA PR3 ANCA, MODEL NUMBER 17748/17796
FDA 510(k)
FDA Class 2
·Immunology
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 24, 2013
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYS INC.·Product code LZG·June 16, 2011
GE OEC 9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 3, 2008
MAGNETOM Aera magnetic resonance diagnostic devices Model # 10432914
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·August 28, 2019
ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026