19 results
·
18ms
·
Sources: EU EUDAMED, US FDA
ACME LOW-PROFILE CHAIR SCAL 7300
FDA 510(k)
FDA Class 1
·General Hospital
n/a
FDA UDI
Hager & Meisinger Gesellschaft mit beschränkter Haftung·E0HM51008513140141·Rotary diamond instrument for dental application
Sklar®
FDA UDI
SKLAR CORPORATION·10649111364051·VAN BUREN SOUND 14FR 11"
BISPECTRAL INDEX MONITOR
FDA Adverse Event
Malfunction
·UNK·Product code OLW·January 2, 2026
NA
FDA UDI
Zimmer, Inc.·00889024196667·
Continuum® Trilogy® Allofit® Vivacit-E®
FDA UDI
Zimmer, Inc.·00889024155121·
Continuum® Trilogy® Allofit® Vivacit-E®
FDA UDI
Zimmer, Inc.·00889024155091·
NA
FDA UDI
Zimmer, Inc.·00889024196674·
NA
FDA UDI
Zimmer, Inc.·00889024196681·
Continuum® Trilogy® Allofit® Vivacit-E®
FDA UDI
Zimmer, Inc.·00889024155114·
Continuum® Trilogy® Allofit® Vivacit-E®
FDA UDI
Zimmer, Inc.·00889024155107·
Aura DR 43C-AG flat panel detector
FDA 510(k)
FDA Class 2
·Radiology
SILENT PARTNER SERIES OSA APPLIANCES
FDA 510(k)
FDA Class 2
·Dental
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523178285·MIS Acetabular Instrument Case Tray
XENFORM
FDA Adverse Event
Other
·TEI BIOSCIENCES INC.·Product code FTM·May 22, 2014
12X100MM KII BALLOON BLUNT TIP SYSTEM
FDA Adverse Event
Malfunction
·APPLIED MEDICAL·Product code GCJ·November 16, 2012
MICRO SAGITTAL SAW
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code ERL·September 23, 2010
Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025
Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025