17 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Wireless Digital Flat Panel Detector
FDA 510(k)
FDA Class 2
·Radiology
ZEUS-L
FDA UDI
SPINAL ELEMENTS·00840916141363·ZEUS® LLIF 18mm x 25mm x 50mm x 21° TRIAL
ZEUS-L
FDA UDI
SPINAL ELEMENTS·00840916120733·ZEUS®-L Hyper, 18 x 25 x 50mm, 21 Degree
ZEUS-L
FDA UDI
SPINAL ELEMENTS·00840916141288·ZEUS® LLIF 18mm x 25mm x 50mm x 07° TRIAL
ZEUS-L
FDA UDI
SPINAL ELEMENTS·00840916120740·ZEUS®-L Hyper, 18 x 25 x 50mm, 28 Degree
ZEUS-L
FDA UDI
SPINAL ELEMENTS·00840916134457·ZEUS®-L, Lateral Lumber Interbody Fusion Device...
ZEUS-L
FDA UDI
SPINAL ELEMENTS·00840916120726·ZEUS®-L Hyper, 18 x 25 x 50mm, 14 Degree
ZEUS-L
FDA UDI
SPINAL ELEMENTS·00840916141370·ZEUS® LLIF 18mm x 25mm x 50mm x 28° TRIAL
ZEUS-L
FDA UDI
SPINAL ELEMENTS·00840916141332·ZEUS® LLIF 18mm x 25mm x 50mm x 14° TRIAL
CAPILLARYS HEMOGLOBIN, CAPILLARYS FLEX PIERCING SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
ICS IMPULSE
FDA 510(k)
FDA Class 2
·Neurology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 14, 2025
1.8MM TI VA LCKNG BUTTRESS PIN WITH T8 STARDRIVE RECESS/20MM
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HRS·September 1, 2016
INTRALASE FS2
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HNO·October 17, 2014
ACCU-CHEK SPIRIT COMBO
FDA Adverse Event
Injury
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·July 19, 2011
GYNECARE TVT SECUR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code PAH·June 21, 2013
cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014