17 results · 24ms · Sources: EU EUDAMED, 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