12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GRINDGUARD
FDA 510(k)
FDA Unclassified
·Unknown
MODIFICATION TO GLOBALCARDIO
FDA 510(k)
FDA Class 2
·Cardiovascular
IND URINARY TRACT INFECTION (UTI) TEST STRIPS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 29, 2025
JETPREP FLUSHING DEVICE OL-103037 / OL-133037 / OL-168037 / PE-105038 / PE-150038 / PE-170038 / FU-169038
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
JETPREP FLUSHING DEVICE OL-103037, JETPREP FLUSHING DEVICE OL-133037, JETPREP FLUSHING DEVICE OL-168037, JETPREP FLUSHIN
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SECURE ACUTE CARE BED 3/01
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 29, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 17, 2011
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Injury
·ROCHE DIAGNOSTICS·Product code LFR·August 19, 2008
HNM LATERAL ANCHOR
FDA Adverse Event
Injury
·HNM STAINLESS, LLC DBA HNM MEDICAL·Product code HWC·April 16, 2018
CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 48
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·April 18, 2023
The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. The system also includes signal analysis and display equipment, patient and equipment supports, components, and accessories. Philips Inclusive CT has a 72cm bore and includes a detector array that provides 50cm scan field of view.
FDA Enforcement
Class II
·Completed·Philips North America Llc·December 27, 2023