9 results
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20ms
·
Sources: EU EUDAMED, US FDA
LASER BACKPOINTER ASSEMBLY, MOD. 01-2487
FDA 510(k)
FDA Class 1
·Radiology
DXH 300 COULTER CELLULAR ANALYSIS SYSTEM, DXH 300C COULTER CELLULAR ANALYSSI SYSTEM MODEL: 71772, 71771
FDA 510(k)
FDA Class 2
·Hematology
ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST
FDA 510(k)
FDA Class 2
·Immunology
ACCU-CHEK ® MOBILE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·May 8, 2014
SUMMIT POR TAPER SZ7 HI OFF
FDA Adverse Event
Injury
·DEPUY RAYNHAM·Product code LPH·October 22, 2012
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR - REDWOOD CITY·Product code MGB·August 12, 2010
EQUINOXE REVERSE SHOULDER COMPONENTS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·May 18, 2023
BAXJECT II HI-FLOW NEEDLESS TRANSFER DEVICE
FDA Adverse Event
Malfunction
·TAKEDA PHARMACEUTICALS U.S.A., INC.·Product code LHI·May 4, 2026
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021