18 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DISTAL PERFUSION CATHETER (1.5 CM) AND (2.5CM)
FDA 510(k)
FDA Class 2
·Cardiovascular
ihcDirect® TTF1 Ab, 15mL
FDA UDI
NOVODIAX, INC.·00850000596658·Clone R373
ihcDirect® TTF1 Ab, 5mL
FDA UDI
NOVODIAX, INC.·00850000596641·Clone R373
ihcDirect® TTF1 Ab Conjugate 15mL
FDA UDI
NOVODIAX, INC.·00850030934703·Clone R373
ihcDirect® TTF1 Ab Conjugate 5mL
FDA UDI
NOVODIAX, INC.·00850030934697·Clone R373
THE HAMMER MODEL H100
FDA 510(k)
FDA Class 2
·Cardiovascular
WILLI GELLER CREATION & AV PORCELAIN
FDA 510(k)
FDA Class 2
·Dental
MARGRON STEM (K032641)
FDA Adverse Event
Injury
·PORTLAND ORTHOPAEDICS PTY LTD·Product code KWY·May 31, 2005
PENUMBRA SYSTEM SEPARATOR 032/041
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·January 19, 2010
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code MGB·October 21, 2021
PERCLOSE PROGLIDE¿
FDA Adverse Event
Injury
·ABBOTT VASCULAR INC.·Product code MGB·January 2, 2025
STARCLOSE SE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code MGB·July 14, 2017
GPS STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FPO·March 6, 2013
RENEGADE¿ HI-FLO¿ FATHOM¿ KIT
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code KRA·March 28, 2011
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·April 21, 2008
MODIFICATION TO: HALO COAGULATION CATHETER, MODELS 32041-18, 32041-20, 32041-22, 32041-25, 32041-28, 32041-31, 32041-34
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PERCLOSE PROGLIDE¿
FDA Adverse Event
Injury
·ABBOTT VASCULAR INC.·Product code MGB·June 7, 2024
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012