19 results
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19ms
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Sources: EU EUDAMED, US FDA
READYSWIM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Zirlux
FDA UDI
HENRY SCHEIN, INC.·H65890113460·Zirlux Titanium Screw compatible with: Strauman...
Sanibel Supply A/S
FDA UDI
Interacoustics A/S·05711117019025·ETB standard electrode cable kit/5pcs (BRWYB), ...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450218433·
EZ2C
FDA UDI
FGX INTERNATIONAL INC.·00193033278536·
EZ2C
FDA UDI
FGX INTERNATIONAL INC.·00193033278512·
EZ2C
FDA UDI
FGX INTERNATIONAL INC.·00193033278543·
EZ2C
FDA UDI
FGX INTERNATIONAL INC.·00193033278529·
EZ2C
FDA UDI
FGX INTERNATIONAL INC.·00193033278499·
EZ2C
FDA UDI
FGX INTERNATIONAL INC.·00193033278505·
ULTIMUM HEMOSTASIS INTRODUCER, MODEL 4076XX
FDA 510(k)
FDA Class 2
·Cardiovascular
KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VA-LCP-2-COLUMN DRP2.4 VOLAR NARR LE SHA
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HRS·March 19, 2013
ALTRX +4 10D 36IDX52OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·March 4, 2011
TAXUS EXPRESS2 PALITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code NIQ·March 11, 2008
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
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
paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024
smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024