11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYNCHRON SYSTEMS CREATININE REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LIFEMATE HEMOFILTRATION SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MONOJECT PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
PROSPACE PEEK IMPLANT 5 7X8X22MM
FDA Adverse Event
Malfunction
·AESCULAP AG AND CO. KG·Product code MAX·June 21, 2013
TSPACE PEEK IMPLANT 26X11X7MM
FDA Adverse Event
Malfunction
·AESCULAP IMPLANT SYSTEMS·Product code MAX·October 30, 2015
VITROS CHEMISTRY PRODUCTS GENT REAGENT
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code LCD·July 17, 2012
COOK DIALYSIS CATHETER
FDA Adverse Event
Injury
·BARD MEDICAL DIVISION·Product code MSD·April 11, 2013
EEA 31MM SINGLE-USE STAPLER
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY USSC PUERTO RICO, INC.·Product code GDW·September 5, 2014
SYNCHROMED EL
FDA Adverse Event
Injury
·RICE CREEK MANUFACTURING·Product code LKK·July 8, 2008
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
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018