10 results
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19ms
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Sources: EU EUDAMED, US FDA
QUIDEL CHLAMYDIA POSITIVE CONTROL
FDA 510(k)
FDA Class 1
·Microbiology
Swish™ Overdenture Abutment
FDA UDI
IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307116301·
Swish™ Multi-Unit Abutment
FDA UDI
IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307127291·
Sklar®
FDA UDI
SKLAR CORPORATION·10649111392436·SEMM VAGINAL SPEC 90MM/14-18MM
LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MAC 600 RESTING ECG ANALYSIS SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
DURATA STS OPTIM ACTIVE FIXATION
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·June 30, 2014
ANIMAS 2020
FDA Adverse Event
Malfunction
·ANIMAS·Product code LZG·January 7, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·November 20, 2010
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