10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Syntec Osteo-plate and screw Fixation
FDA UDI
SYNTEC SCIENTIFIC CORPORATION·04712782853960·Cortex Screw Self-Tappingφ2.7 x L34mm
NA
FDA UDI
Synthes GmbH·10886982144836·2.7MM CORTEX SCREW SELF-TAPPING 34MM
LEONE SPA
FDA UDI
LEONE SPA·08033707061137·BRACKETS 22 PREM
SRS VAGINAL EMG/STIMULATION PERINEOMETER SENSOR SRS ANAL EMG/STIMULATION PERINEOMETER SENSOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DINAMAP PRO 1000 MONITOR WITH SUPERSTAT, MODEL 1000
FDA 510(k)
FDA Class 2
·Cardiovascular
INFINITI VISION SYSTEM
FDA Adverse Event
Injury
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·October 17, 2008
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
KINETRA
FDA Adverse Event
Death
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·July 2, 2013
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