12 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ACCUVIX XQ DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809844566·FOR MEN 20-30 MM HG KNEE HIGH CLOSED TOE EXTRA ...
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWQ·January 10, 2019
3I LOCATER ABUTMENT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
XSCAN32 TELERADIOLOGY SOFTWARE
FDA 510(k)
FDA Class 2
·Radiology
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·April 13, 2011
LAMITRODE 44C
FDA Adverse Event
Injury
·ST. JUDE MEDICAL NEUROMODULATION·Product code LGW·April 2, 2013
MICROSTAAR INJECTOR CARTRIDGE
FDA Adverse Event
Malfunction
·STAAR SURGICAL CO·Product code MSS·May 22, 2008
LABOR & DELIVERY PPS , Model No LLLD64O LLLD64O-01 LLLD64O-02
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·March 26, 2025
MYNX CONTROL VCD 6F 7F
FDA Adverse Event
Malfunction
·CORDIS SANTA CLARA·Product code MGB·January 27, 2023
MYNX CONTROL VCD 6F 7F
FDA Adverse Event
Malfunction
·CORDIS SANTA CLARA·Product code MGB·January 27, 2023
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