11 results
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27ms
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Sources: EU EUDAMED, US FDA
BREAS VIVO 40 SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809843903·FOR MEN 30-40 MM HG KNEE HIGH CLOSED TOE MEDIUM...
ONYX-RAD TELEMEDICINE PACS
FDA 510(k)
FDA Class 2
·Radiology
BIPAP PRO 2 BI-LEVEL SYSTEM WITH BI-FLEX
FDA 510(k)
FDA Class 2
·Anesthesiology
APPLIANCE, FIXATION DEVICE, PROXIMAL FEMUR
FDA Adverse Event
Injury
·SYNTHES USA·Product code JDO·November 13, 2014
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·November 13, 2014
ALTRUA
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·April 11, 2013
SYNCHROMED II
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LKK·March 1, 2011
CAROTID WALLSTENT MONORAIL
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code NIM·May 23, 2008
Alere iScreen Dx Urine Drug Screen Card, 20 Drug Detection, Kit Contents include 26 individually pouched devices and 1 IFU insert. The Alere iScreen Dx Drug Screen Card is a rapid urine screening test that can be performed without the use of an instrument. The test utilizes monoclonal antibodies to selectively detect elevated levels of specific drugs in urine
FDA Recall
Terminated
·Ameditech Inc·Product code LFH·June 26, 2017
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