10 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VERTEFIX PEDICLE SCREW SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SYMPULSE COMPUTER SYSTEM FOR FONAR MRI SCANNERS
FDA 510(k)
FDA Class 2
·Radiology
DEPUY SUMMIT FX CEMENTED HIP PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
X3 TRIATHLON CS INSERT #3 9MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·May 13, 2014
ABRAMS MULTIDENSITY POLYURETHAN FOAM WOUND DRESSING SYSTEM
FDA Adverse Event
Other
·DR LEN'S MEDICAL PRODUCTS·Product code FRO·October 11, 2005
OUTLOOK ES
FDA Adverse Event
Malfunction
·B. BRAUN MEDICAL, INC.·Product code FRN·April 12, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·April 19, 2011
BIPOL LEAD MODEL 300
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·June 20, 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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015