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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MAMMOSITE MULTI LUMEN
FDA 510(k)
FDA Class 2
·Radiology
MedStream
FDA UDI
MEDICAL SPECIALTIES DISTRIBUTORS, LLC·00842472105599·DRESSING CHANGE KIT
SPINAL EPIDURAL NEEDLES
FDA 510(k)
FDA Class 2
·Anesthesiology
EXTRUDE MODIFIED
FDA 510(k)
FDA Class 2
·Dental
SIZE 3 ACCOLADE II 127 DEG
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code MEH·May 3, 2013
POWER PRO AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code INK·May 3, 2011
PUMP MMT-522NAL PRDGM INS V2.2 CL EN
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·August 1, 2008
ABG II Modular Hip Stem Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430 Stryker Ireland Carrigtwohill Industrial Estate, Carrigtwohill County Cork, Ireland. The ABG II Modular range of implants is constituted of 8 right stems and 8 left stems. The necks are made of GADS Vitallium, a proprietary Co Cr alloy that Stryker has developed. GADS stands for Gas Atomized Dispersion Strengthened. IT is a Co Cr alloy that is a corrosion resistant and demonstrates qualities of improved fatigue strength (with respect to regular Co Cr alloy). Neck Range - The ABG II modular neck range is composed of 10 reversible neck implants. There are different options in terms of length, version and neck angle. The AG II Modular necks come in two different lengths: 28 mm (short) and 36 mm (long). The necks are offered in two version angles ; 0 and 7. The 0 and 7 necks are available in 125, 130 and 135 neck angles.
FDA Enforcement
Class II
·Ongoing·Stryker Howmedica Osteonics Corp.·August 1, 2012
Cancellous Bone Screw, 6.5 x 50 mm, Model 0214807
FDA Recall
Terminated
·Plus Orthopedics USA·Product code JWH·June 3, 2005
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