16 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BIVONA ADJUSTABLE AND FIXED NECKFLANGE HYPERFLEX TRACHEOSTOMY TUBES
FDA 510(k)
FDA Class 2
·Anesthesiology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517284297·CoRoent® LO Ti, 14x10x40mm 5°
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X0814400·8mm H x 14mm W x 40mm L x 0 degrees XLIF
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810057371349·Shoulder Chair Lateral Brace Pad
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16740814400·
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587L081440120·8mm H x 14mm W x 40mm L XLIF Trial 12 degree Lo...
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X081440120·8mm H x 14mm W x 40mm L x 12 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X08144080·8mm H x 14mm W x 40mm L x 8 degrees XLIF
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1674081440060·
BONESOURCE HAC
FDA 510(k)
FDA Class 2
·Neurology
NEXTSTITCH CARDIOVASCULAR VALVE SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 11, 2014
ACTIVA PC
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·April 22, 2011
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code NIQ·July 25, 2008
CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
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