10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TRITON/TRU-TRAC/TX/TRITON DTS TRACTION
FDA 510(k)
FDA Class 2
·Physical Medicine
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809842654·FOR MEN 30-40 MM HG KNEE HIGH OPEN TOE EXTRA LA...
GEON DIGITAL CLINICAL THERMOMETER
FDA 510(k)
FDA Class 2
·General Hospital
PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM (PVOCS)
FDA 510(k)
FDA Class 2
·Anesthesiology
STAR/HEXDRIVE SCREWDRIVER T25 3.5MM HEX/SELF-RETAINING
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HXX·April 5, 2016
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·April 11, 2013
ESPRIT VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC.·Product code CBK·May 28, 2008
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 13, 2011
Bone Void Filler, sterile orthopedic product, 510 (k) #K053228. The product is delivered in a syringe which is packaged in an aluminum-backed polyethylene pouch and is distributed one (1) pouch per box. The product affected by this recall was distributed by the recalling firm under six (6) different names. They are: Form-Putty; SBvFShape; Valeo BP; X-Putty; TheriGraft Putty; and SynFlow. The product is indicated for use in filling the gaps or voids of osseous defects surgically created or resulting from trauma and are intended for treatment of osseous defects not intrinsic to the stability of the bone structure. The products are intended for use in defects of the skeletal system (i. e. the extremities, spine and pelvis).
FDA Recall
Terminated
·Theken Spine Llc·Product code NOX·August 26, 2010
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