10 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CARBOXYLATE CEM, PHOSPHATE CEM
FDA 510(k)
FDA Class 2
·Dental
Optimotion Blue CR HCCR Total Knee System
FDA UDI
OPTIMOTION IMPLANTS LLC·B6961014P0817020·CR Tibial Insert, UHMWPE + Vitamin E, Size 8, ...
VERTIS PNT CONTROL UNIT, VERTIS PNT SAFEGUIDE KIDS, MODELS CU100, SGXXX
FDA 510(k)
FDA Class 2
·Neurology
CRYOBAG, MODEL CB
FDA 510(k)
FDA Unclassified
·Unknown
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 26, 2023
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 29, 2013
AD PRO
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORP.·Product code MKJ·April 12, 2011
CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES·Product code KRH·July 22, 2008
GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R Intended for the temporary stabilization of bone segments or fragments
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·December 28, 2016
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