11 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KIT
FDA 510(k)
FDA Class 2
·Microbiology
MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL OSR9Q229
FDA 510(k)
FDA Class 2
·Clinical Toxicology
MACROPORE OS TRAUMA
FDA 510(k)
FDA Class 2
·Orthopedic
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 18, 2023
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 17, 2023
TPRLC XR T1 PPS 17X154MM MM T1
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code LPH·November 22, 2019
ASR ACETABULAR IMPLANT 60
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·April 26, 2013
DEPTH GAUGE SMALL
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code LXH·April 14, 2011
ASTRA TECH DENTAL IMPLANT SIZE 3
FDA Adverse Event
Injury
·ASTRA TECH·Product code DZE·July 23, 2008
ARTICULEZE M HEAD 36MM +5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910 ·Product code JDI·May 11, 2012
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