11 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INNOVANCE D-DIMER, MODEL OPBP09
FDA 510(k)
FDA Class 2
·Hematology
INNOVANCE D-DIMER
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH·Product code DAP·July 14, 2017
HairCheck-DT (Cocaine)
FDA UDI
Quest Diagnostics·00868586000209·HairCheck-DT (Cocaine) is an ELISA test kit use...
DEVILBISS HUMIDIFIER
FDA 510(k)
FDA Class 2
·Anesthesiology
AML HAIRCHECK-DT (COCAINE)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
OXF UNI CMNTLS TIB SZ AA RM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·May 7, 2019
OXF ANAT BRG RT X-SM 3MM PMA
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·May 7, 2019
ARTICULEZE M HEAD 36MM +5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·May 6, 2013
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·September 4, 2014
CLEARSTAR PUMP
FDA Adverse Event
Malfunction
·ABBOTT NUTRITION·Product code LZH·April 6, 2011
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