12 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MICROSCAN MICROSTREP PLUS PANEL TETRACYCLINE (0.006 TO 16 MCG/ML)
FDA 510(k)
FDA Class 2
·Microbiology
DYNAMIC JOINT DISTRACTOR II EXTERNAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ARTHREX FIBERWIRE, USP SIZE 5, MODEL AR-7201
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BD¿ SYRINGE E/T EMERALD
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·December 31, 2018
TRANSSEPTAL NEEDLE, BRK 1, 71CM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC. (AF-MINNETONKA)·Product code DRC·April 12, 2013
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 21, 2011
SYNCHROMED EL
FDA Adverse Event
Injury
·RICE CREEK MANUFACTURING·Product code LKK·June 19, 2008
LINER STANDARD 3.5 MM OFFSET 36 MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·January 29, 2024
BD¿ SYRINGE E/T EMERALD
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·December 6, 2018
COAGUCHEK XS SYSTEM
FDA Adverse Event
Injury
·ROCHE DIAGNOSTICS·Product code GJS·August 10, 2020
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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015