12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SILGIMIX ALGINATE REPLACEMENT IMPRESSION MATERIAL
FDA 510(k)
FDA Class 2
·Dental
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809848045·FOR MEN 15-20 MM HG KNEE HIGH CLOSED TOE EXTRA ...
BACT/ALERT® FN PLUS
FDA Adverse Event
Malfunction
·BIOMERIEUX INC.·Product code MDB·March 26, 2019
MAXONE, BLOOD, BLOOD PRODUCTS AND IV FLUID WARMER
FDA 510(k)
FDA Class 2
·General Hospital
LORENZ LACTOSORB LARYNGOTRACHEAL RECONSTRUCTION IMPLANTS
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
NATURA
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code EXE·October 16, 2019
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·April 11, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 12, 2011
INDURA
FDA Adverse Event
Death
·RICE CREEK MANUFACTURING·Product code LKK·May 27, 2008
BD INTIMA-II 24GAX0.75IN PRN SLM NPVC
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·November 25, 2025
CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·October 30, 2024
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