10 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AVC A/H5N1 FLU TEST
FDA 510(k)
FDA Class 2
·Microbiology
COMPLETE HUMAN TUBAL FLUID (HTF) WITH SERUM SUBSTITUTE SUPPLEMENT, MODEL 9922
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
TINA-QUANT APOLIPOPROTEIN A-1 VER.2
FDA 510(k)
FDA Class 1
·Immunology
9611993-2023-083278
FDA Adverse Event
Injury
·NOBEL BIOCARE (PRODUCTION) AB·Product code DZE·July 1, 2023
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 29, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 10, 2011
ZENITH AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
FDA Adverse Event
Injury
·COOK, INC.·Product code MIH·July 25, 2008
Femoral Nail, A/R, R1500 T2 Femur ¿10x320 mm, Product Number 18281032S
FDA Enforcement
Class II
·Terminated·Stryker GmbH·July 18, 2018
Femoral Nail, A/R, R1500 T2 Femur ¿12x380 mm, Product Number 18281238S
FDA Enforcement
Class II
·Terminated·Stryker GmbH·July 18, 2018
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