11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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WAVELIGHT AURIGA
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INTERGRO DBM
FDA 510(k)
FDA Class 2
·Orthopedic
BIOMET CRANIOFACIAL ACRYLIC CEMENT
FDA 510(k)
FDA Class 2
·Neurology
BD INSULIN PEN NEEDLE
FDA Adverse Event
Injury
·BECTON DICKINSON AND CO.·Product code FMI·November 9, 2015
TERUFLEX BLOOD BAG SYSTEM
FDA Adverse Event
Malfunction
·TERUMO CORPORATION/TERUMO BCT·Product code KSR·April 10, 2013
SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL
FDA Adverse Event
Injury
·STAAR SURGICAL COMPANY·Product code HQL·April 7, 2011
2 X 200ML SYRINGE W/60" Y-TUBING AND NO
FDA Adverse Event
Malfunction
·COVIDIEN·Product code FPA·May 16, 2008
ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG
FDA Adverse Event
Injury
·COOK INC·Product code MIH·July 19, 2017
BD MAXPLUS¿ PRESSURE RATED EXTENSION SET WITH REMOVABLE NEEDLELESS CONNECTOR
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·January 3, 2023
BD MAXPLUS¿ PRESSURE RATED EXTENSION SET WITH REMOVABLE NEEDLELESS CONNECTOR
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·January 3, 2023
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