11 results · 24ms · Sources: EU EUDAMED, US FDA

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CHIROFLEX LENS MICROSERT

FDA 510(k)
FDA Class 1 ·Ophthalmic

Brigade

FDA UDI
Nuvasive, Inc.·00887517963857·Brigade Lateral Trial, 9x38x32mm 12°

AUTOSOFT XC

FDA Adverse Event
Malfunction ·UNOMEDICAL A/S·Product code FPA·July 5, 2024

PREGNANCY ONE STEP RAPID TEST

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2

FDA 510(k)
FDA Class 2 ·Neurology

PRESSUREGUARD EASY AIR

FDA Adverse Event
Malfunction ·SPAN-AMERICA MEDICAL SYSTEM, INC.·Product code FNM·November 12, 2010

LARYNGOSCOPE

FDA Adverse Event
Malfunction ·KARL STORZ·Product code CCW·December 31, 2012

530G INSULIN PUMP

FDA Adverse Event
Death ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·June 30, 2014

STEALTHSTATION¿ S8 SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·May 8, 2025

RESONANCE STENT SET

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FAD·April 25, 2014

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