13 results · 21ms · Sources: EU EUDAMED, US FDA

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3.5 MM LCP DISTAL HUMERUS SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

Baltic Denture System BDLoad

FDA UDI
Merz Dental GmbH·D7091033995·Baltic Denture System BDLoad BDLoad ↓ Lw6 PLSEu...

MODIFICATION TO MAS CARDIOLMMUNE TL; DADE CARDIAC TL

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

SPECULITE/ORALLITE

FDA 510(k)
FDA Class 1 ·Dental

RAD-5V HANDHELD

FDA Adverse Event
Malfunction ·MASIMO CORPORATION·Product code DQA·July 10, 2015

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·February 10, 2025

RAD-5 PULSE OXIMETER

FDA Adverse Event
Malfunction ·MASIMO - 40 PARKER·Product code DQA·July 13, 2018

ACTIVA

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·December 18, 2018

MECHANICAL (MANUAL) WHEELCHAIR

FDA Adverse Event
Malfunction ·INVACARE TAYLOR STREET·Product code IOR·April 3, 2013

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code MDS·March 18, 2011

SINGLE TRAY KIT

FDA Adverse Event
Injury ·ARROW INTL., INC.·Product code LJT·April 25, 2008

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

Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024