13 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
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