12 results · 19ms · Sources: EU EUDAMED, US FDA

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SEDLINE WITH FRONTAL PSI

FDA 510(k)
FDA Class 2 ·Neurology

Baltic Denture System BDLoad

FDA UDI
Merz Dental GmbH·D7091033999·Baltic Denture System BDLoad BDLoad ↓ Sw6 PLSEu...

MetaSystems Probes

FDA UDI
MetaSystems Probes GmbH·04251315810686·XL SS18 BA, 10x100µl, Break Apart Probe

LODOX, MODEL BASELINE

FDA 510(k)
FDA Class 2 ·Radiology

AVIVA SYSTEM, MODEL SL 2020; AVIVA SLX SYSTEM SYSTEM, MODEL SLX 1010

FDA 510(k)
FDA Class 2 ·Cardiovascular

RAD-5V HANDHELD

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

RAD-5 PULSE OXIMETER

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

POWERED WHEELCHAIR

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

GLOBAL ANCHOR PEG GLENOID 52MM

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWS·March 17, 2011

SJM MASTERS SERIES MECHANICAL HEART VALVE

FDA Adverse Event
Injury ·ST. JUDE MEDICAL, PUERTO RICO, B.V.·Product code LWQ·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