12 results · 26ms · Sources: EU EUDAMED, US FDA

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KODAK DRYVIEW 8900 LASER IMAGER MAMMOGRAPHY ACCESSORY

FDA 510(k)
FDA Class 2 ·Radiology

Baltic Denture System BDLoad

FDA UDI
Merz Dental GmbH·D7091033821·Baltic Denture System BDLoad BDLoad ↓ Mm6 PLSEu...

SILK TOUCH POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)

FDA 510(k)
FDA Class 1 ·General Hospital

SIMUPLAN TREATMENT PLANNING SYSTEM, MODEL V. 7.5

FDA 510(k)
FDA Class 2 ·Radiology

KYPHX HV-R BONE CEMENT

FDA Adverse Event
Injury ·KYPHON, INC.·Product code NDN·June 23, 2006

KYPHX HV-R BONE CEMENT

FDA Adverse Event
Injury ·KYPHON, INC.·Product code NDN·June 20, 2006

8015 ALARIS SYSTEM PC UNIT

FDA Adverse Event
Malfunction ·CAREFUSION SD·Product code FRN·November 24, 2020

COULTER® ACT DIFF2 HEMATOLOGY ANALYZER

FDA Adverse Event
Malfunction ·BECKMAN COULTER·Product code GKZ·April 3, 2013

UNKNOWN DEPUY ASR CUP

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·March 17, 2011

NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

FDA Adverse Event
Injury ·CYTYC SURGICAL PRODUCTS·Product code MNB·April 24, 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