10 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DIMENSION SIRO FLEX REAGENT CARTRIDGE AND DIMENSION SIROLIMUS CALBIRATOR, MODELS DR 306, DC 306
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY
FDA 510(k)
FDA Class 2
·Immunology
SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
11MM/130 DEG TI CANN TROCH FIXATION NAIL 360MM/LEFT
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HSB·February 11, 2016
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 29, 2013
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-CLONMEL·Product code NIQ·May 9, 2011
PRO-VENT PLUS ARTERIAL BLOOD SAMPLING KIT (RAPIDLYTE)
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code JKA·July 18, 2008
VIASYS
FDA Adverse Event
Other
·CAREFUSION 207, INC·Product code CBK·October 27, 2009
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
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021