10 results · 21ms · Sources: EU EUDAMED, 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