16 results · 30ms · Sources: EU EUDAMED, US FDA

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NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX

FDA 510(k)
FDA Class 2 ·Neurology

SYNTHETIC POWDER FREE VINYL PATIENT EXAMINATION GLOVES

FDA 510(k)
FDA Class 1 ·General Hospital

VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

CD HORIZON® SPINAL SYSTEM

FDA Adverse Event
Malfunction ·Product code KWP·November 2, 2021

CD HORIZON® SPINAL SYSTEM

FDA Adverse Event
Malfunction ·Product code KWP·November 2, 2021

CD HORIZON® SPINAL SYSTEM

FDA Adverse Event
Malfunction ·Product code KWP·November 2, 2021

OT ULTRA2 METER

FDA Adverse Event
Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 3, 2013

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·March 28, 2011

ASCENSIA BREEZE2 TEST STRIPS (100)

FDA Adverse Event
Malfunction ·BAYER HEALTHCARE, LLC·Product code NBW·April 15, 2008

NIBP CUFFS

FDA Adverse Event
Injury ·PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH·Product code OED·August 8, 2025

LIFEWISE BLOOD PRESSURE MONITOR

FDA Adverse Event
Injury ·RADIOSHACK·Product code DXN·October 20, 2004

The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.

FDA Enforcement
Class II ·Terminated·CHG Hospital Beds Inc·March 23, 2016

Spirit Plus Bed, A-C Powered Hospital Bed

FDA Enforcement
Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

Spirit Select Bed, A-C Powered Hospital Bed

FDA Enforcement
Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

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