14 results · 22ms · Sources: EU EUDAMED, US FDA

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EMBRACE WET-BOND RESTORATIVE MATERIAL

FDA 510(k)
FDA Class 2 ·Dental

Ophthalmic Spatula

FDA UDI
KATENA PRODUCTS, INC.·00841668102299·BONFADINI DALK SPATULA

FF450 PLUS FUNDUS CAMERA AND VISUPAC DIGITAL IMAGE ARCHIVING SYSTEM, OR FF450 PLUS VISUPAC SYSTEM

FDA 510(k)
FDA Class 2 ·Ophthalmic

CODMAN SLIM-LOC SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

8100 ALARIS PUMP MODULE

FDA Adverse Event
Malfunction ·CAREFUSION SD·Product code FRN·November 12, 2020

MED SYSTEMS ELECTRO FLO 5000 PERCUSSOR, 30 POWER/FREQUENCY SETTINGS AN

FDA Adverse Event
Injury ·MED SYSTEM, INC.·Product code BYI·September 21, 2018

OT VERIO IQ METER

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

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

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

CONTOUR TEST STRIPS (50)

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

WALLFLEX COLONIC

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code MQR·December 31, 2024

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

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