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

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IKONISCOPE ONCOFISH BLADDER TEST SYSTEM

FDA 510(k)
FDA Class 2 ·Hematology

NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE

FDA 510(k)
FDA Class 2 ·Orthopedic

AUTODIMER ASSAY MODEL # 1431

FDA 510(k)
FDA Class 2 ·Hematology

MOSAIC

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code DYE·December 11, 2025

WALLFLEX DUODENAL

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code MUM·January 22, 2025

CALCIUM

FDA Adverse Event
Malfunction ·ABBOTT LABORATORIES (IRVING IA/CC)·Product code CJY·September 1, 2020

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 17, 2013

ENT PRECISION CUTTER AGGRESSIVE SERRATED ESSX/HUMMER 4

FDA Adverse Event
Malfunction ·STRYKER ENDOSCOPY·Product code FZT·April 15, 2011

VERSACARE

FDA Adverse Event
Malfunction ·HILL-ROM RITTER·Product code FNL·June 18, 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

CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

FDA Enforcement
Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015