21 results · 23ms · Sources: EU EUDAMED, US FDA

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ADVIA RETIC PLUS

FDA 510(k)
FDA Class 2 ·Hematology

TiWAVE L Lumbar Cage System

FDA UDI
Kalitec Direct LLC·B07323K0104010·Caddie Lid, Trials

NIDO Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07315K0100610·Caddie Lid, Modular Bone Screws

InTess Lumbar Cage

FDA UDI
Kalitec Direct LLC·B07312K0104010·Caddie Lid, Cages, Universal

URINE CANNABINOIDS (THC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 95A

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

TPN NUTRITION BAG (EVA), EMPTYING TUBE, BAG SYRINGE FILL SET

FDA 510(k)
FDA Class 2 ·General Hospital

AUTOSOFT XC

FDA Adverse Event
Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·July 10, 2025

INSET I

FDA Adverse Event
Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·August 6, 2025

8010461-2005-00001

FDA Adverse Event
Other ·Product code LXH·May 13, 2005

INSET

FDA Adverse Event
Malfunction ·UNOMEDICAL A/S·Product code FPA·November 10, 2025

INSET

FDA Adverse Event
Malfunction ·UNOMEDICAL A/S·Product code FPA·November 10, 2025

INSET

FDA Adverse Event
Malfunction ·UNOMEDICAL A/S·Product code FPA·November 10, 2025

INSET

FDA Adverse Event
Malfunction ·UNOMEDICAL A/S·Product code FPA·November 10, 2025

AUTOSOFT XC

FDA Adverse Event
Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·July 10, 2025

AUTOSOFT XC

FDA Adverse Event
Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·July 10, 2025

COCR 01.25.011 COCR BALL HEAD 12/14 28 SIZE S -3.5

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·September 15, 2021

FREESTYLE FLASH

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·May 11, 2007

LASSO¿ ELECTROPHYSIOLOGY CATHETER

FDA Adverse Event
Malfunction ·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code DRF·March 19, 2013

ACCU-CHEK ® AVIVA TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·March 8, 2011

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