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

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LDR SPINE ROI-C IMPLANT

FDA 510(k)
FDA Class 2 ·Orthopedic

AIMSTEP PREGNANCY

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

STERILMED INTERMITTENT COMPRESSION SYSTEM, GARMENT MODELS 400 SERIES

FDA 510(k)
FDA Class 2 ·Cardiovascular

BD¿ SYRINGE WITH PRECISIONGLIDE¿ NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMF·October 24, 2022

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 29, 2013

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·May 11, 2011

CLINICAL CHEMISTRY BILIRUBIN

FDA Adverse Event
Malfunction ·ABBOTT MANUFACTURING, INC.·Product code CIG·July 29, 2008

INFOV.A.C. THERAPY SYSTEM

FDA Adverse Event
Injury ·KINETIC CONCEPTS, INC·Product code OMP·March 4, 2021

Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).

FDA Enforcement
Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

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