15 results · 20ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

MODIFIED 650 MAMMOGRAPHY SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

QUICK SET

FDA Adverse Event
Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V·Product code FPA·January 9, 2026

BETSEY JOHNSON

FDA UDI
FGX INTERNATIONAL INC.·00193033478035·

BETSEY JOHNSON

FDA UDI
FGX INTERNATIONAL INC.·00193033478042·

Navagio

FDA UDI
Kalitec Direct LLC·B07330K0132090·Trial, TLIF, 27L OB CRV 7Deg, 9mm

NIDO Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07315K0132000·Rod Reducer, Axial, NIDO

BETSEY JOHNSON

FDA UDI
FGX INTERNATIONAL INC.·00193033478059·

Navagio

FDA UDI
Kalitec Direct LLC·B07330K0132100·Trial, TLIF, 27L OB CRV 7Deg, 10mm

RAPIDIA

FDA 510(k)
FDA Class 2 ·Radiology

PROGNOST ES, MODEL 0302 0000

FDA 510(k)
FDA Class 2 ·Radiology

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 20, 2013

CONTINUUM HB RIM IMPACTOR

FDA Adverse Event
Malfunction ·ZIMMER, INC.·Product code HWA·March 8, 2011

HELICAL BLADE COUPLING SCREW

FDA Adverse Event
Malfunction ·SYNTHES BRANDYWINE·Product code HWC·March 14, 2008

BD PHOENIX¿ NMIC-306

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 20, 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